PART 3
CONDITIONS WHICH APPLY IN RELATION TO AN ADULT ABLE TO CONSENT OR WHO HAS GIVEN CONSENT PRIOR TO THE ONSET OF INCAPACITY
1. The subject 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 subject has been informed of his or her right to withdraw from the clinical trial at any time.
3. The subject has given his or her informed consent to taking part in the clinical trial.
4. The subject may, without being subject to any resulting detriment, withdraw from the clinical trial at any time by revoking his or her informed consent.
5. The subject has been provided with a contact point where he or she may obtain further information about the trial.