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What is a Certificate of Confidentiality and do I need one?

Certificates of Confidentiality are issued to protect the privacy of research subjects by protecting investigators and institutions from being compelled to release information that could be used to identify subjects in a research project. They allow the investigator and others who have access to research records to refuse to disclose identifying information in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. However, researchers are not prevented from the voluntary disclosure of matters such as child abuse, reportable communicable diseases, or subject's threatened violence to self or others.

Subjects may disclose information to physicians or other third parties. They may also authorize in writing the investigator to release the information to insurers, employers, or other third parties. In such cases, researchers may not use the Certificate to refuse disclosure.

In the informed consent form, investigators should tell research subjects that a Certificate is in effect. Subjects should be given a fair and clear explanation of the protection that it affords, including the limitations and exceptions noted above. Every research project that includes human research subjects should explain how identifiable information will be used or disclosed, regardless of whether or not a Certificate is in effect.

If you believe that it is appropriate for you to obtain a Certificate due to the sensitive nature of your biomedical, behavioral or clinical research, you will find information on the application process and other issues at:



Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov

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