Once submitted, your research proposal will be reviewed by IRB administrators and, if needed later in the process, board members and expert consultants. To avoid delays, researchers are expected to provide a fully complete application where all required documents are attached and the details remain consistent across all materials.

What Happens After You Submit?

Once you submit your application, the IRB staff performs an initial check called “pre-review.” Pre-review is only done after the application is submitted to the IRB office, not before. During this step, IRB staff will:

1. Assess the application and supporting documents for consistency across materials and that nothing is missing.
2. Verify that the required human subjects research training is complete and valid for all NC State University members of the research team and any individual investigators. Please note: Research team members may be required to complete other training due to a federal funder, research sponsor, or research site. The NC State IRB only checks for the IRB-required training. It is the research team’s responsibility to check and ensure that they are compliant with all training requirements.
3. Review applicable research regulations, guidelines and risks to decide what kind and level of IRB review the study needs (e.g., Is the study minimal risk or more than minimal risk? Is the study eligible for an exemption determination or does it require a higher level of review?)

Please Note: It is completely normal for the IRB to return an application for revisions once or twice at this stafe. Researchers may be asked to provide more detail, upload missing materials, or align documents with regulatory requirements or recent changes. Prolonged revision cycles are usually a result of researchers ignoring or not fully incorporating the IRB’s provided feedback. Reviewing and thoroughly addressing all IRB feedback before resubmitting a protocol application is expected if you wish for your application to move forward.

Final Review

Protocol applications move to final review once the pre-review process is complete and the application has been submitted to the IRB office in a condition that it is ready for final review. The final review process and associated timeline greatly depend on the level of IRB review required, the risk involved in the study, and what policies, regulations, and standards the study is subject to.

Once the application is ready for final review, IRB staff will either:

1. Conduct the final review and approval for studies that are eligible for an exemption determination, including a limited review if necessary. This is a quicker process than the other more stringent levels of IRB review because exempt studies are low risk in nature but an exemption determination is not always immediately upon submission for final review. The actual IRB approval timeline depends on when the application is ready and submitted for final review (not the date of initial submission), the number of other protocols waiting in line to be reviewed when the application is resubmitted, and IRB staff availability when the protocol is ready for final review. Please note: A study that receives an exemption determination doesn’t mean that a research team skips the IRB review process; it just means that the study is exempt from some of the stricter U.S. regulations for human subjects research. Even if a study is exempt, all policies, regulations, and standards that apply to the study must be followed – especially if it is stricter than what the IRB requires.
2. Refer the application with all supporting documents for final review by one or two convened full board member with relevant research methods and participant population(s) expertise for studies that are minimal risk and eligible for review at the expedited (mid-level) review level. The board member(s) have 15 business days, excluding University closures, to evaluate the protocol and return the application to the IRB office with a determination to approve the study with no changes, approve with minor changes (and specify what those changes are), or to send the application to the convened full board for review.
3. Refer the application and all supporting documentation to the entire convened full board membership for final review. These are studies that are more than minimal risk, are minimal risk but cannot fit into any of the federally designated IRB review categories at the exempt or expedited level, are assessing the safety or efficacy of a test article” as defined by 21 CFR Part 50.3 and other federal regulations, and other types of studies as needed. All convened full board studies are reviewed by the full committee. This type of final review takes the longest because board meetings only occur on set dates and members are sent and review all application materials in advance of the meeting. At a meeting, the members will discuss the application as a group, sometimes invite the main researcher (and their faculty member if this is a student protocol) into the meeting to answer questions about the application, and vote whether or not to approve an application with no changes, approve with stipulations that the researcher needs to address, defer the application for a future meeting so that application materials can be revised or issues identified by the convened full board are addressed, or to disapprove a study (this decision is final).

Addressing Final Review Feedback

After the final review, the IRB will either approve your study or, more commonly, return it with a list of required changes (often called “stipulations”). This is where many researchers get tripped up and experience delays in their IRB approval process.

To get your study approved as quickly as possible, avoid these common mistakes:

1. Not explaining and documenting your changes: When resubmitting an application that received approval with stipulations, clearly communicate what was changed and where the IRB can find those changes to verify them.
2. Only addressing some of the approval stipulations: It is easy to miss a comment but skipping requested changes guarantees your application will be sent back again. Read the stipulations carefully and treat them as a mandatory revision checklist.
3. No justification provided for unaddressed stipulations: If you decline to make changes that were stipulations of approval because you disagreed with them, you can respectfully provide your reasoning. Ignoring stipulations without providing a rationale will delay your approval; even with a rationale, the application package with the researcher’s justification for not addressing the stipulation(s) must be reviewed by the stipulating party before any final determination can be made.
4. Research description, procedures, and supporting documents inconsistencies: If the convened full board asks you to change an activity in your research procedures, it’s likely that you also need to edit your consent material to match. Fixing an issue in one procedural document but forgetting to update the others is a very common cause for delays.
5. Changing your research design, procedures or participant groups in ways that were not specified in the approval stipulations nor reviewed as part of the “approve with stipulations” process.

Before clicking resubmit, do a final side-by-side comparison of the stipulations provided to you with your revised application and supporting documentation to ensure every single point has been addressed.

Researchers should utilize the following IRB webpages to prepare for the IRB review process and for guidance on how to draft application materials.

• IRB Forms and Templates webpage
• IRB Policies, Rules, and Regulations webpage
• IRB Procedures and Guidance webpage

Estimated Review Timeframe

The review timeframes provided are only for planning purposes and are not guaranteed deadlines. Please note that the review “clock” begins only when a fully complete application—including all required supplemental documents—is ready for final review. This is usually not when an application is first submitted to the IRB office.

What Affects Approval Timeline?

Protocol approval will likely take longer (or, occasionally, happen sooner) based on a few key factors:

• The quality, clarity, and completeness of your submitted materials
• The complexity of your study design
• The specific level of IRB review required
• Whether additional (ancillary) reviews are needed

Average Approval Processing Times

• Administrative Review (Exemption Determinations including Limited Review and FLEX): 1-2 weeks
• Expedited Review: 4-5 weeks
• Convened Full Board Review: 6-7 weeks
• Renewals of Existing Protocol Approval: 2-7 weeks (depending on the level of review needed)
• Amendments to Existing Protocols: 2-7 weeks (depending on the level of review needed)

Important Note for Student Researchers

The estimated timelines above do not apply to student projects. Because student research requires a highly collaborative, iterative process, IRB approval typically takes much longer. If you are a student, please be aware of the following:

• Faculty Submission Required: Students cannot submit applications directly to the IRB. Only your faculty advisor can submit the protocol on your behalf.
• Collaborative Drafting and Editing: While the NC State IRB provides templates, training, and guidance, students must work closely with their faculty advisor to draft and revise all IRB application materials. Faculty members are subject matter experts in your field and they are overseeing your academic process, including your IRB application and human subjects research.
• Setting Appropriate Expectations: Please work directly with your faculty advisor to establish realistic timelines for your specific project’s review and approval. Typically, these are much longer that the estimated timelines above due to learning curve and processes that student protocols demand.

Additional (Ancillary) Reviews

Depending on your study’s design, funding, or technology, your protocol may require additional reviews. These reviews usually occur during the IRB pre-review process; a few occur after IRB approval. All of these reviews ensure your study meets specific legal, regulatory, or safety standards.