This response engages with Barnes et al.’s proposal on using blockchain and generative AI to enable "demonstrated consent" in biobanking. While acknowledging the importance of improving informed consent and leveraging creative technologies in repository-enabled research, the authors express concern over major implementation hurdles. They argue the proposed framework faces critical technical challenges, overlooks key biobank operations, and introduces new regulatory complications.
Technical Implementation Challenges. The authors identify critical technical barriers that hinder the practical deployment of blockchain and generative AI tools in biobank consent processes.
Biobanking Context Alignment. The commentary argues that the proposed framework fails to account for fundamental operational and structural features of repository-enabled research.
Regulatory Complexity. The response highlights how integrating generative AI and blockchain mechanisms introduces novel regulatory concerns beyond existing consent governance.
McNealy, J. E., & Doerr, M. (2025). Challenges to Demonstrated Consent in Biobanking: Technical, Ethical, and Regulatory Considerations. The American Journal of Bioethics, 25(4), 124–127. https://doi.org/10.1080/15265161.2025.2470655
