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News Release

FOR IMMEDIATE RELEASE
Wednesday, July 19, 2006

Contact: OHRP Press Office
(301) 928-5480

New Members Appointed to Human Research Protections national Advisory Committee

HHS Secretary Michael Leavitt has appointed seven new members to the Secretary’s Advisory Committee on Human Research Protections (SACHRP).

“The expertise of these individuals will help HHS maintain the highest standards of ethical human research,” Secretary Leavitt said. “Their contributions will strengthen and enhance the network of protections for all who take part in HHS-related research studies.”

The 11-member committee, which meets three times a year, is composed of leaders in human subject protections and/or clinical research. Its members are appointed to four-year terms and provide recommendations to the Secretary on the responsible conduct of research involving human subjects.

They are responsible for reviewing and evaluating the activities of the Office for Human Research Protections (OHRP) and other offices/agencies within HHS which are responsible for human subject protection in both biomedical and behavioral research.

The SACHRP committee also offers advice and recommendations on policy and program development, program implementation, evaluation and other matters of significance to the human research-related mission and goals of HHS.

The new members are:

James M. Powell, M.D., serves as senior medical director and head of the clinical pharmacology and pharmacokinetics department at Proctor & Gamble Pharmaceuticals. In this capacity, his responsibility includes managing the company’s global clinical pharmacokinetics programs and early human testing of new prescription pharmaceutical products. Dr. Powell also serves as a member of the Physician Investigator Certification Council for the American Academy of Pharmaceutical Physicians.

Neil R. Powe, M.D., M.P.H., M.B.A., is a professor of medicine at the Johns Hopkins University’s school of Medicine, a professor of epidemiology and health policy and management in the school of public health, and holds a joint appointment in the school of nursing. He serves as director of the Welch Center for prevention, epidemiology and clinical research, a multidisciplinary research and training center at the Johns Hopkins Medical Institutions focused on clinical and population-based research.

Jeffrey Botkin, M.D., M.P.H., is a professor of pediatrics and medical ethics and associate vice president for research integrity at the University of Utah. Dr. Botkin is a fellow of the Hastings Center and chairperson of the American Academy of Pediatrics Committee on Bioethics. He has written extensively on the ethical, legal and social implications of genetic testing and research at the pediatric and adult levels for more than 15 years. Dr. Botkin serves as a member of the SACHRP Subcommittee on Research Involving Children.

Myron Genel, M.D., serves as professor emeritus of pediatrics, Yale University School of Medicine. A pediatrician with a subspecialty in endocrinology, Dr. Genel served for 19 years as the associate dean and director of the Yale University School of Medicine office of government and community affairs. Dr. Genel’s clinical interests are general endocrinology, growth development, and disorders of sexual development. Dr. Genel is a former chair of the AAMC Council of Academic Societies and the AMA Council on Scientific Affairs.

Daniel K. Nelson, M.S., is associate professor of social medicine and pediatrics and director, office of human research ethics, University of North Carolina at Chapel Hill. Mr. Nelson has responsibility for providing global oversight for seven Institutional Review Boards (IRBs) and approximately 400 research studies. His previous work experience includes faculty appointments at the Mayo Clinic and the University of Rochester, where he was director of research in a clinical unit and chair of a hospital IRB.

Francine C. Romero, Ph.D., M.P.H., an epidemiologist, serves as the director of the Northern Plains Tribal Epidemiology Center, Rapid City, S.D. This center focuses on collecting and reporting health data regarding the 42 Pacific Northwest tribes. Dr. Romero has both a personal and professional interest in Native American and Alaska Native health issues; she is a member of the Pueblo of Jemez, New Mexico. Dr. Romero serves as a member of several health boards and has been active in the Indian Health Service’s Portland Area IRB.

Samuel Tilden, M.D., J.D., L.L.M., is professor of pediatrics, deputy provost for human subjects research and research compliance officer, University of Alabama at Birmingham. Dr. Tilden, a pediatrician with subspecialties in pediatric pulmonology and critical care, has served on numerous national and institutional advisory panels and committees. He is an experienced clinical investigator in the conduct of clinical trials in children and licensed to practice law. Dr. Tilden has had advanced degree training in health law.

More information about the work of the Secretary’s Advisory Committee on Human Research Protections (SACHRP) is available at http://www.hhs.gov/ohrp/sachrp/.

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Last revised: July 19, 2006