The NIH is currently not issuing Certificates of Confidentiality (CoCs) for non-NIH funded research. Study teams collecting highly sensitive data should check the NIH website periodically and, if/when available again, submit a Change of Protocol to request a discretionary CoC. In the meantime, study teams should work with their IRB analyst to determine what additional data protection measures may be appropriate, such as altering the study design to not collect identifiers, if possible; confirming that identifiers will be destroyed at the earliest possible time; and/or including the following italicized text below in the consent form in the “What happens to the information collected for the research?” section:

“However, we cannot promise complete confidentiality. We will share information with individuals or organizations identified in this consent form. Federal or state laws may permit or require us to show information to university or government officials [and to study sponsors] responsible for carrying out or monitoring this study. This includes University of Wisconsin and its representatives and affiliates, including those responsible for ensuring compliance, such as the Human Research Protection Program. In addition, while the university will strive to protect your data, in the rare instance that the university receives a court order to disclose data, it must comply.”