As mobile technology enables self-directed participation in research, how can we ensure that the core tenants of informed consent – informedness, comprehension, and voluntariness – are upheld? Sage Bionetworks has designed a scalable, self-guided, and self-paced open-source electronic consent (eConsent) process administered via smartphone. We have deployed this eConsent process in several minimal-risk research studies.
Sage’s e-consent strategy addresses two competing needs:
1. The need to enable an ethically appropriate mechanism to inform participants of the risks and benefits of the research study and to enroll them, even though those individuals never directly spoke to study personnel.
2. The need to develop an onboarding process for the app that is engaging and informative without being so burdensome as to hinder participation.
Careful consideration was given to the democratizing effect of smartphones as research tools on research participation; the anticipated broad range of health literacy levels and research experience of prospective participants drove design and content features. The eConsent has a deliberately structured format and carefully curated content designed to maximize participant understanding and engagement. Key features include a tiered, hierarchical interface using standardized icons and structured text to convey key concepts and a post-eConsent quiz as a check on participant comprehension and voluntariness.
The following formatting principles guide the eConsent design:
- Focus on the essential:
- Create a narrative focused on the most salient information
- Limit concepts to one per screen
- Follow national plain language and health literacy guidance
- Organize content deliberately:
- Prioritize key words/concepts presented on each screen
- Create information tiers for conceptual elaboration
- Enable participants to navigate to their desired level of detail
- Create a multi-modal learning environment
- Encourage engagement through interactive elements
The eConsent framework is designed to be customizable. We harmonized content and flow to be reusable in other research studies. We mined open-source icon libraries and assembled the PCC toolkit with on-task illustrations for each concept relevant to participating in research. The framework is available on GitHub; all assets can be freely accessed and adapted. As for any consent, application of the eConsent framework should be reviewed and approved by accredited independent IRB to confirm appropriateness and completeness prior to implementation for human subjects research. The implementation of our eConsent framework was evaluated and approved by the Western Institutional Review Board.