The Secretary of Health and Human Services may issue Certificates of Confidentiality under Section 301(d) of the Public Health Service Act (42 USC 241(d)). These Certificates are intended to protect researchers from compelled disclosure of the identities of research subjects. The Secretary has delegated the authority to issue these Certificates to all Public Health Service agencies.
A Certificate of Confidentiality protects all identifiable information for any research subject (i.e., an individual about whom the investigator maintains identifying information) any time the Certificate is in effect. The protection afforded by the Certificate is permanent, meaning that subjects enrolled within the specified study period are protected even after the study ends. However, subjects enrolled in a study outside the specified timeframe of the Certificate are not covered by the Certificate.
The Certificate protects against the involuntary disclosure of information that could identify subjects. It does not govern the voluntary disclosure of identities of research subjects. Researchers are not prevented from the voluntary disclosure of matters such as child abuse or a subject’s threatened violence to self or others. However, if a researcher intends to make such voluntary disclosures, the informed consent form provided to research subjects should clearly indicate this.