Improving the Efficiency of IRB through Joint IRB in Multicenter Clinical Trials in Korea

IRB Accreditation and Local IRB Operations

Ohio CTSAs implement a reliant IRB model for investigator-initiated multicenter clinical trials.

Introduction E ff ective clinical and translational research is an essential component of improving human health as delineated in the National Institutes of Health (NIH) roadmap, 1,2 yet effi ciently conducting that research remains problematic. 3,4 Challenges include the high costs of conducting research, a shortage of qualified investigators, 5 low subject enrollment rates, 6,7 slow dissemina...

To IRB or not to IRB?

Improving medical practice begins with the improvement of medical education. In this process, most academic medical faculty assume the dual roles of both teacher and researcher, often without intending to or realizing that they are. With the increased tightening of regulation and supervision of biomedical research in the United States, academic medical institutions and their individual faculty ...

IRB Proposal

The carbapenem antibiotic meropenem was initially approved by the FDA in 1995 with the dosing regimen of 1 g to be administered every 8 hours. Subsequent studies involving mathematical modeling of pharmacokinetic behavior of this antibiotic proposed a smaller effective dose of 500 mg given every 6 hours, resulting in a lower total daily dose by 1 g. Three previous clinical studies evaluating th...

Irb 101.

Residents, fellows, students, faculty, and team members are all human subjects. Assessments, test results, focus groups, journals, needs assessments, and other education projects involve human subjects. Using previously collected evaluation data obtained from human subjects (eg, trainees) also represents research qualifying for IRB review. Reviews, meta-analyses, or descriptions of educational ...