Developing a genetic return of results service core

TL;DR

This paper introduces a service to return genetic test results to research participants, aiming to improve trust and health equity.

Contribution

The paper presents a new protocol and service for returning genetic results with a focus on transparency and accessibility.

Findings

Less than 6% of genomic research protocols included plans to return results to participants.

The gROR service reduces investigator burden and provides participants with genetic information and guidance.

Investigator costs are subsidized to encourage delivery of actionable genetic test results.

Abstract

Research participants should be informed of genetic test results that could impact their health, particularly when they have expressed interest in receiving such information. Furthermore, the return of genetic test results is essential to improve trust, transparency, and health equity. However, investigators often encounter barriers in returning genetic test results to research participants. We examined genomic research at a large, research-intensive medical school and found less than 6% of protocols included plans to return results to participants. This study describes our development of protocols for returning primary and secondary genetic test results and implementation of a Genomic Return of Results (gROR) service. This arose through a collaboration with experts in community engagement, genetics, and pathology to consider consent adequacy, analytical/clinical validity, and clinical utility when returning results. The gROR service reduces investigator burden and provides participants with genetic information and guidance to address any potential health risks. Genetic results are returned by a genetic counselor at no cost to participants or their family. Investigator costs are subsidized to incentivize the delivery of actionable genetic test results to research participants. Our approach prioritizes transparency, accessibility, and informed decision-making, thereby promoting equitable sharing of genetic knowledge and personalized healthcare interventions.

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