42 C.F.R. § 93.309

Current through November 30, 2024
Section 93.309 - [Effective 1/1/2025] Reporting to ORI on the decision to initiate an investigation
(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.

42 C.F.R. §93.309

89 FR 76295 , 1/1/2025