The ethics of employing placebos in clinical and community research

Abstract

Placebos in clinical use show both subjective and provable objective effects. In research, placebos also retain a fair amount of activity, causing unpredictable and unreliable effects. Therefore, when used as comparators with a new drug, they should not be considered as inactive controls. If placebos are unreliable comparators, they have no further justification beyond serving as inexpensive agents that are simpler to both handle and compare than active therapies. Nevertheless, if they lack scientific justification, placebos should not be employed because all subjects falling in the control group will become therapeutic orphans, since patients under routine medication will be at risk of not receiving necessary treatment, at least for the duration of the trial. Studies in the area of public health, especially in epidemiology, are often encouraged to employ the randomized control technique, which includes using placebos in the control arm. Community based research is expected to be pertinent and beneficial to the host site, therefore inactive control arms will deny numerous subjects the benefit supposedly sought by the research. Placebos are tolerated by major research guidelines, in spite of heavy opposition by those bioethicists that believe them to put research subjects at unjustified risks. Local Bioethics Research Committees should protect research subjects by only accepting placebo protocols under exceptionally justified conditions.