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 various sections that have been revised in this version, including additional instructions and clarifications regarding exemptions, document submission requirements, and guidance on subject materials. The guide emphasizes the importance of submitting all necessary documents for initial review to avoid additional fees and provides best practices for submitting advertising and recruitment materials. It also discusses the regulatory framework affecting clinical research, including HIPAA compliance, conflicts of interest, and informed consent processes. The document includes specific sections on the consent process, including responsibilities of investigators, issues to consider, and requirements for consent forms. Additionally, it addresses special considerations for various types of research, including drug and device studies, and provides resources for researchers to navigate the IRB review process effectively.
