Consent Is Dead, Long Live Ethical Oversight: Integrating Ethically Sourced Data into Demonstrated Consent Models

Consent Is Dead, Long Live Ethical Oversight: Integrating Ethically Sourced Data into Demonstrated Consent Models
Open Peer Commentaries
Jean-Christophe Bélisle-Pipon, Vardit Ravitsky
American Journal of Bioethics, 7 April 2025
Excerpt
Barnes et al. (Citation2025) propose a demonstrated consent model that seeks to address challenges in modern biomedicine by transforming consent from a static, one-time transaction into a dynamic process. Their model integrates blockchain technology with generative artificial intelligence (AI) to allow donors to monitor the use of their biological samples in real time and adjust their preferences as research evolves. This approach helps to respond to the limitations of traditional consent frameworks—a concern echoed by Evans and Bihorac (Citation2024), who note that “informed consent for data use, as conceived in the 1970s, seems dead.” They argue that modern computational methods introduce privacy risks not only through direct data breaches but also via inferences drawn from aggregated data, affecting even those who have not directly consented. Barnes and colleagues’ model embeds increased transparency and user agency into consent processes. However, it also raises ethical questions: Does this approach truly empower donors, or might it overwhelm them with technical complexity? Can blockchain’s transparency and AI’s capacity to personalize consent overcome systemic inequities, or will they obscure deeper structural imbalances? These questions are essential to assessing whether demonstrated consent can adequately safeguard autonomy, privacy, and justice in biomedical research…