[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: 
[email protected].

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

[[Page 55724]]

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