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OVERSIGHT OF NIH AND FDA: BIOETHICS AND

THE ADEQUACY OF INFORMED CONSENT

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Printed for the use of the Committee on Government Reform and Oversight

U.S. GOVERNMENT PRINTING OFFICE

WASHINGTON : 1997

44_389 CC

For sale by the U.S. Government Printing Office
Superintendent of Documents, Congressional Sales Office, Washington, DC 20402

ISBN 0-16-055827-1

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 STEVEN SCHIFF, New Mexico

EDOLPHUS TOWNS, New York CHRISTOPHER COX, California

PAUL E. KANJORSKI, Pennsylvania ILEANA ROS-LEHTINEN, Florida

GARY A. CONDIT, California JOHN M. MCHUGH, New York

CAROLYN B. MALONEY, New York STEPHEN HORN, California

THOMAS M. BARRETT, Wisconsin JOHN L. MICA, Florida

ELEANOR HOLMES NORTON, Washington, THOMAS M. DAVIS, Virginia

DC DAVID M. MCINTOSH, Indiana

CHAKA FATTAH, Pennsylvania MARK E. SOUDER, Indiana

ELIJAH E. CUMMINGS, Maryland JOE SCARBOROUGH, Florida

DENNIS J. KUCINICH, Ohio JOHN B. SHADEGG, Arizona

ROD R. BLAGOJEVICH, Illinois STEVEN C. LATOURETTE, Ohio

DANNY K. DAVIS, Illinois MARSHALL “MARK” SANFORD, South JOHN F. TIERNEY, Massachusetts Carolina

JIM TURNER, Texas JOHN E. SUNUNU, New Hampshire

THOMAS H. ALLEN, Maine
PETE SESSIONS, Texas

HAROLD E. FORD, JR., Tennessee
MICHAEL PAPPAS, New Jersey
VINCE SNOWBARGER, Kansas

BERNARD SANDERS, Vermont
BOB BARR, Georgia

(Independent) ROB PORTMAN, Ohio

KEVIN BINGER, Staff Director
DANIEL R. MOLL, Deputy Staff Director

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

DENNIS J. KUCINICH, Ohio DAVID M. MCINTOSH, Indiana

THOMAS H. ALLEN, Maine MARK E. SOUDER, Indiana

TOM LANTOS, California MICHAEL PAPPAS, New Jersey

BERNARD SANDERS, Vermont (Ind.) STEVEN SCHIFF, New Mexico

THOMAS M. BARRETT, Wisconsin

Ex OFFICIO
DAN BURTON, Indiana

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

R. JARED CARPENTER, Clerk
CHERKI BRANSON, Minority Counsel

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CONTENTS

Page

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Hearing held on May 8, 1997

Statement of:

Caplan, Arthur, professor of bioethics, University of Pennsylvania; Ben-

jamin Wilfond, professor of pediatrics, University of Arizona; Peter

Lurie, professor of medicine, University of California-San Francisco;

and Laurie Flynn, director, National Alliance for the Mentally Ill

Raub, William, Deputy Assistant Secretary for Science Policy, Depart-

ment of Health and Human Services; David Satcher, Centers for Dis-

ease Control and Prevention; Harold Varmus, Director, National Insti-

tutes of Health; and Mary Pendergast, Deputy Commissioner, Food

and Drug Administration

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

Caplan, Arthur, professor of bioethics, University of Pennsylvania, pre-

pared statement of

Flynn, Laurie, director, National Alliance for the Mentally Ill:

Information concerning ways to protect mentally ill research partici-

pants

Prepared statement of

Lurie, Peter, professor of medicine, University of California-San Fran-

cisco, prepared statement of

Pendergast, Mary, Deputy Commissioner, Food and Drug Administration:

Information concerning waiver of informed consent

Prepared statement of

Raub, William, Deputy Assistant Secretary for Science Policy, Depart-

ment of Health and Human Services,

prepared statement of

Satcher, David, Centers for Disease Control and Prevention, prepared

statement of

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

of Connecticut, prepared statement of

Towns, Hon. Edolphus, a Representative in Congress from the State

of New York, letters concerning the subject of Public Citizen's news

release

Varmus, Harold, Director, National Institutes of Health:

Information concerning clinical trials

Prepared statement of .

Wilfond, Benjamin, professor of pediatrics, University of Arizona, pre-

pared statement of

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