On September 12, 2024, the U.S. Department of Health and Human Services (“HHS”), through the Office of Research Integrity (“ORI”) issued its Final Rule, the long-anticipated update to the 2005 Public Health Service Policies on Research Misconduct (“2005 PHS Regulations”), updating the current guidelines imposed in 42 C.F.R. § 93.000, et. seq. The Final Rule, which comes almost one year after ORI issued a Notice of Proposed Rulemaking (“NPRM”) to update the 2005 Rule on October 6, 2023, provides updated guidance for research institutions and notably marks ORI’s attempt to clarify expectations for handling potential research misconduct concerns and address significant shifts in the use of technology across the research community.
The Final Rule did not include all of the changes proposed in the NPRM, which were far more extensive and met with sharp criticism by many stakeholders during the public comment process. Among others, the Final Rule did not adopt two NPRM sections affording ORI more direction over institution proceedings, including (1) the proposal permitting ORI to publish notice of institutional actions that did not result in settlement or findings of research misconduct; and (2) the proposal making an inquiry compulsory if the preliminary assessment is not completed within 30 days. Neither provision was included in the Final Rule. Similarly, several NPRM provisions providing for earlier and more direct ORI intervention, such as the requirement that ORI approve in advance an institution’s reliance on the Subsequent Use Exception to review allegations beyond the six-year period of limitation, were similarly not adopted in the Final Rule.
While the Final Rule is effective January 1, 2025, the new regulations are not applicable until January 1, 2026. However, institutions can elect to implement the Final Rule if the respondent agrees. All institutions should promptly review and understand the regulatory changes and consider the impacts on their process.
Notable changes to the Rule are as follows:
Subpart A
- Confidentiality. The Final Rule clarifies the breadth of the “need to know” exception permitting an institution to reveal information about respondents and complainants involved in an otherwise confidential research misconduct proceeding. Specifically, the Final Rule adds witnesses as among those protected by the Final Rule’s confidentiality provision, and provides a non-exhaustive list of third-parties to whom the institution may disclose information, such as institutional review boards, journals, editors, publishers, co-authors, and collaborating institutions. The Final Rule further clarifies the identity of respondents, complainants, and witnesses that may be disclosed, beyond those fitting within this “need to know” classification, after the institution makes a final determination of research misconduct. This change provides helpful guidance on how institutions can fulfill their contractual and ethical obligations and still maintain confidentiality. The Final Rule further codifies a previously unresolved question of whether an institution may identify a respondent (or complainant) after findings of research misconduct are made. Finally, the Final Rule makes clear that the Rule’s broad confidentiality provision does not prohibit institutions from addressing problematic data that has been published or for which reliability has been questioned during the institutional process.
- Subsequent Use Exception. The Final Rule retains the six-year time limitation set forth in the 2005 PHS Regulations. However, the Final Rule clarifies that the “Subsequent Use Exception” applies narrowly to a respondent’s “use of, republication of, or citation to the portion(s) of the research record (e.g., processed data, journal articles funding proposals, data repositories) that is alleged to have been fabricated, falsified, or plagiarized” in materials submitted or published in connection with or relying on PHS funding. The inclusion of “portion” in this definition presents a unique problem for institutions, now tasked with determining when a “portion” of the research record has been cited. The Final Rule also adds an additional step for institutions when determining timeliness of allegations. The Final Rule requires institutions to now document their determination of whether the Subsequent Use Exception applies to an allegation(s) that could potentially fall under this Exception. Institutions must retain the documentation as part of the research record.
- Evidentiary standards. The Final Rule further addresses how concerns for data destruction and the absence of available data influences the preponderance of the evidence analysis of whether research misconduct occurred. The Final Rule clarifies that a respondent’s destruction of research records documenting the research in question may be evidence of research misconduct if the preponderance of the evidence establishes the respondent intentionally or knowingly destroyed such records after being informed of the research misconduct allegations. Additionally, a respondent’s refusal to provide research records constitutes evidence of research misconduct. This clarification resolves existing ambiguity over the significance of unavailable raw data and focuses the query on the respondent’s conduct rather than the availability of the data.
- Allegation. The Final Rule clarifies that an allegation, previously described as any written or oral disclosure of possible research misconduct, must be brought directly to the attention of an institutional or HHS official. Likely, in response to the sharp increase in allegations made via X/Twitter, PubPeer, and other online forums, this revised definition narrows the scope of concerns that require an institutional response under Part 93.
Subpart B: Definitions
- Intentionally. The Final Rule incorporates the definition of “intentionally” as included in the NPRM. Under the Final Rule, to act “intentionally” means to act with the aim of carrying out the act. Of note, ORI clarified that it intends to explore opportunities to harmonize this definition across other federal entities.
- Knowingly. Under the Final Rule, to act “knowingly” means to act with awareness of the act. This definition draws parallels with the federal criminal definition, where a defendant may be found to have acted “knowingly,” in the context of mail or wire fraud, where the defendant “was conscious and aware of his/her actions, realized what he/she was doing, or what was happening, around him/her, and did not act because of ignorance, mistake, or accident.”
- Recklessly. The Final Rule clarifies that “recklessly,” consistent with the definitions provided in ALJ’s Recommended Decision in ORI v. Kreipke, Decision No. CR5109 (May 18, 2018), means, “to propose, perform, or review, research, or report research results, with indifference to a known risk of fabrication, falsification, or plagiarism.”
- Good Faith. ORI clarifies that “good faith” as applied to a complainant or witness, means “having a reasonable belief in the truth of one’s allegation or testimony, that a reasonable person in the complainant’s or witness’s position could have, based on the information known to the complainant or witness at the time.” Under this new standard, “good faith” is an objective determination that can be used to vet out complainants who lack a “good faith” basis to bring forth an allegation of research misconduct.
Subpart C
- Institutional Assessment. The Final Rule requires that institutions evaluate concerns of misconduct and prescribes new criteria for institutions to assess those concerns before opening or declining to open a formal proceeding. While the 2005 Rule required there be a threshold finding that an allegation was “sufficiently credible and specific” to discern evidence of potential research misconduct (frequently referred to as the Preliminary Assessment) before an inquiry commenced, no formal or written process was required. The Final Rule inserts a new section requiring an institutional assessment be conducted. The assessment should be undertaken with the goal of “determining whether an allegation warrants an inquiry.” The Final Rule directs RIO or their designee to “promptly” determine if the allegation falls within the definition of research misconduct, is within 93.102, and is credible and specific – maintaining the three criteria imposed under the 2005 Rule. The Final Rule further requires institutions to document the assessment and promptly sequester all research records, perhaps before noticing an inquiry. Assessments for which no inquiry is opened should be “sufficiently detailed” for later review by ORI documenting the reasons why the institution did not conduct an inquiry.
- Institutional Inquiry. The Final Rule clarifies that an institution has discretion to conduct an inquiry through a committee of faculty members (which is typical) but may also delegate this responsibility to the RIO, a delegee or a panel of experts. Further, the Final Rule extends the timeline of institutional inquiries from 60 to 90 days, providing additional time for institutions to complete a thorough inquiry.
- Small Institutions. ORI now has guidance for small institutions handlings of conflicts of interests. Notably, if a small institution believes it has a conflict of interest during any phase of a research misconduct proceeding, they may contact ORI for guidance.
The NPRM provisions left out of the Final Rule provide some helpful insight and guidance into ORI’s expectations moving forward in this new era of research misconduct review.
For example, the Final Rule did not include ORI’s proposal to define “honest error” as “a mistake made in good faith.” Notably, honest error was not defined in the Final Rule. ORI also declined to incorporate a change clarifying that institutions electing to provide a respondent or complainant the right to object to participation of individuals in a research misconduct proceeding must afford that same right to all respondents and/or complainants in a single proceeding. Further, ORI did not incorporate a change that would have required unanimous investigation committee decisions for a finding of research misconduct. Finally, and as discussed above, the Final Rule does not include a proposed revision permitting ORI to publish notice of institutional research misconduct findings that did not result in settlements or findings of research misconduct.
As noted, while the Final Rule did not change the regulations to the extent that was anticipated with the NPRM, there may be significant implications to process. It is important that all institutions carefully review and understand the impact of these changes.
