Certificates of Confidentiality

In special circumstances, the Federal government will issue what is called a “Certificate of Confidentiality,” to protect the privacy of research subjects. These certificates are granted to investigators and protect them against the “compelled disclosure of identifying information about subjects of biomedical, behavioral, clinical and other research.” Thus, it protects investigators from being forced to reveal the identity of participants in their research project in legal proceedings. This formal protection can be granted when the research is of a sensitive nature such that the protection is judged necessary to achieve the research objectives. A research project is considered sensitive if it involves any of the following categories:

1. Information relating to sexual attitudes, preferences, practices, or gender identity;
2. Information relating to the use of alcohol, drugs, or other addictive products;
3. Information pertaining to illegal activity;
4. Information that, if released, could reasonably be damaging to an individual’s financial standing, employability, or reputation within the community;
5. Information that would normally be recorded in a patient’s medical record, and the disclosure of which could reasonably lead to social stigmatization or discrimination;
6. Information pertaining to an individual’s psychological well-being or mental health; and
7. Genetic information.

Investigators conducting research that warrants this kind of protection may apply for a certificate. Certificates are granted by representatives from different research funding agencies, (although funding is not a prerequisite). More information can be found at “Certificates of Confidentiality – Privacy Protection for Research Subjects: OHRP Guidance” or the National Institute of Health’s Information Kiosk on Certificates of Confidentiality.

In circumstances where the Investigator requests participants to divulge sensitive information, such as illegal activities, and where the information will be linked to the participant’s identity, the IRB may require an Investigator to apply for a Certificate of Confidentiality to ensure that participants are more fully protected.

If you are unsure whether you should obtain a Certificate of Confidentiality for your research, please contact the IRB Administrator.