1. The subject’s legal representative has had an interview with the investigator, or another member of the investigating team, in which he has been given the opportunity to understand the objectives, risks and inconveniences of the trial and the conditions under which it is to be conducted.
2. The legal representative has been provided with a contact point where he may obtain further information about the trial.
3. The legal representative has been informed of the right to withdraw the subject from the trial at any time.
4. The legal representative has given his informed consent to the subject taking part in the trial.
5. The legal representative may, without the subject being subject to any resulting detriment, withdraw the subject from the trial at any time by revoking his informed consent.
6. The subject has received information according to his capacity of understanding regarding the trial, its risks and its benefits.
7. The explicit wish of a subject who is capable of forming an opinion and assessing the information referred to in the previous paragraph to refuse participation in, or to be withdrawn from, the clinical trial at any time is considered by the investigator.
8. No incentives or financial inducements are given to the subject or their legal representative, except provision for compensation in the event of injury or loss.
9. There are grounds for expecting that administering the medicinal product to be tested in the trial will produce a benefit to the subject outweighing the risks or produce no risk at all.
10. The clinical trial is essential to validate data obtained—
(a)in other clinical trials involving persons able to give informed consent, or
(b)by other research methods.
11. The clinical trial relates directly to a life-threatening or debilitating clinical condition from which the subject suffers.
12. Informed consent given by a legal representative to an incapacitated adult in a clinical trial shall represent that adult’s presumed will.
13. The clinical trial has been designed to minimise pain, discomfort, fear and any other foreseeable risk in relation to the disease and the cognitive abilities of the patient.
14. The risk threshold and the degree of distress have to be specially defined and constantly monitored.
15. The interests of the patient always prevail over those of science and society.