Updated WPPs Available
The IRB’s Written Policies and Procedures (WPPs) were updated as of 4/15/2021 and are now available on the IRB’s website.
Many of the updates were minor, such as adding new links to resources on state-mandated disease reporting, IRB guidance on cold calling and use of social media, and an IRB video about reconsenting children when they turn 18. Several edits were made to clarify nuances of certain IRB procedures.
WPP #: XVII-17 was revised to remove the National Institute on Disability and Rehabilitation Research (NIDRR) requirements for human subject protection. This WPP will not only relate to Department of Education requirements.
Finally, several WPPs were updated to remove references about not using REDCap to obtain consent signatures.
The REDCap team at the Wright Center has developed new e-Consent templates that can now support obtaining legally valid signatures when the necessary settings and approvals are in place. Additional guidance and instructions on when and how to use REDCap’s e-Consent templates and what to submit in amendments will be forthcoming from the IRB.
CAUTIONS about the use of REDCap for e-Consent:
- Minimal risk studies wishing to use REDCap in the consent process may still request waivers of documentation of consent.
- Investigators MUST USE the e-Consent Project templates (a series of 4+ forms/surveys) in order to have the workflows to obtain valid signatures.
- Selecting only the eConsent Framework/PDF Auto Archiver setting within Survey Settings does NOT obtain valid signatures – the full template must be used.
- The IRB must specifically approve studies to use REDCap for electronic consent signatures.
For more information on methods of obtaining remote consent signatures, see the Informed Consent accordion at https://research.vcu.edu/human-research/hrppirb/hrpp-policies-and-guidance/
Categories Announcements and Updates, Uncategorized