J. Bester, C.M. Cole, & E. Kodish.
AMA J Ethics. 2016;18(9):869-886.
doi: 10.1001/journalofethics.2016.18.9.peer2-1609.
Abstract
In this paper, we examine the limits of informed consent with particular focus on ways in which various factors can overwhelm decision-making capacity. We introduce overwhelm as a phenomenon commonly experienced by patients in clinical settings and distinguish between emotional overwhelm and informational overload. We argue that in these situations, a clinician’s primary duty is prevention of harm and suggest ways in which clinicians can discharge this obligation. To illustrate our argument, we consider the clinical application of genetic sequencing testing, which involves scientific and technical information that can compromise the understanding and decisional capacity of most patients. Finally, we consider and rebut objections that this could lead to paternalism.
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Overwhelm and Information Overload
The claim we defend is a simple one: there are medical situations in which the information involved in making a decision is of such a nature that the decision-making capacity of a patient is overwhelmed by the sheer complexity or volume of information at hand. In such cases a patient cannot attain the understanding necessary for informed decision making, and informed consent is therefore not possible. We will support our thesis regarding informational overload by focusing specifically on the area of clinical whole genome sequencing—i.e., identification of an individual’s entire genome, enabling the identification and interaction of multiple genetic variants—as distinct from genetic testing, which tests for specific genetic variants.
We will first present ethical considerations regarding informed consent. Next, we will present three sets of factors that can burden the capacity of a patient to provide informed consent for a specific decision—patient, communication, and information factors—and argue that these factors may in some circumstances make it impossible for a patient to provide informed consent. We will then discuss emotional overwhelm and informational overload and consider how being overwhelmed affects informed consent. Our interest in this essay is mainly in informational overload; we will therefore consider whole genome sequencing as an example in which informational factors overwhelm a patient’s decision-making capacity. Finally, we will offer suggestions as to how the duty to protect patients from harm can be discharged when informed consent is not possible because of emotional overwhelm or informational overload.
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How should clinicians respond to such situations?
Surrogate decision making. One possible solution to the problem of informed consent when decisional capacity is compromised is to seek a surrogate decision maker. However, in situations of informational overload, this may not solve the problem. If the information has inherent qualities that would overwhelm a reasonable patient, it is likely to also overwhelm a surrogate. Unless the surrogate decision maker is a content expert who also understands the values of the patient, a surrogate decision maker will not solve the problem of informed consent. Surrogate decision making may, however, be useful for the emotionally overwhelmed patient who remains unable to provide informed consent despite additional support.
Shared decision making. Another possible solution is to make use of shared decision making (SDM). This approach relies on deliberation between clinician and patient regarding available health care choices, taking the best evidence into account. The clinician actively involves the patient and elicits patient values. The goal of SDM is often stated as helping patients arrive at informed decisions that respect what matters most to them.
It is not clear, however, that SDM will be successful in facilitating informed decisions when an informed consent process has failed. SDM as a tool for informed decision making is at its core dependent on the patient understanding the options presented and being able to describe the preferred option. Understanding and deliberating about what is at stake for each option is a key component of this use of SDM. Therefore, if the medical information is so complex that it overloads the patient’s decision-making capacity, SDM is unlikely to achieve informed decision making. But if a patient is emotionally overwhelmed by the illness experience and all that accompanies it, a process of SDM and support for the patient may eventually facilitate informed decision making.
