Research with incapacitated participants

The WMO applies the ‘no, unless’ principle for incapacitated participants. 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 participant (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 participants 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.

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