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Preparation of Graphene-Supported Microwell Liquid Cells for In Situ Transmission Electron Microscopy
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Evaluation of a REDCap-based Workflow for Supporting Federal Guidance for Electronic Informed Consent.

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Implementing electronic informed consent (eConsent) using REDCap supports 86% of federal guidance requirements. This research workflow may reduce barriers to eConsent adoption in clinical research.

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Area of Science:

  • Clinical Research Informatics
  • Regulatory Science

Background:

  • Electronic informed consent (eConsent) offers benefits over paper-based methods, including enhanced patient comprehension and improved workflow.
  • Despite advantages, eConsent adoption in research settings remains low.

Purpose of the Study:

  • To evaluate the adherence of a REDCap-based eConsent workflow to federal guidance.
  • To identify potential barriers and facilitators for eConsent implementation.

Main Methods:

  • A REDCap eConsent workflow was implemented at an institutional level.
  • Federal guidance from the Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA) was reviewed, yielding 29 specific requirements.
  • The REDCap eConsent solution was assessed against these 29 requirements.

Main Results:

  • The REDCap eConsent workflow supported 24 out of 29 (86%) federal guidance requirements.
  • This evaluation represents one of the initial assessments of an eConsent approach against established federal guidelines.

Conclusions:

  • The REDCap eConsent solution demonstrates substantial alignment with federal requirements for electronic informed consent.
  • Findings suggest REDCap can mitigate adoption barriers for eConsent, potentially encouraging wider use.
  • Recommendations are made for OHRP and FDA to encourage integration of eConsent solutions with broader clinical and research information systems.