Year: 2020

You have submitted and received approval for your IRB application (yay!). Now you have to submit another form to make changes to your original study (amendment), acknowledge a reliance agreement with another institution, request a continuation for your study (renewal/termination form) or terminate your study (renewal/termination form).

All subsequent forms submitted have to be processed through the study page of the initial submission. The initial application established a study page with your study number. Your study number should be connected to every form that is submitted for that particular study thereafter.

You access your study page by clicking on the hyperlinked study number on your home page. Once you click on your study number, that will take you to a page that looks like this.

Notice that your study number is at the top of the page. When you look on the side column, you will notice the “start x form” in the side toolbar (circled below). Push “start x form” on your study page and that will take you to the next screen.

You will see all of the forms you can use in relationship to your study number. From here, you should be able to submit your form.

If for some reason you are not able to access your study page, please contact the IRB Office.

Here is a short video that provides instructions.

If it’s been weeks since you’ve submitted your IRB form and you are wondering why you haven’t heard back yet, there is a likely chance that you haven’t completed the submission process.

Each form requires two steps for submission: sign and submit. If you have seen a screen that asks for you to enter your username and password, then you haven’t signed off on your form. If you haven’t seen a submit screen, then you haven’t actually submitted your form.

Here is what you should look for.

After you enter your information in the form, push “next” at the bottom of your form. On the next screen you will see a page that asks for you to sign off on your form. Push “sign” and this will take you to a screen that asks for your username and password, same as when you log on to IRBManager. Once you complete that step, you should see this screen.

This screen verifies that you have actually signed your form. You will need to push next again to go to the next screen.

When you push “submit” your form will be sent to the next level of review. If you are a student, your faculty advisor will receive the form. If you are a faculty or staff researcher, your form will go to the IRB Office.

Once you see the above screen, your form has been submitted.

If you have completed these steps and you require your faculty advisor to sign off on the form, please make sure that your faculty advisor has done so. Once they have signed off on the form and you still haven’t heard back in two weeks, then please reach out to the IRB Office to make sure that your form has been reviewed.

You submitted your IRB application, Renewal or Termination and may not be sure sure why you haven’t heard back from the IRB. Here are a few reasons why this may be the case:

• You are a student whose faculty advisor did not sign off on your study. This is the most common issue for why this happens. Every student study submitted to the IRB requires approval from your faculty advisor. If you haven’t been in touch with your faculty advisor, check  in with them to find out if they actually reviewed your study after your submission to the IRB. Faculty advisors are now responsible for agreeing to providing proper oversight over student research that requires IRB approval and to provide a one-page plan on how they will monitor student research projects. Once a faculty advisor completes that process and actually pushes the “submit” button, then the project comes to the IRB for review. If your study is sent back to you during the pre-review, review, and post-review stage (if a full board study), then your faculty advisor is required to review and submit it again before the IRB reviews your changes. Keep in contact with your faculty advisor to make sure that they are actually responding to emails received from IRBManager.
• You are a PI with a different submitter for your study. The IRB application has a place to indicate whether the person is the submitter and/or PI. If that person is one in the same, then the submission should move forward without an issue. If a student or staff person submits a study on behalf of someone else, then the system requires that the PI sign off on the study prior to IRB review. The IRB Office sees numerous studies at this stage all the time.  Please be sure to check for emails from the IRB Office, or research@roosevelt.edu. You likely have been sent an email that requires your attention and response.  Once you receive an email notification from the IRB, please go into your study, review it and push “submit” to complete the submission process.
• You did not use your actual Roosevelt University email address to submit your study. All study information is tied to your Roosevelt profile. The system recognizes this information for everyone to have single sign-on access through Roosevelt and to access your CITI training information. Any submitter that uses a personal email address while accessing IRBManager or providing contact information for the IRB Office to process is creating a situation that confuses the system’s ability to recognize you as a submitter. Applications submitted with private contact information are not processed by the system and require the IRB Office to delete the second contact information and for the submitter to begin again with another form.
• You didn’t actually complete the submission process by pushing “submit”. We have found that many submitters simply do not push “submit”.  The submission will only be completed once this task is completed.
• You received an email notification requesting changes to your application that you haven’t responded to. Please be sure to check your emails to make sure that you are being responsive to any feedback, questions, or required changes to your study.
• If you have addressed any or all of the above concerns and you are still haven’t received a response in 5-10 business days following your submission, please check in IRBManager to see if there has been a status change to your submission. If it shows as “under review” please call or email the IRB Office to inquire about the status of your study for exempt or expedited studies. If your level of review is full board, please know that it will be reviewed at the next full board meeting. If your level of review is exempt or expedited, it will be reviewed by one or two IRB reviewers, which should not take as long. Please contact the IRB Office (dsomerville@roosevelt.edu) if the review time has been longer than 10 business days for your exempt or expedited study.