COVID-19 has made seeing participants for the consenting process logistically challenging and potentially unsafe. Remote consent can allow the investigator/designee and potential participant to engage in the informed consent process in a way that is similar to what would be conducted in-person under normal circumstances. These conversations may occur via telephone, conference call, video conferencing, or telemedicine app.
- Considerations and Best Practices
- Federal and provincial guidelines on personal health information (PHI) handling must be followed where applicable. Consider whether e-signatures may be acceptable to all parties when using remote consent. This process may reduce the burden on participants, but may require additional technology or resources.
- Policy and requirements for signatures will vary by site and sponsor.
- When using a video conferencing platform, there may be requirements for the research team to be using only approved platforms or physical locations (e.g., at the institution).
- REBs and Institutions should develop clear guidelines for appropriate remote consent processes.
- Determine if REB SOPs regarding informed consent are the same for in-person and remote consent. Clarify where it is different.
- Consent procedures must adhere to ethical principles and privacy requirements. Research teams must be aware of and comply with any additional requirements from their sponsors, funders, and institutions (e.g., institutional policies for contacting potential participants).
- Documentation requirements will vary based on type of study. Both consent plan and documentation plan should be reviewed by the REB.
- Each site must determine its own remote consent process and document requirements.
- Documentation of discrepancies in date of signature should be included where applicable.
- Participants should be properly educated on the use of the technology and ensure that the participant has access to the required technology and internet.
- Confirm participant identity and ensure consent of the participant is being given, not the caregiver.
- Resources from stakeholder institutions including sample guidance and template documents.
- Queen’s University, Kingston Health Sciences Centre, and Kingston General Health Research Institute templates
- Lawson Research Institute templates
- Transcelerate Biopharma recommendations
- FDA guidance on the Use of eConsent
- Guidance documents from federal agencies.
- Other tools