3.15 - Information Needed When Applying for External Funding

The Transmittal Sheet is the official University form for the documentation of the concurrence of University officials with plans and commitments contained in proposals for externally funded programs. One of its purposes is to document other institutional reviews that may be necessary because of the specific nature of the program, e.g., use of human subjects.

The second page of the Transmittal Sheet contains a check-off for use of human subjects and a space for IRB signature. If your IRB protocol has been approved, enter your protocol number in the space provided. If your IRB protocol has not yet been approved, or if you have not yet submitted a protocol, write “Pending” on the line.

It is important to check with the external agency to whom you are applying to find out if IRB approval is required at the time the proposal is submitted. PHS, for example, requires certification of IRB approval within 60 days after the application receipt date. (See the PHS 398 application kit for more information.) If not, you have a choice of submitting a protocol before or after a funding decision is made by the agency. Note that if you wait, you run the risk of either having to return the funds, or experiencing a delay in being allowed to spend funds, should the proposal be funded and the protocol not be approved by the IRB. However, preparing a protocol for a project which will not be funded may not be the best use of your time. Often, it is wise to consult with IRB staff before submitting a proposal to determine if there may be problems with IRB approval.

In cases where a grant is awarded for the purpose of developing and administering a questionnaire, IRB approval will be granted in two stages. A conditional approval will allow the Principal Investigator to precede only with the instrument development phase of the project. The IRB must review the completed instrument before full approval can be granted and human subject contact initiated. Please be aware that the IRB must be satisfied that the instrument meets IRB regulations or approval will be suspended. In this event, depending on the granting agency and the project, you may be responsible for returning all or part of the original award.