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Beginning October 1, 2022, the NIH IRB expects new protocols to describe involving human genomic sequencing, and existing protocols being modified to add genomic sequencing, to include a plan for returning clinically actionable secondary genomic findings to research participants, unless there is a strong justification not to do so.  The most commonly acceptable reasons for not returning results will beare: 1) the absence of a clinical relationship with participants or 2) the data being generated by the study are insufficient for conducting secondary analyses. 

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