Informed Consent and Psychiatric Patients

To the Editor: Both the editorial by Dr. Appelbaum and the article on informed consent procedure by Dr. Wirshing and colleagues raise serious concerns. The approach presented in these two articles is technical and nominalistic. It appears to be based on an assumption that understanding the information in a consent form is equivalent to the ability to give consent.

Dr. Wirshing and colleagues applied a rigorous procedure to maximize patients’ potential for understanding and to assess their ability to understand. In their Method section, the authors wrote about understanding, comprehension, knowledge, and the ability to grasp. They kept administering the Informed Consent Survey “until the patient answered all items of the survey correctly, at which point the informed consent form was signed” (italics added) (p. 1509). Evidently, the procedure was not about assessment of comprehension only. It was about securing the consent. Despite their acknowledgment of “a phase for decision making” (p. 1508), the authors reduced the consent process to a phase in which information is transmitted.

However, is being able to learn the “correct” answers to a series of questions by heart the same as being capable of giving informed consent to having one’s treatment possibly postponed or significantly altered?

Dr. Appelbaum writes that “even substantially impaired understanding does not mean that a person with schizophrenia cannot comprehend information about a research project” (p. 1487). Well, is the ability to comprehend information about a research project the same as the ability to appreciate the consequences of a decision to partake in this research or to refuse participation in it? Is it mainly the impairment of understanding that affects informed decision making in patients with schizophrenia?

Many of these patients, frequently those with unaffected intelligence, understand the information provided or, at least, are able to comprehend and memorize it after repetitive teaching. But what about their ability to appreciate the meaning of their choice, the value of the consequences of a decision that may be based on peculiarities of their delusional thinking and hallucinatory perceptions?

Such an impairment does not necessarily interfere with the ability to understand the information, as Dr. Wirshing and colleagues found, not surprisingly, and presented in table 2 of their article. But the very decision (to consent or not) can still be based on reasoning stemming from psychopathology, reasoning so alien to and distant from those mental processes that allow for appreciation of the real consequences of such a decision.

The ability to understand the information is only one of the capacities necessary to give informed consent—a necessary one, but not sufficient.