Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance.
Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance.
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DOI：
10.1002/eahr.500092
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发表时间：
2021-05
影响因子：
--
通讯作者：
Calvert SB
中科院分区：
文献类型：
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作者：
Corneli A;Dombeck CB;McKenna K;Calvert SB
修订后的《共同规则》要求美国使用单一的机构审查委员会（sIRB）-基于、多地点、非豁免、联邦政府进行或支持的人类参与者研究。《21世纪治愈法案》指示卫生与公众服务部（HHS）协调HHS与美国食品药品监督管理局（FDA）人类受试者法规之间的差异。预计FDA可能会更新其2006年集中IRB指南，我们对34名参与FDA监管临床研究的利益相关者进行了访谈，以确定使用sIRB的益处和挑战，并收集修订FDA指南的建议。主要好处是：一致性和标准化、速度和效率以及精简和简化。主要的挑战是：地方机构的不确定性，包括处理当地情况;研究审查进程的及时性降低;进程多变;沟通不足。FDA指南的几项建议侧重于当地环境和沟通计划。调查结果表明，sIRB审查过程可能会变得有效，但挑战仍然存在。
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 21 Century Cures Act directs the Department of Health and Human Services (HHS) to harmonize differences between HHS and the Food and Drug Administration (FDA) human subject regulations. Anticipating that 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 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 the sIRB review process may be becoming efficient although challenges remain.