Certificates of Confidentiality Following Enactment of the 21st Century Cures Act.

Abstract

The 21st Century Cures Act significantly strengthens privacy protections for participants in biomedical, behavioral, clinical or other research by requiring the Secretary of the U.S. Department of Health and Human Services to issue a Certificate of Confidentiality to such research if identifiable, sensitive information is collected during the research. Under the new law, the number of Certificates that need to be issued by the National Institutes of Health will be substantially larger than in the past, and requiring individual applications to be submitted for a significant fraction of NIH-funded research would create an increased burden on institutions, investigators and NIH resources. NIH implemented measures that will reduce burden and ensure applicable NIH-funded research is issued a Certificate in a timely manner, including elimination of the application process for NIH-funded research. The agency has also delineated four types of research that involve the collection or use of identifiable, sensitive information, and is therefore deemed to be issued a Certificate.