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Children in Medical Research - Access versus Protection (Paperback)
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Children in Medical Research - Access versus Protection (Paperback)
Series: Issues in Biomedical Ethics
Expected to ship within 12 - 17 working days
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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
createnew 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."
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