Delay in Protocol Screening for External IRB Reviews
Hello Esteemed Colleagues, During the next several weeks, the Human Research Protections Program (HRPP) will be undergoing a few changes in personnel that may impact the timeline for screening submissions pertaining to external IRB reviews and reliance agreements. Mr. Logan Clary, the IRB Reliance Coordinator, will be moving on to a new opportunity, and his […]
New Investigator Tips: What Should I Do if I am Bringing a Research Study from My Old Institution to VCU?
Federal regulations for the protection of human subjects contain various areas of flexibility, where institutions are allowed to set policy and procedures for certain aspects of the conduct of human research. While many aspects of conducting human research remain the same between institutions, there are certain areas that can vary between institutions. This means investigators […]
IRB Mythbusters – External Reliance
The VCU Human Research Protection Program presents IRB Mythbusters — a periodic newsletter clarifying common misconceptions about conducting human research and the IRB! In this issue, “myths” surrounding External IRB Reliance (i.e.: when an external IRB, such as WCG, Advarra, or another academic institution reviews a VCU study) are addressed. View the attachment to see […]
UPCOMING CHANGE: Studies Reviewed by External IRBs Will Require Department Review
On 6/17/2021, RAMS-IRB will undergo a patch to make several changes. One change that will be implemented during the upcoming RAMS-IRB patch on 6/17/2021 is the addition of studies that request EXTERNAL IRB REVIEW being routed to department review first. When VCU cedes IRB review to another institution, we retain responsibility for ensuring that the […]
Training for NEW WIRB Electronic Submission System: WCG IRB Connexus
WIRB has announced the rollout of their new electronic submission system WCG IRB Connexus. Training will be held on Tuesday November 10th at 10am. Please ensure that a member of the study team either attends the training or reviews the recorded session prior to initiating registration in the new Connexus system. Study teams should continue to use […]
OHRP Exception Determination: Single IRB (sIRB) Requirements
On October 8, 2020, the Office for Human Research Protections (OHRP), on behalf of the Department of Health and Human Services (HHS), issued an exception determination (as permitted by 45 CFR 46.114(b)(2)(ii)) stating that certain categories of cooperative research supported or conducted by HHS and subject to the 2018 Requirements are not required to comply […]
Training Opportunity: Advarra CIRBI training for VCU
On Tuesday July 14th, Advarra will host a web-based training opportunity in the CIRBI system. This training is appropriate for new Advarra users, and as a refresher for current users. To add this training to your google calendar, use the following link:https://calendar.google.com/event?action=TEMPLATE&tmeid=MDYzOG9scmtnaW5ucDFmaGY4OHRramV2OWEgb3JzcEB2Y3UuZWR1&tmsrc=orsp%40vcu.edu Or, join the training on Tuesday July 14th at 12PM using one of […]
Reliance Requests with the VCU HRPP – Educational Video
Stacy West, MS, CIP, IRB Reliance Agreement Specialist, presents on submitting reliance requests to the VCU HRPP. Prevent extended delays in the process with West’s explanation of the screening process. You can also access the video here. For questions, please contact Stacy West, at [email protected] or 804-827-1446
Learn About External IRB Review at the One VCU Clinical Research Teams Meeting
Are you participating in multi-site research that requires external IRB review? Stacy West and John Horigan will be presenting on everything you need to know about external IRB submissions (reliance agreements) at the monthly meeting of the One VCU Clinical Research Teams, on Tuesday, February 11th. Please see below for information on how to join […]