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It is possible to question whether patients suffering from the early phase of an acute myocardial infarction (AMI) are able to give free and informed consent and whether or not it is ethically defensible to include them—those patients suffering from more severe symptoms, in particular—in research projects.1 In fact, it has been shown that a reasonable number of patients who have given their consent in this situation are only able to recall very little of the information they received about the study and that only a minority read through the consent form before signing it.2–4
The aim of this study is to determine how physicians, who have been involved in including patients in intervention trials in the early phase of their AMIs, experienced the informed consent procedures. In our view, data obtained from those people who are actually confronted by the research subjects and who are responsible for carrying out the consent procedure should also be taken into account, when the most appropriate ways of including these patients in studies are discussed. To our knowledge no survey of physicians relating to this issue has previously been undertaken.
A questionnaire containing questions relating to the informed consent procedure in the context of AMI was distributed to all 1002 physicians registered as members of the Swedish Society of Cardiology in 2001. In all, 739 questionnaires were returned, giving a response rate of 74%. Those without experiences of including AMI patients in trials were excluded (n = 174). Questionnaires were also excluded, if more than two questions were incorrectly filled in (n = 21). The results are based on an analysis of the remaining 544 questionnaires.
Statistical analyses were performed in order to determine whether the respondent’s sex, their experiences of including patients in trials during the last year, and the setting in which they were working influenced their way of answering.
The respondents were able to comment on all the items, making it possible for them to clarify their answers or to provide some additional information. A total of 881 comments were distributed between the nine questions, ranging between 58–149 for each individual question.
The main results from the survey are presented (table 1). Two thirds (68%) of the physicians felt that too much information had to be given to the potential research subject suffering from an AMI. Most of the physicians (86%) felt that the patients were not generally able to understand more than some parts of the information given to them. Approximately one in three respondents estimated that the patients in question read through the consent form in some detail.
Fifty six per cent felt that it should also be compulsory to provide written information in the acute situation. Male doctors were more inclined to prefer only to provide verbal information compared with their female counterparts (question 7: 45% v 33%, p < 0.01). Half the male physicians felt that the need to obtain informed consent could be abandoned when the patients were unable to understand information, whereas only a third of their female colleagues felt the same (question 8: 50% v 32%, p < 0.01).
Most of the respondents had not experienced patients reacting negatively to being asked to participate in a trial, at least not to any great extent. Fifteen per cent felt that the patients’ trust in the physicians was affected negatively by the process of obtaining informed consent, whereas 34% actually felt the contrary.
It was apparent from the written comments that the physicians act in different ways when they obtain informed consent. Moreover, the large variation among patients, for example, when it came to their ability to understand information, was emphasised. One common criticism focused on the need to obtain the patients’ signature on paper during the acute phase of the disease. Some stressed that the understanding of the potential research subjects and their willingness to participate in a study are to some extent dependent on how the physician acts.
One major methodological problem, which has to be taken into consideration when analysing the results, is the fact that the questions were generally formulated. The respondent’s answers therefore had to be based on a rough estimation of the average situation when it came to their experience of including a variety of patients in trials of different kinds.
The physicians in this survey felt that that the amount of information that was to be given about the trials was excessive, mainly because most patients suffering from an AMI are not regarded as being capable of reaching more than a limited level of understanding in this situation. Even though physicians are expected to follow the instructions given in the consent form and to apply them generally, there appears to be a great deal of variation among physicians when it comes to the way they actually obtain informed consent. Perhaps the best approach is to assume the patient has been given clear and brief information about some essential aspects of the study and then to ask for verbal consent.3 To minimise the number of patients who find this request unpleasant, physicians should consider not only whether they should ask but also how to behave when doing so.
The complexity of the question of whether or not it should it be possible to include a patient with AMI, whose capacity to understand information is highly limited, is illustrated by the different opinions expressed by the respondents. Some of them emphasised the principle of respecting the patients’ autonomy, whereas others put the medical benefits, which could be achieved by permitting research, first. The latest version of the Declaration of Helsinki states that research on groups with reduced autonomy is permitted “if the physical/mental condition that prevents obtaining informed consent is a necessary characteristic of the research population”. Moreover, if certain conditions are satisfied, it is said that research can be initiated even though informed consent has not been obtained instantly (paragraphs 24–26).5 It can be claimed that patients who are severely impaired by an AMI represent “a necessary characteristic of the research population”. As some respondents pointed out, the benefits of a new treatment might actually be greatest in those patients who are most affected by the disease.
We feel that it is important for the international societies of cardiology to develop more specific instructions for dealing with the need to obtain informed consent when patients are suffering from acute cardiac conditions, which most often and to a varying degree influence their autonomous capacity.
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