Certificates of Confidentiality
Certificates of Confidentiality (CoC) are an important tool to protect the privacy of research study participants. Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. They allow the 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.
To apply for the CoC, you must first submit your IRB application for approval. Once the project has been approved and it has been determined that you are collecting sensitive identifiable information, it may be suggest that you submit to NIH for a CoC. Please visit their website for further information on how to proceed (http://grants.nih.gov/grants/policy/coc/). If and once you have been approved for a CoC, please submit an amendment form to the HSPP office to add the CoC language in the Confidentiality section of the Consent Form.
Below is an example of the language that might be issued by the NIH to as an Amendment to your consent form. Please do not use this language without referring to NIH first.
To help us further protect your privacy, the investigators have obtained a Confidentiality Certificate from the Department of Health and Human Services (DHHS).
With this Certificate, the investigators cannot be forced (for example by court subpoena) to disclose research information that may identify you in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings. Disclosure will be necessary, however, upon request of DHHS for audit or program evaluation purposes.
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. Note that if an insurer or employer learns about your participation and obtains your consent to receive research information, then the investigator may not use the Certificate of Confidentiality to withhold this information. This means that you and your family must also actively protect your own privacy.
Finally, you should understand that the investigator is not prevented from taking steps, including reporting to authorities, to prevent serious harm to yourself or others.