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Table 2 New synthesized constructs for electronic informed consent

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

 

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

  

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

  

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

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