The sponsoring agency wants to see that the study has IRB approval prior to releasing funds, but I haven't finished developing my study yet. What should I do?
Approval in Principle is granted to satisfy sponsoring agency requirements or to allow investigators to have access to funding to begin aspects of the project that do not involve human subjects. Funds may not be used to conduct research with human subjects until a study-specific protocol has been reviewed and approved.
Under the federal regulations (§46.118) and in accordance with the OSU IRB’s Standard Operating Procedures, certain types of applications for grants, cooperative agreements, or contracts are submitted to departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal.
These include activities such as:
- institutional type grants when selection of specific projects is the institution's responsibility;
- research training grants in which the activities involving subjects remain to be selected; and,
- projects in which human subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of compounds.
These applications need not be reviewed by an IRB before an award may be made. However, no human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the IRB.
If you have already submitted an application to the IRB:
If you have already submitted your application to the IRB, it is under review. Please contact the IRB office immediately upon receiving any favorable correspondence from the sponsoring agency indicating that your proposal may be funded or recommended for an award.
If your project already has IRB approval:
If your funding proposal is for a project that already has IRB approval, please submit a project revision to add the sponsor if your proposal is funded.
For NSF-funded Proposals:
As of March 2014, NSF will no longer accept an Approval in Principle.
If you have not yet submitted an application to the IRB:
We urge you to stay in touch with your Program Director and submit your application to the IRB as soon as you receive any hint that your project may be funded. If you would like to submit your application early for a pre-review by the staff, we would be happy to ensure that your application contains all of the necessary documents and is ready to assign to a reviewer at a moment’s notice.
Alternatively, prepare and submit your IRB protocol at your earliest possible convenience, even if you have not heard from NSF. While we recognize that the effort of preparing an IRB application may be unnecessary if your NSF proposal is not funded, this action may also save your proposal should yours be one that is moving forward for recommendation. This latter path is especially critical for any human subjects research that must go to the full board, as the board only meets 1-2 times each month.
If you have any questions, please contact Lisa Leventhal, the IRB Administrator.