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Obtaining Informed Consent for Research: A Model for Use with Participants Who Are Mentally Ill

Published online by Cambridge University Press:  01 January 2021

Norman G. Poythress
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An issue of ongoing concern to clinical investigators, medical ethicists, and institutional review board (IRB) members is the problem of obtaining informed consent in research that involves people with mental illness as research participants. Although the presence of a mental disorder per se does not render a person incapable of giving informed consent, some individuals afflicted with significant cognitive impairment, formal thought disorder, substantial anxiety or depression, or a variety of other symptoms may be impaired in their capacity to comprehend consent disclosures and therefore to exercise consent to research participation in a competent manner.

The stakes surrounding this informed consent issue are significant. On the one hand, the inclusion in research of participants who are not capable of giving informed consent may result in their exposure to unwarranted risks and significant harm. These concerns may be exacerbated in certain clinical trials in which patients are required to discontinue their medications during “washout periods” at the onset of a study, or are randomly assigned to a placebo treatment and remain off medication for (potentially) extended periods.

Type
Article
Information
Journal of Law, Medicine & Ethics , Volume 30 , Issue 3 , Fall 2002 , pp. 367 - 374
Copyright
Copyright © American Society of Law, Medicine and Ethics 2002

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References

For purposes of brevity, the model described in this paper is framed in terms of generic mental illness. Arguably, the discussion is most relevant to research involving people with more serious mental illnesses — such as schizophrenia, bipolar disorder, and dementia — and less relevant where people with milder disorders are involved.Google Scholar
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Capacity may not necessarily be evaluated in normative terms. Particularly, where weak (i.e., undemanding) tests of comprehension are involved, arguments can be made that people must demonstrate an absolute level of performance in order to be considered competent.Google Scholar
My evidence for this assertion is necessarily anecdotal, as I have found no published studies where researchers require prospective research participants to pass a test of research disclosure comprehension in order to participate. Moreover, in over three years of service as a member of the University of South Florida institutional review board (IRB), I have not seen a single study that employed such a device to help inform the researcher's judgment about a prospective participant's capacity to consent.Google Scholar
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Currently, neither our IRB staff nor anyone else monitors investigators' informed consent dialogues with prospective participants. There is probably a wide range of “effort” exerted by research team members across different studies. Anecdotally, I have observed investigators who took considerable time in the diligent presentation and discussion of consent forms. I have also interviewed a medical researcher who asserted that obtaining informed consent from a (presumably exhausted, potentially frightened) woman at the end of ten to twelve hours of unsuccessful labor using a consent form of some ten to twelve pages in length would take “about five minutes.”Google Scholar
The choice of two standard deviations below the mean performance cut-off score of a non-mentally ill group, though arbitrary, is rational. As one reviewer noted, it is a commonly used choice in distinguishing “normal” from “abnormal” physiological parameters. It is also frequently used to distinguish “normal” from “pathological” scores on psychological measures. As the text notes, it is a cut-off score that would exclude few non-mentally ill individuals from research participation, and thus is one that comports closely with current practice. Although this is a defensible criterion in principle, it may be a flawed criterion in practice if investigators fail to adequately test the competence-related capacities of the “normal” group. Furthermore, as a second reviewer noted, it is not necessary that the research community accept any single standard — two standard deviations below the “normal” group mean or otherwise, for all studies. The research community could well consider more stringent standards for studies that involve greater risk and lesser ones for studies involving no more than minimal risk. These considerations go beyond the scope of this paper, though they are highly relevant to the broader development of research guidelines. As noted supra note 14, it is possible to fashion competence measures that rely on absolute rather than normative performance levels. Relevant to the present context, the previous work of Taub and colleagues employed an 80 percent performance cut-off to evaluate the capacities of elderly individuals to consent to research participation.Google Scholar
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