Understanding Barriers To Recruitment And Why Patients And Surrogates Consent For Critical Care Research: The Consent Study (A CCCTG Project)

Rates and determinants of informed consent: A case study of an international thromboprophylaxis trial

“…This rate is comparable with the 81% a priori consent rate for a multicenter trial of pulmonary artery catheters in the United Kingdom, which used both a priori and deferred consent [11]. In a recent multicenter study, 435 consent encounters for various studies across 22 Canadian ICUs were analyzed; when a consent discussion occurred for enrollment in either a randomized trial or observational study, consent was obtained after 77% of encounters [16].…”

“…Participating centers had a median of 20 ICU beds [16,26] and 2 full-time equivalent research staff [1,2]. Most patients (4448, 97.6%) were invited to participate in universityaffiliated ICUs.…”

“…Among oncology patients considering enrollment in a phase III drug study, consent was more likely when the patient was first approached by a physician rather than a research coordinator [28]. In contrast, a Canadian cross-sectional investigation of multiple studies found no difference in consent outcomes based upon the professional designation of the person attempting to obtain consent [16]. The impact of a physician introduction on research consent rates in the ICU is currently being tested in a randomized trial (clinicaltrials.gov, NCT01232621).…”