Recent debates over the use of sham surgery as a control for studies of fetal tissue transplantation for Parkinson’s disease have focused primarily on rival interpretations of the US federal regulations governing human-subjects research. Using the core ethical and methodological considerations that underwrite the equipoise requirement, we nd strong prima facie reasons against using sham surgery as a control in studies of cellular-based therapies for Parkinson’s disease and more broadly in clinical research. Additionally, we believe that these reasons can be generalized to apply to the use of other placebo controls that carry signi cant risks of positive harms in and of themselves. As a result, our arguments are centrally relevant to the emerging drive to subject therapies with a surgical component to the same rigorous standards of evaluation as those governing the approval of new pharmaceuticals.
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Citations of this work BETA
Sham Surgery: An Ethical Analysis.Franklin G. Miller - 2004 - Science and Engineering Ethics 10 (1):41-48.
The Potential Benefit of the Placebo Effect in Sham-Controlled Trials: Implications for Risk-Benefit Assessments and Informed Consent.R. L. Brim & F. G. Miller - 2013 - Journal of Medical Ethics 39 (11):703-707.
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