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