S.L. 458.43 Art. 5Clinical trials on minors.

Without prejudice to any other relevant restriction, a clinical trial on minors may only be undertaken if -

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

(b) the minor has received information according to his capacity of understanding, from staff with experience with minors, regarding the trial, the risks and the benefits;

(c) the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation or to be withdrawn from the clinical trial at any time is given due consideration by the investigator or, where appropriate, the principal investigator;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) some direct benefit for the group of patients is expected from the clinical trial and only where such research is essential to validate data obtained in clinical trials on persons able to give informed consent or by other research methods; additionally, such research should either relate directly to a clinical condition from which the minor concerned suffers or be of such a nature that it can only be carried out on minors;

(f) the corresponding scientific guidelines of the Agency have been followed;

(g) 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 have to be specially defined and constantly monitored;

(h) the Ethics Committee, with pediatric expertise or after taking advice in clinical, ethical and psychosocial problems in the field of pediatrics, has endorsed the protocol; and

(i) the interests of the patient always prevail over those of science and society.