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Research on Human Subjects

Ethics, Law and Social Policy

1st Edition - August 1, 1998

Editor: D.N. Weisstub

Hardback ISBN:

9 7 8 - 0 - 0 8 - 0 8 8 5 6 0 - 5

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… Read more

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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.

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.