The Privacy Rule requires researchers to obtain written authorizations from research subjects before using the subjects’ protected health information (PHI) in the course of that research. Among other exceptions to this rule, one exception is for the use of decedents’ PHI, after filing an appropriate certification.
When you wish to use the PHI of any deceased subject, you may use the Privacy Rule exception by making a certification. The certification is appropriate when: (1) the PHI sought via the certification is only that of decedents, (2) you can document the death of each individual if asked to do so, and (3) the PHI is necessary to the research purposes.
The Common Rule does not apply to research involving decedents. Rather, the Common Rule applies only to research involving “human subjects”, who are defined as “living” individuals.
You may make a certification for research on the PHI of decedents when all subjects in your protocol, or in a distinct part of that protocol, are deceased. If your research protocol involves the use of PHI of both living and non-living subjects, but no distinct part of your protocol is directed at the use of decedent’s PHI, you should not use the process here, but rather obtain an authorization, or seek a waiver of authorization, before using the PHI. It is not necessary to file a certification to continue using PHI of a research subject who dies during the course of your research, as you will have obtained an authorization, or waiver of authorization, for the subject while living that will allow you to continue using that PHI.