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COMMITTEE ON GOVERNMENT REFORM AND OVERSIGHT

DAN BURTON, Indiana, Chairman BENJAMIN A. GILMAN, New York

HENRY A. WAXMAN, California J. DENNIS HASTERT, Illinois

TOM LANTOS, California CONSTANCE A. MORELLA, Maryland ROBERT E. WISE, JR., West Virginia CHRISTOPHER SHAYS, Connecticut

MAJOR R. OWENS, New York CHRISTOPHER COX, California

EDOLPHUS TOWNS, New York ILEANA ROS-LEHTINEN, Florida

PAUL E. KANJORSKI, Pennsylvania JOHN M. MCHUGH, New York

GARY A. CONDIT, California STEPHEN HORN, California

CAROLYN B. MALONEY, New York JOHN L. MICA, Florida

THOMAS M. BARRETT, Wisconsin THOMAS M. DAVIS, Virginia

ELEANOR HOLMES NORTON, Washington, DAVID M. MCINTOSH, Indiana

DC MARK E. SOUDER, Indiana

CHAKA FATTAH, Pennsylvania JOE SCARBOROUGH, Florida

ELIJAH E. CUMMINGS, Maryland JOHN B. SHADEGG, Arizona

DENNIS J. KUCINICH, Ohio STEVEN C. LATOURETTE, Ohio

ROD R. BLAGOJEVICH, Illinois MARSHALL “MARK” SANFORD, South DANNY K. DAVIS, Illinois Carolina

JOHN F. TIERNEY, Massachusetts JOHN E. SUNUNU, New Hampshire

JIM TURNER, Texas PETE SESSIONS, Texas

THOMAS H. ALLEN, Maine
MICHAEL PAPPAS, New Jersey

HAROLD E. FORD, JR., Tennessee
VINCE SNOWBARGER, Kansas
BOB BARR, Georgia

BERNARD SANDERS, Vermont
DAN MILLER, Florida

(Independent) RON LEWIS, Kentucky

KEVIN BINGER, Staff Director

DANIEL R. MOLL, Deputy Staff Director
DAVID A. Kass, Deputy Counsel and Parliamentarian

JUDITH McCoy, Chief Clerk
PHIL SCHILIRO, Minority Staff Director

SUBCOMMITTEE ON HUMAN RESOURCES

CHRISTOPHER SHAYS, Connecticut, Chairman VINCE SNOWBARGER, Kansas

EDOLPHUS TOWNS, New York BENJAMIN A. GILMAN, New York

THOMAS H. ALLEN, Maine DAVID M. MCINTOSH, Indiana

TOM LANTOS, California MARK E. SOUDER, Indiana

BERNARD SANDERS, Vermont (Ind.)
MICHAEL PAPPAS, New Jersey

THOMAS M. BARRETT, Wisconsin
DENNIS J. KUCINICH, Ohio

Ex OFFICIO

DAN BURTON, Indiana

HENRY A. WAXMAN, California
LAWRENCE J. HALLORAN, Staff Director and Counsel
ANNE MARIE FINLEY, Professional Staff Member
ROBERT NEWMAN, Professional Staff Member

JESSE S. BUSHMAN, Clerk
CHERRI BRANSON, Minority Counsel

(II)

CONTENTS

Page

1

Hearing held on June 11, 1998

Statement of:

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

of Health and Human Services

Letters, statements, etc., submitted for the record by:

Appelbaum, Paul S., M.D., American Psychiatric Association, prepared

statement of

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,

Office of Extramural Research, National Institutes of Health, U.S. De-

partment of Health and Human Services, prepared statement of
Grob, George_F., Deputy Inspector General for Evaluation and Inspec-

tions, U.S. Department of Health and Human Services, prepared state-

ment of
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

statement of

Moreno, Jonathan D., Ph.D., professor of biomedical ethics, director of

the center for biomedical ethics, University of Virginia, prepared state-

ment of
Shays, Hon. Christopher, a Representative in Congress from the State

of Connecticut, information concerning IRBs

Spilker, Bert, Ph.D., M.D., senior vice president, Scientific and Regu-

latory Affairs, Pharmaceutical Research and Manufacturers of America,

prepared statement of

Walsh, B. Timothy, M.D., co-chair, Institutional Review Board, New York

Psychiatric Institute, prepared statement of

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