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The regulation of medical research involving human subjects : a comparative study

This thesis is concerned with finding an appropriate legal response to medical research involving human subjects. The first section contains Chapter One which consists of an historical account of forms of unethical research and asks two questions; first, how could such things have been done in the name of research? Secondly, how could society allow them to take place? How were the safeguards overridden? What was the environment or climate within which unethical research was allowed to flourish? The history of the regulation of medical research testifies to the social climate within which research has been conducted. This includes the evolution of the doctor as scientist which led to the objectification of human beings as research subjects, the presence of ideologies in times of war, for instance, which took hold of national consciousness and conscience thereby shifting the goal posts of justification, and the development and maturing of medical careers. Chapters Two, Three and Four comprise section two and deal with the intellectualisation of questions of research at the abstract level of the medico/legal debate. In particular, Chapter Two outlines the terminology of medical research, the monopoly over which has been secured by scientists through scientific reasoning. Chapter Three considers legal reasoning in relation to the concept of informed consent and considers the implications of an approach based on medical negligence, in itself a retrospective 'after the fact' approach; it will be argued that medical research should be viewed prospectively within a framework which is more informed by public than private law. Chapter Four considers the role of moral reasoning in relation to its main protagonists, 'bioethicists', who retain a firm grip on the ethical implications of medical research. An alternative rationale will be suggested which is both universally applicable and normatively neutral. It will be further argued that moral reasoning should involve the public sphere and should not be confined to the private realms consisting of the educated intuitions of researchers and other members of the professional elite. The third section consists of Chapters Five and Six and are concerned with the applied level of the medical research debate as seen in research ethics committees in both the United Kingdom and Germany.

Identiferoai:union.ndltd.org:bl.uk/oai:ethos.bl.uk:641171
Date January 1998
CreatorsAziz, Miriam
PublisherUniversity of Edinburgh
Source SetsEthos UK
Detected LanguageEnglish
TypeElectronic Thesis or Dissertation
Sourcehttp://hdl.handle.net/1842/21357

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