5/18/01

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

Dear Dr. Shapiro:

I am pleased to provide you and the National Bioethics Advisory Commission (NBAC) with the response of the Department of Health and Human Services to your report, Research Involving Human Biological Materials: Ethical Issues and Policy Guidance. The NBAC report is indeed a valuable contribution to the national discourse on the ethical issues related to the use of human biological materials in biomedical research. It will also help inform some of the relevant policy decisions that may need to be made by DHHS.

The Departmental response was prepared by a DHHS interagency working group consisting of representatives from the National Institutes of Health, the Food and Drug Administration, the Centers for Disease Control and Prevention, the Health Resources and Services Administration, the Indian Health Service, the Office for Human Research Protections, the Office of General Counsel and the Office of the Assistant Secretary for Planning and Evaluation. I believe that the document prepared by this working group provides a thoughtful and well reasoned response to the recommendations made by NBAC.

Enclosure