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.