Certificates of Confidentiality

• What is a Certificate of Confidentiality (CoC)? It is an authorization from the Department of Health and Human Services (DHHS) that helps researchers and their institutions safeguard the privacy of research participants enrolled in sensitive biomedical and behavioral research by protecting against compulsory legal demands such as subpoenas for identifying information.
  
  
• What does it do? Research institutions can use a CoC to avoid forced disclosure of names and other identifying characteristics about research participants. It is used to oppose subpoenas and other compulsory demands.
  
  
• Are there circumstances where a CoC cannot be used to resist disclosure?
• When the disclosure is requested in writing by the research participant, their legal guardian, or their legal representative.
• To  DHHS or FDA in certain situations such as research audits as required by law
  
  
• Are there circumstances where information about study participants may be voluntarily disclosed by the Investigator or Institution? Investigators and their institutions may (and should be prepared to) make disclosures to prevent serious harm to the participant or to someone else, including child abuse and to voluntarily comply with state and local reporting requirements for communicable diseases.  The consent form should explain these and any other circumstances of voluntary disclosure.
  
  
• What DHHS agencies are authorized to issue CoCs?: NIH, CDC, HRSA, HIS, and SAMSA can issue CoCs for research that they fund; FDA is authorized to issue CoCs for studies with an IND/ IDE that do not have other DHHS funding.
  
  
• Is research that is not funded by DHHS eligible for a CoC? NIH is authorized to issue CoCs for sensitive research that is not federally funded, at its discretion, if the research is related to the NIH mission.  Additionally, the research must be approved by an IRB operating under an approved Federal-wide Assurance and must accurately reflect the protections and limitations of the CoC in the subject consent form.
  
  
• Can graduate or undergraduate students apply?   Yes, although there are additional application requirements; see FAQ C9 for details ( http://grants.nih.gov/grants/policy/coc/faqs.htm )

If you are planning on applying for a CoC, you need to include the following information in your Informed Consent process (the exact wording below is an example – you may change the wording if appropriate to match the reading or understanding level of your participants:

To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National Institutes of Health. With this Certificate, the researchers cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. The researchers will use the Certificate to resist any demands for information that would identify you, except as explained below.

The Certificate cannot be used to resist a demand for information from personnel of the United States Government that is used for auditing or evaluation of Federally funded projects or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA).

You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers may not use the Certificate to withhold that information.

[The researchers should include language such as the following if they intend to make voluntary disclosure about things such as child abuse, intent to hurt self or others, or other voluntary disclosures.] The Certificate of Confidentiality does not prevent the researchers from disclosing voluntarily, without your consent, information that would identify you as a participant in the research project under the following circumstances. [The researchers should state here the conditions under which voluntary disclosure would be made. If no voluntary disclosures will be made, the researchers should so state.]

For more information or to apply for a Certificate of Confidentiality, go to: http://grants.nih.gov/grants/policy/coc/

Last Updated: 08/03/2011