Subjects incapable of giving informed consent

Some adults (in this context, that is people aged 16 and over) and children are incapable of giving informed consent, for example people with dementia, intellectual disabilities or a severe psychiatric disorder and coma patients. They are considered ‘decisionally incompetent’. They are not always able to determine what is in their own interest.

Important decisions are made for them by a representative, such as their parents, spouse or children. Sometimes the court appoints a representative.

People who are decisionally incompetent can participate in research but only if it meets stricter criteria, for example about the risks and stress factors that they can be exposed to. The risks and burden of participation may not be excessive. There are also specific rules about giving consent. The decision about whether the person will participate in a research project is made by their representative.  A representative can also decide that the person should stop taking part in the research project.

If a decisionally incompetent person displays resistive behaviour during the research project, their participation is halted. Before the research project begins, the researcher will discuss with the representative what will be regarded as resistive behaviour, for example severe anxiety, distress or anger.