• Do I need to file a Certification for Research on the Protected Health Information of Decedents in order to continue to use PHI if a research participant dies during the course of my research?

• What authorization or certification is required if my research involves the use of PHI of both living and non-living persons?

• If my research involves retrospective medical record review and I am unaware whether the subjects whose records I wish to review are living or deceased, how do I proceed?

Do I need to file a Certification for Research on the Protected Health Information of Decedents in order to continue to use PHI if a research participant dies during the course of my research?

No. If you are in the process of conducting research using PHI, you already have an authorization or waiver of authorization to use that PHI. The certification for research on the PHI of decedents is an exception to an authorization, and applies only when all subjects in your research protocol, or in a distinct part of that protocol, are deceased. In other words, the certification should be used when your research protocol, or a distinct part of that protocol, is directed at PHI of decedents.

What authorization or certification is required if my research involves the use of PHI of both living and non-living persons?

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 decedent’s PHI, you should obtain an authorization, or seek a waiver of authorization, before using the PHI.

If my research involves retrospective medical record review and I am unaware whether the subjects whose records I wish to review are living or deceased, how do I proceed?

There may be instances when you do not know if potential research subjects are living or deceased. If the subjects’ status as deceased is an eligibility requirement for your protocol, and you believe a review of the subjects’ medical records will provide the answer, you may file a Certification for Preparatory to Research Activities in order to use the subjects’ records for the purpose of determining whether the subjects are living or deceased. If, however, the subjects’ status as living or deceased is irrelevant to your research protocol, or you do not believe that a review of the subjects’ medical records will aid you in your determination, you should obtain an authorization, or seek a waiver of authorization, before using the PHI.