IRB reliance: An informatics approach

IRB Accreditation and Local IRB Operations

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 ...

Quantum Approach to Informatics