A 50-year-old man is brought to the emergency department for evaluation of lethargy. The patient has alcohol on his breath. There were also some sleeping pills in his apartment when his friend found him.
The patient is easily arousable and able to answer questions coherently. Is his consent for admission to the emergency department valid?
Later in his work-up, the physician wishes to perform a lumbar puncture as part of his diagnostic tests. The patient is informed of the potential complications and asked to sign a consent form.
How valid is this informed consent? What alternatives does the physician have?
Commentary
The informed consent of the patient is a general moral and legal requirement for the performance of medical procedures.
That requirement is reasonably set aside under two conditions possibly present in this case — what can be called the emergency and the incompetence exceptions.
When medical care must be given immediately to a patient to prevent serious and not easily reversible harm, or to prevent loss of life, and when there is not time to seek informed consent before such care is given, the care may reasonably be given without informed consent on grounds of emergency.
The moral basis for doing so is the reasonable presumption, in the absence of specific evidence to the contrary regarding the particular patient’s desires, that most persons would want medical care necessary to prevent serious harm or loss of life.
Exceptions to the Informed Consent Rule.
- Emergency — medical care needed immediately to prevent serious and not easily reversible harm.
- Incompetence — patient is unable to give or withhold permission for medical procedure.
This is, of course, only a presumption, and sometimes there is evidence that this patient in fact does not want the care required, in which case the presumption for treatment in an emergency is rebutted.
In this case as presented, no evidence is offered that there is not time to seek consent, so that the emergency exception to the requirement for consent might apply.
Nor is there clear evidence of imminent and serious harm in the absence of immediate treatment, though the references to lethargy and sleeping pills may suggest such a risk. Needless to say, not all care in the emergency department is true emergency care.
It is the second, incompetence exception to the informed consent requirement which is more important to the case.
The patient is described at admission as “easily arousable and able to answer questions coherently.” Later, when consent for a lumbar puncture is sought, the implication is that the patient remains coherent when the complications of that procedure are explained to him.
Thus, presumably at neither time is the patient simply unable to give or withhold permission for admission or for the lumbar puncture.
The question is, rather, whether his giving or withholding of consent is valid and must be honored by his physicians. In the law, and in much moral analysis of these questions as well, that question takes the form of whether the patient is competent to give or refuse consent.
The evidence suggesting possible incompetence is that he has been brought to the emergency department for evaluation of lethargy, though we have no further specification of what this involves, and that he has been using alcohol and, possibly, sleeping pills.
On the other hand, as already noted, the patient is described as “easily arousable and able to answer questions coherently.” The evidence presented regarding competence is extremely limited and appears conflicting and ambiguous.
How can the admitting and attending staff decide whether the patient is competent to give consent?
To answer that, we need to consider briefly the nature and purpose of the competence evaluation. Doing so will also bring out what kinds of additional information would be needed in a case like this to determine competence, since, as presented, it is simply not possible to determine with any confidence whether the patient’s consent should be accepted.
Of course, if this turns out to be a genuine case of borderline competence, even the best analysis and understanding of competence will not, indeed should not, change its borderline character, and however the staff proceeds regarding competence may involve significant uncertainty and doubt.
But at least we can clarify somewhat the nature of the competence determination.
DETERMINING COMPETENCE
Competence is not a global determination. A particular person may be competent to perform a particular task at a particular time.
Here, the question is whether this particular patient in his present condition is able to consent, first, to admission and, later, to the lumbar puncture.
While hospitals commonly obtain blanket consents at admission for whatever treatment may be deemed medically necessary, this does not obviate their moral obligation to obtain specific consent for significant individual procedures such as a lumbar puncture.
Giving valid consent requires that the patient be able to participate in a process of communication in which relevant information is conveyed to him in a manner which he is able to understand.
This information should include at least the following: (a) the nature of the alternatives before him, (b) the possible risks and benefits, with their associated probabilities, of the alternatives of admission or its refusal and of diagnostic evaluation with or without the lumbar puncture, and (c) the physician’s recommendation.
Besides a simple understanding of this information, the patient must be capable of using it himself in a process of reasoning about whether he wants the admission and the diagnostic procedure.
And to do that, he must have some set of values or conception of his good with which to evaluate the alternatives. In a sentence, he must be able to understand his situation and the alternatives he faces, to evaluate the extent to which different alternatives will serve his particular aims and values and to select an alternative as best for him.
The crucial issue for competence is how well must he be able to perform these tasks to be judged competent?
Lethargy, alcohol, and sleeping pills suggest possible serious deficiencies of judgment, while answering questions coherently suggests the contrary. The evidence appears inconsistent.
The issue is: What level of competence should be required for consent for admission and the lumbar puncture? To try to answer that question we must ask what role the competence determination plays in the overall informed consent process.
The answer to that question is, fundamentally, to distinguish those decisions of a person to accept or refuse treatment that must be respected by others as binding from those in which his decision can be set aside and another permitted to decide for him.
His interest in being able ultimately to decide for himself whether to accept or to reject a recommendation for medical treatment is at stake.
What values are served by requiring that a person be competent if his consent or refusal of treatment is to bind others? There are, primarily, I believe, two: the patient’s well-being and his self-determination.
When a patient is significantly incompetent — and so, unable to understand relevant information or reason soundly in the choice of an alternative — the likelihood increases that his choice may be harmful to his own well-being.
We each reasonably want some competence requirement on those of our medical care choices that must be respected by others in order to protect ourselves from the potentially harmful consequences of our choices if we are incompetent.
The other principal value is our interest in our own self-determination, in our making important decisions about our lives for ourselves and having those decisions respected by others.
When a patient is expressing a preference for an alternative for which there is clear and convincing evidence that the alternative is in conflict with his own most deeply held values, the value of that exercise of self-determination is diminished.
But often when a choice may appear to others to be contrary to the chooser’s own best interests, there may be no such evidence.
And then a balancing is required between the conflicting values of protecting the patient’s well-being and respecting his self-determination. It is in setting and employing the standard of competence that balancing is done.
Where, then, should that balance be set? Plainly, it is not enough that the patient merely be able to express some preference for or against admission or the lumbar puncture.
That would provide him with no protection at all against the harmful consequences of his own bad choices; that would let every choice be a competent choice, and so be no standard of competent choice.
At the other extreme, we might adopt some objective criteria of “rational” choices or “correct” choices — for example, whatever the physician recommends or whatever most reasonable persons would choose.
But such a standard would permit us to set aside persons’ choices as incompetent merely because of the content of what they decided and the fact that their decision was “irrational” or “incorrect” in the specified sense.
It would give insufficient weight to persons’ self-determination, their right to pursue their own aims and ends, or conception of the good, even when that conception is not shared by most others.
IMPORTANCE OF PATIENT’S REASONING PROCESS IN DETERMINATION OF COMPETENCE
I would suggest that, at least in principle, the appropriate standard of competence, and the competence examination itself, should look to the nature of the actual reasoning process of the patient.
Has the patient been given and understood the information relevant to his decision, and is his reasoning about the alternatives free from serious mistakes?
The point is to examine his reasoning process about this decision so as to try to determine whether he has reasoned soundly that the alternative chosen will promote his overall aims and values.
(This means that questions concerning such matters as his orientation to time and place may be initial crude indicators of competence, but the evidence ultimately should concern the patient’s understanding and reasoning in the treatment decision at hand.)
The point is not to substitute or impose our own different values or conception of what would be best for him in place of his values. In this way we can seek to respect his values, and so his self-determination, while at the same time protecting him against the consequences of choices seriously in conflict with his own view of his good.
Often, of course, such balancing attempts must be made in the face of great uncertainty. Often, in emergency situations, there is not time for the careful examination required.
Often we are unable to determine just how well important information has been understood, what the patient’s relevant values are, and what reasoning underlies the patient’s giving or refusal of consent.
But we can at least say that the more serious the consequences of the patient’s choice, and in particular the more serious the likely harm to the patient on the patient’s own view of his well-being, the higher the level of competence that should be required of his choice.
The more serious the risks of harm, the more and better evidence we should want that the patient’s choice really does correctly reflect his own settled values. Stated simply, the more at stake, the more careful we should be about competence.
It is worth noting that persons may sometimes reasonably exercise their right to decide (or to self-determination) by asking another to decide for them. This often happens when patients put substantial trust in their physician deciding in their (the patient’s) best interest.
“You do whatever you think is best, Doc,” should not be taken as necessarily inconsistent with the patient’s self-determination or as evidence of incompetence or an unacceptable consent.
But it must be a genuinely freely given transfer of the right to decide by the patient. And for policy reasons, legal requirements may limit, for significant procedures, a patient’s freedom to choose not to be informed and to have others decide for him.
IMPLICATIONS FOR THIS CASE
What are some implications of this view of competence and valid consent for this case? One implication may be surprising to many. It may not be true that if one is competent to consent to a treatment, one must always be competent also to refuse it.
The reason is that the effects for the patient’s well-being, which are to be balanced against respecting his self-determination in the competence judgment, may be very different if consent is given or refused.
In this case, for example, suppose the patient is able to answer some questions coherently, but not others, and it is unclear in questioning him just how much of his situation he understands.
And also suppose that his apparent state suggests some possibility of a condition that might be life-threatening or result in serious irreversible harm to him. Further diagnostic tests are required.
In such circumstances, the potential harmful effects for the patient are far more grave if his refusal of treatment were honored than if his consent is accepted.
Others might reasonably decide that his apparent marginal and uncertain competence to make this admission decision was sufficient to accept his consent to enter the emergency facility for treatment but was not sufficient to accept his refusal of admission or of the lumbar puncture.
On the other hand, suppose the case were different from that presented only in that the lumbar puncture provided a very small marginal diagnostic advantage, and not doing it added no significant additional risk to the patient.
With no change in the evidence about the patient’s competence to refuse the lumbar puncture, the physician might now reasonably decide that the reduced risk to the patient’s well-being warranted respecting his self-determination and honoring his refusal.
It should be emphasized that before any finding of incompetence and setting into motion of procedures for surrogate decision making, the first step of the physician should be, where possible, to try to reduce or remove the factors diminishing the patient’s competence.
In this case, for example, it may be possible to take steps to counter the possible effects of alcohol or sleeping pills on the patient’s judgment; if the situation is deemed not to require emergency measures, merely waiting until the effects “wear off” may be adequate.
In general, it is an obligation of physicians to help patients to be competent decision makers about their treatment and not to be too quick to find the patient incompetent.
DECISION MAKING FOR INCOMPETENT PATIENTS
If the physician’s concerns about the patient’s competence to consent to or to refuse admission or the lumbar puncture remain serious, and steps to alleviate that concern are unavailing, he must employ alternative decision-making procedures.
Exactly what procedures are legally required will vary from state to state, but it is a responsibility of health care institutions to have clear written policies concerning procedures to be followed by staff in cases of patient incompetence.
Again, if it is assumed that emergency care is not required, these procedures should generally make provision for a surrogate decision maker to decide for the incompetent patient.
Hospital policies should specify, among other things, under what circumstances health care personnel must seek formal appointment of a surrogate decision maker by the courts.
In many circumstances it will be possible to turn to a family member, or even a close friend, as may be the alternative in this case, as a substitute decision maker for the patient.
In the absence of specific evidence to the contrary about a particular case, a family member can reasonably be presumed to be concerned for the interests of the patient and to know best how the patient would have decided if he or she were competent.
When turning to another as a surrogate decision maker, the physician must seek to insure that the surrogate attempts to decide as the patient would have decided, if he was competent.
This so-called “substituted judgment” rule is designed to seek to have the decision best reflect the patient’s values, given the patient’s inability to do so by deciding himself, and to avoid surrogates substituting their own sometimes quite different preferences for those of the patient.
MEDICAL CARE AS SHARED DECISION MAKING
Health care decision making should, in general, be a joint undertaking between health care personnel and patients to which each party brings the special knowledge and perspective that the other commonly lacks — the physician his medical expertise, and the patient his personal aims and values.
Both are essential for decisions which best serve patients.
Unless the patient is unable to participate in decision making at all, which is not true of this case, the determination of whether the patient is competent to give a valid consent should take place as an integral and inextricable part of that process of shared treatment decision making.
I have not tried to say whether the patient’s consent (or possible refusal) for admission and for a lumbar puncture in this case is valid and should be accepted.
Considerably more detailed information is needed to decide that. I have tried to suggest what kind of information the competence inquiry requires, as well as the nature and role of the competence determination in the overall process of securing the patient’s consent for treatment.
