42 CFR 93.309 - Reporting to ORI on the decision to initiate an investigation.
(a) Within 30 days of finding that an investigation is warranted, the institution must provide ORI with the written finding by the responsible institutional official and a copy of the inquiry report which includes the following information -
(1) The name and position of the respondent;
(2) A description of the allegations of research misconduct;
(3) The PHS support, including, for example, grant numbers, grant applications, contracts, and publications listing PHS support;
(4) The basis for recommending that the alleged actions warrant an investigation; and
(5) Any comments on the report by the respondent or the complainant.
(b) The institution must provide the following information to ORI on request -
(1) The institutional policies and procedures under which the inquiry was conducted;
(2) The research records and evidence reviewed, transcripts or recordings of any interviews, and copies of all relevant documents; and
(3) The charges for the investigation to consider.
(c) Documentation of decision not to investigate. Institutions must keep sufficiently detailed documentation of inquiries to permit a later assessment by ORI of the reasons why the institution decided not to conduct an investigation. Consistent with § 93.317, institutions must keep these records in a secure manner for at least 7 years after the termination of the inquiry, and upon request, provide them to ORI or other authorized HHS personnel.
(d) Notification of special circumstances. In accordance with § 93.318, institutions must notify ORI and other PHS agencies, as relevant, of any special circumstances that may exist.