This book is the first major work that addressesa core question
in biomedical research: the question of acceptable risk. The
acceptable level of risks is regulated by the requirement of
proportionality in biomedical research law, which state that the
risk and burden to the participant must be in proportion to
potential benefits to the participant, society or science.
This investigation addresses research on healthy volunteers,
children, vulnerable subjects, and includes placebo controlled
clinical trials.It represents a major contribution towards
clarifying the most central, but also the most controversial and
complex issue in biomedical research law and bioethics. The EU
Clinical Trial Directive, the Council of Europe's Oviedo Convention
(and its Additional Protocol), and national regulation in member
states are covered.Itis a relevant work for lawyers andethicists,
and thepractical approach makesa valuable tool for researchers and
members of research ethics committees supervising biomedical
research."
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