eIC Reviewer Resources
Reviewer Considerations:
Click here to access a quick reference table for each protocol type.
Use of the technology:
- Will the population be able to use eConsent?
- Will the population have access to the devices/internet to use eConsent?
- The readability of the eConsent on different devices (phones, tablets, desktop computers)
- Verify changes to the eTemplates are appropriate and needed
- Verify that only approved software and communications products are used (Qualtrics, REDCap, Zoom)
Remote eConsent:
- Was the email of the participant/LAR obtained in a compliant manner?
- How will the research be explained to the participant/LAR (Zoom, telephone call)?
- How will the contact be scheduled with the transmission of the eConsent form? When will the form be sent and when will the contact occur?
- The FDA requires some form of verification of identity for remote eConsent. For Example, checking a form of official ID such as a birth certificate, government issue passport, driver's license OR the use of three security questions to use as a login for the link to the eConsent. For minors, Assent and Parental/LAR Consent.
- If assistance is needed for reviewing and signing the eConsent form, how will this be provided?
In Person eConsent:
- How will the participant/LAR receive a copy of the signed form if using eConsent in person
- What device will be used?
Using Paper and eConsent Together:
- Federally Funded research requires that a paper form be offered unless the research cannot be completed without remote eConsent.
- Paper Informed Consent Forms (PDFs) cannot be emailed to/from participants/LARs unless approved by the WVU IRB and SECURE email controls are used.
Review the eTemplate:
- Is the PDF of the Informed Consent Form loaded as a readable image? OR are the contents of the Informed Consent Form/Letter entered in a readable manner?
- Is the PDF of the Informed Consent Form attached as a PDF for ADA compliance and for records (Qualtrics Only) IF the contents of the Informed Consent Form/Cover Letter were not entered as text into the eTemplate?
Protocol Submission Requirements:
- The eIC Submission Worksheet
- The url to the eConsent eTemplate (included in the eIC Submission Worksheet) - Note Informed Consent Forms and Cover Letters will not be included for the submission, the placeholder documents will be included in the eTemplate. The researcher will attach and upload the approved and watermarked PDFs AFTER protocol approval.
- The PDF of the eConsent eTemplate attached in the Attachments section
- The Word document for the Informed Consent Form/Cover Letter/HIPAA Authorization if applicable
- Links and PDF attachments for other electronic materials that will be presented to the participant/LAR.