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Chunk #0 — INTRODUCTION

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Managing incidental findings and research results in genomic research involving biobanks and archived data sets.
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An ongoing debate focuses on the question of whether researchers bear duties to analyze and offer back to research participants incidental findings (IFs) and individual research results (IRRs) generated in genetic and genomic research. Much less has been written on the responsibilities of biobanks collecting data and/or samples for use in genetic and genomic research over time. Yet biobanks, a term we use broadly here to cover a range of structured collections including biorepositories and databases (see Appendix A), are now crucial engines of large-scale genetic and genomic research. They are the central part of what we will call a “biobank research system,” comprising primary research or collection sites, the biobank, and secondary research sites accessing biobank data or samples for further research. IFs and IRRs can arise at multiple points in this system. How they should be handled and the role of biobanks in facilitating this process, are pressing concerns and the focus of this paper.