eConsent is an innovative consenting method that uses multimedia components (such as videos and interactive presentations) to better explain the risks and benefits of participating in a clinical trial. This method supports an interactive and engaging informed consent experience, and offers flexibility for diverse learning styles (e.g. auditory, visual).
- Considerations and Best Practices
- Consideration must be made to properly educate the participant on use of the technology and ensure that the participant has access to the required technology and internet.
- Policy and requirements for signatures will vary by site and sponsor.
- Documentation requirements will vary based on type of study. Both the consent plan and the documentation plan should be reviewed by the REB.
- REBs and Institutions should develop clear guidelines for appropriate eConsenting.
- Determine if REB SOPs regarding informed consent are the same for eConsent versus paper based. Clarify where it is different.
- 3rd party vendors must have proper data security and privacy protections in place.
- Each site must determine and document its own eConsent process and documentation requirements.
- Resources from stakeholder institutions including sample guidance and template documents.
- Western University templates
- Transcelerate Biopharma recommendations
- Federal agencies guidance on eConsent
- Other tools