Reconceptualizing the right to withdraw in stem cell research: Striking a balance between donor autonomy and scientific utility

This paper seeks to address the challenges with applying a right to withdraw to pluripotent stem cell (PSC) research. PSC lines are unique in that they can be expanded indefinitely, disseminated globally, transformed into multiple derivatives, and employed as therapeutic products, rendering withdrawal not only logistically unfeasible, but also a substantive risk to research stability. Following an analysis of whether the classical right to withdraw can be suitably modified to address the tensions between donor freedoms and transformative biomedical research, we argue for a recalibration of donor control. Specifically, we present a hybrid model that combines up-front broad consent (including an expression of initial preferences for currently known ethically contentious areas of stem cell research), ongoing dynamic consent, and robust governance. While the paper reviews existing consent and withdrawal models, its primary contribution is to show why these models fail to adequately address the PSC-specific tension between respect for donor autonomy and provision of research certainty and to propose a hybrid, autonomy-preserving alternative that is designed to deliver greater research stability than a modified right to withdraw.