A Certificate of Confidentiality (COC) is issued by either the National Institutes of Health (NIH) or the Food and Drug Administration (FDA). Investigators may apply for a COC to protect identifiable research information from forced disclosure. A COC allows an investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. By protecting researchers and institutions from being compelled to disclose information that would identify research subjects, Certificates of Confidentiality help achieve the research objectives and promote participation in studies by helping assure confidentiality and privacy to participants.
COCs can be applied for through either the NIH or the FDA regardless of funding. COCs are issued through the FDA if the study involves an Investigational New Drug (IND) Authorization, or is otherwise FDA regulated. NIH issues most other COCs.
Whether or not a COC is necessary depends on the sensitivity of the research data and the potential impact it may have on subjects should it be disclosed (e.g., potential damage to their financial standing, employability, insurability, or reputation). Examples of sensitive research data include:
Tools and information provided by the NIH:
Information about how to apply for a Certificate of Confidentiality may be found at:
Information about where to send your Certificate of Confidentiality may be found at:
The FDA is authorized to issue a Certificate Confidentiality for studies with an IND or IDE that do not have any other HHS funding.
For information about how to apply to the FDA for a Certificate of Confidentiality, please refer to this link for the most up-to-date FDA contact information. Note there are different contacts; a contact person for drugs and a different contact for biologics: Certificate of Confidentiality to the FDA
Last Modified: Tuesday, 18-Jul-2017 14:07:14 EDT