The Ethics Police?: The Struggle to Make Human Research Safe

433 Pages·2015·2.896 MB·English

by  Robert Klitzman

The Ethics Police?
Other books by Robert Klitzman
A Year-long Night: Tales of a Medical Internship
In a House of Dreams and Glass: Becoming a Psychiatrist
Being Positive: The Lives of Men and Women with HIV
The Trembling Mountain: A Personal Account of Kuru, Cannibals and
Mad Cow Disease
Mortal Secrets: Truth and Lies in the Age of AIDS (With Ronald Bayer)
When Doctors Become Patients
Am I My Genes?: Confronting Fate and Family Secrets in the Age
of Genetic Testing
The Ethics Police?
The Struggle to Make Human Research Safe
ROBERT L. KLITZMAN, M.D.
1
1
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Library of Congress Cataloging-in-Publication Data
Klitzman, Robert, author.
The ethics police? : the struggle to make human research safe / Robert L. Klitzman.
p. ; cm.
ISBN 978–0–19–936460–2
I. Title.
[DNLM: 1. Ethics Committees, Research—United States. 2. Government Regulation—
United States. 3. Ethics, Research—United States. 4. Human Experimentation—ethics—
United States. W 20.55.E7]
R853.H8
174.2′8—dc23
2014021924
9 8 7 6 5 4 3 2 1
Printed in the United States of America
on acid-free paper
Three umpires were once talking amongst themselves.
“I calls ’em as they is,” the first one said.
“No, I calls them as I sees ’em,” the second one said.
“No,” responded the third. “They ain’t nothing till I calls ’em”
—Old joke
Whoever hath an absolute Authority to interpret any written, or spoken
Law, it is He, who is truly the Law-giver, to all intents and Purposes; not the
Person who first wrote, or spoke them.
—Bishop of Bangor, preaching before the King of England on March 31, 1717
But who will guard the guards?
—Juvenal

To the men and women who shared their views and experiences with me for this book,
and to Rénee C. Fox for her extraordinary guidance and inspiration.

CONTENTS
PART I ■ I NTRODUCTION
 1. P rotecting the People We Experiment On
CHAPTER 3
PART II ■ W HO IRBs ARE
 2. “ Inside the Black Box”: Becoming and Being
CHAPTER
IRB Members
35
PART III ■ W HAT IRBs DO: THE CONTENTS OF
IRB DECISIONS
 3. W eighing Risks and Benefits, and Undue
CHAPTER
Inducement
69
 4. D efining Research and How Good It Needs
CHAPTER
to Be
98
 5. W hat to Tell Subjects: Battles over
CHAPTER
Consent Forms
117
 6. F rom “Nitpicky” to “User-Friendly”: Inter-IRB
CHAPTER
Variations and Their Causes
142