Ethics and Methods in Surgical Trials
Journal of Medical Ethics 2009 September; 35(9): 579-583
This paper focuses on invasive therapeutic procedures, defined as procedures requiring the introduction of hands, instruments, or devices into the body via incisions or punctures of the skin or mucous membranes performed with the intent of changing the natural history of a human disease or condition for the better. Ethical and methodological concerns have been expressed about studies designed to evaluate the effects of invasive therapeutic procedures. Can such studies meet the same standards demanded of those, for example, evaluating pharmaceutical agents? This paper describes a research project aimed at examining the interplay and sometimes apparent conflict between ethical standards for human research and standards for methodological rigor in trials of invasive procedures. The paper discusses how the authors plan to develop a set of consensus standards that, if met, would result in substantial and much-needed improvements in the methodological and ethical quality of such trials.
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A Taxonomy of Multinational Ethical and Methodological Standards for Clinical Trials of Therapeutic Interventions Ashton, Carol M; Wray, Nelda P; Jarman, Anna F; Kolman, Jacob M; Wenner, Danielle M; Brody, Baruch A (2011-06)If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials ...