Here are our top 6 tips for making sure your application is off to a running start!
The more complete your initial application is, with all of the pieces in place, the more it may help to avoid unnecessary delay and frustration.
1. Submit your application as soon as possible
Give yourself enough time for requested clarifications from the IRB Reviewer. Also remember that quality counts! Answer all questions in the ESTR SmartForm and IRB Template Protocol that pertain to your research. By doing so, there will be less back and forth between you and the IRB Reviewer.
2. List your Faculty Sponsor on the Study Team Members page, with the role “Faculty Sponsor”
If your faculty sponsor is not listed in ESTR, the Ancillary Review notification will not be triggered, and this will slow down the turnaround time of your application. Note that the ancillary review notification is a function that has to be manually triggered by the CUHS staff, and until that has been done, the “Submit Ancillary Review” checkbox is not visible to the reviewer. So if you submit your application on a weekend, it will most likely not be triggered until the next weekday. When the function has been triggered, your faculty sponsor will get an email with a link to the application and we also post step-by-step instructions in ESTR for how to complete the ancillary review. Learn more about Faculty Sponsors here.
3. Upload ALL the required forms and documents to the correct sections in ESTR
The reason that we might seem so “picky” about the location of the documents is that ESTR decides which document receives an “IRB Approved” stamp based on where it is uploaded. This is especially important with study informed consent forms. If a document is uploaded to the wrong section of the SmartForm, the CUHS reviewer will request that the document be placed in the correct section.
Here is a guide to help you upload your documents in the correct SmartForm section in ESTR:
All forms may be downloaded in ESTR.
4. Ethics training and checking Faculty Sponsor listing
Once you have finished filling out the online form and uploaded the documents, take a look under the Project Contacts tab to make sure that everyone’s ethics training is listed and up to date, and that your faculty sponsor is listed here.
If there are missing or expired certificates, ask the team members to complete the [correct] CITI course and remind them to check to make sure that their HUID is listed in their profile in CITI so that their training will be imported to ESTR (this happens every Friday, so it will not show up in ESTR until the following Friday). For instructions on which course to take and how to get to it, please see the Required Ethics Training page.
If there are study team members who have already completed ethics training through another institution (within the last 3 years), go back and upload those certificates on the Study Team Members page.
If you do not see your faculty sponsor listed on this page, go back and add him/her to the Study Team Members page.
5. Click “Submit”
Clicking the red “Submit” arrow in the menu on the left side of the screen (visible to the PI only) sends the application to us. If the status of the application says “Pre-Submission”, you have not yet submitted it. If it says “Pre-Review” it has been submitted and is in line to be assigned for review (note that the application stays in this state until it has been reviewed, aside from when it is in “Clarifications Requested”).
6. Additional or helpful notes specific to your application
Time constraints? Do you have a presentation coming up where you need to present the results of the study? A plane ticket already booked to conduct the study in another location? Let us know by adding a comment on the ESTR main page of your submitted study – that way, we will see it right away.
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