Ethox Seminar: The Ethics of Donation under Double Uncertainty

Abstract

Informed consent is a cornerstone of biomedical research ethics, whose normative force is typically grounded in respect for the autonomy of research participants. We argue, however, that informed consent cannot bear the full justificatory weight commonly placed upon it in research domains characterized by what we call ‘double uncertainty’: substantial epistemic uncertainty about the future uses of donated biospecimens and derived data, combined with substantial moral uncertainty about the ethical significance of those uses. Paradigm cases arise in cutting-edge stem cell research involving embryo models and organoids. In these domains, neither donors nor scientific experts can fully anticipate what research trajectories donated materials will follow, what data will be generated, which ethical questions will emerge as the science develops, and which developmental thresholds will prove morally significant. This ignorance is not accidental but structural, built into the frontier nature of the science itself; hence it cannot be resolved by merely adopting a relational conception of autonomy in place of an individualistic one, nor by more sophisticated consent modes such as technology-supported dynamic consent. While informed consent retains ethical value—signalling a donor’s willingness to participate and helping to avert coercion—it cannot, under these conditions, constitute genuinely autonomy-respecting authorization for donation. Our argument therefore shifts normative attention from donor consent to institutional accountability: the development of oversight mechanisms, publicly defensible criteria for permissible research use of donated materials, and participatory governance structures capable of safeguarding donor rights and interests under conditions of limited foresight.

EVENT DETAILS

• Ethox Seminar, Tuesday 23 June, 11:00-12:30
• This will be a hybrid seminar in the Big Data Institute, Lower Ground Seminar Room 0, or on MS Teams
• Speaker: Tsutomu Sawai
• Open to: Members of the University
• Register here