Genomic Advisory Panel: Human Subjects Protection in a Brave New World


Description of the Research
In response to ongoing technological enhancements and ethical challenges in the field of genetic research, our IRB/PB has established a Genomic Advisory Panel to serve the Center as a resource for our scientists, physicians, and research staff. The Panel has been charged with reviewing genetic research findings brought forth by investigators who seek advisement on whether it is appropriate to discuss these germ line research findings with our participants and/or their family designees. 

Over the course of a year, the IRB/PB in collaboration with our Office of Clinical Research established institutional policies governing the Panel and enhanced our consenting process to ensure ongoing compliance in this field. These particular policies outlined the Panel’s role in our research community, member composition/duties, authority in decision making on behalf of our IRB/PB, and the responsibilities to both our Center and our patients participating on one of our clinical studies. 

Since inception at the beginning of 2015 and as of April this year, the Panel had reviewed 30 incidental findings potentially representing inherited susceptibilities to cancer (e.g., BRCA) or other diseases during the course research employing next generation sequencing research. Twenty-eight percent of those findings were deemed clinically actionable for the patient and/or the family and appropriate to refer the patient to our Clinical Genetics Service. 

This poster will outline the measures taken to establish the Panel, mode of operations of the Panel, de-identified data on cases for review and reasoning behind deciding on return or no return, and future enhancements to broaden our scope to ensure continued human subjects protection for all participants on our clinical genetic studies.