VCU REDCap eConsent Guide

This document provides a step-by-step guide on implementing the REDCap eConsent framework.

Please note that VCU IRB approval is required prior to developing and implementing the REDCap eConsent process.

• It is intended that users of this guide have basic REDCap platform knowledge with experience designing and configuring REDCap projects.VCU REDCap eConsent Guide Download

HELP GETTING STARTED

To obtain technical assistance developing your REDCap eConsent project, please submit a support request and the Wright Center Informatics team will contact you.

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You may email redcap@vcu.edu for general REDCap questions.

INTRODUCTION

Obtaining informed consent electronically is an increasingly important capability for clinical research.

The VCU IRB has released guidance (informed consent) that provides definitions and requirements for implementation of systems that support electronic consent (eConsent).

The Wright Center and the VCU Human Research Protections Program have worked collaboratively to develop REDCap-based eConsent templates and guidance to facilitate development of an eConsent process for either in-person or remote consent of research participants.

REDCap eConsent functionality ((IRB Guidance for Using REDCap Electronic Informed Consent) is intended for studies that will require a signature and are not FDA regulated (21 CFR Part 11). REDCap eConsent is not for use:

1. with studies conducted under an IND (21 CFR part 312) or an IDE (21 CFR part 812) or where data is intended to be submitted to FDA in support of a 510K submission. If eConsent is needed for an FDA regulated study the Part 11 DocuSign platform is available.
2. to obtain assent electronic signatures, although the REDCap eConsent may be used to facilitate the assent discussion with children or decisionally impaired adults.

For exempt studies not requiring a signature please refer to the IRB Guidance for Using REDCap Platform for EXEMPT Study Participant Information Sheet.

Using REDCap for eConsent development requires using REDCap survey functionality. Study team personnel build the eConsent using a REDCap eConsent template (strongly recommended) AFTER IRB approval of the consent form and use of REDCap eConsent functionality

(IRB Guidance for Using REDCap Electronic Informed Consent).

The Wright Center?s REDCap team does not prescribe the consent process. Study teams are responsible for obtaining IRB approval for the consent process and building a REDCap eConsent that is consistent with the IRB approval. The VCU IRB requires final approval of the REDCap eConsent product prior to use.

Depending upon the study requirements for consent, other more advanced features of REDCap may be required. eConsent support services are available through the Wright Center Informatics Request Form.

In order to ensure a successful eConsent implementation, study teams should plan for extended development and testing time, and possibly additional support. In addition to the technical complexities, the eConsent process may introduce some additional regulatory requirements that should be accounted for in planning.