[Federal Register Volume 65, Number 235 (Wednesday, December 6, 2000)]
[Notices]
[Pages 76260-76264]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 00-30852]
=======================================================================
-----------------------------------------------------------------------
OFFICE OF SCIENCE AND TECHNOLOGY POLICY
Executive Office of the President; Federal Policy on Research
Misconduct; Preamble for Research Misconduct Policy
AGENCY: Office of Science and Technology Policy.
ACTION: Notification of Final Policy.
-----------------------------------------------------------------------
SUMMARY: The Office of Science and Technology Policy (OSTP) published a
request for public comment on a proposed Federal research misconduct
policy in the October 14, 1999 Federal Register (pp. 55722-55725). OSTP
received 237 sets of comments before the public comment period closed
on December 13, 1999. After consideration of the public comments, the
policy was revised and has now been finalized. This notice provides
background information about the development of the policy, explains
how the policy has been modified, and discusses plans for its
implementation.
EFFECTIVE DATE: December 6, 2000.
FOR FURTHER INFORMATION CONTACT: Holly Gwin, Office of Science and
Technology Policy, Executive Office of the President, Washington, DC
20502. Tel: 202-456-6140; Fax: 202-456-6021; e-mail:
hgwin@ostp.eop.gov.
SUPPLEMENTARY INFORMATION: Advances in science, engineering, and all
fields of research depend on the reliability of the research record, as
do the benefits associated with them in areas such as health and
national security. Sustained public trust in the research enterprise
also requires confidence in the research record and in the processes
involved in its ongoing development. For these reasons, and in the
interest of achieving greater uniformity in Federal policies in this
area, the National Science and Technology Council (NSTC) initiated
discussions in April 1996 on the development of a research misconduct
policy. The Office of Science and Technology Policy (OSTP) provided
leadership and coordination. The NSTC approved the proposed draft
policy in May 1999, clearing the way for the October 14, 1999 Federal
Register notice. Public comments in response to that notice have been
reviewed. The purpose of this notice is to provide information about
the policy as it has now been finalized.
This policy applies to federally-funded research and proposals
submitted to Federal agencies for research funding. It thus applies to
research conducted by the Federal agencies, conducted or managed for
the Federal government by contractors, or supported by the Federal
government and performed at research institutions, including
universities and industry.
The policy establishes the scope of the Federal government's
interest in the accuracy and reliability of the research record and the
processes involved in its development. It consists of a definition of
research misconduct and basic guidelines for the response of Federal
agencies and research institutions to allegations of research
misconduct.
The Federal agencies that conduct or support research will
implement this policy within one year of the date of publication of
this notice. An NSTC interagency research misconduct policy
implementation group has been established to help achieve uniformity
across the Federal agencies in implementation of the research
misconduct policy. In some cases, this may require agencies to amend or
replace extant regulations addressing research misconduct. In other
cases, agencies may need to put new regulations in place or implement
the policy through administrative mechanisms.
The policy addresses research misconduct. It does not supersede
government or institutional policies or procedures for addressing other
forms of misconduct, such as the unethical treatment of human research
subjects or mistreatment of laboratory animals used in research, nor
does it supersede criminal or other civil law. Agencies and
institutions may address these other issues as authorized by law and as
appropriate to their missions and objectives.
Summary of Comments
The Office of Science and Technology Policy received 237 comments
on the proposed Federal Research Misconduct Policy. Letters were signed
by individuals, and by representatives of universities, university
associations, Federal agencies, and private entities. Comments are
available for review. Comments that resulted in a modification of the
policy are summarized below. A section that addresses other questions
raised by the comments follows the summary of modifications.
Uniform Federal Policy
Issue: Many comments recommended various mechanisms to ensure
uniform implementation of this policy.
Response: An NSTC research misconduct policy implementation group
has been formed to foster uniformity among the agencies in their
implementation of the policy.
Section I: Research Misconduct Defined
Issue: A number of comments suggested that the definition of
fabrication be modified to read as follows: ``Fabrication is making up
data or results and recording or reporting them.'' (Italicized words
are suggested addition.) This change is to clarify that the raw data
collected or generated in the research process can be fabricated just
as can the results of the research.
Response: This change was accepted.
Issue: A number of commenters interpreted the definition of
plagiarism to imply that using material gathered during the peer review
process was acceptable as long as it is cited.
Response: The policy is intended to address the problem of
reviewers who take material from the peer review process and use it
without attribution. This constitutes plagiarism. We have deleted the
phrase ``including those obtained through confidential review of
others' research proposals and manuscripts'' to avoid any appearance of
condoning a breach of confidentiality in the peer review process.
Issue: Despite general support for the rationale for the phrase
``does not include honest error or honest differences of opinion,''
several comments requested various clarifications.
Response: This phrase is intended to clarify that simple errors or
mere differences of judgment or opinion do not constitute research
misconduct. The phrase does not create a separate element of proof.
Institutions and agencies are not required to disprove possible
``honest error or differences of opinion.'' The phrase has been
retained, with the deletion of the second ``honest'' of the phrase as
redundant.
Issue: A number of comments raised questions about what fields of
research are included in the definition of research. For example, some
readers were unsure about the applicability of
[[Page 76261]]
the policy as written to medicine or the social sciences.
Response: The policy applies to research funded by the Federal
agencies. In order to be responsive to specific inquiries about what
fields of research are covered by the policy, an illustrative, non-
exclusive list of selected fields of research is now included in the
policy itself.
Section II: Findings of Research Misconduct
Issue: Several comments stressed the need for greater precision in
the phrase ``significant departure from accepted practices of the
scientific community.''
Response: This phrase is intended to make it clear that behavior
alleged to involve research misconduct should be assessed in the
context of community practices, meaning practices that are generally
understood by the community but that may not be in a written form. For
clarification purposes and in order to be more comprehensive, the term
``scientific community'' has been modified to read ``relevant research
community.'' The policy is not intended to ratify those ``accepted
practices'' but rather to indicate that these may vary among different
communities.
Issue: Several comments requested clarification regarding the level
of intent that is required to be shown in order to reach a finding of
research misconduct.
Response: Under the policy, three elements must be met in order to
establish a finding of research misconduct. One of these elements is a
showing that the subject had the requisite level of intent to commit
the misconduct. The intent element is satisfied by showing that the
misconduct was committed ``intentionally, or knowingly, or
recklessly.'' Only one of these needs to be demonstrated in order to
satisfy this element of a research misconduct finding.
Section III: Responsibilities of Federal Agencies and Research
Institutions
Issue: Some comments indicated that this section could be
incorrectly construed to require appeal of the agency misconduct
finding back to the institution.
Response: The policy has been clarified to affirm that each agency
should establish an appeals process for persons found by the agency to
have engaged in research misconduct. The subject of the agency finding
cannot appeal the agency decision back to the institution, although
some institutions do offer an appeal of the institutional finding at
the institutional level.
Section IV: Guidelines for Fair and Timely Procedures
Issue: The comments indicated some uncertainty about to whom the
actions section applied.
Response: The actions delineated are those that may be taken by the
Federal agencies if research misconduct has been shown to have
occurred. The section has thus been renamed ``Agency Administrative
Actions.''
Issue: The suggestion was made that publications based on false or
fabricated data, or including such data, should be required to be
officially withdrawn.
Response: Correction of the research record has been added to the
list of possible actions to be taken if a researcher is found to have
engaged in research misconduct.
Issue: The suggestion was made that safeguards for informants and
subjects of allegations be made more explicit.
Response: More explicit safeguards have been added to the policy
for both informants and subjects.
Other Comments
Several comments and clarifications are addressed in the following
question and answer format rather than through modification of the
policy.
Will agencies be required to announce the details of their
implementation plans? Yes. Agencies will announce the details of their
implementation plans, including those plans that do not require formal
rulemaking.
What types of misconduct are covered by this policy? This policy is
limited to addressing misconduct related to the conduct and reporting
of research, as distinct from misconduct that occurs in the research
setting but that does not affect the integrity of the research record,
such as misallocation of funds, sexual harassment, and discrimination.
This policy does not limit agencies or research institutions from
addressing these other issues under appropriate policies, rules,
regulations, or laws. In addition, should the behavior associated with
research misconduct also trigger the applicability of other laws
(including criminal law) this policy is not intended to limit agencies
or research institutions from pursuing these matters under separate
authorities.
Does this policy address misrepresentation of a researcher's
credentials or publications? Yes, misrepresentation of a researcher's
qualifications or ability to perform the research in grant applications
or similar submissions may constitute falsification or fabrication in
proposing research.
Are authorship disputes covered by this policy? Authorship disputes
are not covered by this policy unless they involve plagiarism.
Does research misconduct include the mistreatment of human subjects
or animals in research? This policy addresses activity that occurs in
the course of human subjects or animal research that involves research
misconduct as defined by the policy. Thus, falsification, fabrication,
or plagiarism that occurs during the course of human or animal research
is addressed by this policy. However, other issues concerning the
ethical treatment of human or animal subjects are covered under
separate procedures and are not affected by this policy.
Why doesn't the policy provide immunity for research misconduct
investigative committees? Providing immunity to research misconduct
investigative committees and other participants in institutional and
agency research misconduct proceedings would require significant
statutory or regulatory initiatives which will be explored separately
from this policy.
Aren't there circumstances when omission of data or results is
appropriate? A number of commenters suggested that there are
circumstances when it may be appropriate to omit data in reporting
research results. It is not the intent of this policy to call accepted
practices into question. However, the omission of data is considered
falsification when it misleads the reader about the results of the
research.
Does this policy supersede institutional policies regarding
research misconduct? Non-federal research institutions have authority
to establish policies for research and employee misconduct that serve
their own institutional purposes. However, the Federal research
misconduct policy (as implemented by the agencies) provides the
relevant guidance to institutions for purposes of Federal action.
Does this policy supersede other agency policies, procedures,
rules, and regulations? Agencies must comply with all relevant Federal
personnel policies and laws in responding to allegations of research
misconduct. However, personnel actions may not adequately protect the
public from the consequences of falsified, fabricated or plagiarized
research. For example, Federal personnel policies may permit
termination of an employee who commits research misconduct, but may not
address the problem of research misconduct or seek to prevent it from
recurring. The administrative actions available under the Federal
research misconduct policy, such as debarment from federal funding,
supervision and certification of research, and correction
[[Page 76262]]
of the literature, are designed to specifically address the problems
raised by research misconduct.
Must all three elements in the Finding of Research Misconduct
section be present for there to be a finding of research misconduct?
Yes.
Who makes the final determination about whether or not there is a
finding of research misconduct? The Federal agency will make the final
decision about whether to make an agency finding of research
misconduct. However, within its own internal jurisdiction, a non-
Federal research institution may establish policies and take actions as
appropriate to its needs and as consistent with other relevant laws.
Shouldn't the burden of proof be more stringent, e.g., require
``clear and convincing evidence'' to support a finding of research
misconduct? While much is at stake for a researcher accused of research
misconduct, even more is at stake for the public when a researcher
commits research misconduct. Since ``preponderance of the evidence'' is
the uniform standard of proof for establishing culpability in most
civil fraud cases and many federal administrative proceedings,
including debarment, there is no basis for raising the bar for proof in
misconduct cases which have such a potentially broad public impact. It
is recognized that non-Federal research institutions have the
discretion to apply a higher standard of proof in their internal
misconduct proceedings. However, when their standard differs from that
of the Federal government, research institutions must report their
findings to the appropriate Federal agency under the applicable Federal
government standard, i.e., preponderance.
Why don't the Federal agencies conduct all inquiries and
investigations? Research institutions are much closer to what is going
on in their own institutions and are in a better position to conduct
inquiries and investigations than are the Federal agencies. While the
Federal agencies could have taken on the task of investigating all
allegations of research misconduct, or established a separate agency
for this purpose, this would have involved a substantial new Federal
bureaucracy, which is not thought desirable. An agency may take steps,
as appropriate, should a research institution demonstrate a lack of
commitment to the policy's guidelines.
How will a lead agency be identified? If more than one Federal
agency has jurisdiction over allegations of research misconduct, those
agencies should work together to designate a lead agency.
What criteria will be used for selecting the research institution
that will handle the response to the allegation of research misconduct?
In most cases, agencies will rely on the researcher's home institution
to respond to allegations of research misconduct. However, in cases
where the subject has switched institutions, it may be more appropriate
for the institution where the alleged research misconduct occurred to
respond to the allegation. The institution where the questioned
research was conducted may have better access to the evidence and
witnesses and therefore will have the capability to undertake a more
efficient and thorough response.
Shouldn't the policy be more explicit about time lines for a
response to allegations of misconduct? In establishing reasonable time
lines the Federal agencies must balance the interests of concluding the
process expeditiously while ensuring it has been conducted fairly and
thoroughly. This will allow flexibility for the research institutions
while at the same time ensuring that the process does not extend for an
unreasonably long period. Research institutions should have the option
to request reasonable extensions of agency timelines in individual
cases.
What can informants or subjects of allegations expect with regard
to confidentiality? The policy strives for confidentiality for all
involved to the extent consistent with a fair and thorough process and
as allowed by law, including applicable Federal and state freedom of
information and privacy laws.
Should the policy punish informants who act in bad faith or
individuals who harass informants? The principal aim of this policy is
to communicate to the research community those behaviors that
constitute research misconduct and to take actions where research
misconduct is found to have occurred. As employers and managers of the
research, non-Federal research institutions may adopt policies to
address the consequences of false, malicious, or capricious allegations
and to respond to retaliation against informants. Agencies may also
address this issue in their implementation of this policy.
How should the ``seriousness'' of the research misconduct be
evaluated and how will this relate to any actions taken? In determining
what action to take, agencies should fully consider the level of intent
of the misconduct, the consequences of the behavior, and other
aggravating and mitigating factors.
Next Steps
The Federal agencies have up to one year from the date of
publication of this notice to implement the policy. An interagency
implementation group has been established under the auspices of the
National Science and Technology Council to assist agencies in their
implementation process and to strive for the highest level of
uniformity possible and as appropriate in their implementation plans.
Federal Policy on Research Misconduct \1\
I. Research \2\ Misconduct Defined
Research misconduct is defined as fabrication, falsification, or
plagiarism in proposing, performing, or reviewing research, or in
reporting research results.
---------------------------------------------------------------------------
\1\ No rights, privileges, benefits or obligations are created
or abridged by issuance of this policy alone. The creation or
abridgment of rights, privileges, benefits or obligations, if any,
shall occur only upon implementation of this policy by the Federal
agencies.
\2\ Research, as used herein, includes all basic, applied, and
demonstration research in all fields of science, engineering, and
mathematics. This includes, but is not limited to, research in
economics, education, linguistics, medicine, psychology, social
sciences, statistics, and research involving human subjects or
animals.
---------------------------------------------------------------------------
Fabrication is making up data or results and recording or
reporting them.
Falsification is manipulating research materials,
equipment, or processes, or changing or omitting data or results such
that the research is not accurately represented in the research
record.\3\
---------------------------------------------------------------------------
\3\ The research record is the record of data or results that
embody the facts resulting from scientific inquiry, and includes,
but is not limited to, research proposals, laboratory records, both
physical and electronic, progress reports, abstracts, theses, oral
presentations, internal reports, and journal articles.
---------------------------------------------------------------------------
Plagiarism is the appropriation of another person's ideas,
processes, results, or words without giving appropriate credit.
Research misconduct does not include honest error or
differences of opinion.
II. Findings of Research Misconduct
A finding of research misconduct requires that:
There be a significant departure from accepted practices
of the relevant research community; and
The misconduct be committed intentionally, or knowingly,
or recklessly; and
The allegation be proven by a preponderance of evidence.
[[Page 76263]]
III. Responsibilities of Federal Agencies and Research Institutions
\4\
Agencies and research institutions are partners who share
responsibility for the research process. Federal agencies have ultimate
oversight authority for Federally funded research, but research
institutions bear primary responsibility for prevention and detection
of research misconduct and for the inquiry, investigation, and
adjudication of research misconduct alleged to have occurred in
association with their own institution.
---------------------------------------------------------------------------
\4\ The term ``research institutions'' is defined to include all
organizations using Federal funds for research, including, for
example, colleges and universities, intramural Federal research
laboratories, Federally funded research and development centers,
national user facilities, industrial laboratories, or other research
institutes. Independent researchers and small research institutions
are covered by this policy.
---------------------------------------------------------------------------
Agency Policies and Procedures. Agency policies and
procedures with regard to intramural as well as extramural programs
must conform to the policy described in this document.
Agency Referral to Research Institution. In most cases,
agencies will rely on the researcher's home institution to make the
initial response to allegations of research misconduct. Agencies will
usually refer allegations of research misconduct made directly to them
to the appropriate research institution. However, at any time, the
Federal agency may proceed with its own inquiry or investigation.
Circumstances in which agencies may elect not to defer to the research
institution include, but are not limited to, the following: the agency
determines the institution is not prepared to handle the allegation in
a manner consistent with this policy; agency involvement is needed to
protect the public interest, including public health and safety; the
allegation involves an entity of sufficiently small size (or an
individual) that it cannot reasonably conduct the investigation itself.
Multiple Phases of the Response to an Allegation of
Research Misconduct. A response to an allegation of research misconduct
will usually consist of several phases, including: (1) an inquiry--the
assessment of whether the allegation has substance and if an
investigation is warranted; (2) an investigation--the formal
development of a factual record, and the examination of that record
leading to dismissal of the case or to a recommendation for a finding
of research misconduct or other appropriate remedies; (3)
adjudication--during which recommendations are reviewed and appropriate
corrective actions determined.
Agency Follow-up to Institutional Action. After reviewing
the record of the investigation, the institution's recommendations to
the institution's adjudicating official, and any corrective actions
taken by the research institution, the agency will take additional
oversight or investigative steps if necessary. Upon completion of its
review, the agency will take appropriate administrative action in
accordance with applicable laws, regulations, or policies. When the
agency has made a final determination, it will notify the subject of
the allegation of the outcome and inform the institution regarding its
disposition of the case. The agency finding of research misconduct and
agency administrative actions can be appealed pursuant to the agency's
applicable procedures.
Separation of Phases. Adjudication is separated
organizationally from inquiry and investigation. Likewise, appeals are
separated organizationally from inquiry and investigation.
Institutional Notification of the Agency. Research
institutions will notify the funding agency (or agencies in some cases)
of an allegation of research misconduct if (1) the allegation involves
Federally funded research (or an application for Federal funding) and
meets the Federal definition of research misconduct given above, and
(2) if the institution's inquiry into the allegation determines there
is sufficient evidence to proceed to an investigation. When an
investigation is complete, the research institution will forward to the
agency a copy of the evidentiary record, the investigative report,
recommendations made to the institution's adjudicating official, and
the subject's written response to the recommendations (if any). When a
research institution completes the adjudication phase, it will forward
the adjudicating official's decision and notify the agency of any
corrective actions taken or planned.
Other Reasons to Notify the Agency. At any time during an
inquiry or investigation, the institution will immediately notify the
Federal agency if public health or safety is at risk; if agency
resources or interests are threatened; if research activities should be
suspended; if there is reasonable indication of possible violations of
civil or criminal law; if Federal action is required to protect the
interests of those involved in the investigation; if the research
institution believes the inquiry or investigation may be made public
prematurely so that appropriate steps can be taken to safeguard
evidence and protect the rights of those involved; or if the research
community or public should be informed.
When More Than One Agency is Involved. A lead agency
should be designated to coordinate responses to allegations of research
misconduct when more than one agency is involved in funding activities
relevant to the allegation. Each agency may implement administrative
actions in accordance with applicable laws, regulations, policies, or
contractual procedures.
IV. Guidelines for Fair and Timely Procedures
The following guidelines are provided to assist agencies and
research institutions in developing fair and timely procedures for
responding to allegations of research misconduct. They are designed to
provide safeguards for subjects of allegations as well as for
informants. Fair and timely procedures include the following:
Safeguards for Informants. Safeguards for informants give
individuals the confidence that they can bring allegations of research
misconduct made in good faith to the attention of appropriate
authorities or serve as informants to an inquiry or an investigation
without suffering retribution. Safeguards include protection against
retaliation for informants who make good faith allegations, fair and
objective procedures for the examination and resolution of allegations
of research misconduct, and diligence in protecting the positions and
reputations of those persons who make allegations of research
misconduct in good faith.
Safeguards for Subjects of Allegations. Safeguards for
subjects give individuals the confidence that their rights are
protected and that the mere filing of an allegation of research
misconduct against them will not bring their research to a halt or be
the basis for other disciplinary or adverse action absent other
compelling reasons. Other safeguards include timely written
notification of subjects regarding substantive allegations made against
them; a description of all such allegations; reasonable access to the
data and other evidence supporting the allegations; and the opportunity
to respond to allegations, the supporting evidence and the proposed
findings of research misconduct (if any).
Objectivity and Expertise. The selection of individuals to
review allegations and conduct investigations who have appropriate
expertise and have no unresolved conflicts of interests help to ensure
fairness throughout all phases of the process.
Timeliness. Reasonable time limits for the conduct of the
inquiry, investigation, adjudication, and appeal
[[Page 76264]]
phases (if any), with allowances for extensions where appropriate,
provide confidence that the process will be well managed.
Confidentiality During the Inquiry, Investigation, and
Decision-Making Processes. To the extent possible consistent with a
fair and thorough investigation and as allowed by law, knowledge about
the identity of subjects and informants is limited to those who need to
know. Records maintained by the agency during the course of responding
to an allegation of research misconduct are exempt from disclosure
under the Freedom of Information Act to the extent permitted by law and
regulation.
V. Agency Administrative Actions
Seriousness of the Misconduct. In deciding what
administrative actions are appropriate, the agency should consider the
seriousness of the misconduct, including, but not limited to, the
degree to which the misconduct was knowing, intentional, or reckless;
was an isolated event or part of a pattern; or had significant impact
on the research record, research subjects, other researchers,
institutions, or the public welfare.
Possible Administrative Actions. Administrative actions
available include, but are not limited to, appropriate steps to correct
the research record; letters of reprimand; the imposition of special
certification or assurance requirements to ensure compliance with
applicable regulations or terms of an award; suspension or termination
of an active award; or suspension and debarment in accordance with
applicable government-wide rules on suspension and debarment. In the
event of suspension or debarment, the information is made publicly
available through the List of Parties Excluded from Federal Procurement
and Nonprocurement Programs maintained by the U.S. General Services
Administration. With respect to administrative actions imposed upon
government employees, the agencies must comply with all relevant
federal personnel policies and laws.
In Case of Criminal or Civil Fraud Violations. If the
funding agency believes that criminal or civil fraud violations may
have occurred, the agency shall promptly refer the matter to the
Department of Justice, the Inspector General for the agency, or other
appropriate investigative body.
VI. Roles of Other Organizations
This Federal policy does not limit the authority of research
institutions, or other entities, to promulgate additional research
misconduct policies or guidelines or more specific ethical guidance.
Barbara Ann Ferguson,
Assistant Director for Budget and Administration, Office of Science and
Technology Policy.
[FR Doc. 00-30852 Filed 12-5-00; 8:45 am]
BILLING CODE 3170-01-P