Human Research Protection Program

Certificates of Confidentiality

A certificate of confidentiality provides an extra layer of privacy protection for human subjects research participants by prohibiting the forced disclosure (e.g., in cases of compulsory legal demands, such as court orders and subpoenas) of identifiable, sensitive research information to anyone not associated with the research project.

Research projects funded by the National Institutes of Health are now issued certificates of confidentiality automatically as part of the terms and conditions of the award. In addition, researchers may request a certificate from the National Institutes for health-related studies not funded by NIH, provided they fall under the mission of the institute.

Certificates of confidentiality may be granted for biomedical, behavioral or clinical research that collects or uses identifiable sensitive information, or information that is gathered or used during such research where participants are identified or where there is even a very small risk that the identity of the participants may be deduced.

Note that, while a certificate of confidentiality protects subject information in perpetuity (if the subject was enrolled when the research was covered by a CoC), if a research project continues to enroll additional participants after relevant funding ends, those subjects will not be protected by the certificate of confidentiality unless the investigator receives a new certificate for non-NIH funded research.