Comment: Capacity, consent, and country in acute stroke research

As a general principle, any research involving humans requires voluntary participation based on informed consent.1 This also applies to enrollment in clinical trials und usually requires participants to give written informed consent after having received detailed information about potential benefits and risks as well as alternative treatment options, and after having had adequate time for consideration. Trials in acute stroke, however, present several challenges to this approach. Reperfusion therapies in acute stroke show a clear time-dependent effect, being more effective the earlier treatment is started, or reperfusion achieved.2,3 Both routine care and clinical trials in acute stroke are carried out under pressure of time. Thus, time available for consideration is very short. In addition, the brain injury commonly compromises language function, awareness of neurologic deficits, conscious level, and physical abilities, including vision and writing, relevant to the usual consent process. Since most stroke patients lack capacity to provide consent,4,5 alternative approaches are needed,6,7 and the bias introduced by systematic exclusion of certain subgroups of stroke patients, e.g., those with aphasia, has been reviewed critically.8
Source: Neurology - Category: Neurology Authors: Tags: ARTICLE Source Type: research