eIRB Review Guide For Committee Members Version 02/11/2015 1

Before we begin… Please make sure that the pop-up blocker on your browser has been disabled. The eIRB system is compatible with IE, Chrome, Firefox and Safari, as long as the pop-up blocker has been disabled. For instructions on disabling the pop-up blocker and for answers to many other questions please visit the following link: ups.docx 2

Locating the PI’s Protocol 3 NOTE, please! Some examples of screens will not look the same because of editing being done in the eIRB.

1. Look at the sent to you by and locate the number of the protocol that you have been assigned to. 4

2. Access the eIRB by following one of these options: Follow the link below: OR Find the link through the IRB website at: OR Follow the link that will be included in the sent to you from 5

3. After you have logged in, the main menu page will appear. Left click on Files & Documents. 6 NOTE, please! Files are like the whole folder. Inside are documents like the protocol, ICFs, surveys, etc. The words “Document” and “protocol” are equivalent. All other supporting documents attach to the file.

4. Your screen will now display those protocols you are actively involved with. Here, locate the protocol that you will review by the number that is found on the that was previously sent to you. Once you have found it, right click on the File title of the protocol. 7

5. A drop down menu will appear after left clicking on the title of the protocol. Here you will notice that there is a “file” and a “document” associated with the protocol. Left click on the document’s title to access the actual protocol form. 8

6. The protocol form will look like the picture below. Under each tab on the left, you will find the PI’s responses to the questions in the protocol form. Go through each section and read each section. 9 IRB members see this tab, PI’s do not.

7. To find the supporting documents that go along with the protocol, left click on to go to the main menu. RIGHT click on the paperclip next to the protocol’s file title (in the purple bar). Left click on Edit attachment. The paper clip shows only when there is an attachment. 10

8. A pop-up window will appear. Left click on the attachment that you wish to view. After clicking, the attachment will be automatically downloaded. 11

9. Posting Comments: Now that you have read the protocol, you are ready to leave your review comments. Access the protocol form by following steps 4-5. Once you have entered the protocol form, left click on the Review button to post your comments.steps

10. The pop-up screen below should appear. On the left side, select the tab that you would like to comment on. Then click the Start New Topic button. 13

11. Type your comments into the purple box, and indicate the type of comment you made by selecting an option from the bottom dropdown menu (red circle on the right). Click the Publish button to save the comment and the selected option from the dropdown menu. When you have published all the comments, close the window to exit the review function. 14

12. When you are done... When you are satisfied that you have made all the comments you want, there is one last step. Go back to the menu by hitting the Back button. 15

13. RIGHT click over the section titled IRBP Document Status (under the blue bar). This should bring up a menu. Choose the option IRBCO ADMINISTRATIVE REVIEW. From here, the administrative reviewer will send the protocol to the PI for revisions. 16

14. After the PI has responded to your comments You will receive an informing you that the PI has responded to your comments. You will need to log back into the eIRB and Review their responses. Then decide if they are satisfactory to you and if the protocol can be approved. To view their responses, access the protocol form by following steps 4-6, and click on Review.steps

15. Choose the “All” button at the bottom to see all the comments. Click on each of your comments to bring up the PI’s response. 18

16. Below is how the comments will appear: your comment will be at the top and the PI’s response will be right below. 19

17. Be sure to review the updated documents Besides changes to the protocol, the PI will likely have re-uploaded other revised attached “documents.” If so, you will need to locate them and review them. They will be uploaded in the manner which was discussed earlier (see steps 7-8).(see steps 7-8). If the protocol was entered manually, the changes which the PI made will be in RED or BOLD in the document. 20

18. When you are completely satisfied with the protocol Instead of sending the protocol back to the PI for revisions (which you may do as much as needed), choose the option of IRBCO ADMINISTRATIVE REVIEW. Then, the IRB administrative reviewer to inform him/her that the protocol is ready to be approved by the chair. [Technically, in expedited review with DIR (designated IRB member), you are approving. The chair’s role is to acknowledge the approval and that all appropriate review and approval steps have occurred.] 21

That’s it! You are now ready to complete a review using the eIRB! Please contact one of us if you have any questions. CONGRATZ. 22 NOTE, please! These instructions need critical feedback from friends, too. Please offer your suggestions.