Graduate studies at Western
|Abstract||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.|
|Keywords||No keywords specified (fix it)|
No categories specified
(categorize this paper)
|Through your library||Only published papers are available at libraries|
Similar books and articles
Howard Mann (2003). Sham Surgery in Randomized Trials: Additional Requirements Should Be Satisfied. American Journal of Bioethics 3 (4):5 – 7.
Teresa Swift & Richard Huxtable (2013). The Ethics of Sham Surgery in Parkinson's Disease: Back to the Future? Bioethics 27 (4):175-185.
R. L. Albin (2002). Sham Surgery Controls: Intracerebral Grafting of Fetal Tissue for Parkinson's Disease and Proposed Criteria for Use of Sham Surgery Controls. Journal of Medical Ethics 28 (5):322-325.
Franklin G. Miller & Howard Brody (2002). What Makes Placebo-Controlled Trials Unethical? American Journal of Bioethics 2 (2):3 – 9.
Joan Box (2004). Placebos and the UK Medical Research Council — and the Consumer Perspective. Science and Engineering Ethics 10 (1):95-101.
R. L. Albin (2005). Sham Surgery Controls Are Mitigated Trolleys. Journal of Medical Ethics 31 (3):149-152.
Jeremy Sugarman (2004). Using Empirical Data to Inform the Ethical Evaluation of Placebo Controlled Trials. Science and Engineering Ethics 10 (1):29-35.
Connie Peck & Grahame Coleman (1991). Implications of Placebo Theory for Clinical Research and Practice in Pain Management. Theoretical Medicine and Bioethics 12 (3).
Franklin G. Miller (2004). Sham Surgery: An Ethical Analysis. Science and Engineering Ethics 10 (1):41-48.
Added to index2009-08-24
Total downloads7 ( #142,473 of 739,367 )
Recent downloads (6 months)1 ( #61,680 of 739,367 )
How can I increase my downloads?