TABLE 6.

Potential advantages and challenges of alternative methods to re-consent for already included research participants.

Obtaining oral consent, supplemented with email confirmation
(Potential) advantages	(Potential) challenges
• Saves participants to visit the research site • No pressure to provide research information during a medical consultation • Manageable	• Legality • Adequate email encryption to avoid a data breach • Identity check of participants • Traceability in case of audits and inspections
Obtaining oral consent, followed by an appropriately signed and dated IC as soon as possible
(Potential) advantages	(Potential) challenges
• Saves participants to visit the research site • No pressure to provide research information during a medical consultation • Appropriate security and attributability	• Legality • Identity check of participants • Susceptible to documentation issues because of the risk of forgetting to obtain the participants’ written IC later on
Using validated electronic systems
(Potential) advantages	(Potential) challenges
• Saves participants to visit the research site • No pressure to provide research information during a medical consultation • Unequivocal documentation and storage of signed consent forms • Information can be provided via multiple media	• Legality • Complex for participants who lack digital literacy • Access to electronic means • Numerous eIC systems are confusing • The setup may place time and logistical demands on the sponsor/study team