TABLE 7.
Obtaining oral consent in the presence of an impartial witness, who signs and dates the IC | |
(Potential) advantages | (Potential) challenges |
• Trustworthy • Ensures impartiality |
• Legality • Susceptible to documentation issues • Burdensome |
Signing and dating separate IC forms, followed by an appropriately signed and dated IC form as soon as possible | |
(Potential) advantages | (Potential) challenges |
• Pragmatic solution | • Legality • Susceptible to documentation issues • Burdensome |
Using validated electronic systems | |
(Potential) advantages | (Potential) challenges |
• Saves patients to visit the research site • 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 |