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  • Cited by 116
      • Ruth Macklin, Albert Einstein College of Medicine, New York
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    • Publisher:
      Cambridge University Press
      Publication date:
      12 November 2009
      27 May 2004
      ISBN:
      9780511495359
      9780521833882
      9780521541701
      Dimensions:
      (228 x 152 mm)
      Weight & Pages:
      0.585kg, 290 Pages
      Dimensions:
      (228 x 152 mm)
      Weight & Pages:
      0.466kg, 290 Pages
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    Book description

    This book examines the ethical controversies that have surrounded the design and conduct of international medical research sponsored by industrialized countries or industry, and carried out in developing countries. The chief concern is that research subjects in developing countries may be exploited because sponsors of research employ double standards. One debate focuses on whether the standard of care provided to subjects of medical research in developing countries should be the same as what research subjects receive in North America and Europe. Other concerns are whether the process of obtaining informed consent in developing countries is adequate, and whether prior ethical review of research meets standards that are well established in the industrialized world. Recent international developments show that essential medications can be made affordable and accessible to developing countries, and that double standards need not prevail.

    Reviews

    '… a very readable overview and analysis of the main issues in one of the most acrimonious international debates the field of ethics has seen in recent times … As an easily digested overview this book could well become the standard textbook for researchers and students in postgraduate courses in biomedical ethics.'

    Source: British Medical Journal

    'It is written in an interesting and informative way and is one of the few substantial books on the topic.'

    Peter Smith - London School of Hygiene & Tropical Medicine

    'The strength of the book lies in its breadth of coverage … Macklin’s experience on international committees and study teams adds to the depth of her considerations. Her details account of the latest revisions of the Declaration of Helsinki and the Council for International Organizations of Medical Sciences' international ethical guidelines - and particularly, of disagreements over the interpretation of apparently straightforward statements - is illuminating … Macklin’s aim … is not to offer solutions but to provide a solid theoretical base from which to analyze and critique the current state of affairs. In this she has made an important and timely contribution to the thinking of medical and pharmaceutical professionals, policymakers, and ethicists.'

    Source: Journal of the American Medical Association

    'Double Standards in Medical Research in Developing Countries is a thought provoking summation of the most troubling bioethical issues in clinical research trials, a worthy addition to the Law, Medicine and Ethics series of the Cambridge University Press.'

    Source: Canadian Medical Association Journal

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