Returning Incidental Findings to Study Participants in Genomic Research: A Discussion of the Ethical Aspects

Nowadays, the capacity to generate genetic data is enormous, genotyping and sequencing platforms being more and more accessible. Each genome contains various information about one's health and disease risk. Understanding the significance of genetic variance and its impact requires large genomic studies, involving analyzing the genetic data of millions of individuals. However, it is complicated to foresee what would reveal the analysis of each person’s genetic data at the beginning of the study. Considering this context, this paper addresses the issue of returning incidental findings to study participants in genomic research, with a focus on the ethical aspects and the clinical consequences of revealing the result to the sample donor. Deciding whether to return incidental findings or not to study participants is a complex issue. All stakeholders (sample donors, researchers and clinicians) are open to revealing incidental findings, but the decision depends on the clinical impact of a variant and its actionability. The content of the informed consent must be adapted to dealing with genomic data and incidental findings when enrolling study participants. Sample donor’s wishes, expressed in the informed consent, ethical aspects and clinical relevance of the variant must be integrated to decide whether a specific incidental finding should be reported.