Procedures for the Review, Investigation and Report of Allegations of Misconduct in Science
Effective November 8, 1989, all entities applying for or receiving funds\from the Public Health Service (PHS) of the Department of Health and Human Services must submit an assurance that they have established "an administrative process to review reports of scientific misconduct in biomedical or behavioral research and will report to the Secretary of Health and Human Services any investigation it undertakes “of alleged scientific misconduct that appears substantial”.
“’Misconduct in Science’ means fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretation or judgment of data.”
In addition to establishing policies and procedures for dealing with scientific misconduct and informing ORI of the PHS of investigations, the institution must inform "scientific and administrative staff of the policies and procedures and the importance of compliance with those policies and procedures" and must take "immediate and appropriate action as soon as misconduct on the part of employees or persons within the organization's control is suspected or alleged."
The following procedures for responding to allegations of misconduct in science meet the specific requirements and incorporate specific language of the PHS.
- All allegations or other evidence of misconduct in science shall be brought to the attention of the Dean of the Faculty.
- The Dean of the Faculty shall appoint a subcommittee of the Science Advisory Board to inquire immediately into the allegations or other evidence of possible misconduct. The subcommittee shall be composed of individuals without real or apparent conflicts of interest in the case and with appropriate scientific expertise for judging the facts of the case and determining whether an investigation is warranted.
- The Dean of the Faculty and the inquiring subcommittee shall protect, to the maximum extent possible, the privacy of those who in good faith report apparent misconduct and shall provide to the maximum extent possible, confidential treatment of the accused individual(s).
- The inquiry must be completed within 60 days of its initiation unless circumstances clearly warrant a longer period. The subcommittee shall prepare a written report that states what evidence was reviewed, summarizes relevant interviews, and includes the conclusions of the inquiry. The accused individual(s) shall be given a copy of the report. If they comment on the report, their comments shall be made a part of the record. If the inquiry takes longer than 60 days to complete, the record of the inquiry shall include documentation of the reasons for exceeding the 60-day period.
- The Dean of the Faculty shall maintain sufficiently detailed documentation of inquiries to permit a later assessment by authorized DHHS personnel of the reasons for determining that an investigation was not warranted, if necessary.
- The Dean of the Faculty shall notify the Director, ORI, when, on the basis of the initial inquiry the institution determines that an investigation is warranted. The Dean of the Faculty shall notify the Director, ORI, when, prior to the decision to initiate an investigation, any of the following conditions exist:
- There is an immediate health hazard involved.
- There is an immediate need to protect Federal funds or equipment.
- There is an immediate need to protect the interests of the person(s) making the allegations or of the individual(s) who is (are) the subject of the inquiry.
- It is probable that the alleged incident is going to be reported publicly.
- There is reasonable indication of possible criminal violation (in which case ORI must be informed within 24 hours of when the information was obtained).
- If such conditions arise during an investigation, the Dean of the Faculty shall also inform the Director, ORI of them.
- The Dean of the Faculty shall inform those who reported the apparent misconduct and the accused individual(s) of whether or not an investigation is warranted. If the inquiry provides sufficient basis an investigation shall be undertaken within 30 days of the completion of the inquiry.
- The Dean of the Faculty in consultation with the inquiring subcommittee of the Science Advisory Board will choose the members of the investigating committee. Those individuals may be chosen from within or outside of the College. They should be without real or apparent conflicts of interest in the case and should have scientific knowledge appropriate to the case. Prior to empanelling the investigating committee, the Dean of the Faculty shall identify the potential members of the investigating committee to the accused individual(s) to insure that the members of the investigating committee are without real or apparent conflicts of interest in the case from the accused individual's(s') point of view.
- The investigation should ordinarily be completed within 120 days of its initiation. If it is determined that the investigation will not be complete in 120 days, a request for an extension must be submitted to the ORI.
- The investigation normally will include examination of all documentation, including but not necessarily limited to relevant research data and proposals, publications, correspondence, and memoranda of telephone calls. Whenever possible, interviews should be conducted with all individuals involved either in making the allegations or against whom the allegation is made, as well as other individuals who might have information regarding key aspects of the allegations; complete summaries of these interviews should be prepared, provided to the interviewed party for comment or revision and included as part of the investigatory file. The investigating committee shall keep the Dean of the Faculty fully informed of its procedures and proceedings.
- The investigating committee shall prepare and maintain the documentation to substantiate the committee's findings. The Dean of the Faculty shall make the documentation available to the Director, ORI, who will decide whether to proceed with an independent investigation.
- The Dean of Faculty with the assistance of the Treasurer shall take interim administrative actions, as appropriate, to protect Federal funds and insure that the purposes of the Federal financial assistance are carried out. The Dean of the Faculty shall keep the ORI apprised of any developments during the investigation which disclose facts that may affect current of potential DHHS funding for the individual(s) under investigation or that the PHS needs to know to insure appropriate use of Federal funds and otherwise protect public interest.
- When the investigating committee's proceedings are complete, the committee shall submit a full report of its findings to the Dean of the Faculty. This report should be offered to the accused individual(s) for review and shall include any corrections or responses provided by the accused individual(s).
- The Dean of the Faculty and the investigating committee shall undertake diligent efforts, as appropriate, to restore the reputations of persons alleged to have engaged in misconduct when allegations are not confirmed, and also undertake diligent efforts to protect the positions and reputations of those persons who, in good faith, make allegations.
- When the investigating committee's report finds that the allegation of misconduct has been substantiated, the Dean of the Faculty shall inform the accused individual(s), those who reported the misconduct, and the President. The individual(s) may at this point promptly appeal the investigating committee’s decision. The grounds for appeal should be limited to failure to follow appropriate procedures. The Dean of Faculty shall choose an appeals committee consisting of scientists who were not either members of the inquiring subcommittee or the investigating committee.
- When the appeal has been concluded, the appeals subcommittee shall inform the President of the findings. The President, in consultation with the Dean of Faculty and with the Board of Trustees, shall then take whatever action she considers appropriate. Such actions may include removal from a particular project, special monitoring or future work, probation, suspension, or dismissal.
- The Dean of the Faculty shall provide ORI with a detailed account of the investigation as well as a description of any sanctions taken by the institution.
Note: All quotations are from the DHHS-PHS document "Responsibilities of Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science" published as a final ruling in the Federal Register, August 8, 1989, 54(#151),32446-32451.
December 8, 1989
Revised, January 14, 1994
Revised February 14, 1996