S.L. 458.43 Art. 6Clinical trials on incapacitated adults not able to giveinformedlegal consent.

(1) For the performance of clinical trials on persons incapable of giving informed legal consent, all relevant requirements listed for persons capable of giving such consent shall also apply. Furthermore, clinical trials on incapacitated adults who have not given and not refused informed consent before the onset of their incapacity, shall only be allowed if:

(a) the informed consent of the legal representative has been obtained; consent must represent the subject’s presumed will and may be revoked at any time, without detriment to the subject;

(b) the person not able to give informed legal consent has received information according to his capacity of understanding regarding the trial, the risks and the benefits;

(c) the explicit wish of a subject who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time is given due consideration by the investigator or where appropriate the principal investigator;

(d) no incentives or financial inducements are given except agreed compensation;

(e) such research is essential to validate data obtained in clinical trials on persons able to give informed consent or by other research methods and relates directly to a life-threatening or debilitating clinical condition from which the incapacitated adult concerned suffers;

(f) clinical trials have been designed to minimise pain, discomfort, fear and any other foreseeable risk in relation to the disease and developmental stage; both the risk threshold and the degree of distress shall be specially defined and constantly monitored;

(g) the Ethics Committee, with expertise in the relevant disease and the patient population concerned or after taking advice in clinical, ethical and psychosocial questions in the field of the relevant disease and patient population concerned, has endorsed the protocol;

(h) the interests of the patient always prevail over those of science and society; and

(i) there are grounds for expecting that administering the medicinal product to be tested will benefit the patient outweighing the risks or produce no risk at all.