Public Health Service Policies on Research Misconduct

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <CFR>42 CFR Part 93</CFR> <RIN>RIN 0937-AA12</RIN> <SUBJECT>Public Health Service Policies on Research Misconduct</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> U.S. Department of Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> This final rule revises the regulations governing Public Health Service Policies on Research Misconduct. The final rule reflects both substantive and non-substantive revisions in response to public comments and to improve clarity. The purpose of the final rule is to implement policy changes and respond to technological changes that occurred over the past several years applicable to research misconduct. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> <E T="03">Effective Date:</E> This final rule is effective January 1, 2025. <E T="03">Applicability Date:</E> All regulatory requirements are applicable beginning on or after January 1, 2026. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> Address any comments or questions regarding the final rule to Sheila R. Garrity, JD, MPH, MBA, Director, Office of Research Integrity (ORI), 1101 Wootton Parkway, Suite 240, Rockville, MD 20852. Some commonly asked questions and answers will be posted on the ORI website prior to the effective date of the final rule. The URL for the ORI website is <E T="03">https://ori.hhs.gov.</E> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Justina Lawrence, (240) 453-8200. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> The Office of Research Integrity (ORI) within the Department of Health and Human Services (HHS) oversees and directs Public Health Service (PHS) research integrity activities on behalf of the HHS Secretary, with the exception of the regulatory research integrity activities of the Food and Drug Administration. ORI was established in 1993 by amendment to section 493 of the Public Health Service Act (42 U.S.C. 289b). The HHS Secretary has authority under section 493 to promulgate a regulation that provides an administrative process for entities that apply for or receive PHS funding for biomedical or behavioral research to respond to research misconduct allegations in connection with such research and to provide assurances to the Department that the entities have an administrative process in place to respond to research misconduct allegations, investigate research misconduct allegations, and comply with the Department's regulation. Section 493 also authorizes the HHS Secretary to promulgate a regulation addressing ORI's actions, including appropriate remedies, with respect to research misconduct. In 2005, HHS updated regulations implementing section 493 that predated ORI's establishment. Specifically, HHS removed 42 Code of Federal Regulations (CFR) part 50, subpart A and added 42 CFR part 93, Public Health Service Policies on Research Misconduct. Since 2005, ORI and regulated entities experienced policy developments and technological changes applicable to research misconduct, such as the 2008 NIH Public Access policy; the 2023 NIH Data Management and Sharing policy; the shift to saving data on the cloud; and the ability to use artificial intelligence to detect image falsification, among many other developments. Therefore, ORI decided to revise part 93. On October 6, 2023, ORI issued a Notice of Proposed Rulemaking (NPRM) that proposed revisions to 42 CFR part 93 based on the experience ORI and institutions gained with the regulation since it was promulgated in 2005 (88 FR 69583). In addition, the NPRM was issued in response to increasing public concerns about research integrity in science and institutional questions about research misconduct review proceedings. The NPRM proposed several changes to provide clarity, transparency, and a better streamlined process. The NPRM proposed changes to subpart A. These changes included requiring grant recipients to take responsibility for the research integrity assurances of their subrecipients; adding ORI oversight of and increasing reporting requirements for subsequent use exception determinations; reducing disclosure limitations; and expanding institutional reporting obligations. Proposed changes to subpart B in the NPRM included adding or revising definitions of commonly used terms such as institutional record, administrative record, honest error, intentionally, knowingly, recklessly, and accepted practices of the relevant research community. Proposed changes to subpart C in the NPRM included clarification for maintaining active institutional research integrity assurances and addressing apparent or actual conflicts of interest. The NPRM also proposed changes to the institutional research misconduct review process, including assessments, sequestration of research records, inquiries, investigations, and the maintenance of institutional records. Proposed changes to subpart D in the NPRM included clarification of institutional assembly of administrative records and potential ORI actions for institutional noncompliance. In addition, ORI proposed clarifying that the lack of an ORI finding of research misconduct does not overturn an institution's determination of research misconduct. Other proposed changes to subpart D included when and how ORI may disclose information about a research misconduct proceeding. Proposed changes to subpart E in the NPRM included a streamlined process for contesting ORI findings of research misconduct and HHS administrative actions. The proposed appeals process included Administrative Law Judge (ALJ) review of an administrative record, rather than a <E T="03">de novo</E> review of evidence presented at a hearing before an ALJ. The NPRM sought comments from individuals, institutional officials, organizations, institutions, research funding agencies, and other members of the public on the proposed revisions and how to improve the clarity of the existing regulation. <HD SOURCE="HD1">II. Overview of Comments and Significant Changes in Final Rule</HD> ORI received 269 comments via <E T="03">Regulations.gov</E> . ORI also received comments as part of its interagency review process. ORI received 199 relevant comments representing the views of two main constituent groups: institutions and individuals. In several instances, duplicative comments were posted by the same institution or individual. ORI received 171 unique comments submitted by 123 institutions and 46 individuals. In two cases, an institution submitted two separate sets of comments; since the content of each submission was distinct, ORI counted each submission as a unique comment. In addition, some comments were endorsed by multiple individuals or institutions. For example, one institutional comment was explicitly supported by 70 separate commenters. Another institutional comment was explicitly supported by 83 separate commenters. Ten commenters supported an additional institutional statement, and three commenters supported other representative groups' statements. Most comments addressed multiple sections of the proposed rule. Many commenters made general statements supporting the more efficient execution and oversight of research misconduct proceedings proposed in the NPRM; however, most commenters recommended changes to enhance the clarity of the proposed regulation. These comments generally involved maintaining the balance between ensuring a complete review of misconduct allegations and protecting the rights of respondents and recognizing the potential for administrative burden and cost on institutions. Most commenters anticipated administrative burden resulting from various parts of the NPRM. These comments were divided among five topics: burden related to the assessment phase, burden related to determining honest error, burden related to transcribing interviews, burden related to reporting, and burdens placed on small institutions. Several commenters requested more time to implement the final rule, and the amount of time requested varied widely. A majority requested one year, while others requested different timelines. Many commenters recommended revisions to or removal of proposed definitions. Commenters also made general comments on the proposed rule, with most commenters recommending additions, revisions, or removal of various sections. Commenters expressed a variety of concerns about potential conflicts of interest but did not recommend the removal or revision of any particular section of the proposed regulation. Commenters also expressed concerns about harm to respondents' reputation; these concerns included ORI's access to assessment reports and potential breaches of confidentiality when sharing transcripts. Commenters also expressed concerns about the effects of the proposed regulation on whistleblowers. These concerns included fears of retaliation, negative effects on reporting misconduct, and breaches of confidentiality. The NPRM proposed several substantive changes in which commenters provided feedback that informed the drafting of the final rule. The following paragraphs provide an overview of the feedback received from commenters. More detailed descriptions of comments on specific sections of the proposed regulation are addressed below in section III. <HD SOURCE="HD2">Subpart A Summary of Significant Public Comments and Changes</HD> Proposed § 93.102(a) would require primary PHS grant recipients to take responsibility for the compliance of their subrecipients. A number of commenters recommended removing the proposed requirement making each PHS funding recipient responsible for the compliance of their subrecipients, because institutional responsibility for regulatory compliance was not clarified. ORI did not intend to impose a new burden on prime funding recipients; in the final rule subr ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 218k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━