As part of the campus-wide Research Administration Support Systems (RASS) rollout, the current process of submitting IRB protocol applications via email has been replaced with Cornell’s new online RASS-IRB protocol system. The system launched Tuesday, February 1, 2022, at 10AM! RASS-IRB is now being used to support human participant research protocol creation, submission, review and approval functions for new studies, amendments, and continuing reviews.
- Replaces the paper IRB protocol form and email-based review and approval process with an online protocol management system that provides visibility into the current status of your IRB protocol and review process.
- Replaces the email-based amendment process with version control to easily compare the current amended IRB protocol with the previous approved version.
- Reminds you if your protocol requires a continuing review so that you can submit the renewal request prior to your protocol’s expiration.
- Keeps track of your IRB protocol details so that you can easily print or view your IRB approval letters, access important protocol documents such as consent forms and recruitment documents, and view previous versions including changes requested as part of IRB review.
- Allows you to connect your protocol to your sponsored proposal or award that is already in RASS Sponsored Projects.
- Replaces the paper form for reporting to the IRB protocol deviations or unexpected events that have taken place during the research.
What Should I Do Now?
- The IRB office stopped accepting all emailed protocol submissions (including amendments for Expedited and Full Board protocols) at 5PM on Friday, January 21. New submissions should now be created in RASS-IRB.
- High level data about current, active protocols from the current IRB system has been transferred to the new system. (Data about closed or abandoned IRB protocols, or protocols determined not to be human subjects research, will not be transferred to RASS.) The first time you amend a protocol imported from the old IRB system, you will need to fill in portions of the protocol application in RASS-IRB. Please anticipate needing to spend at least an hour on that process. Most information requested in RASS-IRB can be copied from your previous protocol applications, but there are a few questions collecting new information. Learn more about this amendment requirement and the reasons behind it here. If you have trouble filling out the form, you can review how-to documentation on the RASS Guide Site, watch a recording of a Zoom training, or request a 1:1 consultation with RASS or IRB staff. We will be happy to help you!
- For those of you conducting active data or biospecimen collection, RASS-IRB requires that all informed consent/assent forms must be uploaded as PDFs. Please prepare your consent forms as PDFs the next time you create a new protocol or amend an existing protocol. The system will stamp IRB-approved consent/assent forms in the bottom right-hand corner, so please leave space there (1” from the bottom, 2” from the right edge).
- If you have approved protocols that need to be closed or pending protocols or amendments that are no longer needed, please email email@example.com ASAP.
What Happens When RASS-IRB Launches?
We've launched! You should now use RASS-IRB to:
- Create and submit all new IRB protocols (including protocols for which you intend to rely on another IRB, and requests for an IRB determination for a funding agency before the protocol is fully developed).
- Amend IRB protocols.
- Note 1: As mentioned in the previous section, the first time you amend a protocol imported from the old IRB system you will need to fill in portions of the protocol in RASS-IRB, so anticipate needing to spend at least an hour on that process. Training and support will be made available (see information below). Learn more about this amendment requirement and the reasons behind it here.
- Note 2: For existing Exempt protocols imported from the old system, amendment requests will continue to be accepted via email for now. However, new Exempt protocols created in RASS-IRB will need to be amended in that system. (FYI IRB SOP #2 on Exemption Requests is in the process of being revised, in part to better clarify the types of modifications that require an amendment to an Exempt protocol. Watch for that updated SOP in the coming months.)
- Submit continuing review requests.
- Report adverse events and protocol deviations.
- Provide your attestation that you will act as faculty advisor for your student’s IRB protocols.
Training and Support
How-to guidance documents are posted on the RASS Guide Site for a number of different tasks researchers might conduct within the system.
RASS and IRB staff are available for Zoom consultations. Schedule via Microsoft Bookings.
For help, questions or feedback about the RASS-IRB system, contact the Research Administration Support Systems (RASS) team at: firstname.lastname@example.org.
For questions about the RASS project, contact: Carrie Susskind, RASS Product Manager at email@example.com. For content-related questions on your IRB protocol or other IRB issues, email firstname.lastname@example.org.
Notes on the RASS Project
The RASS project is a campus-wide, complete overhaul of the systems Cornell uses to support research administration. We have successfully implemented the Sponsored Projects portion of the project and will upgrade the IRB and IACUC (Institutional Animal Care and Use Committee) systems in early 2022. The next phases will bring upgrades to the systems used for IBC (Institutional Biosafety Committee) and COI (Conflicts of Interest).
The project timeline is maintained here: https://guide.rass.cornell.edu/timeline/.
The RASS project has already simplified and improved many procedures involved in sponsored projects. When the project is complete, Cornell will have a set of modern, integrated, and simplified tools supporting our research enterprise.