Commentary

Professor Doyal's viewpoint commented on a number of articles on the topic of patient consent that appeared in a recent issue of Heart (vol 86, No 6). We invited the authors of those articles to respond to Professor Doyle's comments, and below is the reply from one group.

INFORMED CONSENT: ARE THERE ETHICALLY JUSTIFIED CONDITIONS FOR EXCEPTIONS?

Are good clinical practice and informed consent inseparable? This depends, to some extent at least, on what is meant by “inseparable”. Does this refer to a logical relation, on the assumption that “good clinical practice” by definition includes informed consent, to an empirical generalisation about current medical practice, or a normative statement about how it ought to be? Different arguments pro and contra are relevant depending on whether the statement is interpreted as a logical statement, an empirical generalisation, or as a normative statement.

We do not dispute the moral ground for the requirement of informed consent in general,¹ and we agree with the statement that “the clinical duty to obtain proper informed consent is now widely believed to be an essential component of good clinical practice”. Neither do we dispute that improved training in communication skills and more time for doctors to communicate with their patients would be a good thing—and probably make more patients participate in the decision process.²

What we wished to do in our paper³ was to discuss whether there might not be situations in which exceptions from the general requirement of informed consent would be acceptable. We hope that such a debate could help to define stringent and precise conditions when such exceptions could be morally and legally acceptable. One general assumption we share is the idea that such an exception is reasonable, if insisting on the requirement of informed consent causes more harm than good. In its turn, this presupposes a discussion of criteria of harm and benefit and who should decide about the relative magnitude of harm and benefit. Verification after the event by the patients in question could in certain situations be worth investigating. If there is a verification by the patients concerned, in the sense that they afterwards confirm that they think that an exception from the general requirement was ethically justified, then the concept of an exception from the general main rule is supported by referring to what the patients themselves want. If autonomy is taken seriously, references to what the patients say they want cannot be dismissed lightly.

Our ambition with the study published³ was not to suggest any radical changes regarding the informed consent procedure when a patient is suffering from an acute myocardial infarction and is a potential research subject, nor to draw any general conclusions from the results obtained. Instead, we wanted to elucidate the possible problems and disadvantages associated with the process of obtaining informed consent in this particular situation. Primarily we wanted to stimulate the debate on the following two issues:

1. Does a patient in the midst of a life crisis have to put his/her signature on a consent form in order to be included in an intervention trial?

2. Are there ethically justified alternatives to informed consent when a researcher wants to include a patient in a study, who is not capable of giving a free and informed consent in research?

We stated: “All possible measures to increase the autonomy of the patients under the prevailing circumstances should be carried out”. Thus, we do not suggest that all patients with acute myocardial infarction should be treated as incompetent. However, what we have tried to do in our study is to bring forth and highlight empirical evidence, which seems to show that in this particular situation some patients do not have the capacity to give a true informed consent for study participation.

Professor Doyal adds another argument, to the effect that even if the patients afterwards do not remember anything, this does not reduce the moral importance of relevant information disclosure. The main question is what is meant by “relevant information disclosure”, and who decides what this is. Suppose (a) that it is left to the patient to decide what is relevant information disclosure, (b) that additional information does not change the decision of the patient, and (c) they do not want this additional information, which conclusion should be drawn from this?

We claim that it is time to adjust the informed consent procedure to the patients' capacity in this particular situation. Moreover, the patient should be spared the “actual demand” of signing the consent form in the early phase of an acute myocardial infarction.