Even if the capacity to consent is impaired, the researcher should try to obtain at least an assent as an expression of respect for the patient and as a trust-building measure,

whereas a dissent of an incompetent patient must be respected in any case. Particularly patients who are in remission from an episode of mental illness and/or who have regained the capacity to consent, as well as patients in early stages of a progressive neurodegenerative disease but still with the capacity- to consent should be encouraged and empowered to develop an selleck products advance directive lor medical interventions in situations to be expected in Inhibitors,research,lifescience,medical the future, eg, relapses/recurrences or Inhibitors,research,lifescience,medical the worsening of the illness, in

which their capacity to consent may be impaired. If possible and acceptable with regard to the value profile of the patient he/she should be asked to include a statement on a possible participation in a research project in this advance directive.48 Information on the risk:benefit ratio of the research intervention to the potential research participant (or his authorized guardian) is a core requirement of obtaining a valid consent. Recommendations Ethical questions of research with human subjects must be answered not only for controlled trials but also for naturalistic trials as well. They are related to Inhibitors,research,lifescience,medical risk-benefit-assessment and to informed consent. Informing Inhibitors,research,lifescience,medical the patient is not only a legal requirement but much more a chance to develop trust. (Hie patient who is armed with information, who wants to ask questions, should be seen as an asset in the process of care and not an impediment to it.“ (Donaldson,

cited Inhibitors,research,lifescience,medical in ref 49). It needs time and should be considered in planning the research study. In particular, vulnerable research participants should be empowered at least to assent to the research procedure besides the substituted informed consent by authorized persons. Mentally ill patients with still maintained (eg, in neurodegenerative diseases) or regained capacity to consent alter an illness episode should be encouraged to develop an advance directive for medical interventions including a possible participation in a research project. Assessment of competence to consent is needed to be sure of the validity of consent. However, there is still a lack of both Oxygenase scientifically proven and practicable standardized tests which should be overcome by further research. Consent should be related to the relevant matter in question. Occasionally it will be considered also to relate the threshold for acceptance of the competence to consent to the risk of an intervention. In practice this may be a valid consideration in order to avoid an uncritical consent of a patient to a risky intervention.