e-consent within REDCap

[Liz Johnson]

Morning all,

This query possibly relates more to UK based health research, so apologies if it's not relevant.

We have a longitudinal research database in REDCap that was opened and established with paper consent forms; the CI is keen to investigate e-consent as well in order to improve recruitment. Obviously REC approvals for this change aside, I have been having a test of this and I am not sure if it would be better practice to incorporate the consent fields and surveys into the original project, or have a seperate 'consent' project so the original database doesn't break.

The team have been keeping an enrolment log where ID's are assigned, but I'm not sure if the consent survey can only auto assign a study number to the participant, or if there is a way for us to create the ID and then send the survey to the participant for consent? I'm conscious if we have a mixed model of paper and e-consent we might end up getting the study ID's mixed up. 

Does anyone have any experience using it, and have any tips for best practice? We've not used e-consent before, so any advice greatly appreciated!

Thanks,

Liz

[Rick Watts]

Here in our academic clinical trials in Canada we almost always separate the consent from the clinical database. There are a couple of reasons for this...

1. Separating the two reduces the number of potential identifiers in the clinical database. (We always have identifiers in the eConsent and separating the two is more acceptable to our REB and privacy office).
2. Often, our projects do not enter screen failures into the main database. Therefore, if a patient does not consent they are not "taking up space" in the main study database. This generally makes the data management and reporting easier.

Rick Watts

Team Lead, Research Informatics, Women and Children’s Health Research Institute

Health Research Data Strategist, College of Health Sciences

rick....@ualberta.ca

University of Alberta

5-083 Dianne and Irving Kipnes Health Research Academy

11405 87 Avenue NW Edmonton, AB T6G 1C9

F:  (780) 248-5616

        

WCHRI is a partnership between the University of Alberta and Alberta Health Services, funded by the generosity of the Stollery Children's Hospital Foundation and the Alberta Women’s Health Foundation.

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