Opinion 2.076 - Surgical "Placebo" Controls

The term surgical "placebo" controls refers to the control arm of a research study where subjects undergo surgical procedures that have the appearance of therapeutic interventions, but during which the essential therapeutic maneuver is omitted.

The appropriateness of a surgical "placebo" control should be evaluated on the basis of guidelines provided in Opinion 2.07, "Clinical Investigation," as well as the following requirements:

(1) Surgical "placebo" controls should be used only when no other trial design will yield the requisite data.

(2) Particular attention must be paid to the informed consent process when enrolling subjects in trials that use surgical "placebo" controls. Careful explanation of the risks of the operations must be disclosed, along with a description of the differences between the trial arms emphasizing the essential procedure that will or will not be performed. Additional safeguards around the informed consent process may be appropriate such as using a neutral third party to provide information and get consent, or using consent monitors to oversee the consent process.

(3) The use of surgical "placebo" controls may be justified when an existing, accepted surgical procedure is being tested for efficacy. It is not justified when testing the effectiveness of an innovative surgical technique that represents only a minor modification of an existing, accepted surgical procedure.

(4) When a new surgical procedure is developed with the prospect of treating a condition for which no known surgical therapy exists, using surgical "placebo" controls may be justified, but must be evaluated in light of whether the current standard of care includes a non-surgical treatment and the benefits, risks, and side effects of that treatment.

(a) If foregoing standard treatment would result in significant injury and the standard treatment is efficacious and acceptable to the patient (in terms of side effects, personal beliefs, etc), then it must be offered as part of the study design.

(b) When the standard treatment is not fully efficacious, or not acceptable to the patient, surgical "placebo" controls may be used and the standard treatment foregone, but additional safeguards must be put in place around the informed consent process. (I, V)