An application is submitted by the Principal Investigator of a specific research project. It includes assurances of compliance with certain basic requisites. Since a certificate is generally issued to a sponsoring research institution, the application, and its assurances, must be signed by a faculty member, or a senior official. However, that lead institution must agree to be sure that all participating institutions conform to the Application assurances and inform their subjects, appropriately, 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.
Research subjects vary widely in their cultural and educational backgrounds.
The Confidentiality Certificate description should cover the basic points - privacy protection means that the subject will not be identified as participating in the study, unless the subject consents, or a disclosure is made to protect the subject or another from serious harm. Researchers may adapt the example to the special needs of their clientele, and to the subject matter of the study. Researchers should also review the language about confidentiality which is routinely included in consent forms to be sure that it is consistent with Confidentiality Certificate protections. For example, consent forms sometimes refer to state law reporting requirements. Thus, note that the example simply describes the circumstances in which disclosures would be made.