University of Cincinnati, Cincinnati, Ohio 45267-0525, USA.
Cerebrovasc Dis. 2011;32(4):321-6. doi: 10.1159/000328815. Epub 2011 Sep 15.
'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.
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.
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.
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.
“研究的知情同意豁免（EFIC）”是 FDA 监管的一项严格程序，要求社区同意，但允许在没有患者或家属同意的情况下入组。最近，几项急性中风试验探索了使用 EFIC 来提高入组率。我们在患者中风时获得了中风幸存者对假设性临床试验入组的意见，而无需患者或其代理人的同意。
2005 年期间，前瞻性采访并随访了 460 名符合病例标准的缺血性中风患者（或其代理人）。2 年后，患者被要求回想他们中风时的情况，并表明在获得个人或代理同意之前，他们是否希望参加一项急性中风研究，因为此后将尽快寻求同意，他们还根据不同的侵袭性程度对不同程度的急性中风研究的可接受性进行了评分。使用逻辑回归分析了对假设研究的积极意见的预测因素。纳入模型的变量包括年龄、种族、性别、教育程度、初始 NIHSS、中风前和中风后 30 天的改良 Rankin 量表，以及代理人与患者的应答者。
中风后 2 年，排除患者死亡、数据缺失或拒绝后，共有 194 名患者/代理人的回复纳入了本分析。总体而言，72-79%的回复者对未经同意进行病历回顾或采血表示赞成。对关于药物或侵袭性策略的问题回答同意的比例较小（62.9%和 59.8%）。年龄较大的患者不太可能对使用药物[OR 0.97 岁（95%CI 0.94-0.99）]和侵袭性治疗[OR 0.97 岁（95%CI 0.94-0.99）]的回答表示同意。非黑人比黑人更倾向于同意进行侵袭性治疗。男性同意采血的可能性是女性的两倍。
我们发现，大多数接受采访的缺血性中风患者同意在知情同意豁免的情况下参加急性中风研究，尽管在已经同意研究的患者队列中，同意率低于我们的预期。年龄较大的患者、黑人种族和女性更不可能同意采血或治疗策略。
