When evaluating exempt protocols, we often get the comment, “Hey! This study is super simple, and obviously exempt. What’s the deal with the revisions?!”. While this is often very much the case, the IRB must evaluate what is presented against what is required by regulations. The protocol may allude to the information needed to make a determination, but often does not articulate it clearly enough. The tips presented below are a compilation of some of the most common items that are either present or missing from exempt studies, that may cause unnecessary delays. With just a bit more attention to detail, exempt determinations can pass through the review process even more efficiently. Which, after all, is the goal, right?
- Make sure your submission is complete!
This is probably the most obvious tip, but often the most common reason for returning an exempt submission to the study team. In the days of everyone getting pulled in several different directions all at once, it can be easy to miss a section. It is easier, still, to forget about that one section you meant to revise before submission. The time it takes to give the documents one last read through before submission can be saved several times over when waiting on a round of revisions for something that you already knew needed to be addressed, but simply forgot.
- Formatting and templates – easy is best!
When submitting to any IRB, I would recommend using their provided templates if available. The IRB members are accustomed to reviewing these documents daily and know exactly where to find the information for which they are looking. When the templates just won’t work for your project—no worries! Create your own template or use your own internal formatting guidelines. After you have everything put together, grab an IRB-provided template to make sure you hit all the key areas or sections.
- Understand exemption requirements
You don’t need to work tirelessly to make yourself an expert in all things IRB to make a quality submission. However, you should understand the basic requirements of the exemption for which you are applying. One of the best resources is the HHS Decision Charts. They provide a clear flowchart to guide you through the determination processes. The IRB will use these and the corresponding regulations to make the determination, so why not provide them with the exact information they require? Your IRB administrators will appreciate the work, and review times will reflect this.
- Wait, what? I don’t understand that question…
If you don’t know—ask! There is no reason to stuggle with trying to interpret a question that you do not understand. The IRB is always more than happy to clarify or explain any question or section of a protocol form that you do not understand. Frankly, you are probably not the only one who has had difficulties with the same question. The IRB is proactive in trying to improve processes, and if we see that a question just isn’t working, we try to fix it. We must know where we can improve, and that starts with taking action based on the questions we receive from study teams.
- Please find the attached…
There is ample space for attachments of every sort and variety; nevertheless, we often receive proposals that try to fit everything into one document. The inconsistent formattingand sections, margin errors, etc. can really degrade an otherwise beautiful submission. Please don’t stress trying to combine all the documents into one—just attach the different documents!
- Identify yourself! (or don’t)
Five of the eight available exemption categories explicitly ask whether the identity of the subjects can be readily ascertained directly OR through identifiers. Given that this is such a key determination for the IRB to make, the study should be very clear on how subjects will or will not be identified. Details on how the study team is protecting the identity of the subjects is crucial to a successful submission. This includes how you are assigning participant numbers, who has access to the key, and how the data will be stored.
- Inclusion/Exclusion criteria
Last, but certainly not least, are the participant selection criteria. While most studies are very clear on the age ranges and high-level criteria that they are utilizing, they miss the small but critical details. The most common mistake is not excluding those who are unable to consent. Another critical error is not considering the local regulations in relation to the age of majority. While 18 is the age of majority across most states, there are some outliers. Moreover, as we look internationally, the age of majority differs and should be addressed explicitly in the protocol.
The tips listed above may seem obvious to seasoned authors, but we often become blinded to the items with which we are most comfortable. To those less experienced authors, we hope that this short list has given you a few things to think about during your next IRB submission. As always, if you require any assistance with IRB or its associated services, please feel free to reach out to Pearl IRB.