An e-consent framework for tiered informed consent for human genomic research in the global south, implemented as a REDCap template
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Date
2022
Journal Title
Journal ISSN
Volume Title
Publisher
BMC Medics
Abstract
Research involving human participants requires their consent, and it is common practice to capture consent information
on paper and store those hard copies, presenting issues such as long-term storage requirements, inefficient
retrieval of consent forms for reference or future use, and the potential for transcription errors when transcribing
captured informed consent. There have been calls to move to electronic capture of the consent provided by research
participants (e-consent) as a way of addressing these issues. A tiered framework for e-consent was designed using
the freely available features in the inbuilt REDCap e-consent module. We implemented ‘branching logic’, ‘wet signature’
and ‘auto-archiver’ features to the main informed consent and withdrawal of consent documents. The branching
logic feature streamlines the consent process by making follow-up information available depending on participant
response, the ‘wet signature’ feature enables a timestamped electronic signature to be appended to the e-consent
documents and the ‘auto-archiver’ allows for PDF copies of the e-consent documents to be stored in the database.
When designing the content layout, we provided example participant information text which can be modified
as required. Emphasis was placed on the flow of information to optimise participant understanding and this was
achieved by merging the consent and participant information into one document where the consent questions were
asked immediately after the corresponding participant information. In addition, we have provided example text for a
generic human genomic research study, which can be easily edited and modified according to specific requirements.
Building informed consent protocols and forms without prior experience can be daunting, so we have provided
researchers with a REDCap template that can be directly incorporated into REDCap databases. It prompts researchers
about the types of consent they can request for genomics studies and assists them with suggestions for the language
they might use for participant information and consent questions. The use of this tiered e-consent module can ensure
the accurate and efficient electronic capture and storage of the consents given by participants in a format that can
be easily queried and can thus facilitate ethical and effective onward sharing of data and samples whilst upholding
individual participant preferences.
Description
Keywords
Tiered informed consent, Participant information, REDCap
Citation
Tamuhla, T., Tiffin, N., & Allie, T. (2022). An e-consent framework for tiered informed consent for human genomic research in the global south, implemented as a REDCap template. BMC Medical Ethics, 23(1) doi:10.1186/s12910-022-00860-2