The Common Rule, revised extensively to enhance human subjects protections and to reduce burdens to investigators and institutional review boards (IRBs), was implemented on January 19, 2019. We analyzed IRB performance metric data from 2016 through 2021 to evaluate the potential impact of the revised Common Rule on the quality and performance of IRBs. From 2016 to 2021, exempt protocols increased by 159% and protocols requiring IRB continuing reviews decreased by 28%. As only 48% of all protocols in 2021 were subjected to the revised Common Rule requirements, numbers of exempt protocols and protocols requiring IRB continuing reviews will continue to increase and decrease, respectively, in the next few years. Among a total of 16 IRB performance metrics studied, 4 improved, 4 deteriorated, and 8 remained unchanged from 2016 through 2021. This study represents the first effort to evaluate the impact of revised Common rule on IRB quality and performance.

2019 年 1 月 19 日实施了广泛修订的通用规则，以加强对人类受试者的保护并减轻调查人员和机构审查委员会 (IRB) 的负担。我们分析了 2016 年至 2021 年的 IRB 绩效指标数据，以评估修订了关于 IRB 质量和绩效的通用规则。从 2016 年到 2021 年，豁免协议增加了 159%，需要 IRB 继续审查的协议减少了 28%。由于 2021 年只有 48% 的协议受到修订后的共同规则要求的约束，因此在未来几年中，豁免协议和需要 IRB 继续审查的协议的数量将分别继续增加和减少。从 2016 年到 2021 年，在研究的总共 16 个 IRB 绩效指标中，4 个改善，4 个恶化，8 个保持不变。