Return of Results
Many research studies conducted at the University of Utah involve DNA analysis. Through these studies, clinically actionable findings are identified in participants. The Genetic Counseling Shared Resource (GCSR) has developed a Return of Research Results (ROR) protocol to confirm clinically actionable findings in CLIA certified germline testing laboratories and return confirmed results to participants. Clinical genetic results can be entered into the patient’s medical record, utilized by their healthcare teams, and lead to testing of at-risk family members. The ROR protocol provides researchers at the University of Utah with a resource to return potentially impactful health information to their participants.
The American College of Medical Genetics have recommended 59 genes for reporting incidental findings. These genes are related to health conditions for which there are established strategies for prevention or early detection of disease.
The GCSR is available to consult with researchers to determine if their IRB and data are appropriate for identifying and returning actionable findings to participants. Thus far, individuals from a variety of research projects have been successfully contacted and the results of their research findings have been confirmed in a CLIA certified laboratory.
If you have questions or would like more information about the Return of Research Results protocol, please contact the study coordinator, Jo Anson, at 801-587-9831 or jo.anson@hci.utah.edu.
Processes & Case Examples
For Living Research Participants
Case Example: Return of a pathogenic BRCA mutation impacts clinical management of a research participant.
For Deceased Research Participants W/ Living Next of Kin
Case Example: The daughter of a deceased research participant was confirmed to have inherited a pathogenic ATM mutation from her father, with implications for her cancer risk and clinical management.