INFO: REDCap: eConsent / Paperless Consent

REDCap eConsent Definitions:

1. Informed Consent in Online Research 

IRBs may waive the requirement for written documentation of informed consent when the research

presents no more than minimal risk of harm to subjects and involves no procedures for which written

consent is normally required outside of the research context or when the only record linking the

subject and the research would be the consent document and the principal risk would be potential

harm resulting from a breach of confidentiality. Online research involving adults often meets one of

these conditions. A consent procedure in which subjects are provided with a written statement about

the research followed by a button to click that states, “I AGREE TO PARTICIPATE IN THIS

RESEARCH” is often acceptable.

2. Informed Consent obtained via paper then scanned to electronic certified copy

PHRC Guidance for Electronic Storage of Research Documents

HOW TO: Scan and Store Research Documents in REDCap

 

3. Informed Consent where a computer/device can be substituted for paper; study team interaction is same as paper process; also known as Paperless Consent or eConsent

This is a handwritten signature applied to electronic media (21 CFR Part 11)

Executed in REDCap by uploading IRB Stamped/Approved PDF Consent Document w/Signature Field Type

HOW TO: REDCap eConsent/ Paperless Consent

 

4. Electronic Informed Consent (eIC) where a computer/device takes the place of paper and people (everything in online/electronic)

No 'template' REDCap solution. Requires participant identity management and demonstration of understanding of IC.

 

Contact EDCSupport for additional information

PHRC Guidance for

Guidance on Research Using the Internet > Informed Consent in Online Research

REDCap Project: Consent text is Descriptive Text field + Radio Button / Checkbox: