Informed consent and decision-making capacity in neuromodulation: ethical considerations.

In neuromodulation treatment and research, the informed consent of the patient or research subject is considered to be a moral precondition. In order to be morally valid, the consent of the person should be informed and voluntarily given, and the person should have decision-making capacity. Decision-making capacity matters from a moral point of view because it enables the patient or research subject to make a well-considered decision about treatment or research participation. Decision-making capacity is an ideal and in the practice of neuromodulation may be compromised as a result of different circumstances. These may be internal or external. Internal are factors related to illness (ie, cognitive and emotional defects; feelings of desperation and hopelessness); external are factors related to the context (ie, shortcomings in patient education and communication). In this paper, it is argued that full decision-making capacity in the context of neuromodulation is an illusion. This does not imply that we should do away with the moral ideals of decision-making capacity and valid informed consent. It is part of the responsibility of clinicians involved in neuromodulation to be aware of and sensitive to the different threats to the decision-making capacity of patients suffering from neurological and neuropsychiatric disorders, and to assist patients in making decisions that are as well considered as possible in the given circumstances.