Excerpt

Concerns about the adequacy of the system for protecting child participants in research, combined with the public commitment to expanding clinical research involving children, provided the impetus for this Institute of Medicine (IOM) report, which was requested in the Best Pharmaceuticals for Children Act of 2002 (P.L. 107-109). The legislation charged the IOM with preparing a report that reviewed federal regulations, reports, and research and that made recommendations about desirable practices in clinical research involving children. Specifically designated topics were (1) the appropriateness of the regulations for children of various ages, (2) the interpretation of regulatory criteria for approving research, (3) the processes for securing parents' and children's agreement to a child's participation in research, (4) the expectations and comprehension of children and parents about participating in research, (5) the appropriateness of payments related to the child's participation in research, (6) compliance with and enforcement of federal regulations, and (7) the unique roles and responsibilities of institutional review boards (IRBs).

Contents

• The National Academies
• Committee on Clinical Research Involving Children
• Preface
• Acknowledgments
• Reviewers
• Summary
  • REGULATORY CONTEXT
  • INTERPRETING RESEARCH RISK AND OTHER REGULATORY CONCEPTS
  • UNDERSTANDING AND AGREEING TO CHILDREN'S PARTICIPATION IN RESEARCH
  • PAYMENT RELATED TO RESEARCH PARTICIPATION
  • REGULATORY COMPLIANCE, QUALITY IMPROVEMENT, AND ACCCREDITATION
  • ROLES AND RESPONSIBILITIES IN PROTECTING CHILDREN INVOLVED IN RESEARCH
• 1. Introduction
  • ORIGINS OF STUDY AND OVERVIEW OF REPORT
  • DEFINITIONS: RESEARCH, CLINICAL RESEARCH, AND HUMAN SUBJECTS OR RESEARCH PARTICIPANTS
  • A SYSTEMS PERSPECTIVE ON PROTECTING HUMAN PARTICIPANTS IN RESEARCH
  • ETHICAL PRINCIPLES FOR A SYSTEM TO PROTECT HUMAN RESEARCH PARTICIPANTS
  • HISTORICAL EVOLUTION OF POLICIES FOR PROTECTING HUMAN PARTICIPANTS IN RESEARCH
• 2. The Necessity and Challenges of Clinical Research Involving Children
  • CONTEXT
  • DEFINITIONS: INFANTS, CHILDREN, AND ADOLESCENTS
  • IMPLICATIONS FOR PEDIATRIC INVESTIGATION
  • CHALLENGES OF DESIGNING AND CONDUCTING PEDIATRIC STUDIES
  • DATA ON THE EXTENT OF CHILDREN'S PARTICIPATION IN CLINICAL RESEARCH
  • INITIATIVES TO INCREASE INVOLVEMENT OF CHILDREN IN RESEARCH
  • CONCLUSION
• 3. Regulatory Framework for Protecting Child Participants in Research
  • FEDERAL REGULATIONS TO PROTECT CHILD PARTICIPANTS IN RESEARCH
  • ADDITIONAL FEDERAL POLICIES FOR MONITORING SAFETY OF PARTICIPANTS IN CLINICAL RESEARCH
  • FEDERAL RULES FOR RESEARCH CONDUCTED IN OTHER COUNTRIES
  • CONCLUSION
• 4. Defining, Interpreting, and Applying Concepts of Risk and Benefit in Clinical Research Involving Children
  • BASIC CONCEPTS OF RISK, HARM, AND BENEFIT
  • ASSESSING THE LEVEL OF RISK POSED BY A RESEARCH PROTOCOL
  • OTHER ISSUES RELATED TO THE ASSESSMENT OF RISK
  • CONCLUSION
• 5. Understanding and Agreeing to Children's Participation in Clinical Research
  • ETHICAL PRINCIPLES AND LEGAL REQUIREMENTS
  • RESEARCH RELEVANT TO PARENTS' COMPREHENSION OF CHILDREN'S PARTICIPATION IN RESEARCH
  • CHILDREN'S AND ADOLESCENTS' COMREHENSION OF RESEARCH PARTICIPATION
  • IRB AND INVESTIGATOR POLICIES AND PRACTICES
  • IMPROVING PROCESSES FOR REQUESTING PERMISSION AND ASSENT
  • CONCLUSION
• 6. Payments Related to Children's Participation in Clinical Research
  • TYPES OF PAYMENTS RELATED TO RESEARCH PARTICIPATION
  • ETHICAL PRINCIPLES AND REGULATORY POLICIES
  • IRB POLICIES AND PRACTICES
  • STATEMENTS OF PROFESSIONAL ORGANIZATIONS
  • OTHER CONCERNS ABOUT PAYMENT RELATED TO CHILDREN'S RESEARCH PARTICIPATION
  • IMPROVING PRACTICES AND POLICIES ON PAYMENT RELATED TO CHILDREN'S PARTICIPATION IN RESEARCH
  • CONCLUSION
• 7. Regulatory Compliance, Accreditation, and Quality Improvement
  • CONTINUED CONCERN ABOUT OVERSIGHT OF RESEARCH INVOLVING HUMANS
  • GOVERNMENT OVERSIGHT OF REGULATIONS PROTECTING CHILD PARTICIPANTS IN RESEARCH
  • COMPLIANCE IN THE CONTEXT OF VOLUNTARY ACTION, QUALITY IMPROVEMENT, AND ACCREDITATION
  • CONCLUSION
• 8. Responsible Research Involving Children
  • ROLES AND RESPONSIBILITIES
  • CONCLUSION
• References
• Appendices
  • A Study Origins and Activities
  • B State Regulation of Medical Research with Children and Adolescents: An Overview and Analysis
  • C Health Care Privacy and Conflict-of-Interest Regulations Relevant to Protection of Human Participants in Research
  • D Glossary, Acronyms, and Laws and Regulations
  • E Committee Biographical Statements

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.

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.