The federal Office of Science and Technology Policy issued a final Federal research misconduct policy on December 6, 2000 in 65 FR 76260-76264. The Federal policy consists of a definition of research misconduct and basic guidelines to help Federal agencies and Federally funded research institutions respond to allegations of research misconduct. The policy directs Federal agencies that support or conduct research to implement the Federal policy.
Prior to the issuance of the Federal-wide policy referenced above, only two agencies (the Public Health Service and the National Science Foundation) had adopted formal policies on research misconduct. This Supplement incorporates the NSF revisions of 2002 and PHS revisions of 2005. In cases involving any other Federal agencies, the Vice President for Research should be consulted.
National Science Foundation – Regulations on Misconduct
NSF regulations, which became effective July 1, 1987, were published in the Federal Register, Volume 52, pages 24486 ff on July 1, 1987, and amended on May 14, 1991 (Federal Register, Volume 56, pages 22287 ff) and on April 17, 2001 (Federal Register, Volume 67, pages 11936 ff). The NSF regulations are contained at 45 CFR 689, “Misconduct in Science and Engineering Research” as modified by the April 17, 2002 issuance in the Federal Register.
The NSF statement of general policies and responsibilities with respect to misconduct are set forth in Section 689. The National Science Foundation has adopted the government-wide definition of research misconduct as follows:
- Research Misconduct means fabrication, falsification, or plagiarism in proposing or performing research funded by NSF; reviewing research proposals submitted to NSF, or in reporting research results funded by NSF.
- Fabrication means making up data or results and recording or reporting them.
- Falsification means manipulation 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 means the appropriation of another person’s ideas, processes, results or words without giving appropriate credit.
- Research for purposes of paragraph (a) of this section, includes proposals submitted to NSF in all fields of science, engineering, mathematics, and education and results from such proposals.
- Research misconduct does not include honest error or difference of opinion.
Role of NSF
The initial handling of alleged misconduct matters by NSF staff who learn of it and the subsequent role of the NSF Office of the Inspector General (OIG) are covered in Section 689.5. The role of OIG in notifying NSF officials of alleged misconduct and the circumstances under which reviewers and panelists will be informed are set forth in Section 689.7. The interim actions that NSF may take to protect Federal interests are set forth in Section 689.8, and the possible actions that NSF may take upon a determination that misconduct has occurred under an NSF award are set forth in Section 689.9.
Role of Awardee Institution
The NSF policy provides that “Awardee institutions bear primary responsibility for prevention and detection of research misconduct and for the inquiry, investigation, and adjudication of alleged research misconduct.” Section 689.4 sets out the role of the awardee institution with respect to initiating an inquiry and conducting an investigation and the steps to be taken if the institution wishes NSF to defer independent inquiry or investigation.
Disposition and Appeal
The review and disposition within NSF of the report from an investigation is covered in Section 689.9 and depends upon whether the report confirms or fails to confirm the alleged misconduct. As stated in Section 689.10 appeals may be made to the NSF director.
Public Health Service – Research Misconduct
The applicable requirements are set forth in a Final Rule issued in the Federal Register dated May 17, 2005; 42 CFR Parts 50 and 93. This final rule removes 42 CFR Part 50, subpart A. Requirements not already reflected in the MIT Policy Statement on Academic Misconduct, Policies and Procedures, Section 10.1 are set forth below.
Research Misconduct is fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. It does not include honest error or differences of opinion. A finding of research misconduct requires that there be a significant departure from accepted practices of the relevant research community, the misconduct be committed intentionally, knowingly, or recklessly, and the allegation be proven by a preponderance of the evidence. A preponderance of the evidence is defined as proof by information that, compared with that opposing it, leads to the conclusion that the fact at issue is more probably true than not.
An Inquiry is preliminary information gathering and preliminary fact-finding that meets the criteria and follows the procedures of § 93.307 – 93.309.
An Investigation is the formal development of a factual record and the examination of that record leading to a decision not to make a finding of research misconduct or to a recommendation for a finding of research misconduct which may include a recommendation for other appropriate actions, including administrative actions.
An inquiry must be completed within 60 calendar days of its initiation unless circumstances clearly warrant a longer period. If the inquiry takes longer than 60 days, the record of the inquiry shall include documentation of the reasons for exceeding the 60-day period. If a decision is made that an investigation is not warranted the institution must keep sufficiently detailed documentation to permit a later assessment of the reasons for determining that an investigation was not warranted. The records will be maintained in a secure manner in the Office of the Vice President for Research for a period of seven years after the termination of the inquiry, and shall, upon request, be provided to ORI or other authorized Health and Human Service (HHS) personnel.
Notice of the results of the Inquiry to the respondent must include a copy of or refer to CFT Parts 50 and 93 as well as to the institution’s policies and procedures adopted under its assurance.
If an institution plans to terminate an inquiry or investigation for any reason without completing all relevant requirements of the final rule cited above, a report of such planned termination, including a description of the reasons for such termination, shall be made to the National Institutes of Health (NIH) Office of Research Integrity (ORI), which will then decide whether further investigation should be undertaken.
An institution’s decision to initiate an investigation must be reported in writing to the Director of ORI on or before the date that an investigation begins. At a minimum the notification should include: the name of the person(s) against whom the allegations have been made, the general nature of the allegation(s), and the PHS application or award number(s) involved.
Information provided through the notification will be held in confidence to the extent permitted by law, will not be disclosed as part of the peer review and Advisory Committee review processes, but may be used by the Secretary in making decisions about the award or continuation of funding.
An investigation must be initiated within 30 days after determining that an investigation is warranted. The Director of ORI must be notified on or before the date the investigation begins and provided an inquiry report as described above. The investigation should be thorough, sufficiently documented, and include examination of all research records and evidence relevant to reaching a decision on the merits of the allegations. Steps should be taken to ensure an impartial and unbiased investigation to the maximum extent practicable, including participation of persons with appropriate scientific expertise who do not have unresolved personal, professional, or financial conflicts of interest with those involved with the inquiry or investigation. Interviews will include each respondent, complainant, and any other available person who has been reasonably identified as having information regarding any relevant aspects of the investigation, including witnesses identified by the respondent. Interviews should be recorded or transcribed and the recording or transcription must be provided to the interviewer for correction, and must be included in the record of the investigation. All significant issues and leads relevant to the investigation, including any evidence of additional instances of possible research misconduct should be pursued.
An investigation must ordinarily be completed within 120 days of its initiation. This includes conducting the investigation, preparing the report of findings, making that report available for comment by the subjects of the investigation, and submitting the report to the ORI. If unable to complete the investigation in 120 days, the institution must ask ORI for an extension in writing. ORI may direct the institution to file periodic progress reports.
The investigation report submitted to the ORI must include items a-g of § 93.313 and the institution must maintain and provide to ORI upon request all relevant research records and records of the institution’s research misconduct proceeding, including results of all interviews and transcripts or recordings of such interviews.
In conducting its review of misconduct proceedings, the ORI may review the information in order to determine whether the investigation has been performed in a timely manner and with sufficient objectivity, thoroughness and competence to support the conclusions. The ORI may then request clarification or additional information and, if necessary, perform its own investigation.
Documentation will be maintained in the Office of the Vice President for Research to substantiate the findings of the investigation. This documentation will be made available to the ORI Director, who will decide whether that office will either proceed with its own investigation or will act on the institution’s findings. Such records shall be maintained for a period of at leave seven years after PHS acceptance of the final report.
Protecting Federal Interests: The institution will (1) take interim administrative actions, as appropriate, to protect Federal funds and insure that the purposes of the Federal financial assistance are carried out, and (2) keep the ORI apprised of any developments during the course of the investigation which disclose facts that may affect current or potential Department of Health and Human Services funding for the individual(s) under investigation or that the PHS needs to know to ensure appropriate use of Federal funds and otherwise protect the public interest.
The institution is responsible for notifying the ORI immediately if it ascertains at any stage of the inquiry or investigation that any of the following conditions exist:
- Health or safety of the public is at risk, including an immediate need to protect human or animal subjects.
- HHS resources or interests are threatened.
- Research activities should be suspended.
- There is reasonable indication of possible violations of civil or criminal law.
- Federal action is required to protect the interests of those involved in the research misconduct proceeding.
- The research institution believes the research misconduct proceeding may be made public prematurely so that HHS may take appropriate steps to safeguard evidence and protect the rights of those involved.
- The research community or public should be informed.