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| RESEARCH ON HUMAN SUBJECTS
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Ethics, Law and Social Policy
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Edited By
D.N. Weisstub, Chaire de Psychiatrie Légale at d'Éthique Biomédicale Philippe Pinel, Faculté de Médecine, Université
de Montréal, CP 6128, Succ, Centre-Ville, Montréal, Québec H3C 3J7, Canada
Description
There have been serious controversies in the latter part of the 20th century about the roles and functions of scientific and medical research.
In whose interests are medical and biomedical experiments conducted and what are the ethical implications of experimentation on subjects
unable to give competent consent? From the decades following the Second World War and calls for the global banning of medical research
to the cautious return to the notion that in controlled circumstances, medical research on human subjects is in the best interest of
the given individual and the broader population, this book addresses the key implications of experimentation on humans. This volume covers
major ethical themes within biomedical research providing historical, philosophical, legal and policy reflections on the literature and
specific issues in the field of research on human subjects. Focusing on special populations (the elderly, children, prisoners and the
cognitively impaired) it represents the most up-to-date review of the special ethical and legal conflicts that arise with relation to
experimentation on subjects from these groups.
In the light of current initiatives for law reform pertaining to research ethics the
world over, this volume provides a timely, comprehensive and provocative exploration of the field. The volume has been carefully organized
to present important philosophical perspectives on organizing principles that should underlie any practical application. A forward-looking
historical review of the regulatory regimes of principal jurisdictions, including of the legal controls already in place, provides the
backdrop for future policy initiatives. Additionally, in the light of global restructuring of health care systems, several chapters have
been devoted to epidemiological research and related issues.
Audience
Ethicists, legal scholars and academic healthcare lawyers, policy makers, medical and biomedical researchers (and their graduate fellowship
training program personnel), philosophers, IRB and ethics committee members, public policy and government advisors; corporations engaging
in the development and marketing of biological and medical products.
Contents
Contributors. Acknowledgements. Preface. The ethical parameters of experimentation (D.N. Weisstub).
Bringing ethics to human experimentation:
the American experience (D.J. Rothman). Beyond consent (M. Gregg Bloche). Roles in clinical and research ethics (D.N. Weisstub). The
concept of goodness in medical research: an action-theoretic approach (J.H. Solbakk). Drawing the distinction between therapeutic research
and non-therapeutic experimentation: clearing a way through the definitional thicket (S.N. Verdun-Jones, D.N. Weisstub)
The distinction
between "clinical practice" and "research": the case of pituitary derived hormones and Creutzfeldt-Jakob disease (M. Allars). "Consensual"
research with cognitively impaired adults: resolving legal shortcomings in adult guardianship (G.F. Tomossy, D.N. Weisstub). French law
and biomedical research: a practical experiment (C. Byk). Consent to human experimentation in Quebec: the application of the civil law
principle of personal inviolability to protect special populations (S.N. Verdun-Jones, D.N. Weisstub). The advance directive in research:
prospects and pitfalls
(D.N. Weisstub, A. Moorhouse). The regulation of human experimentation: historical and contemporary perspectives
(S.S. Fluss). International trends in research regulation: science as negotiation (P.M. McNeill). Models for regulating research: the
Council of Europe and international trends
(B. Starkman). Research ethics committees and the principle of justice: putting ethics and
law to the test (M.-L. Delfosse).
The institutional review board: its origins, purpose, function, and future (C.R. McCarthy). The regulation
of biomedical experimentation in Canada: developing an effective
apparatus for the implementation of ethical principles in a scientific
milieu (S.N. Verdun-Jones, D.N. Weisstub). Establishing the boundaries of ethically permissible research with vulnerable populations
(D.N. Weisstub et al.). Biomedical experimentation with children: balancing the need for protective measures with the need
to respect children's developing ability to make significant life decisions for themselves (D.N. Weisstub et al.). Biomedical
experimentation involving elderly subjects: the need to balance limited, benevolent protection with recognition of a long history of
autonomous decision-making (D.N. Weisstub et al.). Ethical research with vulnerable populations: the mentally disordered (J.
Arboleda-Florez, D.N. Weisstub).
Ethics in psychiatric research with incompetent patients (H. Helmchen). The conditions of personhood
as applied to incompetent persons (M. Silberfeld). Ethical research with vulnerable populations: the developmentally disabled
(D.N. Weisstub,
J. Arboleda-Florez). Ethics in research with detained individuals (N. Nedopil). Prisoners as subjects of biomedical experimentation:
examining the arguments
for and against a total ban (S.N. Verdun-Jones et al.). Ethical questions pertaining to the use of
placebos
(C. Mormont). Resolving the Inherent Dissonance between the doctor's roles as healer and researcher: a proposal (D. Sprumont).
Ethical issues in epidemiological research
(J. Arboleda-Florez et al.). Ethical guidelines for epidemiological research (P.
Riis). Epidemiology and the ownership of health data: ethical, legal and social aspects
(C.-G.Westrin, T. Nilstun). Bibliography.
| Bibliographic details |
Hardbound, 0 pages, publication date: OCT-1998
ISBN-13: 978-0-08-043434-6
ISBN-10: 0-08-043434-7
Imprint: PERGAMON
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