The SGFS requires that protocols include appropriate language for the evaluation and return of secondary findings. Participants must understand that their samples will be evaluated by our service and that they may be re-contacted at a later time. We have provided some suggested language to incorporate into protocols and consent forms.
As with all parts of your consent form, it is crucial you talk with your participants about secondary findings analysis. Below are some practical points to emphasize during your consent conversation:
- The purpose of annotating for and returning secondary findings is to improve outcomes for participants - most participants are very comfortable with this idea, even if seems like initially unwelcome information
- Secondary variants will only be present in a small fraction of your participants
- Not having any secondary findings present does not mean that a person has a "clean genetic bill of health" - they can still get any of the diseases associated with the genes we look at in our analysis
- Participants who have secondary findings will receive genetic counseling about what the finding means for them and their family members and what next steps to take
In our experience, the wait between told that there is a possible secondary finding and actually getting that finding confirmed can be very anxiety provoking. To mitigate this, the SGFS staff member who will contact your participant to coordinate getting a confirmatory sample will not know the participant's possible finding. They will simply state that there is a potential genetic finding that your team would like to learn more about and that this will require submission of a new sample. When consenting participants, it may be helpful to emphasize that the participant may be re-contacted in the future to provide another sample for any number of reasons, not solely to confirm a potential secondary finding.
