Published in: Neuromodulation: Technology at the Neural Interface, XI, 2008, 3, 156-162.
Informed consent and decision-making capacity in neuromodulation: ethical
considerations (abstract)
Decision-making capacity is an ideal and in the practice of neuromodulation may be compromised as a result of different circumstances. These may be internal or external. Internal are factors related to illness (i.e. cognitive and emotional defects; feelings of desperation and hopelesness); external are factors related to the context (i.e. shortcomings in patient education and communication).
In this paper it is argued that full decision-making capacity in the context of neuromodulation is an illusion. This does not imply that we should do away with the moral ideals of decision-making capacity and valid informed consent. It is part of the responsibility of clinicians involved in neuromodulation to be aware of and sensitive to the different threats to the decision-making capacity of patients suffering from neurological and neuropsychiatric disorders, and to assist patients in making decisions that are as well considered as possible in the given circumstances.
Keywords: neuromodulation, informed consent, decision-making capacity, ethics, research
considerations
Ron L.P. Berghmans, PhD
Importance of informed consent in treatment and research
In neuromodulation treatment and research, the informed consent of the patient or research subject or his or her representative is a moral precondition. In order to be morally valid, the consent of the person should be informed, voluntarily given and the person should have decision-making capacity (1,2). Ideally, informed consent describes an interactive process in which an individual voluntarily agrees to undergo treatment or to join a study after the purpose, risks, benefits and alternatives have been thoroughly described and understood (3). In what follows the focus is on the context of neuromodulation research involving patients, although many of the observations also will have relevance for clinical practice. The views expressed are partly based on a general ethical consensus, and where such consensus is lacking, they are based on the views of the author (particularly in the last paragraph: conclusions and points to consider).
The importance of informed consent in research is underscored in different international legal and ethical documents such as the Nuremberg Code, the Declaration of Helsinki, and the International Covenant on Civil and Political Rights (4). It is also reflected in the Dutch Medical-Scientific Research with Human Subjects Act, which states that the goal of informed consent is to enable candidate research subjects “to make a well-considered decision about research participation“(5). And in 2002, the OCD-DBS Collaborative Group articulated ethical norms applying to work in the area of DBS in patients suffering from obsessive compulsive disorders and other psychiatric conditions, also stressing the importance of informed consent (6, 7).
Informed consent as a moral ideal
Showing respect for patients and research subjects as persons implies that in the context of care and research they should not be used instrumentally. And as it is important to promote informed and well-considered decision-making, so it is important to pay serious attention to the issue of decision-making capacity.1
What is decision-making capacity and why is it important?
Decision-making capacity matters morally as well as legally. In most jurisdictions regulating medical research with human beings, the permissibility of research with patients who suffer from neuropsychiatric illnesses depends upon the decision-making capacity of the patients. If they have decision-making capacity, then research with them is allowable under the same conditions as research with other groups of subjects. If the patients lack decision-making capacity, only limited forms of research can legitimately take place, particularly if no direct benefits to the research subjects are involved. This raises the issue of how decision-making capacity should be conceptualised and how it should be assessed in practice (12). Given the legacy of psychosurgery and electroconvulsive treatment (56, 57), and the societal context in which research on neuromodulation takes place, paying serious attention to the issue of (promoting) decision-making capacity is of central importance.
Issues of consensus and dissensus regarding decision-making capacity
1. Firstly, it is agreed that in general there ought to be a legal presumption in favour of decision-making capacity. Unless there are reasons for the opposite, patients ought to be considered to have decision-making capacity. This presumption applies equally to all groups of patients, i.e. those suffering from somatic illnesses, as well as those who suffer from mental illnesses, neuropsychiatric disorders or are mentally handicapped. This presumption may be viewed as expressing a priori respect for the autonomy and dignity rights of persons (14). This means that the burden of proof lies with the health care worker who takes the view that a patient lacks decision making capacity (15). This legal presumption, however, may become problematic in cases when medical or other interventions are not primarily in the best interest of the patient, as in research participation (16). The presumption of decision-making capacity in those cases may then permit patients with impaired decision making capacity to give consent to and to participate in risky and/or burdensome biomedical research protocols without being appreciative of what are the interests which are at stake. This can be particularly problematic in case of biomedical research which involves more or less serious risks and burdens to the subject, and no or little promise of compensatory benefit.
2. Secondly, it is agreed that decision-making capacity is task specific and decision relative (17, 18). Decision making capacity is not directly connected to specific disorders or diagnoses. Neither implies a judgment about decision-making capacity a general qualification of the person involved. Capacity is always related to a specific treatment or research decision. This means that patient A. may lack capacity to decide about decision X, but at the same time may be competent to decide about decision Y (18).
The decision-relative approach to decision-making capacity implies that more is asked of a patient when a complex decision is involved, than in case of a less complex, more straightforward decision. In terms of understanding complex decisions are more demanding.
There is controversy whether decision-making capacity above that ought to be considered in a risk-relative sense (18, 19). Risk-relativity would imply that a more demanding standard is applied in case the decision of the patient involves greater risks (20, 21, 54). This approach is based on the conviction that our concern for the patient’s welfare requires that a higher level of decision making capacity should be demanded for decisions pertaining to life and death, than for decisions which may result in lesser harms (22, 23). This approach to the assessment of decision-making capacity has been labeled the ‘sliding scale approach' (54).
Against this approach two major objections are raised (24, 25, 26). The strongest objection is that it supports an asymmetric view of decision-making capacity: an individual may at the same time be competent to consent to treatment but lack capacity to refuse it. It might for example imply that a locked-in patient with a brainstem stroke, who is only able to signal simple “yes” and “no” answers, is considered to have decision-making capacity in case of a “yes” answer to a proposal of life-saving treatment, and to lack decision-making capacity in case of a “no” answer to the same proposal.
Many consider this implication counterintuitive, because it rejects the apparently intuitive ‘principle of symmetrical capacity’ (20). Proponents of a fixed standard who reject a risk-related approach pose the question: ‘what level of capacity is necessary for an individual to make a certain decision?’ Proponents of a risk-related standard pose another question: ‘what level of capacity is necessary for an individual to grant that individual decisional authority with regard to a specific choice?’ The first approach focuses on decisional capability, the second on decisional authority. The latter perspective does not exclusively focus on individual capabilities, but incorporates risk as a relevant factor in deciding what level of decision-making capabilities is required (27).
The second objection is that the risk-related approach conflates two issues: on the one hand, the question whether or not an individual has capacity, and on the other hand, whether or not his or her choices should be respected or might be overruled on paternalistic grounds (19, 21). Those who argue against the risk-related approach defend that a two-step model ought to be followed: first, the assessment of decision-making capacity, and second the question of whether to overrule the decision of the individual. Upon this view, decision-making capacity and decisional authority are separate issues. And as already said, proponents of a risk-related approach see capacity and authority in a connected sense.
3. Thirdly, consensus exists with regard to the quality of the decision making process – and not the outcome of this process - which ought to be decisive for a judgment about decision-making capacity. It is generally recognised that the outcome of the decision making of the patient cannot be the basis for a judgment about decision-making capacity. Even if this outcome is considered unwise, irresponsible or irrational by healthcare workers or others, it depends on the decision making process as well as the values involved whether the decision should be considered to be a sign of decision-making capacity.
4. Fourthly, agreement exists that decision-making capacity involves a normative judgment (18, 23, 28, 29). Whether or not a person is judged to have or to lack decision-making capacity is not decided by scientific data. Given the fact that a judgment about decision-making capacity has implications for the rights of the patient, and given the fact that such a judgment involves an answer to the question whether or not the decision-making of the patient is ‘good enough’ to deserve respect of the health care worker or researcher, values inherently are involved in such a judgment. Obviously, this is not to deny that descriptive aspects also are involved.
5. Lastly, it is agreed that although decision-making capacity can be seen as a continuous concept which is task-specific and decision-relative, in the practice of research and therapy it may involve a binary decision. From a legal point of view, as for instance in case of research with vulnerable groups of subjects, it may be necessary to qualify a patient either as someone who has or who lacks decision-making capacity. To grant or deny a person decisional authority then requires an ‘either-or’ decision.
Standards and criteria for competent decision-making
1. According to one approach, decision-making capacity involves the capacity to make any decision. If the patient is able to express a choice, he/she has decision-making capacity, regardless of the content of the decision. Here, the underlying conception of the moral principle of respect for autonomy is one of respect for spontaneous behaviour and preferences. In this approach, no attention is paid to the extent to which the behaviour and preferences reflect comprehension of the situation in which the subject finds him- or herself. As a result, this approach is generally considered too liberal and insufficiently protective (4).
This implies that at least some measure of understanding, reasoning, and appreciation of the situation at hand, seems to be relevant in the context of assessing decision-making capacity in medical research in general and in neuromodulation research in particular.
Factors which may constrain well-considered decision making
Internal psychological defects and problems
Internal psychological defects and problems which may negatively affect decision-making a.o. are: cognitive impairments, memory problems, illness denial, depression, delusions and hallucinations, feelings of desperation and hopelessness, and fear and anxiety. It is important to notice that each of these factors may reduce decision-making capacity, but that no single factor necessarily makes a patient incompetent.
Therapeutic misconception
An important source of confusion for patients who are subjects in research is the so-called therapeutic misconception (32, 33). The therapeutic misconception occurs whenever a research subject fails to appreciate the distinction between the imperatives and goals of clinical research and those of ordinary treatment, and, therefore, inaccurately attributes therapeutic intent to research procedures (34). Clinical research is misinterpreted as aimed at delivering care. This leads potential research subjects to believe that there will be some personal health benefit involved as a result of participating in research, and to an underestimation of or disregard for the potential risks and disadvantages associated with the research procedures (32).
The therapeutic misconception may comprise well-considered decision making and reduce decision-making capacity, particularly in severely ill patients and their relatives who are desperate or who evaluate their situation as hopeless. At present, neuromodulation and deep brain stimulation are generally considered as either an experimental intervention or regular treatment in refractory illness, depending on the indication, such as Parkinson’s disease (regular treatment) or other neurological and (neuro)psychiatric disorders such as obsessive-compulsive disorders and depression (experimental intervention). This means that patients and their relatives in many cases will consider deep brain stimulation as an intervention of last resort. Patients and their relatives may feel desperate and hopeless. This may reduce/restrain well-considered decision making and give fuel to the therapeutic misconception.
The therapeutic misconception not only occurs in patients with psychiatric or neurological disorders (34). It has also been described in trials of anticancer agents, particularly with regard to non-therapeutic phase-I studies involving patients whose treatment options have been exhausted (35, 36) and in pediatric research (37). Issues related to the therapeutic misconception can also arise in clinical neuromodulation practice, in the sense that patients attribute larger than actually reasonable benefits to a particular treatment (4).
Enhancing decision-making capacity
Different strategies to enhance subjects’ decision-making capacity and to improve the consent process in research have been or are being explored (38; 39, 40, 41). Much attention has been paid to methods to improve understanding.
In a recent review article, it is concluded that:
- multimedia interventions do not improve understanding in research candidates;
- improvement of patient information forms is of limited value, although some evidence suggests that brevity and the elimination of irrelevant information helps research participants understand;
- using a standard consent process and adding an extra meeting with a qualified person appears to be effective, and
- it might be ideal to use a nurse or outside educator to reduce the risk that a physician with a vested interest in the study might unduly influence the research participant’s decision (39).
There are no indications that participants will be dissatisfied with interventions to improve understanding or that interventions will diminish accrual. Above that, it has been reported that a training intervention aimed at communicative skills of researchers led to positive results (42, 43).
Another promising approach to promote correct understanding and well-considered decision making in research subjects is so-called cognitive interviewing (44). Cognitive interviewing is predicated on the notion that understanding of information fails because of problems at some point in the cognitive processing chain. Cognitive interviewing is a tool that investigates problems in this processing chain and identifies their source with respect to the evaluated materials (44).
It may be concluded that patients’ understanding of disclosed material can be improved with appropriate modifications in the way the information is provided, and thus decision-making capacity should not necessarily be viewed as unmodifiable, even when patients initially seem to lack adequate decision making capacity (45).
Above that, it is important for researchers to be aware that informed consent is a process, and not a single event.
Conclusion and points to consider
1. Ensuring fully valid informed consent in medical research in general, and in neuromodulation research in particular, may be an unattainable goal. As a moral ideal, however, well-considered decision making underscores the importance of respect for persons as the guiding moral principle in medical research in general, and neuromodulation research in particular.
So, ideally, being a subject in neuromodulation research should take place on the basis of a well-considered decision of the patient involved (6, 46). This implies that factors which may hinder well-considered decision making should be identified and addressed by the research team. Here an important moral obligation lies with researchers. They should be sensitive to possible shortcomings in the decision making process of patients and do their best to promote well-considered decision-making and to enhance decision-making capacity.
2. Although there is a general presumption of decision-making capacity, in the context of neuromodulation research it is important not to assume too easily that subjects from vulnerable patient groups have the capacity to consent to research participation. This is particularly the case when research involves no or only remote benefits for the subject, or when the risk-benefit ratio of the research protocol is unfavourable. Only in some strictly legally defined cases research with patients who are evaluated as lacking decision-making capacity can be justified. Then surrogate consent by a legal representative is a precondition. Here it should be stressed that an unavoidable tension exists between the protection of vulnerable groups in research (which may lead to constraints on research participation) and access of these groups in research (which may lead to new and/or better therapies).
3. Regarding the assessment of decision-making capacity in the different contexts of care and research, the application of different standards is justified (47). This implies that generally a more strict standard should be applied in case of research than in case of treatment and care, and within the context of research a more stringent standard as the risk-benefit ratio becomes less favourable for the research subject.
4. Researchers should be sensitive to the therapeutic misconception. Potential research subjects should be made aware of the fact that a clinical researcher is not exclusively dedicated to the patient’s best interests (47, 48). As already mentioned, it might be ideal to use a nurse or outside educator in the informed consent procedure to reduce the risk that a physician with a vested interest in the study might unduly influence the research participant’s decision. This may also be helpful to prevent that patients perceive the role of the researcher primarily in a clinical and therapeutic perspective.
By optimizing the informed consent process and by promoting decision-making capacity of research subjects, we will allow for autonomy of choice for the largest number of people possible, and also permit research and treatment to expand into populations that need them most (41).
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Notes
1. Here, decision-making capacity is discussed in the context of the informed consent process in research. In
neuromodulation, mental capacity may also be at stake in another way, i.e. in the sense that as a result of
neurostimulation mental capacity may be influenced in a negative way (31, 49).
2. Different psychosocial side effects of and behavioural changes and complications accompanying DBS
have been documented (50, 51, 55). Above that, there is a significant incidence of adverse events associated
with the DBS procedure (52, 53).
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