Since a certificate is generally issued to sponsoring research institutions, the application and its assurances must be signed by a faculty member or senior official. Ordinarily, a certificate is issued for a single project not broad groups or classes of projects. However, that lead institution must agree to be sure that all participating institutions conform to the application assurances and inform their subjects about the certificate, its protections and the circumstances in which voluntary disclosures would be made. When a researcher obtains a confidentiality certificate, the subjects must be told about the protections afforded by the certificate, and any exceptions to that protection. This information is usually included in an informed consent form.
Research subjects vary widely in their cultural and educational backgrounds.
Here is an example of language used by researchers for this purpose. Researchers may adapt the language to the special needs of their clientele and to the subject matter of the study. Researchers should also review the language about confidentiality routinely included in consent forms to be sure it is consistent with confidentiality certificate protections. For example, consent forms sometimes refer to state law reporting requirements. However, HHS general counsel advises that such a disclosure would be voluntary, even though required by state law because the certificate protects the researcher from the compulsion of that law.