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| The Institutional Inquiry | 93.307 – 93.309 | ||||||||||
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42 U.S.C. 216 and 289b
89 FR 76295, Sept. 17, 2024, unless otherwise noted.
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Subscribe to: 42 CFR Part 93 Subpart C - The Institutional Inquiry
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(a) Criteria warranting an inquiry. An inquiry is warranted if the allegation meets the following three criteria:
(1) Falls within the definition of research misconduct under this part;
(2) Is within the applicability criteria of § 93.102; and
(3) Is sufficiently credible and specific so that potential evidence of research misconduct may be identified.
(b) Purpose. An inquiry's purpose is to conduct an initial review of the evidence to determine whether an allegation warrants an investigation. An inquiry does not require a full review of the evidence related to the allegation.
(c) Notice to the respondent. At the time of or before beginning an inquiry, an institution must make a good faith effort to notify in writing the presumed respondent, if any. If the inquiry subsequently identifies additional respondents, the institution must notify them. Only allegations specific to a particular respondent are to be included in the notification to that respondent. If additional allegations are raised, the respondent(s) must be notified in writing of the additional allegations raised against them.
(d) Sequestration of records. An institution must obtain all research records and other evidence needed to conduct the research misconduct proceeding, consistent with § 93.305(a).
(e) Conducting the inquiry —
(1) Multiple institutions. A joint research misconduct proceeding must be conducted consistent with § 93.305(e).
(2) Person conducting the inquiry. Institutions may convene committees of experts to conduct reviews at the inquiry stage to determine whether an investigation is warranted. The inquiry review may be done by a RIO or another designated institutional official in lieu of a committee, with the caveat that if needed, these individuals may utilize one or more subject matter experts to assist them in the inquiry.
(3) Interviews. Institutions may interview witnesses or respondents that would provide additional information for the institution's review.
(f) Inquiry results —
(1) Criteria warranting an investigation. An investigation is warranted if:
(i) There is a reasonable basis for concluding that the allegation falls within the definition of research misconduct under this part and involves PHS-supported biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training, as provided in § 93.102; and
(ii) Preliminary information-gathering and fact-finding from the inquiry indicates that the allegation may have substance.
(2) Findings of research misconduct. Findings of research misconduct, including the determination of whether the alleged misconduct is intentional, knowing, or reckless, cannot be made at the inquiry stage.
(g) Inquiry report.
(1) The institution must prepare a written report that meets the requirements of this section and § 93.309.
(2) If there is potential evidence of honest error or difference of opinion, the institution must note this in the inquiry report.
(3) The institution must provide the respondent an opportunity to review and comment on the inquiry report and attach any comments received to the report.
(h) Time for completion.
(1) The institution must complete the inquiry within 90 days of its initiation unless circumstances warrant a longer period.
(2) If the inquiry takes longer than 90 days to complete, the inquiry report must document the reasons for exceeding the 90-day period.
(a) Notice to respondent. The institution must notify the respondent whether the inquiry found that an investigation is warranted. The notice must include a copy of the inquiry report and include a copy of or refer to this part and the institution's policies and procedures adopted under its research integrity assurance.
(b) Notice to complainant. The institution is not required to notify a complainant whether the inquiry found that an investigation is warranted. The institution may, but is not required to, provide relevant portions of the report to a complainant for comment. If an institution provides notice to one complainant in a case, it must provide notice, to the extent possible, to all complainants in the case.
(a) Within 30 days of determining that an investigation is warranted, the institution must provide ORI with a copy of the inquiry report, which includes the following information:
(1) The names, professional aliases, and positions of the respondent and complainant;
(2) A description of the allegation(s) of research misconduct;
(3) The PHS support, including, for example, grant numbers, grant applications, contracts, and publications listing PHS support;
(4) The composition of the inquiry committee, if used, including name(s), position(s), and subject matter expertise;
(5) Inventory of sequestered research records and other evidence and description of how sequestration was conducted;
(6) Transcripts of any transcribed interviews;
(7) Timeline and procedural history;
(8) Any scientific or forensic analyses conducted;
(9) The basis for recommending that the allegation(s) warrant an investigation;
(10) The basis on which any allegation(s) do not merit an investigation;
(11) Any comments on the inquiry report by the respondent or the complainant; and
(12) Any institutional actions implemented, including communications with journals or funding agencies.
(b) The institution must provide the following information to ORI whenever requested:
(1) The institutional policies and procedures under which the inquiry was conducted; and
(2) The research records and other evidence reviewed, and copies of all relevant documents.
(c) Institutions must keep detailed documentation of inquiries to permit a later assessment by ORI of the reasons why the institution decided not to investigate. Such documentation must be retained in accordance with § 93.318.
(d) In accordance with § 93.305(g), institutions must notify ORI of any special circumstances that may exist.