Ischemic Stroke Survivors’ Opinion Regarding Research Utilizing Exception from Informed Consent

Abstract

Introduction: ‘Exception from informed consent for research’ (EFIC) is a rigorous procedure regulated by the FDA that requires community assent but allows enrollment without patient or family consent. Recently, several acute stroke trials have explored the use of EFIC to improve enrollment. We obtained ischemic stroke survivors’ opinions regarding hypothetical enrollment into a clinical trial at the time of their stroke without personal or proxy consent. Methods: During 2005, 460 ischemic stroke patients (or their proxy) who met case criteria were prospectively interviewed and followed. After 2 years, patients were asked to think back to the time of their stroke and indicate whether they would have wished to be enrolled in an acute stroke research study before individual or proxy consent could be obtained, understanding that consent would be sought as soon as possible thereafter, and they rated how agreeable they would have been to acute stroke research with different levels of invasiveness. Predictors of a positive opinion regarding the hypothetical research were analyzed using logistic regression. Variables included in the model were age, race, sex, education, initial NIHSS, modified Rankin Scale prior to stroke and 30 days after stroke, and proxy versus patient responder. Results: At 2 years after stroke, after excluding patient deaths, missing data or refusals, there were 194 patient/proxy responses included in this analysis. Overall, 72–79% of responses were favorable for chart review or blood draw without consent. The proportions answering agreeably to questions about medications or invasive strategies were smaller (62.9 and 59.8%). Older subjects were less likely to offer an agreeable response regarding use of medications [OR 0.97 per year (95% CI 0.94–0.99)] and invasive procedures [OR 0.97 per year (95% CI 0.94–0.99)]. Nonblacks tended to be more agreeable than blacks to invasive procedures. Men had twice the odds of being agreeable to blood draws than women. Conclusions: We found that the majority of interviewed ischemic stroke patients were agreeable to being enrolled in acute stroke research with exception from informed consent, although the rates of agreement were lower than we expected among a cohort of patients who had already agreed to research. Older subjects, black race, and women were less likely to agree to blood draws or treatment strategies.

Effect of informed consent on patient characteristics in a stroke thrombolysis trial

“…In prospective interview studies, a majority of patients agreed to participate in acute stroke trials without conventional informed consent. 26 , 27 The concept of exception from informed consent for clinical research in neurologic emergency conditions like stroke was also generally accepted and deemed appropriate given approval of institutional review boards in a qualitative study of several focus groups including stroke patients, their families, and healthy young individuals. 28 …”

Exception from informed consent for emergency research

“…6–15 Because each potential emergency research protocol draws on a uniquely different “community,” it is essential that researchers consult with the “community” from which the subjects will be drawn to truly engage in the consultation process. While defining the community of interest may be the most obvious first step, it is perhaps one of the most challenging requirements of emergency research.…”

SCING—Spinal Cord Injury Neuroprotection with Glyburide: a pilot, open-label, multicentre, prospective evaluation of oral glyburide in patients with acute traumatic spinal cord injury in the USA

“…As a result, in preparation for the next potential exploratory trial phase, we are currently evaluating the option of administering glyburide under (EFIC; 21 Code of Federal Regulations §50.24) guidelines,44 which would need to be undertaken with patient/public consultation and in collaboration with emergency medical services. While time-consuming and expensive, the stroke research field has ultimately benefited significantly from EFIC trials 45–49…”