Date: March 5, 2021
You should all have received an email regarding the first module of the training.
1. Toolkit and Practical Overview
There will be 2 additional training sessions during the transition:
2. An IRB Regulatory Refresher Training (Criteria for Approval review), and
3. A step-by-step guide to reviewing an assigned study submission and ARROW changes, including the new protocol-based application.
These courses will be offered virtually and/or via a video recording of the session. We encourage you to attend all three sessions. If there are additional training sessions that you feel would be helpful for you, please email me at IRBDIRECTOR@hsirb.wisc.edu. Continuing education and training will be offered more regularly in the future.
Our IRB staff are excellent. They have extensive human subjects regulatory experience, which they will continue to use to support both the study teams and the committee. While the staff review document with which you are familiar will be gradually transitioned into revised pre-review material, the pre-review performed by staff with research teams will not.
Staff will continue to support the IRB members by performing a pre-review to ensure that the study is ready for review by the full committee, including:
As is the case now, IRB staff will communicate with the study team via ARROW during pre-review to ensure the study is ready for review by the committee. Several surveys of investigators have highlighted their frustration with multiple rounds of review prior to full board review. Our goal for pre-review is to have a single round of review questions before full board review unless the study is obviously not board review ready.
As a member of the IRB, you bring a unique perspective and expertise to the evaluation of human subjects research. In compliance with federal regulations, the IRB must utilize members’ scientific/ medical/ unaffiliated experience for protocol review. This can only happen when the committee members read and are familiar with the protocol and other study documents to fully understand the study the Investigator is proposing and assess how the study meets the regulatory criteria for approval.
Most of you conduct your reviews in this manner, demonstrating amazing insights and thoroughness. These contributions to the human subjects’ protection process cannot be underestimated. If this is your practice, little will change for you to complete your reviews as a result of the IRB Efficiency Project.
The regulatory criteria and decisions that IRB members make will not change. The new IRB Toolkit will add resources and guides to assist members in the systematic identification and documentation of the regulatory criteria that apply to the studies they review. This will be made easier with the launch of the protocol-based application as there will be a single source of information: either the protocol or the application (for studies without a protocol to be reviewed by the Minimal Risk Research Committee). Neither the IRB staff nor the committee members will need to reconcile the multiple sources of information. IRB staff will ensure you have a complete application to review, will continue to highlight issues important for discussion and will continue to be available to support you if you have questions.
During the transition, staff will continue to provide a written staff review, but these will gradually contain less material they have synthesized from the protocol. Instead, the staff will direct the committee members to the sections of the protocol that contain the appropriate information and reminders of the questions that need to be addressed for approval.
Remember that if during your review you have questions you have resources: