Reassessing Informed Consent in the Era of Large-Scale Genomic Biobanking

Abstract

The consent model underlying most genomic biobanks was designed for discrete, time-limited studies, and it sits uneasily with an infrastructure built to store and reuse samples indefinitely. This review surveys the major consent models now in use -- broad, tiered, dynamic, and meta-consent -- and the empirical evidence on how participants actually experience the trade-off between autonomy and practicality that each represents. It then examines three unresolved fault lines that recent literature has sharpened rather than settled: the mismatch between data-protection law and bioethical consent norms, the operational and ethical difficulty of returning individual results, and the gap between individual consent and the collective interests of communities, particularly Indigenous communities, whose genomes are studied without a comparable mechanism for group consent. We also examine the right to withdraw, which recent analyses describe as considerably weaker in practice than consent documents imply, since data and derived results already shared or published cannot be meaningfully recalled. We conclude that no single consent model resolves these tensions on its own, and that defensible biobank governance likely requires combining broad consent with genuinely independent oversight, a narrow and honest disclosure policy for actionable findings, and, where warranted, a community-level governance layer
that individual consent cannot substitute for.