Transparency and choice in learning healthcare systems

Learning healthcare systems rely on potentially sensitive data and biospecimens from patients who typically have no knowledge of secondary uses of these resources for research. While this failure to inform patients of these practices is consistent with human subject regulations for research, these practices risk controversy and a loss of trust in the integrity of healthcare institutions. This article reviews recent controversies in this domain and argues for new institutional practices that entail patient education about secondary uses of data and biospecimens and the opportunity for patient choice in the form of an opt-out system. This approach would enhance transparency and reduce the risk of a loss of public trust in the research enterprise.