Commentary: No consent means not treating the patient with respect

BMJ 1997; 314 doi: (Published 12 April 1997) Cite this as: BMJ 1997;314:1076
  1. Sheila McLean, professor of law and ethics in medicinea
  1. a School of Law Stair Building University of Glasgow Glasgow G12 8QQ


    It is presumably often difficult for researchers to commit themselves wholeheartedly to the notion that before consent (or refusal) is obtained for research it is necessary that the person concerned should be given the fullest information about the project for which his or her agreement is wanted. The concerns expressed by the researchers–not least the possibility of biasing results–are intelligible. However, they are also insufficient to justify deviation from the general rule.

    Researchers in many topics face the same problems about possibly influencing results and seek to minimise the possible impact this may have. Many kinds of research–clinical and non-clinical–must and do tackle similar problems while still turning out high quality work. However, this and the other rationales cited by Dennis et al disguise a deeper problem. The researchers claim they did not think that failure to provide the fullest possible information would harm their patients. Though this is probably true in a physical sense, it omits to consider the underlying rationale for providing full information–namely, that good research should not only be scientifically sound but it must also at all times respect the subject. Any failure to offer this respect is in itself a harm, even if its consequences are not physical. Indeed, it could plausibly be argued that omitting any substantial factor in the research protocol is enough to render the research unethical, no matter how important the postulated outcome. This is particularly true given that no researcher can know in advance that his or her results will be important.

    Everyone starting a project believes that there is value in knowing the answer to the question being asked. But it is only when the answer is found that the truth or falsehood of that assumption can be known. Thus there is an inbuilt intellectual bias in any project which presumes that the answer is important enough to ignore a fundamental tenet of research method and respect for people.

    We must also accept that had people been asked and then regretted their decision this would be unfortunate. It is difficult, however, to see how this differs from other projects. Moreover, that the person in question was rendered vulnerable by the nature of the condition argues for more rather than less information. There are always concerns about including in studies people whose condition is precarious. That this research was not directly physical does not remove those concerns or minimise obligations. In addition, I am puzzled by the argument that, as patients and their families would be included, it was “unclear” who might give consent. The answer is clear: anyone who is to be studied must be given the fullest possible information.

    We can agree that the conclusions of the study are of considerable interest and that no physical harm was done to patients whose agreement to participate was based on partial rather than full information. It is, however, also dangerous to believe that this is enough. Nor are possible feelings of disappointment on the part of those who might not have agreed to randomisation different from findings in other research settings.

    In sum, the arguments against providing full information are frankly unconvincing, however well intentioned. If certain research cannot be undertaken to the maximum standards of scientific inquiry the question is not how much information can be withheld, it is whether the research should be done in the first place. Otherwise we embark on a slippery slope away from one of our most fundamental ethical principles. In the long run the critical issue is not the consequential one; what matters is that people have not been treated with enough respect.

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