Developing a genetic return of results service core.

Area of Science:

• Genomic Medicine
• Bioethics
• Public Health

Background:

• Returning genetic test results to research participants is ethically imperative for health equity and trust.
• Investigators face significant barriers in returning genetic findings, with less than 6% of protocols including such plans.
• Existing research practices often fail to inform participants about potentially health-altering genetic information.

Purpose of the Study:

• To develop and implement protocols for returning primary and secondary genetic test results to research participants.
• To establish a Genomic Return of Results (gROR) service to streamline the return of genetic information.
• To address barriers and promote transparency, accessibility, and informed decision-making in genomic research.

Main Methods:

• Collaborative development of protocols involving experts in community engagement, genetics, and pathology.
• Consideration of consent adequacy, analytical validity, and clinical utility for result return.
• Implementation of a dedicated gROR service offering genetic counseling and guidance.

Main Results:

• The gROR service effectively reduces investigator burden.
• Participants receive genetic information and guidance on potential health risks at no cost.
• Investigator costs are subsidized to encourage the return of actionable genetic results.

Conclusions:

• The developed gROR service promotes equitable sharing of genetic knowledge.
• Prioritizing transparency and informed decision-making enhances personalized healthcare interventions.
• The service facilitates the return of clinically relevant genetic results, improving participant outcomes and research integrity.