Ethics Considerations Regarding Donors’ and Patients’ Consent

Ethics Considerations Regarding Donors’ and Patients’ Consent
Book Chapter
Jeremy Sugarman
Brain Organoids in Research and Therapy, 10 July 2022; pp 121-130 [Springer]
Abstract
Informed consent is a crucial factor in determining whether particular uses of brain organoids for research and clinical translation are ethically acceptable. In the context of basic research, the consent of donors whose tissues are used to derive brain organoids is of primary concern, whereas in clinical translation the consent of both allogeneic donors and patients may be relevant. In this chapter, I examine key ethics considerations related to informed consent for brain organoid research and clinical translation. In order to do so, I first describe both a standard conceptual approach to informed consent that aims at meeting the ethical goal of respecting the autonomy of persons and some of the other ethically relevant functions of informed consent. This conceptual work provides a foundation for mapping ethics considerations related to informed consent in regard to the decision-making capacity and voluntariness of those being asked to consent, disclosure requirements associated with brain organoids in general and for particular proposed uses that involve morally significant aspects, threats to understanding that must be overcome, and considerations for authorization. Finally, I offer some suggestions for grappling with such informed consent challenges related to brain organoids.