Getting your research through the Institutional Review Board (IRB) can feel like a challenge, but it’s a crucial step in making sure your study meets ethical standards. The IRB is there to protect your participants and ensure that your research is safe, responsible, and well-executed. That said, many researchers run into roadblocks—not because their study is flawed, but because of avoidable mistakes in their IRB submission.
The good news? By steering clear of common errors, you can make the process a whole lot smoother. In this blog, we’ll highlight five major “red flags” that often trip up researchers during IRB review. Plus, we’ll offer practical tips to help you avoid these issues and improve your chances of quick approval. Whether you’re just getting started or you’ve been through the process before, these insights will help you navigate the IRB with confidence. Let’s dive into five key red flags and how to fix them before they become obstacles in your research submission.
Red Flag #1: Incomplete or Inaccurate Protocols
One of the fastest ways to hit a roadblock with your IRB submission is by turning in an incomplete or unclear protocol. Think of the protocol as the blueprint for your entire research project—it lays out everything from your research design to how you plan to collect data and select participants (Schwenzer, 2008). If any part of this blueprint is missing or poorly explained, the IRB will likely ask for revisions, which can delay the approval process.
Common areas where researchers slip up include vague descriptions of methodologies, incomplete participant selection criteria, or failure to detail how data will be collected and analyzed. For example, leaving out specifics on how you’ll ensure participant confidentiality can lead to questions from the IRB about whether the study is ethically sound. The IRB depends on a detailed, comprehensive protocol to assess the risks, benefits, and overall feasibility of your research. So, when your protocol is incomplete or unclear, it raises red flags about whether the study is ready to move forward (Lynch, 2018).
Suggestion #1: Double-Check Your Protocol for Completeness
Before you submit, be meticulous about reviewing your protocol. Go section by section—objectives, methodology, participant details, and data collection plans—to ensure that everything is well-detailed and easy to understand. Ask yourself: Would someone unfamiliar with my project be able to follow along? If the answer is no, then it’s time to make some revisions. Clear, complete, and consistent information is key to getting the IRB’s green light without unnecessary delays. A little extra attention now can save you a lot of back-and-forth later.
Red Flag #2: Inadequate Informed Consent Procedures
Informed consent is one of the cornerstones of ethical research, yet it’s also one of the most commonly overlooked areas in IRB submissions (Bhutta, 2004). The informed consent form isn’t just a formality—it’s a comprehensive document designed to ensure that participants fully understand the nature of the study they’re agreeing to. It explains everything from the purpose and procedures of the study to potential risks and benefits, as well as the voluntary nature of participation. If this document is unclear, overly technical, or missing key details, it’s a major red flag for the IRB.
Why is this so important? The IRB’s role is to protect participants, ensuring they understand exactly what they’re getting into before they give their consent. If your form leaves out important details or is written in a way that participants may struggle to understand, the IRB will likely question whether participants can genuinely provide informed consent. For instance, if your form doesn’t explain the potential risks or how participant data will be used, it may lead to ethical concerns about whether participants are making an informed choice. This often results in requests for revisions, slowing down the approval process and delaying your research.
Another common mistake is using overly technical language (Feinberg et al., 2024). Even though your research might involve complex concepts, the informed consent form needs to be written in plain language that anyone, regardless of their background, can easily understand. If participants can’t follow the language in your form, they can’t make an informed decision about whether to participate. This not only raises ethical red flags but can also damage trust between researchers and participants.
Suggestion #2: Simplify and Clarify Informed Consent
The key to creating a strong informed consent form is to prioritize simplicity and clarity (King & Moulton, 2021). Use straightforward, non-technical language that’s accessible to all participants, regardless of their education level. Make sure to include all the essential elements, such as the study’s purpose, the procedures involved, any potential risks and benefits, and the voluntary nature of participation.
Think of the consent form as a conversation between you and your participants. They should be able to walk away from reading it with a full understanding of what the study entails and how it might impact them. A clear, well-organized informed consent form not only ensures participants’ rights are protected but also speeds up the IRB approval process. By demonstrating that you’ve prioritized transparency and ethical responsibility from the outset, you’ll be well on your way to a smoother, faster review process.
Red Flag #3: Lack of Clear Data Security Measures
One thing that can instantly trigger IRB concerns is failing to clearly outline how you plan to protect participant data. Research involving human subjects often collects sensitive personal information, and the IRB needs to be confident that you have solid measures in place to ensure privacy and confidentiality (Lepley et al., 2023). If your submission doesn’t clearly explain how data will be stored, who will have access, or how you’ll anonymize the information, you’re likely to face delays or requests for clarification.
Why is this so important? Beyond just being an ethical responsibility, protecting participant data is essential for maintaining trust between researchers and participants. If participants don’t feel confident that their information is secure, it can undermine the integrity of your study. Moreover, IRBs are responsible for ensuring that studies meet strict standards around privacy and confidentiality, so any vague or incomplete data security plans will likely raise red flags. This is particularly critical in studies involving vulnerable populations or sensitive topics.
Suggestion #3: Prioritize Data Security in Your Plan
To avoid issues, make sure your data security plan is crystal clear. Outline exactly how you’ll store participant data—whether it’s in encrypted digital files, physically locked storage, or both—and who will have access to that data. Include specific details on how you’ll protect confidentiality, such as using anonymization techniques or de-identifying participant information. This level of detail will not only reassure the IRB but also show that you’ve thought carefully about protecting your participants’ privacy from the very beginning.
Red Flag #4: Poor Description of Risk Minimization
One of the biggest mistakes researchers make when submitting their IRB protocols is failing to adequately address risk minimization. Every research study involving human participants comes with some level of risk—whether it’s physical, psychological, or related to privacy and confidentiality. The IRB’s job is to ensure that these risks are properly identified and managed before the study gets the green light (Liberale & Kovach, 2017). If your protocol either downplays or glosses over the risks without offering a clear plan to handle them, that’s a major red flag.
Why does this matter so much? Participant safety is the number one concern for the IRB. They’re not just reviewing your protocol to check boxes—they’re ensuring that your study protects the well-being of participants at all times. If your submission doesn’t clearly show that you’ve considered all potential risks and created effective strategies to minimize or mitigate them, it signals to the IRB that your study might not be as ethically sound as it should be. However, this isn’t just about avoiding harm. Poor risk management can lead to questions about whether your study design is strong enough to handle unexpected challenges, which could ultimately jeopardize the validity of your research.
Additionally, if risks aren’t properly addressed upfront, the IRB will be forced to ask for revisions or additional clarifications, which delays the entire approval process. What could have been a relatively quick review process can turn into a drawn-out back-and-forth as you work to update your protocol. This is a situation every researcher wants to avoid—especially when getting your study approved on time is critical for your timeline.
So what does it mean to properly address risk minimization in your protocol? First, it requires being realistic about the potential risks involved in your study. No research is completely risk-free, and trying to downplay or ignore risks is a surefire way to raise suspicions during the IRB review. You need to adequately identify any possible risks—whether they’re related to physical health, psychological stress, or even the confidentiality of participant data. And once you’ve identified these risks, it’s essential to show how you plan to manage them.
This means developing concrete strategies that demonstrate your commitment to reducing harm. For instance, if your study involves physical interventions, you’ll need to explain the safety measures you’ve put in place to prevent injuries or adverse effects. If you’re conducting interviews or surveys on sensitive topics, explain how you’ll protect participants from psychological distress (Stirling & Takarangi, 2024). And if the risk relates to privacy—such as handling personal data—describe in detail how you’ll safeguard this information, whether it’s through anonymization, encryption, or limiting access to the data. The more specific and thoughtful your risk management plan is, the more confident the IRB will be that your study is safe and ethical.
Suggestion #4: Provide a Thorough Risk Minimization Plan
To keep your IRB review process moving smoothly, your protocol should include a comprehensive and detailed plan for risk minimization. Start by identifying every possible risk that could arise from your study—physical, psychological, and privacy-related. Be honest and thorough during this step. Don’t assume the IRB will overlook any risk, no matter how small. It’s better to acknowledge a minor risk and explain how you’ll mitigate it than to have the IRB flag your submission because something was left unaddressed.
Once you’ve outlined the risks, your next task is to describe how you’ll reduce or manage them. For example, if there’s a risk of emotional distress from participating in the study, you might offer participants the option to skip questions or withdraw from the study at any time without penalty. If there’s a risk related to privacy, such as handling sensitive personal data, explain exactly how you’ll ensure confidentiality—this could include anonymizing data, storing it securely, and restricting who has access to it.
If physical risk is a concern, detail the precautions you’re taking to prevent harm. This could be as simple as having medical personnel on-site or as involved as designing specific safety protocols for procedures. Whatever the risk, the goal is to show the IRB that you’ve thought about every possible angle and have taken proactive steps to keep participants safe.
Remember, the IRB’s primary role is to protect participants, and a well-developed risk minimization plan demonstrates that you take this responsibility seriously. It also signals that you’re prepared to handle any challenges that may arise during your study. This not only increases the likelihood of a faster approval process but also ensures that your study is built on a foundation of ethical integrity.
Red Flag #5: Insufficient Description of the Participant Population
When submitting a research protocol, one of the most critical areas for the IRB is how you describe the participants in your study. If the details about your participant population are vague, incomplete, or missing key information, such as inclusion and exclusion criteria, you’re likely to face delays in approval. The IRB needs to know exactly who will be involved in the study, why they’ve been chosen, and whether selecting this group aligns with ethical guidelines and research objectives. Failing to provide a clear description of your participant group raises concerns about whether your study is ethically sound and whether the participant selection process is appropriate.
One common issue is not specifying the demographic characteristics of participants. For example, if your study focuses on a specific age group, gender, or population segment (e.g., a particular medical condition), this must be explicitly stated in your protocol. If this information is left too general, the IRB may worry that your participant selection process lacks focus or, worse, that it could unintentionally exclude or exploit certain groups. Additionally, not outlining the inclusion and exclusion criteria can create further complications, as the IRB relies on this information to determine whether your study treats participants fairly and protects vulnerable populations.
Another key concern is whether the participant group aligns with the research objectives. The IRB wants to ensure that your chosen population is appropriate for the study’s aims. For example, if you’re conducting a study on mental health interventions, it’s crucial to justify why you’ve selected a certain age range or population and how this choice contributes to answering your research questions. If this justification isn’t provided, the IRB may view the selection as arbitrary or unethical.
Suggestion #5: Clearly Define Your Participant Population
To avoid delays and potential rejections, make sure to thoroughly define your participant population in your protocol. Provide detailed demographic information, such as age, gender, socio-economic status, or any other relevant characteristics that pertain to your study. Explain why these demographics are important for your research and how they relate to your objectives. For example, if your study focuses on older adults, explain why this age group is necessary for your research and how your findings will benefit that population.
In addition, it’s essential to specify both your inclusion and exclusion criteria. The inclusion criteria should outline the characteristics participants must have to be part of the study, while the exclusion criteria should explain why certain individuals may not be eligible. This shows the IRB that you’ve thought carefully about who should—and should not—be included in the study, preventing any ethical issues around participant selection.
Finally, ensure that your justification for choosing this particular population is clear. The IRB wants to know that your selection is not just convenient, but that it serves the purpose of your research and contributes to the field. A clear and detailed description of your participant population will demonstrate that your study is thoughtfully designed, ethically sound, and ready for IRB approval (Jach et al., 2020).
Conclusion
Navigating the IRB approval process can feel overwhelming, but avoiding frequent mistakes can greatly ease the journey. We’ve highlighted five major red flags—incomplete protocols, inadequate informed consent, unclear data security, poor risk minimization, and insufficient participant descriptions—all of which can slow down approval or raise ethical concerns.
To avoid these delays, remember the key solutions: double-check your protocol, simplify informed consent, prioritize data security, detail your risk minimization plan, and clearly define your participant population. Taking these proactive steps will make your submission stronger and more ethically sound, helping you move through the IRB process more smoothly.
There’s no need to go it alone—let BeyondBound help you unlock the full potential of your research. We don’t just give advice; we provide comprehensive, bespoke support, guiding your submission from start to finish with efficient, stress-free service. With 18 years of expertise and care in handling the process, we know how to eliminate obstacles and get you to ‘yes’ faster than anyone else. Plus, our IRB HEART training program equips you with the knowledge and certification to stay compliant, while we handle the heavy lifting. And all of this comes with transparent pricing and unbeatable value, delivering premium service without breaking your budget.
At BeyondBound, we’re more than just an IRB—we’re your research partner, ensuring your project is approved swiftly, accurately, and with full confidence. Ready to move forward with ease? Let’s guide you to “yes”.
References
Bhutta, Z.A. (2004). Beyond informed consent. Bulletin of the World Health Organization, 82 (10), 771-778.
Feinberg, I.Z., Gajra, A., Hetherington, L. et al. Simplifying informed consent as a universal precaution. Sci Rep 14, 13195 (2024). https://doi.org/10.1038/s41598-024-64139-9
Jach, E., Gloeckner, G., & Kohashi, C. (2020). Social and Behavioral Research with Undocumented Immigrants: Navigating an IRB Committee. Hispanic Journal of Behavioral Sciences, 42(1), 3-17. https://doi.org/10.1177/0739986319899979
King JS, Moulton BW. Rethinking Informed Consent: The Case for Shared Medical Decision-Making. American Journal of Law & Medicine. 2006;32(4):429-501. doi:10.1177/009885880603200401
Lepley, A., Norte, G. E., & Ferlic, M. (2023). Chapter 75 – Data management: how to manage data safely and effectively in an organized manner. In Handbook for Designing and Conducting Clinical and Translational Research, Translational Sports Medicine, pp. 377-382. https://doi.org/10.1016/B978-0-323-91259-4.00059-X.
Liberale, A. P. & Kovach, J. V.(2017). Reducing the time for IRB reviews: A case study. Journal of Research Administration, 48(2), pp. 37-50.
Lynch, H. F. (2018). Opening closed doors: Promoting IRB transparency. The Journal of Law, Medicine & Ethics, 46(1), 145-158. https://doi.org/10.1177/1073110518766028
Schwenzer, K. J. (2008). Practical tips for working effectively with your Institutional Review Board. Respiratory Care October 2008, 53 (10) 1354-1361.
Stirling, N.J. & Takarangi, M.T. (2024). The participant’s voice: crowdsourced and undergraduate participants’ views toward ethics consent guidelines. Ethics & Behavior. https://doi.org/10.1080/10508422.2024.2341639