Addressing Key Gaps Before You Submit
At Solutions IRB, we’ve seen that small oversights can cause big delays in the path to successful IRB submissions. In Part Three of our IRB Approval Success series, we’re focusing on three common gaps that can slow down your path to approval — and how you can address them before you hit “submit.”
1. International Studies – Missing Local Government Approval or Evidence of Exemption
When conducting research outside the U.S., it’s not enough to secure IRB approval alone. Many countries require local government authorization or confirmation that such approval is not necessary.
Why it matters: Without documented permission (or proof that it isn’t needed), your study may face delays or even rejection at the IRB stage.
What to do:
Research the regulatory requirements for your study’s location early in the planning phase.
Obtain official documentation in writing, translated into English if necessary.
Include this documentation with your IRB application to avoid a request for revisions.
Pro tip: Even if you believe no local approval is required, include a statement from an official authority confirming this — it demonstrates due diligence and strengthens your submission.
2. Missing Permission Letters for Educational or Academic Settings
Any study conducted within an academic setting — from preschool through graduate school — typically requires permission from the institution. This includes universities, school districts, and individual sites.
Why it matters: IRBs cannot approve research in these settings without written permission, and waiting for letters after submission almost always causes delays.
What to do:
Identify all relevant institutions early.
Reach out to the appropriate administrators (e.g., principals, district offices, university research departments) to secure letters.
Ensure each letter includes the institution’s name, your study title, and a clear statement granting permission.
Pro tip: Start this process early — institutional approvals often have their own internal review timelines.
3. Avoiding Vague Terminology in Study Protocols
Language like “participants may be asked to…” or “you will be asked to complete 2–5 tasks” creates ambiguity and signals to the IRB that your study procedures aren’t finalized.
Why it matters: The IRB must be able to understand exactly what will happen, to whom, when, and how. Vague descriptions prevent others from replicating the study and undermine participant protections.
What to do:
Be precise and consistent in describing tasks, timelines, and participant expectations.
Replace “may” with definitive statements when applicable.
Avoid ranges unless there is a clear, justified reason, and explain it.
Pro tip: If someone unfamiliar with your research can read your protocol and describe exactly what will happen without asking questions, you’re ready to submit.
Setting Yourself Up for IRB Approval Success
The most successful IRB submissions are thorough, precise, and supported by all required documentation. By securing local and institutional permissions and clearly defining your study procedures, you can reduce back-and-forth revisions and keep your project timeline on track.
At Solutions IRB, we help researchers navigate these requirements with confidence. Whether your study is international, educational, or both, our team ensures your submission is complete and ready for review.
Need help preparing your IRB application? Contact Solutions IRB today to make your next submission your smoothest one yet.