Achieving Successful IRB Submissions

At Solutions IRB, we know that researchers want their studies to move forward smoothly. Yet, even well-prepared applications can run into delays during the IRB review process. In this fourth installment of our IRB Approval Success series, we highlight several recurring issues that can hinder successful IRB submissions and present delays during the review process.

Over-Optimistic Timelines

A common mistake researchers make is underestimating how long their study will take. While it is natural to be eager to begin and complete a project, overly ambitious timelines raise concerns for reviewers. The IRB needs to be confident that the study is feasible and that participant protections remain in place throughout the research period.

When a timeline is not realistic, reviewers may question whether the team has carefully planned resources, recruitment, and analysis. This can lead to requests for clarification or adjustments, extending the review process. Investigators should build in buffer time not only for recruitment challenges, participant scheduling, and unexpected obstacles, but also before the study begins to account for IRB approval, additional oversight, and the processing of funding or institutional agreements. A realistic, transparent timeline shows the IRB that the research team has thoughtfully prepared for the demands of the study.

Risk Identification

A key element of a strong submission is the research team’s ability to clearly identify and disclose all potential risks to participants. This responsibility extends beyond major concerns to include risks that may appear minor at first glance. For example, even a simple survey could pose a risk of loss of anonymity if data handling procedures are not clearly explained.

When risks are overlooked, the IRB must request clarification, which can delay approval and raise concerns about whether the study has been fully and thoughtfully designed. By contrast, transparent and thorough identification of risks demonstrates the research team’s preparedness and commitment to participant protections.

Acknowledging risks does not weaken a protocol; it strengthens it. When teams openly describe potential challenges and clearly outline mitigation strategies, they provide the IRB with confidence that the study has been carefully planned and that participant safety is a central priority.

PI Attestation: The PI Must Sign

The Principal Investigator is ultimately responsible for the research. For this reason, the PI—not a co-investigator, research assistant, or administrator—must sign the PI attestation on the application. Each time an application is resubmitted, the PI’s signature confirms that they are fully aware of any revisions or changes and remain accountable for the study.

When someone other than the PI signs, it not only causes delays but also undermines the assurance that the PI understands the study’s details. This step may seem small, but it is vital for compliance and for the IRB’s confidence in the oversight of the research.

Forgetting to Resubmit After Revisions

One of the most common causes of delay is surprisingly simple: the application is revised but never resubmitted. Research teams often address reviewer comments, update documents, and prepare responses—but unless the study is formally resubmitted, the IRB cannot see those changes.

At Solutions IRB, our system includes a “Completeness Check” function, which helps research teams confirm that all sections are filled out and that the application is ready for submission. Utilizing this tool can prevent avoidable delays. Investigators should make it a standard practice to run the completeness check and confirm that the study is officially resubmitted after every round of revision.

Final Thoughts

The IRB approval process is designed to protect research participants and ensure ethical standards, but small oversights can create big delays. Over-optimistic timelines, incomplete risk identification, incorrect signatures, and forgotten resubmissions are all preventable problems.

At Solutions IRB, we encourage investigators to slow down, review carefully, and use the tools available in the application system to double-check their submissions. With careful attention to detail, researchers can avoid unnecessary setbacks and move their studies forward with confidence.

This concludes Part Four of our IRB Approval Success series. By addressing these common pitfalls, you’ll be one step closer to a smooth and timely approval.