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. § 93.307

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.

Notes of Decisions
Cited in 8 cases (2 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 4× “” 42 C.F.R. § 93.307 (c), (d) (2005). The person accused of research misconduct must be placed on notice of an inquiry.”
Anversa v. Partners Healthcare System, Inc. (2016) ca1 “See 42 C.F.R. §§ 93.307 (g), 93.311(b). Such flexibility is crucial, given the regulatory imperative that institutions must “[p]ursue diligently all significant issues and leads discovered that are determined relevant to the investigation.”
Cabi v. Boston Children's Hospital (2016) mad “Plaintiffs also allege that BCH has denied Cabi and Cakir access to information and reports that Plaintiffs are entitled to pursuant to 42 C.F.R. § 93.307 (f). Id. ¶¶ 49-51,197-198 .”
Medici v. Lifespan Corp. (2017) mad “42 C.F.R. § 93.307 . The purpose of an inquiry is to “to decide if an *364 allegation warrants an investigation.”
Anversa v. Partners Healthcare System, Inc. (2015) mad · cites it 2× “¶ 44 (citing 42 C.F.R. § 93.307 ). The PHS rule and the HMS and Partners bylaws require that the inquiry be completed within 60 days unless circumstances warranting a longer period are documented.”
HOUSER v. FELDMAN (2021) paed · cites it 6× “42 C.F.R. § 93.307 (b). The inquiry requires an “initial review of the evidence”, which includes all research records, interviews and other necessary evidence, to determine whether the allegation warrants an investigation.”
Goldman v. The University of Kansas (2020) kanctapp · cites it 2× “Federal regulation 42 C.F.R. § 93.307 (d)(1) (2019) states: "An inquiry's purpose is to decide if an allegation warrants an investigation.”
Pichiorri v. Burghes (2024) ohsd “) Although the Court is credible allegation of research misconduct ( 42 C.F.R. §§ 93.307 , 93.310), report any such investigations to ORI ( 42 C.”
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