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eConsent

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).

 

  • Tab IconConsiderations and Best Practices
  • Tab IconResources

Considerations

  • 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.

Best Practices

  • 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.

 

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