The Office of Research Integrity, ORI, Model Policy for institutions developing policies for responding to scientific misconduct.
This is the U.S. Department of Health and Human Services Office of Research Integrity model policy as of the OEC symposium on Responding to Allegations of Research Misconduct in 10/1999. The ORI's current model policy along with the ORI model procedures is available on the ORI website in PDF format.
Sections that are based on requirements of the PHS regulations codified at 42 C.F.R. Part 50, Subpart A have endnotes that indicate the applicable section number, e.g., 42 C.F.R. ? 50.103(d)(1).
The policy and associated procedures will normally be followed when an allegation of possible misconduct in science is received by an institutional official. Particular circumstances in an individual case may dictate variation from the normal procedure deemed in the best interests of [Institution] and PHS. Any change from normal procedures also must ensure fair treatment the subject of the inquiry or investigation. Any significant variation should be approved in advance by the [designated official] of [Institution].
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The Research Integrity Officer will appoint the inquiry and investigation committees and ensure that necessary and appropriate expertise is secured to carry out a thorough and authoritative evaluation of the relevant evidence in an inquiry or investigation. The Research Integrity Officer will attempt to ensure that confidentiality is maintained.
The Research Integrity Officer will assist inquiry and investigation committees and all institutional personnel in complying with these procedures and with applicable standards imposed by government or external funding sources. The Research Integrity Officer is also responsible for maintaining files of all documents and evidence and for the confidentiality and the security of the files.
The Research Integrity Officer [Option: Deciding Official] will report to ORI as required by regulation and keep ORI apprised of any developments during the course of the inquiry or investigation that may affect current or potential DHHS funding for the individual (s) under investigation or that PHS needs to know to ensure appropriate use of Federal funds and otherwise protect the public interest. 4
The whistleblower is responsible for making allegations in good faith, maintaining confidentiality, and cooperating with an inquiry or investigation.
The respondent is responsible for maintaining confidentiality and cooperating with the conduct of an inquiry or investigation. If the respondent is not found guilty of scientific misconduct, he or she has the right to receive institutional assistance in restoring his or her reputation.5
At any time, an employee may have confidential discussions and consultations about concerns of possible misconduct with the Research Integrity Officer [Option: also list other officials] and will be counseled about appropriate procedures for reporting allegations.
Employees should immediately report any alleged or apparent retaliation to the Research Integrity Officer.
Also the institution will protect the privacy of those who report misconduct in good faith to the maximum extent possible. For example, if the whistleblower 6 requests anonymity, the institution will make an effort to honor the request during the allegation assessment or inquiry within applicable policies and regulations and state and local laws, if any. The whistleblower will be advised that if the matter is referred to an investigation committee and the whistleblower's testimony is required, anonymity may no longer be guaranteed. Institutions are required to undertake diligent efforts to protect the positions and reputations of those persons who, in good faith, make allegations.7
Institutional employees accused of scientific misconduct may consult with legal counsel or a non- lawyer personal adviser (who is not a principal or witness in the case) to seek advice and may bring the counsel or personal adviser to interviews or meetings on the case. [Option: Some institutions do not permit the presence of lawyers at interviews or meetings with institutional officials.]
The Research Integrity Officer will notify the respondent of the proposed committee membership in [suggested: 10 days]. If the respondent submits a written objection to any appointed member of the inquiry committee or expert based on bias or conflict of interest within [suggested: 5 days], the Research Integrity Officer will determine whether to replace the challenged member or expert with a qualified substitute.
At the committee's first meeting, the Research Integrity Officer will review the charge with the committee, discuss the allegations, any related issues, and the appropriate procedures for conducting the inquiry, assist the committee with organizing plans for the inquiry, and answer any questions raised by the committee. The Research Integrity Officer and institutional counsel will be present or available throughout the inquiry to advise the committee as needed.
The Research Integrity Officer will notify the respondent of the proposed committee membership within [suggest: 5 days]. If the respondent submits written objection to any appointed member of the investigation committee expert, the Research Integrity Officer will determine whether to replace the challenged member or expert with a qualified substitute.
During the investigation, if additional information becomes available that substantially changes the subject matter of the investigation or would suggest additional respondents, the committee will notify the Research Integrity Officer, who will determine whether it is necessary to notify the respondent of the new subject matter or to provide notice to additional respondents.
The investigation will normally involve examination of all documentation including, but not necessarily limited to, relevant research records, computer files, proposals, manuscripts, publications, correspondence, memoranda, and notes of telephone calls.14 Whenever possible, the committee should interview the whistleblower(s), the respondent(s), and other individuals who might have information regarding aspects of the allegations.15 Interviews of the respondent should be tape recorded or transcribed. All other interviews should be transcribed, tape recorded, or summarized. Summaries or transcripts of the interviews should be prepared, provided to the interviewed party for comment or revision, and included as part of the investigatory file.16
The Deciding Official's determination, together with the investigation committee's report, constitutes the final investigation report for purposes of ORI review.
When a final decision on the case has been reached, the Research Integrity Officer will notify both the respondent and the whistleblower in writing. In addition, the Deciding Official will determine whether law enforcement agencies, professional societies, professional licensing boards, editors of journals in which falsified reports may have been published, collaborators of the respondent in the work, or other relevant parties should be notified of the outcome of the case. The Research Integrity Officer is responsible for ensuring compliance with all notification requirements of funding or sponsoring agencies.
[Institution] will take appropriate administrative actions against individuals when an allegation of misconduct has been substantiated.31
If the Deciding Official determines that the alleged misconduct is substantiated by the findings, he or she will decide on the appropriate actions to be taken, after consultation with the Research Integrity Officer. The actions may include:
If the respondent, without admitting to the misconduct, elects to resign his or her position prior to the initiation of an inquiry, but after an allegation has been reported, or during an inquiry or investigation, the inquiry or investigation will proceed. If the respondent refuses to participate in the process after resignation, the committee will use its best efforts to reach a conclusion concerning the allegations, noting in its report the respondent's failure to cooperate and its effect on the committee's review of all the evidence.
After completion of a case and all ensuing related actions, the Research Integrity Officer will prepare a complete file, including the records of any inquiry or investigation and copies of all documents and other materials furnished to the Research Integrity Officer or committees. The Research Integrity Officer will keep the file for three years after completion of the case to permit later assessment of the case. ORI or other authorized DHHS personnel will be given access to the records upon request.34
Issued April 1995, Revised February 1997