The potential benefit of the placebo effect in sham-controlled trials: implications for risk-benefit assessments and informed consent

• Published in: Journal of medical ethics Vol. 39; no. 11; pp. 703 - 707
• Main Authors: Brim, Remy L, Miller, Franklin G
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group Ltd and Institute of Medical Ethics 01.11.2013; BMJ Publishing Group; BMJ Publishing Group Ltd; BMJ Publishing Group LTD
• Series: Paper
• Subjects: Acupuncture; Arm; Bioethics; Clinical outcomes; Clinical significance; Clinical trials; Committees; Consent Forms; Controlled Clinical Trials as Topic - ethics; Dopamine; Ethical aspects; Ethics Committees, Research - ethics; Ethics, Research; Experimentation; Health outcomes; Humans; Informed Consent; Informed consent (Medical law); Informed Consent - ethics; Intervention; Pain; Parkinson's disease; Physiology; Placebo Effect; Placebos; Policy Guidelines/Inst. Review Boards/Review Cttes; Research Ethics; Risk Assessment - ethics; Risk Assessment - standards; Surgery; Surgical specialties; United States; Research Ethics; Informed Consent; Policy Guidelines/Inst. Review Boards/Review Cttes

There has been considerable debate surrounding the ethics of sham-controlled trials of procedures and interventions. Critics argue that these trials are unethical because participants assigned to the control group have no prospect of benefit from the trial, yet they are exposed to all the risks of t...