Management of Incidental Findings from Genetic Tests: Perspectives of Ethics Committee Members

Leigh Jackson, Anita O’Connor, Lesley Goldsmith and Heather Skirton

New genomic technologies, whilst allowing comprehensive and cost-effective access to disease-causing mutations, also increase the possibility of incidental findings unrelated to the original research question. These findings may have health, reproductive or familial implications for the research participant concerned. There are diverse opinions regarding the obligations of researchers and appropriate management strategies regarding how or whether to return this information to research participants. As the empirical data on which these arguments are based is still fairly limited, we undertook a qualitative study, using a thematic analysis approach, to explore the topic further. We interviewed members of UK NHS research ethics committees to ascertain their experiences regarding genetic incidental findings, as well as their opinions regarding future challenges and management. The interviews were transcribed, coded and analyzed for common themes. Three themes emerged; facilitating participant consent, supporting the validity of consent, and risks and rights. Ethics committee members were aware of the issues raised by genetic incidental findings despite limited practical experience in the projects they have assessed. There was no consensus as to how information should be presented to potential participants during recruitment for research involving genome-wide technologies, or whether blanket or checklist-based consent was most useful. Participants also discussed the difficulties in balancing the rights and obligations of research participants, their families, researchers, and clinicians when considering the return of incidental findings. Some supported overruling patient consent in order to return clinically actionable incidental findings. In the absence of national guidance on these issues, the lack of consensus evident in this study could potentially lead to a disparity between research ethics committees in the way genetic research studies are appraised. A wider discussion on the suitability of the current informed consent model for complex genomic research may also be required.