Electronic Informed Consent SOP (description of the central IRB-approved eConsent process)
All ICECAP sites should plan to use the electronic version of the consent form, with paper consent available as a last resort. The eConsent platform, Redcap, has been approved by the central IRB for eConsent use in ICECAP. A unique eConsent form link for your site will be provided to you after your site application has received central IRB approval.
e-Consent Checklist (coming soon)
IDE Approval Letter 6/9/16
Approval letter with conditions 4/29/16
Protocol Approval with Modifications Letter (January 2020)
Checklist (Please note your site manager will send you a site specific link once you are at that stage in the process)