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 contributor has been offered the option of consenting to return of individual findings (either in the initial informed consent process or subsequently, as indicated in (A) above) and has opted to receive them;The findings reveal an established and substantial risk of likely health or reproductive importance or personal utility to the contributor and return is likely to provide net benefit from the contributor’s perspective.We recommend that researchers in the biobank research system not return IFs and IRRs offering unlikely net benefit from the contributor’s perspective, including findings whose likely health or reproductive importance or personal utility cannot be ascertained.
