Y 4.G 74/7:R 26/17

FED-DOCS

DO CURRENT FEDERAL REGULATIONS ADE-
QUATELY PROTECT PEOPLE WHO PARTICIPATE
IN MEDICAL RESEARCH?

STANFORD

LIBRARIES

HEARING

BEFORE THE

767-88

SUBCOMMITTEE ON CRIMINAL JUSTICE,
DRUG POLICY, AND HUMAN RESOURCES

OF THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED SIXTH CONGRESS

FIRST SESSION

DECEMBER 9, 1999

Serial No. 106-145

Printed for the use of the Committee on Government Reform

KEVIN BINGER, Staff Director

DANIEL R. MOLL, Deputy Staff Director

DAVID A. KASS, Deputy Counsel and Parliamentarian
LISA SMITH ARAFUNE, Chief Clerk

PHIL SCHILIRO, Minority Staff Director

SUBCOMMITTEE ON CRIMINAL JUSTICE, DRUG POLICY, AND HUMAN RESOURCES

CONTENTS

Hearing held on December 9, 1999

Statement of:

Lawrence, Arthur J., Ph.D., Deputy Assistant Secretary for Health, Office

of Public Health and Science, U.S. Department of Health and Human

Services, accompanied by Gary Ellis, Director, Office of Protection from

Research Risks, National Institutes of Health; Mark Yessian, Regional

Inspector General for Evaluations and Inspections, Office of Inspector

General, U.S. Department of Health and Human Services, accompanied

by Laura McBride, Policy Analyst; Eric Cassell, M.D., Commissioner,

National Bioethics Advisory Commission, accompanied by Eric Maslin,

executive director, National Biology Commission; and John Oldham,

M.D., director, New York State Psychiatric Institute, accompanied by

Timothy Walsh, M.D., former director of the IRB at the New York

Institute

Zucker, Cliff, executive director, Disability Advocates, Inc., Albany, NY;
Adil Shamoo, Citizens for Responsible Care in Psychiatry and Re-
search, New York, NY; Charisse Johnson, Brooklyn, NY; and Sherry
Grenz, National Alliance of Mentally Ill

Letters, statements, et cetera, submitted for the record by:

Page

1

8

88

Cassell, Eric, M.D., Commissioner, National Bioethics Advisory Commis-

sion, prepared statement of

44

Grenz, Sherry, National Alliance of Mentally Ill, prepared statement

of

120

Lawrence, Arthur J., Ph.D., Deputy Assistant Secretary for Health, Office

of Public Health and Science, U.S. Department of Health and Human

Services, prepared statement of

Oldham, John, M.D., director, New York State Psychiatric Institute, pre-

pared statement of

Shamoo, Adil, Citizens for Responsible Care in Psychiatry and Research,
New York, NY, prepared statement of

Yessian, Mark, Regional Inspector General for Evaluations and Inspec-
tions, Office of Inspector General, U.S. Department of Health and
Human Services, prepared statement of

Zucker, Cliff, executive director, Disability Advocates, Inc., Albany, NY,

prepared statement of.