The impact of central IRB's on informed consent readability and trial adherence in SPRINT.

ABSTRACT:

Background

Federal agencies have encouraged the use of central institutional review boards (CIRBs) for multi-site clinical trials. There is limited evidence supporting the use of CIRBs. Our aim is to evaluate how SPRINT sites regulated by CIRBs performed regarding informed consent readability and participant trial adherence compared to those regulated by local IRBs.

Methods

We conducted a cohort study using the SPRINT clinical trial. We collected the IRB of record from the stamped and approved 2012 informed consents from each of the sites. We defined CIRB as an IRB for more than one SPRINT site. Our outcomes were informed consent readability measured using the Flesch-Kincaid readability scale and trial adherence defined as a loss to follow-up, consent withdrawal, and missed

SUBMITTER: Tamariz L 

PROVIDER: S-EPMC6627564 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature