Managing Incidental Genomic Findings in Clinical Trials: Fulfillment of the Principle of Justice
- Genome/exome data are likely to play an increasing role in clinical trials, and incidental findings are likely to be viewed as potential benefits for individuals of research participation.
- Participants in clinical trials across differing trial sites utilizing genome/exome sequencing information should be afforded the same standard of care, including return of incidental genomic findings.
- Participants may opt in to receiving incidental genomic findings, and clinical trial investigators should implement mechanisms to ensure provision of timely and appropriate care to prevent or ameliorate conditions associated with incidental findings.
- Ensuring the provision of such interventions in countries lacking a universal public health-care system may prove more challenging than in countries with public health-care support.