Article 60: Performance studies 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 performance study may be conducted only where, in addition to the conditions set out in Article 58(5), 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 59(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 59(2) to refuse participation in, or to withdraw from, the performance study at any time, is respected by the investigator;

(d) no incentives or financial inducements are given to subjects or their legally designated representatives, except for compensation for expenses and loss of earnings directly related to the participation in the performance study;

(e) the performance study is essential with respect to incapacitated subjects and data of comparable validity cannot be obtained in performance studies on persons able to give informed consent, or by other research methods;

(f) the performance study relates directly to a medical condition from which the subject suffers;

(g) there are scientific grounds for expecting that participation in the performance study will produce:

(i) 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 performance study 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. The subject shall as far as possible take part in the informed consent procedure.

3. Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the conduct of those performance studies on incapacitated subjects, where there are no scientific grounds to expect that participation in the performance study will produce a direct benefit to the subject outweighing the risks and burdens involved.