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Please also refer to the content in the NIH IRBO Research Protocol Templates ("RETURN OF SECONDARY GENOMIC RESULTS") and the Consent Library (SECONDARY GENETIC FINDINGS – RETURN OF RESULTS) for additional requirements and template language.


Resources Available for Returning Genomic Secondary Findings

The IRB believes that returning clinically actionable genomic research results is an ethically required when protocols build substantial clinical relationships with participants.  The obligation, however, should be primarily borne by the NIH IRP rather than individual investigators.  As such, there are a number of available resources to assist in the process of searching for and returning secondary genomic findings.  Please check with these resources before including them in your protocol.

Please review the following article which supports the idea of the a Secondary Genomic Findings Service: A Clinical Service to Support the Return of Secondary Genomic Findings in Human Research


A number of commercial services are available to analyze genomic sequence data for secondary findings in a CLIA environment.  While the NIH cannot endorse any specific companies, some examples include GeneDx, Invitae, PerkinElmer Genomics, and Prevention Genetics.



  • IRBO consent library; “Secondary genetic findings – Return of results”