Certificates of confidentiality and unexpected complications for pragmatic clinical trials
Judith Carrithers, JD, Director of Regulatory Services, co-authored the article Certificates of confidentiality and unexpected complications for pragmatic clinical trials in Learning Health Systems.
The need to protect the confidentiality of research data has long been recognized. One means to help protect research data from use in civil or criminal matters in the United States is a Certificate of Confidentiality (CoC). Until recently, investigators applied for a CoC when conducting research that was sensitive, stigmatizing or where the disclosure of private information could possibly result in civil or criminal liability. However, effective October 1, 2017, CoCs are automatically issued for much research supported by the National Institutes of Health (NIH). While automatic issuance reduces administrative burden, it also poses some surprising unanticipated challenges for research in general and pragmatic clinical trials (PCTs) in particular, which are key elements of learning health systems.