AGENCY: Office of Science and Technology
Policy
ACTION: Request for public
comment on proposed Federal policy on research misconduct.
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, D.C. 20502.
FOR FURTHER INFORMATION CONTACT: Sybil Francis, Office of Science and Technology Policy, Executive Office of the President, Washington, D.C. 20502. Tel: 202-456-6040; Fax: 202-456-6027; e-mail: sfrancis@ostp.eop.gov.
SUPPLEMENTAL 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
Research misconduct is defined as
fabrication, falsification, or plagiarism in proposing, performing, or
reviewing research, or in reporting research results.
· 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.
· 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
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 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,
the agency should refer the matter to the appropriate criminal investigative
body.
Office of Science
and Technology Policy
1600 Pennsylvania
Ave, N.W
Washington, DC
20502
202.395.7347
Information@ostp.eop.gov