paperKB
coga / coga-kb
Help
Sign in

Chunk #22 — PART I. DEFINITIONS

Source
Managing incidental findings and research results in genomic research involving biobanks and archived data sets.
Embedded
yes

Text

Our research has uncovered biobanks, studies, and policies that indeed recognize a difference between IFs and IRRs. Yale University’s IRBs, for example, have generated policy recognizing that in some studies, a determination may be made to return IFs but not IRRs.21(p1) Policies contemplating return of IFs but not IRRs may be based on a number of factors, including anticipation that IRRs, as the focus of the research, may not be as well understood and validated, whereas many IFs may be fully validated and well understood findings commonly communicated in clinical care. UK Biobank is an example of a biobank that offers contributors IFs (such as elevated blood pressure) discovered in baseline screening at enrollment, but not IRRs from the genetics/genomic analysis ensuing.22,23 In planning the Cancer Human Biobank (caHUB), NCI has contemplated return of a finding of discrepant diagnosis when specimen pathology is checked upon submission to the biorepository and the diagnosis differs from that at the source site, but not necessarily return of ensuing genetic and genomic research results.24(pp27–28) Indeed, any study or biobank collecting or archiving either medical