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Ethics in Biology, Engineering and Medicine: An International Journal
Sham Surgeries: Have We Gone Too Far?
Victor K. Wu
CLARITY Research Group, McMaster University, Hamilton, Ontario, Canada
CLARITY Research Group, McMaster University, Department of Orthopedic Surgery Musculoskeletal Research Unit, Canada and Division of Orthopaedic Surgery and Department of Clinical Epidemiology & Biostatistics, Hamilton General Hospital, Canada
The use of placebo surgeries can be ethically justified under certain conditions depending on the current state of evidence existing for surgical procedures, methodological considerations of the randomized controlled trial (RCT), and the welfare of research participants. It may be impossible to eliminate all risks associated with placebo surgery, but the mitigation of risk has moral weight and is already practiced outside of health research. If ethics is a reflection of social and cultural values of the society in which it operates, one can reasonably conclude that certain placebo procedures can be used in surgical RCTs. However, in situations whereby quality of life is irrevocably lost, as in the case of placebo procedures that directly or indirectly invoke serious and irreversible harm, the undertaking of such a trial would be inappropriate. Research ethics boards (REBs) may play a role in research involving placebo surgery by: i) ensuring clinical equipoise between intervention and placebo treatments; ii) increasing transparency between the research ethics board, the researcher, and the participant; and iii) ensuring that adequate time is given for the individual to contemplate participation.
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