TABLE 7.
Potential advantages and challenges of alternative methods to obtain informed consent from COVID-19 patients.
| 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 |