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. § 93.403

ORI review of research misconduct proceedings

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(a) In conducting its review of research misconduct proceedings, ORI will:

(1) Determine whether this part applies;

(2) Consider the institutional record and determine whether the institutional record is sufficient, provide instructions to the institution(s) if ORI determines that revisions are needed or additional allegations of research misconduct should be addressed, and require institutions to provide the respondent with an opportunity to respond to information or allegations added to the institutional record;

(3) Determine whether the institution conducted the proceedings in a timely and fair manner in accordance with this part with sufficient thoroughness, objectivity, and competence to support the conclusions; and

(4) After reviewing in accordance with paragraphs (a)(1) through (3) of this section, determine whether to close the case without further action or proceed with the case.

(b) If ORI determines to proceed with the case, ORI will:

(1) Obtain additional information or materials from the institution, the respondent, complainants, or other sources, as needed;

(2) Conduct additional analyses, as needed;

(3) Provide the respondent the opportunity to access the institutional record, any additional information provided to ORI while the case is pending before ORI, and any analysis or additional information generated or obtained by ORI;

(4) Provide the respondent the opportunity to submit information to ORI;

(5) Allow the respondent and the respondent's attorney, if represented, to meet virtually or in person with ORI to discuss the information that the respondent has provided to ORI;

(6) Have ORI's virtual or in-person meeting(s) with the respondent transcribed and provide a copy of the transcript to the respondent for review and suggested correction;

(7) Close the administrative record following paragraphs (b)(3) through (6) of this section;

(8) Provide the respondent the opportunity to access the complete administrative record; and

(9) Take any other actions necessary to complete ORI's review of the research misconduct proceedings.

Notes of Decisions
Cited in 6 cases (2 in the last 5 years), 2008–2025 · leading case: Anversa v. Partners Healthcare Sys., Inc., 835 F.3d 167 (1st Cir. 2016).
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Anversa v. Partners Healthcare Sys., Inc., 835 F.3d 167 (1st Cir. 2016). “First, although ORI examines the institution’s handiwork in determining whether to carry out its own investigation, see 42 C.F.R. § 93.403 (c), there is no formal process for a respondent to prefer charges that an institution has violated the regulations in the course of either…”
Brodie v. United States Dep't of Health & Human Servs., 715 F. Supp. 2d 74 (D.D.C. 2010). “42 C.F.R. §§ 93.403 -.404 (2009). If the office does conclude that a researcher committed misconduct, it notifies the researcher by sending him a “charge letter” in which it describes the misconduct found and the sanctions proposed, which may consist of “debarment or suspension”…”
Uzelmeier v. United States Dep't of Health & Human Servs., 541 F. Supp. 2d 241 (D.D.C. 2008). “” 42 C.F.R. § 93.403 . It may “make appropriate research misconduct findings and propose HHS administrative actions.”
William Helm, mb.bchir v. Allison Ratterman, Phd (Ky. Ct. App. 2022). “42 C.F.R. § 93.403 (c). Here, the federal ORI did just that.”
Frech v. U.S. Dep't of Health & Human Servs. (D.D.C. 2025). “42 C.F.R. § 93.403 (2005). ORI may then “[r]ecommend[] that HHS seek to settle the case” or “propose[] and obtain[] HHS approval of administrative actions.”
Brodie v. United States Dep't of Health & Human Servs. (D.D.C. 2010). “42 C.F.R. §§ 93.403 -.404 (2009). If the office does conclude that a researcher committed misconduct, it notifies the researcher by sending him a “charge letter” in which it describes the 2 HHS considerably expanded its regulations governing institutional monitoring and…”
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