Biobanks as fiduciaries of biosamples and data: a legal and ethical analysis in the light of international standards.

Abstract

This article argues that biobanks are best conceptualized as fiduciaries of biospecimens and associated data. Building on fiduciary legal theory and Anglo-American fiduciary jurisprudence, it explains how long-term discretionary control, informational asymmetry, and donors' limited ability to monitor downstream uses justify duties of care and loyalty, even though legal recognition and enforceability remain jurisdiction-dependent. The argument is situated within earlier trust-based and fiduciary accounts of biobank governance and is connected to international governance standards, including ISO 20387 (which frames the biobank as a legal entity) and the International Society for Biological and Environmental Repositories Best Practices, treating them as practical specifications of fiduciary stewardship rather than sources of binding law. The fiduciary framework reconceives broad consent as an ongoing governance commitment rather than a one-time authorization, justifies cost recovery as reimbursement for professional stewardship, and subjects intellectual property and benefit-allocation arrangements to loyalty-based constraints. It also situates this fiduciary approach alongside EU General Data Protection Regulation principles of accountability, purpose limitation, and transparency. It argues that public trust is a condition of sustainable biobank governance and that fiduciary governance supports proactive, accountable promotion of research uses of samples and data.