What is a Certificate of Confidentiality?

A Certificate of Confidentiality is a document that federal agencies issue to investigators to protect the privacy and welfare of subjects by preventing the release of protected health information and other sensitive information regarding subjects who are participating in a research study. Certificates of Confidentiality allow investigators to refuse to disclose identifying and sensitive information obtained as part of research, in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. An investigator should consider obtaining a Certificate of Confidentiality for IRB-approved research when he or she collects information from or about a subject that is identifiable and sensitive (i.e., could lead to discrimination, social stigmatization, legal prosecution, damage to their financial standing, employability, insurability, or reputation).

Even if a Certificate of Confidentiality is issued, research investigators should be aware that federal, state, or local law may require that licensed health care providers and/or certain other individuals report identifiable information regarding subjects involved in research if they have reasonable cause to suspect issues such as child abuse, a possible threat to self or others, or reportable communicable disease. Other disclosures may also be required by federal, state, or local law. For example, Certificates of Confidentiality do not authorize researchers to refuse to disclose information regarding a subject if such disclosure is required by federal law (e.g., required disclosures as set forth in the Food, Drug, and Cosmetic Act or if federal agency requests information for auditing or program evaluation purposes).