Consent, decisional capacity and guardianship in mental health research

Abstract

Background: Research with adults who cannot give informed consent has important social value. However, enrolling adults who cannot consent in research raises significant ethical concerns. Methods: To evaluate how researchers in low and middle-income countries (LMICs) can assess individuals’ decisional capacity, and the conditions under which it is appropriate to include and the conditions under which it is appropriate to exclude individuals who lack decisional capacity. Results: In LMICs, where resources may be limited, implementing protections for adults with decisional incapacity can be especially challenging. Recognition of the ethical concerns, and awareness of the circumstances and available resources, offers the means to protect these vulnerable participants. Conclusions: Researchers in low and middle-income countries should be aware of steps they can take to ensure appropriate protections for subjects with decisional impairments while conducting clinical trials on methods to improve their clinical care.

Evaluating the Decisional Capacity for Informed Consent of Transition age Children to Adolescents in Human Subject Research

“…In general, informed consent involves four components: the subject's understanding of the relevant information, appreciation of how the information applies to one's own condition, reasoning with the information provided, and evidence of choice regarding participation in the research (Appelbaum & Grisso, 2001; Gupta, 2013; Undurraga et al, 2023). Therefore, the capacity to consent represents an individual's ability to understand the information, reason, and reflect to make decisions.…”