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.118 Determinations are 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:
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.
To request a .118 Determination, please complete and submit an application to the IRB through iRIS. Please see 'Preparing an Initial Submission' for instructions on how to submit an application in iRIS.
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:
NSF has provided institutions with the template language for these determinations and will accept them under the circumstances listed above.
If you encounter issues having this determination accepted by a program officer, please refer them to Jeff Mantz, Human Subjects Research Officer, National Science Foundation (firstname.lastname@example.org or (703) 292-7783).
If you have any questions, please contact Lisa Leventhal, the IRB Administrator.