NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.

Support for this project was provided by N01-OD-4-2139, Task Order No. 80, received support from the evaluation of set-aside Section 513, Public Health Service Act. The views presented in this report are those of the Institute of Medicine Committee on Assessing the System for Protecting Human Research Participants and are not necessarily those of the funding agencies.

Library of Congress Cataloging-in-Publication Data

Responsible research : a systems approach to protecting research participants / Daniel D. Federman, Kathi E. Hanna, and Laura Lyman Rodriguez, editors ; Committee on Assessing the System for Protecting Human Research Participants.

p. ; cm.

Includes bibliographical references and index.

1. Human experimentation in medicine—Moral and ethical aspects. 2. Medical ethics. 3. Medical protocols. 4. Patients—Legal status, laws, etc.

[DNLM: 1. Clinical Protocols. 2. Human Experimentation. 3. Patient Rights. 4. Safety. W 20.55.H9 R475 2002] I. Federman, Daniel D., 1928- II. Hanna, Kathi E. III. Rodriguez, Laura Lyman. IV. Institute of Medicine (U.S.). Committee on Assessing the System for Protecting Human Research Participants.

R853.H8 R476 2002

174′.28—dc21

2002015090

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The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.