On October 5, 2023, the Office of Research Integrity (ORI) issued a Notice of Proposed Rulemaking (Notice) to update the 2005 Public Health Service Policies on Research Misconduct (2005 PHS Regulations), 42 C.F.R. § 93.000, et. seq. The 2005 PHS Regulations, in effect for almost two decades, provide an important roadmap for universities, colleges, academic medical centers, hospitals, addressing allegations of potential research misconduct. (Notably, PHS includes the National Institutes of Health (NIH), which is responsible for providing approximately $40 billion in annual funding for biomedical and behavioral research.) The Regulations set forth the procedure, reporting requirements, and safeguards each institution must adopt to handle complaints of potential research misconduct compliant with PHS’ expectations. If adopted, the proposed revisions would be the first update to the PHS regulations since 2005, and would be applied prospectively to newly reported cases.

The Notice explains the revisions were prompted by ORI, which has “gained extensive experience handling all aspects of the HHS research integrity program,” and now “seeks to capitalize on that experience” through the proposed regulatory revisions. The proposed revisions are not superficial – in many cases, the proposed changes to the institutional research misconduct procedure represent a drastic about-face from the last two decades of institutional result. Indeed, the proposal to publicize the outcome of internal reviews through ORI no doubt blurs the lines between the institutional review process – a confidential review conducted pursuant to an institutional policy that complies with but often deviates from the “floor” set by 42 CFR § 93.00 – and the mandated review process carried out by ORI and HHS under the PHS Regulations.

The Notice proposes a variety of changes to the 2005 PHS Regulations. Some of the most significant changes include:

Notable Changes to Subpart A

• Confidentiality. ORI proposes clarifying which individuals are considered among “those who need to know, consistent with a thorough, competent, objective and fair research misconduct proceeding” of the respondent’s identity, a carve-out currently set forth in § 93.108’s confidentiality provision, a change directly addressing past uncertainly about what information can be disclosed and to whom.
• Time Limitations. The six-year time limitation in the 2005 PHS Regulations is maintained, but ORI proposes language clarifying that the “subsequent use exception” in  93.105(b)(1) applies to instances “when the respondent uses, republishes, or cites to the portion(s) of the research record that is alleged to have been fabricated, falsified, or plagiarized” in materials such as “submitted or published manuscripts, submitted PHS grant applications, progress reports submitted to PHS funding components, posters, presentations, or other research records.”

Notable Changes to Subpart B

• Clarification of “Plagiarism.” ORI proposes further elaborating on the regulatory definition of research misconduct – fabrication, falsification, and/or plagiarism – by adding the definition of plagiarism within this subpart, clarifying that plagiarism refers to the “appropriation of another person’s ideas, processes, results, or words, without giving appropriate credit.” § 93.230. ORI further proposes adding new subsections, § 93.230(a) and (b). Proposed § 93.230(a) differentiates unattributed text copied verbatim or nearly verbatim from the limited use of identical or nearly-identical phrases which describe a commonly-used methodology; and proposed § 93.230(b) addresses self-plagiarism and authorship or credit disputes, clarifying that so-called “self-plagiarism” and authorship disputes do not meet the definition of research misconduct and are outside of ORI’s jurisdiction.

New Definitions.

• ORI proposes defining “honest error” – which has been carved out as a categorical exception to an act of research misconduct – as “a mistake made in good faith.” 93.217.

ORI proposes defining the term “recklessly,” consistent with the definitions provided in ALJ’s Recommended Decision in ORI v. Kreipke, Decision No. CR5109 (May 18, 2018). The proposed changes also clarify that “accepted practices of the relevant research community” refers to practices established under 42 CFR 93.00, PHS funding agencies, and professional codes – purportedly eliminating reliance on local customs and practices. § 93.200.

Notable Changes to Subpart C

• Conflict of Interest. ORI proposes clarifying that § 93.300(b)’s requirement that institutions ensure individuals responsible for carrying out the research misconduct proceeding do not harbor unresolved personal, professional or financial conflicts of interest with the respondent or other participations. It does not require respondents be afforded an opportunity to object to committee members’ participation prior to their appointments to the process. Rather, ORI proposes simply clarifying in § 93.305(h)(5) 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.
• Sequestration of Research Records. ORI proposes adding language to codify that the institution may rely on copies (as opposed to original raw data) in the event the original research records are not available. ORI further proposes removing the requirement that an institution obtain “custody” of original records as part of sequestration efforts, particularly when research data is stored in cloud-based storage. § 305.
• Institutional Assessment. ORI proposes adding in § 93.306(b)(1)(i) through (iii) specific criteria for an institutional assessment – previously undefined – that guides whether an allegation of research misconduct warrants a formal inquiry. ORI proposes that upon receiving an allegation of research misconduct, the RIO or other designated institutional officials promptly assess the allegation to determine whether it falls within the definition of research misconduct, is within the jurisdictional criteria of § 93.102, and is sufficiently credible and specific so that potential evidence of research misconduct may be identified. § 93.306.
• Institutional Inquiry.
  • ORI proposes clarifying the decision to proceed to a formal investigation requires finding: (i) a reasonable basis for concluding that an allegation falls within the definition of research misconduct under 42 CFR part 93; and (ii) the research involves PHS supported biomedical or behavioral research, research training or activities related to that research or research training.§ 93.307(f)(1)(i). ORI further clarifies dismissal of an allegation as honest error or difference of opinion should not occur during an inquiry but an evidentiary basis for such a finding should be noted.
  • Additionally, ORI proposes revising § 93.307(e)(2), to allow institutional discretion in convening committees of experts to conduct reviews at the inquiry stage to determine whether an investigation is warranted.
  • Finally, ORI proposes adding an explicit requirement in § 93.309 to require institutions keep “sufficiently detailed documentation” to allow ORI a later assessment of a decision not to conduct an investigation.
• Institutional Investigation. ORI proposes revising § 93.310(h) to indicate that, at the investigation stage, the institution may choose to add to or expand the ongoing investigation by including any new allegations pertaining to the same respondent or research records in question brought to the institution’s attention during the pendency of the investigation, and need not open an inquiry to review those new allegations.

Notable Changes to Subpart D

• Publication of Institutional Research Misconduct Findings by ORI. ORI proposes, in § 93.410(b), a revision permitting ORI to publish notice of institutional research misconduct findings and implemented institutional actions with the stated goal of informing the public and research community. The Notice contemplates that respondents would have an opportunity to provide comments or information prior to publication.

Notable Changes to Subpart E

• Streamlined Administrative Appeal. ORI proposes implementing a streamlined process for contesting ORI findings of research misconduct and HHS administrative actions, in which an ALJ would review the administrative record to determine whether ORI’s findings (and certain proposed administrative actions), are not based on a material error of law or fact. ORI also proposes the opportunity for a limited hearing on matters involving a genuine dispute over material fact.

A copy of the Notice of Proposed Rulemaking, to update the 2005 PHS regulations, is available here. The comment period on the NPRM is open until December 5, 2023, you can comment here. ORI anticipates release of the final rule in the summer of 2024, with implementation to begin a minimum of 4 months afterward.

Given the extensive nature of ORI’s revisions, institutions and investigators alike should be prepared for a profoundly different research misconduct procedure moving forward. Stakeholders should speak up and provide ORI with candid feedback to ensure the proposed amendments to the 2005 PHS Regulations strike the appropriate balance between protecting the integrity of PHS-funded research and protecting investigators’ rights to a fair and confidential process that requires the institution/HHS prove misconduct by a preponderance of the evidence.