An e-consent framework for tiered informed consent for human genomic research in the global south, implemented as a REDCap template
Database
Tsaone Tamuhla, Nicki Tiffin, Taryn Allie
BMC Medical Ethics, 24 November 2022; 23(119)
Open Access
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.

Toward Dynamic Consent for Privacy-Aware Pervasive Health and Well-being: A Scoping Review and Research Directions
Hyunsoo Lee, Uichin Lee
IEEE Pervasive Computing, 2022; pp 1-8
Abstract
Recent advances in sensor-enabled services have facilitated the use of mobile, wearable, and IoT devices; for example, an extensive range of sensor data are used to automatically track symptoms and diagnose health and well-being status of an individual (e.g., depression). As personal data are being continuously and unobtrusively sensed and collected at large scale, this raises privacy concerns in certain contexts (e.g., GPS data collection at privacy-sensitive places). Current one-off informed consent in such pervasive sensing scenarios does not offer context-awareness support that enables selective data disclosure based on a user’s needs or preferences (e.g., disabling GPS data collection when visiting hospitals). A lack of context-awareness support in informed consent would be a critical barrier to user acceptance of data-intensive pervasive computing for health and well-being. As an alternative method, we introduce the concept of “dynamic consent,” a type of informed consent that enables granular data consent and management, initially introduced in biomedical research for patient data management. We explore how this consent practice within biomedical research might inform usable privacy designs in pervasive computing by conducting a scoping review of dynamic consent literature and discussing future research directions.