Avoid These IRB Submission Mistakes to Speed Up Approval
Historically, IRB submissions can be daunting – strange forms, specific questions and lots of acronyms. We know that you have tight turnaround times and numerous emails to wade through each day, and the last thing you want is another ping from the IRB asking for clarification about a submission you thought you submitted correctly. At Sabai, we truly desire for your experience to be smooth sailing, so we turned to our team of highly experienced IRB Analysts for common mistakes they see on IRB submissions. By avoiding these common pitfalls, you receive less emails and the IRB will finish your submission faster! Truly a win-win.
Pitfall #1: Applying your Federalwide Assurance (FWA)
We get it – you see “FWA,” and you think ‘oh yeah, my site has that of course!’ and check ‘Yes.’ But this question is not asking if you have an FWA; it is asking whether your site has elected to apply the FWA’s DHHS regulations to ALL studies, not just federally funded ones. If you check ‘Yes’ and your consent form is missing the required additional DHHS language, your analyst will have to stop processing your submission to address this discrepancy and confirm with you.
Bottom line: Please, do not check ‘Yes’ to the question “Does your institution have a federalwide assurance (FWA) that applies federal regulations (45 CFR 46) to all human subjects research, not just research that is federally funded?” on your site application unless you add the additional DHHS language to ALL your consent forms.
Pitfall #2: Legally Authorized Representatives (LARs)
Our eagle-eyed IRB Analysts are always on the lookout for any hint that a protected population may be involved in your study to ensure that additional regulations and protections are addressed. If you do not select any vulnerable populations in your submission form, but later answer “Yes” or “N/A” to the question about LARs and/or include LAR signature lines on your informed consent form, your IRB Analyst will send you an email asking you to confirm that no LARs or adults with diminished capacity to consent are being included in this study.
Bottom line: Please do not put N/A or ‘Yes’ in the box for LARs if there are no adults with diminished capacity to consent in your study population. In addition, if there are no adults with diminished capacity to consent included in the study population, please do not include any LAR lines in your informed consent documents.
Pitfall #3: Describing how the consent process happens
Consent and information surrounding how it is obtained are some of the things on the form that our IRB Analysts pay the closest attention to. They are exceptional about gathering the information needed to get a clear picture, and , when an analyst sees “N/A” in the box asking you to describe the consent process, they will need to rely on you to provide a detailed description in order to proceed.
"Write 1-5 sentences about where the consent process will occur, and the time given to participants to decide."
Bottom line: Please do not put N/A in the box that asks you to briefly describe the consent process and setting. Please instead write 1-5 sentences about where the consent process will occur, and the time given to participants to decide. Common examples include “The consent process will take place in a private room, where the participant will be given as much time as needed to read and ask questions. Participants will be allowed to take the consent form home and discuss with family members or primary care providers before deciding whether to take part. An interpreter will be provided if the participant does not speak English.”
Pitfall #4: Referring to another application
Life in this field is full of paperwork, so we totally understand wanting to find shortcuts, but it is imperative that site-specific information is entered in full for each submission, rather than a statement prompting the IRB to look at another submission for relevant experience, consent process or compensation/reimbursement information. Having complete standalone submissions enables our Analyst team and IRB to review submissions most effectively and efficiently, without adding any delays or inadvertent clerical errors.
Bottom Line: Please do not put a statement referring to another site submission’s responses when asked for a site’s relevant clinical research experience, compensation/reimbursement and/or informed consent process. Instead, reach out to our team to help show you how you can take advantage of the Copy feature in our IRB portal system to see if that can bring the same information over faster, while still enabling a complete, standalone submission.
Pitfall #5: Continuing Review stamp dates
There is a question on the continuing review form that asks you to provide the IRB approval dates for the most current version of the informed consent (and/or assent) documents. We understand continuing reviews come around once a year and it can be tricky to dig around and find all the information we ask you to provide. To clarify, we are asking for the approval date, not the version number or date, of the informed consent documents. You can find the approval date at the bottom of any pages of the consent document. It says “Castle IRB Approved: Month, Day, Year”. Please be sure to list the most recent approval date of every consent form, to include Pregnant Partner, Optional Biopsy, and Spanish translations of informed consent. Also note that the Master (study level template consent) and Site informed consent stamps often have different approval dates; be sure to use the Master stamp date for the Master (study-level) continuing review, and the Site stamp date for the Site continuing reviews.
Bottom Line: Please do not put the version # or date or list the date of the master ICF on the site level, or vice versa when submitting your Continuing review forms. Please be sure you list the approval date (found at the stamp on the bottom), whether master or site. Also please include the approval dates for every consent document. Your IRB Analysts will thank you!!
Here at Sabai we are all about the ‘no worries’ experience. This list provides you with the practical tools needed for a smooth and efficient IRB submission experience. Our analysts strive to make your life as stress-free as possible; by utilizing these tips you will be doing yourself a huge favor. We hope you choose Sabai next time you need IRB services.
Author: Caylee Kinney, IRB Analyst
