[House Hearing, 109 Congress]
[From the U.S. Government Printing Office]


 
                    PROTECTIONS FOR FOSTER CHILDREN
                      ENROLLED IN CLINICAL TRIALS

=======================================================================

                                HEARING

                               before the

                    SUBCOMMITTEE ON HUMAN RESOURCES

                                 of the

                      COMMITTEE ON WAYS AND MEANS
                     U.S. HOUSE OF REPRESENTATIVES

                       ONE HUNDRED NINTH CONGRESS

                             FIRST SESSION

                               __________

                              MAY 18, 2005

                               __________

                            Serial No. 109-8

                               __________

         Printed for the use of the Committee on Ways and Means

                     U.S. GOVERNMENT PRINTING OFFICE

36-660 PDF                 WASHINGTON DC:  2007
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                      COMMITTEE ON WAYS AND MEANS

                   BILL THOMAS, California, Chairman

E. CLAY SHAW, JR., Florida           CHARLES B. RANGEL, New York
NANCY L. JOHNSON, Connecticut        FORTNEY PETE STARK, California
WALLY HERGER, California             SANDER M. LEVIN, Michigan
JIM MCCRERY, Louisiana               BENJAMIN L. CARDIN, Maryland
DAVE CAMP, Michigan                  JIM MCDERMOTT, Washington
JIM RAMSTAD, Minnesota               JOHN LEWIS, Georgia
JIM NUSSLE, Iowa                     RICHARD E. NEAL, Massachusetts
SAM JOHNSON, Texas                   MICHAEL R. MCNULTY, New York
PHIL ENGLISH, Pennsylvania           WILLIAM J. JEFFERSON, Louisiana
J.D. HAYWORTH, Arizona               JOHN S. TANNER, Tennessee
JERRY WELLER, Illinois               XAVIER BECERRA, California
KENNY C. HULSHOF, Missouri           LLOYD DOGGETT, Texas
RON LEWIS, Kentucky                  EARL POMEROY, North Dakota
MARK FOLEY, Florida                  STEPHANIE TUBBS JONES, Ohio
KEVIN BRADY, Texas                   MIKE THOMPSON, California
THOMAS M. REYNOLDS, New York         JOHN B. LARSON, Connecticut
PAUL RYAN, Wisconsin                 RAHM EMANUEL, Illinois
ERIC CANTOR, Virginia
JOHN LINDER, Georgia
BOB BEAUPREZ, Colorado
MELISSA A. HART, Pennsylvania
CHRIS CHOCOLA, Indiana
DEVIN NUNES, California

                    Allison H. Giles, Chief of Staff

                  Janice Mays, Minority Chief Counsel

                                 ______

                    SUBCOMMITTEE ON HUMAN RESOURCES

                   WALLY HERGER, California, Chairman

NANCY L. JOHNSON, Connecticut        JIM MCDERMOTT, Washington
BOB BEAUPREZ, Colorado               BENJAMIN L. CARDIN, Maryland
MELISSA A. HART, Pennsylvania        FORTNEY PETE STARK, California
CHRIS CHOCOLA, Indiana               XAVIER BECERRA, California
JIM MCCRERY, Louisiana               RAHM EMANUEL, Illinois
DAVE CAMP, Michigan
PHIL ENGLISH, Pennsylvania

Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public 
hearing records of the Committee on Ways and Means are also published 
in electronic form. The printed hearing record remains the official 
version. Because electronic submissions are used to prepare both 
printed and electronic versions of the hearing record, the process of 
converting between various electronic formats may introduce 
unintentional errors or omissions. Such occurrences are inherent in the 
current publication process and should diminish as the process is 
further refined.










                            C O N T E N T S

                               __________

                                                                   Page

Advisory of May 11, 2005, announcing the hearing.................     2

                               WITNESSES

U.S. Department of Health and Human Services, Hon. Donald Young, 
  M.D., Principal Deputy Assistant Secretary for Planning and 
  Evaluation.....................................................     7

                                 ______

The New York Academy of Medicine, Alan Fleischman................    27
Wisconsin Department of Health and Family Services, Roberta 
  Harris.........................................................    31
Association for the Accreditation of Human Research Protection 
  Programs, Inc., Marjorie Speers................................    36
American Academy of Pediatrics, Moira Szilagyi...................    38

                       SUBMISSIONS FOR THE RECORD

Ablechild.org, New Canaan, CT, Sheila Matthews and Gloria M. 
  Wright, statement and attachment...............................    50
Alliance for Human Research Protection, New York, NY, Vera 
  Hassner Sharav and John H. Noble, Jr., Ph.D., statement........    52
American Family Rights Association, Morongo Valley, CA, Cheri 
  Carlene Campbell, statement....................................    55
Asplund, Linn, Waterbury, CT, statement..........................    57
Child Welfare League of America, Alexandra Yoffie, statement.....    58
Jacobi Medical Center, Bronx, NY, Andrew Wiznia, letter..........    58
Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 
  Alfred Sommer, M.D., letter....................................    60
National Institute of Allergy and Infectious Diseases, Division 
  of Aids, Office for Policy in Clinical Research Operations, 
  Potomac, MD, Jonathan M. Fishbein, M.D., letter................    61
New York City Administration for Children's Services, New York, 
  NY, John Mattingly, statement..................................    63
Pediatric Aids Clinical Trials Group, University of California, 
  San Diego, La Jolla, CA, Stephen A. Spector, M.D., statement...    67
Sabato, Patricia, Sandy Hook, CT, statement......................    68
Schuldt, Sharon, Rockford, IL, letter............................    69
William Glasser, Inc., Chatsworth, CA, William Glasser, M.D., 
  letter.........................................................    71


                    PROTECTIONS FOR FOSTER CHILDREN


                      ENROLLED IN CLINICAL TRIALS

                              ----------                              


                        WEDNESDAY, MAY 18, 2005

             U.S. House of Representatives,
                       Committee on Ways and Means,
                           Subcommittee on Human Resources,
                                                    Washington, DC.

    The Subcommittee met, pursuant to notice, at 2:09 p.m., in 
room B-318, Rayburn House Office Building, Hon. Wally Herger 
(Chairman of the Subcommittee) presiding.
    [The advisory announcing the hearing follows:]

ADVISORY

FROM THE 
COMMITTEE
 ON WAYS 
AND 
MEANS

                    SUBCOMMITTEE ON HUMAN RESOURCES

                                                CONTACT: (202) 225-1025
FOR IMMEDIATE RELEASE
May 11, 2005
No. HR-2

              Herger Announces Hearing on Protections for

              Foster Children Enrolled in Clinical Trials

    Congressman Wally Herger (R-CA), Chairman, Subcommittee on Human 
Resources of the Committee on Ways and Means, today announced that the 
Subcommittee will hold a hearing on protections for foster children 
enrolled in clinical trials. The hearing will take place on Wednesday, 
May 18, 2005, in room B-318 Rayburn House Office Building, beginning at 
2:00 p.m.
      
    In view of the limited time available to hear witnesses, oral 
testimony at this hearing will be from invited witnesses only. Invited 
witnesses will include experts familiar with issues related to the 
enrollment of foster children in clinical trials. However, any 
individual or organization not scheduled for an oral appearance may 
submit a written statement for consideration by the Subcommittee for 
inclusion in the printed record of the hearing.
      

BACKGROUND:

      
    Recent media reports raised concerns regarding protections in place 
prior to the enrollment of foster children in clinical drug trials. 
These included allegations that in some cases foster children may have 
been enrolled in studies without the benefit of certain protections, 
such as the appointment of an independent advocate for the child. At 
the same time, individuals familiar with these studies contend that the 
enrollment of foster children enhanced their health by offering the 
best medical treatment available and that independent advocates were 
not necessary in all cases.
      
    For children who may not safely remain with their families, foster 
care is a temporary setting in which foster parents, social workers, 
and court personnel work to protect the child's best interests in lieu 
of their biological parents. Federal policy has been enacted, most 
recently with the Adoption and Safe Families Act of 1997 (P.L. 105-89), 
to ensure that the safety of foster children is paramount in any 
decision made on the child's behalf. This hearing will examine (1) 
policy issues surrounding the enrollment of foster children in clinical 
trials, and (2) whether adequate protections are in place to ensure the 
safety and well-being of foster children in such trials.
      
    In announcing the hearing, Chairman Wally Herger said: ``This 
hearing will explore issues surrounding the placement of foster 
children in clinical drug trials, including under what conditions 
participation is permitted. We are concerned about recent allegations 
involving the enrollment of foster children in such trials. This 
hearing will help us assess whether there is any substance to these 
allegations and if so, what response is appropriate.''
      

FOCUS OF THE HEARING:

      
    The focus of the hearing is on protections for foster children 
enrolled in clinical trials.
      

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FORMATTING REQUIREMENTS:

      
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noted above.

                                 

    Chairman HERGER. Good afternoon, and welcome to today's 
hearing. To begin the hearing today, I would like to make note 
that we have a new Member on the Subcommittee, Mr. Devin Nunes 
of California. Welcome, Devin. We look forward to working with 
you on the many important issues within the Subcommittee's 
jurisdiction.
    At today's hearing, the Subcommittee will examine an 
extraordinarily sensitive topic, the enrollment of children in 
foster care in clinical drug trials involving experimental but 
potentially lifesaving drugs. Children in foster care have been 
separated from their biological parents and placed in a 
temporary setting which can last for years or, in some cases, 
their entire childhood. Many of these children have special 
medical needs, including life-threatening illnesses like 
Acquired Immunodeficiency Syndrome (AIDS). Thousands of foster 
children in the late 1980s and early 1990s were afflicted by 
AIDS. Treatments for children had not yet been found or tested. 
For some of these children, clinical trials were seen as a 
promising and possibly only way to save, lengthen or improve 
these young lives. When biological parents could not be found 
or were incapacitated due to addiction or illness, social 
workers, court personnel and others involved in the children's 
care had to make life-and-death decisions about whether foster 
children should be placed in clinical trials. Those trials 
involved both hope and risk. Concerns have been raised about 
the right balance between hope and risk, and who gets to make 
that critical decision.
    Recent news stories report that States have a variety of 
policies for when children in foster care may or may not 
participate in clinical trials. Even though there are Federal 
guidelines, there is no consistent policy across States. These 
reports also suggest that, in some cases, protections were 
either not enforced or were inadequate. These are serious 
allegations. That is why it is important that we closely 
examine the facts. It seems to me there are three main 
questions involved in today's hearings. First, should children 
in foster care be involved in clinical trials? Second, if 
foster children are permitted to participate in clinical 
trials, what are the protections now in place to ensure their 
safety? Third, are those protections adequate? Some States have 
adopted the policy that children in foster care simply cannot 
participate in clinical trials, as we will hear described 
shortly. Other States permit participation, but only based on 
the decision of a judge or following the naming of an 
independent advocate to monitor the foster child's best 
interest. Still other States rely on the foster care system and 
its caseworkers, medical experts and foster parents to make 
these decisions. In some cases, these decisions are made after 
trying to consult the child's biological parents.
    As I mentioned earlier, our purpose today is to understand 
these various measures, all of which are designed to protect 
children in foster care to determine whether those protections 
are adequate and appropriate. In other words, how do we balance 
risk and hope? Given the lack of available information on this 
topic, I have asked the U.S. Department of Health and Human 
Services (HHS) to survey the 50 States about the specific 
policies and protections they have in place regarding the 
enrollment of foster children in clinical trials. I look 
forward to the results of that survey.
    We welcome all our witnesses today to explore these issues. 
I note there are no Democrat or Republican witnesses here 
today. I appreciate the cooperation of Mr. McDermott and his 
staff in selecting the witnesses appearing before us. Joining 
us are experts on topics ranging from Federal protections for 
children enrolled in clinical studies to individuals familiar 
with State policies regarding foster child enrollment. I would 
also note that we have written background information and 
written testimony from a variety of sources who could not join 
us today, including the child protection agencies of New York 
City and the State of Illinois. The official record of this 
hearing will remain open for 2 weeks should others wish to 
offer their input for this Subcommittee's consideration.
    We look forward to today's testimony and our witnesses' 
help in answering our many questions and helping us decide how 
best to proceed. Without objection, each Member will have the 
opportunity to submit a written statement and have it included 
in the record at this point. Mr. McDermott, would you care to 
make a statement?
    [The prepared statement of Chairman Herger follows:]
   Opening Statement of The Honorable Wally Herger, Chairman, and a 
        Representative in Congress from the State of California
    Today the Subcommittee will examine an extraordinarily sensitive 
topic--the enrollment of children in foster care in clinical drug 
trials involving experimental, but potentially life-saving drugs.
    Children in foster care have been separated from their biological 
parents and placed in a temporary setting which can last for years or, 
in some cases, their entire childhood. Many of these children have 
special medical needs, including life-threatening illnesses like AIDS.
    AIDS afflicted thousands of foster children in the late 1980s and 
early 1990s Treatments for children had not yet been found or tested. 
For some of these children, clinical trials were seen as a promising, 
and possibly only, way to save, lengthen or improve these young lives.
    When biological parents could not be found or were incapacitated 
due to addiction or illness, social workers, court personnel and others 
involved in the children's care had to make life and death decisions 
about whether foster children should be placed in clinical trials.
    Those trials involved both hope and risk. Concerns have been raised 
about the right balance between hope and risk, and who gets to make 
that critical decision.
    Recent news stories report that states have a variety of policies 
for when children in foster care may or may not participate in clinical 
trials. Even though there are federal guidelines, there is no 
consistent policy across States.
    These reports also suggest that in some cases, protections were 
either not enforced or were inadequate. These are serious allegations. 
That is why it is important that we closely examine the facts.
    It seems to me there are three main questions involved in today's 
hearing:

      First, should children in foster care be involved in 
clinical trials?
      Second, if foster children are permitted to participate 
in clinical trials, what are the protections now in place to ensure 
their safety?
      And third, are those protections adequate?

    Some states have adopted the policy that children in foster care 
simply cannot participate in clinical trials, as we will hear described 
shortly.
    Others states permit participation, but only based on the decision 
of a judge, or following the naming of an independent advocate to 
monitor the foster child's best interests.
    Still other states rely on the foster care system and its 
caseworkers, medical experts, and foster parents to make decisions 
about whether foster children may be included in clinical trials, in 
some cases after trying to consult the child's biological parents.
    As I mentioned earlier, our purpose today is to understand these 
various measures, all of which are designed to protect children in 
foster care, to determine whether those protections are adequate and 
appropriate.
    In other words, how do we balance risk and hope.
    Given the lack of available information on this topic, I have asked 
the Department of Health and Human Services to survey states about the 
specific policies and protections they have in place regarding the 
enrollment of foster children in clinical trials. I look forward to the 
results of that survey.
    We welcome all our witnesses today to explore these issues. Joining 
us are experts on topics ranging from federal protections for children 
enrolled in clinical studies to state policies regarding foster child 
enrollment.
    I would also note that we have received background information and 
written testimony from a variety of sources who could not join us 
today, including the child protection agencies of New York City and the 
State of Illinois.
    And the official record of this hearing will remain open for two 
weeks should others wish to offer their input for the Subcommittee's 
consideration.
    We look forward to today's testimony, and our witnesses' help in 
answering our many questions and helping us decide how best to proceed.

                                 

    Mr. MCDERMOTT. Surely. Thank you, Mr. Chairman. First of 
all, I want to thank the Chairman for having this hearing. I 
think it is an important issue and one that requires us to be 
thoughtful. Sometimes issues like this can be sort of 
explosive, but I think this is an issue to be thoughtful about 
because I am sure many were shocked when they read the recent 
press accounts of foster kids being involved in clinical trials 
without adequate protection. As a physician, I know the role 
medicine plays in saving and improving lives every day. I have 
been involved in the AIDS epidemic beginning when I was with 
the State Department in 1987, so I have seen the evolution of 
the Department. Many of these cases we are talking about here 
were late eighties cases, early nineties cases. I think we have 
to put things in perspective of the real crash feeling there 
was in those days about getting some treatment and figuring out 
what we could do for a variety of people in this situation.
    However, we learned through top-notch investigative 
reporting by the AP that children in the child welfare system 
had participated in scientific experiments used to determine 
the effectiveness of AIDS medication, and that participating, 
in my view, is not necessarily bad. I want to say that right up 
front, because trials are scientific paths to new and more 
effective treatments. I think what is true, however, is we must 
be assured that the system defends the best interests of the 
children involved in these studies. They are alone. They have 
been taken away from their parents. They are without an 
advocate. They are vulnerable, and they could be taken 
advantage of by the system if it fails them.
    Over the last 18 months, this Subcommittee has heard 
hearings about a number of issues affecting kids in the 
Federal, State child welfare programs, and this issue is like 
many of them: It is has the potential for being explosive. The 
child welfare program in the richest, most powerful country in 
the world is and has been often an abysmal failure. Now, we 
don't need proof of more of that. We can give you all kinds of 
examples of it. We know about kids losing their lives in the 
child welfare system. Practically every State legislature every 
year deals with one case or another, and everybody wrings their 
hands, and the problems go on. The kids are sometimes locked 
up. Sometimes starved under the supervision of the agencies. We 
know the children have been used without proper supervision for 
drug testing.
    Now, the question the public has to ask us and I think we 
have to ask ourselves on this Subcommittee is, how do we give 
that proper supervision? When are we going to reform the child 
welfare system so that we protect these vulnerable kids and 
provide them with the opportunity to succeed? They have enough 
strikes against them going in because they are in the foster 
system, and the question really is, what can we do not to make 
it worse for them but to make it better?
    We have a group of distinguished witnesses here today, and 
I for one expect them to give us ideas about how we can improve 
the system for children. The Subcommittee put out a press 
release announcing today's hearing. Now, press releases are one 
part of the political process, but our challenge and really 
what the public should demand of us is a bipartisan 
Subcommittee action. I really think, Mr. Chairman, we need to 
act to improve the welfare of children that do not have a 
stable and safe family. We really need reform on a variety of 
things, but it takes courage and leadership and new resources, 
but it needs to be done. It is not an easy job. I dealt with 
these issues when I was in the State legislature, and they are 
no less contentious now up here than they were down there. Our 
Nation's children need us. They need what we put together in a 
child welfare program that lifts them up rather than puts them 
down or lets them down. I for one am grateful for you for 
having this hearing, and I hope that we can come out of it with 
some things that we can then put into law and actually do 
something. We have talked a lot and listened a lot, but it is 
time for us to do something. Thank you, Mr. Chairman.
    Chairman HERGER. Thank you, Mr. McDermott. Before we move 
on to our testimony, I want to remind our witnesses to limit 
their oral statement to 5 minutes. However, without objection, 
all the written testimony will be made a part of the permanent 
record. To start our hearing this afternoon, we will hear from 
the Honorable Donald Young, M.D., who is the acting principal 
deputy assistant secretary for planning and evaluation at HHS. 
Dr. Young, please proceed with your testimony.

   STATEMENT OF DONALD YOUNG, M.D., ACTING PRINCIPAL DEPUTY 
     ASSISTANT SECRETARY FOR PLANNING AND EVALUATION, U.S. 
            DEPARTMENT OF HEALTH AND HUMAN SERVICES

    Dr. YOUNG. Mr. Chairman, distinguished Members of the 
Subcommittee, thank you for inviting me here today to discuss 
Federal protections for foster children enrolled in clinical 
trials. I am Dr. Donald Young, deputy assistant secretary for 
planning and evaluation in HHS. The President and Secretary 
Leavitt have as a first principle the protection of the most 
vulnerable in our population. Foster children are certainly 
vulnerable, and failing to protect them will not be tolerated.
    Dramatic advances in prevention and treatment of disease 
have been achieved through research. A crucial part of these 
medical advances involves participation of human subjects, 
including children, in clinical trials. The Department of 
Health and Human Services is deeply committed to ensuring the 
protection of the rights and welfare of every individual who 
participates in clinical research. This afternoon, I will 
discuss the evolution of the Human Immunodeficiency Virus 
(HIV)/AIDS, the management of the disease, pediatric AIDS and 
foster care, and the Federal protections in place to ensure the 
safety of human subjects, including children, and children who 
are wards.
    In 1990, as many as 2,000 babies were born infected with 
HIV. Now that number has been reduced to a bit more than 200 a 
year in the United States.. HIV has evolved from a disease that 
kills to a disease that is chronic and manageable. Clinical 
research including research in children is necessary to make 
advances in medicine. Clinical research involves risks, 
however, and it is the responsibility of the medical research 
community to ensure that all trial participants fully 
understand both the potential benefits and the potential risks 
of their participation.
    It is estimated that, through 1989, between 16 and 22 
percent of pediatric AIDS patients were children in foster 
care. Many of these children were placed in foster care because 
the caretaker parent had died or become incapacitated by AIDS, 
or because of neglect, abuse, or abandonment associated with 
parental drug abuse. The fact that fewer than 2 percent of 
foster children diagnosed as HIV-positive in 1989 were 
participating in clinical trials was viewed as evidence that 
the foster care system had failed to completely and effectively 
cope with the influx of HIV-infected children.
    At the time, most State laws allowed only for standard 
medical treatment for children in foster care; because there 
were no standard treatments for HIV-infected children, this 
limitation represented a critical barrier to medical care for 
children with HIV. Federal regulations are in place to provide 
protections for human subjects, including children and foster 
children, involved in HHS conducted, supported or regulated 
research. Ultimately, however, it is the State and in some 
cases county foster care agencies that decide who provides 
permission for these children to be enrolled in clinical 
trials. Institutional review boards (IRB)--working with 
researchers establish within Federal guidelines what procedures 
should be followed to acquire consent in specific study 
protocols. The HHS and Food and Drug Administration (FDA) 
regulations also contain a number of other requirements 
relating to IRB membership and procedures, criteria for IRB 
approval of research, suspension or termination of IRB approval 
research and general requirements for informed consent.
    The regulations permit IRBs to approve three categories of 
research or clinical investigation involving children as 
research subjects. A fourth category requires an additional 
level of review. First, research or clinical investigations not 
involving greater than minimal risk to the children: There, the 
IRB must determine that the research or clinical investigation 
presents no greater than minimal risk to the children. Second, 
research or clinical investigation involving greater than 
minimal risk but preserving the prospect of direct benefit to 
the individual child subjects: Here, the IRB must determine the 
risk is justified by the anticipated benefits to the subjects, 
the relation of the anticipated benefit to the risk presented 
by the study is at least as favorable to the subjects as that 
provided by alternative available approaches.
    In each of the next two categories, HHS and FDA regulations 
include a provision that provides additional protections for 
children who are wards of the State or any other agency, 
institution, or entity. First, research or clinical 
investigations involving greater than minimal risk and no 
prospect for direct benefit to the individual child subjects 
but likely to yield generalizeable knowledge about the 
subject's disorder or condition: The IRB must determine the 
risk of the research or clinical investigation represents a 
minor increase over minimal risk; the intervention or procedure 
presents experiences to the child subjects that are reasonably 
commensurate with those inherent in their actual or expected 
medical, dental, psychological, social or educational 
situations; the intervention or procedure is likely to yield 
generalizeable knowledge about the subject's disorder or 
condition which is of vital importance for the understanding or 
amelioration of the disorder or condition. Second, research or 
clinical investigation that the IRB believes does not meet the 
above categories of the HHS or FDA regulations but finds that 
the research presents a reasonable opportunity to further the 
understanding, prevention or alleviation of a serious problem 
affecting the health or welfare of children requires a specific 
level of HHS review beyond that provided by the IRB.
    In all cases, the IRB must ensure that adequate provisions 
have been made for soliciting permission of parents or legal 
guardians and the assent of the children to the extent required 
by HHS and FDA regulations. Before children who are wards of 
the State or any other agency, institution or entity can be 
included in either of the last two categories of research or 
clinical investigations, the research must meet the following 
conditions: The research must either be related to the 
children's status as wards or conducted in schools, camps, 
hospitals, institutions or similar settings in which the 
majority of children involved as subjects are not wards. The 
IRB must require appointment of an advocate for each child who 
is a ward in addition to any other individual acting on behalf 
of the child as guardian.
    The Office of Human Research Protections (OHRP) and FDA 
have implemented oversight activities both to respond to 
complaints and to monitor compliance with Federal regulations. 
OHRP's compliance oversight activities can be divided into 
three major categories. First, for-cause oversight 
investigations; second, not-for-cause compliance oversight 
surveillance evaluations; and, third, review and analysis of 
institutional reports of noncompliance, unanticipated problems 
involving risks to subjects, or suspensions or terminations of 
IRB approval of research.
    FDA regulation and oversight for clinical research extend 
not only to IRBs and institutions but to clinical 
investigators, research sponsors, contract research 
organizations, laboratory facilities conducting preclinical 
research and bioequivalence firms. As you know, Mr. Chairman, 
of recent press reports there is an ongoing investigation, and 
I will not be able to answer any questions related to the 
investigation.
    In conclusion, we continue to address challenges posed by 
the threat of HIV/AIDS and are committed to basic and clinical 
research to strengthen the Nation's ability to cope with this 
infectious disease. The protection of human subjects, including 
children, in clinical trials has been and will remain a top 
priority for HHS. HHS is firmly committed to the protection of 
the rights and welfare of every individual who participates in 
human research, consistent with sound ethical standards and 
regulatory requirements. I will be happy to answer any 
questions.
    [The prepared statement of Dr. Young follows:]
    Statement of The Honorable Donald Young, M.D., Principal Deputy 
  Assistant Secretary for Planning and Evaluation, U.S. Department of 
                       Health and Human Services
    Mr. Chairman and Distinguished Members of the Subcommittee, thank 
you for inviting me here today to discuss federal protections of foster 
children enrolled in clinical trials. I am Dr. Donald Young, the Deputy 
Assistant Secretary for Planning in Evaluation in the U.S. Department 
of Health and Human Services. The President and Secretary Leavitt have 
as a first principle the protection of the most vulnerable in our 
population. Foster children are certainly vulnerable and failing to 
protect them will not be tolerated. Dramatic advances in prevention and 
treatment of disease have been achieved through research. A crucial 
part of this research involves the participation of human subjects, 
including children, in clinical trials. Clinical trials of drugs are 
necessary in children to determine their safety and efficacy in this 
age group of patients; studies in adults may not adequately predict 
drug properties in children. Federal policy has sought to preserve the 
benefits of this research, while at the same time protecting against 
possible abuse or harm to research subjects. The Department of Health 
and Human Services is deeply committed to ensure the protection of the 
rights and welfare of every individual who participates in clinical 
research.
    To provide a better understanding of the issue, I will discuss with 
you the evolution of HIV/AIDS and the management of the disease, 
pediatric AIDS and foster care, and the federal protections in place to 
ensure the safety of human subjects, including children and children 
who are wards, in research.
Evolution in the Management of HIV/AIDS
    Since the world first became aware of AIDS in 1981, the disease has 
spread around the globe. Today, approximately 39.4 million people 
worldwide are living with HIV/AIDS. Approximately 2.2 million children 
are now living with HIV/AIDS. During the past year, approximately 
640,000 new HIV infections and 510,000 deaths occurred in children.
    Despite these sobering statistics, dramatic advances have been made 
in the management of HIV infection since HIV was first discovered over 
two decades ago. In 1990, as many as 2000 babies were born infected 
with HIV; now that number has been reduced to a bit more than 200 a 
year in the U.S. From 1985 to 1999, AIDS cases in U.S. children 
decreased 81%. From 1998 to 2002, the estimated number of children 
dying from AIDS decreased 68%.
    Much has been accomplished since the early days of the HIV/AIDS 
epidemic, including significant advances in treatment and prevention. 
HIV has evolved from a disease that kills to a disease that is chronic 
and manageable. Research has been pivotal to understanding HIV/AIDS and 
managing the disease. In the United States and other western countries, 
potent combinations of anti-HIV drugs have dramatically reduced the 
numbers of new AIDS cases and deaths due to HIV/AIDS. Today, there are 
over 20 antiretroviral medications that are approved by the Food and 
Drug Administration (FDA). As another example of the success of 
research, a pivotal National Institutes of Health (NIH)-supported study 
conducted in Uganda demonstrated that a single dose of the drug 
nevirapine given to an HIV-infected woman at the onset of labor, 
combined with a single dose for the infant just after birth, was 50 
percent more effective in preventing transmission to the baby than was 
a short course of the drug AZT. Research is now underway to determine 
if the use of nevirapine or other drugs can prevent transmission 
through breastfeeding, a major mode of mother-to-infant transmission. 
Other HIV prevention strategies include development of effective 
chemical and physical barrier methods, research on the use of these 
methods among different populations, and a study of how antiretroviral 
therapy might prevent transmission by reducing how much virus a patient 
sheds in their genital track or in breast milk. However, the early 
clinical trials of these therapies were conducted only in adults. 
Pediatric formulations of these treatments were not approved for young 
children with HIV/AIDS because sufficient studies had not been 
conducted in children.
Importance of Clinical Research
    Clinical research, including research in children is necessary to 
make advances in medicine. Clinical research involves risks, however, 
and it is the responsibility of the medical research community to 
ensure that all trial participants fully understand both the potential 
benefits and the potential risks of their participation.
    As I will describe in more detail below, federal regulations 
provide specific protections for children and additional protections 
for wards of the state participating in some forms of clinical trials. 
Ultimately, however, it is the state, and in some cases county foster 
care agencies that decide how informed consent is provided for these 
children. Institutional Review Boards (IRBs) working with researchers, 
establish, within federal guidelines, what procedures should be 
followed to acquire consent in specific study protocols.
    HHS continues to believe strongly that clinical trials to test new 
treatments in children are essential and that the framework established 
by the existing regulation offers adequate protection for individuals 
participating in trials. We also recognize, however, the importance of 
continued vigilance to ensure the regulations are adhered to by 
investigators and the IRBs that oversee their activities.
Pediatric AIDS and Foster Care--An Historical Perspective
    Nearly three-quarters of the 3,000 pediatric AIDS cases recorded by 
the Centers for Disease Control and Prevention by 1991 were in children 
with at least one parent who was an intravenous drug user. Many of 
these children were placed in foster care because the caretaker parent 
had died or become incapacitated by AIDS, or because of neglect, abuse 
or abandonment associated with parental drug abuse. This was also the 
period during which ``boarder babies'' regularly made the headlines--
children abandoned in hospitals who were ready to leave but for whom 
appropriate foster care placements were unavailable. It is estimated 
that through 1989, that between 16 and 22 percent of pediatric AIDS 
patients were children in foster care. This significant overlap between 
risk factors for HIV and the need for foster care meant that pediatric 
AIDS became a particular concern for child welfare agencies in large 
cities, where most pediatric AIDS cases were concentrated.
    As pediatric AIDS became more prevalent, little was known about the 
effectiveness or proper dosages in children of drug therapies that were 
yielding good results in adults. But these treatments seemed to hold 
the promise of longer and higher quality life for many children who 
otherwise seemed doomed. State child welfare agencies were strongly 
urged to reduce barriers to foster children's participation in such 
trials. The fact that fewer than 2% of foster children diagnosed as HIV 
positive in 1989 were participating in clinical trials was viewed as 
evidence that ``the foster care system has failed to competently and 
effectively cope with the influx of HIV-infected children'' (McNutt, 
1994).
    A study published in 1990 found that only seven states had 
implemented formal policies regarding the participation of foster 
children in clinical trials, and five states had ``mechanisms'' through 
which it was possible to enroll such children in trials. Although the 
state had legal custody of the children, the permission of biological 
parents was required in four of the twelve states that had either 
``policies'' or ``mechanisms'' (Martin and Sacks, 1990). The same 
research study found that 16 percent of 432 children enrolled in 
pediatric AIDS trials at the time were in foster care (a total of 69 
children), and that nearly three times that many foster children were 
known to be eligible for those trials but could not be enrolled because 
a parent or guardian's permission could not be obtained.
    In the Omnibus Budget Reconciliation Act of 1987, (P.L. 100-203, 
section 9138), Congress required the Secretary of HHS to provide 
information about children with AIDS who had been placed in foster 
care. The report prepared in response to this congressional mandate 
found that, in 1989, the states were aware of 804 current and 979 
cumulative cases of HIV positive children in foster care nationally, 
most of them concentrated in just a few states. By that year only 6 
states had seen at least 50 cumulative cases of HIV among children in 
foster care, and 20 states had never cared for a foster child with HIV. 
At the time, most state laws allowed only for ``standard medical 
treatment'' for children in foster care. But because there were no 
standard treatments for HIV-infected children, this limitation 
represented a critical barrier to medical care for children with HIV. 
The report recommended that ``State and local child welfare agencies 
should create systems to manage the participation of children in foster 
care in special medical treatment and experimental trials'' (HHS/ASPE, 
1989, p. 60).
    Efforts in the early 1990s to increase the enrollment of foster 
children in clinical trials affected state policies that in many cases 
continue to the present. Today, child welfare agencies continue to 
differ in their policies regarding whether or under what circumstances 
children in foster care may be enrolled in clinical trials. Information 
gathered from several state foster care agencies suggests that 
authority to provide permission for other than standard medical 
treatment typically lies either with the judge supervising the foster 
care case, with a senior official within the foster care agency, or 
with a guardian ad litem. Some states continue to preclude the 
enrollment of foster children in experimental trials altogether, or 
will provide permission on behalf of the child only if the biological 
parents also give permission for the child's participation. Under the 
federal foster care program, health care decisions on behalf of 
individual foster children are left to states that are acting as 
parents with respect to children in their custody and that are 
responsible for assuring the health care needs of foster children are 
met. With respect to enrolling children in particular clinical trials, 
the procedures established for each study by the IRB and researcher, 
working within the federal human subjects regulations described below, 
would guide children's participation.
Protection of Human Subjects Regulations
    Federal Regulations are in place to provide protections for human 
subjects involved in HHS conducted, supported, or regulated research. 
Regulations exist to protect human subjects, including children and 
foster children, who participate in research.
    The HHS and FDA Protection of Human Subject Regulations are 
codified at 45 CFR part 46, and 21 CFR part 50 and 56, respectively. 
The regulations in subpart A of 45 CFR part 46 include basic 
protections for human subjects involved in both biomedical and 
behavioral research.
    In 1991, 14 other Federal departments and agencies joined HHS in 
adopting a uniform set of regulations that are identical to subpart A 
of 45 CFR part 46. This uniform set of regulations is known as the 
Federal Policy for the Protection of Human Subjects, also referred to 
as the Common Rule. FDA's Protection of Human Subjects regulations at 
21 CFR parts 50 and 56 are similar to those in the Common Rule.
    The HHS protection of human subject regulations are based in large 
part on the Belmont Report written in 1978 by the Congressionally 
created National Commission for the Protection of Human Subjects of 
Biomedical Behavioral Research. The Belmont Report identifies three 
fundamental ethical principles for all human subjects research--respect 
for persons, beneficence, and justice.
    The HHS regulations at 45 CFR part 46 apply to all non-exempt 
research involving human subjects that is conducted or supported by 
HHS. These regulations include provisions for IRB review, informed 
consent, and assurances of compliance. For example, through an 
assurance of compliance that is approved by the Department's Office for 
Human Research Protections (OHRP), an institution pledges to conduct 
its HHS-funded or supported research in accordance with the human 
subjects protections of 45 CFR part 46. An institution also may 
voluntarily extend its assurance to apply to all human subjects 
research it conducts regardless of funding source.
    In addition to assurances of compliance required by the HHS 
regulations at 45 CFR part 46, the HHS and FDA regulations also contain 
a number of other requirements for institutions engaged in HHS-
conducted, -supported, or FDA regulated research involving humans, 
including requirements relating to, for example, IRB membership and 
procedures, criteria for IRB approval of research, suspension or 
termination of IRB approval of research; and general requirements for 
informed consent.
Additional Protections for Children Involved in Research
    Children have long been recognized as a special and vulnerable 
population, and are accorded special protections in many areas, 
including research. In 1983, HHS adopted additional protections for 
children involved as subjects in research at 45 CFR part 46, subpart D, 
and in April 2001, FDA adopted similar requirements for children under 
an Interim Final Rule, 21 CFR part 50, subpart D, Additional Safeguards 
for Children in Clinical Investigations.
    When a proposed research study involves children and is supported 
or conducted by HHS funding, the research institution's IRB must take 
into consideration the special regulatory requirements that provide 
additional protections for the children who would be involved in 
research. If the proposed research involves FDA-regulated products, 
then FDA's parallel regulations would apply.
    Both the HHS' and FDA's Subpart D regulations permit IRBs to 
approve three categories of research or clinical investigations 
involving children as research subjects:

45 CFR 46.404 and 21 CFR 50.51--Research or clinical investigations not 
involving greater than minimal risk to the children. To approve a 
research study or clinical investigation in this category, the IRB must 
make the following determination:

      the research or clinical investigation presents no 
greater than minimal risk to the children.

45 CFR 46.405 and 21 CFR 50.52--Research or clinical investigations 
involving greater than minimal risk but presenting the prospect of 
direct benefit to the individual child subjects. To approve a research 
study or clinical investigation in this category, the IRB must make the 
following determinations:

      the risk is justified by the anticipated benefits to the 
subjects;
      the relation of the anticipated benefit to the risk 
presented by the study is at least as favorable to the subjects as that 
provided by available alternative approaches.

45 CFR 46.406 and 21 CFR 50.53--Research or clinical investigations 
involving greater than minimal risk and no prospect of direct benefit 
to the individual child subjects, but likely to yield generalizable 
knowledge about the subject's disorder or condition. In order to 
approve a research study or clinical investigation in this category, 
the IRB must make the following determinations:

      the risk of the research or clinical investigation 
represents a minor increase over minimal risk;
      the intervention or procedure presents experiences to the 
child subjects that are reasonably commensurate with those inherent in 
their actual, or expected medical, dental, psychological, social, or 
educational situations;
      the intervention or procedure is likely to yield 
generalizable knowledge about the subject's disorder or condition which 
is of vital importance for the understanding or amelioration of the 
disorder or condition.

    A fourth category of research or clinical investigation requires a 
special level of HHS review beyond that provided by the IRB:

45 CFR 46.407 and 21 CFR 50.54--Research or clinical investigation that 
the IRB believes does not meet the above categories of the HHS or FDA 
regulations, but finds that the research presents a reasonable 
opportunity to further the understanding, prevention, or alleviation of 
a serious problem affecting the health or welfare of children. The 
research or clinical investigation may proceed only if the following 
conditions are met:

      the IRB finds and documents that the research or clinical 
investigation presents a reasonable opportunity to further the 
understanding, prevention, or alleviation of a serious problem 
affecting the health or welfare of children; and
      the HHS Secretary and/or FDA Commissioner, after 
consultation with a panel of experts in pertinent disciplines (e.g., 
science, medicine, education, ethics, law) and following an opportunity 
for public review and comment, determines either:

            that the research in fact satisfies one or more of 
        the above categories of the HHS or FDA regulations (i.e., 45 
        CFR 46.404, 46.405, or 46.406 under the HHS regulations, and 21 
        CFR 50.51, 50.52, or 50.53 under the FDA regulations) or;
            that the following conditions are met:
            the research or clinical investigation presents a 
        reasonable opportunity to further the understanding, 
        prevention, or alleviation of a serious problem affecting the 
        health or welfare of children;
            the research or clinical investigation will be 
        conducted in accordance with sound ethical principles.

    In all cases noted above (i.e., 45 CFR 46.404, 46.405, 46.406, and 
46.407), the IRB must ensure that adequate provisions have been made 
for soliciting permission of parents or legal guardians and the assent 
of the children, to the extent required by HHS and FDA regulations.
Additional Protections for Children Who are Wards
    The HHS and FDA regulations also include a provision in subpart D 
that provides additional protections for children who are wards of the 
State or any other agency, institution, or entity. These special 
protections for wards apply to two categories of research or clinical 
investigations: (1) research or clinical investigations that involve 
greater than minimal risk and no prospect of direct benefit to the 
individual child subjects involved in the research or clinical 
investigation (research/clinical investigations approved under 45 CFR 
46.406 or 21 CFR 50.53); or (2) research or clinical investigations 
determined by the IRB not to meet the conditions of the HHS regulations 
at 45 CFR 46.404, 46.405, or 46.406, or FDA's regulations at 21 CFR 
50.51, 50.52, or 50.53, but found to present a reasonable opportunity 
to further the understanding, prevention, or alleviation of a serious 
problem affecting the health or welfare of children (research/clinical 
investigation approved under 45 CFR 46.407 or 21 CFR 50.54).
    Before children who are wards of the State or any other agency, 
institution, or entity can be included in either of the two categories 
of research or clinical investigations described above, the research 
must meet the following conditions:

      the research must be either related to the children's 
status as wards; or conducted in schools, camps, hospitals, 
institutions, or similar settings in which the majority of children 
involved as subjects are not wards;
      and the IRB must require appointment of an advocate for 
each child who is a ward, in addition to any other individual acting on 
behalf of the child as guardian or in loco parentis.

    One individual may serve as advocate for more than one child, and 
must be an individual who has the background and experience to act in, 
and agrees to act in, the best interests of the child for the duration 
of the child's participation in the research. The advocate should 
represent the individual child subject's interests throughout the 
child's participation in the research. The HHS and FDA regulations 
further require that the advocate not be associated in any way (except 
in the role as advocate or member of the IRB) with the research, the 
investigator(s), or the guardian organization.
HHS Compliance Oversight Activities
    Due to the nature of the research that is subject to the HHS and 
FDA regulations, each entity has developed its own system to respond to 
complaints and monitor compliance with its regulations. These 
activities are complementary, and the results are shared between OHRP 
(implementing the HHS regulations) and FDA.
OHRP
    OHRP's compliance oversight activities can be divided into three 
major categories: (1) for-cause compliance oversight investigations; 
(2) not-for-cause compliance oversight surveillance evaluations; and 
(3) review and analysis of institutional reports of noncompliance, 
unanticipated problems involving risks to subjects, or suspensions or 
terminations of IRB approval of research.
For-Cause Compliance Oversight Investigations
    OHRP initiates for-cause compliance oversight investigations in 
response to substantive written allegations or indications of 
noncompliance with the HHS regulations for the protection of human 
subjects. Until recently, nearly all of OHRP's compliance oversight 
activities involved for-cause compliance oversight investigations.
    Institutions engaged in human subject research that is conducted or 
supported by HHS must provide written Assurances of Compliance to HHS 
describing the means that they will employ to comply with the HHS 
Regulations. OHRP approves these Assurances on behalf of the HHS 
Secretary. An Assurance approved by OHRP commits the institution(s) and 
its personnel to full compliance with the HHS regulations. In carrying 
out its oversight responsibility, OHRP evaluates all substantive 
written allegations or indications of noncompliance with the HHS 
regulations derived from any source.
    OHRP holds accountable and depends upon institutional officials, 
committees, research investigators, and other agents of the institution 
to assure conformity with the institution's Assurance and, thus, with 
the regulations. Only through the partnership established by the 
Assurance can the shared responsibility to protect the rights and 
welfare of human subjects be discharged in accordance with Section 491 
of the Public Health Service Act.
Sequence of Events for an OHRP For-Cause Compliance Oversight 
        Investigation
    The typical sequence of events to be followed in an OHRP compliance 
oversight evaluation is as follows:
    1.  OHRP discovers or receives a substantive written allegation or 
indication of noncompliance with the HHS Regulations (45 CFR Part 46).
    2.  OHRP determines that it has jurisdiction in the matter on the 
basis of HHS support and/or an applicable Assurance of Compliance.
    3.  Upon confirmation that it has jurisdiction, OHRP initiates a 
compliance oversight investigation by writing to appropriate 
institutional officials to advise them of OHRP's investigation and to 
request that the institution investigate the matter and report back to 
OHRP by a specified date. Activities expected of the institution are 
explained in writing initially and at appropriate times during the 
course of the evaluation. Except in rare circumstances when sound 
ethics dictates the need to act immediately, OHRP takes no action 
against any institution without first affording the institution an 
opportunity to offer information which might refute indications of 
noncompliance or to develop satisfactory corrective actions if the 
allegations or indications of noncompliance are substantiated.
    4.  OHRP evaluates the institution's report and any other pertinent 
information to which it has access. OHRP may (a) request that the 
institution submit additional information in writing; (b) conduct 
telephone interviews with institutional officials, committee members, 
and/or research investigators; or (c) conduct an on-site evaluation of 
protections under the applicable Assurance of Compliance.
    5.  OHRP issues in writing a determination for each evaluation to 
appropriate institutional officials. The determination letter to the 
institution summarizes (i) findings of noncompliance with the HHS 
Regulations, if any; and/or (ii) the corrective actions proposed and/or 
implemented by the institution that appropriately address the findings 
of noncompliance. In such circumstances, any complainant(s) are 
ordinarily informed in writing of OHRP's determination upon completion 
of its investigation.
    6.  An OHRP determination letteris made accessible on the OHRP 
website http://www.hhs.gov/ohrp) once the document has been requested 
under FOIA, or ten working days after the document is issued to the 
institution, whichever occurs first.
    7.  An institution may request review by the Director of OHRP of 
determinations and findings resulting from a compliance oversight 
evaluation.
Possible Outcomes of an OHRP For-Cause Compliance Oversight 
        Investigation
    Corrective actions based on compliance oversight investigations are 
intended to remedy identified noncompliance with the HHS regulations 
and to prevent reoccurrence. Because each case is different, OHRP 
tailors its corrective actions to foster the best interests of human 
research subjects, and to the extent possible, the institution, the 
research community, and HHS. Most compliance oversight evaluations and 
resultant corrective actions are resolved at the OHRP level. In some 
instances, however, OHRP recommends actions to be taken by other HHS 
officials.
    OHRP's compliance oversight evaluations may result in one or more 
of the following outcomes:
    1.  OHRP may determine that protections under an institution's 
Assurance of Compliance are in compliance with the HHS Regulations.
    2.  OHRP may determine that protections under an institution's 
Assurance of Compliance are in compliance with the HHS Regulations but 
that recommended improvements to those protections have been 
identified.
    3.  OHRP may determine that protections under an institution's 
Assurance of Compliance are not in compliance with the HHS Regulations 
and require that an institution develop and implement corrective 
actions.
    4.  OHRP may restrict its approval of an institution's Assurance of 
Compliance. Affected research projects continue to be supported by HHS 
only if the terms of the restriction are being satisfied. Examples of 
such restrictions include, but are not limited to:
      a.  suspending the Assurance's applicability relative to some or 
all research projects until specified protections and corrective 
actions have been implemented;
      b.  requiring prior OHRP review of some or all research projects 
to be conducted under the Assurance;
      c.  requiring that some or all committee members and 
institutional officials, as well as investigators conducting research 
under the Assurance, receive appropriate human subject education; and
      d.  requiring special reporting to OHRP.
    5.  OHRP may withdraw its approval of an institution's Assurance of 
Compliance. The institution's research projects cannot be supported by 
any HHS component until an appropriate Assurance is approved by OHRP.
    6.  OHRP may recommend to appropriate HHS officials that:
      a.  an institution or an investigator be temporarily suspended or 
permanently removed from participation in specific projects, and/or
      b.  peer review groups be notified of an institution's or an 
investigator's past noncompliance prior to review of new projects.
    7.  OHRP may recommend to HHS that institutions or investigators be 
declared ineligible to participate in HHS-supported research, known as 
Debarment. Note that a suspension of eligibility for Federal funding 
may precede a Debarment. If OHRP makes this recommendation, the 
Debarment process will be initiated in accordance with the procedures 
specified at 45 CFR Part 76. Any Debarment is Government-wide, and not 
just applicable to HHS funding.
Not-for-cause Compliance Oversight Surveillance Evaluations
    In 2001 OHRP initiated a not-for-cause compliance oversight 
surveillance program. Under this program, OHRP selects institutions 
without any active for-cause compliance oversight investigations and 
conducts an assessment of their human subject protection programs. OHRP 
initiates a not-for-cause compliance oversight evaluation by writing to 
appropriate institutional officials at a selected institution to advise 
them of OHRP's evaluation and to request that the institution provide 
OHRP by a specified date with IRB records and other documents relevant 
to the institution's program for the protection of human subjects. In 
most cases, OHRP conducts a site visit following review of the 
requested documents. OHRP issues a determination in writing for each 
evaluation to appropriate institutional officials. The determination 
letter to the institution summarizes: (i) findings of noncompliance 
with the HHS regulations, if any; and/or (ii) the corrective actions 
proposed and/or implemented by the institution that appropriately 
address the findings of noncompliance. The possible outcomes of a not-
for-cause compliance oversight evaluation are the same as for a for-
cause investigation.
FDA
    FDA's compliance oversight activities dovetail with some of OHRP's 
activities described above. FDA has developed a Good Clinical Practice 
Program, which has prominently displayed the process for filing 
complaints with the Agency. This is available on FDA's website at: 
http://www.fda.gov/oc/gcp/complaints.html. Generally, complaints are 
investigated and handled by the particular Center within FDA (e.g., 
involving Drug Evaluation and Research; Devices; Biologics, etc.) 
responsible for the study, which would also be the most knowledgeable 
about the issues involved in the complaint.
FDA's Bioresearch Monitoring Program
    FDA developed its Bioresearch Monitoring Program (BIMO Program) to 
ensure the protection of the rights, safety, and welfare of human 
research subjects and the quality and integrity of data submitted to 
the agency. The BIMO Program encompasses all FDA product areas: drugs, 
biological products, medical devices, radiological products, foods, and 
veterinary products. Among other things, the BIMO Program involves site 
visits to clinical investigators, sponsors, monitors, contract research 
organizations, IRBs, nonclinical (animal) laboratories, and 
bioequivalence analytical laboratories. FDA uses Compliance Policy 
Guide Manuals (CPGM) to instruct its field personnel on the conduct of 
inspectional and investigational activities. These are available at: 
http://www.fda.gov/oc/gcp/compliance.html.
    FDA conducts IRB inspections to determine if IRBs are operating in 
compliance with current FDA regulations and if the IRBs are following 
their own written procedures. The FDA regulations pertinent to IRBs 
include 21 CFR Part 50 (Protection of Human Subjects), Part 56 
(Institutional Review Boards), Part 312 (Investigational New Drug 
Application), and Part 812 (Investigational Device Exemptions).
    FDA inspections of IRBs generally fall into one of two categories:

      Surveillance inspections--periodic, scheduled inspections 
to review the overall operations and procedures of the IRB; and
      Directed inspections--unscheduled inspections focused on 
the IRB's review of a specific clinical trial or trials. Directed 
inspections may result from a complaint, clinical investigator 
misconduct, or safety issues pertaining to a trial or site.

    During an inspection at the site of a clinical investigator, FDA 
personnel typically verify:

      who performed various aspects of the protocol (e.g., who 
verified inclusion and exclusion criteria, who obtained informed 
consent, who collected adverse event data);
      the degree of delegation of authority (e.g., how the 
clinical investigator supervised the conduct of the study);
      where specific aspects of the study were performed;
      the accuracy of the data submitted;
      how accountability for the investigational product was 
maintained;
      how the monitor communicated with the clinical 
investigator; and
      how the monitor evaluated the study's progress.

    FDA personnel also audit the study data by comparing the data filed 
with the Agency or the sponsor with all available records that support 
the data. These records may come from the doctor's office, hospital, 
nursing home, laboratories, and other sources. FDA may also examine 
patient records that predate the study to find out whether: the medical 
condition under study was in fact diagnosed; the study eligibility 
criteria were met; and the patient received a possibly-interfering 
medication before the study began. FDA personnel may also review 
records covering a reasonable period after completion of the study to 
determine if there was proper follow-up as outlined in the protocol, 
and if the clinical investigator reported all signs and symptoms 
reasonably attributable to the product's use.
    After headquarters review, one of the following types of letters is 
typically sent from the Center to the IRB or clinical investigator 
depending upon the type of inspection:

    1.  A letter that generally states that FDA observed no significant 
deviations from the regulations. This letter does not require any 
response. Note that a letter may not always be sent when FDA observes 
no significant deviations.
    2.  An informational or untitled letter that identifies deviations 
from regulations and good clinical practices. This letter may request a 
response from the recipient. If FDA requests a response, the letter 
will describe what is necessary and identify a contact person for 
questions.
    3.  A Warning Letter that identifies serious deviations from 
regulations needing prompt correction and a formal written response to 
FDA. The letter will identify an Agency contact person for questions. 
For investigator inspections, FDA may inform both the reviewing IRB and 
the study sponsor of the deficiencies and advise the sponsor if the 
clinical investigator's procedural deficiencies suggest ineffective 
monitoring by the sponsor.

    In addition to issuing these letters, FDA may take regulatory 
actions for serious deviations from the regulations. FDA may disqualify 
the IRB, institution, or clinical investigator. A disqualified clinical 
investigator is ineligible to receive investigational products. FDA may 
also place lesser administrative sanctions on the IRB.
    Under the BIMO program, FDA conducts approximately 1000 inspections 
annually of all of thevarious parties that conduct or oversee clinical 
research studies (i.e., clinical investigators, sponsors, monitors, 
contract research organizations, and IRBs). Of these inspections, about 
two-thirds are clinical investigator inspections, approximately 250-300 
are inspections of IRBs (mostly drawn from FDA's inventory of about 
1600 IRBs identified as responsible for reviewing FDA-regulated 
research), and the remainder are sponsor or monitor/contractresearch 
organization inspections. For clinical investigations of drugs alone, 
FDA conducted approximately 75 inspections of studies involving 
pediatric subjects from 2001 to 2004.
Review and Analysis of Institutional Reports
    The HHS and FDA regulations require that IRBs follow written 
procedures to ensure the prompt reporting to the IRB, appropriate 
institutional officials, and the pertinent agency head (OHRP Director 
for research conducted under an OHRP-approved assurance or FDA 
Commissioner for research involving FDA-regulated products) of the 
following incidents:

    1.  any unanticipated problems involving risks to subjects or 
others;
    2.  any serious or continuing noncompliance with this policy or the 
requirements or determinations of the IRB; and
    3.  any suspension or termination of IRB approval.

    (See 45 CFR 46.103(b)(4)(iii) for HHS-conducted or-supported 
research and 21 CFR 56.108(b) for FDA-regulated research.)
    When reviewing a report of an unanticipated problem, OHRP or FDA 
assesses mostclosely the adequacy of the actions taken by the 
institution to address the problem. Likewise, when reviewing reports of 
non-compliance or suspension or termination of IRB approval, OHRP or 
FDA assesses most closely the adequacy of the corrective actions taken 
by the institution. In particular, an assessment is made whether or not 
the corrective actions will help ensure that the incident will not 
happen again, either with the investigator or protocol in question, or 
with any other investigator or protocol. When appropriate, corrective 
actions are applied institution-wide.
Conclusion
    We continue to address challenges posed by the threat of HIV/AIDS 
and are committed to basic and clinical research to strengthen the 
nation's ability to cope with this infectious disease. The protection 
of human subjects, including children, in clinical trials has been and 
will remain a top priority for HHS. HHS is firmly committed to the 
protection of the rights and welfare of every individual who 
participates in human research consistent with sound ethical standards 
and regulatory requirements.

                                 

    Chairman HERGER. Thank you, Dr. Young. The gentleman from 
California, Mr. Nunes, to inquire.
    Mr. NUNES. Thank you, Mr. Chairman, and thank you for 
welcoming me to the Subcommittee. Welcome, Dr. Young. In 
relation to some of the news reports that have been out there 
recently, do we know whether any children in foster care today 
are participating in clinical trials? If so, do you know how 
many?
    Dr. YOUNG. I do not have that information. We know that 
across the National Institutes of Health (NIH) there are a 
number of clinical trials ongoing and children participating, 
but I do not have numbers of children in foster care that might 
be in that group.
    Mr. NUNES. Okay. Could that be something that you could 
find out? Could you submit that to the Subcommittee if you do?
    Dr. YOUNG. If we can find it through our survey 
information, I will.
    Mr. NUNES. Okay. Another question. Your testimony says that 
the State child welfare agencies were strongly urged to reduce 
barriers to foster children's participation in such trials. In 
the early days of the AIDS crisis, what were those barriers, 
and who strongly urged State officials to reduce those 
barriers?
    Dr. YOUNG. I think that the desire to reduce those came 
from across the community. In those years, as I said in my 
testimony, there was no treatment unless you were involved in a 
clinical trial. This was an emerging disease, and treatments 
were just emerging at that time, so there was wide support. The 
barriers included the State laws and requirements that I 
mentioned in my testimony that said only standard care could be 
given to individuals in foster care. That prevented them from 
being enrolled, and the feeling was that the children in foster 
care should have the same opportunity to make a decision, an 
election or to have their wards do it for them, to participate 
if they wanted to participate and get the value and advantage 
of that trial.
    Mr. NUNES. Thank you, Doctor. Thank you, Mr. Chairman.
    Chairman HERGER. Thank you. The gentleman from Washington, 
Mr. McDermott, to inquire.
    Mr. MCDERMOTT. Thank you, Dr. Young. Good testimony and I 
would like to ask you a couple questions about the structuring 
of the clinical trials. Is there anything in the NIH 
requirements that require a State to have in place an advocacy 
requirement? Or can any physician who wants to do a trial in 
whatever State send in an application and operate within the 
laws of that State and be considered acceptable to NIH? In 
other words, does NIH have a set of standards that require that 
the State must fit?
    Dr. YOUNG. The Office of Human Protection is the Federal 
agency, has a baseline set of requirements that must be adhered 
to and that the IRB must follow. That deals with, as I said in 
my testimony, the last two categories, those clinical trials 
where there is more than a minimal risk involved. Under those 
circumstances, then, an advocate needs to be appointed for 
children in foster care to make the decision and ensure that 
the child is protected and fully informed.
    Mr. MCDERMOTT. The question then comes down to these--it is 
always words. In your testimony, you said you may say that 
protection is not required if the research has minimal risk--
minimal being the operative word--or if it has the prospect of 
direct benefit. Those again being the operative words. Who 
makes those decisions as to what is minimal, what is direct 
benefit to the child? How is that determined?
    Dr. YOUNG. The Institutional Review Board has the 
responsibility to approve all research protocols that are put 
forward by investigators. Most of those institutional review 
boards are under a hospital, academic medical center or other 
place that also has the responsibility to ensure that there is 
IRB compliance to that. There is a set of Federal rules. There 
are then the requirements that the IRB must consider in making 
a decision whether to approve the research as well as any 
additional requirements that come from the institution. Beyond 
that, there are a number of States that have also passed laws 
that may--putting stronger requirements in place.
    Mr. MCDERMOTT. Could it be possible today to have a child 
brought into a clinical trial in a State where there was no 
requirement for advocacy for something--these AIDS drugs when 
we were looking back at them in 1987 and 1988 and 1989, there 
was no children's research being done. What this was about is 
really the first children's research. How did anybody decide it 
was minimal risk or that it was a direct benefit to the kids? 
How did they come up--without an advocate--it would seem to me 
like you would want to automatically have an advocate in 
something as new as that.
    Dr. YOUNG. Yes. There are two parts to your question. One 
is the advocate and the situations more than minimal risk that 
there must be an advocate. That is not to say, however, in all 
situations there isn't the State agency or a ward that is 
making decisions. Somebody has to consent to it, and it has to 
be an informed consent. It is only when the risk is more than 
minimal and the conditions that I described in my testimony 
that, in addition to that, you need a special advocate for the 
patient. Now, the second part of that are the rules and 
requirements for research to make sure that it is conducted 
properly. You need an advocate, but you need a research 
protocol that is laid out that protects the individuals in that 
trial, whether they are foster children, adults or children not 
in foster care.
    Mr. MCDERMOTT. The reason I ask those questions, I can 
envision a situation in which a child care worker who is 
dealing with AIDS cases coming out of a city hospital or 
whatever may have 30, 40 kids or 60 kids, and to expect the 
child care worker to be on top of the case, it seems to me, 
sets the ground for kids slipping through the cracks as they do 
in a variety of different ways in the system. I wonder if you--
, if you don't have minimum requirements for how many--or 
maximum requirements for how many kids a worker is responsible 
for, to expect he or she to cover 60 kids, all of whom are in 
AIDS treatment programs all over the city or whatever, it seems 
like you would want to have somebody for each kid to look after 
or at least--you can see my problem.
    Dr. YOUNG. I do, and let me try to explain it one more 
time. There is an advocate appointed for the children in foster 
care. That advocate is different under the requirements. That 
advocate is different than the State agency. That advocate 
could be part of the PRB. It could be somebody who is 
particularly interested in kids. Each advocate might have one, 
two or three kids. This is not the caseworker who is the 
advocate under those situations. The advocate is somebody in 
addition to the State foster care agency.
    Mr. MCDERMOTT. So, this is a volunteer who comes in and 
gets involved in the advocacy program in the local State agency 
and has three kids with maybe no background whatsoever in the 
specific issues.
    Dr. YOUNG. No. There are requirements also regarding the 
advocacy that are part of the PRB requirements, that the 
advocate have the knowledge and be familiar with the condition. 
It is not anyone off the street can come in and be an advocate.
    Mr. MCDERMOTT. I wasn't implying that they were just off 
the street. This is a specific, very difficult decision to put 
a kid into a treatment case., the reason I am sensitive about 
this is, we have a cancer center in Seattle. I have seen what 
happens when you are using advanced treatments in cancer and 
then people later say, well, I didn't know the risks. There is 
a whole lot of responding backward and forwards about what 
people knew. In this case, you have a kid who doesn't have a 
clue what is going on. He is being brought or she is being 
brought, put into the system, and I am wondering how you know, 
how you can guarantee that that kid has somebody who really 
understands what is going on?
    Dr. YOUNG. I understand your question. That is the issue of 
what is informed consent, and how much knowledge must you have 
to achieve informed consent? That question is directly relevant 
to all research, and particularly to research on kids, and then 
foster kids add an additional level and layer. So, there is a 
responsibility to attempt to communicate as clearly as one can, 
but as you know, in lay terms, it is sometimes difficult to 
communicate fully and yet keep a message simple that people can 
understand. That is a challenge for this kind of research. It 
is a challenge for cancer research in children, any kind of 
research that has substantial risks but substantial rewards.
    Chairman HERGER. The gentleman's time has expired. The 
gentleman from Colorado, Mr. Beauprez, to inquire.
    Mr. BEAUPREZ. I thank the Chairman, and I thank Dr. Young 
as well for his testimony and for being here with us today. I 
think the gentleman from Washington has probably already begun 
going down a path that is of most concern to the Subcommittee. 
Let me stay in that track for a minute. Doctor, as I first 
heard about this issue, I guess one of the knee-jerk reactions 
would be, well, let us just not submit foster children to 
clinical trials. That is not really where we want to go. Is it? 
I am guessing that the numbers--they are staggering numbers, 
frankly, that you shared with us of 16 to 22 percent of 
children now with HIV back in 1990 were foster care children. 
We would actually want them to have access to some of the 
state-of-the-art treatment. I am assuming that that is correct?
    Dr. YOUNG. Yes, sir, I agree with you. They should have the 
opportunity to make their--their guardians should have the 
opportunity to make the decision if they wish to participate. 
If they choose not to, that is fine. To exclude them from even 
having the opportunity to make that decision I don't believe is 
correct.
    Mr. BEAUPREZ. Unfortunately, sometimes, it is that very 
population that disproportionately is burdened with some of the 
diseases we would like to get a handle on.
    Dr. YOUNG. That was particularly true back in the late 
eighties for HIV/AIDS when clinical research, clinical trials 
was the only opportunity, the only hope for treatment.
    Mr. BEAUPREZ. The question becomes who then best make this 
decision or assist the child in making this decision and that 
is what I want to probe a little bit more with you. I contacted 
some of our folks back in Colorado who wrestle with this, and 
the idea of the child advocate seemed to make perfect sense to 
me: Let us get someone out there who has maybe even met some 
standard across some threshold on the per chance that we have 
got a foster parent--because we hear about these tragic cases 
where the foster parent was not the best choice for the child's 
well-being, and we all are traumatized by that, as the child 
who at least is traumatized. What I found out is that, in the 
opinion at least of the medical professionals back in my State, 
many, many, many times it is the foster parent on their way to 
becoming the adoptive parent because, apparently, we have a 
very high percentage of exactly that that happens, that may 
well be the person with the child's best interest at heart. It 
crosses my mind that we would not want to categorically 
preclude foster parents from the process, either. Would that be 
a fair assessment?
    Dr. YOUNG. Yes, I think that is a fair assessment. We are 
balancing a lot of different factors here. There is also the 
biologic parent and what role they should have. Some States 
allow both or even require both be appointed. Those kinds of 
decisions in many cases are best made locally by the people who 
know the State, know the procedures, know what is going on 
there. There is room for Colorado to make modifications in 
keeping with the broad set of Federal basic requirements.
    Mr. BEAUPREZ. Which gets me to, I guess, the next question 
I would raise of you. I understand that we have got Federal 
guidelines, but as you testified just moments ago to us, really 
it is up to State and local and many cases city and/or county 
officials to not only apply the rules, but in some cases, I 
suppose, adjust the rules. They have some local flexibility. Is 
there more than ought to be done at the Federal level to 
protect certainly the interests of the child? I will emphasize 
again, the interest of the child can go both ways. We certainly 
don't want them to get put into a clinical trial situation that 
we would all think was inappropriate, too great a risk, but we 
also don't want to somehow subjectively preclude them from 
having the opportunity to have access to the latest state-of-
the-art medical techniques. What should we be doing at the 
Federal level?
    Dr. YOUNG. I think your points are good ones. I think one 
of the things the Department will be doing very closely is, 
following this hearing, following what you are learning and 
hearing from the witnesses. We are not aware of any changes 
that we believe need to be made. If they are identified, we 
will be very happy to consider them and make a decision as how 
best to proceed. We share with you the concern about the 
adequate protection of foster children. At the same time, the 
opportunity to let them participate and get the advantage of 
clinical research, if that is theirs and their guardian's 
decision.
    Mr. BEAUPREZ. If there is a second left, can you comment on 
the difference between assent and consent.
    Dr. YOUNG. Consent means that you have the legal authority 
to agree to participate, in this case in research. A minor, 
generally under 18, legally cannot consent by law, but the 
minor can assent. There are requirements that the subjects need 
to assent to. That is to say, yes, I am willing to do this. 
That doesn't carry the legal weight of consent, but it says 
that the minor has agreed to participate. One is a legal 
concept; one is a concept of agreeing.
    Mr. BEAUPREZ. Thank you. Thank you, Mr. Chairman.
    Chairman HERGER. Thank you. The gentleman from California, 
Mr. Becerra, to inquire.
    Mr. BECERRA. Thank you, Mr. Chairman. Dr. Young, thank you 
for being with us and thank you for your testimony. Let me ask 
a preliminary question, because I am not real familiar with how 
this all works. How much knowledge does HHS have, first of all, 
with regard to the number of foster care children who 
participate in these different studies?
    Dr. YOUNG. We do not have good detailed information on that 
to answer that question.
    Mr. BECERRA. Let me back up even further then. We know 
there is value in some of the research and the clinical trials 
that occur, and we know that, oftentimes, we want to be able to 
help children because they have so many years of life ahead of 
them if we are able to do some good work and help them 
medically. At what point do we believe that our responsibility 
by using taxpayer dollars to help fund some of this research or 
these trials extends to ensuring that we know who those who are 
conducting the trials or the research are when they approach 
these children, especially foster children, are trying to 
protect their rights?
    Dr. YOUNG. That is where the Department's compliance 
activities come into place. As I said, we will follow up where 
we hear reports. We will do random surveys periodically. We 
will talk to the State agencies, but that then becomes an issue 
of Federal checking, investigation, if you would, of compliance 
to identify problems and to correct those problems.
    Mr. BECERRA. Now, how large is your Office of Human 
Research Protection?
    Dr. YOUNG. I am sorry. I will have to submit that for the 
record. I do not know that.
    Mr. BECERRA. Any idea? How many folks do you have to 
investigate?
    Dr. YOUNG. I am not in the Office of Human Protection and 
Research. I am in HHS assistant secretary for planning and 
evaluation. I just don't have that information.
    Mr. BECERRA. Do you have anybody here with you who might be 
able to answer that question?
    Dr. YOUNG. I don't believe so.
    Mr. BECERRA. Well, give me your sense from what you know of 
how much--how much in resources do we have to try to provide 
some surveillance, some oversight to ensure that, in the first 
instance, those who are using Federal tax dollars to conduct 
their research or these clinical trials are at least trying to 
follow Federal law? Certainly, there must be State law that is 
implicated because the State has custody of these foster care 
children. Do you have any sense of what kind of resources we 
spend?
    Dr. YOUNG. I am sorry, sir, I just don't. As I say, that is 
not an issue that I looked at in preparation for this hearing.
    Mr. BECERRA. Mr. Chairman, perhaps what we could do is ask 
Dr. Young to see if HHS could get back to us with some 
information.
    Dr. YOUNG. I would be happy to.
    Mr. BECERRA. To get a better sense, because I suspect one 
of the problems we have is you all just don't have the 
resources to try to be more vigilant about how these clinical 
trials or this research is being conducted. So, the first thing 
is, we have to get a handle on whether or not folks are 
following through and at least abiding by their commitments 
when they obtain Federal funding to follow Federal law. I 
suspect that the State probably would respond the same way and 
all the different States would respond the same way, saying 
they probably don't have enough money to probably do some 
oversight over their wards, the children that are within their 
custody through the foster care system. Let me ask. In terms of 
the type of oversight that you might think would be helpful--
because we can't have someone overseeing every clinical trial 
or every bit of research that we fund. Is there some guidance 
you can give us on what we should be looking to see HHS do when 
it comes to protecting the interest of that child as we try to 
promote their well-being?
    Dr. YOUNG. First, let me remind you again that the first 
level of oversight is at the local institution, and there is 
substantial oversight at that level; that these research 
protocols are on patients who have physicians taking care of 
them, who may or may not be involved in the research, who 
provide oversight. The Institutional Review Board will provide 
oversight.
    Mr. BECERRA. Dr. Young, how do we ensure that that first 
instance of oversight is occurring? We are giving Federal tax 
dollars. Most of the research will be done locally in a 
particular State. States have obligation to take care of these 
wards, the wards of the State or kids who are in foster care. 
How do we ensure that, when we release those Federal dollars, 
that in fact, at that local level, that oversight will occur? 
While locally there is more control and responsibility for the 
child, I think all of us would still believe that we should not 
relinquish whatever rights we have to ensure that that child is 
taken care of or handled properly.
    Dr. YOUNG. I absolutely agree with you. There is the level 
that is local at the physician, the physician caring for the 
patient. There is the Institutional Review Board. There is the 
institution, that may be a hospital, in which the Institutional 
Review Board is housed. There are the State agencies on foster 
care, and then there is the Federal rules on compliance and on 
investigations that flow from that compliance. We will get back 
to you with the information you asked in terms of the size of 
the agency budget, and so forth.
    Mr. BECERRA. Mr. Chairman, may I ask one last question, 
quick question?
    Chairman HERGER. The gentleman's time has expired.
    Mr. BECERRA. Fifteen seconds.
    Chairman HERGER. One other quick question.
    Mr. BECERRA. Just a quick comment. Then maybe what we can 
do is, if you can tell us if there are any consequences for 
those who we have found to not be following Federal regulations 
or even State law in the--as they use these Federal tax dollars 
to do their research or trials, clinical trials, to see how we 
can try to get to those who aren't following through with their 
own responsibility.
    Dr. YOUNG. A very quick answer. Yes, there are ways to do 
that. The FDA regulations in fact lay out, specifically, 
sanctions that can be brought toward those who do not follow 
the rules.
    Mr. BECERRA. Thank you. Thank you, Mr. Chairman.
    Chairman HERGER. Thank you. The gentleman from Michigan, 
Mr. Camp, to inquire.
    Mr. CAMP. Well, thank you, Mr. Chairman. I want to follow 
up on that compliance line of questioning that Congressman 
Becerra brought up. I realize you can't talk about ongoing HHS 
investigations, but can you tell us about any previous findings 
of noncompliance with HHS regulations involving children in 
foster care and their participation in clinical trials?
    Dr. YOUNG. I cannot. I simply don't have that information 
as to the past history of any investigations and the outcome of 
those.
    Mr. CAMP. What happens if an institution is found to be out 
of compliance in such cases? Are you aware of that?
    Dr. YOUNG. Yes. Individuals cannot be allowed to 
participate in research if the findings are egregious enough 
from the research side. Or the Institutional Review Board will 
be asked to restructure and to change its membership to get a 
better mix of membership that is more appropriate to dealing 
with the problems so that there are a number of ways that there 
can be changes made if there are deficiencies going on. The 
ultimate is, of course, not funding the research.
    Mr. CAMP. Has that actually happened? Have institutions 
been suspended from receiving Federal funding or declared 
ineligible to participate?
    Dr. YOUNG. As I said a moment ago, I simply don't know the 
answer to that question.
    Mr. CAMP. All right, so we don't know what institutions. 
For what reasons?
    Dr. YOUNG. There may be some information on that that I 
simply don't have.
    Mr. CAMP. All right, to Congressman Nunes, I believe your 
response was that you don't have any knowledge of the number of 
children in foster care in clinical trials.
    Dr. YOUNG. That is correct.
    Mr. CAMP. Are you making attempts to find that out? Is 
there a process in place to determine that? Or is that not 
something you are pursuing?
    Dr. YOUNG. The Chairman mentioned the survey that is 
ongoing, and I will have to look in more detail to see what the 
content of that survey will be.
    Mr. CAMP. All right. Do we have any idea of whether there 
are any States that require independent advocates for children 
to be--any foster children who might be participating in the 
clinical trials?
    Dr. YOUNG. The anecdotal reports, including those in the 
press, suggested that there are some States. I do not have any 
primary knowledge on that question one way or the other.
    Mr. CAMP. Federal regulations require advocates under 
certain circumstances, do you know how many persons have served 
as advocates for children in clinical trials? Do you know of 
any number.
    Dr. YOUNG. I do not have information on that.
    Mr. CAMP. I guess what I am trying to get at is, how do we 
know about the nature of the trials, the relative risk and 
benefit for children without that information?
    Dr. YOUNG. We are depending primarily, again, at the local 
level, on the Institutional Review Boards, the institutions, 
and the oversight that is provided there. We in turn then at 
the Federal level will do the investigations as currently being 
reported in the press and the compliance activities. There is a 
lot of reliance on what is happening locally, the medical and 
research community at the local level.
    Mr. CAMP. The Institutional Review Boards are charged with 
determining how and under what conditions children may 
participate in those trials. To what extent does that 
information get back to HHS?
    Dr. YOUNG. We don't routinely collect information from the 
IRBs. We have the broad set of rules, and we will check 
compliance overall, but we will not collect information.
    Mr. CAMP. All right. Thank you, Mr. Chairman.
    Chairman HERGER. Thank you. Dr. Young, there were several 
questions that Mr. Camp inquired of and I believe another 
Member. So, would you mind responding in writing to the 
Subcommittee on that? Our record will be open for 2 weeks.
    Dr. YOUNG. Yes.
    Chairman HERGER. Thank you. The gentleman from California, 
Mr. Stark, to inquire.
    Mr. STARK. Dr. Young, I am sorry I missed your testimony, 
but we did have a chance to review it. I want to go back to 
this, as I just heard in the few minutes that you have been 
responding to questions, that you feel that having an 
independent advocate for each foster child is taken care of 
locally, but in the Federal regulations, the rules state, for 
example, that in experiments involving prisoners, the IRB has 
to include a prisoner advocate to protect the rights of 
prisoners. Why shouldn't children get that same protection?
    Dr. YOUNG. The same rules apply to children as to----
    Mr. STARK. No.
    Dr. YOUNG. Well, just a moment. As to prisoners, there, the 
rules are that, where there is a frequent IRB interaction, if 
there is one prison study and a lot of others that are not, the 
IRB does not have to. They are encouraged to have people who 
understand and know the situation, whether it is children or 
prisoners, but they do not have to have a prisoner if there is 
a single research protocol that has gone forward through the 
IRB.
    Mr. STARK. Well, I am not at all sure that you and the 
inspector of the GAO agree, but let us come back. I am going to 
stick with my assertion from the CRS that the Federal 
regulations in fact do require that the IRB has to include a 
prisoner advocate if there is in fact a prisoner involved in 
the study. Now, we can find that out subsequently, and I am 
sure that your knowledge of the law is superior to mine. Based 
on that, why in the world wouldn't it be--what would be wrong 
with requiring an advocate for a child, for a foster care child 
in these experiments?
    Dr. YOUNG. The current rules do require an advocate. Now, I 
am making a distinction between the IRB's composition and the 
advocate. The advocate requirement is above and beyond the IRB, 
and the advocate requirement is there when there is more than 
minimal risk----
    Mr. STARK. Okay.
    Dr. YOUNG. When there is more than minimal risk and where 
the value of it is not commensurate with that. There needs to 
be----
    Mr. STARK. Who decides whether there is more than minimal 
risk?
    Dr. YOUNG. The IRB.
    Mr. STARK. You don't think it would be necessary on the IRB 
to have a child's advocate?
    Dr. YOUNG. If the IRB is involved in looking at a 
substantial number of research protocols, for example, in a 
pediatric hospital, then, yes, I think that is a very 
reasonable requirement.
    Mr. STARK. What about any program in which a foster child 
is involved? Why shouldn't the IRB include an advocate for that 
child?
    Dr. YOUNG. If there is a--let me make sure I understand 
your question. If there is a research protocol going through 
that is no more than minimal risk, then the IRB will look at 
it. That IRB does not need to have a pediatrician on the IRB, 
and there is no requirement separate from that for an advocate. 
I think that gives adequate protection.
    Mr. STARK. Dr. McDermott, would you yield to me? Do you 
think that is adequate protection?
    Mr. MCDERMOTT. I don't know. Let me think about it.
    Mr. STARK. Okay. I am talking to a pediatrician in his 
former life.
    Mr. MCDERMOTT. Psychiatrist.
    Mr. STARK. Well, pediatric psychiatrist, as I recall, and 
it just troubles me that my suspicion is that we have more 
concern about prisoners and more protections than we do for 
kids. We have seen so many examples of minimal risk in drug 
testing, for instance. We have got to bring the pharmaceutical 
industry to heel. They have been testing things, you know, 
giving drugs to kids without involving them in tests. My 
feeling is that children, and particularly children in foster 
care who perhaps have a higher--we have an adverse selection 
there. I would guess that it is fair to suggest, Mr. Chairman, 
that children in foster care children tend to be poorer and 
perhaps have had poorer health care for whatever reason as a 
population and would be more apt to show up in many of these 
studies. I am worried that the tendency is to say, well, it is 
okay to let the local people take care of that, because I am 
not sure that all local jurisdictions would be--for instance, 
here in Washington, D.C., and I conclude, they can't find half 
the kids in foster care. How would you like to have a foster 
care child from the District of Columbia when its present 
foster care system is in a State of upheaval and say, Gee, they 
will take care of it? I don't think I believe that. I would 
rather you doing it. I trust you.
    Chairman HERGER. The gentleman's time has expired. Dr. 
Young, what do Federal regulations require in terms of the 
naming of independent advocates for foster children in clinical 
trials?
    Dr. YOUNG. If the clinical trial involves more than minimal 
risk and if the value of the clinical trial is not commensurate 
with that for the individual patient, then the advocate must be 
appointed to make the decision for the child in foster care.
    Chairman HERGER. Is there evidence to suggest that children 
with advocates who participated in these trials had better 
outcomes, they live longer, had better health, are still alive 
today than those without advocates?
    Dr. YOUNG. I don't believe there is any information on that 
subject. I would not see why there would be any particular 
difference related to the variable of an advocate only. The 
advocate is there for a decisionmaking of yes or no. It is the 
ethical structure of the clinical trial that determines whether 
it is appropriate, number one, for the individual to even be 
eligible for the trial. So, I don't know information of that, 
but I would not expect that that would be a variable.
    Chairman HERGER. Well, I thank you very much, Dr. Young, 
for your testimony. With that, I would like to invite our next 
panel to have seats at the table. On this panel we will be 
hearing from Dr. Alan Fleischman, senior advisor at the New 
York Academy of Medicine; Ms. Roberta Harris, Deputy Secretary 
of the Wisconsin Department of Health and Family Services; Dr. 
Marjorie Speers, executive director of the Association of 
Accreditation of Human Research Protection Programs; and Dr. 
Moira Szilagyi, on behalf of the American Academy of 
Pediatrics. Dr. Fleischman.

  STATEMENT OF ALAN FLEISCHMAN, M.D., SENIOR ADVISOR, THE NEW 
          YORK ACADEMY OF MEDICINE, NEW YORK, NEW YORK

    Dr. FLEISCHMAN. Mr. Chairman, Subcommittee Members, thank 
you for inviting me. My name is Alan Fleischman. I am a 
physician, pediatrician and medical ethicist. My professional 
background and expertise is in the written testimony, but I 
speak today as and individual. Clinical research with 
therapeutic intent involving children in foster care is an 
ethical imperative and can, and was, performed in an 
appropriate manner fully consistent with good ethical practice 
and compliant with Federal regulations that govern research. In 
order to understand the issue of enrollment, I will share with 
you some of the data that Dr. Young did as well about the late 
eighties and early nineties in HIV care and treatment of 
children.
    Twenty-five percent of babies born to women who were HIV-
infected developed HIV, AIDS was universally fatal in children, 
and 25 percent of infected children died by age 5. Many of the 
young children with HIV were boarder-babies, were in foster 
care because they had become orphans due to the death of their 
mothers or because their mothers were impaired. Great strides 
were being made at that time with new drugs developed for the 
treatment of HIV and AIDS and its complications, but initial 
trials were only in adults. These new treatments were not 
available for children, and there weren't any pediatric 
formulations of the drugs available to the doctors caring for 
such children.
    The National Institutes of Health developed clinical 
research trials, and that is our first step of safety for the 
children in order to study the effectiveness of the various new 
treatments in children. Some of the drugs had potential for 
side effects. They were serious drugs. They were against a 
serious virus, but those possible risks were far outweighed, as 
doctors would know, by the potential therapeutic benefits. In 
New York City, the agency responsible for supervision of foster 
children developed mechanisms that made enrollment of foster 
children in clinical trials possible, because it would have 
been unjust not to offer these children the very best prospect 
of life-saving treatments. The first protection was that 
individual medical institutions conducted the trials only after 
Institutional Review Board prospective review and approval.
    The consent of biologic mothers or legal guardians was 
obtained when possible. An agency permission on an individual 
basis was required before the child could be enrolled in the 
trial, and foster parents were involved in these discussions 
because of their need to administer treatments and bring 
children back for follow-up visits to the hospital in order to 
be successful in the trials. The appointment of advocates for 
the children, while a laudable procedural approach, was not 
required. We did choose that approach in the Bronx, but we were 
not required to do that by the Federal regulations.
    Today, pediatric AIDS treatment in the United States is 
different, because of clinical trials there are effective 
treatments to prevent children from becoming infected in utero, 
and there are effective treatments to prevent children from--
there are effective standard treatments for the smaller number 
of children who are now infected. AIDS in children has become a 
chronic disease with less than 1 percent mortality each year 
for children treated in AIDS centers in the United States. 
Children in foster care who are infected with AIDS today are 
getting standard treatments and are rarely participating in 
clinical trials because it is no longer a matter of life and 
death. There may be a time in the future, perhaps with the 
emergence of a new dreaded disease, when we will once again be 
faced with the critical need to enroll foster children in 
clinical trials in order to provide needed life-saving 
treatments. Our past experience with HIV and AIDS and the 
present Federal regulatory structure on research allows us to 
do that, if we need to.
    In conclusion, those of us involved in the treatment of 
children infected with HIV knew that a large percentage of our 
patients were poor, minority children, and many of those 
children were in foster care. We demanded the very best 
treatment for these vulnerable children. The only way to 
provide it, in fact, to provide treatment in HIV care to any 
child with AIDS, at that time was through clinical trials. We 
enrolled children in treatment trials and gathered information 
on the effects of the new drugs on children while we attempted 
to save and enhance lives of our patients. It would have been 
unethical to have behaved in any other way. Thank you.
    [The prepared statement of Dr. Fleischman follows:]
Statement of Alan Fleischman, M.D., Senior Advisor, New York Academy of 
  Medicine; Ethics Advisor, National Children's Study at the National 
Institute of Child Health and Human Development; Clinical Professor of 
   Pediatrics and Clinical Professor of Epidemiology and Population 
        Health, Albert Einstein College of Medicine in New York
    Mr. Chairman and Committee members, thank you for inviting me to 
share my views with the Committee on the issue of Protection of Foster 
Children Enrolled in Clinical Trials. My name is Alan Fleischman; I am 
a physician, pediatrician and medical ethicist. I am Senior Advisor at 
The New York Academy of Medicine and Ethics Advisor to the National 
Children's Study at the National Institute of Child Health and Human 
Development, as well as Clinical Professor of Pediatrics and Clinical 
Professor of Epidemiology and Population Health at the Albert Einstein 
College of Medicine in New York. I speak today as an individual, the 
opinions I will express represent my own and do not represent the views 
or opinions of any organization or institution with which I am or have 
been affiliated.
    In the late 1980s and the early 1990s I was Professor of Pediatrics 
and Professor of Epidemiology and Social Medicine at the Albert 
Einstein College of Medicine in New York and served as Director of the 
Division of Neonatology at the Montefiore Medical Center, that included 
responsibility for the newborn services at the voluntary hospital, 
Montefiore, and two public hospitals operated by the New York City 
Health and Hospital Corporation, Jacobi Medical Center and North 
Central Bronx Hospital. I was also a member of the two Institutional 
Review Boards for research involving human subjects that was 
responsible for approval of all research involving humans conducted at 
each of these hospitals.
    I was a member of the American Academy of Pediatrics National 
Bioethics Committee from 1983-1989, and a member of the American 
Academy of Pediatrics AIDS Committee from 1993-1999. In New York State, 
I was a member of the Department of Health, AIDS Advisory Council Work 
Group on Ethical Issues in Access to Treatment. In addition, I was 
asked, in 2001, by the Secretary of the U.S. Department of Health and 
Human Services (DHHS) to serve as a member of the National Human 
Research Protections Advisory Committee to the Office for Human 
Research Protections and to chair the review of the federal regulations 
that govern research involving children. I have also served as an 
expert advisor to the Institute of Medicine's Committee on Ethical 
Conduct of Clinical Research Involving Children.
    I am currently a member of the New York State Governor's Task Force 
on Life and the Law, the New York City Mayor's Commission on Women's 
Issues, the DHHS Secretary's Advisory Committee on Human Research 
Protections' Subcommittee on Research Involving Children, and the 
Institute of Medicine Committee on Ethical Issues in Housing-Related 
Health Hazard Research Involving Children Youth, and Families.
    I am here today to express my strong belief that clinical research 
with therapeutic intent involving children in foster care is an ethical 
imperative and can be performed in an appropriate manner fully 
consistent with good ethical practice and compliant with federal 
regulations that govern research.
    In order to understand the issue of the enrollment of foster 
children in AIDS clinical trials, you need to have a picture of AIDS 
care for children in the late 1980s and the early 1990's:

    -- 25% of babies born to women who were HIV infected developed HIV 
through viral transmission in utero;
    -- AIDS was a universally fatal disease in children, with 25% of 
infected children dying by 5 years old;
    -- many of the young children with HIV were ``boarder-babies'' who 
stayed in hospitals or were placed in foster care because they had 
become orphans due to the death of their mothers from AIDS, or because 
their mothers were too ill or impaired to care for them;
    -- great strides were being made with new drugs developed for the 
treatment of HIV and AIDS and its complications, but initial trials of 
these drugs included only adults; multiple drug therapy was shown to 
save lives, and reverse some of the major life-threatening illnesses 
associated with AIDS, but these new treatments were not available to 
children;
    -- in fact, pediatric formulations of these drugs were not 
available to physicians caring for young children with HIV and AIDS;
    -- the National Institutes of Health developed clinical research 
trials in order to study the effectiveness of various new treatments in 
children; Some of the drugs had the potential for side effects, but 
those possible risks were viewed by doctors to be far out weighed by 
the potential therapeutic benefit of the new drugs against AIDS, then a 
uniformly and often rapidly fatal disease.

    A large percent of the children with HIV and AIDS in the late 1980s 
and the early 1990s in New York City and other parts of the country 
were poor, minority children, and many of these children required 
foster care. It would have been unconscionable and unjust, not to offer 
these children the very best prospect of life saving and life-enhancing 
treatment. Enrollment in clinical trials was the only way to accomplish 
that goal. If the agencies responsible for supervising the care of 
foster children in the early 1990s refused to allow children to be 
enrolled in treatment trials, I and many other clinicians would have 
demanded action in the interests of those children.
    In New York, the Administration for Children's Services, the agency 
responsible for supervision of foster children, developed mechanisms 
that made enrollment of foster children in clinical trials possible. 
Local Institutional Review Boards for research involving human 
subjects, like ours in the Bronx, approved the NIH treatment trials for 
use in all children infected with HIV and helped investigators and the 
Administration for Children's Services to develop mechanisms to allow 
enrollment of children in foster care.
    The consent of biologic mothers was obtained when possible, agency 
permission on an individual basis was obtained, and foster parents were 
involved in these discussions because of their need to administer 
treatments and bring children back for followup visits to the hospital.
    Let me also comment on the federal regulations that govern research 
involving children with a specific emphasis on the section on ``wards'' 
in the regulations (Sec. 45CFR46.409). I took the opportunity last week 
to clarify the regulations with a senior member of the Office for Human 
Research Protections at the U.S. Department of Health and Human 
Services and I believe that my views of the regulations are consistent 
with his.
    Clinical trials that include treatment with the prospect of direct 
benefit to the individual child are governed by section 
Sec. 45CFR46.405 of the federal regulations. This section requires the 
permission of the parent or legal guardian in order to enroll any child 
in a study. It does not require the creation of an advocate for each 
child that is a ward or in foster care. This approach is based on a 
clinical treatment model. Only if the proposed research does NOT 
provide the prospect of direct benefit for the individual child AND has 
a level of risk greater than minimal is the creation of an advocate 
required by the regulations (Sec. 45CFR46.409).
    Let me add that virtually all of the research projects involving 
foster children in New York City were treatment trials with therapeutic 
intent. The individual institutions conducting the trials had an 
Institutional Review Board that had to prospectively approve the 
studies and may or may not have created special advocates or processes 
for enrolling foster children. We did in the Bronx, but it was not 
mandated by the regulations. What was required was the permission of 
the biologic parent or of the guardian, either the legal guardian or 
the agency fulfilling that responsibility for the child.
    Today, Pediatric AIDS treatment in the U.S. is different. Because 
of clinical trials conducted in the 1990s, there are effective 
treatments to prevent children from becoming infected in utero and 
standard treatments for the small number of children who are infected. 
AIDS in children has become a chronic disease with less than 1% 
mortality each year for children treated in AIDS centers in the U.S. 
Children in foster care infected with HIV are getting standard 
treatment and are rarely participating in clinical trials because it is 
no longer a matter of life and death. But there may be a time in the 
future, perhaps with the emergence of a new dreaded disease, when we 
will once again be faced with the critical need to enroll foster 
children in clinical trials in order to provide needed life saving 
treatments. The present federal regulations allow us to do that, if we 
had to.
    In conclusion, those of us involved in the treatment of children 
infected with HIV in the late 1980s and 1990s knew that a large 
percentage of our patients were poor, minority children and many of 
those children were in foster care. We demanded the very best treatment 
for these vulnerable children. The only way to provide the best 
treatment to any child with HIV at that time was through clinical 
trials--the drugs were just not available any other way. We enrolled 
children in treatment trials and gathered information on the effects of 
the new drugs on children, while we attempted to save and enhance the 
lives of our patients. It would have been unethical to have behaved in 
any other way; if we denied those new treatments to children in foster 
care we would stand today open to severe criticism for having allowed 
our most vulnerable children to have suffered or even die rather than 
offer them the best chance of survival and the possibility of a good 
future quality of life. Thank you.

                                 

    Chairman HERGER. Thank you, Dr. Fleischman. Ms. Harris.

   STATEMENT OF ROBERTA HARRIS, DEPUTY SECRETARY, WISCONSIN 
  DEPARTMENT OF HEALTH AND FAMILY SERVICES, MADISON, WISCONSIN

    Ms. HARRIS. Mr. Chairman, Members of the Subcommittee, 
thank you for this opportunity to provide information to the 
Subcommittee on this important topic. Children in the child 
welfare system, whether in their own homes or in some form of 
out-of-home care, are some of the most vulnerable children in 
our country. We must do everything that we can to ensure that 
these children are protected from any additional trauma. 
Clearly we need legitimate medical and other research. 
Significant advances are made every day as a result of well-
designed and implemented research studies. In Wisconsin, we 
have not approved medical research on foster children or any 
subgroup of foster children as a class. In the child welfare 
system, we believe it is our responsibility to provide as much 
safe--as much of a safe and nurturing environment for the 
children in foster care as possible.
    Today I would like to make some comments related to the 
lack of homogeneity of foster children, the problems with 
voluntary participation on the part of families, and the legal 
framework of our authority to consent to such research. Let me 
begin with lack of homogeneity. Research, whether medical or 
otherwise, should not be limited to a particular group unless 
there is some homogeneity within that group that is unique. In 
this regard, there is very little, if anything, that can be 
regarded as homogeneous among children in foster care other 
than that they have been removed from their homes.
    As many of us know, children in foster care are there for a 
variety of reasons; abuse or neglect of themselves or their 
siblings, mental health issues of a severe nature, medical or 
developmental disabilities with special care and treatment 
needs that cannot be provided by their parents, and/or 
delinquency. Many of our children are also from low-income 
families. As has been mentioned here today, recent news 
articles have indicated that foster children have participated 
in medical studies related to research endeavors dealing with 
acquired immunodeficiency syndrome. It is true that some 
children in foster care have HIV or AIDS. It is also true that 
many children not in foster care have HIV or AIDS. To focus a 
study on medication related to that condition only on children 
in foster care where there are potential negative effects of 
those medications certainly leads to a perception that somehow 
foster children are valued less than other children.
    In Wisconsin, our position on the involvement of foster 
children in research, especially medical research, is based in 
large part on a variety of ethical codes related to medicine, 
social work, and mental health. These codes place great 
emphasis on the voluntary nature of participation research. We 
believe that our children and our child welfare system are 
vulnerable, and it is our role to do what we can to ensure the 
safety and welfare of the children in our system. In addition, 
as I testified to earlier, many children in the child welfare 
system are economically disadvantaged. We must recognize this 
position and protect the family from giving consent under 
duress. Voluntary consent goes to the heart of the nature of 
the relationships among children, their families, and the child 
welfare system. ``Voluntary'' is defined as acting or 
performing without external persuasion or compulsion.
    Generally, out-of-home placements are ordered by the court. 
When the agency that has authority to determine when a child be 
returned to the parent recommends to that parent that the 
child's participation in medical research--recommends to that 
parent that that parent approve the child's participation in 
medical research, at least on a perceived basis it is 
questionable whether the parent would feel that his or her 
approval is truly voluntary.
    This brings me to legal status. We need to look at the 
issue of who can approve the involvement of a foster child in 
any type of research, medical or otherwise. In the child 
welfare system, there are generally four types of legal 
relationship between a child and an individual agency acting on 
behalf of that child: physical custody, legal custody, 
guardianship and parental relationship. In most cases in 
Wisconsin, the legal custody of a child in foster care remains 
with the parent, because under Wisconsin statutes, there shall 
be a policy of transferring custody of a child from the parent 
only when there is no less drastic alternative.
    If the parent's rights have not been terminated, and if 
guardianship has not been inferred on another party, then it is 
clear that the parent should make the medical decisions for the 
child. As noted previously, however, if the request for 
research participation comes to the parent through the agency 
having the authority to decide when the child is returned to 
the parent, one must legitimately question whether the approval 
of the parent is given freely and voluntarily. If a 
representative of the Wisconsin child welfare system has court-
appointed legal custody or guardianship and has the authority 
to approve the participation of the foster child in medical 
research, it is our position that the approval for such 
participation should not be given solely on the basis of the 
child being a foster child.
    We are not opposed to the participation of a child--of a 
foster child in appropriate and beneficial medical research on 
a case-by-case basis if a foster children meets the 
requirements for a medical research study based on some 
physical, mental, emotional or developmental condition; and the 
child's parent or parents were informed and, as is appropriate 
to their legal status, approved of their child's participation; 
and the child's personal physician, therapist and other 
qualified professional recommends to the system authority the 
child be involved in that research; and children with similar 
or related conditions will also participate; and the group of 
children, and other individuals in the study, include children 
outside of the child welfare system; and finally, the child is 
appointed an advocate with the express responsibility for 
determining whether participation is in the child's best 
interest, including, if possible, ascertaining the child's 
position. If all of these are met, we would consider granting 
that authority.
    In summary, in Wisconsin, we believe it is our 
responsibility to help provide a safe, nurturing environment 
for the children in our foster care system so that they may 
become thriving, healthy adults. We are opposed to a foster 
child being involved in any such research solely because the 
child is a foster children. It is inappropriate to single out 
foster care children as a group for medical research based 
simply on the fact that they are children in the child welfare 
system. Thank you again for your invitation to address this 
important issue. I trust that the legislative initiatives that 
will be forwarded will reflect the values Wisconsin uses with 
regard to foster child protection in medical studies.
    [The prepared statement of Ms. Harris follows:]
Statement of Roberta Harris, Deputy Secretary, Wisconsin Department of 
             Health and Family Services, Madison, Wisconsin
    Thank you for this opportunity to provide information to the 
committee on this very important topic. Children in the child welfare 
system, whether in their own homes or in some form of out-of-home care, 
are some of the most vulnerable children in our nation. It is critical 
that child welfare professionals, child advocates, medical 
professionals, elected representatives, and the general public do all 
that we can to ensure that these children are protected from any 
additional trauma.
    It is not my intent to denigrate the important work reflected in 
most legitimate medical and other research. Clearly, significant 
advances are made every day as a result of well designed and 
implemented research studies.
    In Wisconsin, we have not approved medical research on foster 
children as a class, or any subgroup of foster children, because we 
believe it is our responsibility to provide as much of a safe, 
nurturing environment for the children in foster care as possible. The 
types of research that have unfortunately occurred in our nation in the 
past would also make it difficult for us to earn the trust and 
confidence of the families we are seeking to help, who desperately need 
the services we can offer.
    As such, I would like to offer our comments on the topic related to 
the lack of homogeneity of foster children, the problems with voluntary 
participation on the part of families, and the legal realities of our 
authority to consent to such research.

1.  Lack of Homogeneity

        Research, whether medical or otherwise, should not be limited 
to a particular group, unless there is some homogeneity within that 
group that is unique. In this regard, there is very little--if 
anything--that can be regarded as homogenous among children in foster 
care, other than that they have been removed from their homes; in most 
cases, involuntarily.
        Children in foster care are there for a variety of reasons: 
some have been abused or neglected or had siblings who were abused or 
neglected; some have mental health issues of a severe nature, sometimes 
as a result of the trauma of being removed from their homes, parents, 
and siblings; some are medically fragile or developmentally disabled 
with special care and treatment needs that cannot be provided by their 
parents; some children are delinquent. Certainly, many are from low 
income families.
        Recent news articles have indicated that several states have 
allowed foster children to participate in medical studies related to 
research endeavors dealing with Acquired Immunodeficiency Syndrome 
(AIDS). It is certainly true that some children in foster care have HIV 
or AIDS. It is also true that many children not in foster care have HIV 
or AIDS. To focus a study, then, on medication related to that 
condition only on children in foster care, when there are known 
potential negative effects of those medications, certainly leads to a 
perception that somehow foster children are valued less than other 
children.

2.  Voluntary Nature of Participation

        In Wisconsin, our position on the involvement of foster 
children in research, especially medical research, is based in large 
part on a variety of ethical codes related to medicine, social work, 
and mental health. A major document forming the basis of our position 
is embodied in the The World Medical Association Declaration of 
Helsinki, originally adopted in 1964, and as amended in 1975, 1983, 
1989, 1996, 2000, 2002, and 2004, which places great emphasis on the 
voluntary nature of participation in research.
        Paragraph 1 of that document states, in part, that ``. . . Some 
research populations are vulnerable and need special protection. The 
particular needs of the economically and medically disadvantaged must 
be recognized. Special attention is also required for those who cannot 
give or refuse consent for themselves, for those who may be subject to 
giving consent under duress. . . .''
        We believe the children in our child welfare system are 
vulnerable based upon the trauma within their home, along with the 
distress that can be caused from being removed from their family and 
placed into foster care. We believe it is our role to do what we can to 
help ensure the safety and welfare of the children in our system. In 
addition, as I testified to earlier, many children in the child welfare 
system are economically disadvantaged. We must recognize their needs 
and protect the family from giving consent under duress.
        To continue from the World Medical Association Declaration of 
Helsinki, Paragraph 20 states that ``The subjects must be volunteers 
and informed participants in the research project.''
        Paragraph 23 states ``When obtaining informed consent for the 
research project the physician should be particularly cautious if the 
subject is in a dependent relationship with the physician or may 
consent under duress. In that case the informed consent should be 
obtained by a well-informed physician who is not engaged in the 
investigation and who is completely independent of this relationship.''
        Paragraph 24 states that ``For a research subject who is 
legally incompetent, physically or mentally incapable of giving consent 
or is a legally incompetent minor, the investigator must obtain 
informed consent from the legally authorized representative in 
accordance with applicable law. These groups should not be included in 
research unless the research is necessary to promote the health of the 
population represented and this research cannot instead be performed on 
legally competent persons.''
        Paragraph 25 states that ``When a subject deemed legally 
incompetent, such as a minor child, is able to give assent to decisions 
about participation in research, the investigator must obtain that 
assent in addition to the consent of the legally authorized 
representative.''
        I raise these issues related to consent because, to a certain 
extent, they go to the heart of the nature of the relationships among 
children, their families, and the child welfare system. In the context 
noted above, two definitions of the term ``voluntary'' should be 
carefully considered:

       Voluntary: Done, given, or proceeding from the free or 
unconstrained will of a person. [The World Book Dictionary]
       Voluntary: Acting or performed without external persuasion or 
compulsion. [The American Heritage Dictionary of the English Language]

        With the exception of some of the small percent of voluntary 
placements, out-of-home placements are ordered by the court. As such, 
when the agency that has the authority to determine when a child will 
be returned to the parent recommends that the parent approve the 
child's participation in medical research, at least on a perceived 
basis, it is questionable whether the parent would feel that his or her 
approval is truly voluntary.

3.  Legal Status

        This brings us to the issue of who can approve the involvement 
of a foster child in any type of research, medical or otherwise. In the 
child welfare system, there are generally four types of legal 
relationship between a child and an individual or agency acting on that 
child's behalf. These are physical custody, legal custody, 
guardianship, and the parental relationship, which are defined as the 
following:
        Physical custody means actual custody of the person in the 
absence of a court order granting legal custody to the physical 
custodian. [s. 48.02(14)] In the context of this hearing, the foster 
parent would be a physical custodian only, because in Wisconsin, they 
would not generally have legal custody.
        Legal custody is a status created by the order of a court, 
which confers the right and duty to protect, train and discipline the 
child, and to provide food, shelter, legal services, education and 
ordinary medical and dental care, subject to the rights, duties and 
responsibilities of the guardian of the child and subject to any 
residual parental rights and responsibilities and the provisions of any 
court order. [s. 48.02(12)] In most cases in Wisconsin, the legal 
custody of a child in foster care will remain with the parent because, 
under our statutes, ``. . . there shall be a policy of transferring 
custody of a child from the parent . . . only when there is no less 
drastic alternative. If there is no less drastic alternative for a 
child than transferring custody from the parent, the judge shall 
consider transferring custody to a relative whenever possible.'' [s. 
48.355(1)]
        We believe that maintaining the parents' involvement, 
responsibility, and authority when a child is placed outside of the 
home is critical, if the goal is to reunify the child with the family.
        Guardianship means a status granted by the court to a person 
who has the duty and authority to make important decisions in matters 
having a permanent effect on the life and development of the child and 
the duty to be concerned about the child's general welfare, including 
but not limited to:

        The authority to consent to marriage, enlistment in the 
U.S. armed forces, major medical, psychiatric and surgical treatment, 
and obtaining a motor vehicle operator's license.
        The authority to represent the child in legal actions 
and make other decisions of substantial legal significance concerning 
the child but not the authority to deny the child the assistance of 
counsel as required by this chapter.
        The right and duty of reasonable visitation of the 
child.
        The rights and responsibilities of legal custody except 
when legal custody has been vested in another person or when the child 
is under the supervision of the department of corrections . . . or the 
supervision of a county department . . . [s. 48.023]

        The parental relationship, of course, is one in which the 
parent has all of the rights and responsibilities related to the care 
of his or her child which have not been otherwise altered by the action 
of a court.
        Parental Authority for Participation. If parental rights have 
not been terminated, and if guardianship has not been inferred on 
another party, the parents retain the right to make medical decisions 
for the child.
        System Authorization for Participation. Occasionally, a 
representative of the Wisconsin child welfare system is granted court-
appointed legal custodianship or guardianship and would have the 
ability to approve the participation of a foster child in medical 
research. In these instances, it is our position that approval for such 
research participation should not be given solely on the basis of the 
child being a foster child, but rather reviewed on a case-by-case basis 
for medical benefits.
        In other words, we are not opposed to the participation of a 
foster child in appropriate and beneficial medical research if:

        a foster child meets the requirements for a medical 
research study based on some physical, mental, emotional, or 
developmental condition and
        the child's parent or parents were informed and, as 
appropriate to their legal status, approved of their child's 
participation and
        the child's personal physician, therapist, or other 
professional recommends to the system authority that the child be 
involved in that research and
        children with similar or related conditions will also 
participate and
        the group of children and other individuals in the 
study include children outside of the child welfare system and
        the child was appointed an advocate with the express 
responsibility for determining whether participation is in the child's 
best interest (including ascertaining the child's position),

   the representative may consider granting that authority. In 
Wisconsin, we believe it is our responsibility to help provide a safe, 
nurturing environment for the children in foster care so that they may 
become healthy, thriving adults. We are opposed to a foster child being 
involved in any such research solely because the child is a foster 
child. It is inappropriate to single out foster care children as a 
group for medical research, based simply on the fact that they are in 
the child welfare system.

    Thank you again for your invitation to address this important 
issue. I wish you well and trust that legislative initiatives will be 
forwarded that reflect the values Wisconsin uses with regard to foster 
child participation in medical studies.

                                 

    Chairman HERGER. Thank you, Ms. Harris. Dr. Speers to 
testify.

   STATEMENT OF MARJORIE SPEERS, Ph.D., EXECUTIVE DIRECTOR, 
ASSOCIATION FOR THE ACCREDITATION OF HUMAN RESEARCH PROTECTION 
                         PROGRAMS, INC.

    Ms. SPEERS. Good afternoon, and thank you for inviting me 
to speak about the roles of IRBs and protections for children 
when they are research subjects. IRBs have a broad 
responsibility to safeguard the rights and welfare of research 
subjects. Thus, they should be sufficiently qualified to review 
the research that comes before them and to ascertain the 
acceptability of proposed studies in terms of institutional 
commitments and requirements, applicable law and standards of 
professional practice. IRBs and institutions that receive funds 
from the Department of Health and Human Services or review 
research that the Food and Drug Administration regulates must 
abide by Federal regulations to protect research subjects and 
Subpart D, which provides additional protections for children 
participating in research. As stipulated in the regulations, 
IRBs must have at least five members with varying backgrounds 
to promote complete and adequate review of research. At least 
one member must have primary concerns in the scientific area, 
at least one member must have primary concerns in nonscientific 
areas, and at least one member must not be otherwise affiliated 
with the institution.
    The primary role of the IRB is to determine whether a 
proposed study is ethically justifiable. The Federal 
regulations lay out seven criteria for IRB approval of 
research. They include risks to subjects are minimized; risks 
to subjects are reasonable in relation to potential benefits, 
including direct benefits to subjects and the importance of the 
knowledge that might be gained; subjects are selected 
equitably; informed consent is sought from each prospective 
subject or legally authorized representative and documented; 
and when appropriate, the research plan includes monitoring the 
data to ensure the safety of subjects and includes provisions 
to protect the privacy of subjects and to maintain the 
confidentiality of the data. IRBs use written procedures, 
checklists and other tools to assist them in complying with the 
regulations. During IRB meetings, an IRB member usually 
describes the proposed study, and all members discuss and 
debate the ethical and scientific issues relating to the 
protection of prospective subjects. In the end, they come to a 
conclusion to approve or disapprove the study, request more 
information, or require modifications of the study in order to 
approve it.
    Involving children in research poses special ethical 
dilemmas. Aside from State laws governing the age of majority 
and who may consent on behalf of the child to participate in 
research, children, by nature of their developing cognitive 
abilities, are unable to give voluntary informed consent to 
participate in a study. IRBs consider this carefully in 
research involving children. IRBs must make specific 
determinations regarding the level of risk involved in a 
proposed study and whether there is a prospect of direct 
benefit to the individual subject. They may approve research 
only when it falls into one of four permitted categories. 
Research involving greater than minimal risk can only be 
approved when it meets certain regulatory criteria. These 
determinations are not easy to make because IRBs must interpret 
regulatory terms such as ``minimal risk'' or ``minor increase 
over minimal risk.''
    One of the main protections for children is the requirement 
that IRB approve research in which investigators solicit assent 
from the child and permission from the parents or guardians, 
individuals who are authorized under law to consent on behalf 
of a child. Under the regulations, IRBs may approve research 
involving children who are wards. Depending on the level of 
risk and whether there is a possibility of direct benefit to 
the child-subject, a child advocate might be required. For 
example, in order to approve a study involving greater than 
minimal risk and no prospect of direct benefit to the 
individual subjects, IRBs must find that the research is 
related to their status as wards or is conducted in settings 
such as schools where the majority of children involved as 
subjects are not wards. Further, IRBs must require the 
appointment of an advocate for each child who is a ward, in 
addition to anyone who is acting on behalf of the child as a 
guardian.
    In summary, there are a number of regulatory requirements 
to ensure that children participating in research are 
adequately protected. When IRBs and investigators implement 
these additional protections, the system works well. Thank you 
for the opportunity to address the Subcommittee.
    [The prepared statement of Dr. Speers follows:]
 Statement of Marjorie Speers, Ph.D., Executive Director, Association 
   for the Accreditation of Human Research Protection Programs, Inc.
    Good afternoon. My name is Marjorie Speers. I am the Executive 
Director of the Association for the Accreditation of Human Research 
Protection Programs--an organization that accredits institutional 
review boards, or IRBs, as part of a broader human research protection 
program. I was invited to speak about the roles of IRBs and protections 
for children when they are research subjects.
    IRBs have a broad responsibility to safeguard the rights and 
welfare of research subjects. Thus, they should be sufficiently 
qualified to review the research that comes before them and to 
ascertain the acceptability of proposed studies in terms of 
institutional commitments and requirements, applicable law, and 
standards of professional practice.
    IRBs in institutions that receive funds from the Department of 
Health and Human Services or review research that the Food and Drug 
Administration regulates must abide by federal regulations to protect 
research subjects and Subpart D, which provides additional protections 
for children participating in research.
    As stipulated in the regulations, IRBs must have ``at least five 
members with varying backgrounds to promote complete and adequate 
review of research,'' at least one member must have primary concerns in 
the scientific area, at least one member must have primary concerns in 
nonscientific areas, and at least one member must not be otherwise 
affiliated with the institution.
    The primary role of the IRB is to determine whether a proposed 
study is ethically justifiable. The federal regulations lay out seven 
criteria for IRB approval of research. Briefly, they include: risks to 
subjects are minimized; risks to subjects are reasonable in relation to 
potential benefits, including direct benefits to subjects and the 
importance of the knowledge that might be gained; subjects are selected 
equitably; informed consent is sought from each prospective subject or 
legally authorized representative and documented; and when appropriate, 
the research plan includes monitoring the data to ensure the safety of 
subjects and includes provisions to protect the privacy of subjects and 
to maintain the confidentiality of the data.
    IRBs use written procedures, checklists, and other tools to assist 
them in complying with the regulations. During IRB meetings, an IRB 
member usually describes the proposed study and all discuss and debate 
the ethical and scientific issues relating to the protection of 
prospective subjects. In the end, they come to a conclusion to approve 
or disapprove the study, request more information, or require 
modifications of the study in order to approve it.
    Involving children in research poses special ethical dilemmas. 
Aside from state laws governing the age of majority and who may consent 
on behalf of the child to participate in research, children by nature 
of their developing cognitive abilities are unable to give voluntary 
informed consent to participate in a study. IRBs consider very 
carefully research involving children.
    IRBs must make specific determinations regarding the level of risk 
involved in a proposed study and whether there is a prospect of direct 
benefit to the individual subjects. They may approve research only when 
it falls into one of four permitted categories. Research involving 
greater than minimal risk can only be approved when it meets certain 
regulatory criteria. These determinations are not easy to make because 
IRBs must interpret regulatory terms, such as ``minimal risk'' or 
``minor increase over minimal risk.''
    One of the main protections for children is the requirement that 
IRBs approve research in which investigators solicit assent from the 
child and permission from the parents or guardians--individuals who are 
authorized under law to consent on behalf of a child. Under the 
regulations, IRBs may approve research involving children who are 
wards. Depending on the level of risk and whether there is a 
possibility of direct benefit to the child-subject, a child advocate 
might be required. For example, in order to approve a study involving 
greater than minimal risk and no prospect of direct benefit to 
individual subjects, IRBs must find that the research is related to 
their status as wards or is conducted in settings, such as schools, 
where the majority of children involved as subjects are not wards. 
Further, IRBs must require the appointment of an advocate for each 
child who is a ward, in addition to anyone who is acting on behalf of 
the child as a guardian.
    In summary, there are a number of regulatory requirements to ensure 
that children participating in research are adequately protected. When 
IRBs and investigators implement these additional protections, the 
system works well. Thank you for the opportunity to address the 
Subcommittee.

                                 

    Chairman HERGER. Thank you, Dr. Speers. Dr. Szilagyi to 
testify.

    STATEMENT OF MOIRA SZILAGYI, M.D., Ph.D., FELLOW OF THE 
   AMERICAN ACADEMY OF PEDIATRICS, ON BEHALF OF THE AMERICAN 
                     ACADEMY OF PEDIATRICS

    Dr. SZILAGYI. Mr. Chairman, I am grateful for the 
opportunity to testify as this important hearing on children in 
foster care and clinical trials. My name is Dr. Moira Ann 
Szilagyi, and I am proud to speak on behalf of 60,000 primary 
care pediatricians, pediatric medical subspecialists and 
pediatric surgical specialists of the American Academy of 
Pediatrics. For the past 19 years, I have specialized in the 
medical care and developmental issues of children in foster 
care. I am an associate professor of pediatrics at the 
University of Rochester Medical Center in Rochester, New York; 
a medical director of Monroe County Department of Health's 
Foster Care Pediatrics Clinic. I also serve on the American 
Academy of Pediatrics Committee on Early Childhood, Adoption 
and Dependent Care. The academy has a deep and abiding interest 
in the health care provided to children in the child welfare 
system. In fact, the academy has numerous published policy 
statements, clinical guidelines and studies regarding children 
in foster care, including this, a 170-page handbook for 
pediatricians on health care standards for children in foster 
care. I was proud to chair the District II Task Force on Health 
Care for Children in Foster Care, which authored this resource 
manual.
    The 540,000 children in foster care comprise one of many 
vulnerable populations to which the academy urges special 
attention in the provision of health care. Compared with 
children from the same socioeconomic background, children in 
foster care have much higher rates of serious emotional and 
behavioral problems, chronic physical disabilities, birth 
defects, developmental delays, and poor school achievement. 
Typically these conditions are chronic, underidentified, and 
undertreated, and they have an ongoing impact on all aspects of 
their lives, even long after these children and adolescents 
have left the foster care system. As a result, children in 
foster care warrant special attention in all aspects of their 
health care. One aspect in which children in foster care 
deserve particularly close and special consideration is their 
inclusion in clinical trials. It is the position of the 
American Academy of Pediatrics that drugs be studied in 
children to determine their safety and efficacy in this age 
group. Indeed, the academy considers it a moral imperative to 
formally study drugs in children so that they can enjoy equal 
access to existing as well as new therapeutic agents.
    Research participation is often beneficial to participants 
and may allow them access to care they could not otherwise 
receive. Therefore, children in foster care, as a population 
that tends to have a greater preponderance of special health 
care needs, should be afforded the same opportunities and 
access to safe and effective treatments. However, special 
consideration is necessary when allowing children in foster 
care who are in the care and custody of the State to take part 
in certain studies that may contain greater than minimal risk 
to the child.
    The academy has developed extensive guidelines and 
standards related to the ethical conduct of clinical trials 
involving children. The academy also agrees with the Department 
of Health and Human Services' regulations governing the 
inclusion of children in clinical research. For the purposes of 
today's hearings, however, perhaps the most relevant standards 
deal with consent. Young children are, by definition, incapable 
of consenting to medical procedures. Consent must be given on 
their behalf by a parent, a legal guardian or an individual or 
institution acting in loco parentis; that is, in place the of 
the parent. In all cases, however, the overriding consideration 
must be the best interest of the child.
    HHS regulations outline issues of consent. Consent must be 
obtained from the adult acting legally on behalf of the child. 
When developmentally appropriate, the assent of the child must 
be gained prior to participation in any clinical trial. The 
question, then, for children in foster care is whether adequate 
safeguards are established when consent is obtained for trials 
that contain above minimal risk to the child or when the 
research does not hold the prospect of providing direct medical 
benefit to the child him or herself.
    For children in the foster care system, an important 
safeguard is a special advocate who can help the foster family 
or State agency navigate medical issues, ensure that the 
child's medical care needs are being met, assist the child in 
determining whether or not he or she should participate, and 
provide a source of continuity for the child and the legal 
guardians throughout the duration of the study. Even in cases 
of less than minimal risk or studies with prospect of direct 
benefit, an advocate, while not required, could play an 
important role in the child's support system. It is my 
understanding that the Subcommittee is concerned by press 
reports about the participation of children in foster care in 
clinical trials of HIV drug treatments that began in the late 
eighties. My own professional experience includes a number of 
cases of HIV-positive children in foster care in my community 
who received HIV multidrug treatments during the early 
nineties. When our patients took these drug combinations, we 
saw a startling improvement in lifespan and quality of life. 
Before the introduction of these combination drugs, our HIV-
positive children in care were literally wasting away before 
our eyes.
    There were some side effects with the drugs, but not that 
many, and the side effects were nothing compared to the 
devastation of the disease. I recall one 2-year-old child in 
particular who was literally dying. One year after receiving 
combination therapy, he was essentially indistinguishable from 
his healthy peers. He was able to go to preschool, live in a 
family instead of the hospital, and have hope for a longer 
life. He is still alive today and was eventually adopted by his 
foster family. Mr. Chairman, the decision to enroll a child in 
a clinical trial is never an easy one, even in a traditional 
family structure. While the headlines seem to suggest that 
children in foster care were somehow singled out as hapless 
guinea pigs, my experience indicates that children in foster 
care are actually less likely than other children to be 
considered for participation in a clinical trial. In fact, 
numerous barriers exist for children in foster care to even 
obtain routine health care and necessary health services. 
Participation in a clinical trial where access would be far 
more complex is even less likely to occur.
    The American Academy of Pediatrics believes that children 
in foster care deserve to be offered the same opportunities as 
other children to benefit from newer drugs and treatment 
protocols, especially when a child's condition is so grave that 
there are few options available to them. Indeed, it would be 
unethical to do otherwise and systematically deny access to 
clinical trials that could have saved their lives or vastly 
improved the health of critically ill children in foster care. 
It is clear that children in foster care are a special 
population, and that they deserve additional protections when 
being considered for inclusion in clinical trials.
    Mr. Chairman, and Members of the Subcommittee, I deeply 
appreciate this opportunity to offer testimony on behalf of the 
American Academy of Pediatrics. A more detailed version of my 
testimony has been submitted for the record. I stand ready to 
answer any questions you may have, and I thank you for your 
commitment to the health of the children of our Nation.
    [The prepared statement of Dr. Szilagyi follows:]
 Statement of Moira Ann Szilagyi, M.D., Ph.D., Associate Professor of 
 Pediatrics at the University of Rochester Medical Center, Rochester, 
   New York; Medical Director, Foster Care Pediatrics Clinic, Monroe 
County Department of Health; and Member, Committee on Early Childhood, 
      Adoption and Dependent Care, American Academy of Pediatrics
    Mr. Chairman, I am grateful for the opportunity to testify at this 
important hearing on children in foster care and clinical trials. My 
name is Dr. Moira Ann Szilagyi, and I am proud to speak on behalf of 
the 60,000 primary care pediatricians, pediatric medical 
subspecialists, and pediatric surgical specialists of the American 
Academy of Pediatrics. For the past 19 years, I have specialized in 
medical care and developmental issues of children in foster care. I am 
an associate professor of pediatrics at the University of Rochester 
Medical Center in Rochester, New York and Medical Director of the 
Monroe County Department of Health's Foster Care Pediatrics clinic. I 
also serve on the American Academy of Pediatrics' Committee on Early 
Childhood, Adoption and Dependent Care.
    The Academy has a deep and abiding interest in the health care 
provided to children in the child welfare system. In fact, the Academy 
has published numerous policy statements, clinical guidelines, and 
studies regarding children in foster care, including a 170-page 
handbook for pediatricians on health care standards for children in 
foster care. I was proud to chair the District II Task Force on Health 
Care for Children in Foster Care, which authored that resource manual.
    The 540,000 children in foster care comprise one of many vulnerable 
populations to which the Academy urges special attention in the 
provision of health care. Compared with children from the same 
socioeconomic background, children in foster care have much higher 
rates of serious emotional and behavioral problems, chronic physical 
disabilities, birth defects, developmental delays, and poor school 
achievement.\1\ Typically, these conditions are chronic, under-
identified, and under treated, and they have an ongoing impact on all 
aspects of their lives, even long after these children and adolescents 
have left the foster care system.\2\ As a result, children in foster 
care warrant special attention in all aspects of their health care.
---------------------------------------------------------------------------
    \1\ Committee on Early Childhood, Adoption and Dependent Care. 
``Health Care of Young Children in Foster Care.'' Pediatrics, Vol. 109, 
No. 3, March 2002.
    \2\ Task Force on Health Care for Children in Foster Care. 
Fostering Health: Health Care for Children in Foster Care. 2nd ed. 
American Academy of Pediatrics, 2005.
---------------------------------------------------------------------------
    One aspect in which children in foster care deserve particularly 
close and special consideration is their inclusion in clinical trials. 
It is the position of the American Academy of Pediatrics that drugs 
must be studied in children to determine their safety and efficacy in 
this age group. Indeed, the Academy considers it a moral imperative to 
formally study drugs in children so that they can enjoy equal access to 
existing, as well as new, therapeutic agents.\3\ Research participation 
is often beneficial to the participants, and may allow them access to 
care they could not otherwise receive. Therefore, children in foster 
care, as a population that tends to have a greater preponderance of 
special health care needs, should be afforded the same opportunities 
and access to safe and effective treatments. However, special 
consideration is necessary when allowing children in foster care who 
are in the care and custody of the state to take part in certain 
studies that may contain greater than minimal risk to the child.
---------------------------------------------------------------------------
    \3\ Committee on Drugs. ``Guidelines for the Ethical Conduct of 
Studies to Evaluate Drugs in Pediatric Populations.'' Pediatrics, Vol. 
95, No. 2, February 1995.
---------------------------------------------------------------------------
    The Academy has developed extensive guidelines and standards 
related to the ethical conduct of clinical trials involving children. 
The Academy also agrees with the Department of Health and Human 
Services' (HHS) regulations governing the inclusion of children in 
clinical research (CFR 45 Part 46, Subpart D). For the purposes of 
today's hearing, however, perhaps the most relevant standards deal with 
consent. Young children are, by definition, incapable of consenting to 
medical procedures. Consent must be given on their behalf by a parent, 
a legal guardian, or an individual or institution acting in loco 
parentis --that is, in the place of the parent.
    The Academy's foster care handbook, Fostering Health, dedicates an 
entire chapter to medical consents for children and adolescents in 
foster care.\4\ States and localities have varying laws and detailed 
policies related to the ability of individuals involved in a child's 
care to consent to medical care or procedures. Many localities have 
convened multidisciplinary teams to determine what is in a child's best 
interest when confronted with complex health issues for children in 
their care. In general, legal guardianship remains with the birth 
parents (a term which includes legal guardians) unless a child is freed 
for adoption. There have certainly been cases when children who are in 
foster care are enrolled in clinical trials with the full consent of 
their birth parents. In certain cases when the birth parents are 
unavailable or uncooperative, agencies may approve or seek a court 
order for medical procedures--such as participation in clinical 
trials--for which written consent is required and which are deemed to 
be in the best interests of the child. Once a child is freed for 
adoption, the state agency assumes sole responsibility for consenting 
for a child's medical care.\5\ In all cases, however, the overriding 
consideration must be the best interest of the child.
---------------------------------------------------------------------------
    \4\ Committee on Drugs. ``Guidelines for the Ethical Conduct of 
Studies to Evaluate Drugs in Pediatric Populations.'' Pediatrics, Vol. 
95, No. 2, February 1995.
    \5\ Task Force on Health Care for Children in Foster Care. 
Fostering Health: Health Care for Children in Foster Care. 2nd ed. 
American Academy of Pediatrics, 2005.
---------------------------------------------------------------------------
    HHS regulations outline issues of consent: consent must be obtained 
from the adult acting legally on behalf of the child, and, when 
developmentally appropriate, the assent of the child must be gained 
prior to participation in any clinical trial. The question, then, for 
children in foster care is whether adequate safeguards are established 
when consent is obtained for trials that contain above minimal risk to 
the child, or when the research does not hold the prospect of providing 
direct medical benefit to the child him or herself. For children in the 
foster care system, an important safeguard is a special advocate who 
can help the foster family or state agency navigate medical issues, 
ensure that the child's medical care needs are being met, assist the 
child in determining whether or not he or she should participate, and 
provide a source of continuity for the child and legal guardians 
throughout the duration of the study (section 46.409). Even in cases of 
less than minimal risk or studies with prospect of direct benefit, an 
advocate, while not required, could play an important role in the 
child's support system.
    HHS regulations state--and the Academy concurs--that children in 
foster care should not be considered for studies which contain the 
prospect of greater than minimal risk and in which there is no direct 
benefit to the child him or herself (46.406-407). For these studies, it 
is only appropriate to consider using children in foster care under 
certain circumstances, such as if the research is related to their 
status as wards of the state. In other words, they should only be 
included when involvement of children in foster care is necessary since 
the research aims to answer a question related to conditions 
specifically affecting children in foster care. In these rare 
instances, it is imperative that an advocate be appointed to act on 
behalf of the child for the duration of the study to assist the child 
and foster family for the reasons stated above: to navigate medical 
issues, ensure that the child's medical care needs are being met, 
assist the child in determining whether to participate, and provide a 
source of continuity for the child and legal guardians throughout the 
duration of the study.
    It is my understanding that the subcommittee is concerned by recent 
press reports about the participation of children in foster care in 
clinical trials of HIV drug treatments that began in the late 1980s. 
While attention has been paid specifically to these HIV drug trials, 
children in foster care have been known to participate in other types 
of clinical trials, including those focused on cancer treatment. My own 
professional experience includes a number of cases of HIV-positive 
children in foster care in my community who received HIV multi-drug 
treatments during late 1980s and early 1990s. When our patients took 
these drug combinations, we saw a startling improvement in lifespan and 
quality of life. Before the introduction of these combination drugs, 
our HIV-positive foster children were literally wasting away before our 
eyes. There were some side effects with the drugs, but not that many. I 
recall one two-year-old child in particular who was literally dying. 
One year after receiving combination therapy, he was essentially 
undistinguishable from his healthy peers. He was able to go to 
preschool, live in a family instead of the hospital, and have hope for 
a longer life. He is still alive today and was adopted by his foster 
family.
    Mr. Chairman, the decision to enroll a child in a clinical trial is 
never an easy one, even in a ``traditional'' family structure. While 
the headlines seem to suggest that children in foster care were somehow 
singled out as hapless guinea pigs, my experience indicates that 
children in foster care are actually less likely than other children to 
be considered for participation in a clinical trial. In fact, numerous 
barriers exist for children in foster care even to obtain routine 
health care and necessary services. Participation in a clinical trial, 
where care would be far more complex, is even less likely to occur.
    The American Academy of Pediatrics believes that children in foster 
care deserve to be offered the same opportunities as other children to 
benefit from newer drugs and treatment protocols, especially when a 
child's condition is so grave that there are few options available to 
them. Indeed, it would be unethical to do otherwise and systematically 
deny access to clinical trials that could have saved the lives or 
vastly improved the health of critically ill children in foster care. 
It is clear that children in foster care are a special population, and 
that they deserve additional protections when being considered for 
inclusion in clinical trials.
    Mr. Chairman and Members of the Subcommittee, I deeply appreciate 
this opportunity to offer testimony on behalf of the American Academy 
of Pediatrics. I stand ready to answer any questions you may have, and 
I thank you for your commitment to the health of the children of our 
nation.

                                 

    Chairman HERGER. Thank you, Dr. Szilagyi. The gentleman 
from Colorado Mr. Beauprez to inquire.
    Mr. BEAUPREZ. Thank you, Mr. Chairman. Doctor, let's just 
start with you, if I might. I am intrigued by your testimony 
and especially, I think, your closing assertion that the very 
children that may need the opportunity to participate in these 
trials, may need good health care in general, are ones that, 
perhaps, are being denied, foster children. I am concerned that 
perhaps in our zeal to do something, we maybe do too much. 
Congress sometimes can do that. If you can enlighten me a 
little bit, what maybe should we be doing; and even more 
specifically, since we're focused on HIV/AIDS, and that seems 
to be a situation that occurred quite a few years ago, tell me 
from what you know, and you would appear to be a pretty good 
expert at this, what sort of clinical trials are going on 
today? We're talking a lot of about what went on 10 or 15 years 
ago. What is going on today, and what, in your opinion, should 
Congress do?
    Dr. SZILAGYI. Are you asking me about specifically what 
clinical drug trials or what types of trials?
    Mr. BEAUPREZ. What type of trials?
    Dr. SZILAGYI. I think most of the research that is centered 
on children in foster care from the health perspective now has 
to do with mental health interventions for children, and 
possibly developmental interventions for children; visitation, 
mentored visitation interventions. I put those in health 
because I look at health as a very global issue for children in 
foster care. There are still occasionally children who might be 
enrolled in a drug trial, but those are usually children with 
rare illnesses, childhood cancers that haven't responded to 
more traditional therapies, and that they be offered the same 
opportunity as any other child to become involved in a 
therapeutic drug trial, that may be their own only last best 
option for life. That is an extremely rare event. It has 
happened--I have taken care of probably close to 9,000 children 
in foster care over the last 19 years of my practice, and, you 
know, that number--those faces change all the time because of 
the nature of my practice. I have really only had occasion to 
have that situation outside of the HIV situation come up 
probably two other times. So, it is not--you know, we don't 
have vast numbers of children involved in these randomized 
controlled clinical trials.
    Mr. BEAUPREZ. Ms. Harris, near the end of your testimony, I 
think it is on page 4 of your written testimony, you outlined, 
I believe, six different criteria for a child--a foster care 
child to be included in a clinical trial. Are any of those--do 
all of those have to be met in the affirmative in order for a 
child to be included?
    Ms. HARRIS. Yes, as stated.
    Mr. BEAUPREZ. Which raises, actually, another question, and 
I fully understand and appreciate how we could get to that 
point. Another concern I actually had raised to me about the 
very point you're talking about, about making these kind of 
opportunities available, not precluding foster children from 
the population, is that perhaps in our concern about making 
sure the wrong thing doesn't happen to the wrong child for the 
wrong reasons, that by an abundance of regulations and hoops to 
jump through we actually do just that; that it is not a very 
attractive target--a very attractive population, excuse me--a 
very attractive population to even look at for clinical trials 
because of the regulation burden we put in front of them.
    Ms. HARRIS. Well, my guess is that most of these criteria, 
with the exception of appointing an advocate, would be 
applicable to all children that are going to be involved in 
medical trials.
    Mr. BEAUPREZ. So, in my case, if it were one of my 
children, it would be another advocate. Would there--since I am 
the parent, the biological parent, I have legal custody, we 
wouldn't be setting up another hurdle, would we?
    Ms. HARRIS. No, not with respect to the advocate.
    Mr. BEAUPREZ. I am not suggesting the advocate go away. 
Actually, Dr. Fleischman, I wanted to pursue that a little bit 
with you. What exactly did you do in the Bronx? I want to be 
sure and ask, I think, two related questions: Why is this-- if 
most of this occurred--most of what we read in the press 
occurred 10, 15 years ago, why are we just now kind of hearing 
about it? It is being brought to light, and I think HHS 
regulations neither preclude now nor mandate certainly that 
there be any payment made, but are you familiar with payments 
ever being made; and, if so, who gets paid for these clinical 
trials?
    Dr. FLEISCHMAN. The why now question, I think you're going 
to have to ask people other than myself. I have no idea why 
now. I find no rational reason for what I thought was a 
rewriting of history in much of the media circus. In terms of 
the question of why, what we did in the Bronx, we did appoint a 
physician advocate who was in one of our public hospitals to 
share his views on these trials with each of the foster 
families, and we did use his expertise to help the foster 
families, help decide whether the child ought to be in the 
trial after the other steps had been gone through of 
individualized consent from the agency, legal guardian or 
parent, review. This was an adjunct, an added thing, that we at 
the Albert Einstein College of Medicine felt was important. In 
terms of the payment, families who enroll children in clinical 
trials generally do receive some compensation for their efforts 
in bringing the child to the clinic; transportation, time away 
from work, things of that sort. To my knowledge, there were no 
dollars in true payment for using children or commodifying 
children in such clinical trials, and most IRBs would not 
tolerate such.
    Mr. BEAUPREZ. Good.
    Chairman HERGER. The gentleman's time has expired.
    Mr. BEAUPREZ. Thank you, Mr. Chairman.
    Chairman HERGER. The gentleman from Washington Mr. 
McDermott to inquire.
    Mr. MCDERMOTT. Thank you, Mr. Chairman. As I listen to this 
panel, I come away with a question. I guess it sounds like in 
Wisconsin you wouldn't get into a clinical trial like this; is 
that correct?
    Ms. HARRIS. With foster care children as a class. We are 
not saying that we don't think foster care children should be 
eligible for clinical trials. If they are eligible, they should 
be treated as any other child and have parental consent or 
consent of the legal authority that has legal custody of the 
child.
    Mr. MCDERMOTT. I asked my staff after I listened to all of 
you, why are we here? Not exactly Mr. Beauprez's question. I 
read these articles from the Newsday and from the New York 
papers that covered this issue. I tend to agree with Dr. 
Fleischman. There seems to be a--this was a long time ago, and 
a whole different scene. What I would really like to hear from 
you, you all are advocates for children, all of you. Is there 
anything that we should do to make a uniform system across the 
country so that there is no real magical difference? This whole 
question about should we override what goes on at the State 
level, is that a good idea in this area? Or do you see 
something where there is a Federal role that we should do? None 
of you made any recommendations. I don't know whether that was 
because you didn't have any or didn't think there should be any 
changes, or it was all perfect out there. So, Dr. Fleischman?
    Dr. FLEISCHMAN. I, individually, myself, had three 
opportunities through service to the government to review the 
regulations for children, and in each of those times, we felt 
those regulations were adequate. The National Bioethics 
Advisory Commission, Dr. Shalala, Secretary Shalala's Human 
Research Protections Advisory Committee, and the now 
Secretary's Advisory Committee have all suggested, as well as 
the IOM Institute's reports, the Institute of Medicine reports, 
all suggested that we would benefit in this country, not 
specifically in the foster care, only in foster care, in a 
basic data collection system that would assist us in 
understanding who are the subjects of research in our country, 
what are the criteria that IRBs are using in approving 
research, and what are the outcomes based in those research 
studies. The Office of Human Research Protection has not 
requested that. They feel, I believe, that they don't have the 
authority to do that. I don't speak for them, but we would be 
well served by having a database that at least gives us the 
baseline information about such. That is one. Two, all of those 
groups have recommended that there be expertise in pediatrics--
you can call it advocates or experts in pediatrics--on any IRB 
that is reviewing things related to children. It isn't required 
in the regulations. It could be strongly urged, or it could be 
required. All of those learned groups have made those 
recommendations, and I believe for the most part IRBs fulfill 
those recommendations. In these cases, since these were--these 
research prospects were in AIDS clinical trials centers, 
centers of excellence in our cities, all of those IRBs had 
advocates for children and had children's experts on them. In 
general, if we are looking to fix, or help, or support the 
present regulatory structure of the data collection system and 
expertise in the areas related to the kinds of subjects who are 
being reviewed like prisoners, or children, or mentally ill 
people, or retarded people, or people of any variety----
    Mr. MCDERMOTT. Any of the others of you have a comment?
    Dr. SZILAGYI. I probably have a broader perspective on the 
whole issue of health care for children in foster care than the 
more narrowly defined. I agree with everything Dr. Fleischman 
said. Let me start there. I think that children in foster care 
have huge health care needs. Forty-five percent of them have 
chronic medical illness. Sixty percent of children under the 
age of 5 have developmental disabilities. Forty-five percent of 
our school-age children are in special education placements, 
and eighty percent of children over the age of 4 have mental 
health needs. Their access to health care services is abysmal 
in this country. There are multiple barriers. One of you asked 
about barriers before. Those barriers include their high 
mobility in and out of the system; the high mobility of 
professionals in the system; Medicaid as a funding resource, 
which, while it offers some benefits in terms of routine 
preventive care, is a barrier to many other types of care. The 
whole system is underfunded and under-resourced, and I would 
suggest that every child in foster care deserves to have a 
medical home where they receive high-quality care that is 
comprehensive, well-coordinated, and that works very closely 
and in collaboration with the child welfare system. I think 
that that would afford a high level of protection in terms of 
enrolling children in clinical research trials. In our 
community, whenever a question comes up about an end-of-life 
issue for a child, a surgical procedure that is being offered 
to a child, bone marrow transplant or child with cancer who 
needs a more advanced protocol than is currently available as a 
standard of care, those questions come back to our office where 
we are the primary care doctor in the medical home. I think 
trying to change the whole system of care for our kids so that 
it was much more modeled on a medical home model would go a 
long way toward preventing these types of issues.
    Dr. FLEISCHMAN. Well said.
    Mr. MCDERMOTT. If the Chairman would just give me 1 more 
second. The database you are talking about, I remember when I 
did some research when I was in my residency, and I found the 
databases could give me two left-handed plumbers living in 
towns of less than 20,000 people. Are you suggesting a national 
database for all health care data so that we would then have 
that capacity to do that kind of research? Do you think 
politically that is possible?
    Dr. FLEISCHMAN. No. I am suggesting that we have a database 
on all subjects of research in this country.
    Mr. MCDERMOTT. Oh, just research.
    Dr. FLEISCHMAN. That we ask IRBs to review research, and we 
ask investigators to tell IRBs and then tell the government how 
many subjects, what was the kind of research, what were the 
criteria in which the IRB reviewed the research, and move 
forward with it.
    Mr. MCDERMOTT. Thank you, Mr. Chairman.
    Chairman HERGER. Thank you. The gentleman from California 
Mr. Becerra to inquire.
    Mr. BECERRA. Thank you, Mr. Chairman. Thank you all for 
your testimony. I want to go back to the gentleman of 
Washington's question, because I think it is the correct one. 
Is there something we should be doing? My sense is that we are 
trying to find out if there is this purgatory where children 
are where it is not clear if they really should participate in 
these clinical trials, and we are concerned that they actually 
may be used as a commodity in some of these clinical trials. I 
am not sure if you have answered that question for us to leave 
us with a feeling that there is something we can do, or we 
needn't do anything. So, if you can give us some clarity, is 
there something we should do? If you say yes, please try to 
give us a specific.
    Ms. HARRIS. I think one of the questions that comes to mind 
is is the determination of whether research carries minimal 
risk and the child would directly benefit subjective? Who makes 
that determination? What are the criteria? That is one of the 
questions I think that is unanswered, and that was sort of 
central to some of the HIV/AIDS research.
    Mr. BECERRA. Before anyone goes on, Ms. Harris, let me ask, 
are you saying then that Wisconsin, since you are more 
restrictive than other States, and I think my State of 
California is also very restrictive in requiring some judicial 
order to allow a child, a foster child, to participate, are you 
saying that there is a concern that, in fact, there might be a 
problem in protecting that child sufficiently through the IRB 
process without a child advocate?
    Ms. HARRIS. Yes, and if there is, if there is, that right 
now within the IRB process, there is lack of clarity with--in 
that determination.
    Mr. BECERRA. Thank you.
    Ms. SPEERS. I would suggest three items. One is to just 
reinforce what Dr. Fleischman suggested, which is any IRB that 
is reviewing research involving children, that IRB should have 
expertise in pediatrics; but more than just pediatrics, in the 
interests of children so that it might not be a pediatrician. 
It might be a social worker. It might be an individual school, 
someone who understands the needs of children. That is not a 
requirement in the Federal regulations at this time. Secondly, 
the additional protections pertaining to children in Subpart D 
are not universally adopted across the Federal agencies that 
conduct or sponsor human research. Subpart D is followed by the 
Department of Health and Human Services. It was added in 2001 
to the Food and Drug Administration regulation.
    Mr. BECERRA. Who else would be part of that, what other 
agencies?
    Ms. SPEERS. There are 16 other agencies.
    Mr. BECERRA. Can you give us those you believe should fall 
under the jurisdiction of Subpart D?
    Ms. SPEERS. I want to say also that the Department of 
Education does have Subpart D. Those are the three that do, but 
the other ones, in particular one is the National Science 
Foundation.
    Mr. BECERRA. Do me a favor. If you could just submit those 
so that way you can get to your third part, because otherwise I 
am going to run out of time.
    [The information was not received at time of printing.]
    Ms. SPEERS. The third is I wanted to suggest that there 
should be an education requirement for IRBs. IRB members now 
have no education requirement under the Federal regulation. It 
would be much easier for IRBs to follow the regulations and 
understand the regulations if they had some type of education 
requirement.
    Mr. BECERRA. Dr. Szilagyi, I hope I pronounced that 
correctly, do you have anything you would like to add?
    Dr. SZILAGYI. No.
    Mr. BECERRA. A quick question then before I run out of 
time. Is there any standard throughout that is applied, that 
should be applied, a best practices standard that we could use?
    Ms. HARRIS. I am not aware of an existing best practices.
    Mr. BECERRA. Is it good policy to allow the various States 
to come up with what they believe is the best practice for 
these decisions in regards to foster children?
    Dr. FLEISCHMAN. One very powerful method is that Office of 
Human Research Protection has the ability to give guidance to 
all IRBs around the country.
    Mr. BECERRA. Does it do so?
    Dr. FLEISCHMAN. They do. They have not yet done that in 
this area. The Secretary has an advisory committee to that 
office on human research protection.
    Mr. BECERRA. Should they do so?
    Dr. FLEISCHMAN. I believe they should, as well as to 
clarify for Ms. Harris the definitions of minimal risk, and 
minor increase over minimal risk, and prospect of direct 
benefit, which the Subcommittee on children has already 
provided and requested that a guidance be produced.
    Mr. BECERRA. One last question as my time runs out. If the 
best interest of a child is not upheld, who should be 
responsible?
    Dr. FLEISCHMAN. Everyone. Starting with the investigators, 
starting with those people in agencies who are responsible for 
those children, and going back toward the IRB, the institution 
that conducted that IRB. Ultimately, at the Federal level, 
there is some responsibility. The real responsibility stands at 
the local level.
    Mr. BECERRA. Anyone else?
    Chairman HERGER. Thank you. The gentleman from California 
Mr. Stark may inquire.
    Mr. STARK. Thank you, Mr. Chairman. Just a couple of 
comments. Dr. Szilagyi, I am a little bit concerned. I 
appreciate your idea that it is through experiments, and the 
poor children can get health care, but I wonder is it right in 
this country, and this is just an aside, should they have to be 
guinea pigs to get health care? I think that is wrong.
    Dr. SZILAGYI. I don't believe I said that.
    Mr. STARK. Well, you didn't say that. To me it implies 
that. One of the good things about getting foster children into 
these programs is that they wouldn't get health care otherwise. 
I am suggesting to you that that is a travesty. It is has 
nothing to do with these rules, but that is one of the 
travesties of having uninsured children.
    Dr. SZILAGYI. Then I would like to clarify. What I intended 
to say was that for some children in certain circumstances, and 
the HIV/AIDS phenomenon of the early 1990s was one of those----
    Mr. STARK. Let's move ahead, though. Dr. Szilagyi. ----the 
only way for them to get certain kinds of care was actually for 
them to be enrolled in studies because that was the only way to 
obtain these drugs.
    Mr. STARK. Going back, very quickly, and, Mr. Chairman, I 
ask unanimous consent to put both subpart C and subpart D of 
45(c) in the record.
    [The information was not received at time of printing.]
    Basically, there is a difference. Young was wrong. There 
are additional protections for prisoners; and basically, if I 
can just paraphrase in the time allowed, it says that all 
regulations relative to prisoners will be enforced regardless 
of other regulations in this subpart. It goes on to say that 
because prisoners may be coerced, they have got to have an 
advocate; yet subpart D for kids, and that is not there. There 
is in my mind a question. If you still had an Eloise Anderson 
around someplace, she would sacrifice children for--you don't 
know who she was, do you? You dumped her from Wisconsin, did 
the California, thank you very much, send her back and give you 
three free kicks. There is a question that perhaps foster 
children are--present company completely excepted--you and the 
Committee are an easy target because they are there, and they 
may not have to go through as much pleading with the parent and 
explaining because it is a much more institutionalized group of 
children, and you are able to find research subjects in that 
population. That worries me. It would be a simple thing, it 
seems to me, for us--what is good enough for Haldeman, 
Erlichman or Martha Stewart ought to be good enough for my 
kids, right? Prisoners can have an advocate required; it 
doesn't seem to prohibit us from using prisoners in these 
cases. I think maybe we could make some simple changes, which--
in States other than the ones represented here which don't have 
such good protection. I think there are some States, Mr. 
Chairman, where we find it has been more casual in their 
outlook as to how foster children are protected. I don't think 
we would impose any great impact or regulatory burden by 
considering in this Subcommittee whether we might coordinate 
the requirements for prisoners and children. I hope you all 
will have staff look at these requirements, and we could ask 
the witnesses perhaps to respond to us later whether the 
prisoner requirements would unduly hamper research and the 
opportunity for children to participate in these programs. Then 
we could sleep a little better at night knowing that at least 
we put in the requirement, the children would have adequate 
advocates in the program. If anybody wants to disagree with 
that, that is fine with me, but that is what I am reading here.
    Dr. FLEISCHMAN. As long as you are aware of that, the 
Office of Human Research Protection has just created the 
Institute of Medicine broad-based study on prisoners research, 
and the Secretary's Advisory Committee is taking up that issue 
as well. There is a broad-based review of research with 
prisoners that is going on as we speak. We need to be sure to 
coordinate that thinking with whatever thinking you have.
    Mr. STARK. I think, Mr. Chairman, with foster kids, they 
don't have the complete freedom, just as a prisoner doesn't, 
and it is that minor extra protection that we might want to 
consider in any legislation that you might consider, Mr. 
Chairman. I thank all of you for taking the time, and your 
concerns. I thank you all for everything, except Eloise 
Anderson. You can have her back.
    Chairman HERGER. I thank the gentleman. Ms. Harris, beyond 
participation in clinical trials, could you tell me about drug 
use of children in foster care more generally? For example, who 
decides whether children are to receive medications such as 
antidepressants or stimulants, the doctors, foster parents, 
caseworkers, all of the above? What do we know about the 
medications provided children in foster care; for example, what 
share are on medication and for how long?
    Ms. HARRIS. I can't speak specifically to certain 
medications. We can certainly get that information to the 
Subcommittee. The determination is parents retain the rights of 
any other parent with respect to children in Wisconsin's foster 
care system, unless the parent is incapacitated or for some 
other reason incapable of making that decision. Then the court 
can grant authority for decisionmaking, either a temporary--
through temporary guardianship through the system. Generally, 
even if the child is not physically placed with the parent, the 
parent retains the right to make all decisions with respect to 
all medical decisions.
    Chairman HERGER. Thank you. Dr. Fleischman, the purpose of 
this hearing this afternoon is that there has been some very 
serious allegations made recently, especially about the 
treatment of children in New York City, in clinical trials for 
AIDS medicines in the late 1980s and 1990s. These go to race 
and whether certain children were targeted because of their 
race or their being in foster care. Our purpose today is to 
review whether current protections are adequate or not. 
Obviously, we are concerned about the allegations that have 
been raised. You were not only there, but you treated many of 
these children and sat on the Institutional Review Boards, 
whose purpose was to determine the propriety of their 
participation. Would you care to comment directly about some of 
the more inflammatory charges that have been made of late?
    Dr. FLEISCHMAN. The charges saddened me. I thought they 
were extremely inaccurate; that the doctors, the Institutional 
Review Boards and the institutions caring for children with HIV 
and AIDS were extremely sensitive to the areas of cultural 
sensitivity, race, ethnicity, the concerns of poverty. Our 
children, all of our children with HIV, the vast majority, were 
from poor families and minority families. We were very 
sensitive to those issues. The IRBs were extremely concerned. 
We believe we developed procedures that protected their 
interests and enhanced their quality of life and their lives in 
general.
    Chairman HERGER. Thank you. I want to thank each of our 
witnesses this afternoon for taking the time to appear here 
today. I appreciate your help in understanding this issue 
further. With that, the Subcommittee stands adjourned.
    [Whereupon, at 3:55 p.m., the hearing was adjourned.]
    [Submissions for the record follow:]
 Statement of Sheila Matthews and Gloria M. Wright, Ablechild.org, New 
                          Canaan, Connecticut
Wards of the State: Protection of human subjects ``Special Population''

Ablechild Background: a non-profit 501C-3 organization whose Board of 
Directors consist of doctors, teachers, psychologists, and other mental 
health providers dedicated to protecting the health and well-being of 
children. These true professionals wholeheartedly support parental 
rights, informed consent (full disclosure), and a parent's right to 
choose regardless of legal status.We have spoken out on this issue in 
many media outlets: CNN Today Show, CBS Evening News, Good Morning 
America, Hannity & Colmes, A&E Investigative Reports, Montel Williams 
Show, John Walsh Show, Discovery Health Gary Null Show, WXIA TV NBC 
Atlanta, NBC Health Page, Time Magazine, New York Times, USA Today, G. 
Gordon Liddy Show, Sean Hannity Radio Show, Armstrong Williams Show, 
Martha Zoller Show, WDUN, The Riley Report Many Other Shows and 
Publications Numerous Websites.

    My name is Sheila Matthews and I am a Connecticut mother who 
testified before the public health committee on the first law to 
prohibit schools from recommending psychotropic ``medication'' to 
children as a requirement for attending school. I am also the National 
Vice President and Co-founder of Ablechild.org a non-profit national 
parent organization that works on educating the public on the issues of 
informed consent and the right to refuse psychiatric ``treatment''.
    Our organization is very concerned with the outcome of this hearing 
because we hear directly from parents victimized by the trafficking of 
their children into clinical drug trials while in state custody. 
Ablechild has documented cases of children that have been placed on 
drugs, completely unaware if they are participating in a clinical drug 
trial, and without knowing that they have the right to ``opt out'' of 
participating. The fact is, the State holds the responsibility of 
providing informed consent to parents and children, and lacks any 
procedure to protect and safeguard this right.
    A clear conflict of interests exists between the pharmaceutical 
industry and the experimentation occurring on children within state 
custody. This fact is clearly demonstrated by workshops sponsored by 
the pharmaceutical and biotechnology industries designed to optimize 
strategies for drug development and trials in children. One such 
workshop was held in New Haven, Connecticut on May 19th-21st, 1997 and 
brought together representatives of the drug industry, government, and 
the academia.
    The workshop was specifically designed to focus on ``New Pediatric 
Regulations,'' ``Vaccine Development,'' ``Strategies for Identifying 
New Gene Targets,'' ``Novel Drug Delivery Systems,'' and ``Neuro-
Behavioral Disorders''. What this workshop failed to focus on was the 
informed consent process, the right to refuse process, and the special 
rights afforded to the vulnerable population, ``Wards of the State''.
    Sponsors included Yale Department of Pediatrics and Yale Child 
health Research Center New Haven CT, Yale Child Study Center, New Haven 
Connecticut, National Institute of Child Health and Human Development, 
and NIH Bethesda, MD. Corporate Sponsors included Bayer Corporation, 
Pfizer, Inc., SmithKline Beecham Pharmaceuticals, Biological Division, 
Wyeth-Lederle Vaccines, and Pediatrics.
    Our organization points out the problems that resulted from 
strategies designed to target and exploit these children, strategies 
that were highlighted at the workshop in 1997.
    The Connecticut Advocate reported these resulting problems in its 
June 5th, 2001 article, ``Study Calls for Review of Psychiatric Drugs 
Prescribed to Kids.'' Within this news story, the authors of a new 
study questioned why 396 children under 4 years old covered by Medicaid 
were prescribed psychiatric drugs. Some of these children were less 
than 1 year old.
    Trafficking children into clinical drug trials is a violation of 
basic human rights. Past history of this United States human rights 
violation is clearly illustrated by one landmark case, Willowbrook that 
was brought to public light in 1987. This case addressed the right to 
informed consent of any institutionalized person. It is our hope that 
these hearings will reform this human rights violation and uphold their 
rights.

                                 ______
                                 

                                                      Ablechild.org
                                           Hendersonville, NC 28791
                                                       May 18, 2005
Congressman Wally Herger
2268 Rayburn House Office Building
Washington, DC 20515

Dear Congressman Herger:

    As a grandparent and a member and officer of Ablechild, a 501(C) 3 
organization, I wish to bring to your attention our cry for the 
protection of human rights of foster children across America!
    Our organization frequently hears from parents across the nation 
that implore us for assistance in the matter of the clinical trial/
experimental drugging of their children while in state custody and in 
foster care. These children have been placed on clinical trial drugs 
without a legal advocate responsible for safeguarding their health, nor 
their life. As minors these children are unable to opt out of these 
tests/experiments, the parents have been denied their right to dissent 
and there obviously are no procedures in place to safeguard the rights 
of the children.
    Ablechild is aware of your committee's investigative hearings into 
Child Protective Services which was held in March 2004. Wreckless 
endangerment of children in the custody of most states across the 
nation became fairly apparent during those hearings. Illegal seizure of 
many children was noted. Methods used and justification to seize 
children from the safekeeping and love of their parents and thus 
placing them in foster care was well exposed at that time. Now these 
very children are being forced into clinical trials--or 
experimentation--while being forced to SURRENDER THEIR HUMAN RIGHTS 
while at the same time endangering their present/future health.
    Congressman Herger, Ablechild calls upon your committee to enact a 
law whereby all pediatric clinical trials, without express consent of 
the parents, be prohibited. This law should include children in foster 
care and should not preclude those children who are at home with their 
parents or custodial family members. Congressman, the importance of 
such legislation goes beyond the giving of a pill to a child. This 
matter is about Human Rights--and those rights of children have been 
gravely sacrificed and the health and future of these children may have 
been imperiled.
    Ablechild stands ready to support you and your committee on behalf 
of America's children and we would appreciate having dialogue with you 
and/or your committee members in this matter and others that greatly 
impact our America's children and their families.

            Sincerely,
                                                      Gloria Wright
                                                  NC Vice President

                                 
Statement of Vera Hassner Sharav and John H. Noble Jr., Ph.D., Alliance 
           for Human Research Protection, New York, New York
    On March 10, 2004, The ALLIANCE FOR HUMAN RESEARCH PROTECTION 
(AHRP) filed a complaint with both the Food and Drug Administration and 
the federal Office of Human Research Protection (OHRP) when we learned 
that 36 Phase I and Phase II AIDS drug experiments had been conducted 
on infants and children who were under the guardianship of the New York 
City Administration for Children's Services (ACS). The children were 
living at Incarnation Children's Center, a foster care facility under 
contract with ACS and the Catholic Archdiocese. We had reason to 
believe that the experiments were unethical, illegal, and coercive--and 
that federal regulations have been violated. We did not know at the 
time that children in foster care nationwide were subjected to research 
exploitation at prestigious medical research institutions.
    Historically such children have been abused and exploited in 
medical experiments--for that reason, federal regulations were enacted 
to restrict the use of foster care children in research. The Associated 
Press confirms that for more than two decades, government officials 
colluded with hospitals and researchers to facilitate the enrollment of 
children who were in the care of the state for experimental drug 
trials. Nationwide, an estimated 698 to 1,388 foster children were used 
to test experimental AIDS drugs--at least 465 of those children were in 
the care of NYC's ACS--almost all were children of color. How ironic it 
is that children, who were placed by the courts into the protective 
custody of foster care agencies pursuant to the provisions of the 
Adoption and Safe Homes Act of 1997, should end up further victimized 
by their caretakers.
    These children were exposed to pain, risks, and potentially harmful 
experimental drugs--the children suffered, some died. In some cases the 
children were diagnosed with HIV infection--in other cases infants were 
merely ``presumed'' to be HIV-infected.
    The Code of Federal Regulations (45 CFR 46.409 and 21 CFR 50.56) 
prohibits subjecting children who are wards of the state to experiments 
involving greater than minimal risk:
    (a) Children who are wards of the State or any other agency, 
institution, or entity can be included in research approved under 
46.406 or 46.407 only if such research is:
    (1) related to their status as wards; or
    (2) conducted in schools, camps, hospitals, institutions, or 
similar setting in which the majority of children involved as subjects 
are not wards.
    (b) If the research is approved under paragraph (a) of this 
section, the IRB shall require appointment of an advocate for each 
child who is a ward, in addition to any other individual acting on 
behalf of the child as guardian or in loco parentis.
    The advocate shall be an individual who has the background and 
experience to act in, and agrees to act in, the best interests of the 
child for the duration of the child's participation in the research and 
who is not associated in any way (except in the role as advocate or 
member of the IRB) with the research, the investigator(s), or the 
guardian organization.
    The Phase I and Phase II experimental drug and vaccine trials in 
question were unrelated to their status as wards--the NYC-ACS 
enrollment guidelines applied to foster care children only. The ACS 
guidelines falsely stated that the trials posed ``minimal risk,'' and 
the guidelines clearly focused on facilitating rapid enrollment of as 
many foster children as possible--rather than ensuring that the trials 
were in the children's best interest: [Attached]
    ``ACS will review clinical trial protocols for HIV-infected 
children as soon as such protocols become available, before a specific 
hospital decides to participate in the study. The National Institutes 
of Health (NIH) and pediatric AIDS specialists throughout New YorkState 
will make ACS aware of protocols as soon as they are in final form, 
before hospitals are ready to enroll children. This procedure will 
expedite ACS' decision-making even before physicians are ready to start 
treating children in the protocols.''
    The Associated Press confirmed our suspicion that most of the 
children in the care of ACS did not have a personal advocate--as 
required under federal regulations. Indeed, of the 465 NYC children in 
the experiments, only 142 had an advocate. Furthermore, ACS even waived 
the requirement for individual consent for these children--encouraging 
them to be herded en masse into drug trials as if they were animals.
    Phase I and Phase II drug experiments involve the highest level of 
risk, uncertainty, and discomfort--the safety and toxicity of drugs as 
well as maximum dose tolerance are tested in these trials. Experiments 
at that testing stage are unlikely to have any direct benefit for the 
children in whom the drugs are tested. In some trials children were 
diagnosed with HIV infection--in some cases infants were merely 
``presumed'' to be HIV-infected:
    #292: A Double-Blind Placebo-Controlled Trial of the Safety and 
Immunogenicity of a Seve n Valent Pneumococcal Conjugate Vaccine in 
Presumed HIV-Infected Infants
    #345 A Study of Ritonavir (an Anti-HIV Drug) in HIV-Positive 
Infants and Children, last amendment 3/13/2000.
    ``Replacement infants . . . are either presumed HIV infected or 
have already been shown to be HIV-infected . . .''
    Infants and children were exposed to experimental HIV vaccines--
which have never been successful:
    #218 A Placebo-Controlled, Phase I Clinical Trial to Evaluate the 
Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-
1gp160 and gp120 in Children >=1 Month Old with Asymptomatic HIV 
Infection.
    Although more than 4 AIDS drugs had never been tested in children, 
foster care children were exposed to an 8 drug cocktail ``some at 
higher than usual doses'' (which was reduced to 7 drugs because of 
``significant toxicity'' 11/9/2001).
    #1007 Multi-Drug Antiretroviral Therapy for Heavily Pretreated 
Pediatric AIDS Patients: A Phase I Proof of Concept Trial
    Among the drugs tested in foster care children, is Nevirapine, a 
drug whose safety has been the center of controversy. [AP] Because 
Nevirapine confers resistance following even a single (low) dose, its 
manufacturer cautions that its use should be restricted to ``previously 
untreated women with HIV infection who present at labor'' for the 
prevention of mother-to-child transmission of HIV. Yet, 4 to 17 year 
old children in foster care were exposed to Nevirapine.
    A Phase I trial of a Glaxo Wellcome drug, Valacyclovir 
hydrochloride was terminated in 1997--Why? Typically, trials terminated 
at such an early stage show unacceptable levels of toxicity.
    The Associated Press reported: ``Some foster children died during 
studies, but state or city agencies said they could find no records 
that any deaths were directly caused by experimental treatments.'' It 
is not for those city agencies to decide the cause of death. ACS 
Commissioner, John B. Mattingly, testified before a City Council 
General Welfare Committee, that he knows of just 19 children--out of 
465--who remain within the NYC foster care system.
    In addition, a series of recent investigative mediareports from 
Texas, Florida, Ohio, New York, California, Illinois, raise concerns 
that over 50% of all children in foster care are currently being 
prescribed untested, experimental combinations of powerful, mind 
altering, psychotropic drugs--including antipsychotics (e.g., 
Risperdal, Zyprexa), anticonvulsants (e.g., Depakote, Neurontin), 
antidepressants (Zoloft, Paxil, Prozac, Celexa and others), 
tranquilizers (Klonopin, Xanax), stimulants (Ritalin, Adderall), as 
well as heavily sedating drugs such as the anti-hypertensive medication 
clonidine. These prescribing patterns are essentially uncontrolled 
experimental drug trials. [See: The Columbus Dispatch series by 
Encarnacion Pyle. Forced medication straitjackets kids, Sunday, April 
24, 2005 http://www.dispatch.com/reports-story.php?story=dispatch/2005/
04/24/20050424-A1-00.html.
    Clinical trials approved by the FDA study only a *single* drug 
given in tightly controlled dosages. Combinations of two and three or 
more different psychotropic drugs have simply never been studied in a 
rigorous and responsible manner. Furthermore, the foster parents and 
social workers who are mostly entrusted with supervising these children 
have less than rudimentary knowledge about these drugs' adverse 
effects, and even less skills in monitoring these children to avoid 
dangerous drug reactions. This is of course less than the protection 
afforded subjects in ordinary clinical trials. It is worth repeating: 
none of these idiosyncratic drug combinations--called polypharmacy--
have ever been studied by any responsible government or other agency, 
and the children receiving them may be considered guinea pigs in a 
gigantic uncontrolled medical experiment.
    How can the Congress fail to take strong corrective action?
    The public has a right to know:

      How many children in foster care have been enrolled in 
clinical trials?
      What happened to foster children who were used as human 
guinea pigs?
      What adverse effects did the children suffer during and 
after participation?
      How many children died during the experiments?
      A question has been raised about the size of the cemetery 
plot in which children in ACS custody are buried: Were any children 
buried in mass graves?
      What were the specific sources of funding for these Phase 
I and Phase II clinical trials?
      Did the foster care agencies or foster families receive 
payment, fees, or other rewards for enrollment of the children in these 
trials?
      How much money was paid to the researchers and 
participating hospitals?
      What happened in 2001 that the AIDS drug trials in foster 
children were stopped?
      What other drug trials are being conducted on foster 
children?

    The other questions we pose below suggest that there may have been 
a breakdown in the implementation of the Adoption and Safe Families Act 
and/or related federal law governing the protection of children in 
foster care. Our questions, by extension, suggest that the Council on 
Accreditation of Family and Children Services (COA), and one of its two 
founding organizations, the Child Welfare League of America (CWLA), may 
not be meeting their obligations.
    Child protection falls within the purview of the juvenile and 
family court system, which remands abused and neglected children into 
the care of public and private, non-profit foster care agencies. In our 
view, the courts have ultimate jurisdiction and responsibility for what 
happens to these vulnerable children.
    The Congress may want to consider a dual approach in dealing with 
the issues at hand. Child welfare laws operate by regulating the care-
givers. Child abuse reporting laws, for example, require health, 
school, and social service personnel to report suspected child abuse. 
If such laws were to define ``suspected child abuse'' to include 
enrollment of foster children in Type I and Type II clinical trials, in 
violation of the protections afforded by 45 CFR 46.409 and 21 CFR 
50.56), there would be many more eyes watching to protect children from 
overreaching biomedical researchers who, history has shown, have abused 
their authority to exploit children in foster care.

      Were there violations of the provisions of the Adoption 
and Safe Families Act and/or related child welfare legislation by 
officials of the foster care agencies that permitted enrollment of 
foster children in Phase I and Phase II clinical trials?
      Should not the supervising foster parents and/or social 
workers have reported suspected child abuse in these high risk, Phase I 
and Phase II clinical trials of experimental drugs and vaccines?
      What training, if any, is provided to supervising foster 
parents and/or social workers about the conditions that must be 
satisfied by reference to 45 CFR 46.409 and 21 CFR 50.56 in order to 
justify enrollment of foster children in ANY biomedical research 
involving greater than minimal risk?
      Is there a need for new federal legislation that would 
amend the Adoption and Safe Families Act and/or 45 CFR 46.409 and 21 
CFR 50.56 to expressly define children in foster care a ``protected 
class,'' whose enrollment in ANY biomedical research would trigger 
appointment of an independent research ombudsman under the supervision 
of the juvenile or family court that remanded the foster child into 
state custody?

    Finally, if, as we argue, the courts have ultimate jurisdiction and 
responsibility for what happens to children whom the courts remand to 
the protective custody of state and private, non-profit foster care 
agencies, then the Congress might wish to consider amending the 
existing requirement for the appointment of a child advocate by the IRB 
pursuant to 45 CFR 46.4.09 and 21 CFR 50.56 to require instead that the 
child advocate be appointed by and be held accountable to the court of 
original jurisdiction for foster children who may be subjected to 
biomedical research involving greater than minimal risk. The courts, we 
believe, are the last recourse that foster children have to protect 
them from the predatory practices of those who would exploit and take 
advantage of their vulnerability. We should remind ourselves that the 
measure of a society is how it treats its most vulnerable citizens.

                                 
      Statement of Cheri Carlene Campbell, American Family Rights 
                Association, Morongo Valley, California
    This information has been assembled to help equip those attending 
[and those who will influence the outcome of] the hearing on June 9, 
2005 in an effort to protect the greater society. You must look closely 
at the problems surrounding Dept. of Children's Services [DCS] to 
discover that the real problem has nothing to do with how funding is 
related to outcomes for children. It is your moral duty to find a 
solution to this Nationwide dilemma which has been plaguing America for 
decades.
    On March 13, 2004 U.S. Congressman Joe Baca gave the victims of DCS 
a voice and sent 163 evidence books to Washington. The people need to 
know what our elected officials have done to protect us and our 
Posterity since receiving the documents proving the ministerial 
ineffectiveness of DCS.
    Victorville, CA--Daily Press: ``United States Accuses 14 Nations of 
allowing Modern Day Slavery'' reads: U.S. criticizes 14 other nations 
of not doing enough to stop the modern day slave trade (prostitution, 
child sex rings, and forced laborers) involving 800,000 annually. 
Condolezza Rice stated, ``The U.S. has a particular duty to fight this 
scourge because trafficking in persons is an affront to the principles 
of human dignity and liberty upon which this nation was founded. U.S. 
spends $96 million to help other countries combat trafficking.'' The 
U.S. is not included on the list although R. Miller said the country is 
far from immune . . . and includes the U.S.--June 4, 2005
    American children and their families are the victims I speak of. 
Children are routinely seized by DCS agents who blatantly violate Laws 
in place to protect the familial bond which include the California and 
U.S. Constitutions! DCS hides their practices under the confidentiality 
clause, which was designed to protect families receiving public 
assistance from embarrassment, not hide their devious practices. DCS is 
a Government sanctioned agency that receives federal and state funding 
in advance for obtaining children, which clearly makes this a problem 
for each branch of Government.
    I agree with Congressmen Herger who believes there should be better 
outcomes for the safety and well being of our children. However, even 
after thousands of complaints from victims of abuse under color of law 
by DCS, our elected officials continue to look for a solution in the 
wrong place.
    Congresswoman Nancy L. Johnson shared the reasonable solution of 
frontloading the money to help keep the family in tact. This would not 
only save the government billions of dollars, it would effectively 
spare the greater society a whole generation of shattered children and 
adults who have no confidence whatsoever for those in authority.
    The problem is multi-faceted and although they appear to be 
complex, these issues are simple to correct. Cross references from 
legal authorities have been used to substantiate the current immoral 
practices and motives used to obtain, detain and adopt our children 
without Due Process which include: California Benchguide [CAB] 100 
Juvenile Dependency Initial or Detention Hearing--revised 2003; Welfare 
and Institutions Code [WIC]; California Rules of Court [CRC]; CA Dept. 
of Social Services Manual--Child Welfare Services Program [CWS]; Family 
Code [FC]; National Association of Social Workers--Code of Ethics 
[NASW].
    Removal of a child: Federal Law mandates there must be a court 
order or voluntary surrender. Cathy Cimbalo [San Bernardino Director of 
DCS] states her social workers must have the agreement of a police 
officer and a court order. When I offered to show the court order 
during the unjust removal of our grandchildren, Deputy Porter stated 
``I don't care what papers you have, we're taking the children!'' Out 
of thousands of `removals,' no victim has ever seen a court order and 
they have not voluntarily surrendered their child! In fact, many have 
been arrested for verbally trying to dissuade the police officer during 
the unjust removal of their children! CWS 361(b) no dependent child 
shall be taken from his parents/guardian where he resides unless the 
juvenile court finds clear and convincing evidence of: (1) substantial 
danger; no reasonable means child can be protected without removing 
him; WIC 300(e) [child has suffered severe physical abuse] shall 
constitute prima facie evidence minor can not be safely left in custody 
of parent/guardian with whom the minor resided at the time of injury. 
Most children have no injuries, which is proven during the medical exam 
performed after removal. This exculpatory evidence is deliberately 
withheld, and is punishable pursuant to Government Code 820.21 which 
strips away supposed immunity! CAB--100.9 Initiating the Hearing--If 
the social worker determines that the child is to be detained, a 
petition must be filed with the Juvenile Court [JC] clerk, who must set 
the matter for hearing on the detention hearing calendar . . . WIC 
311(a) Filing petition for retention of custody . . . Confrontation by 
and cross-examination of witnesses [Due Process] Most [if not all] 
parents/guardians do not contest due to threat [``if you contest 
termination of guardianship, your children will be separated, adopted 
out and you'll never see them again!''], duress and coercion; CRC 
1442(b)--Time limit on custody, filing petition--A detained child must 
be released within 48 hours . . . if no petition has been filed. The 
contents of the petition are prescribed by WIC sect. 332--A petition to 
commence proceedings . . . to declare a child a ward or a dependent 
child of the court shall be verified . . . and CRC 1407--The petition 
shall be verified and may be dismissed without prejudice if not 
verified. An unverified petition may be dismissed without prejudice. 
The laws are in place, but they are constantly violated! An internal 
review is DCS' only watch dog, as they claim confidentiality prohibits 
`outside' review.
    Perverse financial incentive: WIC 319(c) If the matter is continued 
pursuant to Section 322 or for any other reason, the court shall find 
that the continuance of the child in the parent's or guardian's home is 
contrary to the child's welfare at the initial petition hearing or 
order the release of the child from custody. CAB JUDICIAL TIP: Failure 
to make this finding [contrary to the child's welfare] may cause 
permanent loss of federal funding for foster care. Herein lies the 
problem: financial incentive; empires being built off the backs of our 
children of tender years!
    Prima Facie Evidence: Most Americans still trust the Justice System 
even though millions of its victims exist. CRC 1445(a) Requirements for 
detention--(1) a prima facie [Latin for: at first view] showing has 
been made that the child is described by WIC 300 [child abuse, neglect, 
etc], (2) One or more of the grounds for detention in CRC 1446 is 
found; CRC 1446(a) Grounds for detention--There is a substantial danger 
to the child's physical health, or the child is seriously emotionally 
damaged and removal is the only way to protect the child. DCS agents 
have created ``emergencies'' believing they will never be forced to 
prove the petition's allegations. Most court reports and verbage are 
almost identical in all cases.
    Furthering the destruction of the familial bond without Due Process 
is demonstrated in: CRC 1447 Detention hearings; prima facie hearings 
(d) [Hearing for further evidence; prima facie case--If the court 
orders the child detained, and the child, a parent, a guardian or 
counsel requests that evidence of the prima facie case be presented, 
the court shall set a . . . hearing within three court days to consider 
evidence of the prima facie case, or set a jurisdiction hearing within 
10 court days. If at the hearing petitioner fails to establish the 
prima facie case, the child shall be released from custody. WIC 321 If 
the minor, a parent or guardian or the minor's attorney . . . requests 
evidence of the prima facie case, a rehearing shall be held within 
three judicial days to consider evidence . . . if [it] is not 
established, the minor shall be released from detention. Most victims 
do not have a clue these laws exist until it is too late and although 
Cathy Cimbalo continues to say ``we must trust the justice system'' and 
that her ``460 `professionals' only do what the court says,'' we have 
found this to be a deadly combination. Social worker's libelous reports 
are not challenged and are `found to be true' at the next hearing, we 
are rarely allowed to speak in court and our public defenders do not 
defend our rights!
    In 2004, the Federal Government provided more than $7 billion in 
dedicated funds for child protection. The bulk of these funds [almost 
$5 billion] supported children who had been removed from their homes. 
All this money spent to ``protect'' those in foster/adopt/group homes 
where far too many children have been killed or tortured, proves that 
more money is not the solution. Maybe it's time to try a new approach. 
Carefully consider what you have read. Our right to fair and honest 
government, government accountability to the people, and redress has 
thus far been denied. More importantly, our God given inalienable 
rights have been violated!
    You must invoke the power to open DCS files for the sake of 
investigating the current immoral and illegal practices [full Thesis 
available connecting the above Legal references]. We the people 
nominate expert family advocate Bill Tower and Jane Flickinger at 
Pacific Justice Institute as overseers of this Commission.
    We have sought redress from the proper chain of command and found 
no remedy. San Bernardino [S.B.] County Board of Supervisors were duly 
noticed regarding DCS practices of non-compliance to State and Federal 
mandates; were informed that DCS' ministerial ineffectiveness is 
causing irreparable damage to the greater society; and Chairman Dennis 
Hansberger publicly stated 'his hands are tied'. S.B. Grand Jury 
received 13 official complaints against DCS via certified mail in 2004 
and replied, ``After a thorough review [of complaints, evidence], we 
have decided not to investigate.'' S.B. Assistant District Attorney 
Mike Risley was given copies of these complaints, but no remedy or 
acknowledgement has been given to date.
    In conclusion, I must remind you that the U.S. has a particular 
duty to fight this scourge. Trafficking in persons is an affront to the 
principles of human dignity and liberty upon which this nation was 
founded. The following questions remain unanswered: How will this 
Government offer a gentle return of our children when the mask is torn 
off these ``child protectors''? How many more Logan Marr's will have to 
die or be tortured while in the State's care before DCS is completely 
reformed and held accountable? June 9th is our granddaughter Rainya's 
7th birthday and almost 2 years since we've seen our beautiful 
grandchildren . . . today is a great day to start protecting your 
constituents!
    Thank you for your quick resolve in stopping this egregious silent 
epidemic that is now shouting for remedy. Your response, nomination of 
Bill Tower and Jane Flickinger to oversee the investigation of DCS and 
its inter-related service practitioners, and an outline of remedy will 
be expected within 20 days of this communique. We are not just a few 
disgruntled people, we are millions that are growing weary. We will not 
be comforted for the unjust loss of our Posterity. You must assure the 
people that our Nation's officials are going to stop this modern day 
domestic terrorism and pledge to restore democracy in our own backyard.

                                 
           Statement of Linn Asplund, Waterbury, Connecticut
    Thank you for considering my testimony. When me son was 10 years 
old, he was attending Washington School in Waterbury, CT. He started 
having problems in the beginning of third grade, September 1999. He was 
being picked on and bullied by the other children. His grades started 
suffering and he too started having discipline problems. This bullying 
was brought to the schools attention, but it still went on. The 
principal suggested a PPT. I agreed and at the first PPT I agreed to 
have him tested. I was then told he was ``LD'' (Learning Disabled), but 
it `was not that bad.' I told the school I wanted him to go to a school 
where they had smaller classes in which he could learn at his own pace 
and not be picked on. I knew of schools with such classes. I was denied 
this and told by the Special Education Supervisor there was no such 
class. Next they told me they wanted him to see a psychologist for a 
psychological evaluation, I agreed. I obtained a copy of the 
evaluation. My son told the Doctor that he had no friends at school. He 
liked it better at home and would wake up repeatedly at night with 
thoughts of how to quit school. By this time Dr. Abramavich said my son 
was psychotic and needed to be medicated. I refused. The next thing I 
knew, DCF (Department of Children and Families) was at my door telling 
me the school said my son has special needs that need to be taken care 
of. I still refused the psychiatric drugs. I brought him to ``child 
guidance'' and was told that he was a normal child.
    After several visits form DCF I still refused to drug my son. On 
March 16th 2000, I found court papers on my doorstep. In them my 
husband and I were charged with abuse and neglect and were informed 
that DCF was going to take our son from us. Later that day a social 
worker and police officer arrived and took him away.
    Two weeks later, DCF placed him in Waterbury Hospital where Dr. 
Edwards gave my son Haldol and Attavan--mind altering drugs not 
approved for use in children. A few days after this, Dr. Mennessen put 
him on 100 mg of Wellbutrin a day; also not FDA approved for use in 
children. When I asked Dr. Mennessen why he was giving my son this drug 
without my consent, his reply was ``we need a number of cases to get it 
FDA approved.'' Some of the side effects I saw were loss of hair, dry & 
scaly skin, large hive like rashes and very pale skin. While in DCF's 
care my son lost weight and appeared malnourished.
    There were numerous, outright lies in the documents that DCF had 
from the initial ``anonymous'' report from the school, I can provide 
this information and numerous other internal DCF documents regarding my 
sons ``treatment'' should you require it. This of course is a very 
brief summary of what happened to my family. I finally got my son back 
from DCF in August of 2002. This entire nightmare began because I 
refused to put my son on dangerous, mind-altering drugs.

                                 
     Statement of Alexandra Yoffie, Child Welfare League of America
CWLA STATEMENT ON PERMISSIONS FOR CHILDREN IN FOSTER CARE TO 
        PARTICIPATE IN TREATMENT RESEARCH FOR HIV INFECTION
    The Child Welfare League of America and its nearly 900 member 
agencies believe every child and youth is unique, has an intrinsic 
value to society, and is entitled to have their basic care needs met, 
to be nurtured and protected, to heal when harm is done, and to have 
the opportunity to develop to his or her potential. Ensuring that each 
child receives needed primary and preventive health care is an 
essential part of meeting these universal needs.
    CWLA's Standards for Health Care Services for Children in Out-of-
Home Care serve as a guide for the delivery of routine and specialized 
health services to children in foster care and assert that these 
children have human rights that should be protected. Because of the 
vulnerability of children in foster care and the responsibility of the 
child welfare agency toward children in its care, recognition and 
safeguarding of these rights are foremost considerations.
    Concerns have been expressed regarding states that have allowed 
children in foster care to receive experimental treatments for HIV 
infections without adequate safeguards. CWLA's Standards of Excellence 
for Family Foster Care Services provide guidance in this area, stating, 
``The foster care agency should obtain written consent [for medical 
care] from the child's parents, or alternatively, from the court. . . . 
Parents should grant written consent for their child's medical care,'' 
and for those children whose parent's rights have been terminated, the 
agency ``should obtain written consent from the courts.'' This 
provision applies to all forms of medical care, including treatment for 
HIV infection.
    Allowing children in foster care to receive experimental drugs for 
the treatment of HIV infection without providing an independent 
advocate to protect and ensure the child's safety and well-being-, is 
contrary to CWLA's Standards for Health Care Services for Children in 
Out-of-Home Care and our Standards of Excellence for Family Foster Care 
Services.
    As of December 2002, 821,470 adults and adolescents, and 8,804 
children under age 13, had been diagnosed with HIV/AIDS in the United 
States. Many children, particularly those with HIV/AIDS, lack the kind 
of health care coverage that would allow them to receive state-of-the-
art medical care. Children in foster care should not, as a matter of 
course, be denied access to appropriately reviewed and approved 
treatment research. Nonetheless, it is in their best interests for the 
parents or guardians and the child, when appropriate, to participate to 
the fullest extent possible in the development and implementation of 
the health care plan so that each child's unique needs and concerns are 
considered in any treatment decision.
    We encourage all concerned to take this opportunity to more 
comprehensively examine the health care needs of children in foster 
care, including those who are disabled or have mental health needs. In 
many instances, these children are without adequate care to address 
their treatment needs. Priority must be given to providing the advocacy 
and protections that would help ensure all children in foster care 
receive needed services so they might best heal from the harms of child 
abuse and neglect

                                 

                                              Jacobi Medical Center
                                              Bronx, New York 10461
                                                       May 17, 2005
Congressman Wally Herger
Chairman, Subcommittee on Human Resources
Committee on Ways and Means

To the Committee:

    I am currently the Director of Pediatric HIV Services at Jacobi 
Medical Center, a member of the NYC Health and Hospital Corporation, 
located in the Bronx, New York and have a pediatric HIV provider in the 
Bronx for over 20 years. Our program is one of the largest single site 
programs in the United States and provides integrated, comprehensive, 
multidisciplinary care to HIV infected children and HIV-exposed, 
uninfected children as well as integrative care for infected adults and 
other family members. As the Director of a recognized HIV Center of 
Excellence, our program has worked closely with foster care agencies 
and the NYC Administration for Children's Services in managing the 
healthcare of infected children in foster care.
    In addition, I have been involved in clinical trials involving HIV-
infected children as a member of the NIH funded Pediatric AIDS Clinical 
Trials Group (PACTG)as well as a site investigator in clinical trials 
sponsored by pharmaceutical companies. I am currently the Chairperson 
of the PACTG Primary Therapy Research Action Committee which oversees 
HIV therapeutic treatment protocols sponsored by the PACTG and NIH.
    I would like to present a brief personal historical synopsis of how 
therapies for HIV-infected children have evolved since the first 
description of the pediatric HIV-epidemic since its inception in the 
early 1980's. At that time, most HIV-infected children entered care as 
a result of clinical conditions which resulted from their HIV 
associated immunodeficiency. Treatment focused on the child's clinical 
symptoms such as anti-fungals for thrush, nutritional support for 
weight loss and antibiotics for bacterial infections or pneumocystis 
carinii pneumonia (PCP) but without therapies directed at the 
underlying illness (now known to be HIV), the immunodeficiency 
progressed, the child deteriorated and, frequently, death ensued. For 
example, in 1989, I personally attended 1-2 funerals per month for 
children or their parents who were in our care.
    Late in the 1980's, there were rays of hope as new therapeutic 
agents, with limited but real efficacy, began to emerge. Unfortunately, 
due to many fiscal, practical and regulatory reasons associated with 
drug development for FDA approval, children did not have availability 
to these agents for 1-3 years after they were available for use in 
adults. The only way for an HIV-infected child to gain access to AZT 
(zidovudine, Retrovir) was through a compassionate access protocol 
sponsored by the manufacturer, which required an informed consent by a 
guardian or parent. While this agent, as monotherapy, has extremely 
limited efficacy, for many, especially those who were very ill and 
rapidly deteriorating, the alternative therapy was no therapy. I can 
remember giving out the first pediatric AZT bottles to children and 
their families during our 1989 Christmas party and the joy, tears and 
hugs that accompanied this ``gift.'' To the families and children, it 
was the first concrete impression that there was hope that this 
therapy, or future ones, would significantly prolong lives. At that 
time, if there was no mechanism available for obtaining consent, many 
children in foster care would not be afforded this therapy, subsequent 
therapies and, the hope, for clinical improvement and life extension.
    In fact, this hope has been born out as demonstrated by HIV 
survival data (both pediatric and adult) throughout the medical 
literature as well as statistics from the CDC. On a more local level, 
our program is providing care to over 250 HIV-infected children; over 
the past 12 months only 1 child has died. Some 50% of children in our 
care have ``undetectable viral loads'' which suggests suppression of 
HIV replication and, in general, the majority of children in our care, 
are immunologically (as measured by CD4 numbers and percentages) 
healthier now than they were in 1993. While all therapies have 
potential and real toxicities, especially HIV medications, these 
children are significantly healthier now than in the past and most are 
fully involved in school, after school and other activities shared by 
healthy children.
    I am in total agreement with the need for well defined systems to 
protect the rights of children in foster care systems including the 
appointment of an independent advocate for the child. However, I 
strongly believe as a health care professional caring for children with 
a chronic, life threatening illness, that a reactionary posture in 
response to localized cases where some administrative oversight has 
been missed would be an ethically unacceptable position for our 
society. How can one refuse therapy to a child of a therapy which has 
been demonstrated, in rigorously controlled clinical trials, to be 
effective, simply because there is no one legally capable of signing 
consent for a trial which makes that therapy available? If you are HIV 
infected, severely immunocompromised and resistant to all available 
therapies, shouldn't society be able to provide a mechanism which 
balances the potential for clinical improvement and well-being for this 
child with a mechanism that respects their rights as a participant in a 
clinical trial? As an HIV clinician, I have experienced the pain and 
suffering associated with the lack of access of therapies.
    I would also like to quickly comment on some of the allegations 
about the content of many of the clinical trials in which children in 
foster care may have been participants. In NYC, the ACS had strict 
guidelines for approving clinical trials for children: the bottom line 
was that the trial had to provide the potential of benefit for that 
individual trial. For example, foster children in NYC, in the absence 
of maternal consent, were not allowed to participate in the PACTG 219 
study which was a long-term, natural history study where data was 
collected during regularly scheduled visits. While the result of this 
study has benefited HIV infected children, there clearly was no benefit 
to the individual child.
    However, the Alliance for Human Research Protection listed in their 
3/10/05 letter to the OHRP and FDA that foster children were 
inappropriately enrolled into numerous NIH-PACTG trials. Included in 
this list was PACTG 377 of which I was the co-chairperson. This trial, 
a Phase I/II (not purely a Phase I) trial, strategically compared a 
number of therapeutic regimens for advancing the treatment of HIV 
infected children when contrasted with standard of care. This study was 
linked to PACTG 338 which demonstrated that a protease inhibitor 
containing regimen was superior to the existing standard of care (two 
nuclosides). Importantly, these studies were invaluable as they 
contained provisions that the first 8 children in each arm participate 
in an intensive pharmacokinetic (pk) evaluation to ensure that the 
dosing was appropriate when compared to drug exposure that had been 
demonstrated, in adults, to be safe and effective. This component of 
the study, which required it to be partially labeled a Phase I study, 
protected the study participants as demonstrating the correct dose 
prevented the overdosing of children which would lead to increased 
toxicity or underdosing the child which would lead to inadequate drug 
exposure and rapid development of resistance to that therapy and, 
potentially, other agents in that treatment (i.e.; protease inhibitor) 
class. These studies clearly demonstrated that children metabolize many 
of these agents much more rapidly than adults and that to achieve 
equivalent efficacy with adults, drug dosing in children needed to be 
higher than one would expect.
    In fact, it was data from this study and other studies which were 
important in the signing, by President Bush on 12/3/03, the Pediatric 
Research Equity Act of 2003 (S. 650/H.R. 2857), which restores the 
protections of the Food and Drug Administration's (FDA) 1998 Pediatric 
Rule. This legislation was hailed as a necessary safety net for 
children.
    In addition to ensuring that the dosing was correct (the protocol 
provided provisions for dose modification if needed from the pk 
evaluation), these studies also contain extensive, real time, safety 
evaluations and patient management requirements to protect the health 
of children on the study. The information concerning the safety, dosing 
and efficacy of therapies included in this study, and others, has 
significantly advanced our knowledge about treating pediatric HIV 
infection. This information has been essential for advances in care 
which have been translated into improved health and survival for 
children residing in the developed world. This, I see, every day, when 
I walk into our outpatient pediatric HIV clinic and am greeted by 
healthy looking, HIV-infected children, adolescents and young adults. 
Without early access to therapy for all, including those in foster 
care, I do not believe that this would have been possible.
    The proper response for future children living in foster care with 
chronic, terminal illnesses should not be to have policies which 
prohibit and withhold therapies. In 1986, there were only a handful of 
people who thought that an HIV-infected child would survive to 
adulthood. This is now common in the Bronx.
    We just need to be more diligent in ensuring that successful 
policies and procedures are in place to protect the rights of these 
children. Their rights, however, include having access to therapies 
that provide hope.
    If needed, I am willing to work with this subcommittee, on this or 
any related matter.

            Sincerely,
                                                      Andrew Wiznia
                                           Director of HIV Services

                                 

                    Johns Hopkins Bloomberg School of Public Health
                                          Baltimore, Maryland 21205
                                                       May 31, 2005
Representative Wally Herger, Chairman
Representative Jim McDermott, Ranking Member
Subcommittee on Human Resources
Ways and Means Committee
United States House of Representatives
Washington, DC

Dear Chairman Herger and Ranking Member McDermott,

    We are aware that the Subcommittee on Human Resources of the House 
Ways and Means Committee is reviewing the required procedures for 
protecting children, including children who are wards of the state, 
when they become subjects in research studies. I am writing to describe 
briefly the procedures used by the Institutional Review Boards (IRBs) 
of this School to ensure that all children, including wards, receive 
the additional protections required because of their vulnerable status. 
I also wish to convey our strong support for the current federal 
regulations that govern research that involves children (45 CFR 46, 
Subpart D).
    It is the understanding of our IRBs that the principle of justice, 
as described in the Belmont Report, requires that all populations, 
including children, have the opportunity to take part in research and 
to share in its benefits. Furthermore, we support the strong 
recommendations of both the American Academy of Pediatrics and the FDA 
that research on children is essential in order to determine how new 
findings can be safely and most effectively used for their benefit.
    To achieve these objectives our IRBs require that children be 
included in all of this School's human research activities unless there 
are specific scientific or ethical reasons for excluding them. 
Following the principle of justice, we also require that all children 
have equal opportunity to take part in research unless, again, there 
are scientific or ethical reasons for excluding particular individuals 
or members of specific groups or populations.
    When reviewing proposed research that would include children our 
IRBs follow very carefully the requirements of Subpart D to determine 
the category of research and the requirements for consent and assent 
(46.404, 46.405 or 46.406). The IRBs focus especially on the assessment 
of risk to the child and on the prospect for direct benefit for the 
child. Our assessment of risk is, if anything, overly cautious in favor 
of the child, and the prospect for direct benefit, if any, is 
consistently weighed against this cautious assessment of risk. We 
believe that the categorizations made by our IRBs are consistent with 
the federal requirements and, more importantly, ensure appropriate 
protections for each child.
    In accord with the position described above, we firmly believe that 
children who are wards of the state deserve the opportunity to 
participate in research, and especially so when they suffer 
disproportionately from the condition being studied, an example being 
HIV/AIDS. We would emphasize, however, that wards are not targeted for 
inclusion. Rather, their status as wards is simply coincidental to 
their being eligible for enrollment in the study. We also share the 
view that children who are wards of the state require special 
protection because of their uniquely vulnerable situation. We believe, 
however, that this is adequately ensured by the requirements outlined 
in 46.409, which require an advocate for each child involved in a study 
categorized as involving greater than minimal risk and having no 
prospect of direct benefit for the child (46.406). In our view, 
extending the requirement for an advocate to studies that are greater 
than minimal risk but having the prospect for direct benefit for the 
child (46.405) would create a substantial barrier to conducting such 
studies while providing no clear added protection for the child.
    We hope that these comments and our strong support for maintaining 
the current federal regulations concerning protection of children will 
be of help to the Subcommittee in its deliberations. I would, of 
course, be pleased to respond to any specific queries that may arise.

            Sincerely,
                                             Alfred Sommer, MD, MHS
                                                               Dean

                                 

              National Institute of Allergy and Infectious Diseases
                                            Potomac, Maryland 20854
                                                        May 9, 2005
The Honorable Daniel R. Levinson
Inspector General
U.S. Department of Health and Human Services
330 Independence Avenue, S.W.
Washington, D.C. 20201

Dear Mr. Levinson:

    I am writing you in fulfillment of my obligation as a federal 
employee of the National Institutes of Health to report possible waste 
and fraud under Executive Order 12674 and 12731, and NIH Policy Manual, 
Section 1754(C)(1)(a),(b) and (c). Currently I am the Director of the 
Office of Policy in Clinical Research Operations (OPCRO) in the 
Division of AIDS of the National Institute of Allergy and Infectious 
Diseases (NIAID).
    On Wednesday, May 4th, the Associated Press (AP) reported:

    Government-funded researchers tested AIDS drugs on hundreds of 
foster children over the past two decades, often without providing them 
a basic protection afforded in federal law and required by some states.
    The basic protection denied these foster children was the 
appointment of an advocate ``to act in the best interests of the 
child,'' as explicitly required by 45 CFR 46.409:
Sec. 46.409 Wards.
    (a) Children who are wards of the State or any other agency, 
institution, or entity can be included in research approved under 
Sec. 46.406 or Sec. 46.407 only if such research is:
    (1) related to their status as wards; or
    (2) conducted in schools, camps, hospitals, institutions, or 
similar settings in which the majority of children involved as subjects 
are not wards.
    (b) If the research is approved under paragraph (a) of this 
section, the IRB shall require appointment of an advocate for each 
child who is a ward, in addition to any other individual acting on 
behalf of the child as guardian or in loco parentis. One individual may 
serve as advocate for more than one child. The advocate shall be an 
individual who has the background and experience to act in, and agrees 
to act in, the best interests of the child for the duration of the 
child's participation in the research and who is not associated in any 
way (except in the role as advocate or member of the IRB) with the 
research, the investigator(s), or the guardian organization.
    The AP report further states:
    The research was conducted in at least seven states--Illinois, 
Louisiana, Maryland, New York, North Carolina, Colorado and Texas--and 
involved more than four dozen different studies. The foster children 
ranged from infants to late teens, according to interviews and 
government records.
    These clinical research studies were funded primarily through 
grants awarded to researchers by the Division of AIDS (DAIDS).
    I would like to bring to your attention that according to the NIAID 
Clinical Terms of Award: All clinical research supported by NIAID must 
comply with applicable Parts of U.S. Code of Federal Regulations, Title 
45, Part 46 ``Protection of human subjects.'' (Emphasis added)
    The failure of numerous DAIDS/NIAID-sponsored researchers and their 
institutions to assure that foster children enrolled in their research 
were appointed individual advocates even where a foster parent exists 
constitutes a violation of the terms of their grant awards. By any 
definition, this is a severe violation because it directly impacts the 
health and safety of foster children, among the most vulnerable 
populations in our society.
    Please be advised that 45 CFR 46.409 contains no exceptions to the 
requirement that foster children enrolled in research must be provided 
with advocates, although an advocate may serve more than one child.
    The claim by some researchers that ``oversight boards may decline 
to appoint advocates if they conclude the experimental treatment 
affords the same or better risk-benefit possibilities than alternate 
treatments already in the marketplace'' is simply false. There is no 
provision in either law or regulation that allows researchers or their 
oversight boards to waive the rights of children in clinical trials to 
have advocates.
    I ask that the your office immediately conduct an investigation to 
determine which foster children were denied their rights under the law 
and to seek a full recovery of grant funds from the researchers 
responsible for this lapse.
    Furthermore, I respectfully suggest that your review include a 
comprehensive financial and protocol audit of each of the research 
entities and clinical trial sites involved in these studies. As part of 
this inquiry, the medical and study records of each foster child 
enrolled in their respective AIDS clinical trial should be examined to 
determine whether any of these children were subjected to unnecessary 
risk or injury owing to the toxicity of the drugs administered to them, 
and whether the researchers complied with their obligations to report 
all adverse events.
    Your office should be aware that DAIDS/NIAID currently is 
soliciting applications for HIV/AIDS Clinical Trials Networks and 
Clinical Trial Units. Applications are due this month and in July, 
2005, respectively. Funding for both is expected to total up to $300 
million for the first year and may continue for up to seven years. 
(See: http://www2.niaid.nih.gov/newsroom/Releases/ctu2005).
    It is expected that many of the investigators and their 
institutions responsible for enrolling foster children in AIDS clinical 
trials without the appointment of advocates will be competing for the 
upcoming award.
    It is wholly inappropriate for DAIDS/NIAID to consider making 
awards to any of these applicants who have violated basic human 
research protections until a full, open and independent investigation 
has concluded and full restitution is made to both the government and 
the victims of these unlawful experiments.
    Thank you for your time and attention to this important matter. 
Please feel free to contact me at my home telephone number, 301/983-
4370 if I can be of further assistance.

            Sincerely,
                                         Jonathan M. Fishbein, M.D.
                                                           Director
                                                   Division of Aids
                  Office for Policy in Clinical Research Operations

                                 
    Submission of John Mattingly, New York City Administration for 
                Children's Services, New York, New York
    Good afternoon Chairman Herger and Members of the Subcommittee. I 
am John Mattingly, Commissioner of the New York City Administration for 
Children's Services (Children's Services) and I submit this testimony 
on behalf of Children's Services regarding participation of children in 
foster care in HIV/AIDS clinical trials during the late 1980's and 
early 1990's.
    As a professional whose career has been focused in child welfare 
for over 30 years, I want to begin by stating that it is imperative--
both in terms of our own institutional integrity and our critically 
important relations with the communities we serve--that the serious 
questions that have been raised regarding inclusion of children in 
foster care in HIV clinical trials are fully explored, and that that 
review process be transparent to the public and conducted with due 
diligence.
    That is why I have asked the Vera Institute, a New York-based not-
for-profit research institute which works with government to study a 
variety of social issues, to conduct a comprehensive analysis. An 
independent Medical Oversight Committee, consisting of nationally known 
experts in pediatric AIDS, medical ethics, and the taxonomy of clinical 
trials, will review, respond to, and provide guidance to the Vera 
Institute's review of cases. Having said that, I want to make equally 
clear that I have seen no evidence to date of any wrongdoing or 
malfeasance in regard to these clinical trials, and much of what I've 
seen speaks to the good faith of those who had decision-making 
authority at that time.
History of Clinical Trials in New York City
    Along these lines, I would first like to bring us back to the 
calamity that befell New York City and its children in the late 1980's 
and early 1990's with the arrival of the AIDS epidemic in the lives of 
infants and children.
    At that time, HIV/AIDS, fueled in part by the crack crisis, had 
reached epidemic levels in New York City, and no effective treatment or 
medical regimen to manage the disease had yet been found for children, 
nor did such treatment appear imminent. The mortality rate for those 
who suffered from full-blown AIDS was 100 percent. Newspapers and 
scientific journals, as well as doctors, social workers and 
administrators in the child welfare system, hospitals and beyond, 
struggled with stemming the ominous tide of a disease that, at that 
time, had no end in sight.
    The impact the disease was having on many of the City's children 
and families was devastating. Media accounts from those years described 
the funerals of children who had died of AIDS, of children desperately 
trying to hide from their friends the fact that they had been infected 
with the HIV virus, and of boys and girls who were spending their early 
years in and out of the hospital, suffering from repeated bouts of 
pneumonia and other illnesses as a result of their HIV infection. All 
this suffering occurred without any medical regimen available to even 
begin addressing their illness.
    At that same time, the scientific community was advocating strongly 
for making available to children those HIV/AIDS drugs that were 
beginning to make a difference for adults afflicted with AIDS and the 
HIV virus. The journal Science, one of the most respected scientific 
publications in the world, published an October 1989 article on the 
subject. The author described as ``heartrending,'' the lack of 
availability of AIDS drugs for children, who were characterized as 
``being left out in the cold.''
    Some of the doctors and nurses who treated children infected with 
HIV/AIDS as well as social workers who cared for many of them have told 
us about the heartbreak they experienced, as they watched children 
suffer and die. They also told us of their heartrending frustrations 
that there was so little they could offer by way of treatment.
    The cold numbers bear out what the written historical record 
reveals: in March 1987, 183 children under the age of 13 with full-
blown AIDS had been reported to the City's Department of Health (DOH). 
In 1991, just four years later, DOH reported that the number of 
children in the City with the disease had nearly quadrupled, to 745. By 
then, these reported cases comprised 26 percent of the nationwide 
pediatric caseload. Even more alarming was the fact that City health 
officials at the time believed that there were far more children 
infected with the HIV virus who had not yet developed the AIDS disease.
    The vast majority of HIV positive children contracted the virus 
perinatally. Of the 131,498 babies born in New York City in 1990, 
1,644, or 1.25 percent, tested positive for HIV.
    Nationally, according to the Centers for Disease Control, some 
14,000 children under age 13 had been diagnosed as HIV positive or had 
developed AIDS between the time of the emergence of the illness in the 
mid 1980's and 1993. During the same period in New York City, 3,634 
children under 13 were diagnosed as HIV positive or as having developed 
AIDS.
    In 1989, the NIH AIDS Program Advisory Committee recommended 
``cutting through'' bureaucracies that prevent children from receiving 
potentially beneficial treatment through involvement in research. The 
NIH sponsored clinical trials in seven states: Colorado, Illinois, 
Louisiana, Maryland, New York, North Carolina and Texas. Also, in 1989, 
the Secretary for Health and Human Services' Workgroup on Pediatric HIV 
Infection and Disease, supported by the AmericanAcademy of Pediatrics, 
recommended that guidelines be developed governing the participation of 
foster care children in HIV clinical trials.
The City of New York's Previous Procedures
    In 1988, at the urging of local hospitals, health care workers, and 
advocacy groups, the New York City Human Resources Administration (HRA) 
and its Child Welfare Administration (CWA), first began to develop its 
policy to allow children in foster care to participate in HIV clinical 
trials. This decision was made in the face of the rising number of HIV 
positive children in the New York City foster care system with high 
rates of illness and death.
    Those urging HRA to develop such a policy argued that foster 
children with HIV/AIDS should not be categorically denied access to 
promising treatments that were available to children not in foster care 
who were already being enrolled in these trials by their parents. At 
the time, AZT had just been approved for use in adults and was about to 
begin trials in children; it was the first medication demonstrated to 
slow the progression of AIDS. The only way to receive the medication or 
medication regimen was to participate in a clinical trial. These 
medications were not available to children outside of the trials, even 
though in many cases adults were receiving the medications with 
prescriptions.
    Before making the policy decision that HRA would consider the 
enrollment of children in foster care in HIV clinical trials when 
appropriate, HRA conducted an exhaustive review of the ethical, 
medical, and legal implications of foster child participation in 
clinical trials. The decision to go forward was also made after meeting 
with representatives from the NIH and with several of the New York City 
investigating physicians who were conducting clinical trials. A series 
of discussions with NIH were held in order to clarify the process for 
its scientific approval of protocols. Consultations were also held with 
representatives from the New York City Department of Health, the New 
York State AIDS Institute, and the National Medical Association.
    On January 24, 1989, HRA approved the first HIV clinical trial for 
participation by children in its care. HRA made an initial decision 
that because certain clinical trials offered children a therapeutic 
benefit they fell under the umbrella of ``medical treatment'' and 
outside the definition of human research. The essential criterion for 
permitting such participation was a determination by HRA that the trial 
offered each participating foster child a significant potential 
treatment benefit, along with concomitant minimal risk of injury or 
harm.
    The early approach to assessing a clinical trial and then agreeing 
to enroll a child from foster care was so cautious and the review 
process in place was so cumbersome that the medical community and 
advocacy groups excoriated HRA for delaying critical medical care for 
terminally ill children, and urged HRA to speed up its clinical trial 
approval process. Otherwise, these groups argued, children would miss 
the opportunity to enroll, or their disease would progress to a point 
where they could no longer benefit from the new treatments.
    In response, HRA developed a new procedure, which provided 
comparable safeguards for children, while addressing the need for 
timely response. Beginning in 1991, the NIH agreed to forward approved 
clinical trial protocols to HRA while local hospital Institutional 
Review Boards were conducting their own reviews. HRA then convened a 
panel of two to four physicians specializing in pediatric HIV/AIDS, as 
well as program staff from the HRA/CWA Pediatric AIDS Unit (PAU) and 
HRA legal staff. The physicians on the panel would conduct a scientific 
and medical analysis, including whether there was a significant 
potential medical benefit for the participants, and a discussion of the 
risks associated with the trial. CWA program staff would weigh in, 
offering opinions on the protocol based on the agency's policy.
    Next, the legal staff would synthesize this material, write a 
description and analysis of the protocol for the HRA Commissioner and 
state a legal opinion regarding whether enrollment in the protocol was 
allowable under state law. The final determination for permitting 
children to enroll in the HIV clinical trial was made by the 
Commissioner. For approved trials, a letter of agreement was signed 
between the investigating physician at the hospital and the HRA 
Commissioner.
    When the Commissioner of HRA agreed to permit the enrollment of 
children in foster care in particular clinical trials, it was because, 
after a multi-level review that included the participation of medical 
professionals, the Commissioner had determined that those trials 
provided significant potential medical treatment not available outside 
of the clinical trial. The determination as to whether it was 
appropriate for a particular child to participate in a particular trial 
would follow the approval of the trial itself for potential enrollment 
by children in care. That determined, the consent from the parent would 
then be sought and obtained, unless the parents' whereabouts were 
unknown or the child was freed for adoption, in which case the 
Commissioner or his/her designee would consent.
    Those HIV protocols that had been approved for foster children all 
had a treatment arm that offered a promising drug or therapy that would 
otherwise be unavailable to foster children and were being provided to 
children not in foster care who were enrolled in the clinical trials. 
While it was recognized that there were some risks involved in the use 
of these treatments, such risks were deemed minimal compared to the 
contemplated benefits for these children.
    As the number of pediatric AIDS cases increased across the United 
States, the National Institutes of Health (NIH) AIDS Program Advisory 
Committee (as reported in a 1992 U.S. Surgeon General report entitled 
``Points to Consider: Involving HIV Positive Foster Children Who Are 
Wards Of The State in HIV/AIDS Research'') raised issues concerning 
foster children in clinical trials. ``Committee members recommended 
``cutting through'' bureaucracies that prevent children from receiving 
potentially beneficial treatment through involvement in research. The 
American Academy of Pediatrics (AAP) Committee on Drugs endorsed the 
inclusion of children in state care/custody in clinical trials in 
certain circumstances. The AAP also raised concern about the lack of 
participation of children in clinical research and reported that only a 
small fraction of all drugs marketed in the U.S. had clinical trials 
performed in pediatric patients. The AAP has continually supported the 
inclusion of children in clinical trials as a way of protecting 
children not only from the harms of life threatening diseases, but 
because clinical trials are a controlled setting, they also protect 
children from harms which might result from children taking medications 
whose dosages have only been tested in adult populations.''
    In 1996, the New York City Administration for Children's Services 
was established. The policies and procedures from CWA were continued 
under Children's Services unless specifically changed. In 1998, 
Children's Services revised its HIV testing and assessment procedure 
and included in the new procedure a section on clinical trial 
enrollment, modifying the existing HRA procedure.
    Through this new procedure, the threshold question when a foster 
child's participation in a clinical trial was being considered 
continued to be whether the clinical trial offered a significant 
potential benefit to the child, with a concomitant minimal risk of 
injury or harm. Children's Services continued to convene its panel of 
experts in pediatric HIV disease to advise the agency of the risks and 
benefits of proposed studies or trials for children in foster care 
suffering with HIV/AIDS. This panel of experts, together with 
Children's Services professional staff, then heard a presentation given 
by the lead physician at the hospital conducting the trial.
    The Commissioner, after reviewing the recommendations made by 
Children's Services legal and medical staff, as well as the written 
scientific evaluation and the protocol from the physicians on the 
panel, then decided whether that trial was appropriate for children in 
foster care. Also, for a foster child to be enrolled in the trial, the 
child's mother or legally acknowledged father had to consent to the 
child's participation if her or his whereabouts were known to 
Children's Services. The child's foster parent could not provide 
consent. If the child's birth parent could not be located after written 
and documented reasonable efforts, Children's Services would make the 
decision.
    One key addition was included in the policy enacted in 1998: once 
all of the appropriate actions were taken leading up to an executed 
agreement for the trial, it then required that an independent physician 
would review each child's case to confirm that the study enrollment 
would provide the best available treatment for that child.
    In most of the clinical trials that Children's Services has 
reviewed to date, the medications had already been FDA approved for 
adults and the clinical trials were intended to determine what dosage 
of the medication would be advantageous for children. In other trials, 
the medications had been individually FDA approved and these clinical 
trials were to evaluate the effects of combination treatments and 
dosage involving those medications. In fact, Children's Services only 
approved clinical trials where risks and discomforts to children were 
minimized and the therapeutic value outweighed the risks.
    The vast majority of clinical trials were conducted very early on 
in the HIV/AIDS epidemic and only half the clinical trials reviewed 
were accepted for participation. Between 1996, when Children's Services 
was established as an independent agency, and 2001, only four trials 
were approved and one of these was approved for one child only. No 
clinical trials have been approved since 2001.
    In the late 1990's, there was a dramatic shift in the field of 
pediatric AIDS, as effective treatments were at last available outside 
of clinical trials, treatments which had been developed as a result of 
the information learned from earlier clinical trials. At the same time, 
fewer infants were born HIV positive due to medical interventions that 
dramatically reduced the rate of perinatal transmission. As noted in a 
New York Times article dated January 30, 2005, ``AIDS among infants . . 
. may be on the verge of being eliminated in the United States. . . .'' 
As a result, there was no longer a pressing need for children to have 
access to clinical trials, except in isolated instances, where HIV 
infected children had developed resistance to existing medications.
Recent Events
    Beginning in March 2004, Children's Services initiated an extensive 
review of the agency's PAU hard copy files on HIV children who 
participated in clinical trials. This review garnered a list of 89 
children who appeared to have participated in clinical trials at some 
point between 1989 and 2001.
    To have a more complete understanding of the clinical trial 
enrollment process, 24 cases were selected for a detailed medical 
record review. The sample included 11 children currently in foster 
care; 7 children who, at the time, had been discharged from foster care 
within the past 2 years, either through adoption or reunification; and 
6 children who died while in foster care. All of the six children who 
were deceased had died between 1992 and 1998. There was nothing in the 
records to suggest that clinical trial medications contributed in any 
way to the children's deaths. On the contrary, it appears that the 
medications extended the lives of many children. Five of the children 
died of AIDS-related illnesses and one died of unrelated causes.
    I decided to conduct an internal query of agency records to be sure 
that Children's Services had identified and reviewed all information 
pertaining to the enrollment of foster children in clinical trials. It 
was determined through that review that more children had been enrolled 
in clinical trials than were identified in the initial review. At this 
time, Children's Services believes that approximately 465 children were 
enrolled in clinical trials.
Development of New Policy
    We are now near finalization of a new policy governing the 
enrollment of children in clinical trials. Beginning last summer, this 
policy was developed after a series of meetings with focus groups and 
interviews with a multidisciplinary group of experts in pediatric HIV/
AIDS. It will add additional protections for children in care including 
clarification regarding the importance of parental consent and child 
assent. This proposed policy would further protect children, by 
guarding against any potential conflicts of interest or appearances 
thereof on the part of physicians who review clinical trials and make 
recommendations regarding enrollment of children in foster care.
    It is important to note that this policy is being revised to 
provide further protections as an additional safeguard; not because any 
information suggests children were inappropriately enrolled in clinical 
trials was uncovered. We will be glad to share this new policy upon 
completion of its revision.
Vera Institute of Justice Review
    I have asked the Vera Institute of Justice, to research Children's 
Services' policies and procedures to ensure that HIV-positive children 
and children with AIDS who were in our care were appropriately enrolled 
in clinical trials. The Vera Institute is particularly well qualified 
to carry out this kind of investigation. Over more than four decades, 
Vera has developed an international reputation as an independent, 
nonprofit organization that provides the highest quality research on a 
wide range of justice-related issues. The analysis organized by the 
Vera Institute will also examine whether:

      all necessary consents by parents and other guardians 
were obtained,
      the individual children's enrollments in clinical trials 
were reasonable and appropriate, given the scientific knowledge and 
medical options available at the time,
      NIH protocols were followed, and
      HRA and Children's Services properly monitored children 
after they were enrolled.

    The Vera Institute will also seek to locate the children who 
participated in these trials while in foster care to ascertain their 
current medical condition and solicit their feedback regarding the 
medical care they received.
    We have asked Vera to conduct this study in order to address 
ongoing questions from the public and the press about the history of 
clinical trials. Vera is committed to developing this comprehensive and 
transparent understanding of Children's Services' policies and 
practices during this period. Although we believe that the policies in 
place at the time reflected good practice, and while we have seen no 
evidence that would cast doubt on the intentions of those in decision-
making authority at the time, we are committed to providing transparent 
and accurate information in our dealings with the public.
    In order for us to be effective in our mission to protect New York 
City's children, it is my firm belief that we must have a sense of 
mutual trust with those families we seek to serve. I have only been the 
Commissioner of ACS since August of 2004 but I have worked in the field 
of child welfare for most of my professional life, and I certainly 
understand why this is a subject that causes great concern. It involves 
the well being of children, sick children, and vulnerable children who 
were in the care of Children's Services and not in the care of their 
own parents. We will do all we can to ensure that Vera's review fully 
answers all public concerns about the participation of New York City 
foster children in HIV clinical trials, in the late 1980's and 1990's.
    Vera will organize a review of case records and medical records for 
all of the children identified as clinical trial participants, and will 
prepare a public report regarding its findings. Vera's work will be 
reviewed by an independent Medical Oversight Committee (Committee), 
consisting of nationally known experts in pediatric AIDS, medical 
ethics, and taxonomy of clinical trials. These independent experts--
whose work will be funded by private foundations--will provide 
oversight for Children's Services' current policies and comment on the 
Vera review. This Committee will provide additional expertise and 
accountability for all of the City's actions as part of the Vera 
Institute's review. The Committee's findings will include 
recommendations for future Children's Services policy regarding 
clinical trial participation, as well as an analysis of the procedures 
and protocols that were used in the past. Dr. Robert L. Johnson, an 
expert on HIV/AIDS, will chair the Committee. As with the Vera 
Institute's report, the Committee's comments will be public.
    Concurrent with the Vera Institute's review, Children's Services 
will conduct additional case record reviews to ensure that every child 
in foster care who participated in clinical trials has been identified, 
and will continue to interview Children's Services staff members who 
played a role in developing and implementing the HIV clinical trial 
policy over the last eighteen years.
Conclusion
    Faced with an AIDS epidemic in the late 1980's and early 1990's, 
left without effective treatment for children, and at the urging of 
medical professionals, HRA developed its policy in an effort to allow 
children in foster care to have access to medication that was being 
made available to children not in foster care. The essential criterion 
for permitting the participation of children in foster care was a 
determination by HRA that the trial offered each participating child a 
significant potential treatment benefit, along with concomitant minimal 
risk of injury or harm.

                                 
 Statement of Stephen A. Spector, M.D., Pediatric Aids Clinical Trials 
  Group, and University of California, San Diego, La Jolla, California
    My name is Stephen A. Spector, M.D. I am a Professor of Pediatrics 
at the University of California, San Diego, and Principal Investigator 
and Chair of the Executive Committee of the Pediatric AIDS Clinical 
Trials Group (PACTG). Over the past 15 years the PACTG, funded by the 
National Institute of Allergy and Infectious Diseases and National 
Institute of Child Health and Development, has been the world leader in 
the development of therapies to prevent the HIV mother-to-child-
transmission and to treat children infected with HIV. It is the 
organization that is most responsible for changing pediatric HIV/AIDS 
from a once invariably fatal disease to a chronic illness. I believe my 
comments, in large part, reflect the opinions of all PACTG 
investigators and the American Academy of Pediatrics.
    I am pleased to have an opportunity to respond to the unfounded 
suggestions by some that HIV-infected foster children were 
inappropriately enrolled in clinical trials. In the 1980s and for much 
of the 1990s, HIV/AIDS was a fatal disease with many children not 
surviving beyond their first few years of life. Limited treatments were 
available and the only access for children to potentially life saving 
medications was through clinical trials. These experimental therapies 
were unproven, but offered hope for HIV-infected children and their 
families. Investigators of the PACTG offered children the opportunity 
to participate in clinical trials regardless of race, ethnicity, creed 
or financial status. As pediatricians and child advocates, every effort 
was made to make these potentially life saving treatments available to 
children who were HIV infected and in foster care. At no time were 
clinical trials targeted for foster children and foster children 
comprised only a small proportion children who participated in any 
study. The suggestion that foster children were specifically singled 
out for participation in studies of new treatments is not only false, 
but undermines the heroic efforts of many dedicated health 
professionals who worked tirelessly to help save the lives of all 
children with HIV/AIDS. In fact, many foster children are alive today 
because they able to receive ``experimental'' drugs that were only 
available, at that time, as part of clinical trials. To have left 
foster children out of these clinical trials would have deprived them 
of benefits provided to other children.
    All children, including those in foster care, are perhaps the most 
vulnerable group of the general population with regard to possible 
exploitation in clinical research protocols, and yet they are the group 
that can often have the most significant and prolonged benefit from 
such studies. Every effort must be made to retain the dignity and well-
being of children in every step of the clinical protocol process. This 
includes the request for study participation, explanation of risks and 
benefits of a study, obtaining consent from parents (and in the case of 
foster children, a court appointed advocate) and assent from children 
of appropriate age, monitoring for treatment side effects, and 
presentation and publication of research findings. The success of 
treatments for children with HIV/AIDS demonstrates the benefits that 
studies of new drugs can provide not only for HIV-infected children but 
also for children with other potentially fatal diseases. To deny 
children in foster care an opportunity to benefit from such treatments 
would be medically unacceptable and morally reprehensible.
    Despite the many advances that have been made in the treatment of 
children with HIV/AIDS, much research remains to be done before there 
is a cure. HIV-infected children must continue to have access to new 
treatments. The differences of biological and chemical handling of 
drugs in children is well known, and the assumption that drug 
processing will be similar to that in adults and will require a simple 
dose reduction for children, has proven time and again to be flawed. 
Thus, therapeutic and preventive interventions must be studied in 
children and not extrapolated from studies in adults. Investigators, 
sponsors, research review boards, regulators, and others engaged in 
pediatric research are rightly held to a higher standard of concern 
because of the fragile nature of children and their rights to a life as 
free as possible from pain and suffering. However, the zeal to protect 
children from any harm in entering into clinical trials must be 
transformed into a passion to provide children with scientific 
information on drugs that might vastly improve the quality of their 
lives.
    Although we can celebrate the great strides that have been made in 
treating children infected with HIV, many improvements are still 
required to optimize and hopefully one day cure HIV/AIDS. All HIV-
infected children, including those in foster care, should continue to 
have an opportunity to receive treatment with these new potentially 
beneficial drugs as they become available.

                                 
         Statement of Patricia Sabato, Sandy Hook, Connecticut
    My name is Patricia Sabato. I'm from Newtown, CT and am writing to 
you regarding the hearings on clinical drug trials in children. My son 
Stephen was put on Dexedrine Spansule by Dr. Irivin Jennings of Family 
and Children's Aid in Danbury. CT. He was seven years old and he ended 
up hospitalized at Elmcrest Hospital in Portland, CT and was kept on 
the same medication. In 1998 Stephen was, once again hospitalized. He 
went to Four Wind's Hospital in Katonah, NY. He was put on Prozac and 
Clonadine and received at least one injection of Thorazine. From here 
he went to Hallbrooke Hospital in Westport, CT and remained on these 
drugs. When he returned home, the Dr. at the Danbury Hospital CCATS 
program changed him to Wellbutrin. Dr. Jennings kept Stephen on this 
medication until 1999. Despite my efforts not to medicate my son 
because of the negative side effects and the behaviors he was 
demonstrating, and knowing some of these drugs were not FDA approved 
for children, I was ordered to continue him on these drugs. July 1999 
he was placed in a Residential Treatment Center called Green Chimney's 
in Brewster, NY for one year. I was assured I would be included in his 
full treatment plan, I was not. Stephen remembers having his blood 
taken frequently and was not sure why. He was discharged June of 2000.I 
have had a hard time obtaining any record's of Stephen's. There were no 
safeguards for the right to refuse drugs administered to my child 
during our involvement with The Department Of Children And Families of 
CT or his placement at Green Chimney's in NY. I have no idea if any 
information was derived from the forced drugging of FDA unapproved 
medications and wonder if my son was any part of a clinical drug study.

                                 

                                                 Rockford, IL 61103
                                                       May 31, 2005
Subcommittee on Human Resources
Committee on Ways and Means
United States House of Representatives

Chairman Herger:

    The testimony of Donald Young, M.D., of U.S. Department of Health 
and Human Services referred to as Protections of Children Enrolled in 
Clinical Trials raises questions and concerns, as does the statement of 
Elizabeth Monk, of the Illinois Department of Children and Family 
Services.
    Dr. Young testifies on page 3, that, ``HHS continues to believe 
strongly that clinical trials to test new treatments in children are 
essential and that the framework established by the existing regulation 
offers adequate protection for individuals participating in trials.'' I 
am appalled that any children are used as subjects in any clinical 
trials and that it is sanctioned and aggressively pursued by a U.S. 
department! There can be no justification for this kind of conduct! The 
existence of ``framework established by the existing regulation'' does 
not protect and does not remove the sting of offering up children for 
medical experiments! The young and old of our society, the innocent, 
the weak, the defenseless and vulnerable need protection, yes, not from 
a regulation of appointing an advocate, but protection from being in a 
class of humans upon which researchers can gain access.
    Apparently, at least one of the states do not insist on appointing 
an advocate unless there is significant risk. Ms Monk of Illinois DCFS 
testifies that, ``If DCFS ever decided to approve a research study that 
has more risk with the prospect of direct benefit, these clinic IRBs 
are prepared to assign an independent advocate for our wards in 
compliance with federal regulations.'' There can be risk in taking an 
aspirin! A clinical trial involving any drugs could cause serious 
adverse effects or even aggravate an existing condition, cause pain and 
suffering and even cause death. That is a risk! Experimenting with 
dosage levels causes risk and even death, all of which I understand is 
a concern for this hearing.
    Dr. Young, on pages 5 and 6 refers to the lack of a ``standard 
medical treatment'' for HIV for children in foster care and that a 
report prepared by HHS recommended that State and local child welfare 
agencies should create systems to manage the participation of children 
in foster care in special medical treatment and experimental trials.'' 
Again, no children should be subjected to medical experiments! Further, 
if there is no standard medical treatment, THEN A STANDARD SHOULD BE 
DEVELOPED using the best known treatment! Just because there is a lack 
of a standard that does not justify or give leave for this Government 
to subject children to experimental trials, let alone children who are 
most vulnerable, who cannot give informed consent, and whose biological 
parents may be under distress and duress and cannot give informed 
consent.
    Refer to the testimony of Deputy Secretary Roberta Harris of 
Wisconsin Department of Health and Family Services of May 18, 2005, at 
page 2 refers to World Medical Association Declaration of Helsinki's 
position on the voluntary nature of participation in research. Ms 
Harris states that the children in their welfare system are vulnerable 
because of conditions in the homes they come from. There is the stress 
and trauma of being removed from their homes and an economic 
disadvantage may cause consent under duress. Her comments and quotes 
indicate how difficult it is to reach a status of informed consent for 
all parties involved.
    How well can one be informed in order to give INFORMED consent? 
Some adult clinical trials have had tragic results, some of which have 
been halted before completed. Even though the subjects in those studies 
were adults were they truly able to get enough information? Are there 
protections in place even for the adult to be adequately informed of 
risks?
    Dr. Young's statement refers to ``Efforts in the early 1990's to 
increase the enrollment of foster children in clinical trials affected 
state policies. Today, child welfare agencies continue to differ in 
their policies regarding whether or under what circumstances children 
in foster care may be enrolled in clinical trials.'' It is disturbing 
that HHS was conduction ``Efforts'' to get children in clinical trials. 
What were these ``Efforts''? And how aggressively were they pursued? 
Who and what department or what group(s) were behind the efforts? I 
would urge this Committee to determine what was done to get the states 
to turn over their wards to the researchers. It appears, and to their 
credit, some states resisted.
    The Associated Press articles refer to some children having serious 
adverse effects from these medical experiments and even death may have 
resulted from experimenting with dosage levels. I trust this committee 
will investigate these matters fully and demand accountability.
    I emphasize again that no children should become subjects of 
medical experiments or clinical trials. Just because a procedure was 
put in place to give each child an independent advocate to monitor a 
child subjected to clinical trials does not justify or make more 
acceptable giving access to the most vulnerable of our society to 
medical researchers.
    I refer to page 2 of Ms Monk's (of Illinois) statement. ``If DCFS 
ever decided to approve a research study that has more risk without the 
prospect of direct benefit, these clinic IRBs are prepared to assign an 
independent advocate for our wards in compliance with federal 
regulations.'' What? It appears that NO independent advocate has been 
assigned and further it appears someone preordained the experiments to 
be without risk!
    Also, note Ms Monk says ``one drug protects them from the flu.'' 
Isn't there a standard medical treatment in place for the flu? If there 
is a standard medical treatment in place for flu, how and why would 
Illinois give access to their wards for research on flu vaccines?
    I would hope that all of the Illinois cases be studied carefully. 
It might not be as rosy of a picture as she paints. How many died? Were 
the deaths attributed to the clinical trials? Ms Monk says 20 kids 
presently are on 5 research studies. That's twenty children too many. 
What are these studies for? Children as well as foster children should 
not be subjected to medical experiments. The foster children in most 
cases lack a loving, caring and attentive parent to protect them and 
cannot really give informed consent.
    There was horrific disregard for humanity that took place in World 
War II Germany, some of which started out being directed toward the 
weak and vulnerable, in orphanages and hospitals, but then was directed 
to millions who lost their lives in the concentration camps. A society 
does not just lose their regard for human life overnight. It is a step 
at a time downward and soon that society slips further and faster 
downward. Many vowed, ``Never Again.'' We in the U.S. cannot and should 
not be allowing access to our children for medical research. There is 
no argument that justifies it! Perhaps we need to review the 
transcripts of the Nuremberg trials. There were many, including doctors 
who were held accountable.
    An immediate halt should be called to medical experiments on 
children. Further, any unused grant money should be returned to the 
U.S. Treasury and any grants used for clinical studies on children who 
did not get an independent advocate should be repaid. That money won't 
compensate for loss society experiences from such conduct, but our tax 
money should not be used in this manner. It's a disgrace! If the weak 
and vulnerable continue to be treated in this manner, Lord help us, it 
becomes a slippery slope.

            Respectfully submitted,
                                                     Sharon Schuldt

                                 

                                              William Glasser, Inc.
                                       Chatsworth, California 91311
                                                       May 20, 2005
Congressman Wally Herger
Rayburn House Office Building
Washington, D.C. 20515

    I am very interested in the Congressional Hearing focused on 
protecting children from being involved in experimental psychiatric 
drugs or drugs of any kind. Most of the children enrolled are foster 
children or children who aren't really looked after by any protective 
agency. I believe the government should become the protective agency.
    I am a Board Certified Psychiatrist who has been working in mental 
health for over forty years. I've worked not only with children and 
adults, but also extensively in the schools. In the schools that are 
following my ideas, no children are given any kind of psychiatric drugs 
at the instigation of the schools. We can't stop parents from giving 
their children these drugs, but we can certainly advise parents that 
these drugs are really not necessary. These Glasser Quality Schools are 
highly successful and are perhaps the most successful schools in the 
country where students are not taking any psychiatric drugs.
    Your legislation can certainly close a big gap to the practice of 
using children who have no way of protecting themselves and no parents 
who are really that interested in them. That should not be allowed. 
There should be some sort of protection for the children and that 
protective operation should swing into operation if any children are 
asked to participate in any kind of medical experimentation at all.
    As a Board Member of an organization called Ablechild, I am working 
with Gloria Wright and other members to reduce the drugging of all 
children and the practice of advising parents to put their children on 
drugs. No one knows what the long-term effects are from these drugs. 
The short-term effects, in many cases, are somewhat disastrous and 
include violent activity and suicide.
    I am the President of The William Glasser Institute. We teach and 
train people to deal with mental health all over the world with adults 
and children. I am very well known and have been spending most of the 
latter part of my professional life warning people about the dangers of 
psychiatric drugs. There is no evidence that the drugs are in any way 
helpful, but there is a great deal of evidence that they may be 
harmful. If the purpose of our government is to protect people against 
unwarranted intrusions into their privacy from the people who are 
making money off of these intrusions and paying little or no attention 
to the children, then this is a wrong you should certainly right.
    If you would like to learn more about my work, my website address 
is www.wglasser.com. You will see that there is a lot of information on 
the website that supports what I am saying here.
    I also appreciate being on the Ablechild Board of Directors and I 
am doing everything I can to help them.

            Cordially,
                                              William Glasser, M.D.
                                       Board Certified Psychiatrist