Chapter 15

Certificates of Confidentiality (CoC)

A CoC helps researchers protect the privacy of human research participants enrolled in biomedical, behavioral, clinical and other forms of sensitive research. Certificates protect against compulsory legal demands, such as court orders and subpoenas, for identifying information or identifying characteristics of a research participant.

Research studies that are funded by NIH are automatically issued a certificate under the NIH Policy on Certificates of Confidentiality. Non-NIH funded research that collects identifiable, sensitive information can request a certificate from NIH for health-related studies that are not funded by NIH, but the granting of a CoC in these cases will be at the discretion of the NIH.

Investigators might consider applying for a certificate for research involving participant populations peculiarly prone to face legal or social harm by another’s discovery of their private, confidential, or protected information that can be exploited legally. For example, research that involves participants involved in illegal, stigmatized, or embarrassing behavior; participants with illegal status (alien, child runaway, AWOL, etc.); and participants with a stigmatized disease (HIV, alcoholism, mental illness, etc.) might have additional protection if a CoC has been obtained.

If the study for which the CoC is granted involves informed consent, the investigator must inform research participants of the protections and limits on protection provided by the CoC. If language is not included in the consent form, WCG IRB will insert the following language (or similar):

“Information about a Certificate of Confidentiality for this research:

[Name of research site and investigator] has received a Certificate of Confidentiality from the government which will help protect the privacy of research participants. The certificate protects against the involuntary release of information about participants collected during the course of this research. The researchers involved in this study cannot be forced to disclose any information collected in this study in any legal proceedings.

However, the participant may choose to voluntarily disclose the protected information and this certificate does not prohibit such voluntary disclosure. Furthermore, the parties listed in the Confidentiality / Authorization section of this consent form may review our records under limited circumstances and this certificate does not prohibit such disclosure.”

For some types of research, the Board may direct an investigator to obtain a certificate of confidentiality.

The Department of Justice requires that researchers prepare a “Privacy Certificate” (PC), which is similar to a CoC for all research it regulates. This requirement applies to the Department’s research arm, the National Institute of Justice (NIJ) and its other parts, such as BJA, OJJDP, OJP, etc. More information is available here: https://www.nij.gov/funding/humansubjects/pages/confidentiality.aspx.