**9. Clinical trials on people affected by mental health disorder**

Clinical trials involving patients with psychosocial or cognitive disorders, as well as those suffering from drug or alcohol addiction bring up an ethical question—if these patients are able to make their own rational decisions.

People with intellectual or psychosocial disorders are deprived of their legal capacity and put under some form of guardianship. There are two main guardianship models: full and partial. People under partial guardianship keep their main civil rights but certain capacities are transferred to a legal representative, such as financial affairs. Those under full guardianship, on the other hand, lose almost all of their civil rights.

There are European countries where guardians besides other life spheres are also empowered to take decisions on behalf of the individual in regards to health care. Guardian's consent may result in hospitalisation or medical interventions. This is considered as voluntary, even though the consent from the individual concerned is not present. The interventions might even be against the individual's expressed will, however in a legal sense will still be considered as voluntary. In other European countries, guardians or other legal representatives cannot make health care decisions. However, non-consensual interventions in the psychiatric field are still possible in most countries if a doctor finds them necessary and a court confirms the same.

European legislation outlines additional protection requirements towards inclusion of incapacitated patients into clinical trials:


In the past years, the so-called paradigm shift in disability policy is widely discussed. This is a shift from the deprival of legal capacity to the right to support for exercising legal capacity.

Such example is a person diagnosed with Down's syndrome applying for a certain service. If he/she is provided information in easy-to-read format and adequate time and support, he/ she may be able to understand pros and cons of the service and choose whether or not to use it. In this situation, no disability arises. However, if information is provided in standard language and no additional effort taken to explain it in a manner adequate to person's condition, disability becomes a fact. The paradigm shift calls for legal, attitudinal and environmental changes [12].
