Introduction
The Department of Health and Human Services (HHS) has extended the comment period for the recently issued Notice of Proposed Rulemaking (NPRM) outlining revisions to the Public Health Service (PHS) Policies on Research Misconduct. Seeking input from various stakeholders, including individuals, institutions, and research funding agencies, the NPRM aims to enhance the clarity of substantive and non-substantive aspects of the policies. HHS invites interested parties to submit comments by December 5, 2023, contributing to refining regulations crucial for maintaining research integrity.
Supporting Authority
The proposed revisions, grounded in the authority of 42 USC 289b, reflect ORI’s commitment to optimizing its experience in handling research integrity under 42 CFR part 93. Anticipating the release of the final rule in the summer of 2024, with implementation scheduled for a minimum of 4 months afterward and an effective date of January 1, 2025, ORI aims to streamline institutional reporting. Recognizing the evolving nature of research, the NPRM seeks to address the complexity and missing definitions of the 2005 Final Rule while retaining its essential features. The proposed changes are structured across subparts A through E, focusing on new approaches to enhance the regulation’s effectiveness. As institutions play a pivotal role in fostering research environments that discourage misconduct, this NPRM underscores the importance of informed public discourse in shaping the future landscape of research integrity.
Summary of Proposed Updates
Subpart A – Proposed revisions include refining language to enhance the applicability of the regulation, particularly in coordination with other agencies. Notably, ORI suggests removing references to evidentiary standards and the burden of proof from § 93.106, as revisions throughout Part 93, especially at § 93.104, adequately address the requirements for finding research misconduct. Additionally, the proposed changes aim to address concerns about confidentiality. Furthermore, the proposal scrutinizes the “subsequent use” exception to the six-year limitation on research misconduct allegations and invites public comments on refining expectations and requirements related to this exception.
Subpart B – Proposed revisions focus on definitions and introducing new terms to enhance clarity and consistency. ORI suggests relocating and refining key definitions like “research misconduct,” “fabrication,” “falsification,” and “plagiarism” to streamline the regulatory language in one dedicated section. Additionally, ORI aims to incorporate commonly used terms and introduce the concepts of “institutional record” and “administrative record.”
Subcart C – The revisions include clarifications on the requirements for establishing and maintaining research integrity assurances, with specific guidance tailored for small institutions. Addressing conflicts of interest, ORI aims to provide clear language at § 93.305(h)(5). The proposal also addresses concerns about the sequestration of research records and evidence. ORI also introduces new sections on institutional assessment and inquiry. Additionally, ORI proposes developing, maintaining, and providing an institutional record, defined in § 93.223, as part of a comprehensive administrative record.
Subcart D – The proposed revisions include adding clarity to § 93.404(b), specifying that the absence of an ORI finding of research misconduct does not negate an institution’s determination of professional or research misconduct necessitating remediation under its policy. Additionally, ORI clarifies actions it may take for institutional noncompliance. Notably, there are proposed revisions at § 93.410(b) allowing ORI to publish notices of institutional research misconduct findings and implemented actions.
Subpart E – The proposed revision involves an Administrative Law Judge (ALJ) reviewing the administrative record, which includes information provided by the respondent to ORI, to assess the reasonableness of ORI’s findings and HHS’s proposed administrative actions. A limited hearing would be possible if there’s a genuine dispute over material facts. The proposal eliminates further opportunities for appeal within HHS after this stage, ensuring a more conclusive resolution.
Additional Information
Visit the official notice for more details on the proposed updates and instructions for browsing, submitting, and posting additional comments.
