With Implementation Deadline Looming, ORI Releases Sample Research Misconduct Policies and Procedures

On June 4, 2025, the U.S. Department of Health and Human Services Office of Research Integrity (“ORI”) published a Sample Policies and Procedures for Addressing Allegations of Research Misconduct (“Sample Policy”) to align with the revisions to 42 C.F.R. Part 93 (“Part 93”),¹ which ORI issued on September 12, 2024. Those 2024 changes affected the regulations governing review of research misconduct allegations involving work supported by U.S. Public Health Service (“PHS”) funding—including funding by the National Institutes of Health.² The changes to the regulations take effect on January 1, 2026.³ Shortly thereafter, institutions must formally submit their revised policies to ORI in connection with submission of their annual assurance to ORI for calendar year 2025 (assurances are due by April 30 of each year). The changes to Part 93 are significant, and as such all institutions that receive PHS funding will need to adopt changes to their existing research misconduct policies in order to ensure compliance with the updated regulatory requirements. See here for Ropes & Gray’s client alert dated September 13, 2024, summarizing the most notable changes to Part 93 arising from the September 2024 final rule.

With the issuance of this Sample Policy, ORI is providing a guidance document intended to assist research institutions in identifying and implementing the necessary revisions to their policies and procedures. In large part, the Sample Policy restates relevant provisions from the 2024 regulations in a verbatim or near-verbatim format and provides little additional guidance relating to the interpretational questions left unanswered by the updates to Part 93. While the Sample Policy reflects a very helpful pooling of key provisions from the regulations that institutions should reference as they update their policies and procedures, the Sample Policy will probably not serve as an effective, “off the shelf” policy template for most institutions. Instead, in order to conduct reviews of research misconduct allegations in an effective, efficient, and fair manner, it is our view that most institutions will be better served by carefully considering their existing policies and procedures, identifying areas of uncertainty and disagreement that have arisen under these existing procedures, and revising existing policies and procedures accordingly.

Some key observations from the Sample Policy are outlined below.

• The Sample Policy provides no additional guidance on key questions relating to implementation of the revised Part 93 requirements, such as (i) a narrowing of the so-called “subsequent use exception” to the six-year statute of limitations and (ii) increased institutional flexibility to dismiss research misconduct allegations on the basis of honest error or difference of opinion at an earlier stage of research misconduct proceeding.
  • Subsequent use exception. Regarding the subsequent use exception, Part 93 has a default six-year statute of limitations—the regulatory requirements apply only to research misconduct occurring within six years of the date that an institution receives an allegation of research misconduct.⁴ The “subsequent use exception” extends this time limit if there is any subsequent use by the respondent of the material in question within six years of the date that an institution received an allegation of research misconduct.⁵ For example, if a respondent published allegedly falsified material ten years prior to an institution receiving an allegation of research misconduct, but the respondent cited to this material in subsequent work five years prior to the allegation, the subsequent use exception would bring this allegation of research misconduct within Part 93’s time limitations. The updates to Part 93 clarify that the subsequent use exception only applies to “the portion(s) of the research record” alleged to have been fabricated, falsified, or plagiarized (emphasis added).⁶ Identifying what “portion” of an older publication is the subject of a citation in a more recent research work will in many cases be administratively difficult to implement.
  • Honest error and difference of opinion. ORI’s notice of proposed rulemaking in October 2023 included a provision that would have codified ORI’s prior guidance that a “conclusion of honest error or difference of opinion must not be made at the inquiry stage.”⁷ ORI received significant pushback against this codification in the public comments made in response to the proposed revisions to Part 93, with commenters arguing it would cause significant burden if clear instances of honest error could not be dismissed earlier in research misconduct proceedings.⁸ ORI conceded this point and chose not to include these proposed provisions in the revised version of Part 93.⁹ This silence as to the “findings of honest error should only be made at the investigation stage” principle creates important flexibility for institutions to dismiss allegations at phases earlier than investigation, but institutions must keep adequate documentation of such determinations.¹⁰ In ORI’s September 2024 webinar on the revisions to Part 93, ORI confirmed that under the revised version of Part 93, institutions “are free to make a determination of honest error at the assessment or inquiry stage.”¹¹ How Research Integrity Officers, inquiry committees, and investigation committees should implement this enhanced flexibility is a critical consideration for institutions, as they seek to implement fair, thorough, and efficient reviews of research misconduct allegations. Ropes & Gray has previously written about the potential advantages and disadvantages of providing institutions with additional discretion and flexibility to reach honest error findings.¹²
• The Sample Policy provides that committee members at either the inquiry or investigation stage will have “relevant scientific expertise and be free of real or perceived conflicts of interest with any of the involved parties.”¹³
  • Scientific expertise. This language from the Sample Policy appears to apply to each committee member used at the inquiry and/or investigation stage, and it is therefore more prescriptive than the language used in Part 93 itself, which provides only that at the investigation stage, the investigation will include “participation of persons with appropriate scientific expertise.”¹⁴ Institutions often need to balance many considerations in empaneling an appropriate inquiry or investigation committee, including faculty availability, the need for committee members outside of a respondent’s department, and in some cases the need to enlist expertise outside of the specific scientific area that is the subject of the research in question (for example, expertise in statistical methods generally, as opposed to the particular scientific area of study). Utilizing the language in the Sample Policy could allow for much narrower, administratively difficult criteria for empaneling committee members, or for respondents to object to the appointment of committee members who are not subject matter experts in the exact field of study under review, or for respondents to raise these arguments at the end of a proceeding. Institutions should carefully consider these potential scenarios before determining what language relating to committee appointments will be included in policies. Note that the updates to Part 93 also include an express acknowledgement that the RIO or another designated official can conduct the inquiry in lieu of an inquiry committee, and this provision of the regulations does not expressly state that the RIO or other institutional official must have certain scientific expertise.¹⁵
  • Conflicts of interest. Similarly, while it is helpful in principle for institutions to empanel committees that are free from all “perceived” conflicts of interest (in addition to actual conflicts of interest), a statement requiring committee members to be free from all “perceived” conflicts may be problematic in some cases, as it could encourage respondents in some circumstances to object on the basis of a “perceived” conflict to the appointment of any committee member that they think may not be favorably inclined to them. Part 93 requires only that committee members and other institutions participating in the proceeding “do not have unresolved personal, professional, or financial conflicts of interest relevant to the investigation” (emphases added).¹⁶
• Transcripts. The revisions to Part 93 include an affirmative requirement to transcribe all interviews undertaken at the investigation stage and to provide transcripts of all witness interviews to the respondent.¹⁷ Part 93 is silent as to whether transcripts may be provided to respondents in a redacted format. The Sample Policy expressly acknowledges that transcripts provided to respondents may be made “with redactions as appropriate to maintain confidentiality.”¹⁸ Given the highly technical, fact-specific discussion that occurs during many witness interviews, redactions will often not serve to protect the identity of a witness, as respondents will often be able to easily infer the identity of a particular witness based on the content of the interview. The Sample Policy is silent as to how institutions should manage the potential chilling effect on witness testimony that this new requirement poses, and institutions will need to evaluate how to manage these new interview dynamics.
• Admissions. The process for “settling” cases (i.e., cases in which respondents agree to admit in writing to having committed research misconduct) has long been shrouded in mystery—requiring discussion with ORI and extensive education of respondents and institutional officials in order to resolve the allegations in a fair, transparent, and efficient manner. The revisions to Part 93 largely memorialize ORI’s existing informal processes for discussing potential settlements with institutions and determining when ORI will accept an institution’s proposed settlement of a case with a respondent. The Sample Policy carries over the explicit language appearing in the revised version of Part 93 detailing the core requirements needed to reach a settlement.¹⁹ Inclusion of such language within institutional policies may be very helpful, providing clarity to the settlement pathway and potentially facilitating more dialogue from respondents about the possibility of written admissions and accompanying settlements. However, expressly acknowledging the possibility of a written admission and settlement would be a sea change for many institutions and would require institutional officials to think carefully about the many variables involved in pursuing a written admission and settlement. For example, institutions will need to evaluate what type of legal terms should be included in a settlement agreement that resolves the research misconduct allegations, how to confirm that the scope of a settlement is appropriate, and what types of disciplinary and other corrective actions are warranted when a respondent admits to research misconduct (including, for example, how the institution should view the admission as a “mitigating circumstance” for purposes of disciplinary action). There is also the question of the circumstances under which an institutional official might wish to propose a settlement with a respondent who has not yet admitted responsibility for the issues that are the subject of an ongoing inquiry or investigation, if the institution believes but is not certain that a respondent would be amenable to a settlement conversation.

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There likely are to be many updates from ORI and conversations among the regulated research community about the implementation of Part 93 between now and the January 1, 2026 effective date of the revised regulations.

1. The Sample Policy is actually an “updated” sample policy, replacing a sample policy issued in 2005 around the time that the 2005 regulations were published. The 2025 Sample Policy is vastly different than the 2005 sample policy – it is not a set of incremental edits to the 2005 sample policy. Therefore, we do not compare and contrast the 2005 sample policy and the 2025 Sample Policy in this alert.
2. https://public-inspection.federalregister.gov/2024-20814.pdf.
3. 42 C.F.R. § 93.75(a).
4. Id. at § 93.104(a).
5. Id. at § 93.104(b)(1).
6. Id.
7. 88 Fed. Reg. 69,597 (Oct. 6, 2023).
8. 89 Fed. Reg. 76,285 (Sept. 17, 2024).
9. Id.
10. Theresa Defino, Misconduct Rule Honest Error Provisions Seen as a Win for Institutions, Investigators, COSMOS Report on Research Compliance vol. 21, no. 12, at 2 (Nov. 21, 2024) (quoting a Ropes & Gray webinar).
11. Id. (quoting ORI Director Sheila Garrity).
12. M. Caron, et al., The PubPeer conundrum: Administrative challenges in research misconduct proceedings, 22(4) Accountability in Research at 8 (Aug. 13, 2024).
13. Sample Policy, p. 11.
14. 42 C.F.R. § 93.310(f).
15. Id. at § 93.307(e)(2).
16. Id.
17. Id. at (g).
18. Sample Policy, p. 15.
19. See 42 C.F.R. § 93.317(b); Sample Policy, p. 18.