PART 5
CONDITIONS AND PRINCIPLES WHICH APPLY IN RELATION TO AN INCAPACITATED ADULT
Conditions
1. The subject's guardian has had an interview with the investigator, or another member of the investigating team, in which he or she has been given the opportunity to understand the objectives, risks and inconveniences of the clinical trial and the conditions under which it is to be conducted.
2. The guardian has been provided with a contact point where he or she may obtain further information about the clinical trial.
3. The guardian has been informed of the right to withdraw the subject from the clinical trial at any time.
4. The guardian has given his informed consent to the subject taking part in the clinical trial.
5. The guardian may, without the subject being subject to any resulting detriment, withdraw the subject from the clinical trial at any time by revoking his or her informed consent.
6. The subject has received information according to his or her capacity of understanding regarding the clinical 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of forming an opinion and assessing the information referred to in paragraph 6 to refuse participation in, or to be withdrawn from, the clinical trial at any time is considered by the investigator.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 guardian, except provision for compensation in the event of injury or loss.
9. There are grounds for expecting that administering the medicinal product or medical device 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 —
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(a) in other clinical trials involving persons able to give informed consent; or
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(b) by other research methods.
11. The clinical trial relates directly to a life-threatening or debilitating clinical condition from which the subject suffers.
Principles
12. Informed consent given by a guardian to an incapacitated adult in a clinical trial shall represent that adult's presumed will.
13. The clinical trial has been designed to minimize 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.