Certificates of Confidentiality

A Certificate of Confidentiality (CoC) provides an extra layer of privacy protection for human subjects research participants by prohibiting the forced disclosure (e.g., in cases of compulsory legal demands, such as court orders and subpoenas) of identifiable, sensitive research information to anyone not associated with the research project.

Research projects funded by the National Institutes of Health (NIH) are now issued CoCs automatically as part of the terms and conditions of the award. In addition, researchers may request a CoC from NIH for health-related studies not funded by NIH, provided they fall under the mission of NIH.

Certificates of Confidentiality may be granted for biomedical, behavioral, or clinical research that collects or uses identifiable sensitive information, or information that is gathered or used during such research where participants are identified or where there is even a very small risk that the identity of the participants may be deduced.

Note that, while a COC protects subject information in perpetuity (if the subject was enrolled when the research was covered by a COC), if a research project continues to enroll additional participants after relevant funding ends, those subjects will not be protected by the COC unless the investigator receives a new COC for non-NIH funded research.

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Informed Consent Form Requirements

The protections and limitations of the CoC must be clearly stated on the informed consent form, for example (amend as applicable):

To help protect your privacy, this research is covered by a Certificate of Confidentiality. This means that the researcher may not disclose or use information, documents, or biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, suit, or proceeding, or be used as evidence – if there is a court subpoena, for example – unless you have consented to its use.

Information and documents protected by this Certificate cannot be disclosed to anyone who is not connected with the research unless there is a federal, state, or local law that requires disclosure such as to report child abuse or communicable diseases; if you have consented to the disclosure; or if it is used for other scientific research, as allowed by federal regulations protecting research subjects.

A Certificate of Confidentiality does not prevent you from voluntarily releasing information about yourself or your involvement in this research. If you want your research information released to an insurer, medical care provider, or any other person not connected with the research, you must provide consent to allow the researchers to release it.

Note that reference to an application for a CoC may not be included on the informed consent form if the CoC has not yet been approved.

Non-disclosure Requirements

All recipients of a CoC shall not:

  • Disclose or provide, in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding, the name of such individual or any such information, document, or biospecimens that contains identifiable, sensitive information about the individual and that was created or compiled for purposes of the research, unless such disclosure or use is made with the consent of the individual to whom the information, document, or biospecimens pertains.

  • Disclose or provide to any other person not connected with the research the name of such an individual or any information, document, or biospecimen that contains identifiable, sensitive information about such an individual and that was created or compiled for purposes of the research.

Disclosure is permitted only when:

  • Required by Federal, State, or local laws (e.g., as required by the Federal Food, Drug, and Cosmetic Act, or state laws requiring reporting of communicable diseases to State and local health departments), excluding instances of disclosure in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding.

  • Necessary for the medical treatment of the individual to whom the information, document, or biospecimen pertains and made with the consent of such individual.

  • Made with the consent of the individual to whom the information, document, or biospecimen pertains.

  • Made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects in research.

For Additional Information
For more detailed information regarding CoCs, including how to apply for a CoC for research not funded by NIH, see the NIH website Certificates of Confidentiality (CoC) – Human Subjects and/or NIH's CoC FAQs
To Apply for a CoC (for non-NIH funded research)
For detailed information on how to apply for a CoC for non-NIH funded research, see NIH’s How to Get a CoC?
Questions?

For process or policy-related questions, contact NIH-CoC-Coordinator@mail.nih.gov