Affiliation:
1. McGuire Research Institute, Richmond, VA
Abstract
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.
Subject
Communication,Education,Social Psychology
Reference18 articles.
1. How Closely Do Institutional Review Boards Follow the Common Rule?
2. The Common Rule, Updated
3. National Research Act, Public Law 93-348 (1974) https://www.govinfo.gov/content/pkg/STATUTE-88/pdf/STATUTE-88-Pg342.pdf
4. Office for Human Research Protections. (2016). Federal Policy for the Protection of Human Subject (‘Common Rule’). https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html
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