Titel: Children in Medical Research: Access Versus Protection
Autor/en: Lainie Friedman Ross
OXFORD UNIV PR
Februar 2006 - gebunden - 285 Seiten
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.
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
Dr. Lainie Ross is a general pediatrician and a medical ethicist in the MacLean Center for Clinical Medical Ethics at the University of Chicago.
[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 spans an impressive range of important ethical issues in paediatric research and provides a multitude of thought-provoking arguments...This book should be read by anyone interested in or involved with research with children. Annette Schulz-Baldes, Medicine, Healthcare and Philosophy [this] 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. Karen J. Maschke, The New England Journal of Medicine If the changes Ross proposes do come to pass, the book will still be of value in future years as an example of how an active researcher in the field has developed a body of work to make a strong statement for change. Kathryn Weise, Ethics and Human Research Ross challenges the ethics of greater acceptable research risk for children with acute or chronic illness, critiques current policies on parental consent and child assent, discusses the debate regarding subject payment in pediatric research and examines the meaning of "prospect of direct benefit"...Ross's work prompts discussion of the reasons why parents agree or refuse to enroll their children in medical research, how they understand the potential for benefit or harm and how they balance risks against potential benefits. Emily E. Anderson, American Medical Association Journal of Ethics The essays presented in this book...illustrate the breadth of Ross's research interests. Her work addresses several pressing issues relating to the ethical challenges of pediatric research and lays the ground for further discussions on and interpretation of these issues. Christopher Church, Perspectives in Biology and Medicine an excellent overview over problems in paediatric research and the ethical and legal issues to be addressed. M. Brochhausen, Journal of Comparative Human Biology This book is a systematic critical exploration of the development of policy within the United States in respect of the involvement of children in medical research ... Throughout the book, Ross makes recommendations for amending rules or adding new ones. These are always judicious and thoughtful ... anyone seeking a survey of American regulatory practice on pediatric research will find a comprehensive, extensively documented one in her book. David Archard, Notre Dame Philosophical Reviews