Grant Applications - Projects that need IRB Review Prior to Submission

If your human subjects research project is approved or given an exemption, the IRB will prepare a letter to the granting agency.  If your Application/Proposal lacks definite plans for involvement of human subjects, you will need to request a 45 CFR 46.118 designation letter.

Certain types of applications for grants, cooperative agreements, or contracts are submitted to agencies (i.e. NSF, NIH) 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, except for research exempted or waived under 45 § 46.101 (b) or (i), no human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the IRB, as provided in this policy, and certification submitted, by the institution, to the agency.

Designation under 45 CFR 46.118 is not to be used to delay submitting a human research application until such time funding is likely. It only applies in circumstances where insufficient information is known about the specifics of the research study. 

To receive an IRB 45 CFR 46.118 designation:

• In your application to the IRB, ask for a 45 CFR 46.118 designation and provide a description of the project with the level of detail currently known; what will be done, with whom, under what circumstances, and for what reason. 
• Provide the justification for requesting a 45 CFR 46.118 designation. Specifically, explain why definite plans for research with human subjects would not normally be set forth in the application or proposal, even though you have knowledge that human subjects may be involved within the period of support.
• Give the anticipated date of when the human research plans will be submitted.

Once an activity is provided a designation under 45 CFR 46.118, the PI must submit an initial application to the IRB office for review and approval when definitive plans have been developed. No human subjects may be involved in research until the IRB review and approval has taken place. 

The 45 CFR 46.118 designation will be given an expiration date of one month past the date by which the PI anticipates human research plans will be definitive enough to submit for IRB review but not more than one year from the initial request.