TABLE 7.

points to consider in relation to informed consent.

Procedural	Substantial
- Informed consent from participants with decisional capacity or their legally authorized	- Potential risks, benefits and uncertainties
representative should be obtained
- Relevant information about the trial, should also be presented visually	- Composition of the product
- Patients should be encouraged to ask questions	- The irreversible nature of the intervention
- Scientific jargon should be avoided by using only simple words or easily understood terminology	- How adverse events will be dealt with - The right and practical difficulty
- The teach-back method, exams or questionnaires could be used to ensure that participants	to withdraw
understand the relevant information	- How life-long follow up will be organized
- Participants should be encouraged to ask independent experts/patient advocates for advice or assistance in the decision-making process	- The possibility to consent for partial or complete autopsy in the event of death
- Participants need to be informed that the intervention is not likely to provide direct medical benefits