According to the National Institutes of Health (NIH), the primary purpose of a Certificate of Confidentiality (CoC) is to protect the privacy of research subjects by prohibiting disclosure of identifiable, sensitive research information to anyone not connected to the research except when the subject consents or in a few other specific situations.
The NIH Policy on Certification of Confidentiality states that the Secretary, HHS will issue a CoC to those engaged in biomedical, behavioral, clinical, or other research where sensitive information could be identity is collected. The NIH Policy applies to all clinical, behavioral, biomedical or other research funded in whole or in part by NIH.
The NIH holds institutions and their investigators responsible for determining whether the research they undertake is subject to the Policy and, therefore issued a Certificate. Investigators will need to ask and answer a number of questions to determine if the Policy applies to research conducted or supported by NIH.
All recipients of CoCs are authorized not to disclose or provide the individual’s name or any biological information, documents or samples that contain sensitive, identifying information about that individual to anyone, except with the consent of the individual to whom the information, biospecimen or document is concerned. Information may be disclosed only when required by Federal, State or local laws; or is necessary for medical treatment (including consent of the individual to whom the information is disclosed)