News Release

New Members Appointed to Human Research Protections National Advisory Committee

HHS Secretary Mike Leavitt has appointed a new chair and three 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 volunteer to participate in HHS-funded research studies."

The 11-member committee, which meets three times a year, is composed of leaders in human subject protections and/or the conduct of human subjects research. Its members 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 and other offices/agencies within HHS which are responsible for human subject protection in 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:

Lisa I. Leiden, Ph.D., CIP; Director of Research Support and Compliance, the University of Texas at Austin. Dr. Leiden has over 25 years of experience in research administration beginning with medical schools and including academic hospital administration. She has held a variety of leadership positions at several research institutions. Most recently, she was recruited by the University of Texas at Austin to develop and establish the Office of Research Support and Compliance. In her current position, Dr. Leiden provides leadership and oversight for the university’s research departments and colleges.

Patricia Marshall, Ph.D., Professor of Bioethics and Anthropology, Department of Bioethics, Case Western Reserve University, Cleveland, Ohio. Dr. Marshall conducts empirical research aimed at broadening the historical focus of bioethics to include concerns of culturally diverse communities, both nationally and internationally. She has served on numerous boards and councils including the Advisory Board for the Fogarty International Center at the National Institutes of Health, where she helped establish a program for training health professionals in international research ethics. She also has served as a consultant to the World Health Organization, Council for International Organization of Medical Societies, the National Bioethics Advisory Commission, and was a member of the Council on Accreditation for the Association for the Accreditation of Human Research Protection Programs.

David Strauss, M.D., Chairman, Institutional Review Board (IRB), New York State Psychiatric Institute, and Director, Office of Human Subjects Research and Associate Clinical Professor, Department of Psychiatry, Columbia University College of Physicians and Surgeons. Dr. Strauss was a member of SACHRP’s subcommittee on Federal policy for the protection of human subjects, and is the Co-Chair of SACHRP’s new Subcommittee on Inclusion of Individuals with Impaired Decision-Making in Research. For the last six years, he has served as the chair of the New York State Psychiatric Institute IRB and director of the Office of Human Subjects Research in the Department of Psychiatry at Columbia. He is co-director of the Ethics Core of a National Institute of Health-funded Clinical Research Center for Clinical and Behavioral Research in HIV. Dr. Strauss also serves on the Executive Steering Committee of the Columbia University Center for Bioethics. He sits on the Medical School Conflict of Interest Committee and its Standing Committee on the Conduct of Research.

Dr. Samuel Tilden, M.D., J.D., LLM, a current SACHRP member, has been appointed to serve as the new chairman of SACHRP and will replace Dr. Ernest Prentice, who has served as SACHRP chair for four years. Dr. Tilden is a pediatrician with subspecialties in pediatric pulmonology and critical care. He has served on numerous national and institutional advisory panels and committees, including service as chair of the Committee on Bioethics, Alabama Chapter of the American Academy of Pediatrics; member, Executive Committee of Section on Critical Care of the American Academy of Pediatrics; Member, Pediatric Section of Society of Critical Care Medicine, and has been active in the conduct of clinical trials on children. Dr. Tilden also is a licensed attorney with advanced degree training in health law.

More information about the work of SACHRP is available at http://www.hhs.gov/ohrp/sachrp/.

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Last revised: January 12, 2009