BMJ 1996;313:361 (10 August)

Letters

Patients' consent should have been sought

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, . . . [Full text of this article]


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Psychological support for patients undergoing breast cancer surgery: a randomised study
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