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. 2019 May 6:2019:163-172.
eCollection 2019.

Evaluation of a REDCap-based Workflow for Supporting Federal Guidance for Electronic Informed Consent

Cindy Chen  1 , Scott P Turner  1 , Evan T Sholle  1 , Scott W Brown  1 , Vanessa L I Blau  1 , Julianna P Brouwer  2 , Alicia N Lewis  2 , Curtis L Cole  1   2   3 , David M Nanus  2 , Manish A Shah  2 , John P Leonard  2 , Thomas R Campion  1   3   4
Affiliations

Evaluation of a REDCap-based Workflow for Supporting Federal Guidance for Electronic Informed Consent

Cindy Chen et al. AMIA Jt Summits Transl Sci Proc. .

Abstract

Adoption of electronic informed consent (eConsent) for research remains low despite evidence of improved patient comprehension, usability, and workflow processes compared to paper. At our institution, we implemented an eConsent workflow using REDCap, a widely used electronic data capture system. The goal of this study was to evaluate the extent to which the REDCap eConsent solution adhered to federal guidance for eConsent. Of 29 requirements derived from sixteen recommendations from the United States Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA), the REDCap eConsent solution supported 24 (86%). To the best of our knowledge, this is among the first studies to evaluate an eConsent approach's support for federal guidance. Findings suggest use of REDCap may help other institutions overcome barriers to eConsent adoption, and that OHRP and FDA expand guidance to recommend eConsent solutions integrate with enterprise clinical and research information systems.

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Figures

Figure 1.
Figure 1.
Workflow required by research coordinator and participant for informed consent using REDCap on a tablet.
Figure 2.
Figure 2.
Initial screen displaying fields for participant demographics.
Figure 3.
Figure 3.
Consent election options and signature.
Figure 4.
Figure 4.
Withdrawal decision and reason.
See this image and copyright information in PMC

References

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