Article 31U.K.Clinical trials on incapacitated subjects
1.In the case of incapacitated subjects who have not given, or have not refused to give, informed consent before the onset of their incapacity, a clinical trial may be conducted only where, in addition to the conditions set out in Article 28, all of the following conditions are met:
(a)the informed consent of their legally designated representative has been obtained;
(b)the incapacitated subjects have received the information referred to in Article 29(2) in a way that is adequate in view of their capacity to understand it;
(c)the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing the information referred to in Article 29(2) to refuse participation in, or to withdraw from, the clinical trial at any time, is respected by the investigator;
(d)no incentives or financial inducements are given to the subjects or their legally designated representatives, except for compensation for expenses and loss of earnings directly related to the participation in the clinical trial;
(e)the clinical trial is essential with respect to incapacitated subjects and data of comparable validity cannot be obtained in clinical trials on persons able to give informed consent, or by other research methods;
(f)the clinical trial relates directly to a medical condition from which the subject suffers;
(g)there are scientific grounds for expecting that participation in the clinical trial will produce:
a direct benefit to the incapacitated subject outweighing the risks and burdens involved; or
some benefit for the population represented by the incapacitated subject concerned when the clinical trial relates directly to the life-threatening or debilitating medical condition from which the subject suffers and such trial will pose only minimal risk to, and will impose minimal burden on, the incapacitated subject concerned in comparison with the standard treatment of the incapacitated subject's condition.
2.Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the conduct of those clinical trials on incapacitated subjects, where there are no scientific grounds to expect that participation in the clinical trial will produce a direct benefit to the subject outweighing the risks and burdens involved.
3.The subject shall as far as possible take part in the informed consent procedure.