Phillips Trisha, Earl Jake
Department of Political Science, West Virginia University, Morgantown, USA.
Department of Philosophy, Georgetown University, Washington, USA.
Account Res. 2025 Jul;32(5):675-692. doi: 10.1080/08989621.2025.2451168. Epub 2025 Jan 28.
The Office of Research Integrity (ORI) of the U.S. Department of Health and Human Services (HHS) recently issued the 2024 Final Rule on Public Health Service Policies on Research Misconduct (42 CFR 93), the first major revision of the regulation in nearly twenty years. Much of the commentary published about the 2024 Final Rule has focused on its impacts on research misconduct proceedings at institutions receiving Public Health Service funding. But formally addressing research misconduct is just one part of a larger effort needed to promote research integrity and the responsible conduct of research, and the new rule has the potential to affect this larger effort.
This article examines the evolution of the 2024 Final Rule and analyzes five changes with the potential to have broader impacts on cultures of research integrity at U.S. institutions. We consider changes that did and not happen in development from the 2005 Final Rule to the 2023 Notice of Proposed Rulemaking (NPRM) and the 2024 Final Rule.
We identify three changes that the research community should welcome (partnership between ORI and the regulated community, identifying potential respondents, and defining research integrity), one change of concern (redefining plagiarism), and one change that might or might not be welcome (promoting research integrity and the responsible conduct of research).
Although there is cause for concern about some of the 2024 Final Rule's potential implications for cultures of research integrity at US institutions, the positive changes support an optimistic outlook. In the coming years, it will be critical for HHS, ORI, the research community, and other stakeholders to work hand-in-hand to build on the progress made in the 2024 Final Rule to prevent and address research misconduct as part of a comprehensive effort to promote research integrity and the responsible conduct of research.
美国卫生与公众服务部（HHS）的研究诚信办公室（ORI）最近发布了《2024年公共卫生服务研究不当行为政策最终规则》（42 CFR 93），这是该法规近二十年来的首次重大修订。关于《2024年最终规则》发表的许多评论都集中在其对接受公共卫生服务资金的机构的研究不当行为程序的影响上。但正式处理研究不当行为只是促进研究诚信和负责任的研究行为所需的更大努力的一部分，新规则有可能影响这一更大的努力。
本文考察了《2024年最终规则》的演变，并分析了五项可能对美国机构的研究诚信文化产生更广泛影响的变化。我们考虑了从《2005年最终规则》到《2023年拟议规则制定通知》（NPRM）以及《2024年最终规则》制定过程中发生和未发生的变化。
我们确定了研究界应该欢迎的三项变化（ORI与受监管社区之间的伙伴关系、确定潜在回应者以及定义研究诚信）、一项令人担忧的变化（重新定义剽窃）以及一项可能受欢迎也可能不受欢迎的变化（促进研究诚信和负责任的研究行为）。
尽管《2024年最终规则》对美国机构的研究诚信文化的一些潜在影响令人担忧，但积极的变化支持了乐观的前景。在未来几年，HHS、ORI、研究界和其他利益相关者携手合作，在《2024年最终规则》取得的进展基础上再接再厉，将预防和处理研究不当行为作为促进研究诚信和负责任的研究行为的全面努力的一部分，这将至关重要。
