The Belmont Report principle of Respect for Persons holds that individuals be treated as autonomous agents. An autonomous agent is one who is “capable of deliberation about personal goals and of acting under the direction of such deliberation” (Office for Human Research Protections, 2022). The Report mandates that those who have diminished autonomy are entitled to protection. Such protection and respect for all potential research participants begins with informed consent.
Informed consent of participants is an integral aspect, and federal regulation, of research with human subjects. Informed consent offers an opportunity for individuals to learn about the facts of the study, ask questions, and decide whether they want to partake. Such information disclosed to participants in the informed consent process will generally include details on the research procedure, research purpose, risks and anticipated benefits and details related to the study (Office for Human Research Protections, 2022).
The informed consent process can only be initiated after one’s capacity to consent is determined (Fields and Calvert, 2015). Researchers must assess participants' capacity to consent, and can do so on their own discretion, as there is no current standard assessment for consent capacity. The MacArthur’s Competence Assessment Tool, a semi-structured interview, can be used to assist clinicians in determining competence to consent (Grisso et al., 1997) alongside a researcher's professional training and qualifications to conduct the study.
For individuals with cognitive impairment, the issue of capacity to consent is of utmost concern. In the “Assessing Potential Research Participants’ Capacity to Consent” TC IRB blog post, Kailee Kodama Muscente explained “an individual’s ability to provide capacity to informed consent may diminish or improve depending on their current mental or physical state.” Ability to consent may be affected by a myriad of issues, and each individual’s situation should be assessed on a case-by-case basis, with safeguards in the event capacity to consent is in question.
Consent is an ongoing process and can be revoked by a study participant at any time throughout the research process. Researchers are responsible for also assessing when consent capacity may waver, meaning that even if individuals do not revoke their consent, circumstances may occur in which participants cognitive capacity changes and their consent must be reassessed by the researcher. Asking questions like, “are you okay to proceed,” or “would you like to take a break” are effective ways to monitor how a participant is feeling. Pausing the study activity also provides the researcher with time to consider if continuing the study may cause undue harm to the study subject. A researcher should stop a study if proceeding may impose risk to the individual. To further understand how consent capacity is assessed, in my role as a Research Writing and Ethics intern, I interviewed Dr. Gaurav Patel, Associate Professor of Psychiatry at Columbia University, as well as a researcher at the New York Psychiatric Institute.
Dr. Patel is the director of the Dynamic Social Cognition Lab which uses brain imaging and behavioral measures to study social functioning and its deficits in neuropsychiatric disorders.
When gathering consent, Dr. Patel’s lab uses a consent script, designed for trained researchers to gauge consent capacity with the potential participant by asking tailored questions. The script is designed to address four basic principles, denoted by the acronym CUAR: communication, understanding, assessment, and reasoning (Appelbaum, 2007).
Researchers, like clinicians, interviewing potential research participants must communicate the study goals and risks with the potential participant, gather their level of understanding of the process, consider whether they are able to make appropriate assessments of the risks of the study protocol, and determine whether they are able to reason through the risks in relation to their own situation.
Consent capabilities for individuals with neurocognitive and/or complex brain disorders must receive special considerations. The next blog post in this series, Neurocognitive and Complex Brain Disorders, will discuss the specific challenges of gaining consent when working with populations with neurocognitive and/or complex brain disorders.
References
Appelbaum P. S. (2007). Clinical practice. Assessment of patients' competence to consent to treatment. The New England Journal of Medicine, 357(18), 1834–1840. https://doi.org/10.1056/NEJMcp074045
Fields, L. M., & Calvert, J. D. (2015). Informed consent procedures with cognitively impaired patients: A review of ethics and best practices. Psychiatry and clinical neurosciences, 69(8), 462–471. https://doi.org/10.1111/pcn.12289
Grisso, T., Appelbaum, P. S., & Hill-Fotouhi, C. (1997). The MacCAT-T: a clinical tool to assess patients' capacities to make treatment decisions. Psychiatric services (Washington , D.C.), 48(11), 1415–1419. https://doi.org/10.1176/ps.48.11.1415
Office for Human Resource Protections (2022). The Belmont Report. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html