Abstract
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 Epilogue
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