Article | January 12, 2021

New FDA Certificate of Confidentiality Guidance: What Does It Mean For You?

Source: Advarra

By Luke Gelinas, IRB Chairperson

Confidential iStock-494962264

FDA has recently issued guidance relating to changes for Certificates of Confidentiality (CoCs) brought about by the 21st Century Cures Act (“Cures Act”), which was passed in 2016. In this blog we discuss what has and has not changed regarding CoCs and how this new guidance impacts research sponsors, research sites, and institutional review boards (IRBs).

Background

CoCs are intended to protect the privacy of research participants by preventing sponsors and researchers from being compelled to disclose “identifying, sensitive information,” which is defined as follows:

information that is about an individual and that is gathered or used during the course of research” … and (A) through which an individual is identified; or (B) for which there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual.

As examples of “identifying, sensitive” data, FDA lists data collected during “research on mental health and research on the use and effect of alcohol and other psychoactive drugs,” and states that “genomic data also are often considered to fall automatically into the category of identifiable, sensitive information.”

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