Certificate of Confidentiality (CoC)

A formal protection of privacy of research participant(s) prohibiting forced disclosure of their individually identifiable, sensitive research information, records, or data to anyone not associated with the research, except when the subject consents to such disclosures or in other limited specific situations. CoCs are issued by different federal agencies, most typically by the National Institutes of Health (NIH). If a CoC is issued for the study, specific language must be included in the Informed Consent Form (ICF). This language is added to the informed consent template if the study team indicates that there is a CoC for the study in Institutional Review Board Information System (IRBIS).