By Rana Leed, MPH, Human Research Education Manager,
Clinical Research Resources Office (CRRO)
SuCCessful IRB Submissions: Consistent and Complete
The hottest tip for the start of a cold winter? “The key to a successful IRB submission is to make sure that everything is consistent and complete.” What does this mean, though?
CONSISTENT
In the INSPIR application and the various documents for submission (protocol, consent, recruitment flyer, screening questionnaires, etc.), make sure that you are including information that is the same throughout all the documents. For example, it’s easy to fill out the application with recruitment information, then decide to finalize the protocol with slight changes to the recruitment methods, and then forget to go back and make corresponding updates to the application. Or, you forgot to mention the blood draw at Visit 4 in the protocol, but included it in the consent.
Consistency isn’t only about procedures and information--it’s also as simple as words and numbers. Check to make sure that you aren't using different phrases like “Screening Visit” and “Baseline Visit” to mean the same thing. Check to make sure your enrollment goals are the same, and numbers weren’t mistyped. Even drugs: - do you go back and forth between generic and brand names? It’s important to note though, sometimes it does make sense to use different words; for instance, the consent should be in lay language, but a protocol could include more scientific jargon.
COMPLETE
This one may seem a bit more obvious but here is a common comment that the CRRO provides during pre-IRB submission consultations: “Review the question being asked in this section and make sure you are answering each part”. The INSPIR application, consent templates, and protocol template often include very specific instructions as to what needs to be answered or included in each section. Too often, investigators answer only part of a question, or include information that isn’t relevant. Both of these issues could result in the IRB Analyst sending the submission back with stipulations, or create confusion during an IRB panel review discussion and, thus, delay IRB approval.
A good example of this is the INSPIR application section about sample size: The CRRO often sees that the justification and population access questions are answered with the exact same information, but they are two different questions. It’s easy to copy and paste when sections seem somewhat similar, but that’s a slippery slope to a stipulation. Careful reading of each question, the instructions, and any help text can go far to making sure your application is complete.
“Complete” also means making sure that you have attached all the required documents you need to and that are the correct and most updated version(s). For example, have you been working on the consent with other members of your study team? If so, can you tell which is the most recent consent you have been writing? Do you know which version is the correct one to upload, and have comments and notes been removed?
Most importantly, one of the best ways to check for both consistency and completeness is to do a final review of all documents. Grab a cup of coffee, close your email browser, turn notifications off on your phone, then pull together the application and all documents. Some might find it helpful to print everything and review on paper; others might want to pull up the application on one screen, and each document on another screen--however it works for you! Take the time to review everything you are submitting. Is everything consistent? Are there gaps or missing information? Is there anything that can be interpreted in a different way? If you can, ask another member of the study team to review everything with you. It’s possible that a fresh set of eyes will see something that has been missed previously or is confusing. Make sure that if you update anything during this final review, that it’s consistent across your submission, and that you upload the newest versions of documents!
As we move into winter, it’s smart to make sure you have scarves, gloves, and a hat. Likewise, as you submit to the IRB, it’s smart to make sure that your submission to the IRB is “consistent” and “complete.” Don’t be left out in the cold having to answer a bunch of stipulations that could have been prevented with a more successful INSPIR submission!
The CRRO is supported by the Boston University Clinical Translational Science Institute (CTSI) and the Office of Human Research Affairs.