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.

Table of Contents


Front Matter
Summary
1 Introduction
2 The Necessity and Challenges of Clinical Research Involving Children
3 Regulatory Framework for Protecting Child Participants in Research
4 Defining, Interpreting, and Applying Concepts of Risk and Benefit in Clinical Research Involving Children
5 Understanding and Agreeing to Children's Participation in Clinical Research
6 Payments Related to Children's Participation in Clinical Research
7 Regulatory Compliance, Accreditation, and Quality Improvement
8 Responsible Research Involving Children
References
Appendix A: Study Origins and Activities
Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis
Appendix C: Health Care Privacy and Conflict-of-Interest Regulations Relevant to Protection of Human Participants in Research
Appendix D: Glossary, Acronyms, and Laws and Regulations
Appendix E: Committee Biographical Statements
Index