NRPM: Standards for Privacy of Individually Identifiable Health Information. iii. Research on records of deceased persons.

11/03/1999

In § 164.506(f), we propose that, unlike the protections provided by the remainder of this rule, the protections of this proposed rule will end at the death of the subject for the purpose of disclosure of the subject’s information for research purposes. In general, this proposed rule would apply to the protected health information of an individual for two years after the individual’s death. However, requiring IRB or privacy board review of research studies that use only health information from deceased persons would be a significant change from the requirements of the Common Rule, which apply to individually identifiable information about living individuals only. In addition, some of the Common Rule criteria for waiver of authorization are not readily applicable to deceased persons. To avoid a conflict between Common Rule requirements and the requirements of this proposed rule, we are proposing that the protections of this proposed rule end at the death of the subject for the purpose of disclosure of the subject’s information for research purposes.