Many ethical questions arise from studyBMJ 1996; 312 doi: https://doi.org/10.1136/bmj.312.7041.1302a (Published 18 May 1996) Cite this as: BMJ 1996;312:1302
EDITOR,—I applaud Roisin Kemp and colleagues' efforts to devise and test a means of improving psychotic patients' compliance with antipsychotic drugs.1 I was disappointed, however, that the authors did not address several important issues more fully.
Did the control group receive routine clinical care in addition to the control intervention? If not and they had no opportunity to discuss their treatment with a doctor then several further questions arise. Firstly, was it ethical to offer a treatment short of what many would regard as good practice? The authors themselves refer to “the potentially devastating consequences of relapse,” yet did they withhold from their control group treatment that they had reasonable grounds to believe might help prevent relapse? Secondly, is it acceptable to offer a treatment short of what the NHS patient's charter states a patient has a “right” to expect—that is, to “have any proposed treatment, including any risks involved in that treatment and any alternatives, clearly explained to you before you decide whether to agree to it”?2 Thirdly, how were side effects and response to treatment monitored by the treating psychiatrist?
How was consent for participation in the study obtained from the 25 patients detained under the Mental Health Act? It is interesting that no patient withdrew consent during the early part of the trial, a time when one might expect improvement in mental state to lead to a change of heart.
Both the active and control treatments were delivered by the same investigators. Being motivated to find a difference in outcome between the two treatments would have made it difficult to maintain an unbiased approach.