Ethical approach to informed consent for participants in clinical trials on acute phase stroke

OBJECTIVE: We sought to evaluate the application of the French law for the protection of persons participating in research studies in biology and medi cine. Specifically, we examined comprehension and consequences of informed consent procedures in the field of stroke, characterized by an emergency se tting cognitive impairment and poor prognosis. PATIENTS AND METHODS: Patients (or proxies) included in recent years in cli nical studies conducted in our Neurology Department for evaluating treatmen t of acute phase cerebral ischemia were interviewed to determine their know ledge of the disease, its treatment the study protocol and the legal regula tions, and the affective and psychological consequences of the informed con sent procedure. RESULTS: Among 72 patients included in 7 studies ([fibrinolytic agent: 3 (n = 43), anticoagulant agent: 1 (n = 4), neuroprotective drugs (n = 25)], [7 randomized studies, 6 double-blind versus placebo, 5 with a 6-hour inclusi on time interval]), 15 died during the acute phase, 5 were lost to follow-u p, 4 refused to participate and 7 gave very partial answers. Consent was si gned by the patient in 15% of cases, the spouse in 50%, a descendant in 23% . These persons were aware of the spontaneous risk of death (85%) or defini tive functional impairment (95%). Half of them thought a specific treatment existed, 11% had some idea of the mechanism of action of the proposed trea tment while 67% learned about this mechanism from the information provided. Although they had received information, only 25% of the patients had knowl edge of placebo and 7% of therapeutic risk 37% expected complete recovery f rom the treatment, 44% partial recovery, and 13% were very disappointed by the outcome. 81% felt they were free to make their own decision. Although 8 6% did not know there was a law protecting them, 82% were in agreement with the requirement for their consent while 17% would have preferred to delay consent Most wished to be given the opportunity to discuss the study again, after the acute phase, and to receive the results of the study. CONCLUSION: This study shows that most French stroke victims and their clos est relatives are unaware of the law protecting persons in biomedical resea rch and have poor knowledge of medical data after being given appropriate i nformation. Even so, the quality of information increases the quality of th e patient-physician relationship Patients want to be free to make their own decision to consent to biomedical research, but their desire was more for good information than for the power to make their decision alone. Being ask ed to give informed consent in order to participate in a clinical study acc entuates the affective and psychological consequences of stroke, a factor w hich should be taken into consideration during follow-up.