Analysis and Proposed Actions Regarding the NBAC Report: Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. Cover letter


Dr. Harold Shapiro, Chair
National Bioethics Advisory Commission
6705 Rockledge Drive, Suite 700 MSC 7979
Bethesda, Maryland 20892-7979

Dear Dr. Shapiro:

I am pleased to forward to you a copy of the response of the Department of Health and Human Services (DHHS) to the National Bioethics Advisory Commission’s report, Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. This response is the product of a DHHS working group. consisting of representatives from all the relevant agencies within the Department, that was convened to review and address the specific recommendations of the NBAC report. The decisionmaking capacity report is a valuable document that not only contributes to the public discourse on the protection of vulnerable subjects in research but also provides important insights that will help the Department strengthen its policies and procedures for safeguarding the rights and welfare of such individuals.

With respect to NBAC’s report on Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, another working group within the Department is reviewing the report and formulating a set of responses to its recommendations. We anticipate that a report will be forthcoming within the next few months.

I want to take this opportunity to extend my best wishes to you and the other. Commissioners and express my appreciation for the fine work that all of you have done and will continue to do.


Donna E. Shalala

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