Patients' consent should have been soughtBMJ 1996; 313 doi: https://doi.org/10.1136/bmj.313.7053.361a (Published 10 August 1996) Cite this as: BMJ 1996;313:361
EDITOR,—It is ironic that a study in which informed consent was not sought1 should be published in the same issue as an editorial by Richard Smith calling for action on misconduct in research.2 The study falls well short of good clinical research practice, which is a requirement in trials sponsored by the pharmaceutical industry.3 The hospital ethics committee was surely at fault in allowing the research to proceed in contravention of the Nuremberg Code.
In her commentary Claire Foster addresses some, but not all, of the issues of informed consent raised by the study.1 Women, unlike rats in cages, move around and communicate with each other. In the 1980s Evelyn Thomas, a lecturer in biology with the Open University who fully understood the principles of randomised controlled trials, found to her distress that she had been included in a trial of counselling versus no counselling after her mastectomy. Her case, which led to a formal complaint and was well publicised at the time, should have been a warning to future researchers.
The study raises further problems. It is imprudent for the lead researcher also to be the lead therapist. As Watson pointed out: “This is a major methodological flaw, as it is difficult to eliminate bias from a study where there is an obvious vested interest in the outcome.”4 The fact that two members of the same family are co-researchers should also give cause for concern. It is, moreover, a serious drawback that the voluntary organisation involved in the study, Tak Tent, was not functioning in its usual fashion; this in itself invalidates any conclusions.
A common complaint from cancer support groups is that hospitals act as gatekeepers, often not informing people of the groups' existence.5 Patients should be free to refer themselves at any stage of their cancer journey, according to individual need. It is untrue that the effect of community based support organisations has not been evaluated: the reference that the authors give is out of date.
Breast care nurses do a valuable job; they have no need to compete with self help groups but should cooperate with them. They have limited time and rarely hold qualifications in counselling. They may therefore not pick up, or not be able to deal with, psychological morbidity. If as a result of this study they dismiss the work of voluntary groups and fail to inform patients of other sources of support, the study will have done harm rather than good.