Increasing complexity of clinical studies and the current shift to digital technologies lead us toward adopting an electronic informed consent process to assist in collecting informed consent while considering quality, compliance, patient understanding, and trial retention. eConsent includes multimedia components which can be used to develop an interactive and engaging informed consent experience, offering flexibility for diverse learning styles (e.g., auditory, visual).
Purpose:
This guide describes how to use REDCap to administer electronic informed consent.
How does REDCap do electronic informed consent:
REDCap's survey functionality presents the pages of the traditional paper consent, including the IRB stamp, to a potential research participant, then uses REDCap to present the questions and signature fields that appear on the paper consent. Once an individual agrees to participate, electronically signs the informed consent, then hits submit, a PDF of the completed consent can be automatically generated and saved to a REDCap form to preserve the exact consent text along with the research participant’s responses. Signed Consent can be e-mailed directly to the participant or downloaded and printed.
If emailing a signed consent, please be sure to include #secure in the subject line of the email. This will ensure that the PHI within the consent is sent securely.
Check out more at: https://redcap.vanderbilt.edu/surveys/?s=LPHC37HW3L
•DEMO: eConsent: https://redcap.research.cchmc.org/surveys/?s=ETMA7M893H
What does the FDA say about eConsent?
- Electronic signatures must be compliant with FDA regulations—specifically 21 CFR Part 11
- A copy of the consent must be given but can be electronic
- IRBs must review and approve the electronic consent and any amendments
- Thee Consent must be submitted for FDA approval for IDE studies (as with paper ICFs) and may be required for IND studies in certain circumstances
- During FDA inspection, FDA will require site-specific versions of the eConsent, materials submitted to the IRB for review and approval, all amendments to the site-specific eConsents, and all subject-signed eConsents. Any updates to this document should also be available; these can be available either in electronic or paper form.
Why choose electronic:
Benefits of Electronic
Better inform participants to empower them to make knowledgeable decisions using interactive multimedia components
- Participants well informed while utilizing technology our society has become accustomed to using.
- Incorprate weblinks within the consent that allow participants to view pictures/videos of procedures, medical equipment, or explanations of key terminology.
- Decrease participants' confusion due to variability in literacy levels and cultural diversity.
- Improve patient recruitment process and reduce the withdraw rates.
- Enhance participant comprehension of the consent process by the addition of a set of simple questions at the end of the consent.
Enabling the improved quality and efficiency of clinical studies through insight into the participant experience, improved data quality, and a fully electronic system
- Linked with surveys to assess participant inclusion/exclusion criteria to allow a semless workflow from recruitment to consent.
- Participant compliance increased by gathering metrics on their understanding of study aspects and reducing complex explanations, paperwork and quality risks.
- Easily query databases to inspect compliance and provide numbers needed for review and approval processes
- Quickly enable process efficiencies such as re-consent or remote consent.
- Reduce corrective actions for audits during an inspection of consent findings.
Example eConsent language for IRB protocols
Link: Protocol Language for Electronic Informed Consent Procedure
REDCap database set-up for eConsent Process
IMPORTANT: The REDCap eConsent is a template to be used for those who have approval from the IRB to collect the consent and HIPAA documents for their study electronically.
Developed by Theresa Baker
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