Allegations of Research Misconduct

Research Integrity Officer (RIO) means the institutional official responsible for: (1) assessing Allegations of Research Misconduct to determine if they fall within the definition of Research Misconduct, are covered by 42 CFR § 93, 45 CFR § 689, 7 CFR § 3022, DoDI 3210.7 and other applicable regulations, and warrant an Inquiry on the basis that the Allegation is sufficiently credible and specific so that potential Evidence of Research Misconduct may be identified; and (2) overseeing Inquires and Investigations. These responsibilities include the following duties related to Research Misconduct Proceedings:

1. Consult confidentially with persons uncertain about whether to submit an Allegation of Research Misconduct;
2. Receive Allegations of Research Misconduct;
3. Assess each Allegation of Research Misconduct in accordance with Procedures Section B of this Policy to determine whether it falls within the definition of Research Misconduct and warrants an Inquiry;
4. As necessary, take interim action and notify federal agencies of special circumstances, in accordance with Other Policy Principles Section F of this Policy;
5. Sequester Research data and Evidence pertinent to the Allegation of Research Misconduct in accordance with Other Policy Principles Section E of this Policy and maintain it securely in accordance with this Policy and applicable law and regulation;
6. Provide confidentiality to those involved in the Research Misconduct Proceeding as required by 42 CFR § 93.108, other applicable law, and institutional policy;
7. Notify the Respondent and provide opportunities for him/her to review/ comment/respond to Allegations, Evidence, and panel reports in accordance with Other Policy Principles Section D of this Policy;
8. Inform Respondents, Complainants, and witnesses of the procedural steps in the Research Misconduct Proceeding;
9. Assist the DO in determining whether each person involved in handling an Allegation of Research Misconduct has an unresolved personal, professional, or financial Conflict of Interest and take appropriate action, including recusal, to ensure that no person with such conflict is involved in the Research Misconduct Proceeding;
10. In cooperation with other institutional officials, take all reasonable and practical steps to protect or restore the positions and reputations of Good Faith Complainants, witnesses, and panel members and counter potential or actual retaliation against them by Respondents or other Institutional Members;
11. Keep the Deciding Official and all relevant parties apprised of the progress of the review of the Allegation of Research Misconduct;
12. Notify and make reports to federal agencies as required by law;
13. Ensure that administrative actions taken by the institution and federal agencies are enforced and take appropriate action to notify other involved parties, such as sponsors, funding agencies, law enforcement agencies, professional societies, and licensing boards of those actions; and
14. Maintain records of the Research Misconduct Proceeding and make them available to federal agencies in accordance with Other Policy Principles Section G of this Policy.

Complainant: The Complainant is responsible for making Allegations in Good Faith, maintaining confidentiality, and cooperating with the Inquiry and Investigation. As a matter of good practice, the Complainant should be interviewed at the Inquiry stage, given the transcript or recording of the interview, and have the opportunity to correct and resubmit the transcription. The Complainant must be interviewed during an Investigation, be given the transcript or recording of the interview, and be able to correct and resubmit the transcription. The Complainant is entitled to:

1. reasonable and practical efforts by the institution to maintain the Complainant's identity in confidence, upon request.

Respondent: The Respondent is responsible for maintaining confidentiality and cooperating with the conduct of an Inquiry and Investigation. The Respondent is entitled to:

1. A Good Faith effort from the RIO to notify the Respondent in writing at the time of or before beginning an Inquiry;
2. An opportunity to comment on the Inquiry report and have his/her comments attached to the report;
3. Be notified of the outcome of the Inquiry, and receive a copy of the Inquiry report that includes a copy of, or refers to applicable regulations and the institution's policies and procedures on Research Misconduct;
4. Be notified in writing of the Allegations to be investigated within a reasonable time after the determination that an Investigation is warranted, but before the Investigation begins (within 30 days after the institution decides to begin an Investigation), and be notified in writing of any new Allegations not addressed in the Inquiry or in the initial notice of Investigation within a reasonable time after the determination to pursue those Allegations;
5. Be interviewed during the Investigation, have the opportunity to have the recording or transcript, to correct the transcript, and have the corrected transcript included in the record of the Investigation;
6. Have interviewed during the Investigation any witness who has been reasonably identified by the Respondent as having information on relevant aspects of the Investigation, have the recording or transcript provided to the witness, the opportunity for the witness to correct the transcript, and have the corrected transcript included in the record of Investigation; and
7. Receive a copy of the draft Investigation report and, concurrently, a copy of, or supervised access to the Evidence on which the report is based, and be notified that any comments must be submitted within 30 days of the date on which the copy was received and that the comments will be considered by the institution and addressed in the final report.
   

The Respondent should be given the opportunity to admit that Research Misconduct occurred and that he/she committed the Research Misconduct. With the advice of the RIO and/or other institutional officials, the Deciding Official may terminate the institution's review of an Allegation that has been admitted, if the institution's acceptance of the admission and any proposed settlement is approved by the appropriate federal agency.

As provided by regulation and this Policy, the Respondent will have the opportunity to request an institutional appeal.

All Institutional Members will report observed, suspected, or apparent Research Misconduct to the RIO. If an individual is unsure whether a suspected incident falls within the definition of Research Misconduct, he or she may meet with or contact the RIO to discuss the suspected Research Misconduct informally, which may include discussing it anonymously and/or hypothetically. If the circumstances described by the individual do not meet the definition of Research Misconduct, the RIO will refer the individual or Allegation to other officials with responsibility for resolving the problem.

At any time, an Institutional Member may have confidential discussions and consultations about concerns of possible Misconduct with the RIO and will be counseled about appropriate procedures for reporting Allegations.

Institutional Members will cooperate with the RIO and other institutional officials in the review of Allegations and the conduct of inquiries and Investigations. Institutional Members, including Respondents, have an obligation to provide Evidence relevant to Research Misconduct Allegations to the RIO and other institutional officials.

Institutional Members may not retaliate in any way against Complainants, witnesses, or panel members. Institutional Members should immediately report any alleged or apparent retaliation against Complainants, witnesses or panel members to the RIO. The RIO will review the Allegation of retaliation and, if necessary, work with other institutional officials to make all reasonable and practical efforts to counter any potential or actual retaliation and protect and restore the position and reputation of the person against whom the retaliation is directed.

Protecting the Respondent

As requested and as appropriate, the RIO and other institutional officials shall make all reasonable and practical efforts to protect or restore the reputation of persons alleged to have engaged in Research Misconduct, but against whom no finding of Research Misconduct is made.

During the Research Misconduct Proceeding, the RIO is responsible for ensuring that Respondents receive all the notices and opportunities provided for in 42 CFR Part 93 and the policies and procedures of the University. Respondents may consult with legal Counsel or a personal advisor (who is not a principal or witness in the case) to seek advice and may bring the Counsel or the personal adviser to interviews or meetings on the case. However, Respondent's Counsel or personal advisor presence at interviews or meetings is restricted to advising (as opposed to representing or responding on behalf of) the Respondent

At the time of or before beginning an Inquiry, the RIO must make a Good Faith effort to notify the Respondent(s) in writing, if the Respondent is known. If the Inquiry subsequently identifies additional Respondents, they must be notified in writing. On or before the date on which the Respondent is notified, or the Inquiry begins, whichever is earlier, the RIO must take all reasonable and practical steps to obtain custody of all the Research Records and Evidence needed to conduct the Research Misconduct Proceeding, inventory the records and Evidence and sequester them in a secure manner, except that where the Research Records or Evidence encompass scientific instruments shared by a number of users, custody may be limited to copies of the data or Evidence on such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments. The RIO may consult with federal agencies for advice and assistance in this regard.

The manner in which sequestration shall occur will to the maximum extent possible, while complying with 42 CFR 93.307, 7 CFR § 3022.11(b),(c) and other applicable federal regulations, protect the confidentiality of the Respondent and his or her ability to continue his or her program of Research.

Throughout the Research Misconduct Proceeding, the RIO will review the situation to determine if there is any threat of harm to public health, federal funds and equipment, or the integrity of the Public Health Service (PHS) or other federally supported Research process. In the event of such a threat, the RIO will, in consultation with other institutional officials and appropriate federal agencies, take appropriate interim action to protect against any such threat. Interim action might include additional monitoring of the Research process and the handling of federal funds and equipment, reassignment of personnel or of the responsibility for the handling of federal funds and equipment, additional review of Research data and results or delaying publication. The RIO shall, at any time during a Research Misconduct Proceeding, notify the appropriate federal agency immediately if he/she has reason to believe that any of the following conditions exist:

1. Health or safety of the public is at risk, including an immediate need to protect human or animal subjects;
2. Federal agency resources or interests are threatened;
3. Research activities should be suspended;
4. There is a reasonable indication of possible violations of civil or criminal law;
5. The Research Misconduct Proceeding at any point reveals behavior that may be criminal in nature;
6. Federal action is required to protect the interests of those involved in the Research Misconduct Proceeding;
7. The Research Misconduct Proceeding may be made public prematurely and appropriate federal agency action may be necessary to safeguard Evidence and protect the rights of those involved; or,
8. The Research community or public should be informed.

The RIO must maintain and provide to appropriate federal agencies upon request "records of Research Misconduct Proceedings." Unless custody has been transferred to a federal agency or a federal agency has advised in writing that the records no longer need to be retained, records of Research Misconduct Proceedings must be securely maintained for 7 years after completion of the proceeding or the completion of any federal agency proceeding involving the Research Misconduct Allegation. The RIO is also responsible for providing any information, documentation, Research Records, Evidence or clarification requested by a federal agency to carry out its review of an Allegation of Research Misconduct or of the institution's handling of such an Allegation.

Generally, all Inquiries and Investigations will be carried through to completion and all significant issues will be pursued diligently. The RIO must notify the appropriate federal agency in advance if there are plans to close a case at the Inquiry, Investigation, or appeal stage on the basis that Respondent has admitted guilt, a settlement with the Respondent has been reached, or for any other reason, except: (1) closing of a case at the Inquiry stage on the basis that an Investigation is not warranted; or (2) a finding of no Misconduct at the Investigation stage, which must be reported to the appropriate federal agency, as prescribed in this Policy.

The termination of the Respondent's institutional employment, by resignation or otherwise, before or after an Allegation of possible Research Misconduct has been reported, will not preclude or terminate the Research Misconduct Proceeding or otherwise limit any of the institution's responsibilities.

If the Respondent, without admitting to the Misconduct, elects to resign his or her position after the institution receives an Allegation of Research Misconduct, the assessment of the Allegation will proceed, as well as the Inquiry and Investigation phases, as appropriate based on the outcome of the preceding steps. If the Respondent refuses to participate in the process after resignation, the RIO, DO and any Inquiry or Investigation Panel will use their best efforts to reach a conclusion concerning the Allegations, noting in the report the Respondent's failure to cooperate and its effect on the Evidence.