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Children in Medical Research Access Versus Protection

ISBN-10: 0199230420
ISBN-13: 9780199230426
Edition: 2008
List price: $51.00 Buy it from $6.20
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Description: 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  More...

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Book details

List price: $51.00
Copyright year: 2008
Publisher: Oxford University Press, Incorporated
Publication date: 7/15/2008
Binding: Paperback
Pages: 280
Size: 6.00" wide x 9.00" long x 0.75" tall
Weight: 1.034
Language: English

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 whichaccess 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 firstimplemented 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 tomodify current policies and guidelines. Ross examines the regulatory structures (e.g. federal regulations and institutional review boards), the ad hoc policies (e.g. payment in pediatric research and the role of schools as research venues), the actual practices of researchers (e.g. the race/ethnicity of enrolled research subjects or thedecision to enroll newborns) as well as the decision-making process (both parental permission and the child's assent), in order to provide a broad critique. Some of her recommendations will break down current barriers to the enrolment of children (e.g. permitting the payment of child researchsubjects; allowing healthy children to be exposed to research that entails more than minimal risk without requiring recourse to 407 panels); whereas other recommendations may create new restrictions (e.g., the need for greater protection for research performed in schools; restrictions on whatresearch should be done in the newborn nursery). The goal is to ensure that medical research is done in a way that promotes the health of current and future children without threatening, to use the words of Hans Jonas, 'the erosion of those moral values whose loss . . . would make its most dazzlingtriumphs not worth having'.

Introduction
Access versus Protection
From 1966 to 2005: Balancing Protection and Access in Pediatric Research
Access versus Protection: Minority Representation in Pediatric Research
Challenges to the Regulations
Overview of the Common Rule and Subpart D
Should We Provide Healthy Children with Greater Protection in Medical Research?
Informed Consent in Pediatric Research
Phase I Research and the Meaning of 'Prospect of Direct Benefit'
Strengths and Limits of Current Regulations
Human Subject Protections in Published Pediatric Research
Payment in Pediatric Research
Research in Schools
Case Studies
Minimizing Risks: Diabetes Research in Newborns
Diabetes Prediction and Prevention Research in Childhood
Lead Abatement Research
Clinical Asthma Trials
Research not Otherwise Approvable: A Look at One 407 Protocol
Evolution of the 407 Process
Epilogue
Index

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