How to Conduct a Deferral Response Review in ARROW
Instructions for IRB Members
As an IRB Member, you may be asked to review a study team's response to a previously deferred study as a primary or secondary reviewer. The purpose for reviewing a deferral is to ensure that the study team has addressed all of the IRB's previous concerns and that the study now fulfills criteria for approval. The IRB Staff Reviewer will upload a reviewer checklist for you to review in ARROW that will describe the IRB's previous concerns and provide an assessment of whether the study team has adequately addressed these concerns. To complete your deferral response review, follow these steps:
Click on the "Reviewer Notes" tab to see the issues the IRB identified during initial review.
- Login to ARROW at http://arrow.wisc.edu.
- Make sure you are in your IRB Member role.
- In your IRB member workspace, check your "Inbox: All" Tab for submissions assigned to you.
- Click on the title of the submission in your Inbox in order to access the submission workspace and begin your review.
- Click on the activity on the left side of the screen called "Print Reviewer Checklist". You can use the checklist(s) as a guide when reviewing the initial application.
Click on the button labeled "View Application" to review the initial application SmartForm.
Once you have finished reviewing the application and the supplemental documents uploaded by the research team (e.g. consent forms, study protocol, questionnaires, recruitment materials), you can exit the application using the "Exit" button near the top of the screen. This will take you back to the submission workspace.
If you've been assigned as a primary or secondary reviewer, the final step is to complete the Reviewer Checklist. Please follow the guidance provided in Primary Reviewer Guidance for Initial Reviews.
There are two ways in which reviewers can submit their checklists:
- ELECTRONIC CHECKLIST SUBMISSION: You will click the "Print Reviewer Checklist" button in the study workspace and click SAVE. This will be an editable word document in which you may type your review and submit your completed review directly after the IRB meeting, from your personal email account to email@example.com. There will be no need to "sign" this electronic submission as submitting it from your personal email account will suffice in providing the necessary documentation of who completed the review. **Please Note** If you decide to complete the IR checklist electronically, you will need to bring a laptop to the meeting so that you may reference your electronic copy of the checklist during the IR's meeting discussion and make any additional comments necessary ELECTRONICALLY and then submit the finalized electronic checklist to firstname.lastname@example.org. The IRB staff will be responsible for uploading this electronic copy of the completed checklist to the submission workspace.
- PAPER CHECKLIST SUBMISSION: You will click the "Print Reviewer Checklist" button in the study workspace and click PRINT. You would then write in your comments, bring the printed checklist to the meeting, write any additional comments if necessary during the meeting discussion and put the completed printed checklist in the basket at the end of the meeting. The IRB staff will be responsible for scanning and uploading a copy of your completed checklist to the submission workspace.
- View Differences--Click here for a helpful note on using "View Differences"
- Click on the button labeled “View Differences” in the submission workspace to review the differences between the most current version of the application and a previous version of the application.
- PLEASE NOTE: The system automatically defaults to comparing the SAME version, please click the drop down menu to select a previous version of the application. For assistance in which version to select, contact the assigned staff reviewer.
- Once you have finished reviewing the application differences, you can exit the using the "Close" button near the top of the screen. This will take you back to the submission workspace.
- Change Log
- From the submission workspace, click on the "Change Log" tab to open the list of changes that were made, sorted in the order in which they were made.
- The most recent changes will be on top, and correspond to a page of the application. Click on the top line that says "Change Log" (next to the "i" icon).
- For example, the change log will show the following when a consent form is updated.
- To move to the change made before of after the information you are viewing, click "Previous" or "Next"
- To return to the submission workspace, click on the title of the study directly above the change log information.
Notes for Reviewing a Deferral Response
- The goal of reviewing the deferral response and revised application materials is to ensure that the study team has addressed the IRB’s previous concerns and that the study now fulfills approval criteria. The Primary Reviewer Checklist contains an assessment by the assigned IRB staff reviewer as to whether the study team has addressed concerns and fulfilled the criteria for approval of the study. The Primary Reviewer Checklist is the same document used during the initial review of the study. For further guidance on the Primary Reviewer Checklist and the criteria for approval, please review Primary Reviewer Guidance for Initial Reviews .
- The IRB Request Reviewer Notes should reflect what the IRB determined was needed from the study team in order to fulfill approval criteria. Upon review of the Reviewer Notes and the study team’s response to these notes, you should determine whether the outstanding concerns have been adequately addressed. If you have additional questions or concerns that aren’t addressed by the Reviewer Notes, please include these questions/comments in your Primary Reviewer Checklist.
- The “View Differences” feature is a helpful way to see exactly how the study team revised the IRB application in order to address the IRB’s specific concerns and requests. Upon review of these changes, if you have additional questions or concerns that aren’t addressed by the Reviewer Notes, please include these questions/comments in your Primary Reviewer Checklist.
WHO TO CONTACT
- Help with navigating and using ARROW
- Questions about a specific protocol