Should I obtain a Certificate of Confidentiality for my research?
A Certificate of Confidentiality (CoC) is a tool for protecting certain information from forced or compelled disclosure, e.g., to oppose a subpoena. If your research is not NIH funded, NIH funding has ended, or there is a lapse in NIH funding, and this privacy protection would benefit your research population, you can apply for a CoC. A CoC application can be submitted through the NIH CoC online system. The NIH provides additional information at: https://grants.nih.gov/policy-and-compliance/policy-topics/human-subjects/coc/for-research-not-funded-by-nih.
The National Institute of Justice (NIJ) requires a Privacy Certificate if you work with prisoners. The NIJ Privacy Certificate guidelines are available at http://www.nij.gov/funding/humansubjects/pages/privacy-certificate-guidance.aspx.
The Privacy Certificate is not the same as a Certificate of Confidentiality, and it is important to complete the application to comply with the confidentiality regulations found in 28 CFR Part 22. The NIJ will not accept a CoC in place of a Privacy Certificate. If the NIJ funds your study, a CoC will not automatically be applied, and the NIJ will not approve any CoC language in the informed consent form or privacy certificate.
If you have a Certificate of Confidentiality or a Privacy Certificate, the IRB will consider that information in its review.