IRB Reviewer Guide: Expedited Review

Enrico Sassi
29 steps
7 minutes

Navigate to <https://nmu.app.cayuse.com/>

Click "Products".

Click "Human Ethics".

Click "Role" and select your "Reviewer" role.

Click title of the IRB submission you wish to review. They can be found on your dashboard in the "Submissions where I am the...," you can select *Primary, Secondary* or simply *Reviewer* to view all protocols assigned to you at each level.

Click "Review". Note: toward the bottom of the screenshot you find tabs titled "Approvals", "Task History", "Decisions", and "Attachments". Details and dates can be viewed by clicking each tab.

Use the arrows, at the top and bottom of each page, to click through and review each section. (You can also navigate by clicking on any "Section" in the left, blue margin.)

Click "add comment" directly below each item to note any feedback you have for the review team and the PI.

Click to "save comment".

Comments default to a restricted view, meaning only the review and admin teams can view comments. ONLY the Primary Reviewer should edit comment visibility.

To view the checklist first click "Show Checklist," and be sure that the correct checklist is selected from the drop-down.

Each reviewer will select their review date.

Add any overall comments on the checklist. These comments are optional and are not visible to the PI. Only reviewers and admin can see them.

Click to "Save Checklist".

While the platform auto saves, reviewers can choose to "save" at anytime.

Click "Submission Details" to return to the overall protocol information. Your review is complete. Remember you must complete your review within 10 days of your assignment.

**The following are additional steps for the PRIMARY REVIEWER ONLY.**

Reviewer comments default to a restricted view. Your role is to assimilate all reviewer comments, prepare the comments for the PI, and provide them as Unrestricted comments. You can unrestrict a well-written reviewer comment or prepare a new comment and mark it Unrestricted. (ONLY the Primary Reviewer should edit comment visibility.)

Primary Reviewer should check all reviewer checklists to 1) check the review date, and 2) view any overall comments on each reviewer checklist.

As soon as the team review is completed, click "Submission Details."

On the Submission Details page, click "Make Decision."

Select one of two decisions:\ "Minor Stipulations" if the PI needs to submit changes\ "Approved" if approved. \ If you feel a different decision needs to be made, contact the IRB chair (cc: hsrr@nmu.edu).

Click "Today" or enter the date of decision. Do NOT enter an Administrative Check-In Date.

Click all of the appropriate categories that support the selection.

Anything you enter in Findings or Researcher Notes will be added to the letter that goes to the PI. You can enter a summary of findings, a note to the PI, or nothing. In the letter, the PI is by default directed to look at Comments in the submission itself for revision, so adding anything in Findings/Researcher Notes is optional.

Click to "Save".

Click "Review Complete"

Click "Confirm"

Your job is complete. The identified analyst for the protocol will be notified that a decision has been made and the review is complete, which will tip them off to prepare and send the letter.