Assessing Plans to Maintain Confidentiality

Date: November 11, 2019

Authors: Gretchen L. J Anding, MA; Elizabeth A. Buchanan, PhD

Description: The criteria for IRB approval have always included a requirement that IRBs consider, when appropriate, that there are sufficient protections in place to maintain the confidentiality of data. The revised Common Rule, specifically the new requirements for limited IRB review, place emphasis on this review criterion. Minimal guidance exists to assist IRBs in determining whether proposed safeguards for research data are sufficient. This session will review the challenges IRBs face in reviewing protocols to determine if the plans for maintaining confidentiality are sufficient, and it will highlight solutions for how data management and security review may be incorporated into the IRB review process.



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