WCG Announces IRB Exemption Changes Effective in 2025. IRB Review & Exempt Determinations Merging Into a Single Review Process.
Effective January 2, 2025, WCG’s IRB will merge our IRB review and exempt determinations into a single review process. Instead of following separate pathways for submission, research will be reviewed to assess its regulatory status. If research is determined to be exempt or not human subject research, that determination will be communicated in IRB outcome documents in the same manner as IRB review. Changes to research previously found to be exempt will require a new review. We recognize that some institutions or investigators want IRB review of all research, and WCG will honor requests to have research reviewed by the IRB regardless of its meeting the criteria for an exemption. At this time, Connexus will still have two pathways for submission, but outcome documents for exempt determinations will be organized in Connexus as they are for IRB reviewed research – they will have workspaces and a certificate of action. This harmonization of the two review pathways in Connexus should improve our clients’ experience with managing submissions and outcome documents.
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