National Academies Press: OpenBook
Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

ETHICAL CONDUCT OF CLINICAL RESEARCH INVOLVING CHILDREN

Committee on Clinical Research Involving Children

Board on Health Sciences Policy

Marilyn J. Field and Richard E. Behrman, Editors

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu

Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

THE NATIONAL ACADEMIES PRESS
500 Fifth Street, NW 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.

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.

ISBN 0-309-09181-0 (hardcover)

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

Additional copies of this report are available from the
National Academies Press,
500 Fifth Street, NW, Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu.

For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu.

Copyright 2004 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America.

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.

Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

“Knowing is not enough; we must apply.

Willing is not enough; we must do.”

—Goethe

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

Adviser to the Nation to Improve Health

Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

THE NATIONAL ACADEMIES

Advisers to the Nation on Science, Engineering, and Medicine

The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts is president of the National Academy of Sciences.

The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is president of the National Academy of Engineering.

The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine.

The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council.

www.national-academies.org

Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

COMMITTEE ON CLINICAL RESEARCH INVOLVING CHILDREN

Richard E. Behrman (Chair), Executive Chair,

Education Steering Committee, Federation of Pediatric Organizations, and

Clinical Professor of Pediatrics,

University of California, San Francisco, and George Washington University, Washington, D.C.

Arthur L. Beaudet, Henry & Emma Meyer Professor and Chair,

Department of Molecular & Human Genetics, Baylor College of Medicine

Russell W. Chesney, Le Bonheur Professor and Chair,

Department of Pediatrics, Le Bonheur Children’s Hospital and the University of Tennessee;

Co-director,

Center for Pediatric Pharmacokinetics and Therapeutics, University of Tennessee, Memphis

Francis Sessions Cole III, Park J. White M.D. Professor and Vice Chair,

Department of Pediatrics, and

Professor of Cell Biology and Physiology,

Washington University School of Medicine, and

Director,

Division of Newborn Medicine, St. Louis Children’s Hospital

Deborah L. Dokken, Family Health Care Advocate,

Consultant in Family-Centered Care

Celia B. Fisher, Marie Ward Doty University Chair, Director

Center for Ethics Education, and

Professor of Psychology,

Fordham University

Angela R. Holder, Professor of the Practice of Medical Ethics,

Center for the Study of Medical Ethics and Humanities, Duke University Medical Center

Loretta M. Kopelman, Professor and Chair,

Department of Medical Humanities, Brody School of Medicine, East Carolina University

Susan Z. Kornetsky, Director,

Clinical Research Compliance, Department of Clinical Investigation, Children’s Hospital Boston

Robert M. Nelson, Associate Professor of Anesthesia & Pediatrics,

University of Pennsylvania School of Medicine and The Children’s Hospital of Philadelphia

David G. Poplack, Elise C. Young Professor of Pediatric Oncology and Head,

Hematology/Oncology Section, Department of Pediatrics, Baylor College of Medicine, and

Director,

Texas Children’s Cancer Center, Houston, Texas

Bonnie W. Ramsey, Director,

Cystic Fibrosis Therapeutics Development Network Coordinating Center, Children’s Hospital Regional Medical Center, and

Professor of Pediatrics,

University of Washington School of Medicine

Diane Scott-Jones, Professor of Psychology,

Boston College

Stephen P. Spielberg, Dean,

Dartmouth Medical School,

Vice President for Health Affairs,

Dartmouth College,

Professor of Pediatrics and of Pharmacology and Toxicology,

Dartmouth College

Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Expert Advisor

ALAN R. FLEISCHMAN, Senior Vice President,

The New York Academy of Medicine

Liaisons to Institute of Medicine and National Research Council Boards

Board on Health Sciences Policy:

DANIEL R. MASYS, Director,

Human Research Protections Program, and

Professor of Medicine,

School of Medicine, University of California, San Diego

Board on Children, Youth, and Families:

ELENA O. NIGHTINGALE,

Scholar-in-Residence, Institute of Medicine

National Cancer Policy Board:

SUSAN L. WEINER, President,

The Children’s Cause, Inc.

Committee Consultants

AMY T. CAMPBELL, Senior Instructor,

Department of Psychiatry and Division of Medical Humanities, University of Rochester Medical Center

ERIC D. KODISH, Director,

Rainbow Center for Pediatric Ethics, Rainbow Babies and Children’s Hospital

MYRA BLUEBOND-LANGNER, Distinguished Professor of Anthropology,

Rutgers University and

Director,

Rutgers University Center for Children and Childhood Studies

Study Staff

MARILYN J. FIELD, Study Director

MARGARET A. MCCOY, Research Assistant

PERRY J. LUKSIN, Senior Project Assistant

Board on Health Sciences Policy Staff

ANDREW POPE, Director,

Board on Health Sciences Policy

TROY PRINCE, Board Assistant

Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
   

 The Rationale for Pediatric Drug Research,

 

66

   

 Implications for Pediatric Investigation,

 

72

   

 Challenges of Designing and Conducting Pediatric Studies,

 

74

   

 Data on the Extent of Children’s Participation in Clinical Research,

 

87

   

 Initiatives to Increase Involvement of Children in Research,

 

89

   

 Conclusion,

 

92

3

 

REGULATORY FRAMEWORK FOR PROTECTING CHILD PARTICIPANTS IN RESEARCH

 

93

   

 Federal Regulations to Protect Child Participants in Research,

 

95

   

 Additional Federal Policies for Monitoring Safety of Participants in Clinical Research,

 

105

   

 Federal Rules for Research Conducted in Other Countries,

 

110

   

 Conclusion,

 

112

4

 

DEFINING, INTERPRETING, AND APPLYING CONCEPTS OF RISK AND BENEFIT IN CLINICAL RESEARCH INVOLVING CHILDREN

 

113

   

 Basic Concepts of Risk, Harm, and Benefit,

 

114

   

 Assessing the Level of Risk Posed by a Research Protocol,

 

117

   

 Other Issues Related to the Assessment of Risk,

 

136

   

 Conclusion,

 

145

5

 

UNDERSTANDING AND AGREEING TO CHILDREN’S PARTICIPATION IN CLINICAL RESEARCH

 

146

   

 Ethical Principles and Legal Requirements,

 

147

   

 Research Relevant to Parents’ Comprehension of Children’s Participation in Research,

 

159

   

 Children’s and Adolescents’ Comprehension of Research Participation,

 

178

   

 IRB and Investigator Policies and Practices,

 

193

   

 Improving Processes for Requesting Permission and Assent,

 

195

   

 Conclusion,

 

209

6

 

PAYMENTS RELATED TO CHILDREN’S PARTICIPATION IN CLINICAL RESEARCH

 

211

   

 Types of Payments Related to Research Participation,

 

212

   

 Ethical Principles and Regulatory Policies,

 

213

   

 Use of Payments in Research Involving Children,

 

217

   

 IRB Policies and Practices,

 

220

   

 Statements of Professional Organizations,

 

221

Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

BOXES, FIGURES, AND TABLES

Boxes

S.1

 

Summary of Categories of Research Involving Children That Are Approvable Under Subpart D of 45 CFR 46,

 

4

S.2

 

Questions Parents May Want to Ask When Considering Their Children’s Participation in Clinical Research,

 

12

S.3

 

Key Responsibilities of Investigators for the Ethical Conduct of Clinical Research Involving Infants, Children, and Adolescents,

 

13

S.4

 

Key Ethical and Legal Responsibilities of IRBs and Research Institutions Involved with Clinical Research That Includes Infants, Children, and Adolescents,

 

14

1.1

 

Ethical Principles for Human Research Identified in the Belmont Report,

 

41

1.2

 

Summary of Discussion of Pediatric Research in the 1950s,

 

49

3.1

 

General Criteria That Research Must Meet to Be Approved Under Federal Regulations,

 

98

3.2

 

Definitions in Subpart D That Have Also Been Adopted by the FDA,

 

101

3.3

 

Research Involving Children That DHHS Is Permitted to Conduct or Support,

 

102

3.4

 

General Responsibilities of Data and Safety Monitoring Boards and Data Monitoring Committees,

 

109

4.1

 

Determinations Related to Research Risks and Potential Benefits Required by Regulation for Federally Supported, Conducted, or Regulated Research Involving Children,

 

118

4.2

 

Guidelines for Considering Risk and Risk Minimization in Research That Includes Children,

 

144

5.1

 

Selected Regulatory Provisions for Informed Consent That Also Apply Generally to Parental Permission for a Child’s Participation in Research,

 

152

5.2

 

Questions Parents May Want to Ask When Considering Their Child’s Participation in Clinical Research,

 

178

5.3

 

Questions and Information for Investigators Seeking Waiver of Parental Permission for Adolescent’s Participation in Research,

 

202

7.1

 

Potential Data for a Federal Database on the System for Protecting Adult and Child Participants in Research,

 

240

Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

7.2

 

Examples of What Might Be Included in a Quality Assurance Database Related to Studies Involving Infants, Children, and Adolescents,

 

243

8.1

 

Key Responsibilities of Investigators for the Ethical Conduct of Clinical Research Involving Infants, Children, and Adolescents,

 

249

8.2

 

Key Ethical and Legal Responsibilities of IRBs and Research Institutions Involved with Clinical Research That Includes Infants, Children, and Adolescents,

 

252

8.3

 

Suggested Elements of IRB and Research Institution Guidance on Clinical Research Involving Infants, Children, and Adolescents,

 

256

8.4

 

Example of Protocol Checklist for Investigators That Highlights Requirements for IRB Approval of Research Involving Children,

 

259

8.5

 

Key Responsibilities of Federal Agencies for the Ethical Conduct of Clinical Research Involving Infants, Children, and Adolescents,

 

268

8.6

 

Examples of Protocols Referred for Review by the Secretary of DHHS Under 45 CFR 46.407, by Year of Referral and Institution,

 

271

Figures

1.1

 

Simplified representation of a system for protecting human research participants (2002, 2003),

 

38

4.1

 

Algorithm for making assessments of research protocols as required by 45 CFR 46.404-407 and 21 CFR 50.51-54 (2003),

 

119

Tables

4.1

 

Common Research Procedures by Category of Risk (2002),

 

135

5.1

 

Developmental Differences Influencing a Child’s Participation in Research (1999),

 

180

8.1

 

Example 1—Variability in IRB Approval of a Multicenter Research Protocol That Includes Children,

 

263

8.2

 

Example 2—Variability in IRB Approval of a Multicenter Research Protocol That Includes Children,

 

264

Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

B.1

 

State Education-Related Provisions for Research with Children and Adolescents (in School Settings) (2003),

 

340

B.2

 

Age of Majority (2003),

 

342

B.3

 

Emancipation Conditions (2003),

 

344

B.4

 

Mature Minor Provisions (2003),

 

347

B.5

 

Minor Consent for Certain Conditions/Disorders (2003),

 

354

B.6

 

Regulation of Research with Children and Adolescents in State Custody: Responses from Child Welfare or Social Services Personnel (2003),

 

364

Page xiii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Preface

Those who care about and for children currently face adilemma. We want children to benefit from the dramatic and accelerating rate of progress in medical care that is fueled by scientific research. At the same time, we do not want to place any children at risk of being harmed by participating in such research, even though their very involvement may be essential to improving the overall medical care of children. We also want to discourage research that is of minimal value. The concern is how best to balance these potentially conflicting objectives. Five important considerations should guide us as we seek to resolve our dilemma.

First, because of the inherent vulnerabilities arising from their immaturity, infants, children, and adolescents need additional protections beyond what is provided to competent adults when they participate in research. This principle underlies all others.

Second, the design of the research required to improve the health and well-being of infants, children, and adolescents must consider their physical, cognitive, emotional, and social development. Similarly, when children of any age become participants in such research, the protections provided must be appropriate to their stages of development.

Third, sharing in the advances in medical care for this vulnerable group includes a special emphasis on protecting them from harm caused by standard medical procedures and treatments based on research with adults when the benefits and risks for children of different ages have not been established through scientific research involving these populations. Except

Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

when it is not feasible or reasonable, research with animals, and adults should precede studies with children to minimize research risks.

Fourth, the system for protecting infants, children, and adolescents involved in research, while ensuring such protection, should not unreasonably impede research that may benefit them. The contribution of rules and regulations to desired outcomes as well as possible unintended negative consequences should be considered.

Finally, all of those responsible for research involving infants, children, and adolescents need to understand the special ethical issues that are relevant to the conduct of such research and the additional protection that must be provided. In certain cases, ethical standards will preclude some otherwise desirable research.

Overall, a satisfactory resolution of our dilemma can be achieved. Children involved in research can be appropriately protected as well as share fairly in the increasing benefits of biomedical science. This report suggests ways to balance sometimes conflicting objectives in ways that will contribute to children’s health and well-being now and in the future.

Richard E. Behrman, M.D., J.D.

Committee Chair

Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Acknowledgments

The committee and staff are indebted to a number of individuals and organizations for their assistance in the development of this report. The committee learned much through workshops and public meetings it organized to obtain information and perspectives from groups and individuals knowledgeable and concerned about research involving infants, children, and adolescents. Appendix A includes the meeting agendas and participant lists and also cites the organizations that provided written statements to the committee.

Special thanks go to Carolyn Brokowski, Maureen and Joseph Lilly, Joan and Sarah Lippincott, Andrell Vaughn, and Lise Yasui, who were willing to share their experiences with the committee. Consultants Eric Kodish and Myra Bluebond-Langner provided valuable guidance in addition to their presentations to the committee. The committee also appreciates the contributions of Amy Campbell, who prepared the background paper on state policies relevant to children’s participation in research. Mark Green, a Greenwall Foundation Fellow who served as a summer intern, assisted in developing the discussion of pediatric drug research.

A number of people at the Office for Human Research Protections (OHRP), the Food and Drug Administration (FDA), and the National Institute of Child Health and Human Development (NICHD) contributed to this study. Duane Alexander and Gilman Graves at NICHD, which sponsored this study, were unfailingly constructive in their support for the committee’s work. Michael Carome, Leslie Ball, and Kate Gottfried at OHRP provided useful information about the office’s policies, practices,

Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

and databases. David Lepay, Rosemary Roberts, and Susan Cummins at FDA helped the committee understand FDA policies on the protection of human participants in research and also relevant policies involving other aspects of the agency’s mission. In addition, the committee appreciates the information and insights offered by David Wendler and Benjamin Wilfond at the Department of Clinical Bioethics of the National Institutes of Health Clinical Center.

Meetings with researchers and institutional review board members and administrators at the Children’s Hospital of Philadelphia and Children’s National Medical Center (arranged with much appreciated assistance from John Sever) helped provide additional perspective on the practical realities of administering federal and institutional policies to protect child participants in research. Allison Clarke-Stewart and Virginia Allhusen from the University of California, Irvine, generously shared the knowledge and insights into long-term research gained through their Study of Early Child Care and Youth Development. Among the many others who helped the committee clarify issues, find important information, or otherwise complete its work are Laura Rodriguez, Ellen Wright Clayton, Marion Broome, Scott Powers, George Retsch Bogart, Lisya VanHousen, Adam Fried, Suzanne Rivera, Steven Joffe, Rosemary Galvin, Juliette Schlucter, Jane Burns, Judith Argon, Lea Ann Hansen, James Chamberlain, Jackie Moran, and Stacey Berg.

Many within the Institute of Medicine were, as usual, helpful to the study staff. The committee would especially like to thank Jessica Aungst, Natasha Dickson, Judy Estep, Alex Ommaya, Sally Stanfield, Bronwyn Schrecker, and Jennifer Bitticks.

Page xvii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Reviewers

This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the Report Review Committee of the National Research Council (NRC). The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published reports as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. The committee wishes to thank the following individuals for their review of this report:

MARION E. BROOME, University of Alabama at Birmingham

ELLEN WRIGHT CLAYTON, Vanderbilt University

RONALD E. DAHL, University of Pittsburgh Medical Center

REBECCA S. DRESSER, Washington University in St. Louis

ABIGAIL ENGLISH, Center for Adolescent Health & the Law

PAUL L. GELSINGER, Citizens for Responsible Care and Research

PAUL W. GOEBEL, Chesapeake Research Review, Inc.

DALE HAMMERSCHMIDT, University of Minnesota

GREGORY L. KEARNS, Children’s Mercy Hospitals and Clinics, University of Missouri–Kansas City

MICHELE D. KIPKE, University of Southern California and Childrens Hospital Los Angeles

Page xviii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

JEFFREY L. PLATT, Mayo Clinic

GREGORY H. REAMAN, Children’s Oncology Group and George Washington University

LISE YASUI, Children’s Oncology Group and New Approaches to Neuroblastoma Therapy Consortium

Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by THOMAS F. BOAT, Cincinnati Children’s Hospital Medical Center and University of Cincinnati, and BERNARD LO, University of California, San Francisco. Appointed by the NRC Report Review Committee, these individuals were responsible for making certain that an independent examination of this report was carried out in accordance with the institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×



ETHICAL CONDUCT OF CLINICAL RESEARCH INVOLVING CHILDREN

Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

This page intentionally left blank.

Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
PageR1
Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
PageR2
Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
PageR3
Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
PageR4
Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
PageR5
Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
PageR6
Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
PageR7
Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
PageR8
Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
PageR9
Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
PageR10
Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
PageR11
Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
PageR12
Page xiii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
PageR13
Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
PageR14
Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
PageR15
Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
PageR16
Page xvii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
PageR17
Page xviii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
PageR18
Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
PageR19
Suggested Citation:"Front Matter." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
PageR20
Next: Summary »
Ethical Conduct of Clinical Research Involving Children Get This Book
×
Buy Hardback | $68.00 Buy Ebook | $54.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies.

Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!