Five principles: returning genetic testing results to research participants.

Abstract

In recent years, genomic testing has become increasingly common in both research and clinical trials, sparking a debate over whether and how genomic testing results should be returned to research participants. In the past, many institutional review boards required that the consent form research participants sign must stipulate that they would not have their genetic results returned to them. However, with the increased availability of these results, the question as to whether genomic testing results should be returned to research participants and under what circumstances has become important. A meeting in October 2013 with the Clinical Sequencing Exploratory Research Consortium and the Electronic Medical Records and Genomics Network addressed this issue ( Jarvik et al., 2014). With the idea in mind that research studies should ‘‘be as noncoercive and respectful to participant choice as possible,’’ those attending the meeting agreed on five basic principles that should be followed upon returning genomic testing results to research participants. Principle 1 states that there is a difference between clinical care and research, resulting in a difference in the nature and amount of information returned to the patient between the two situations. Principle 2 states that researchers performing genomic testing would not have to examine areas of the genome that are not already being examined during their study. Principle 3 states that if the results are returned to the participant, this should be done in a way such that the results can be understood well. Principle 4 states that information of an ‘‘important and actionable’’ medical nature discovered about the participant during the research process should be returned to the participant. Principle 5 states that if the participant does not give his or her consent for return of results, then the results should not be returned to the participant.