C.F.R. » Title 42 » CHAPTER I—PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—HEALTH ASSESSMENTS AND HEALTH EFFECTS STUDIES OF HAZARDOUS SUBSTANCES RELEASES AND FACILITIES › PART 93—PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT › Subpart C—Responsibilities of Institutions

42 C.F.R. § 93.309

Reporting to ORI on the decision to initiate an investigation

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(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.

Notes of Decisions
Cited in 5 cases (3 in the last 5 years), 2013–2024 · leading case: Mauvis-Jarvis v. Wong
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Mauvis-Jarvis v. Wong (2013) illappct · cites it 2× “42 C.F.R. § 93.309 (a) (2005). If, however, the inquiry committee determines that it is not necessary to proceed with an investigation, it must merely retain its written report and all relevant evidence collected therein on file within the institution for the next seven years.”
Goldman v. The University of Kansas (2020) kanctapp · cites it 2× “For example, Goldman argues the University did not provide him with a complete list of allegations and claims Krise added new allegations at the hearing, in violation of 42 C.F.R. § 93.309 (a) (2019). Goldman does not explain what allegations the University failed to notify him…”
Yoon v. Garg (2024) ca5 “See 42 C.F.R. §§ 93.309 (a), 93.310(b). The investigation step then requires a full review of all relevant evidence, involves witness interviews, and results in the creation of a substantial factual record.”
HOUSER v. FELDMAN (2021) paed “42 C.F.R. § 93.309 (a). After such a finding, the institution is obligated to conduct a “thorough and sufficiently documented investigation” within 120 days, absent an extension from the ORI.”
Pichiorri v. Burghes (2024) ohsd “310), report any such investigations to ORI ( 42 C.F.R. §§ 93.309 and 93.315), and keep records of proceedings and investigatory reports related to such investigations ( 42 C.”
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