On October 5, 2023, the Office of Research Integrity (“ORI”) of the Department of Health and Human Services (“HHS”) issued a Notice of Proposed Rulemaking intended to update the Public Health Service (“PHS”) Policies on Research Misconduct, last revised in 2005 (the “Proposed Rule”). The Proposed Rule would significantly impact how research institutions handle allegations of research misconduct, particularly those engaging in PHS-funded research.
The Proposed Rule is projected to come into effect on January 1, 2025. Considering the significance of these proposed changes, it is essential for research institutions and other stakeholders to understand and prepare for its potential impacts.
Tightening Assessment Deadlines while Extending Investigation Duration
Upon receiving an allegation of research misconduct, the institution must conduct a preliminary review to determine whether the allegation (a) meets the limited definition of misconduct; (b) occurs in the context of PHS funding; and (c) is sufficiently credible and specific to permit a determination regarding the allegation. A new term is included in the Proposed Rule which would mandate that a preliminary assessment occurs within a 30-day window. If an assessment will take longer than 30 days, the institution will be required to undertake an institutional inquiry culminating in a report. This modification will permit the institution to conduct a brief review of readily available information; there is no obligation to interview any involved parties or to obtain information other than the information that was submitted with the allegation unless further information is needed to determine whether the allegations are credible and adequately specific.
ORI also proposes to extend the expected timeline for the investigation stage from the existing 120 days to 180 days. Traditionally, the 120-day period has been a tight window, prompting institutions to routinely seek extensions from ORI. The Proposed Rule is intended to establish a more realistic cadence and decrease the number of extensions historically submitted to ORI.
This adjustment in timelines reflects ORI’s attempt to balance a swift preliminary assessment with a more realistic and achievable investigation period, aiming to streamline the overall process of addressing research misconduct allegations.
Institutional Record: A New Requirement for Research Conduct Oversight
ORI also proposes a more defined framework for institutional responsibilities, ranging from assessment to record-keeping. While a record of the inquiry and investigation, including findings, is currently required, under the Proposed Rule, institutions would be required to maintain and transmit an “Institutional Record” to ORI upon the completion of an investigation. The Institutional Record will include assessment, inquiry and investigation reports along with decisions by the institutional deciding official and the complete record of any institutional appeal. This record will later form part of the “Administrative Record” for ORI review, thus establishing a clear path from institutional findings to ORI appeal.
Transparency vs. Reputation: Navigating the New Disclosure Landscape
Additionally, ORI is proposing a significant shift in the disclosure policies surrounding research misconduct findings of institutions. Under the new Proposed Rule, ORI could publish an institution’s research misconduct findings, even in cases where ORI does not make a finding of research misconduct, provided it redacts identifiable information of the parties. The motivation behind this change is ORI’s desire to “protect the health and safety of the public, promote the integrity of PHS-supported research and the research process, or conserve public funds.”
Relatedly, under the existing ORI regulations, the disclosure of information is limited to those engaged in the research misconduct proceedings. The term “those who need to know” from the 2005 Final Rule was not clearly defined, causing ambiguity regarding the disclosure of information and its recipients. ORI now seeks to provide clarity that the “need to know” category might include public and private entities, journals, editors and publishers. Additionally, officials at other institutions may fall under the “need to know” category if they possess relevant records, employ a respondent alleged of misconduct or fund the research conducted by such a respondent.
The proposal to publicize institutional research misconduct findings represents a shift towards greater transparency. While this may foster an environment of accountability, it also poses reputational risks for institutions and researchers. A proactive approach to managing an institution’s reputation is crucial to mitigate any negative impacts and maintain its standing in the research community.
Miscellaneous Updates
In addition to the major changes proposed, the ORI has introduced some additional updates aimed at clarifying research misconduct definitions and streamlining the appeals process. These updates include:
Clarification of Research Misconduct Definitions
The Proposed Rule seeks to define certain key terms to simplify research misconduct proceedings. For instance, “honest error” is proposed to be defined as “a mistake made in good faith,” with “good faith” implying a “reasonable belief that one’s actions align with the accepted practices of the relevant research community.” The Proposed Rule also specifies that self-plagiarism, authorship or credit disputes will no longer be classified as “research misconduct,” delegating these matters to be addressed at the institutional level.
Streamlined Appeals Process
Subpart E of the Proposed Rule outlines a more streamlined appeals process for challenging ORI’s research misconduct findings and HHS administrative actions. Unlike the 2005 Final Rule, which entailed a de novo review and a hearing by an Administrative Law Judge (“ALJ”); under the Proposed Rule, ORI will present its Administrative Record (including the Institutional Record) to the ALJ for a more streamlined review, to reduce the administrative burden and duration of the appeals process.
A New Era of Handling Research Misconduct: Practical Takeaways
If finalized, the Proposed Rule will usher in a new era of handling research misconduct, emphasizing clear definitions, faster preliminary assessment and enhanced transparency. Revisions to existing institution policies will be necessary to reflect the requirements of the Proposed Rule, and processes will need to be modified to accommodate the time-sensitive preliminary assessments. Development of a robust Institutional and Administrative Record will be necessary for regulatory and other purposes, and the potential for public disclosure of findings requires both an effective process and a proactive and strategic approach to addressing reputational concerns.
For guidance on how these proposals could impact your institution, our team is available to provide tailored insights and support. Please contact:
- Melissa Markey at (248) 740-7505 or mmarkey@hallrender.com;
- Caitlin Bell-Butterfield at (919) 228-2408 or cbell-butterfield@hallrender.com;
- Kaitlin Nucci at (248) 457-7838 or knucci@hallrender.com;
- Avi Kerendian at (214) 615-2038 or akerendian@hallrender.com; or
- Your primary Hall Render contact.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer an individual’s questions that may constitute legal advice.
