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"The recent explosion in biomedical research has presented new challenges and created new potential ethical dilemmas," Secretary Shalala said. "The advice and insights we receive from this new committee will be invaluable in helping us achieve our goal of further strengthening government oversight in protecting individuals who volunteer to participate in human research studies."

Secretary Shalala established the advisory committee in June 2000 along with the new HHS Office for Human Research Protections (OHRP), which replaced the former Office for Protection from Research Risks at the National Institutes of Health. The creation of the advisory committee and OHRP was one of several new initiatives to further strengthen protections of human research subjects in clinical trials, including those involving gene transfer. The department's actions are designed to heighten government oversight of biomedical research and to reinforce to research institutions their responsibility to oversee their clinical researchers and institutional review boards (IRBs).

The advisory committee will be chaired by Mary Faith Marshall, Ph.D., who is director of the program in bioethics at the University of Kansas Medical Center in Kansas City. The chairperson and 11 other committee members have expertise on a wide range of issues relating to biomedical research, ethics, social sciences, and public health. The committee will also include ex-officio members from all 17 federal agencies that carry out research involving human subjects under a regulation known as the common rule. The inclusion of these federal representatives will provide an opportunity for achieving greater uniformity and integration of federal policies for the conduct and oversight of research involving human subjects. OHRP Director Greg Koski, Ph.D., M.D., will serve as the committee's executive secretary.

The panel will hold its first meeting on Dec. 20-21, 2000, 8:30 a.m. to 4:30 p.m and 9 a.m.
to 3 p.m. respectively, at the Bethesda Marriott at 515 Pooks Hill Road in Bethesda, Md. The meeting will focus on financial arrangements in human research, the newly revised declaration of Helsinki, research involving children, and institutional review and oversight of non-biomedical research under the common rule.

National Human Research Protections Advisory Committee

Mark Barnes, J.D., LL.M., Partner-Proskauer Rose LLP , and Chairman-Committee on Health Care Providers for the New York State Bar Association, New York City.

Sanford Chodosh, M.D., President-Public Responsibility in Medicine and Research, Wayland, Mass.

Elliot N. Dorff, Ph.D., Rector and Distinguished Professor of Philosophy, University of Judaism, Los Angeles, Calif.

Jennie R. Joe, Ph.D., M.P.H., R.N., Professor-Family and Community Medicine, University of Arizona -Tucson.

Robert Levine, M.D., Professor of Medicine, Yale University School of Medicine, New Haven, Conn.

Mary Faith Marshall, Ph.D., (chairperson), Professor of Medicine, School of Medicine and Bioethics Officer at Kansas State University Medical Center.

Ms. Abbey S. Meyers, President-National Organization for Rare Disorders, New Fairfield, Conn.

Mary Z. Pelias, Ph.D., J.D., Professor-Department of Genetics, Louisiana State University Health Sciences Center, New Orleans, La.

Robert R. Rich, M.D., Executive Associate Dean of Research, Emory University School of Medicine, Atlanta, Ga .

Adil E. Shamoo, Ph.D., Professor-Department of Biochemistry and Molecular Biology, University of Maryland School of Medicine-Baltimore.

Judith L. Siegel, Ph.D., Vice President/Head US Clinical Operations, Hoffmann-La Roche, Inc., Caldwell, N.J.

Denyse Thornley-Brown, M.D., Assistant Professor-Division of Nephrology, University of Alabama at Birmingham.

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