Table 2.

Essential Elements of Return of Results Plan for Six Initial Epi4K Participants

Initial contact	Letter sent to participants who have a finding, informing them that they have a finding believed to be causally related to their child’s illness. Follow-up phone call made two weeks after the mailing.
Right not to know	For the follow-up phone call, telephone script used that provides participants the chance to opt out at several points if they prefer not to know their genetic finding.
Consent form	Each participant sent a short consent form via email that can be signed electronically. Coordinator explains the project in detail and answers questions, to assure participant is fully informed, before proceeding. Participants who provide consent proceed to the next step.
Pretest counseling	Pre-test genetic counseling available, but not required.
CLIA confirmation	CLIA confirmation required, to minimize the risk of participants’ receiving an erroneous result.
Sample collection	New sample for CLIA confirmation collected via saliva kit mailed to participant’s home with prepaid return shipping, to reduce participant burden.
Genetic counseling	Results returned in a disclosure session with genetic counselor before the participant receives a copy of the CLIA confirmed result. In case the participant’s current provider is not knowledgeable about epilepsy genomics, the genetic counselor is also available to discuss the finding with the provider.
Educational materials	General information sheet about genetic findings sent to participants for review when they are deciding whether to receive information. One-page information sheet given to participants with their CLIA confirmation, summarizing what the genetic counselor reviews with them.
Qualitative interviews	In-depth qualitative interviews carried out to assess participants’ thoughts, feelings, and behaviors approximately 1 month after the return of results