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Dear RCN,
I have a quick question to ask about REDCap eConsent in preparation for a Friday afternoon meeting. I hope your responses can help our group make some decisions about keeping a current process or making some changes.
Our HRPP policies require that non-exempt research that doesn’t have a waiver of documentation approved will require signing the IRB-approved, stamped consent form. For REDCap consent this means that subjects sign within a REDCap project that includes scrolling through a PDF of the IRB approved stamped consent form. The signatures, and any checkboxes are then completed via the signatures within REDCap, per the REDCap eConsent platform.
I’d like to get a sense of how many institutions follow a similar requirement to use the PDF of the stamped consent form pages, and conversely, how many allow the consent language to be typed into REDCap. And for the latter method, is there anything further information you can provide regarding ensuring that the consent language typed into REDCap is in fact the IRB-approved language?
Thank you!
Mary-Tara
___________________________________________________
Mary-Tara Roth, RN, MSN, MPH
Director, Clinical Research Resources Office
Boston University Medical Campus/Boston Medical Center
72 East Concord Street, Evans 708
Boston, MA 02118
617-358-7679 (ph)
Hi Mary-Tara-
At Cedars-Sinai, we follow the same process you described at BU – a PDF of the IRB stamped consent is uploaded to REDCap and participants are asked to read through that, then sign in the platform. We technically allow the copy/paste method as well, but most teams elect the PDF method. My team reviews each eIC project in REDCap once it is moved to Production, to ensure it conforms with what was IRB approved.
Best,
Leah Silbert
Manager, Post Approval Monitoring and Research Compliance
