An e-consent framework for tiered informed consent for human genomic research in the global south, implemented as a REDCap template

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.

Multiple modes of data sharing can facilitate secondary use of sensitive health data for research

“…Consent protocols and documents must be robust, and those conducting the primary study need to ensure that relevant consent that allows for secondary use of the data is in place, and that the consent documents are aligned with the intended onward use of the data and/or biospecimens 53. This is essential for direct sharing where control over secondary use is completely relinquished and the primary data generators lose oversight of the onward use of the data.…”

“…Consent protocols and documents must be robust, and those conducting the primary study need to ensure that relevant consent that allows for secondary use of the data is in place, and that the consent documents are aligned with the intended onward use of the data and/or biospecimens. 53 This is essential for direct sharing where control over secondary use is completely relinquished and the primary data generators lose oversight of the onward use of the data. In addition, if any commercial onward use is intended, participants need to have specifically consented for the use of their data for commercial purposes, and any share in profits or benefits from such onward use, or lack thereof, needs to be clearly identified in the consent information for the participants.…”

Research Electronic Data Capture (REDCap): A survey of user preferences and needs for health data collection (Preprint)

“…[13] Researchers have reported frequently on implementation, utilization, and interventions using REDCap. [10,[14][15][16][17][18][19][20] Understanding preferences and needs of REDCap administrators and researchers utilizing REDCap to capture data could help enhance existing features and EDC processes in general. While REDCap is a robust clinical research data management system, this study solely focuses on the experience of REDCap as an EDC tool.…”