Version: September 2019
Revisions and Changes to ICTR SRC Review Requirements for Studies Submitted to the HS IRBs with Pending Funding
On October 5th, we are implementing two changes to reduce administrative burden and timelines associated with IRB review:
- Funding pages will be streamlined for ease of identifying funding sources for work described in your protocol.
- Criteria for studies excused from the Institute for Clinical & Translational (ICTR) Scientific Review Committee (SRC) review will be broadened to include studies that have been externally peer-reviewed, but that have not yet been awarded funding. NOTE: These ICTR SRC changes will not affect the review process for studies reviewed by the UWCCC protocol review and monitoring committee (PRMC).
Why are these changes being made?
- Funding pages in the application are being streamlined and simplified to reduce administrative burden for researchers as well as improve efficiency in the IRB review process.
- ICTR SRC review requirements are being revised to recognize that there is often a delay between peer review that satisfy the institutional scientific review requirement and award of funding.
When will these changes become effective?
The changes are effective now. ARROW applications created after October 5th will include new, streamlined funding pages. For studies created before October 5th, with pending funding and notification of an excellent impact score from NIH (or equivalent from other funding agencies) during peer review are encouraged to contact Lynn Haynes (email@example.com) to discuss options for submission of their IRB application.
What changes are coming to the funding pages in the ARROW application?
- Fewer pages, fewer questions!
- A simplified and easier to use “chooser” for identifying funding sources for your application.
- Leveraging data from the chooser to inform the IRB about the funding details- fewer questions!
- Flexibility to add funding that has been peer reviewed, but not yet funded.
How will the ICTR SRC review process change for studies with pending funding?
Principal investigators who receive a notification from a funding agency that their grant application has received rigorous peer review and a highly meritorious score are excused from ICTR SRC review. Many funding agencies communicate the result of their peer review many months before they make funding decisions. To allow study teams to be in a position to have their IRB protocols approved when their highly meritorious grants are awarded, ICTR and the OVCRGE have agreed that these studies should also be excused from ICTR SRC review.
Starting with applications created after October 5th, applications may list pending funding and bypass SRC review if the following is true:
- Federal funding: The funding proposal has received a highly meritorious score. For example, an impact score of 30 or less is an indication of a highly meritorious NIH grant proposal. Receipt of a request for Just in Time documentation is another indication of a highly meritorious proposal.
- Non-federal funding: The study team has received confirmation from the sponsor that funding will be awarded due to the merit of the proposal AND the sponsor has a robust peer-review process.
What happens if pending funding is not awarded? Will SRC review be required?
The HS IRBs Office will regularly monitor applications that bypassed SRC review to assess whether funding has been awarded. If funding has not been awarded, the HS IRBs Office will reach out to study teams to discuss the best path forward for that study. In cases where the study team wishes to pursue the study without the awarded funding, ICTR SRC review may then be required and changes to the IRB application may be required to ensure that correct regulations are applied.
Will the UWCCC’s PRMC (Protocol Review and Monitoring Committee) process change?
No. The PRMC’s processes are independent of the ICTR SRC’s and are not impacted by these changes.
Who can I contact with questions?
If you have questions about these changes, please contact Lynn Haynes (firstname.lastname@example.org).