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In this issue of Current Oncology, Carolyn Freeman and colleagues raise an important question about consent to external-beam radiotherapy. More specifically, they ask
Their practice until now has been to inform patients verbally and to document the discussion in the patient chart. Concerns about that practice led them to investigate what other Canadian radiation oncology departments are doing. The authors found that most of the departments that responded (59%) use a written consent form. Of the departments using a form, most use a generic consent form. A handful use a form specific to radiotherapy, and only two use a form specific to the type and site of the tumour. The authors conclude that current practice falls short of ideal, which they suggest is the use of a written consent form specific to the tumour type and site.
Because informed consent protects patient autonomy, it is a central principle of ethical medical practice. Although autonomy is always valuable, it is particularly important when weighty issues are at stake, as they regularly are in health care.
Written consent is typically required for invasive procedures, but oral consent is often deemed sufficient for noninvasive treatments. Dr. Freeman and colleagues argue that, because external-beam radiotherapy can have “an invasive character from the patient’s perspective,” it, too, should be subject to written consent. In other words, the authors seem to accept the invasive/noninvasive distinction, arguing only that external-beam radiotherapy falls on the invasive side. By contrast, I would suggest that whether external beam radiotherapy is invasive or not, heightened standards of consent are essential. I take this position because I think that the relevant distinction is not between invasive and noninvasive procedures, but between procedures in which more, and procedures in which less, is at stake. In this regard, external-beam radiotherapy does not differ relevantly from technically more invasive procedures such as brachytherapy.
The authors reject the argument that implicit consent has been obtained simply because a “patient attends for consultation and follows through on all of the multiple steps that lead up to the treatment itself.” Here, it might be helpful to distinguish between consent and informed consent. Arguably, by following through on the steps that lead up to the treatment, patients are giving implicit consent in some minimal sense. However, it does not follow that that consent is adequately informed, which is crucial.
It is therefore clear that a heightened standard of informed consent is required for external-beam radiotherapy. The question, then, is whether written consent forms, tailored to the type and site of the tumour, constitute an improvement over the practice of documenting a discussion with the patient. Dr. Freeman and colleagues are correct that a consent form signed by a patient can be empowering to that patient in a way that a chart note, often not seen by the patient, cannot. It is also the case that written forms can avoid the problem of doctors forgetting to mention relevant information. In this way, consent forms can function like a version of a surgical checklist.
However, a serious danger inherent in written consent forms must be avoided if the benefits are not to be outweighed by the costs—specifically, the tendency for written consent forms to become a substitute for obtaining informed consent. Instead of actually informing the patient, the doctor invites the patient to read and sign a form. Patients often do both perfunctorily. Thus, it is crucial that written consent be an aid to, rather than a substitute for, truly informed consent.