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BMJ No 7102 Volume 315 Letters Saturday 26 July 1997 Informed consent Ability to be informed is separate from ability to give consent Editor, The debate over the need for research subjects' informed consent lacked the patients' perspective. It is true that many people would be reluctant to take part in a randomised controlled trial if they knew that they were doing so. And why is this? It is because they have at best only a 50% chance of being in the group with the most positive outcomes, if there is indeed a difference, and because, by the time the trial has established such distinctions, their own treatment may be compromised. Their reasons are rational; they are just inconvenient for the researcher. I am concerned by Len Doyal's and others' ready exclusion of consent for people `not competent' to give consent.(1) In the case of a person with a learning difficulty, a juvenile, or a person with a severe mental health problem (my own field of research), what may perhaps be compromised is the ability to be informed. I would argue that this is separate from the ability to give consent, and failure to recognise the distinction allows researchers to take the arrogant view that the only reason why people refuse to cooperate is because they have failed to understand the information offered. It is easy in practice for researchers to be `economical' with the information, volunteering only those aspects of the study that they suspect are most acceptable to patients. The smaller the potential sample the more likely this subterfuge is, to maximise participation. Jeffrey S Tobias suggests that there is often a conflict of interests between the best interests of the individual patient and those of society as a whole.(2) But it hardly seems appropriate to leave the research community to decide what the interests of society as a whole are, for we would expect their conclusions to be biased. It is undeniable that offering truly informed consent will skew outcomes in most cases, though it will not necessarily affect the outcome variables that are being measured. No research design involving human subjects can avoid the human factor. Perhaps we need to accept, as the average sceptical but rational layperson did a long time ago, that scientific research rarely provides unequivocal outcomes. What it does is substantiate reasonable hypotheses, which will help predict outcomes in most cases. Let's not kid ourselves that we work under laboratory conditions; and let's remember that you can't treat people like rats. Deborah Rutter Research manager Hillingdon Outreach Support Team, Uxbridge, Middlesex UB8 1AR References 1 Doyal L. Informed consent in medical research. BMJ 1997;314:1107-11. (12 April.) 2 Tobias J S. BMJ's present policy (sometimes approving research in which patients have not given fully informed consent) is wholly correct. BMJ 1997;314:1111-4. (12 April.) Home | Current issue | Past issues | Classified ads | Career Focus | Feedback Collections | About this site | About the BMJ | BMA | Medline