Children in Medical Research: Access versus Protection - Issues in Biomedical Ethics (Hardback)
  • Children in Medical Research: Access versus Protection - Issues in Biomedical Ethics (Hardback)

Children in Medical Research: Access versus Protection - Issues in Biomedical Ethics (Hardback)

Hardback 300 Pages / Published: 09/02/2006
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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. 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 the decision 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 research subjects; 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 what research 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 dazzling triumphs not worth having'.

Publisher: Oxford University Press
ISBN: 9780199273287
Number of pages: 300
Weight: 600 g
Dimensions: 242 x 161 x 24 mm

[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 *

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