Education & Outreach Perspectives: Reportable Events
The VCU HRPP’s Education & Outreach Team is composed of professionals who are experts in the field of human research regulations. The unit delivers education and training to IRB members, to ensure high-quality and efficient reviews of research by IRB members. In addition, the unit also engages in education and outreach efforts to the VCU […]
PAMQuIP Perspectives: Reportable Events
The VCU HRPP’s Post-Approval Monitoring and Quality Improvement (PAMQuIP) Team is tasked with providing ongoing oversight and monitoring of human research, following initial approval by the IRB. They help study teams ensure that their research is operationalized in compliance with regulation and in compliance with the IRB-approved protocol. The team is composed of Elizabeth Marlowe, […]
IRB Reliance Perspectives: Reportable Events
The VCU HRPP’s IRB Reliance Team is tasked with managing studies that engage in reliance agreements that cede IRB review to another, non-VCU IRB, or which allow the VCU IRB to review for multiple, non-VCU research sites. They manage externally reviewed research, such as research reviewed by WCG, Advarra, or another institution’s IRB. They also […]
IRB Analyst Perspectives: Reportable Events
The VCU HRPP’s IRB Analysts are professionals who are tasked with reviewing and approving minimal risk research at VCU. They independently review and approve expedited research protocols, perform exempt determinations, and make determinations of “Not Human Subjects Research.” As part of their work, they engage closely with investigators to provide expert regulatory guidance, including pre-submission […]
IRB Administrator Perspectives: Reportable Events
The VCU HRPP’s IRB Administrators are professionals who are tasked with ensuring submissions to the convened panel are ready for review at meetings, managing IRB meetings and providing expert regulatory advice, and working closely with investigators to help them respond to requests for changes or information from the convened panel. In this article, the IRB […]
IRB Chair Perspectives: Reportable Events
Dr. Ron Evans is an Associate Professor in the Department of Kinesiology and Health Sciences and currently serves as Chair of the VCU IRB Social Behavioral/Biomedical panel. Dr. Evans has been a faculty member at VCU since 2003 and an IRB member since 2005. Prior to his current role on the Social Behavioral/Biomedical panel, Dr. […]
IRB Director Perspectives: Reportable Events
Reportable Events: What should be reported to the IRB? By: Sanjur Brooks, DPS, MA The institutional review board (IRB) is an independent board federally mandated to review and monitor research involving intervention and/or interactions with human participants while ensuring the protection of their rights and welfare as research participants. Researchers, regardless of risk level, must […]
New IRB Training on Reportable Events – March 2022
Keep calm and report to the IRB! Sign up for a special training session to learn all about which events must be reported to the IRB, including Unanticipated Problems (UPs) and noncompliance. Sessions will be held virtually using Zoom, on the following dates: Monday, March 14, 4pm-5pm ET (Register here) Wednesday, March 16, 9am-10am ET […]