From: Electronic informed consent criteria for research ethics review: a scoping review
Engagement for comprehension | Digital content | Accessibility | Parental consent | Language | Confidentiality | Autonomy |
---|---|---|---|---|---|---|
1. Undertaking the consent process before the day of intervention | 1. Establish digital technology for participants to track the use of their biological sample over time | 1. Identify the demographics and needs of the participants | 1. Give opportunity to gather information from parents/LAR | 1. Simplify the language | 1. Use encryption for data in transit | 1. Participant is always able to control and restrict the access to the shared record |
2. Support social annotation whereby participants can see each other comments for discussions | 2. Use validated electronic signature | 2. Establish tracking mechanism for separate consents | Â | 2. Use multiple language | 2. Provide secured and proper authentication | 2. Use only explicit consent |
3. Provide interactive personnel to optimize comprehension and trust | 3. Establish digital storing biometric information on cloud storage | 3. Integrate research consent data with electronic health record | Â | Â | 3. Needs to be legally binding | 3. Participant is always able to control their own pace during consent process |
4. Fulfil general requirements and elements of informed consent | 4. Support interactive digital components such as online quiz, graphical media and audio-visual aid | 4. Participants receive a copy of the completed consent form | Â | Â | 4. Provide options to discuss in private | 4. Allow participant to amend their consent |
 | 5. Support information technology infrastructure | 5. Allow IRB oversight and amendment |  |  |  |  |