Evaluation of a scalable method for returning results and genetic findings from genomic research to research participants. J. Y. Tung, S. Wu, B. T. Naughton, J. L. Mountain 23andMe, Inc, Mountain View, CA.
Discussions around the return of research results and incidental findings to research participants have come to the forefront recently, in particular as genome-wide sequencing becomes more common. Studies have shown that most research participants who have donated DNA samples to research would like to receive individual results from studies performed using their samples. While multiple groups have published recommendations on how best to return results, very few research groups have actually returned such data. 23andMe, a personal genomics company, not only provides a service that interprets genetic information for non-scientists but also conducts its own research and shares those results with participating customers. These activities put 23andMe in a unique position to assess methods of returning results and findings to research participants. We describe our approach for returning different types of information and compare it to recommendations made by independent working groups. For example, as recommended by many, our genotyping is performed in a CLIA-certified lab, and we have already developed and implemented a system for evaluating whether a finding should be shared with our participants. In addition, we have an established method for recontacting our participants when new findings become available. We also evaluate differences in information-seeking behavior between individuals who came to our service based on their interest in genetic testing and individuals who joined as part of a research project, and show that these differences vary according to the nature of the information presented and the way the individuals were introduced to the service. Though 23andMes research participants may not be representative of all research participants, these data still suggest that individuals whose primary motivation for joining 23andMe is to participate in research are interested in learning about the incidental findings uncovered in the sample they contributed.
The problem of how to return results and incidental findings to research participants in a responsible, scalable, cost-effective, and updatable way is a daunting one. One possible solution is for researchers to partner with entities like 23andMe that specialize in communicating this type of information. Whatever the channel of communication of results, many lessons can be learned from the work already in progress at personal genomics companies.