Purpose

This policy applies to Sponsor project awards involving human subject research reviewed by the University of Houston’s Institutional Review Board (IRB). The purpose of this policy is to define non-human subject research-related activities that may be permissible prior to IRB approval. This policy is not applicable to grants involving animal research.

Scope

For sponsored projects involving human subject research, no funds should be drawn down from the payment system and no obligations made against funds for research involving human subjects for any period not covered by Institutional Review Board (IRB) approval. However, for activities that do not involve human subjects research, Pre-IRB administrative or protocol development spending may take place if the Principal Investigator has a separate budget in place and an approved Pre-IRB Spending Request form that has been reviewed and approved by the Office of Research Policies, Compliance and Committees (ORPCC) on file with the Office of Contracts and Grants (OCG).

Allowable spending categories Pre-IRB

During the pre-IRB period, when the protocol application is being submitted and the award period has begun, the only type of spending that can be approved is that which is deemed necessary and essential to the protocol development. The work done during Pre-IRB, if budgeted, must be exclusively for the following:

• Protocol development and submission to the review board
• Setting up laboratory or location for the anticipated research
• Research personnel recruiting and training

Process

The steps below must be taken for OCG to process Pre-IRB compliance spending on sponsored projects.

1. Contact the Research Integrity and Oversight (RIO) office at grc@central.uh.edu to verify the project is eligible for Pre-IRB spending.
2. The Pre-IRB Spending Request form must be completed and signed by the PI and by the individuals listed below:
   • Department representative - the department administrator with oversight for the funds in the department
   • Office of Research Policies Representative– the Compliance Specialist that conducts the congruency review of the proposal
   • Office of Contract and Grants Representative – the Post-Award Research Administrator (RA) who sets up and manages the award

2. The RA will use the signed Pre-IRB forms to set up the project cost center with the amount of the requested/approved budgeted.  
   • The cost center accounting end date will be set to end on the pre-IRB spending end date so no additional expenses can post until after the protocol is approved.
3. The PI and DBA will receive the initial Notice of Award setup containing the cost center values that will allow them to spend. The notice will identify the funds as pre-IRB funding and specify allowable costs for the budget that was setup.
4. The Department must indicate on all expenditure documents or backup, the purpose/benefit of the spending.
   • Example: “This expenditure is for protocol development and project set-up exclusively and not related to human subject research.”

5. If the PI wishes to increase or extend the approved pre-IRB budget and/or time a revised form must be completed and approved by the Compliance Specialist.

After Pre-IRB – Full Award Setup

1. Once IRB approval letter is officially issued, the Research Administrator will use the letter to add the additional funding to the same cost center that was used for the pre-IRB spending.
2. The RA will issue a new Notice of Award notification with the increased budget and time, and all the other required terms and conditions for the award.
3. All expenses related to human subject activities must be dated or incurred on or after the date of IRB approval.