Children in Medical Research Access Versus Protection

Name: Children in Medical Research Access Versus Protection
Price: 5.09 USD
Availability: InStock
ISBN: 9780199230426

ISBN-10: 0199230420

ISBN-13: 9780199230426

Edition: 2008

Authors: Lainie Friedman Ross

List price: $68.00

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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 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…

Book details

List price: $68.00
Copyright year: 2008
Publisher: Oxford University Press, Incorporated
Publication date: 7/15/2008
Binding: Paperback
Pages: 304
Size: 6.18" wide x 9.17" long x 0.73" tall
Weight: 1.034
Language: English



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