Research with incapacitated subjects

The WMO applies the ‘no, unless’ principle for incapacitated subjects. Scientific research with these people is in principle forbidden. The only exception to this is research which may be of direct benefit to the research subject (therapeutic) or, in the case of non-therapeutic research, research which is conducted with a selected population (group restricted) and of which the risks and burden for this group are minimal compared to the standard treatment of their condition or, if there is no standard treatment, given the severity and nature of their condition.

Research subjects are capacitated if they:

• are 16 years or older, and
• are able to make a reasonable judgement of their own interests with regards to the study.

Subjects aged 16 years and older who are not able to do this are deemed to be incapacitated. The same applies to subjects under the age of 16 years.