Certificates of Confidentiality for NIH Grants

Earlier this year I wrote a post about the 21^st Century Cures Act and its changes that directly affect the NIH. One part of this new legislation contains provisions to improve clinical research and privacy through certificates of confidentiality.

Currently, certificates of confidentiality (or “CoCs”) are provided upon request to researchers collecting sensitive information about research participants. Soon, CoCs will be automatically provided for NIH-supported research, as set forth in the 21^st Century Cures Act.

CoCs are an important to both the researchers conducting the study, and to the patient volunteers who make the research possible through their participation. CoCs protect researchers and institutions from being compelled to disclose information that would identify their research participants. They also provide research participants with strong protections against involuntary disclosure of their sensitive health information.

NIH-funded research has evolved since CoCs were first introduced in the 1970s. It is now more common to have projects that involve large-scale data sets and genomic information, and likewise, many thoughts leaders have sought to have the CoC process provide privacy protections more broadly.

We will soon be publishing an NIH Guide notice announcing how and when NIH will begin including certificates of confidentiality in the terms and conditions of award. By automatically providing CoCs as part of the NIH award process, we can provide an additional measure of protection to research participants, through a streamlined process that does not add additional burden to researchers. Stay tuned to the NIH Guide for Grants and Contracts for more detailed information.