This page is intended to guide researchers in determining the circumstances for which an Approval-In-Principle Application is appropriate. 

General Considerations

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. For example, projects in which human subjects' involvement is planned for a later phase of the research but it is not possible to know the details for that phase because they will depend upon completion of instruments, prior animal studies, or purification of compounds. This is different from situations where the researchers haven’t completed their IRB materials, haven't hired/trained staff or haven't received all necessary permissions to do their research. The AIP application materials must clearly demonstrate development activities are supported by the award. 

No human subject research activities may occur under the AIP approval (i.e., no recruitment, consent, research interactions/interventions, human data/sample collection or use/study/analysis of identifiable private information or samples from or about humans can be conducted under an AIP). The AIP is just a shell of a project that explains the preliminary activities that need to take place that do not involve human subjects and must be completed before the human subjects research components can be designed. A complete IRB project must be submitted for review and approved 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

After the AIP is Approved

Once your AIP is approved, the approval letter for your AIP will include directions on how to provide the IRB with the documents and details for the human subjects research (HSR) portion of your project or how to extend your AIP. You can find the approval letter in the RAP (see our FAQs page for more information). Renewing your AIP or submitting the details for the HSR portion of the research are both typically done through a Modification and Continuing Review (MODCR) where “other parts of the study” is selected as the scope. This will allow you to change your answers, add or revise documents and other details. 

Note: If you are simply extending your AIP (i.e., you are not yet ready to initiate human subject research activities but the research timeline has been delayed, etc.), you will not need a continuing review application included in your CR/MODCR. As noted above, AIPs do not permit any human subjects research activities so no participants will have been enrolled under an AIP and there would be nothing to include in a continuing review application form since it is designed to update the IRB about HSR activities. Instead of a continuing review application form, please provide a brief explanation of why you need more time than previously expected, identify the new expiration date for your AIP (i.e., new anticipated start date for HSR) by updating the Anticipated End Date in the Other Study Information section of the RAP and confirm that you are still doing preparatory work that does not involve any HSR. If the funding details or information in the existing AIP application are outdated, please also update those details/materials.