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.
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 Protection
1. From 1966 to 2005: Balancing Protection and Access in Pediatric Research
2. Access versus Protection: Minority Representation in Pediatric Research
II. Challenges to the Regulations
3. Overview of the Common Rule and Subpart D
4. Should We Provide Healthy Children with Greater Protection in Medical Research?
5. Informed Consent in Pediatric Research
6. Phase I Research and the Meaning of 'Prospect of Direct Benefit'
III. Strengths and Limits of Current Regulations
7. Human Subjects Protections in Published Pediatric Research
8. Payment in Pediatric Research
9. Research in Schools
IV. Case Studies
10. Minimizing Risks: Diabetes Research in Newborns
11. Diabetes Prediction and Prevention Research in Childhood
12. Lead Abatement Research
13. Clinical Asthma Trials
14. Research Not Otherwise Approvable: A Look at One Protocol
15. Evolution of the 407 Process