To Share or Not to Share: That is the Question.

What ELSI is new (article)This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Catherine A. McCarty, Marshfield Clinic Research Foundation.

I believe that the most important ethical, legal or social issue (ELSI) that must be addressed by the fields of genomics and/or personalized medicine is return of genetic results to research participants. Biobanks attached to electronic medical records are becoming very common and, as demonstrated through the eMERGE network funded by NHGRI, are a cost- and time-effective approach to genetic discovery.

Where subjects have been actively consented to participate in a biobank, they are usually told that they will not have personal genetic results returned to them. The reason for this is two-fold: 1) the research is not being conducted in a CLIA-certified lab, and 2) research results would need to be verified in other labs before being considered to be potentially clinically relevant. The inability to act on results, e.g. there is no cure or treatment, also weighs into the decision not to return research results.

This approach worked well in the era of candidate gene and early genome-wide association studies. As genotyping costs decrease such that it may be possible to sequence the entire genome for $1000, researchers will find that they have clinically relevant data for research subjects who were initially consented under the assumption that genetic results would not be returned to them.

Furthermore, as research findings are confirmed in other laboratories, results that were initially tentative may become truly significant and ideally clinically relevant. Researchers will then need to consider the ethics of withholding information known to be clinically relevant versus the fact that some subjects may have initially chosen to participate because they would not have information returned to them.

In addition to these basic ethical questions, the issue about how to adequately inform subjects about the meaning of the genetic results must be considered. It would be irresponsible to provide genetic information without appropriate genetic counseling. ELSI needs to keep pace with genetic technologies applied to biobanks.