Effect of waivers of consent on recruitment in acute stroke trials: A systematic review.

ABSTRACT: There is urgent need for clinical trials of novel interventions to reduce the burden of acute ischemic stroke. A key impediment to such trials is slow recruitment. Since obtaining written informed consent in the setting of acute stroke is especially challenging, some experts have endorsed relaxing the requirement for informed consent by permitting verbal consent or waivers to facilitate recruitment. This systematic review of 36 randomized controlled trials of acute interventions for ischemic stroke assesses whether alternatives to written informed consent are associated with increased recruitment rates. After the exclusion of 2 outlier trials that differed from other trials in conduct and interventions studied, no association was observed on univariable analysis (8.9 participants/month in

SUBMITTER: Feldman WB 

PROVIDER: S-EPMC4836887 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature