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Meeting the Governance Challenges of Next-Generation Biorepository Research

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Meeting the Governance Challenges of Next-Generation Biorepository Research

Stephanie M Fullerton et al. Sci Transl Med.

Abstract

Advances in clinical translational research have led to an explosion of interest in infrastructure development and data sharing facilitated by biorepositories of specimens and linked health information. These efforts are qualitatively different from the single-center sample collections that preceded them and pose substantial new ethics and regulatory challenges for investigators and institutions. New research governance approaches, which can address current and anticipated challenges, promote high-quality research, and provide a robust basis for ongoing research participation, are urgently required.

Figures

Fig. 1
Fig. 1. Frozen resources
A researcher retrieves medical samples.
Fig. 2
Fig. 2. Changes to accompany next-generation biorepository research
The transition from first- to next-generation biorepository research will require innovative new approaches to privacy, institutional review, informed consent, and data stewardship. IRB, institutional review board.

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