Summary
This document is a guide for researchers working with WCG IRB, detailing the processes and requirements for Institutional Review Board (IRB) review. It outlines changes made in the latest revision, including the removal of references to special considerations for unregulated research and the addition of policies regarding consent forms effective from March 1, 2024. The guide provides clarity on the definition of immediate family in the context of financial interests and introduces a short form process for participants with low literacy or visual impairments. It also describes the use of a 30-day window for continuing reviews and specifies types of recruitment incentives that are not approvable. Furthermore, the document includes sections on the informed consent process, investigator responsibilities, and various special considerations for different types of research, including drug and device studies, as well as multi-center studies.
