Associate professor in the Department of Population Health Sciences at Duke University School of Medicine, a lead social scientist for the Clinical Trials Transformation Initiative, and a faculty member of the Duke Clinical Research Institute.
Research program leader in the Department of Population Health Sciences at Duke University School of Medicine and a research associate of the Clinical Trials Transformation Initiative.
Ethics Hum Res. 2021 May;43(3):26-36. doi: 10.1002/eahr.500092.
The revised Common Rule requires using a single institutional review board (sIRB) for U.S.-based, multisite, nonexempt, federally conducted or supported research with human participants. The 21st Century Cures Act directs the Department of Health and Human Services (HHS) to harmonize differences between HHS and the U.S. Food and Drug Administration (FDA) regulations governing research with humans. Anticipating that the FDA may update its 2006 centralized IRB guidance, we conducted interviews with 34 stakeholders engaged in FDA-regulated clinical research to identify benefits and challenges of using sIRBs and to gather recommendations for revising the FDA's guidance. The main benefits were consistency and standardization, speed and efficiency, and streamlining and simplification. The main challenges were uncertainty at local institutions, including addressing local context; decreased timeliness of the research review process; variable processes; and insufficient communication. Several recommendations for FDA guidance focused on the local context and communication plans. Findings suggest that the sIRB review process may be gaining efficiency although challenges remain.
修订后的《通用规则》要求对涉及美国境内多地点、非豁免、联邦管理或支持的人类参与者的研究，使用单一机构审查委员会（sIRB）。《21 世纪治愈法案》指示卫生与公众服务部（HHS）协调 HHS 和美国食品和药物管理局（FDA）管理人类研究的法规之间的差异。预计 FDA 可能会更新其 2006 年的集中式 IRB 指南，我们对参与 FDA 监管的临床研究的 34 名利益相关者进行了访谈，以确定使用 sIRB 的好处和挑战，并为修订 FDA 的指南收集建议。主要好处是一致性和标准化、速度和效率，以及简化和简化。主要挑战是地方机构的不确定性，包括解决地方情况；研究审查过程的及时性降低；流程多变；以及沟通不足。一些针对 FDA 指南的建议侧重于地方背景和沟通计划。研究结果表明，sIRB 审查过程可能正在提高效率，尽管仍存在挑战。
