Standards for Privacy of Individually Identifiable Health Information. Final Privacy Rule Preamble.. Deceased Persons Exception for Research

12/28/2000

Comment: A few commenters expressed support for the proposal to allow use and disclosure of protected health information about decedents for research purposes without the protections afforded to the protected health information of living individuals. One commenter, for example, explained that it extensively uses such information in its research, and any restrictions were likely to impede its efforts. Alternately, a number of commenters provided arguments for eliminating the research exception for deceased persons. They commented that the same concerns regarding use and disclosure of genetic and hereditary information for other purposes apply in the research context. They believed that in many cases the risk of identification was greater in the research context because researchers may attempt to identify genetic and hereditary conditions of the deceased. Finally, they argued that while information of the deceased does not necessarily identify living relatives by name, living relatives could be identified and suffer the same harm as if their own medical records were used or disclosed for research purposes. Another commenter stated that the exception was unnecessary, and that existing research could and should proceed under the requirements in proposed § 164.510 that dictated the IRB/privacy board approval process or be conducted using de-identified information. This commenter further stated that in this way, at least there would be some degree of assurance that all reasonable steps are taken to protect deceased persons' and their families' confidentiality.

Response: Although we understand the concerns raised by commenters, we believe those concerns are outweighed by the need to keep the research-related policies in this rule as consistent as possible with standard research practice under the Common Rule, which does not consider deceased persons to be "human subjects." Thus, we retain the exception in the final rule. With regard to the protected health information about a deceased individual, therefore, a covered entity is permitted to use or disclose such information for research purposes without obtaining authorization from a personal representative and absent approval by an IRB or privacy board as governed by § 164.512(i). We note that the National Bioethics Advisory Committee (NBAC) is currently considering revising the Common Rule's definition of "human subject" with regard to coverage of the deceased. However, at this time, NBAC's deliberations on this issue are not yet completed and any reliance on such discussions would be premature.

The final rule requires at § 164.512(i)(1)(iii) that covered entities obtain from the researcher (1) representation that the use or disclosure is sought solely for research on the protected health information of decedents; (2) documentation, at the request of the covered entity, of the death of such individuals; and (3) representation that the protected health information for which use or disclosure is sought is necessary for the research purposes. It is our intention with this change to reduce the burden and ambiguity on the part of the covered entity to determine whether or not the request is for protected health information of a deceased individual.

Comment: Some commenters, in their support of the research exception, requested that HHS clarify in the final rule that protected health information obtained during the donation process of eyes and eye tissue could continue to be used or disclosed to or by eye banks for research purposes without an authorization and without IRB approval. They expressed concern over the impediments to this type of research these approvals would impose, such as added administrative burden and vulnerabilities to the time sensitive nature of the process.

Another commenter similarly expressed the position that, with regard to uses and disclosures of protected health information for tissue, fluid, or organ donation, the regulation should not present an obstacle to the transfer of donations unsuitable for transplant to the research community. However, they believed that consent can be obtained for such purposes since the donor or donor's family must generally consent to any transplant purposes, it would seem to be a minimal additional obligation to seek consent for research purposes at the same time, should the material be unsuitable for transplant.

Response: Protected health information about a deceased individual, including information related to eyes and eye tissue, can be used or disclosed further for research purposes by a covered entity in accordance with § 164.512(i)(1)(iii) without authorization or IRB or privacy board approval. This rule does not address whether organs unsuitable for transplant may be transferred to researchers with or without consent.