Information on Use of Electronic Informed Consent: Use of Electronic signatures and Electronic Consent has been proposed as one solution to the challenges researchers have encountered during the COVID 19 epidemic to potentially reduce exposure risk to patients, subject and staff. Electronic Informed Consent (eIC) should follow the same regulatory guidelines and provide the same information as paper ICF. It is not meant to replace the informed consent process between research participant and study staff. There are additional considerations when using eIC as outlined by Office of Human Research Protections (OHRP) and the Food and Drug Administration (FDA).
- eIC must be collected in a platform that is 21 CFR 11 compliant which includes an audit trail of who obtained consent, date and time of consent and archived copy of executed consent.
- All versions of the eIC form and informed consent procedure must be IRB approved prior to subject recruitment.
- Copy of executed eIC must be provided to the subject.
- All eIC must be archived in secure location and available for monitoring and auditing.
- If eIC is being used remotely (ie the potential subject is not present) verification of the authenticity of the subject must be built into the informed consent process:
- For UChicago Patients including provision of birthday, last 4 of ssn or other identifying questions
- For Non patients and/or LAR of UChicago patients who cannot havee demographic verification built into the eConsent platform, studies must describe how they will obtain visual checks of identify documentation and capturing Drivers license number, state ID number
- Documentation of the informed consent process will be essential for subjects who are recruited remotely
Please watch this 20 minute video to learn all about eConsent. If your study is planning to use REDCap for eConsent, please contact the CRI REDCap Administrator Julissa Acevedo for assistance early in project development and to obtain the eConsent form template.