BILH/BIDMC has a custom eConsent platform built upon REDCap that can be used to consent participants for studies over the phone or via an online meeting (such as Zoom), as well as in-person. To use the eConsent platform, the study must be a Expedited, Full-Board or Cede study and have permission from the IRB.
Key Features
- Consent form pulled from IRB document repository (exception: Cede consent forms are loaded manually)
- Built-in: versioning, end of document signatures, attestations, record locking, and sending of completed consent form to signer (subject or LAR)
- Allows layout customizations (adding study specific opt-in/opt-out questions)
- Enforces REDCap’s e-Signature features
- Access control
- Consistent training/documentation for staff
- Can be used for both remote and in-person consents
- 21 Part 11 compliant
Important Considerations
- eConsent may not be used for Exempt studies.
- eConsent is limited to English language consent forms. (Multi-language features under development.)
- All eConsent Investigators (study team members who will be consenting participants) must have an BILH ITS account. This username/password combination is needed to e-sign the Consent Form.
- The subject or LAR must have an email account to participate in a remote consent.
- The subject (or LAR) and the eConsent Investigator should both sign the Consent form during the same consent session, within minutes of each other. If the subject wants a few days to think about it, a new consent session must be scheduled, and a new record created for the participant and investigator to sign. If this process is not followed, it can lead to a study deviation.
See also:
eConsent