Lack of international consensus on ethical aspects of acute stroke trials.

ABSTRACT

Acute stroke trials are becoming increasingly multinational. Working toward a shared ethical standard for acute stroke research necessitates evaluating the degree of consensus among international researchers. We surveyed all 275 coinvestigators and coordinators who participated in the AbESTT II study (evaluating abciximab vs placebo) about their experience with their local institutional review board (IRB) or equivalent, as well as, about their personal beliefs regarding the ethical aspects of acute stroke trials. A total of 90 coinvestigators from 15 different countries responded to our survey. Among the IRBs represented by the responding coinvestigators, only 18% allowed surrogate consent to be obtained over the phone. Although 52% allowed the participation of subjects with aphasia, only 5% allowed the participation of subjects with neglect/hemi-inattention. The National Institutes of Health Stroke Scale score was deemed adequate to establish decisional capacity based on language by 62% of the coinvestigators and 36% of the IRBs. A belief that IRB regulations cause unnecessary delays and fear in relatives/patients was reported by 67% of coinvestigators, and the belief that granting an exemption from informed consent under specific circumstances is appropriate was reported by 41%. There appears to be considerable international diversity in the ethical priorities and informed consent standards among different IRBs and investigators in stroke research. The stroke community should make an attempt to standardize the consent process used in research. Given the critical nature of the time to treatment in stroke care, these standards should be integrated into current frameworks of clinical care and research. The absence of an ethical consensus can become a barrier to advancing stroke treatment internationally.