Development and Validation of a Stakeholder-Driven, Self-Contained Electronic Informed Consent Platform for...

Area of Science:

• Genomic research
• Informed consent process
• Participant engagement

Background:

• Traditional informed consent methods often result in low participant understanding and satisfaction.
• Electronic consent is gaining traction in genomics, but data for trio-based studies are limited.
• This study focuses on cerebral palsy genomic research.

Purpose of the Study:

• To design, develop, implement, and validate an electronic informed consent (iConsent) application for trio-based genomic research.
• To assess participant understanding and satisfaction with the iConsent application.
• To ensure the iConsent application meets stakeholder requirements and facilitates genomic data sharing.

Main Methods:

• Incorporated stakeholder feedback (researchers, patient advocates, IRB members) into iConsent development.
• Integrated principles from prior electronic consenting research and multimedia learning theory.
• Assessed participant understanding using an interactive teachback format.

Main Results:

• Participants demonstrated high understanding and retention of human subjects information.
• High participant satisfaction was reported with the iConsent application.
• Participant understanding, clarity, privacy, and study goal explanations correlated with overall satisfaction.

Conclusions:

• The iConsent application is a feasible approach for trio-based genomic research.
• The iConsent approach satisfies multiple stakeholder requirements.
• Electronic consent can enhance participant understanding and satisfaction while broadening study reach.