Informed Consent: Theory Versus Practice
Informed Consent: Theory Versus Practice
Informed consent has been defined as "an individual's autonomous authorization of a medical intervention or of participation in research". In professional and legal regulations it is widely established that informed consent is a necessary element of good clinical practice. Beyond providing information to patients and potential research participants, it is important that the physician or investigator assesses the patients' competence and understanding, promotes their comprehension and facilitates their participation in the decision-making process. In fact, providing information ensures patients have sufficient understanding so they have a real chance of making a choice in their best interests. This viewpoint examines how consent procedures should be adapted to match a patient's capacity to understand, their preferences in terms of information and their degree of involvement in the decision. In order to provide a nuanced description and analysis of the concept of informed consent, it should be discussed in the light of how things are in the real world.
Defining the key pieces of information that should be presented to patients could help to improve the practice of informed consent. It is difficult, however, to set strict guidelines or refer to a particular standard that constitutes adequate disclosure of information across different clinical contexts. The subjective standard acknowledges that the information given should be tailored to match the specific informational needs of the patient, taking into account factors such as their health beliefs and cultural background. This might be the best ethical standard of disclosure, but referring exclusively to this standard is not sufficient. For example, many patients do not know what information might be relevant to their decision.1 Physicians have a responsibility, therefore, to provide information that is regarded as essential from a professional perspective and insure that patients do not base their decisions on false beliefs. It should also be noted that although patients might feel they have been satisfactorily informed, this is not a guarantee that they know the fundamental facts related to the study or treatment option. A real picture of patients' understanding can be obtained by asking them about information previously given and about their beliefs and concerns.
The translation of what medical risks mean from a population level to an individual level and communicating the magnitude of these risks to patients, together with the uncertainties associated with complex medical decisions based on estimations, is a difficult task. The probability of an adverse outcome can be explained by referring to known nonmedical risks in everyday life, a qualitative term (e.g. high, moderate, low), a numerical expression or a combination of these. Even though the risks are communicated effectively, however, a physician's judgement of risk is prone to subjectivity, as is the patient's interpretation of his or her individual risk in relation to that of others.
Informed consent does not mean that the responsibility for the final decision is handed over to the patient. In clinical practice, physicians are requested to guide patients to a decision and to make recommendations. Furthermore, patients do not always ask for details to make their decision. This is particularly true when it comes to decisions associated with life or death, or when only one medically reasonable alternative exists. For example, potential recipients of an implantable cardioverter-defibrillator generally find it easy to consent to treatment, based on the information that the device is the best treatment available for preventing death caused by cardiac arrhythmias.
Studies have shown that physicians are not always good at guessing their patients' preferences. Consequently, physicians should never assume what their patients want. Nevertheless, asking every patient in advance about his or her attitude towards a life-extending therapy (such as cardiopulmonary resuscitation) to fulfill an ethical obligation, is not realistic. Most patients have a great desire to live and expect physicians to do their best to save or prolong lives. Instead of this general approach, physicians should concentrate on older patients who indicate that they have a poor quality of life or no desire to live, and patients who are severely ill. I feel it is justified to assume, without asking, that patients who do not belong to these categories would choose cardiopulmonary resuscitation.
If not adapted to match patients' capacity to comprehend information, the consent process can be regarded as a meaningless ritual designed to ensure that physicians or investigators avoid claims of negligence. For example, patients in the early phase of acute myocardial infarction often suffer from severe physical and psychologic distress. Despite this, investigators are expected to give patients detailed verbal and written information before including them in a trial. Not surprisingly, a considerable number of participants in these clinical trials lack or have an incomplete understanding of the research protocols and do not read the patient information sheet before they sign the consent form. If we argue that informed consent implies that individuals understand the aims, methods, anticipated benefits and potential risks of the study, and the discomfort it might entail,9 many patients could have been included in trials on morally and legally dubious grounds.
It is a delicate matter to decide whether a patient has more than the minimum acceptable level of understanding, in order to claim that informed consent has been obtained. In my opinion, the threshold is that individuals should feel they are able to make a free decision about study participation. For patients to make choices that are as autonomous as possible, given the circumstances, in an emergency such as acute myocardial infarction, they should be given information that focuses on a few essential aspects of the study, including their right to decline participation. When patients have more severe symptoms, the following choices are faced: either no research is conducted on these kinds of patients; only a low level of understanding is considered sufficient for moral or legal consent in this situation; or patients are included in research without their immediate consent.
Potential research participants who are asked to give their consent might feel astonished at having to sign a paper that they have not read. In addition they might feel dismay at becoming involuntarily responsible for their choice of treatment and feel like the subject of an experiment, in a situation without any real choices. It is important, therefore, that physicians also consider how they act when they give information to a potential research participant.
In general, patients' preferences should determine the kind of information that is given to them—a full summary of my viewpoint on informed consent is provided online in Supplementary Box 1. In one study, approximately half of the patients stated that they did not want to receive any information about the overall risks or risk of death and stroke before undergoing elective cardiac surgery. Correspondingly, not all patients want to be fully informed about their prognosis. So, how can we deal with the fact that some patients do not want to receive information about risks and estimated life expectancy, when this knowledge could influence their decision to undergo the intervention? Physicians sometimes need to strike a delicate balance between providing their patients with the opportunity to give substantially informed consent or refusal and not providing unwanted information, without being dishonest. In order to practice the art of medicine, it is not only important to consider patients' rights, it is also the physicians' duty to avoid harm to the patient.
CLICK HERE for subscription information about this journal.
Informed consent has been defined as "an individual's autonomous authorization of a medical intervention or of participation in research". In professional and legal regulations it is widely established that informed consent is a necessary element of good clinical practice. Beyond providing information to patients and potential research participants, it is important that the physician or investigator assesses the patients' competence and understanding, promotes their comprehension and facilitates their participation in the decision-making process. In fact, providing information ensures patients have sufficient understanding so they have a real chance of making a choice in their best interests. This viewpoint examines how consent procedures should be adapted to match a patient's capacity to understand, their preferences in terms of information and their degree of involvement in the decision. In order to provide a nuanced description and analysis of the concept of informed consent, it should be discussed in the light of how things are in the real world.
Defining the key pieces of information that should be presented to patients could help to improve the practice of informed consent. It is difficult, however, to set strict guidelines or refer to a particular standard that constitutes adequate disclosure of information across different clinical contexts. The subjective standard acknowledges that the information given should be tailored to match the specific informational needs of the patient, taking into account factors such as their health beliefs and cultural background. This might be the best ethical standard of disclosure, but referring exclusively to this standard is not sufficient. For example, many patients do not know what information might be relevant to their decision.1 Physicians have a responsibility, therefore, to provide information that is regarded as essential from a professional perspective and insure that patients do not base their decisions on false beliefs. It should also be noted that although patients might feel they have been satisfactorily informed, this is not a guarantee that they know the fundamental facts related to the study or treatment option. A real picture of patients' understanding can be obtained by asking them about information previously given and about their beliefs and concerns.
The translation of what medical risks mean from a population level to an individual level and communicating the magnitude of these risks to patients, together with the uncertainties associated with complex medical decisions based on estimations, is a difficult task. The probability of an adverse outcome can be explained by referring to known nonmedical risks in everyday life, a qualitative term (e.g. high, moderate, low), a numerical expression or a combination of these. Even though the risks are communicated effectively, however, a physician's judgement of risk is prone to subjectivity, as is the patient's interpretation of his or her individual risk in relation to that of others.
Informed consent does not mean that the responsibility for the final decision is handed over to the patient. In clinical practice, physicians are requested to guide patients to a decision and to make recommendations. Furthermore, patients do not always ask for details to make their decision. This is particularly true when it comes to decisions associated with life or death, or when only one medically reasonable alternative exists. For example, potential recipients of an implantable cardioverter-defibrillator generally find it easy to consent to treatment, based on the information that the device is the best treatment available for preventing death caused by cardiac arrhythmias.
Studies have shown that physicians are not always good at guessing their patients' preferences. Consequently, physicians should never assume what their patients want. Nevertheless, asking every patient in advance about his or her attitude towards a life-extending therapy (such as cardiopulmonary resuscitation) to fulfill an ethical obligation, is not realistic. Most patients have a great desire to live and expect physicians to do their best to save or prolong lives. Instead of this general approach, physicians should concentrate on older patients who indicate that they have a poor quality of life or no desire to live, and patients who are severely ill. I feel it is justified to assume, without asking, that patients who do not belong to these categories would choose cardiopulmonary resuscitation.
If not adapted to match patients' capacity to comprehend information, the consent process can be regarded as a meaningless ritual designed to ensure that physicians or investigators avoid claims of negligence. For example, patients in the early phase of acute myocardial infarction often suffer from severe physical and psychologic distress. Despite this, investigators are expected to give patients detailed verbal and written information before including them in a trial. Not surprisingly, a considerable number of participants in these clinical trials lack or have an incomplete understanding of the research protocols and do not read the patient information sheet before they sign the consent form. If we argue that informed consent implies that individuals understand the aims, methods, anticipated benefits and potential risks of the study, and the discomfort it might entail,9 many patients could have been included in trials on morally and legally dubious grounds.
It is a delicate matter to decide whether a patient has more than the minimum acceptable level of understanding, in order to claim that informed consent has been obtained. In my opinion, the threshold is that individuals should feel they are able to make a free decision about study participation. For patients to make choices that are as autonomous as possible, given the circumstances, in an emergency such as acute myocardial infarction, they should be given information that focuses on a few essential aspects of the study, including their right to decline participation. When patients have more severe symptoms, the following choices are faced: either no research is conducted on these kinds of patients; only a low level of understanding is considered sufficient for moral or legal consent in this situation; or patients are included in research without their immediate consent.
Potential research participants who are asked to give their consent might feel astonished at having to sign a paper that they have not read. In addition they might feel dismay at becoming involuntarily responsible for their choice of treatment and feel like the subject of an experiment, in a situation without any real choices. It is important, therefore, that physicians also consider how they act when they give information to a potential research participant.
In general, patients' preferences should determine the kind of information that is given to them—a full summary of my viewpoint on informed consent is provided online in Supplementary Box 1. In one study, approximately half of the patients stated that they did not want to receive any information about the overall risks or risk of death and stroke before undergoing elective cardiac surgery. Correspondingly, not all patients want to be fully informed about their prognosis. So, how can we deal with the fact that some patients do not want to receive information about risks and estimated life expectancy, when this knowledge could influence their decision to undergo the intervention? Physicians sometimes need to strike a delicate balance between providing their patients with the opportunity to give substantially informed consent or refusal and not providing unwanted information, without being dishonest. In order to practice the art of medicine, it is not only important to consider patients' rights, it is also the physicians' duty to avoid harm to the patient.
CLICK HERE for subscription information about this journal.
Source...