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 D—Responsibilities of the U.S. Department of Health and Human Services

42 C.F.R. § 93.400

General statement of ORI authority

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(a) ORI review. ORI may respond directly to any allegation of research misconduct at any time before, during, or after an institution's response to the matter. The ORI response may include but is not limited to:

(1) Conducting allegation assessments;

(2) Determining independently whether jurisdiction exists under this part;

(3) Forwarding allegations of research misconduct to the appropriate institution or HHS component for inquiry or investigation;

(4) Requesting clarification or additional information, documentation, research records, or other evidence as necessary from an institution or its members or other persons or sources to carry out ORI's review;

(5) Notifying or requesting assistance and information from PHS funding components, other affected Federal and state offices and agencies, or institutions;

(6) Reviewing the institutional record and directing the institution to address deficiencies or additional allegations in the institutional record;

(7) Making a finding of research misconduct; and

(8) Taking actions as necessary to protect the health and safety of the public, to promote the integrity of PHS-supported biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training, or to conserve public funds.

(b) ORI assistance to institutions. ORI may:

(1) Provide information, technical assistance, and procedural advice to institutional officials as needed regarding an institution's research misconduct proceedings and the sufficiency of the institutional record; and

(2) Issue guidance and provide information to support institutional implementation of and/or compliance with the requirements of this part.

(c) Review of institutional research integrity assurances. ORI will review institutional research integrity assurances and policies and procedures for compliance with this part.

(d) Institutional compliance. ORI may make findings and impose ORI compliance actions related to an institution's compliance with this part and with its policies and procedures, including an institution's participation in research misconduct proceedings.

Notes of Decisions
Cited in 2 cases (1 in the last 5 years), 2013–2025 · leading case: Mauvis-Jarvis v. Wong
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Mauvis-Jarvis v. Wong (2013) illappct · cites it 4× “42 C.F.R. § 93.400 (2005). When the ORI does choose to get involved and makes its own finding of research misconduct, it must propose and obtain HHS approval for “administrative actions,” and must notify the respondent of these actions in a formal charge letter.”
Frech v. U.S. Department of Health & Human Services (2025) dcd · cites it 2× “AR 4820; 42 C.F.R. § 93.400 (f) (2005). When reviewing research misconduct proceedings, the Office may consider the reports and records prepared by the institution, gather additional evidence, conduct its own analyses, and decide whether research misconduct occurred.”
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