[Federal Register Volume 64, Number 198 (Thursday, October 14, 1999)]
[Notices]
[Pages 55722-55725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-26608]
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OFFICE OF SCIENCE AND TECHNOLOGY POLICY
Proposed Federal Policy on Research Misconduct To Protect the
Integrity of the Research Record
AGENCY: Office of Science and Technology Policy.
ACTION: Request for public comment on proposed Federal policy on
research misconduct.
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SUMMARY: The Office of Science and Technology Policy (OSTP) proposes a
government-wide Federal policy for research misconduct for adoption and
implementation by agencies that conduct and support research. The
proposed policy addresses behavior that has the potential to affect the
integrity of the research record and establishes procedural safeguards
for handling allegations of research misconduct. It has been cleared by
the National Science and Technology Council (NSTC) and is the result of
an extensive interagency development, review, and clearance process
initiated in April 1996. This policy notice was developed by OSTP in
consultation with the Office of Management and Budget (OMB), and OMB
supports the solicitation of comment on the proposed policy and
procedures.
The policy consists of a definition of research misconduct and
guidelines for handling allegations of research misconduct. Following
consideration of public comments received, the agencies will be
directed to implement the policy. In some cases, this may require
agencies to amend or replace regulations addressing research misconduct
that are already in place. In other cases, agencies may implement the
policy through administrative mechanisms. An important objective of
this policy is to achieve uniformity in research misconduct policies
across the agencies of the Federal government. It is intended that
agencies will adopt the final Federal research misconduct policy, and
therefore potentially affected parties should express their views on
the policy in response to this notice.
DATES: The Office of Science and Technology Policy welcomes comments on
the proposed policy. To be assured consideration, comments must be
postmarked no later than December 13, 1999.
ADDRESSES: Comments should be addressed to Sybil Francis, Office of
Science and Technology Policy, Executive Office of the President,
Washington, DC 20502.
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FOR FURTHER INFORMATION CONTACT: Sybil Francis, Office of Science and
Technology Policy, Executive Office of the President, Washington, DC
20502. Tel: 202-456-6040; Fax: 202-456-6027; e-mail:
sfrancis@ostp.eop.gov.
SUPPLEMENTARY INFORMATION: Advances in science and engineering 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 scientific enterprise also requires
confidence in the research record and in the processes involved in its
ongoing development.
It is for these reasons, and in the interest of ensuring uniformity
in Federal agency policies addressed to behaviors that might affect the
integrity of the research record, that the NSTC initiated discussions
regarding the development of a government-wide research misconduct
policy in April 1996. Since then, the proposed policy has undergone
extensive agency review and clearance at a number of levels. The NSTC's
Research Integrity Panel (RIP), comprised of representatives from the
major research agencies developed the first draft of the policy. It was
tasked by the NSTC to propose a definition of research misconduct and
to develop guidelines for responding to allegations of research
misconduct. The RIP forwarded its report and recommendations to the
NSTC Committee on Science in December 1996, which broadened review of
the policy to additional agencies, subjecting it to further analysis.
The full NSTC approved the proposed policy in May 1999, clearing the
way for this notice of proposed policy. The notice was developed by
OSTP in consultation with OMB, and OMB supports the solicitation of
comment on the proposed policy and procedures.
The proposed policy defines 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 establishes basic guidelines for responding to
allegations of research misconduct, including procedural safeguards. An
important objective of this policy is to achieve uniformity across the
Federal agencies in the definition of research misconduct they use and
consistency in their processes for responding to allegations of
research misconduct. It is expected that the final policy will apply to
all research funded by the Federal agencies, including intramural
research conducted by the Federal agencies, research conducted or
managed by contractors, and research performed at universities.
Commentators are invited to express their views on the proposed policy
and on the premise that a uniform government-wide policy is a desirable
goal.
Following consideration of public comments received, agencies will
be directed to implement the 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 proposed policy addresses behavior subject to administrative
action and applies only to research misconduct as defined in the
policy. It does not supersede government policies or procedures for
addressing other matters, such as the unethical treatment of human
research subjects or mistreatment of laboratory animals used in
research, nor does it supersede criminal or civil law. It does not
limit agency or institutional policies and prerogatives in addressing
other forms of misconduct, including those that might occur in the
course of conducting research, including the misuse of public funds.
Agencies will address these other issues as authorized by law and as
appropriate to their missions and objectives.
Proposed Policy
The proposed policy consists of the following:
I. Research Misconduct Defined
Research1 misconduct is defined as fabrication,
falsification, or plagiarism in proposing, performing, or reviewing
research, or in reporting research results.
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\1\ Research, as defined herein, includes all basic, applied,
and demonstration research in all fields of science, engineering,
and mathematics.
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Fabrication is making up 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.2
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\2\ The research record is defined as the record of data or
results that embody the facts resulting fromscientific inquiry, and
includes, for example, laboratory records, both physical and
electronic, research proposals, progress reports, abstracts, theses,
oral presentations, internal reports, and journal articles.
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Plagiarism is the appropriation of another person's ideas,
processes, results, or words without giving appropriate credit,
including those obtained through confidential review of others'
research proposals and manuscripts.
Research misconduct does not include honest error or
honest 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 scientific community for maintaining the integrity of the
research record;
The misconduct be committed intentionally, or knowingly,
or in reckless disregard of accepted practices; and
The allegation be proven by a preponderance of evidence.
III. Responsibilities of Federal Agencies and Research Institutions
3
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\3\ This includes all organizations receiving Federal research
funds, 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 but it is
understood that they may not have the institutional structures in
place to meet the full range of responsibilities outlined in this
policy. Under such circumstances the agency may elect not to defer
the investigations to the small research institution or independent
researcher.
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Agencies and research institutions are partners who share
responsibility for the integrity of 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 allegations of research misconduct.
Agency Policies and Procedures. Agency policies and
procedures with regard to both their intramural as well as their
extramural programs must conform to those outlined in this document.
Agency Referral to Research Institution. In most cases,
agencies will rely on the researcher's home institution to respond to
allegations of research misconduct.
Agencies will therefore usually direct allegations of
research misconduct made directly to them to the appropriate research
institution. A Federal agency may elect not to defer to the research
institution if it determines the institution is not prepared to handle
the allegation in a manner consistent with the definition of research
misconduct and procedures outlined herein; if Federal agency
involvement is needed to protect the Federal
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government's or the public's interest, including the necessity to
ensure public health and safety; or if the allegation involves an
individual or an entity of sufficiently small size that it cannot
reasonably conduct the investigation itself. At any time, the Federal
agency may proceed with its own inquiry or investigation.
Multiple Phases of the Investigation. An agency's or
research institution's response to an allegation of research misconduct
will usually consist of several phases, including an inquiry to
determine if the allegation has substance and if an investigation is
warranted; and an investigation, the formal examination and evaluation
of the relevant facts leading either to dismissal of the case or a
recommendation for a finding of research misconduct. If an
investigation results in a recommendation for a finding of misconduct,
an adjudication phase follows whereby the recommendations are reviewed
and appropriate action determined. The subject of the allegation may
also appeal a Federal agency finding of research misconduct.
Separation of Phases. Adjudication decisions are separated
organizationally from the agency's or research institution's inquiry
and investigation processes. Any appeals process should likewise be
separated organizationally from the inquiry or investigation.
Institutional Notification of the Agency. When research
institutions receive allegations of research misconduct, they will
notify the relevant responsible agency (or agencies in some cases) of
the allegation upon completion of an inquiry, 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) there is sufficient evidence to proceed to an
investigation. Research institutions will keep the agency informed of
the progress of the investigation, its outcome, and any actions taken.
Upon completion of the investigation, the research institution will
forward to the agency a report of the case and recommendations for its
disposition.
Other Reasons to Notify the Agency. At any time during an
inquiry or investigation, the institution will 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 scientific community or public
should be informed.
Agency Follow-up to Institutional Action. The agency will
review the findings and any corrective actions taken by the research
institution, take additional investigative steps if necessary, and
determine what actions may be required to protect the government's
interests. Upon completion of its review, the agency will take
appropriate administrative action in accordance with applicable laws or
regulations. When the agency has made a final determination and has
closed a case, it will notify the subject of the allegation and the
involved institution of the disposition of the case.
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. In cases where the sanction is less than
government-wide suspension or debarment, agencies may implement their
own administrative actions in accordance with established agency and
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. Implementation of
these guidelines should 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 good faith allegations
of research misconduct to the attention of appropriate authorities or
serve as informants to an investigation without suffering retribution;
Safeguards for the Subject of the Allegation. Safeguards
for the subjects of allegations 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 the subject regarding substantive allegations made
against him or her; a description of all such allegations; and the
opportunity to respond to allegations and to the evidence and findings
upon which they are based.
Objectivity and Expertise. The selection of individuals to
review allegations and conduct investigations who have appropriate
expertise and have no unresolved conflicts of interests, helps to
ensure fairness throughout all phases of the process;
Timeliness. Reasonable time limits for the conduct of the
inquiry, investigation, adjudication, and appeal phases, with
allowances for extensions where appropriate, provide confidence that
the process will be well-managed; and
Confidentiality During Inquiry and Investigation. To the
extent possible consistent with a fair 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 should be
exempt from disclosure under the Freedom of Information Act to the
extent permitted by law and regulation.
V. Actions
Seriousness of the Misconduct. In deciding what
administrative actions are appropriate, the agency should consider the
seriousness of the misconduct, including whether the misconduct was
intentional or reckless; was an isolated event or part of a pattern;
had significant impact on the research record; and had significant
impact on other researchers or institutions.
Administrative Actions. Administrative actions available
include, but are not limited to, 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 the government-wide rule on nonprocurement suspension
and debarment, Subpart 9.4 of the Federal Acquisition Regulation. 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.
In Case of Criminal Violations. If the funding agency
believes that criminal violations may have occurred,
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the agency should refer the matter to the appropriate criminal
investigative body.
Dated: October 5, 1999.
Barbara Ann Ferguson,
Administrative Officer, Office of Science and Technology Policy.
[FR Doc. 99-26608 Filed 10-13-99; 8:45 am]
BILLING CODE 3170-01-P
