The Institutional Review Board (IRB) from the Office of Research Integrity and Assurance (ORIA) has announced a new initiative to populate records in RAMP called RAMP Transition by IRB. This new process, created based on feedback from researchers, involves the RAMP/ORIA team automatically transitioning the most recently approved documents from IRBNet on behalf of PIs. PIs will still need to complete part of the process, although the bulk of the work will be done by members of the IRB/ORIA team.
Process Overview:
Here’s what the RAMP Transition by IRB process will look like.
- We will reach out to you directly via email to initiate the transition process. We will send a list of all of your studies with shell records in RAMP and ask you to confirm which of the studies are still active and which (if any) should be closed
- Once you’ve confirmed the active studies, the IRB team will create a modification in RAMP to populate the study from IRBNet and let you know when it is ready for your review
- You will review the modification and, if the modification is complete and accurate, click “Submit” in RAMP to submit it
- We will approve the modification through an administrative process
- After this approval, you will utilize RAMP for all future submissions related to your study
Due to the large volume of study records to populate (>1500 studies), the effort will likely take several months. Please note that you do not have to wait for us to reach out to you in order to transition your study. The IRB/ORIA team will continue to support the previous process – RAMP Transition by PI – that involves researchers populating the record from IRBNet. See the IRB website for additional information on that process.
Frequently Asked Questions:
Will this effort impact review turnaround times/typical IRB business?
Generally, no. We expect to have a dedicated student worker to support this effort by the end of the year. In the meantime, staff who process/review regular submissions will not be involved in the Study Transition by IRB process to avoid impacting IRB review times.
Why can’t the IRB just do this for me? Why do I have to submit the modification?
In short, because the system will not allow us to. RAMP limits the administrative privileges available to us, and while we can create modifications and other types of submissions, we cannot submit them on your behalf.
When will the IRB contact me about populating my studies?
We are starting with the PIs who have the highest number of studies in RAMP and will work in descending order.
But what if I need to make changes to my study before my turn?
You can always populate the documents via the RAMP Transition by PI process. For more information, please see the IRB website.
Will all of my study documents move over to RAMP?
No. Only the most recently approved versions of documents (e.g., study applications, consents, recruitment materials, etc.) will be migrated into RAMP. All other documents will be maintained in IRBNet, which is still available as read-only. This standard applies to all studies whether transitioned by IRB or by PI.
IRB Training and Guidance
Training videos and documents are available online in MasonLeaps. See the GMU RAMP > Training location to connect to these resources.
The IRB staff are also happy to offer RAMP training for individuals and groups. Please reach out to irb@gmu.edu to request training.
November 14, 2024