Investigator’s Brochures are essential regulatory documents requiring IRB submission and review, but should these documents be submitted as a Modification or as Promptly Reportable Information (PRI)? It depends… IBs are reviewed annually and may be updated with Investigational Product (IP) … Read more

A department’s approval in IRBIS is attesting that the study personnel have the appropriate expertise (e.g., credentialing, licensure, privileges, training), experience (e.g. previous research studies conduct and role in relation to risk level of research), and resources (e.g. committing staff’s … Read more

With the most recent IRBIS update, the application logic rules were changed regarding the Multi-Site Screening question (#6 on the Screening Questions page). The original purpose of the question was to identify studies that were being conducted at multiple sites … Read more

The IRB Meetings and Deadlines Calendar has been published for 2021 on the OHRE website. With the restructuring of the boards to remove the designations of Biomedical, Non-biomedical, and Safety last year, all submissions are assigned to the board agendas … Read more

In order to assure recruitment procedures adequately protect the rights and welfare of prospective subjects, the IRB must review and approve all advertisement and recruitment materials for research conducted under the purview of UNC-Chapel Hill. The following information should be … Read more