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Titel: Children in Medical Research
Autor/en: Lainie Friedman Ross
Autor/en: Lainie Friedman Ross
Access Versus Protection.
29. Mai 2008 - kartoniert - 300 Seiten
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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 considers whether the safeguards work, whether they are fair, and how they apply in actual research practice. She goes on to offer specific recommendations to modify current policies and guidelines.
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
Lainie Ross is the Carolyn and Matthew Bucksbaum Professor of Clinical Medical Ethics, an Associate Director of the MacLean Center and co-director of the Ethics Consultation Service that provides both clinical and research ethics consultation. Dr. Ross has published two books on pediatric ethics: Children, Families and Health Care Decision Making (Oxford University Press, 1998) and Children in Medical Research: Access versus Protection (Oxford University Press, 2006). She is currently writing a third book, The Genetic Testing and Screening of Infants and Children.
[A] very informative publication...The book presents an excellent overview over problems in paediatric research and the ethical and legal issues to be addressed. M. Brochhausen HOMO
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