42 CFR 93.309 : Public Health (Part 1 To Parts 1009-1099) — (Part 1 To Chapters Ii-Iii) — Public Health Service, Department Of Health And Human Services (Part 1 To Parts 138-199) — Health Assessments And Health Effects Studies Of Hazardous Substances Releases And Facilities (§ 90.1 To § 93.523) — Public Health Service Policies On Research Misconduct (§ 93.25 To § 93.523) — Responsibilities Of Institutions (§ 93.300 To § 93.319) — The Institutional Inquiry (§ 93.307 To § 93.309) — Reporting to ORI on the decision to initiate an investigation.

4 Aug 2016

(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.

42 CFR 93.309