IRB Narratives

IRB approval is one of the initial considerations in conducting a human subjects research study. The IRB at each university is unique, but all IRBs have the same goal: ensuring that research study design protects participants and their information according to the principles of the Belmont report.

The requirements for IRB approval for any given study will vary widely, depending on a number of factors such as the study design, the university's requirements, the exemption status and category of the study, and even the forms that particular university IRB uses. However, there are some common considerations that may help you approach writing for your IRB.

Audience

The reviewers at the IRB are typically not faculty members; they are trained to review study designs against university regulations, but they are not trained to be a subject matter expert in your field. Therefore, it's helpful to be as clear as possible when describing your study, its purpose, and its anticipated benefits. Try to avoid jargon and explain any field-specific terms. Similarly, make sure anticipated benefits of the study are phrased in plain language and clearly signposted for the reader.

Purpose

IRB reviewers are looking for specific information about participants in your research, and how you will protect them and their information from harm. This means that the information you most need to communicate is how participants will be affected by your research protocol, what measures you will take to reduce risk for participants while they participate in your study, what data you will collect from participants, and what methods you will use to protect that data's confidentiality. While you may need to give more detail about your study design, you should ensure that these key considerations are highlighted for the reviewers in some way (they might be repeated in multiple places so they're more easily found, or they might be placed in the introduction of a narrative so the reviewer can identify the information easily and quickly, for instance).

Context

Many IRBs process a great deal of proposals in a relatively short time. Since any given reviewer may have a hefty workload, it's a good idea to repeat key information as needed and phrase your proposal in terms that anyone, especially non-experts in your field, can understand.

Another tactic to help your IRB proposal pass the first time is to meet with an IRB specialist (your university's IRB will usually have different specialists for different areas; look on their website, call and ask, or ask your advisor who you should be speaking to). They can help answer questions you may have about your study, its potential exemption status, and its category, so that you're for sure going to fill out the right forms the first time. They may also be able to help you think about your study design in terms of IRB approval, so you can build in good practice from the start rather than having to change your methods later on.