Date: March 5, 2021
What training resources and materials will be available to me?
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.
How will IRB staff pre-review change 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:
- Reading all the submitted documents and ensuring that the application is review ready, which means the protocol is:
- Complete (for example, in addition to the protocol, the proper consent forms have been uploaded and they include all the required elements of informed consent).
- Clear (for example, there are not ambiguities about the study populations or study procedures),
- Consistent (the protocol and the consents are aligned).
- Identifying which of the Toolkit checklists will need to be completed for regulatory purposes. They will complete pre-review checklists and will help with completion of regulatory checklists, where they can. These documents will all be in ARROW.
- The pre-review checklist in ARROW will include a brief summary of the study and regulatory highlights (for example, studies of devices that might need a NonSignificant Risk determination by the IRB). Note, the new pre-review checklists will not contain a synthesis of material from the protocol/application intended to document how the study design and methods allow the study to meet the criteria for approval, as our current staff review document does. This creates a duplicate document that can easily be confused for a source document to be used by the committee to make their determinations.
- Attending IRB meetings to support the review of the study and to ensure they can communicate the committee’s questions appropriately to the study team.
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.
How will IRB member review processes change?
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.
What support will be provided to IRB members to help ease this transition?
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.
What other resources are available to support me in conducting my reviews?
Remember that if during your review you have questions you have resources:
- Reach out to the staff reviewer for the submission. They may have already had a conversation with or asked the same question of the study team.
- Reach out to the IRB Liaisons (Jackie Lee email@example.com and Jessie Johnson firstname.lastname@example.org) if it is a question about ARROW navigation or a general question about IRB responsibilities or processes.
- Reach out to the PI if you feel you need more information. They want their studies to be approved in the most efficient manner, so are often happy to provide more information or supporting documentation. If you are uncomfortable revealing your status as an IRB member, contact the staff reviewer prior to the meeting to pass along your questions.
- Reach out to senior IRB members or the IRB member Chairing the meeting. Hannah (IRBreview@hsirb.wisc.edu) can help you identify more experienced members attending the same meeting or the member chairing the meeting.