For sponsored projects involving human subject research, no funds can be requested and no obligations made against funds for research involving human subjects during a period not covered by Institutional Review Board (IRB) approval. However, the sponsored project funds are needed to conduct activities not involving human subject research prior to IRB review/approval, the Principal Investigator may request a portion of the budget to be released for spending. Pre-IRB activities include development of study instruments, hiring staff, obtaining space in facilities, etc. In these cases, it may be appropriate for PI to submit an application for pre-IRB spending via the Pre-IRB Spending Request form with the understanding that a protocol must be submitted to and approved by the IRB before any research activities involving human subjects can be done.
The chart below outlines the steps, the responsible office or person, and the estimated timeline for the award Pre-IRB process.
|Steps||Responsible Office or Person||Timing|
Contact the Research Integrity and Oversight (RIO) office at firstname.lastname@example.org to verify the project is eligible for Pre-IRB spending
|Principal Investigator||Up to 90 days before the primary award start date|
|Submit the completed and signed Pre-IRB Spending Request form to Research Integrity and Oversight (RIO) Office in the Division of Research||
|Up to 90 days before the primary award start date|
|Review and approve the Request and forward the form for processing to the Office of Contracts and Grant in the Division of Research||Research Integrity and Oversight (RIO)||2-7 days|
|Setup a portion of the budget in the same cost center that will be used to fund the project, and notify PI of its availability||Post-Award Research Administrator||2-7 days|
Use of the award funds in the Pre-IRB period
Spending authority on the cost center will expire when the pre-IRB period ends, and no additional expenses can be posted until the IRB has been approved. If an extension is needed, RIO must approve in writing. The PI must indicate on the expenditure documents paid during this period, the purpose and benefit of pre-IRB costs to demonstrate that they do not involve human subject research.