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Interesting and important ethical questions confront researchers,
regulators, institutional review boards, support personnel, and
research participants committed to the ethical conduct of human
subjects research at all stages of research. Questions encompass -
but are not limited to - study design, enrolling participants,
balancing the clinical needs of participants against the research
agenda, ending trials, discharging post-trial obligations, and
resolving conflicts. Straightforward solutions to these types of
questions are often not found in regulations, ethics codes, or the
bioethics literature. These resources may leave room for
interpretation, offer conflicting guidance, or simply fail to
address particular questions. Ethics consultation, which has been
offered in clinical care settings with regularity since the 1980s,
has since the turn of the century increasingly been sought in the
clinical research context. Because there has only lately been
recognition that ethics consultants can play a valuable role
helping the research community conduct research in the most
ethically informed way, there are many open questions in the field
of research ethics consultation including the appropriate role of
consultants and the best methods of consultation. The Clinical
Center Bioethics Consultation Service has been serving the NIH
community of researchers, administrators, healthcare providers, and
research participants for more than a decade, conducting nearly
1,000 consultations in that time. In this book, members of the
Bioethics Consultation Service reflect on this long track-record
and unparalleled range of research ethics consultations to share a
collection of their most interesting and informative research
ethics consultations and to start a dialogue on remaining open
questions. Although the NIH experience is unique, this book focuses
on cases - and associated lessons - that are generalizable and
valuable for the entire clinical research community. This book will
be valuable to ethics consultants, clinical investigators, students
and teachers, and others desiring insight into clinical research
ethics and ethics consultation.
Millions of children suffer from diseases and illnesses that do not
have adequate treatment, and many other children are harmed by
medicines intended to help them. In order to protect and help these
children, society must conduct pediatric research to identify safer
and more effective medical treatments. This research requires
exposing some children to risks for the benefit of others. Yet,
critics and courts have argued that it is unethical to expose
children to research risks for the benefit of others, and this
practice seems to violate our obligation to protect children from
harm and exploitation. In this way, clinical research with children
presents us with what appears to be an irresolvable dilemma: either
we can protect pediatric subjects from exploitation, or we can
protect pediatric patients from dangerous medicines, but not both.
The Ethics of Pediatric Research is the first work to
systematically evaluate this dilemma, and David Wendler offers an
original justification for pediatric research based on an in-depth
analysis of when it is in our interests to help others. It will be
of interest primarily to scholars in pediatric ethics and clinical
research ethics.
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