Ethics and Research with Children: A Case-Based Approach

In this edited volume, a diverse group of scholars present and discuss challenging cases in the field of pediatric research ethics. After years of debate and controversy, fundamental questions about the morality of pediatric research persist: Is it ever permissible to use a child as a means to an end? How much authority should parents have over decisions about research that involves young children? What should be the role of the older child in decisions about research participation? How do the dynamics of hope and desperation influence decisions about research involving dying children? Should children or their parents be paid for participation in research? What about economic incentives for doctors, researchers and the pharmaceutical industry? Most importantly, how can the twin goals of access to the benefits of clinical research and protection from research risk be reconciled? Following an introductory overview by editor Eric David Kodish, the book is divided into three sections of case studies: Research Involving Healthy Children, Research Involving At Risk Children, and Research Involving Children with Serious Illness. Each case raises compelling ethical issues, and the analysis presented in each chapter illuminate the challenges posed across a wide spectrum of both research protocols and stories of individual case-based approach, this book provides a balanced and through account of the enduring dilemmas that arise when children become research subjects.

Doody Review Services

Reviewer:Anthony Teso, BA(Medical College of Wisconsin)
Description:This is an excellent resource for those charged with the review and conduct of research involving children. The case studies with the questions for discussion at the end of each chapter provide a useful educational tool.
Purpose:This is a resource for students in medical ethics and those taking NIH-required courses in research integrity. It provides guidance for members of IRBs who are charged with important deliberations regarding research involving children as well as pediatric investigators who have the responsibility for both scientific discovery and the protection of the children they study. It is a resource guide for pharmaceutical industry sponsors designing or conducting clinical trials involving children and federal officials administering research policy. It is also a resource for pediatricians providing advice regarding research participation and for parents and children faced with such a decision. This book poses important questions and presents several representative case studies. It meets the author's objectives.
Audience:This book is written for students of medical ethics, principal investigators, medical practitioners, IRB members, and for all who seek a better understanding of research involving children. The author succeeds in providing a useful reference and educational tool. Those already familiar with his expertise in this subject matter will not be disappointed in the selection of contributors chosen to address the many important aspects of ethics and research with children.
Features:The generous selection of case studies provides excellent examples of ethical dilemmas found in a variety of settings. Particularly useful is the discussion regarding payment to research subjects for participation as well as the ethical guidelines and policies related to payment. The chapter covering behavioral research with children brought to light many psychosocial and ethical dilemmas involving impoverished children. The chapter also discusses distributive justice as it relates to research with children. The timely topic of the ethics of predictive genetic testing in prevention trials involving teens provides insight into psychological health and compliance with risk-reducing regimens. The many substantive case studies as well as the questions for discussion following each chapter allow the reader to further contemplate the ethical questions raised by the authors. Additionally helpful is the list of current references found at the end of each chapter. The book offers a well-written index. In chapter one, the author notes that he hopes this book will be helpful to families facing a decision about research participation. However, the reading level may prove challenging for many families.
Assessment:This is an excellent resource for individuals conducting and reviewing research involving children. As there are so few publications addressing the ethics of research with children, this book will be a welcome addition to researchers, students of bioethics, ethics committees, and IRB members and staff.

Dr. Eric Kodish is a teacher, researcher, and physician who cares for children with cancer and blood diseases. He is the Chairman of the Department of Bioethics at The Cleveland Clinic Foundation and a Professor of Bioethics, Pediatrics and Oncology at the Cleveland Clinic Lerner College of Medicine at Case Western Reserve University. His primary rersearch interest has been the study of informed consent for pediatric leukemia trials. He is an appointed member of the Committee on Bioethics of the American Academy of Pediatrics, and chairs the Bioethics Committee of the Children's Oncology Group. He has been active in multiple roles at the National Institutes of Health and the Food and Drug Administration, and is a member of the Secretary's Advisory Committee on Human Research Protections Subcommittee for Research Involving Children.