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RESPONSIBLE RESEARCH A Systems Approach to Protecting Research Participants

The current extraordinary advances in basic biomedical and social sciences have unprecedented potential to improve the human condition. These insights, together with the human genome project and its successor proteomics, will require an enormous commitment to translational research to harvest their applications for medicine and public health. The progress in political and social theory, linguistics, statistics, psychology, and behavioral sciences generally deserves a similarly broad application of human research to reach full expression. These endeavors will require individuals to accept possible risk to themselves, benefiting the greater good with uncertain (or no) benefit accrued in return. Thus, those performing and overseeing research are obligated to provide the most reasonable assurances of. | RESPONSIBLE RESEARCH IB 4 A Systems Approach to Protecting Research Participants INSTITUTE OF MEDICINE oc THE NATIONAL ACADEMIES 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 INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington D.C. www.nap.edu THE NATIONAL ACADEMIES PRESS 500 Fifth Street N.W. Washington DC 20001 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. ISBN 0-309-08488-1 hardcover 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 .