***IMPORTANT NOTICE: WITHDRAWN SUBMISSIONS IN RAMS-IRB***
Dear VCU Research Community,
We’re eagerly gearing up for the upcoming launch of our new electronic IRB system, and as part of our ongoing efforts to prepare, we’re taking proactive steps to ensure a smooth transition. This includes conducting a thorough cleanup in RAMS-IRB, where we recently withdrew approximately 630 studies that had remained in the “In Development” state for an extended period. These studies were withdrawn due to the following: (1) in the withdrawn state for over 30 days, (2) never submitted for review and (3) were created using the former RAMS-IRB application, which did not require a protocol. This cleanup not only sets the stage for seamless integration when the system goes live but also marks an important phase in our journey toward enhanced efficiency and innovation within our research protocols.
***If one of your draft studies was withdrawn and you still intend to submit it to VCU IRB, please follow these steps:
1. Create a new study by using the New Study button from your main page. (Do not copy the withdrawn study using the Copy Study button in the study workspace.)
2. Please ensure to answer all questions in the new application (i.e., smart form) and attach a completed study protocol. To draft a protocol, utilize one of the HRPP’s protocol templates:
- HRP-503 – TEMPLATE PROTOCOL (submission of biomedical studies and clinical trials)
- HRP-503a – TEMPLATE SBS PROTOCOL (submissions not involving an investigational agent)
- HRP-503b – TEMPLATE NHSR (submissions for ‘not human subjects research’ determinations)
- HRP-508 – TEMPLATE Site supplement to sponsor protocol (provides VCU-specific information about research procedures and participant enrollment where there is an accompanying sponsor protocol)
***All of the listed templates are available at this link: HRPP policies and guidance – Office of the Vice President for Research and Innovation – Virginia Commonwealth University (vcu.edu). Simply scroll down to the “Templates” section and click the down arrow to expand it, where you’ll find the mentioned templates.
3. Submit your new research study via the Research Administration Management System (RAMS) at your earliest convenience.
Please Note: While you may use the withdrawn study to copy pertinent text over into your new study, you may not re-submit the withdrawn study. The IRB will return that study to you with a note stating that you must submit a study using the new application.
Thank you for your help with this process. We will continue to update the VCU research community with housekeeping and other efforts in preparation for the new system.
To learn more about the HRPP Transformation, please visit the HRPP Transformation Journey at https://research.vcu.edu/human-research/hrppirb/hrpp-transformation-project/