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.

This study was supported by Contract No. N01-OD-4-2139, TO #115 between the National Academy of Sciences and the National Institute of Child Health and Development and also the U.S. Food and Drug Administration. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

Library of Congress Cataloging-in-Publication Data

Ethical conduct of clinical research involving children / Marilyn J. Field and Richard E. Behrman, editors ; Committee on Clinical Research Involving Children, Board on Health Sciences Policy, Institute of Medicine of the National Academies.

p. ; cm.

Includes bibliographical references and index.

1. Pediatrics—Research—Moral and ethical aspects. 2. Human experimentation in medicine.

[DNLM: 1. Biomedical Research—ethics—Child. 2. Human Experimentation. 3. Research Subjects. W 20.5 E838 2004] I. Field, Marilyn J. (Marilyn Jane) II. Behrman, Richard E., 1931- III. Institute of Medicine (U.S.). Committee on Clinical Research Involving Children.

RJ85.E85 2004

174.2′8—dc22

2004008514

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