Table 1.
Desiderata for Developing a Digital Genomic Informed Consenta
| Key Subject Areas and iConsent Goals | Integration of Desiderata in iConsent |
|---|---|
| Participant engagement: Secure user interface enables continued and individualized consent management and engagement after enrollment 20, 23, 24 | ● Interactive teachback questions ● Consent language downloadable ● Automated study status communications post-enrollment |
| Personalized participation: Transparency through provision of information at recruitment 25, 26 | ● Clear explanation of risks, definitions, method of participant identification ● Opportunities to contact and engage with study team |
| Participant information services: Ability to monitor each researcher’s access to data sets and biological samples over time 27 | ● Impractical given widespread de-identified genomic data-sharing |
| Healthcare integration: For improved prevention, treatment, and care-delivery28, 29 | ● Optional return of results includes choice to share findings with participants and clinical providers |
| Genomic literacy: Facilitate understanding of precision medicine, genomic information, and implications of results 28, 25 | ● Concise explanations within iConsent ● Teachback questions and ‘More Info’ tabs |
| Incidental findings: Bioethical principle of Autonomy supports individual’s right to know and to not know 25, 30, 27 | ● Incidental findings masked by bioinformatics workflow and not returned to participants; ethics committee engaged as appropriate to individual circumstances |
| Digital accessibility: iConsent accessible from all possible electronic formats 9, 27 | ● Mobile, tablet, and laptop/desktop compatibility |
| Identity management: iConsent employs a trusted identity management process 9, 27 | ● Secure user interface within REDCap incorporates authentication and authorization |
| Audit trail: Ability to reliably track consent status 26 | ● Consent tracking status within REDCap framework |
| Security and privacy: Transparent protections 9, 30 | ● Achieved via collaboration with IRB and implementation within iConsent framework |
a
Desiderata derived from Parra-Calderón, et al.22