Avoiding Common Pitfalls in Your Submission
In our first installment of the IRB Approval Success series, we explored how preparation and finalized documentation set the foundation for a smooth IRB review. In Part Two, we’re diving deeper into four common issues that can derail an otherwise promising submission — and how you can avoid them.
1. Lack of Qualifications
The Principal Investigator (PI) is ultimately responsible for the ethical and scientific integrity of the study. IRBs look for clear evidence that the PI is qualified to conduct the proposed research. This is typically demonstrated through:
Past publications in the relevant field.
Education and training directly related to the study’s focus.
Clinical or practical experience with the study population or a similar group.
Your CV is the IRB’s primary tool for assessing these qualifications. A generic, outdated CV can raise red flags. Instead, tailor and update your CV to emphasize your background that directly supports your ability to conduct the study. Highlight prior research with similar populations, relevant coursework or certifications, and any training in human subjects protections.
Remember — the IRB must feel confident in your ability to lead the study ethically and competently.
2. Not Identifying Conflicts of Interest
Conflicts of interest (COI) occur when personal, professional, or financial relationships could bias, or appear to bias, your research conduct or interpretation. Failing to disclose them can jeopardize IRB approval and your credibility as a researcher.
Some common examples include:
Financial interests in a product, service, or company involved in the study.
Personal or professional relationships with participants or sponsors.
Consulting arrangements related to the study’s subject matter.
Always err on the side of transparency. If you are unsure whether something counts as a COI, disclose it and allow the IRB to determine how to manage it. Proper disclosure builds trust with the board and protects the integrity of your research.
3. Misalignment Between Objectives and Methodology
One of the most frequent — and preventable — issues IRBs encounter is misalignment between the research question, study objectives, and methodology. For example:
A study aims to explore stress management strategies, but survey questions focus primarily on physical health habits.
The research objective is to measure workplace satisfaction, yet the data collection tool primarily captures demographic information.
Such misalignment raises questions about whether the study can answer its stated research question. Before submitting, take the time to map each objective to the specific methods and instruments you will use. If a survey question or interview prompt does not clearly connect to an objective, reconsider its inclusion.
4. Too Many Cooks in the Kitchen
Collaboration is essential in research, but when too many people are independently contributing to the IRB application without coordination, inconsistencies and gaps can occur. This often leads to:
Mismatched descriptions of the study population.
Conflicting details about procedures or timelines.
Missing information that each person assumed someone else included.
To avoid this, designate a single point person responsible for reviewing the entire submission before it goes to the IRB. This person should ensure that:
The application tells a consistent, complete story of the study.
All details — from recruitment to consent to data handling — are clearly described.
The IRB application truly functions as a roadmap for the research: outlining the who, what, where, when, and how in sufficient detail.
Final Thoughts
Securing IRB approval requires more than a compelling research idea — it requires a clear, consistent, and credible application. By ensuring the PI’s qualifications are well-documented, disclosing any potential conflicts of interest, aligning methodology with objectives, and centralizing review of the application, you can avoid common stumbling blocks.
At Solutions IRB, we’ve reviewed thousands of applications and have seen how attention to these details can mean the difference between a smooth approval and repeated revision requests. In the next installment of our IRB Approval Success series, we’ll explore how to effectively respond to IRB feedback to keep your project moving forward.
