Conducting the Investigation
The investigation must begin (first investigation committee meeting) within 30 calendar days after the determination by the inquiry committee that an investigation is warranted
The purpose of the investigation is to:
- Develop a factual record by exploring the allegations in detail
- Examine the evidence in depth, leading to recommended findings on whether research misconduct has been committed:
- By whom
- To what extent
The investigation will also determine whether there are additional instances of possible research misconduct that would justify broadening the scope beyond the initial allegations.
This is particularly important where the alleged research misconduct involves:
- Clinical trials
- Potential harm to human subjects or the general public, or
- If it affects research that forms the basis for:
- Public policy
- Clinical practice
- Public health practice
Under 42 CFR 93.313 and 45 CFR 689.4(b)(5), the findings of the investigation must be set forth in an investigation report.
On or before the date on which the investigation begins, the RIO must notify:
- The ORI Director (or NSF OIG as applicable) of the decision to begin the investigation and provide ORI a copy of the inquiry report
- The respondent in writing of the allegations to be investigated.
- The RIO/designee must also give the respondent written notice of any new allegations of research misconduct within a reasonable amount of time of deciding to pursue allegations not addressed during the inquiry or in the initial notice of the investigation.
The committee charged with the inquiry will proceed with the investigation upon the determination that an investigation is warranted.
The committee Chair, in consultation with the RIO, the DO/DO’s designee, and the Provost of the University, will reassess membership to assure that the committee consists of individuals:
- Who do not have unresolved personal, professional, or financial conflicts of interest with those involved with the investigation
- With the appropriate scientific expertise to:
- Evaluate the evidence and issues related to the allegation
- Interview the respondent and complainant
- Conduct the investigation
The RIO may appoint committee members from outside the institution when necessary to secure additional expertise or to avoid conflicts of interest.
The RIO/designee will prepare a written charge for the investigation committee that:
- Describes the allegations and related issues identified during the inquiry
- Identifies the respondent
- Informs the committee that it must conduct the investigation as prescribed in the Investigation process
- Defines research misconduct
- Informs the committee that it must evaluate:
- The evidence and testimony to determine whether, based on a preponderance of the evidence, research misconduct occurred
- The type and extent of misconduct, if any
- Who was responsible for any misconduct
- Informs the committee that in order to determine that the respondent committed research misconduct, it must find by a preponderance of the evidence that:
- Research misconduct, as defined in this policy, occurred (the respondent has the burden of proving by a preponderance of the evidence any affirmative defenses raised, including honest error or a difference of opinion)
- The research misconduct is a significant departure from accepted practices of the relevant research community, and
- The respondent committed the research misconduct intentionally, knowingly, or recklessly
- Informs the investigation committee that they are responsible for preparing or directing the preparation of a written investigation report that meets the requirements of this policy and applicable federal/funding agency requirements.
At the committee’s first meeting, the RIO/designee will:
- Review the following with the investigation committee:
- The charge
- Inquiry report
- Prescribed procedures and standards for the conduct of the investigation, including the necessity for confidentiality and for developing a specific investigation plan
- Seek disclosure of any unresolved personal, professional, or financial conflicts of interest with those involved with the investigation
- Determine how to access additional expertise as needed
- Provide the investigation committee with a copy of this policy, and 42 CFR 93 or 45 CFR 689
The RIO will be present or available throughout the investigation to advise the committee as needed.
The investigation committee and the RIO must:
- Use diligent efforts to ensure that the investigation is thorough and sufficiently documented, including examination of all research records and evidence relevant to reaching a decision on the merits of each allegation
- Take reasonable steps to ensure an impartial and unbiased investigation to the maximum extent practical
- Interview each:
- 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)
- Record or transcribe each interview
- Provide the recording or transcript to the interviewee for correction
- Include the recording or transcript in the record of the investigation
- Pursue diligently all significant issues and leads discovered that are determined relevant to the investigation, including any evidence of any additional instances of possible research misconduct, and continue the investigation to completion.
- Conducting the investigation
- Preparing the report of findings
- Providing the draft report for comment
- Sending the final report to ORI/OIG
However, if the RIO determines that the investigation will not be completed within the required period, he/she will:
- Submit to ORI a written request for an extension, setting forth the reasons for the delay. The RIO will ensure that periodic progress reports are filed with ORI, if ORI grants the request for an extension and directs the filing of such reports.
- If the institution wishes NSF deferral of independent investigation to continue, OIG will be notified, and may require submission of periodic status reports.
The investigation committee and the RIO are responsible for preparing a written draft report of the investigation that:
- The nature of the allegation of research misconduct, including identification of the respondent
- And documents the PHS or other funding agency support, including, for example, the numbers of any grants that are involved, grant applications, contracts, and publications listing PHS support
- The specific allegations of research misconduct considered in the investigation
- Includes the institutional policies and procedures under which the investigation was conducted, unless those policies and procedures were provided to ORI previously
- Identifies and summarizes the research records and evidence reviewed and identifies any evidence taken into custody but not reviewed
- Includes a statement of findings for each allegation of research misconduct identified during the investigation.
- Each Statement of findings must:
- Identify whether
- the research misconduct was falsification, fabrication, or plagiarism, and
- it was committed intentionally, knowingly, or recklessly
- Summarize the facts and the analysis that supports the conclusionEach statement of findings must:
- Consider the merits of any reasonable explanation by the respondent (including any effort by respondent to establish by a preponderance of the evidence that he or she did not engage in research misconduct because of honest error or a difference of opinion)
- specific PHS support
- whether any publications need correction or retraction
- The person(s) responsible for the misconduct
- List any current support or known applications or proposals for support that the respondent has pending with non-PHS federal agencies
- Identify whether
The RIO/designee must give the respondent a copy of the draft investigation report for comment and, concurrently, a copy of or supervised access to the evidence on which the report is based.
The respondent will be allowed 30 calendar days from the date he/she received the draft report to submit comments to the RIO/designee. The respondent's comments must be included and considered in the final report.
Investigation reports are not routinely provided to the complainant. On a case-by-case basis as determined by the RIO, the institution may provide relevant portions of the draft investigation report to the complainant for comment. If the complainant is asked to comment, responses must be received within 30 days and must be included and considered in the final report.
In distributing the draft report, or portions thereof, the RIO/designee will inform the recipient of the confidentiality under which the draft report is made available and may establish reasonable conditions to ensure such confidentiality. For example, the RIO/designee may require that the recipient sign a confidentiality agreement.
The RIO will:
- Assist the investigation committee in finalizing the draft investigation report, including ensuring that the respondent’s comments are included and considered
- Transmit the final investigation report to the DO/DO’s designee, with a copy to the Provost
The DO will determine in writing:
- Whether the institution accepts the investigation report and its findings
- The appropriate administrative actions in response to the accepted findings of research misconduct.
If the DO’s determination varies from the findings of the investigation committee, the DO will, as part of his/her written determination, explain in detail the basis for rendering a decision different from the findings of the investigation committee. Alternatively, the DO may return the report to the investigation committee with a request for further fact-finding or analysis. The final determination might slightly alter the investigation report provided by the investigation committee.
When a final decision on the case has been reached:
- The RIO will normally notify both the respondent and the complainant in writing that the proceeding has been closed.
- The respondent will be provided with the institutional findings, as well as associated institutional administrative actions, if any.
- After informing ORI or NSF OIG or DOD as applicable, the DO/DO’s designee 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 RIO is responsible for ensuring compliance with all notification requirements of funding or sponsoring agencies
- Withdrawal or correction of all pending or published abstracts and papers emanating from the research where research misconduct was found
- For the person responsible for the misconduct:
- Removal of the responsible person from the particular project
- Letter of reprimand
- Special monitoring of future work
- Salary reduction
- Initiation of steps leading to possible rank reduction or termination of employment
- Restitution of funds to the grantor agency as appropriate
- Other actions appropriate to the research misconduct
Within 15 calendar days of receipt of the findings, the respondent may appeal the decision in writing to the Deciding Official. The Deciding Official may request that the RIO reconvene the investigation committee to review the appeal, or may require that a separate committee be convened to reopen the matter. Appeals related to PHS-funded research activities must be addressed within 120 calendar days.
Unless an extension has been granted, the RIO must, within the allowed period for completing the investigation, submit to ORI or NSF OIG or DOD as applicable:
- A copy of the final investigation report with all attachments
- A statement of whether the institution:
- Accepts the findings of the investigation report
- Found misconduct and, if so, who committed the misconduct
- A description of any pending or completed administrative actions against the respondent
- Investigation reports are provided to funding agencies based on agency requirements. Substantiated research misconduct in unfunded research is not federally reported, but might be reported externally based on the final administrative sanctions determined by the DO/designee (for example, journal retractions, collaborators, professional societies). In most of these cases, the full investigation report is not released.
Generally, all inquiries and investigations will be carried through to completion and all significant issues will be pursued diligently.
The RIO must notify ORI in advance if there are plans to close a case at the inquiry, investigation, or appeal stage on the basis that:
- The respondent has admitted guilt, see Admission of Misconduct, above.
- A settlement with the respondent has been reached
Or for any other reason except:
- Closing of a case at the inquiry stage on the basis that an investigation is not warranted, or
- A finding of no misconduct at the investigation stage, which must be reported to ORI or to NSF OIG as applicable, as prescribed in this policy and 42 CFR 93.315 and 42 CFR 93.316(a)