should offer to return IFs and IRRs that meet all of the following criteria: The findings are analytically valid;Returning them to the contributor comports with applicable law, including CLIA (which may require ascertaining or verifying results in a CLIA-certified lab);The contributor has been offered the option of consenting to return of individual findings (either in the initial informed consent process, or in a subsequent consent process that may be a request for an individual’s consent or part of a larger effort to elicit many contributors’ consent) and has opted to receive them;The findings reveal an established and substantial risk of a serious health condition; andThe findings are clinically actionable, meaning that return of findings of health importance allows the contributor or contributor’s clinician to take action with significant potential to prevent or alter the course of the condition or to alter its treatment.We recommend that researchers in the biobank research system may offer to return IFs and IRRs that fail to meet the above criteria, if they instead meet all of the following criteria: The findings are analytically valid;Returning them to the contributor comports with applicable law, including CLIA (which may require ascertaining or verifying results in a CLIA-certified lab);The
