This policy became effective Dec. 6, 2000. It includes a new definition of research misconduct issued by Office of Science and Technology Policy. The policy and definition (although not specific rules of procedure) are to be used by all government agencies that fund research.
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: firstname.lastname@example.org.
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.
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.
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Several comments and clarifications are addressed in the following question and answer format rather than through modification of the policy.
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.
Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.
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.
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.
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:
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
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.
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.
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:
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. 0030852 Filed 12-5-00; 8:45 am] BILLING CODE 3170-01-P