For the first time, this book presents materialsorganized around an analytical framework for acomprehensive and systematic exploration of thehuman experimentation process. The bookexamines and evaluates the authority which shouldbe vested in each of the chief participants in thisprocess — the investigator, the subject, theprofessions and the state - as well as the problemsfor decision which arise at its three basic stages -the formulation of research policy, theadministration of research, and the review ofresearch and its consequences. Through case studies from medicine, psychology, sociology, biology and law as well as commentaryfrom many sources - philosophy, political science, economics, genetics, medicine, anthropology, psychoanalysis, biology, jurisprudence, psychology, theology, journalism and literature - the volumeexplores the problems raised by human researchand the attempts that have been made to resolvethem. Alternative proposals, from allowinginvestigators a completely free hand to imposingcentralized governmental control, are examinedfrom both theoretical and practical perspectives. The conceptual framework of Experimentationwith Human Beings is designed to facilitate notonly the analysis of such concepts as "harm," "benefit" and "informed consent," but also theexploration of the problems posed by man‘s questfor knowledge and mastery, his willingness to riskhuman life, and his readiness to delegate authorityto professionals and rely on their judgment.
The book probes such questions as:• What limits, if any, should be placed onscientific inquiry and what implications do theselimits have for society‘s democratic andegalitarian aspirations? • To what extent should the degree or type ofharm to individuals or society affect the authorityof decisionmakers? • To what extent is the harm of an interventionmitigated by what immediate or long range, certainor uncertain benefits, and to whom should benefitsaccrue? • Under what circumstances and to what extentshould the consent of the subject or patient affectthe decision to intervene?
To what extent should the capacity of subject or patients to comprehend, to communicate or tomake rational choices affect the validity of consent. • Under what circumstances should thebalancing of risks and benefits be left to the personsaffected and when, if ever, should otherdecisionmakers impose limits on risktaking? These and many other questions are presented topromote a greater conscious awareness and arelentless scholarly analysis of the conflictingpurposes of human experimentation - protectingman, advancing science, and improving the well-being of society and future generations. Theultimate goal of this book is to encourage studentsand decisionmakers to sort out these conflicts, foronly then can they begin to formulate rules andprocedures which will minimize harm withouterecting insuperable impediments to the acquisitionof knowledge.
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