When a sponsor requests Institutional Review Board (IRB) documentation before releasing an award, faculty may find themselves balancing a promising funding opportunity with a study protocol that is still in development.

These Just-in-Time, or JIT, requests often arrive after proposal submission and scientific review, but before the sponsor issues the final award. For studies involving human participants, sponsors may ask for IRB approval, certification, human subjects documentation, or other compliance information before funding can move forward.

The U Research IRB has support pathways to help faculty and research teams respond to these requests, meet sponsor requirements, and remain aligned with human subjects research protections.

A common challenge during the funding process

A JIT request usually means a sponsor is considering a project for funding and needs final compliance documentation before releasing the award. Common sponsors may include NIH, NSF, and other federal agencies.

The challenge is timing. Faculty may receive a request before funding is in place and before the study is fully developed. Consent forms, recruitment materials, ancillary reviews, or other details may not yet be ready for a full IRB submission.

Rather than leaving investigators to navigate that pressure alone, the IRB can help determine the best path forward based on the sponsor’s requirements, the due date, and the current stage of the study.

Contact the IRB early

The most important step for faculty is to contact the IRB immediately after receiving a JIT request.

Investigators should email irb@hsc.utah.edu and share any available sponsor documentation, including the program officer notification, award notification, required materials, and due date. If the deadline is under 30 days, investigators should also consider requesting an extension from the sponsor.

Early communication creates the most flexibility. By contacting the IRB as soon as possible, research teams give staff time to review the sponsor’s request, assess the study’s status, and identify the most appropriate support option.

Support options may vary by study

Not every JIT request requires the same response. Depending on how developed the study is, the IRB may recommend a letter of support, a deadline extension request, a full IRB application, or the Concept-Only Approval pathway.

A letter of support may help confirm IRB awareness of the project for sponsor purposes. A deadline extension request may be appropriate when the sponsor’s timeline is very short. If the protocol is ready, the research team may move forward with a full IRB application through the standard review pathway.

For some JIT situations, the IRB may determine that Concept-Only Approval is the right option.

What Concept-Only Approval does

Concept-Only Approval is a streamlined pathway designed specifically for JIT situations. It may be used when a sponsor needs IRB certification before releasing an award, but the study is still being developed and is not ready for a complete protocol package.

This option is available only after consultation with the IRB. It uses a simplified application process and focuses on basic IRB review criteria. The goal is to help determine whether IRB certification can be provided for sponsor purposes during the funding process.

Concept-Only Approval is best understood as one tool the IRB may use to support faculty during the pre-award stage. It is not a substitute for full IRB approval, and it is not intended to authorize the start of research activities.

What Concept-Only Approval does not do

Concept-Only Approval has important limits.

It does not allow enrollment of participants. It does not authorize research activities. It does not approve consent documents, recruitment materials, waivers, or vulnerable population protections.

In practical terms, no human subjects research may begin under Concept-Only Approval. It is an administrative pathway tied to sponsor requirements, not operational approval to conduct the study.

That distinction protects both investigators and participants. Concept-Only Approval may help satisfy a sponsor’s JIT documentation request, but the research team must still complete the full IRB review process before beginning any human subjects research.

After the funding decision

Once the sponsor makes a funding decision, the Concept-Only Approval is closed. It cannot be renewed.

If the project is funded, investigators must submit a new study application and receive full IRB approval before any research activities begin. This includes participant enrollment, recruitment, consent, data collection, or other human subjects research activities.

Faculty should plan for this next step early. Concept-Only Approval may support the award process, but a complete IRB application will still be required before the project can move into active research.

The takeaway for faculty

A JIT request can create pressure, especially when a sponsor’s deadline arrives before a study is fully developed. Faculty do not need to determine the right path alone.

The University of Utah IRB can help investigators understand sponsor requirements, evaluate available options, and determine whether a support letter, extension request, full IRB application, or Concept-Only Approval is appropriate.

The key is early communication. Faculty who receive a JIT request should contact irb@hsc.utah.edu immediately so the IRB can help identify the best path forward.