How to Complete IRB Member Review Office of Research INTEGRITY-2017

How to use this tutorial This tutorial is for IRB members who have been assigned to review a protocol. Use your keyboard’s left/right/up/down arrow (or your mouse/trackpad scroll or the spacebar) to move through the PowerPoint. Office of Research INTEGRITY-2017

RE: Initial Submission Requires IRB Member Review STUDY #: 15-0000-00 1. You are an IRB Reviewer who has received an email notification similar to this. TO: IRB Member FROM: IRB Office DATE: Jan 25, 2016 2:30 PM PST RE: Initial Submission Requires IRB Member Review STUDY #: 15-0000-00 STUDY TITLE: Study Title PI: Name The Initial submission has been submitted for the above-referenced study and has been assigned to you for review. Please log into Cayuse IRB here to review this submission. Thank you. 2. Click in the email link within the email or log in to Cayuse. Office of Research INTEGRITY-2017

1. Once you are logged in, go to your Dashboard and change your role to “Reviewer”. 2. You can then look for the review you need to complete in “My Tasks”. Click on the study you want to review. Office of Research Compliance v1-2016

Now you are in the study’s submission details Now you are in the study’s submission details. You need to click on “Review” to be taken into the protocol. *When reviewing a renewal or modification, you can see the study’s history by clicking “Study Details”  “Submissions”  “Legacy” or “Initial” Office of Research Compliance v1-2016

1. Now you can begin the review process. 2. You can add comments at each question. Click on “ + Add Comment.” Office of Research Compliance v1-2016

2. You can attach your edited documents to your comments. 1. Notice that the comment box has several options such as Bold, Italics, Underline, bullet points, and attachment (red arrow). 3. Once you have finished with your comment, you NEED to “Save Comment” each time. 2. You can attach your edited documents to your comments. Office of Research Compliance v1-2016

1. Once you have saved your comment, this “Visibility” box appears 1. Once you have saved your comment, this “Visibility” box appears. “Restricted” (PI cannot see comment) is set as the default. You must change it to “Unrestricted” (can be seen by PI). Office of Research Compliance v1-2016

1. When you are finished reviewing the protocol and are ready to make a decision about it (approve to move to Chair approval or send it back to PI for revisions/clarifications), click on the back to study button. 1. If you have changed the status to “Unrestricted”, the page will now look like this Office of Research Compliance v1-2016

1. Click on “Make Decision”. You’ll be taken to another page. Analyst name Office of Research Compliance v1-2016

Scroll through this section to choose a decision. 1.This page is where you will make a decision on the type of IRB approval it should have (exempt, expedited, full board) or you can send it back to the PI for revisions/clarifications. Office of Research Compliance v1-2016

3. Then click on Save! You’ll be taken back to the study page. 1. If you want to return it to the PI, select the “Return to PI” decision. 2.For any decision you make, you will need to put a date on it. Click on “Today” to place today’s date. Office of Research Compliance v1-2016

1. Next step, is to click on “Review Complete” Analyst name Office of Research Compliance v1-2016

1. Once you click on “Review Complete”, your screen should look like this and notice that you have no “Required Tasks” and that the status of the study is “Under Post Review” Analyst name Analyst name 2. If you have sent the protocol back to the PI, then the status of the study would say “reopened”. Office of Research Compliance v1-2016

If you have any issues or questions, please contact the IRB Office: irb@chapman.edu or (714) 628-7392 (Natalie Del Rio) or (714) 278-2833 (Maxine de Luna) and for IRB document examples and links, visit our website at https://www.chapman.edu/research/integrity/irb/forms-and- instructions.aspx As this is a new IRB system, please let us know if you find any issues (typos, unclear questions, etc.)! Office of Research INTEGRITY-2017