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#HIPAA Privacy Rule and Its Impacts on Research

Certificates of Confidentiality

Certificates of Confidentiality offer an important protection for the privacy of research study participants by protecting identifiable research information from forced disclosure (e.g. through a subpoena or court order). The certificates allow investigators and others with access to research records to refuse to disclose information that could identify research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the Federal, State, or local level. Certificates of Confidentiality may be granted by the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the FDA, and other Federal agencies for studies that collect information that, if disclosed, could damage subjects’ financial standing, employability, insurability, or reputation, or have other adverse consequences. By protecting researchers and institutions from forced disclosure of such information, Certificates of Confidentiality help achieve research objectives and promote participation in research studies.

The Privacy Rule and Certificates of Confidentiality afford distinct privacy protections for research subjects. The Privacy Rule does not protect against all forced disclosure since it permits disclosures required by law, for example. Certificates of Confidentiality are legal protections that do protect against forced disclosure by giving their holders a legal basis for refusing to disclose information, which, absent the certificate, they would be obliged to disclose.