News for Cornell researchers with human participant research protocols that were submitted to the Cornell IRB via Word or PDF forms, prior to the implementation of the new RASS-IRB system (implemented February 1, 2022). The Cornell IRB Office wants to ensure researchers are aware of the amendment requirements for those “migrated” protocols, as well as the reasons behind them.
For migrated protocols that received Expedited or Full Board Cornell IRB Review:
- Requirement: At the point of amendment or continuing review, all current protocol information must be in the protocol record in RASS-IRB. Unfortunately, our previous system did not allow us to migrate more than basic protocol meta-data and system-issued memos (i.e., protocol title, study personnel, review type, high level details of previous amendments, approval letters). This means that for Expedited and Full Board protocols, the PI or another research team member needs to enter into RASS-IRB all other IRB-approved protocol details and documents that are currently being used for the study, along with any changes being proposed.
- Reason: For the IRB to use RASS-IRB to review protocol amendments and continuing reviews, the staff and committee members need to be able to have all the relevant information about that protocol easily accessible within the protocol record. RASS-IRB is built so that all details about a protocol are easy to find, and amendments are easy to track. In order for the system to work as designed, though, we need the protocol details for all studies requiring IRB review—including those migrated from our old database—to be viewable in this new system of record.
- Additional Points:
- We know for some researchers it is burdensome or frustrating to have to re-enter details about an already-approved study—especially studies that have been amended multiple times—and we do apologize for the inconvenience.
- Unfortunately, the IRB staff do not have the ability to enter the full details of all active Expedited and Full Board protocols (~700) without researchers’ assistance. In addition to capacity issues, we found during usability testing that PIs were better equipped to fill in the gaps in the protocol records, not only because of speed but also accuracy (given some of the questions are phrased differently than in the old forms, and a few questions are new). That being said, the IRB staff are very willing to help as best we can—just ask.
- We believe that this one-time time investment from researchers will pay off in smoother and faster IRB review processes going forward; for all subsequent amendments and continuing reviews, researchers will only need to edit the protocol fields that are being changed, or upload new versions of modified study documents. The system will document the version changes, for easy comparison.
For migrated protocols that were determined to be Exempt from IRB review:
- Requirement: For Exempt protocols migrated from the old system, amendment requests will continue to be accepted via email (email@example.com), for the time being. PIs are welcome to update the protocol record in RASS-IRB and process their Exempt amendments through that system, if they so desire, but it is not required. For exempt protocols submitted through RASS-IRB on or after February 1, 2022, though, please do use RASS-IRB to request amendments.
- Reason: Because Exempt protocols are not beholden to the same rigorous review requirements as Expedited and Full Board IRB protocols, the IRB staff have more flexibility with the review and documentation processes. The review of an amendment to an Exempt protocol primarily serves as a check to make sure the changes will not impact the protocol's eligibility for exemption, so a review of the amendment in the context of the full protocol is often not necessary.
Guidance and Training:
- Visit the RASS Guide Site to find recordings of Zoom trainings, as well as step-by-step, how-to documentation for various tasks within the new system, including amending a protocol. These how-to guides can be found under the IRB tab of the top navigation bar.
- If you have any problems with or questions about the system itself, you can contact the RASS system administrator via firstname.lastname@example.org. For questions about your research or the IRB review process, continue to contact email@example.com.