PURDUE UNIVERSITY LIBRARIES COMMITTEE ON GOVERNMENT REFORM AND OVERSIGHT DAN BURTON, Indiana, Chairman BENJAMIN A. GILMAN, New York MARSHALL "MARK" SANFORD, South JOHN E. SUNUNU, New Hampshire MICHAEL PAPPAS, New Jersey VINCE SNOWBARGER, Kansas BOB BARR, Georgia DAN MILLER, Florida RON LEWIS, Kentucky HENRY A. WAXMAN, California ROBERT E. WISE, JR., West Virginia CAROLYN B. MALONEY, New York ELEANOR HOLMES NORTON, Washington, DC CHAKA FATTAH, Pennsylvania ELIJAH E. CUMMINGS, Maryland DENNIS J. KUCINICH, Ohio ROD R. BLAGOJEVICH, Illinois JOHN F. TIERNEY, Massachusetts THOMAS H. ALLEN, Maine HAROLD E. FORD, JR., Tennessee BERNARD SANDERS, Vermont (Independent) CONTENTS Hearing held on June 11, 1998.... Bowen, Angela, M.D., president, Western Institutional Review Board, Olympia, WA; B. Timothy Walsh, M.D., co-chair, Institutional Review Board, New York Psychiatric Institute, accompanied by John Oldham, M.D., director, New York Psychiatric Institute; Bert Spilker, Ph.D., M.D., senior vice president, Scientific and Regulatory Affairs, Pharma- ceutical Research and Manufacturers of America; Robert J. Levine, M.D., professor of medicine, Yale University School of Medicine, on behalf of the American Association of Medical Colleges; Jonathan D. Moreno, Ph.D., professor of biomedical ethics, director of the center for biomedical ethics, University of Virginia; and Paul S. Appelbaum, M.D., American Psychiatric Association..... Grob, George F., Deputy Inspector General for Evaluation and Inspec- tions, U.S. Department of Health and Human Services, accompanied by Mark R. Yessian, Ph.D., regional Inspector General for Evaluation and Inspections, U.S. Department of Health and Human Services; Eric Meslin, Ph.D., Executive Director, National Bioethics Advisory Commit- tee, U.S. Department of Health and Human Services; Gary B. Ellis, Ph.D., Director, Office of Protection from Research Risks, Office of Extramural Research, National Institutes of Health, U.S. Department Letters, statements, etc., submitted for the record by: Appelbaum, Paul S., M.D., American Psychiatric Association, prepared Bowen, Angela, M.D., president, Western Institutional Review Board, Olympia, WA, prepared statement of.......... Ellis, Gary B., Ph.D., Director, Office of Protection from Research Risks, Levine, Robert J., M.D., professor of medicine, Yale University School of Medicine, on behalf of the American Association of Medical Colleges, prepared statement of......... Meslin, Eric, Ph.D., Executive Director, National Bioethics Advisory Com- mittee, U.S. Department of Health and Human Services, prepared Moreno, Jonathan D., Ph.D., professor of biomedical ethics, director of ment of ....... Shays, Hon. Christopher, a Representative in Congress from the State Spilker, Bert, Ph.D., M.D., senior vice president, Scientific and Regu- latory Affairs, Pharmaceutical Research and Manufacturers of America, Walsh, B. Timothy, M.D., co-chair, Institutional Review Board, New York 77 |