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Related Experiment Videos

Surgical "placebo" controls.

Robert Tenery1, Herbert Rakatansky, Frank A Riddick

  • 1Council on Ethical and Judicial Affairs of the American Medical Association, Chicago, Illinois 60610, USA.

Annals of Surgery
|January 25, 2002
PubMed
Summary
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Ethical guidelines for surgical placebo controls in trials recommend their limited use for new procedures on untreatable diseases. Rigorous informed consent and risk-benefit analysis are essential when employing these controls.

Area of Science:

  • Medical Ethics
  • Surgical Research
  • Clinical Trial Design

Background:

  • Ethical concerns surround surgical trials using placebo controls where interventions are omitted.
  • Existing guidelines for drug placebos do not adequately address surgical placebo controls.

Purpose of the Study:

  • To establish ethical guidelines for the use of surgical placebo controls in surgical trials.
  • To address the ethical considerations specific to surgical placebo interventions.

Main Methods:

  • Developed ethical guidelines through extensive literature review.
  • Consulted with experts in surgical ethics and clinical research.

Main Results:

  • Surgical placebo controls are appropriate for novel procedures targeting diseases without other surgical options, especially if placebo effects are likely.

Related Experiment Videos

  • Standard, effective non-surgical treatments must be offered if available and acceptable to patients.

    • Conclusions:

    • Surgical placebo controls should be reserved for situations where no alternative trial design can provide necessary data.
    • Use of surgical placebo controls requires stringent informed consent and thorough risk-benefit assessment.
    • Guidelines adopted by the American Medical Association (AMA) now include these ethical considerations.