July 2026

What is a Planning Phase application?

In some cases, research grants from Federal agencies will include funds that may be spent on planning activities prior to the initiation of research activities that qualify as human subjects research. As examples, this phase may involve the establishment of a research infrastructure at the study site or focus on the development of research instruments. In such cases, the principal investigator (PI) may ask the Johns Hopkins Medicine Institutional Review Boards (JHM IRB) to specifically review this “planning phase”, so that funds for these activities may be released before the main phase of the project (which includes human subjects) is ready for review and approval. Although these projects do not meet the criteria to be considered “research,” the IRB will issue an approval notification for these projects to meet Federal agency funding requirements.

How do I submit a Planning Phase application?

The PI will submit a new application via eIRB2 and follow the steps below.

1. Once you’ve logged in to eIRB2, select “Create New Application” on the left-hand side of the screen under Current Activities.
2. When the application opens, please select Planning Phase as the review type in Section 1, Item 7, then answer the remaining questions.
   1. NOTE: you should answer “No” to Section 1, Item 7.1.
3. To add study team members to this Planning Phase application, include them within Section 1, Item 25. Please note that it is not necessary to list other study team members as part of your planning phase application, but it may be helpful to have other staff who can work on this or your full IRB application.
   1. Any added study team members must agree to participate before you can submit the Planning Phase application. Please note that this may delay your submission.
4. In Section 3, Item 1, please select “Grant where specific research projects have not been finalized” and upload a copy of your grant application in Item 2. Please provide a brief summary of your planning phase activities in Item 3.
5. Please disclose any Conflicts of Interest in Section 8 (if applicable).
6. Select “Save” on the bottom right corner of your screen, then select “Finalize”.
7. On the left-hand side of the application workspace, select “Request Study Team Participation” under Current Activities if you have added other study team members and wish to notify them that they need to agree to participate.
8. After all study team members have agreed to participate, select “Submit” on the left-hand side of the application workspace, and complete the PI attestation screen to submit the application to the IRB for review.

What happens after I submit a Planning Phase application?

The JHM OHSR staff will review the application in eIRB2 to make sure that there are no activities described in the planning phase that constitute research with human subjects. If no human subjects research activities are involved, the planning phase application will be approved for a one-year period. The planning phase application will remain active until the application for research involving human subjects is approved, at which time the planning phase protocol can be closed by the PI through a further study action to submit a Study Termination.

Can my Planning Phase application be converted to a full application?

The IRB does not allow a Planning Phase application to be converted to an active human subjects research project. Once the investigator is ready to move into the phase of the project that qualifies as human subjects research, a new application must be submitted. Once that new application has been approved the Planning Phase application should be terminated.

Can I submit a Change in Research (CIR) to my Planning Phase application?

The IRB will allow for the submission of limited changes to the Planning Phase application. These may include study team changes or other minor and administrative changes to the application.

Can I renew my approved Planning Phase application?

If the PI needs longer than one year to complete the planning phase activities, they should submit a Continuing Review (CR) of the Planning Phase application. If the CR is approved, a one-year extension of the Planning Phase application is granted.

Who should I contact if I have questions about the Planning Phase application process?

Please contact the following individuals within the JHM OHSR if you have questions about your Planning Phase application. We are happy to help!

• Seth Hall: [email protected]
• Jessica Williams: [email protected]
• Megan Singleton: [email protected]