The revised Common Rule no longer requires IRBs to conduct review of grants to ensure they are consistent with an IRB application. In light of this change, the IRB offices will no longer conduct review of any grant or clinical trial agreement associated with an IRB application. Instead, the PI for the grant will be responsible for confirming that the human subjects research activities described in the grant are covered by an approved or exempt IRB application(s). This FAQ explains how the new process will be implemented as well as future funding-related changes to ARROW.
Why is this change being made?
The flexibility in the revised Common Rule is being leveraged by OVCRGE leadership to replace what has become an at times overly complex funding review process. Principal investigators (PIs) have always been responsible for ensuring that they have obtained the required approvals for human subjects research activities described in their grants. The new process just removes the extra layer of IRB review, which will simplify and help reduce the time applications spend in IRB administrative review.
When will the process be effective?
ARROW will be updated August 3rd to include the changes necessary to the forms and letters for implementation of the streamlined congruency process.
How will the new process work?
ARROW and WISPR will include the following tools and reminders to assist researchers in ensuring that the research described in their IRB application(s) is consistent with the research described in their grant(s) and that they have obtained the appropriate approvals for human subjects research activities described in their funding sources:
- Revised WISPR Attestation: WISPR currently includes attestation language that the PI for a grant checks to confirm they will comply with all relevant requirements. This language will be updated to include text that clarifies that the PI for the grant is responsible for ensuring that they will obtain IRB approval or exemption for all human subjects research activities described in the grant prior to performing any of the human subjects research.
- Revised ARROW Assurance: The assurance on the final page of the initial review and change forms will be updated to include language confirming that the PI is responsible for ensuring that the research activities described in their IRB application is consistent with those described in the fiscal and materials sources of support listed in the application. A temporary popup will display on this page to alert everyone to the new language.
- Removal of Requirement to Upload Grants: The requirement to upload a grant application or clinical trials agreement associated with any funding source will be removed and study teams will no longer need to provide this information to the IRB offices.
- Revised Letters Including Funding Sources: Approval, exemption, and cede letters will now include information on the funding sources listed in the IRB application for that study. Change approval letters also will include information on funding sources.
- Revised PI Responsibilities Documents: This is being revised to specify that PIs are responsible for ensuring grant-supported human subjects research has received IRB approval or exemption.
Will the IRB conduct any review of funding sources?
The IRB will review funding information only to ascertain the type of funding that is listed (e.g., federal vs. not, funding agency if federal). The grant application will no longer be uploaded in the IRB application and hence will not be reviewed by IRB staff. This includes applications for review of training, core, or umbrella grants, for which the study team will need to provide sufficient detail in the application form to enable appropriate IRB review.
Do all funding sources still need to be listed in the IRB application?
Yes, funding sources still need to be listed in the IRB application to ensure both the PI and the institution are in compliance with applicable regulations.
Can I still list more than one source of funding/can one source of funding be used for multiple studies?
Yes and yes. No changes are being made to how many funding sources can be listed in a single IRB application nor to how many studies a grant may support.
Can I still submit a Protocol Development Activities (PDA) application?
Yes. A PDA can still be submitted to allow release of grants funds for study activities NOT involving human subjects research. As previously, study teams are encouraged to consult with their program officer or grants management specialist to confirm that a PDA approval will be acceptable to the funding agency.
Are any other improvements to the funding review process being planned?
Several changes to funding-related review processes are being planned and are targeted for implementation in fall 2019, including:
- Revised funding pages in the ARROW application to make the funding chooser more user friendly and to simplify this area of the form;
- Updated guidance on what types of funding or other support needs to be listed in the IRB application;
- Greater flexibility regarding when an IRB application can be submitted (no longer need to wait until receipt of a Just-in-time (JIT) notice).
Who can I contact with questions?
If you have questions about the new process or upcoming changes to funding-related review processes, please contact Lynn Haynes (firstname.lastname@example.org).