[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2625 Introduced in House (IH)]
112th CONGRESS
1st Session
H. R. 2625
To amend the Public Health Service Act with respect to human subject
research to improve protections for human subjects and, where
appropriate because of the type research involved, to reduce regulatory
burdens.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
July 22, 2011
Ms. DeGette introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Public Health Service Act with respect to human subject
research to improve protections for human subjects and, where
appropriate because of the type research involved, to reduce regulatory
burdens.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Research Participants Protection
Modernization Act of 2011''.
SEC. 2. PROTECTION OF HUMAN SUBJECTS IN RESEARCH; APPLICABILITY OF
RULES.
Part H of title IV of the Public Health Service Act (42 U.S.C. 289
et seq.) is amended by inserting after section 491 the following
section:
``SEC. 491A. PROTECTION OF HUMAN SUBJECTS IN RESEARCH; APPLICABILITY OF
RULES.
``(a) Protection of Human Subjects.--
``(1) In general.--Except as provided in paragraph (2), all
human subject research described in paragraph (3)(A) shall be
conducted in accordance with the HHS Human Subject Regulations,
and as applicable to the human subjects involved in such
research, with the vulnerable-populations rules.
``(2) FDA research.--
``(A) Applicable rules.--All human subject research
that is subject to the Federal Food, Drug, and Cosmetic
Act or to section 351 of this Act shall be conducted--
``(i) in accordance with the provisions of
parts 50, 56, 312, and 812 of title 21, Code of
Federal Regulations (or any successor
regulations); and
``(ii) as applicable to the human subjects
involved in such research, in accordance with
provisions applicable to vulnerable populations
under part 56 of such title 21 (or any
successor regulations) and subpart D of part 50
of such title 21 (or any successor
regulations).
``(B) References.--In the case of human subject
research described in subparagraph (A)--
``(i) each reference in this section or
section 491B to the HHS Human Subject
Regulations shall be treated as a reference to
the provisions described in subparagraph
(A)(i); and
``(ii) each reference in this section to
the vulnerable population rules shall be
treated as a reference to the provisions
described in subparagraph (A)(ii).
``(3) Applicability.--
``(A) In general.--This section applies to human
subject research that is--
``(i) conducted or supported by the
Department of Health and Human Services; or
``(ii) otherwise subject to regulation by
the Department under a provision of Federal law
(other than this section).
``(B) Other federal departments and agencies.--The
Secretary shall make available assistance to any
Federal department or agency seeking--
``(i) to improve the regulation or
oversight of human subject research; or
``(ii) to apply the HHS Human Subject
Regulations or the vulnerable-population rules
to human subject research that is conducted,
supported, or regulated by such department or
agency.
``(b) HHS Human Subject Regulations; Other Definitions.--
``(1) HHS human subject regulations; vulnerable-population
rules.--For purposes of this section:
``(A) Except as provided in subsection (a)(2)(B)
(relating to FDA research), the term `HHS Human Subject
Regulations' means the provisions of subpart A of part
46 of title 45, Code of Federal Regulations (or any
successor regulations).
``(B) Except as provided in subsection (a)(2)(B)
(relating to FDA research), the term `vulnerable-
population rules' means the provisions of subparts B
through D of such part 46 (or any successor
regulations).
``(2) Human subject research.--For purposes of this
section:
``(A) Except as provided in subparagraph (B), the
term `human subject research' means research, as
defined in subpart A of part 46 of title 45, Code of
Federal Regulations (or any successor regulations),
that involves a human subject, as defined in such
subpart A (or any successor regulations).
``(B) In the case of an investigation that is
subject to the provisions of part 50 of title 21, Code
of Federal Regulations (or successor regulations), the
term `human subject' has the meaning given such term in
such part 50, and the term `human subject research'
means a clinical investigation as defined in such part
50.
``(3) Other definitions.--For purposes of this section:
``(A) The terms `institution served by an
institutional review board' and `institution served by
the board' mean the public or private entity
(university, health care provider, health plan,
research organization, government agency, independent
institutional review board, or other entity) that
establishes and is responsible for the operation of the
institutional review board.
``(B) The term `institutional review board' has the
meaning that applies to the term `institutional review
board' under the HHS Human Subject Regulations.
``(C) The term `lead institutional review board'
means an institutional review board that otherwise
meets the requirements of the HHS Human Subject
Regulations and enters into a written agreement with an
institution, another institutional review board, a
sponsor, or a principal investigator to approve and
oversee human subject research that is conducted at
multiple locations. For purposes of this section,
references to an institutional review board include an
institutional review board that serves a single
institution as well as a lead institutional review
board.
``(D) The term `principal investigator', with
respect to human subject research, means the individual
who, at the research location involved, has the
principal responsibility for the conduct of the
research.
``(E)(i) Except as provided in clause (ii), the
term `sponsor', with respect to human subject research,
means the entity that provides the majority or
plurality of the financial support for the conduct of
the research.
``(ii) In the case of an investigation that is
subject to the provisions of part 50 of title 21, Code
of Federal Regulations (or successor regulations), the
term `sponsor', with respect to human subject research,
has the meaning that applies for purposes of such part
50.
``(c) Scope of Authority of Secretary.--
``(1) In general.--The HHS Human Subject Regulations
(including provisions regarding exemptions) and the vulnerable-
populations rules, as in effect on the day before the date of
the enactment of the Research Participants Protection
Modernization Act of 2011, continue to be in effect on and
after such date, subject to paragraph (2).
``(2) Modifications.--
``(A) Compliance with law.--Promptly after the date
of the enactment of the Act referred to in paragraph
(1), the Secretary shall promulgate regulations to make
such modifications to the provisions of the HHS Human
Subject Regulations as may be necessary to ensure that
such provisions implement, and do not conflict with,
this section.
``(B) Other modifications.--This section may not be
construed as affecting the authority of the Secretary
to modify the provisions of the HHS Human Subject
Regulations or the vulnerable-populations rules, except
to the extent that any such modification is in conflict
with this section. Any such modification shall be made
by regulation.
``(C) Consideration of certain matters.--
``(i) In general.--The Secretary shall,
with respect to the HHS Human Subject
Regulations, consider the matters specified in
clause (iii) and make a determination of
whether any of the provisions of such Rule or
any guidance associated with such Rule should
be modified accordingly.
``(ii) Timing.--The Secretary shall publish
the determination required by clause (i) in the
Federal Register--
``(I) except as provided in
subclause (II), not later than 3 years
after the date of the enactment of the
Research Participants Protection
Modernization Act of 2011; and
``(II) in the case of a
determination on the matters specified
in clause (iii)(IX), not later than 18
months after the submission of the
report required by section 5 of the
Research Participants Protection
Modernization Act of 2011.
``(iii) List of matters for
consideration.--The matters referred to in
clause (i) with respect to the HHS Human
Subject Regulations are the following:
``(I) How requirements regarding
the definition and management of
potential financial conflict of
interest, including both investigator
and institutional conflicts of
interest, should be strengthened and
enforced to protect human subjects more
effectively.
``(II) Whether the list of
exemptions from applicability of the
HHS Human Subject Regulations, as in
effect on the day before the date of
enactment referred to in clause
(ii)(I), should be expanded to include
new categories.
``(III) Whether and under what
circumstances research that studies
human tissue or other types of clinical
specimens should not be considered a
clinical investigation.
``(IV) Whether the list of
categories of research that are
eligible for expedited review under the
HHS Human Subject Regulations, as in
effect on the day before the date of
enactment referred to in clause
(ii)(I), should be expanded to include
new categories of research eligible for
expedited review.
``(V) Whether institutional review
boards include sufficient numbers of
minority individuals as board members
when reviewing proposals designed to
include human subjects who are minority
individuals.
``(VI) Whether the requirements for
the number of members of an
institutional review board who are
individuals whose primary expertise is
in nonscientific areas, and the number
of members of an institutional review
board who are individuals who are not
affiliated with the institution served
by the board, should be increased.
``(VII) Whether institutional
review boards include sufficient
numbers of individuals with appropriate
scientific expertise.
``(VIII) How to enhance the
protection of people with diminished
decisionmaking capacity with respect to
their participation as subjects in
human subject research.
``(IX) How the requirements for
institutional review board review in
multisite research should be modified
to reduce regulatory burden while
protecting human subjects, including
use of a lead institutional review
board.
``(X) How the requirements for
managing and reporting adverse events
and unanticipated problems should be
modified--
``(aa) to increase
consistency between such
requirements of the Office for
Human Research Protections of
the Department of Health and
Human Services and the
corresponding requirements of
the Food and Drug
Administration; and
``(bb) to reduce regulatory
burden appropriately while
protecting human subjects.
``(XI) How the requirements for
approval and oversight of human
subjects research that poses no more
than minimal risk to participants
(including requirements of informed
consent, documentation of informed
consent, and continuing review) should
be modified to reduce regulatory burden
(including burden on institutions,
institutional review boards, and
investigators) while protecting
research participants, including
clarification of the circumstances in
which informed consent does not need to
be writing.
``(XII) Whether research that would
be defined as a `clinical
investigation' under part 50 of title
21, Code of Federal Regulations, should
comply with the guideline published by
the Food and Drug Administration and
endorsed by the International
Conference on Harmonisation of
Technical Requirements for Registration
of Pharmaceuticals for Human Use,
entitled `Good Clinical Practice:
Consolidated Guideline', and how
investigators can be educated
effectively regarding compliance with
this guideline.
``(XIII) Such additional matters as
the Secretary determines to be
appropriate.
``(d) Institutional Review Boards.--
``(1) Notification of institutional review board and
sponsors by investigators.--
``(A) Requirement.--In submitting to an
institutional review board a proposal for human subject
research, the investigators for the research shall
notify the institution served by the board--
``(i) of any significant financial
interest, as defined by applicable Federal
regulations;
``(ii) whether the investigators have been
disqualified or restricted by any Federal,
State, or local entity in their ability to
conduct human subject research, including being
ineligible to conduct human subject research
with investigational new drugs, being
ineligible for approval of new drug
applications, or agreeing to some other form of
restriction regarding research; and
``(iii) whether the proposal has been
submitted to any other institutional review
board and, as applicable, of any findings made
by such board.
``(B) Timing.--A notification required by
subparagraph (A) shall be submitted to the institution
served by the board--
``(i) at the time of submitting the
proposal for human subject research to the
board; or
``(ii) in the case of circumstances arising
after such submission, immediately.
``(2) Institutional review of conflicts of interest.--The
institution served by an institutional review board shall--
``(A) review such significant financial interests
as are submitted to the institution under paragraph (1)
to determine whether such interests create or may
reasonably appear to create conflicts of interest; and
``(B) seek to eliminate or manage such conflicts of
interest.
``(3) Cost recovery.--Institutions may recover costs
associated with compliance for human subject protections under
this part from government sponsors of research as direct costs.
``(e) Institutional Programs of Education.--For fiscal year 2012
and subsequent fiscal years, the Secretary may not make an award of a
grant, cooperative agreement, or contract under this Act to a public
entity or a private academic institution, or make an award of a grant,
cooperative agreement, or contract under this Act for the conduct of
research at or through or in affiliation with a public entity or a
private academic institution, unless the public entity or private
academic institution (as the case may be) maintains or contracts for a
program to educate investigators and board members on the protection of
human subjects in research.
``(f) Applicability of Requirements.--The requirements of this
section apply on and after the date of the enactment of the Research
Participants Protection Modernization Act of 2011.''.
SEC. 3. OFFICE FOR HUMAN RESEARCH PROTECTIONS.
(a) In General.--Part H of title IV of the Public Health Service
Act (42 U.S.C. 289 et seq.), as amended by section 2 of this Act, is
amended by inserting after section 491A the following section:
``SEC. 491B. OFFICE FOR HUMAN RESEARCH PROTECTIONS.
``(a) In General.--There is established within the office of the
Secretary an office to be known as the Office for Human Research
Protections (in this section referred to as the `Office'). The Office
shall be headed by a director, who shall be appointed by the Secretary.
The Secretary shall carry out this section acting through the Director
of the Office.
``(b) Certain Duties.--The Director of the Office--
``(1) shall provide for the protection of human subjects in
research by carrying out activities in accordance with section
491A;
``(2) shall establish criteria regarding assurances of
compliance with the requirements of section 491A;
``(3) shall direct activities within the Department of
Health and Human Services, and coordinate the activities of the
Department with other Federal departments and agencies, with
respect to the protection of subjects in human subject
research;
``(4) may, in collaboration with the Director of NIH, the
Commissioner of Food and Drugs, or the head of any other
Federal department or agency, carry out educational and quality
improvement programs for human subject protections for
principal investigators, members of institutional review
boards, and other appropriate persons, including the generation
of resource materials relating to the responsibilities of the
research community for the protection of human subjects in
research;
``(5) shall, upon the request of an entity that conducts or
supports human subject research--
``(A) consult with the entity regarding
improvements in human subject protections in such
research; and
``(B) provide advice on compliance with section
491A, including with respect to differing
interpretations among institutional review boards of a
provision of such section;
``(6) may make grants to entities that conduct or support
human subject research for the purpose of assisting the
entities in carrying out programs to recruit and train minority
individuals to serve as members of institutional review boards;
``(7) shall consult with experts in biomedical, behavioral,
and social sciences research in carrying out the duties of the
Director; and
``(8) shall carry out such additional authorities of the
Secretary regarding the protection of human subjects in
research as the Secretary determines to be appropriate.
``(c) Model Education Programs.--The Director of the Office may
make grants for the development of model education programs that may be
used by institutions served by institutional review boards to promote
best practices in institutional management of human subject research.
``(d) Funding.--
``(1) Authorization of appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $20,000,000 for fiscal year 2012, and such sums as
may be necessary for fiscal year 2013 and each subsequent
fiscal year.
``(2) Model education programs.--For the purpose of
carrying out subsection (c), there are authorized to be
appropriated such sums as may be necessary for fiscal year 2012
and each subsequent fiscal year.
``(3) Rule of construction.--Nothing in this section or
section 491A may be construed as a change in the budget
authority or authorization of appropriations for the Food and
Drug Administration.''.
(b) Functions, Personnel, Assets, and Liabilities.--All functions,
personnel, assets, and liabilities of the Office for Human Research
Protection of the Department of Health and Human Services, as in
existence on the day before the date of the enactment of this Act,
shall be transferred to the Office for Human Research Protections
established by section 491B of the Public Health Service Act, as added
by subsection (a).
SEC. 4. AMENDMENTS REGARDING PROCESS FOR RESPONDING TO REPORTS OF
VIOLATIONS.
Section 491(b)(2) of the Public Health Service Act (42 U.S.C.
289(b)(2)) is amended--
(1) in the first sentence, by inserting ``or the Director
of the Office for Human Research Protections'' after ``the
Director of NIH''; and
(2) in the second sentence, by inserting after ``this Act''
the following: ``, sharing of information between the Director
of NIH and the Director of such Office,''.
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