Consent, decisional capacity and guardianship in mental health research

Juan Undurraga; Hanna Negussie; David Wendler

doi:10.12688/wellcomeopenres.18003.2

Consent, decisional capacity and guardianship in mental health research

Wellcome Open Res. 2023 Jun 15:7:183. doi: 10.12688/wellcomeopenres.18003.2. eCollection 2022.

Authors

Juan Undurraga¹, Hanna Negussie², David Wendler³

Affiliations

¹ Department of Neurology and Psychiatry, Faculty of Medicine, Clínica Alemana Universidad del Desarroll, Santiago, Chile.
² Center for Innovative Drug Development and Therapeutic Trials for Africa, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
³ Department of Bioethics, NIH Clinical Center, Bethesda, MD, 20892, USA.

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, and the conditions under which it is not appropriate to include 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.

Keywords: clinical trials; decisional capacity; informed consent; surrogates.

Grants and funding

This work was supported by Wellcome through funding to the Global Forum on Bioethics in Research (GFBR). GFBR funding is provided by The Wellcome Trust, the National Institutes of Health and the UK Medical Research Council. Juan Undurraga’s work was supported by Agencia Nacional de Investigación y Desarrollo under grant agreements ANID-PIA-ACT 192064, ANID-FONDECYT 1180358, and ANID-FONDECYT 1200601. David Wendler’s work was funded by the intramural research program at the US NIH Clinical Center. However, the views expressed are the authors’ own and do not represent the views of the US NIH or US federal government.