HRPP Newsletter May 2021
New IRB Panels and Meeting Schedule
A key component of the IEP project involves the restructuring of the IRBs themselves, including combining the Education and Social/Behavioral IRB and Minimal Risk IRB into a single Minimal Risk Research board and adding “panels” for each board in order to increase meeting frequency and to ensure appropriate expertise for all types of research.
While the Minimal Risk Research Board merge is planned for later this summer, the Health Sciences IRB restructuring is well underway. Six smaller, more cohesive panels have been created and as a result, the number of meetings each month has increased from 4 to 6. Beginning in May, the first and third week of every month will include a Monday and Thursday panel meeting while the second and fourth weeks will include a Tuesday panel meeting. View the panel meeting schedule here.
New Protocol Templates Now Available
The new Protocol Based Application in ARROW relies on a protocol document to provide the information needed for IRB review and approval. A complete protocol will include the sections listed in in HRP-308 – WORKSHEET – Pre-review. To help research teams create robust protocols that include all necessary information, the IRB website offers these new templates:
- HRP-503 – Biomedical Protocol, appropriate for a broad range of biomedical research, primarily studies that are not FDA-regulated.
- HRP-503a – Registries and Repositories Protocol, for storage of data and/or specimens for future use.
- HRP-508 – Site Supplement, for studies where UW is a participating site and the main protocol comes from an external collaborator, coordinating center, or sponsor, or to supplement a protocol that does not include all the protocol sections listed in HRP-308 – WORKSHEET – Pre-review.
Research teams may use other protocol templates that are appropriate to the study type, provided they include the required elements. For example, ICTR’s Therapeutic Clinical Trial: Drug/Device Interventions and NIH’s Phase 2 and 3 Clinical Trial templates include detailed guidance for studies evaluating drugs, devices, or biologics and are more appropriate than the HRP-503 Biomedical template for this type of study. Social/behavioral intervention studies that require a protocol may use NIH’s Behavioral and Social Sciences Research Involving Humans template or similar templates designed for this type of research. Please note that most Social/Behavioral studies do not need a protocol and therefore should NOT use the Protocol Based Application. Instead, the Standard IRB Application should be used.
Reminder to Submit Feedback on Toolkit Documents – We want to hear from you!
As research teams continue to use Toolkit Documents, including the Investigator Manual, you are encouraged to provide feedback on those documents using the online HRPP Toolkit Feedback Form. IRB staff will be doing a first round of revisions to Toolkit documents in June—the deadline for providing feedback in order to be considered for the June revisions is May 31st. This is the last round of revisions until December. Feedback can continue to be provided at any time, but anything submitted after May 31st will be considered for the December revisions.
- Important reminder: Exempt projects typically do not qualify for review by an external IRB. If you are conducting an exempt project with another institution, please contact us (email@example.com) for guidance before starting a cede application in ARROW.
- Our new Toolkit documents include HRP 502c-TEMPLATE-Standard Consent Language that study teams should use when preparing consent documents for studies reviewed by an external IRB.
- Our new reliance manual includes a section with comprehensive guidance regarding when UW-Madison serves as the reviewing or single IRB.
- Coming in June: Reliance Toolkit Document Orientation
- REMINDER: Your feedback on the reliance manual is important in helping us ensure the manual is helpful for you. To be considered for the June Toolkit revisions, please send your feedback on the reliance manual to firstname.lastname@example.org by May 31st.