This page is intended to guide researchers in determining the circumstances for which an Approval-In-Principle Application is appropriate.
Certain types of applications for grants, cooperative agreements, or contracts are submitted to Federal 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 where selection of activities is the institution’s responsibility, training grants in which activities involving human subjects remain to be selected, and projects where human subject involvement will depend on the design and development of study materials and instruments.
An Approval-in-Principle (AIP) is designed to help facilitate review of research lacking definite plans for the involvement of human subject research in accordance with the regulations set forth in 45 CFR 46.118. The AIP process and approval allows UO Sponsored Project Services (SPS) to release funds associated with preliminary phases of research that are preparatory to planned human subject research activities. However, the AIP application materials must clearly demonstrate development activities are supported by the award.
The AIP application is not for IRB review and approval. No human subject research activities may occur under the AIP approval. A protocol application must be submitted for review and approval by the University of Oregon Institutional Review Board (IRB) prior to initiating human subject research activities.
If approved, the AIP approval period will be issued with an expiration date based on the stated anticipated start date for human subject research activities in the application. In advance of the expiration date and prior to implementing human subject research activities, investigators will need to submit an application and obtain either an exempt determination or IRB approval.
Contact RCS with any questions about whether an application or proposal would qualify for an AIP.
How to Submit?
- All AIPs are submitted through the Research Administration Portal (RAP). See our Approval in Principle (AIP) guide within our RAP guidance for details on how to submit.
- Complete an Approval-In-Principle Application form and attach in your submission
- See our Applications, Forms and Guidance page for a copy of the Approval-In-Principle Application to submit for review.
- Tip: In this application, please include a detailed description of the preparatory activities you need to do that do not involve human subjects and need to be completed before you have the details and documents needed for an IRB submission.
- Provide us with funding documents and details within your submission
- See our Applications, Forms and Guidance page for a copy of the Funding and Sponsorship Form to include in your submission
- Include the funding source and EPCS# for your funding
- Attach a copy of your grant proposal or the portion of your grant narrative that describes what you will do for the project