Children in Medical Research: Access versus Protection

by Lainie Friedman Ross

Overview

Lainie Ross presents a rigorous critical investigation of the development of policy governing the involvement of children in medical research. She examines the shift in focus from protection of medical research subjects, enshrined in post-World War II legislation, to the current era in which access is assuming greater precedence. Infamous studies such as Willowbrook (where mentally retarded children were infected with hepatitis) are evidence that before the policy shift protection was not always adequate, even for the most vulnerable groups. Additional safeguards for children were first implemented in many countries in the 1970s and 1980s; more recent policies and guidelines are trying to promote greater participation. Ross examines whether the safeguards work, whether they are fair, and how they apply in actual research practice, and she offers specific recommendations to modify current policies and guidelines.

Product Details

ISBN-13:	9780199273287
Publisher:	Oxford University Press
Publication date:	04/13/2006
Series:	Issues in Biomedical Ethics
Pages:	300
Product dimensions:	9.30(w) x 6.00(h) x 1.00(d)

About the Author

Dr. Lainie Ross is a general pediatrician and a medical ethicist in the MacLean Center for Clinical Medical Ethics at the University of Chicago.

Table of Contents

I. Access versus Protection1. From 1966 to 2005: Balancing Protection and Access in Pediatric Research2. Access versus Protection: Minority Representation in Pediatric ResearchII. Challenges to the Regulations3. Overview of the Common Rule and Subpart D4. Should We Provide Healthy Children with Greater Protection in Medical Research? 5. Informed Consent in Pediatric Research6. Phase I Research and the Meaning of 'Prospect of Direct Benefit'III. Strengths and Limits of Current Regulations7. Human Subjects Protections in Published Pediatric Research8. Payment in Pediatric Research9. Research in SchoolsIV. Case Studies10. Minimizing Risks: Diabetes Research in Newborns11. Diabetes Prediction and Prevention Research in Childhood12. Lead Abatement Research13. Clinical Asthma Trials14. Research Not Otherwise Approvable: A Look at One Protocol15. Evolution of the 407 ProcessEpilogue

Editorial Reviews

"The book challenges everyone involved in research with children to consider whether current policies and practices provide them with adequate protection, whether additional safeguards are needed, and whether some barriers to enrolling children in medical research should be removed."—The New England Journal of Medicine

"The book presents the arguments on both sides of numerous regulatory and ethical issues, asks important questions, and draws logical conclusions."—Journal of Clinical Research Best Practices

From the Publisher