Processing Exempt Submissions 1-page Reference Guides

2 Program for the Protection of Human Subjects (PPHS) Analyst’s Steps for Processing an Exempt Submission Each of the process boxes in this flowchart corresponds to a slide in this document. Click the box to proceed to the instructional slide.

3 Creating a New Request for Exemption Role of user: PI, or any personnel who will have Signature Authority for this protocol. Prerequisite: You have just created a new, initial application. 2. For the Application Type, select Request for IRB Exemption. 3. The tabs that are appropriate for this type of application will be displayed. Fill them out left to right, top down, to ensure you see every field. 1. You started by selecting Create New | PPHS Protocol.

4 Assigning Access Levels to Research Personnel Role of user: Current PI, or any personnel with Signature Authority for this protocol. Prerequisite: You must be working on a submission that has not yet been approved, and it must be an Initial Application submission or Modification submission. 1. Select the Research Personnel tab. 2. If this is an Initial Application, he access level that you select here will take effect when this submission is approved. If this is a Modification, it will take effect as soon as it is submitted. Explanation of Access Levels No accessCannot see the protocol at all. Read-only AccessCan read the protocol. Cannot edit or create submissions for this protocol. Edit AccessCan create and edit submissions for this protocol, but cannot submit them. Signature AuthorityCan create, edit, and submit additional submissions for this protocol.

5 Assigning PPHS Macro Analyst Role of user: PPHS Intake Position Prerequisite: There is a Macro task on the Analyst’s To-do List, created by a new submission. 1. From the To-do List, the Analyst selected the “Macro” task. 2. From the Action menu, select Assign to Analyst. 3.The Analyst who is selected in this step will perform the triage for the submission. At this point, no decisions have been made. The Analyst selected in this step will be the first one to make a decision on this submission. 4. Clicking Submit will put a task on the selected Analyst’s To-do List. Click to go back to Analyst’s Steps

6 Returning Submission to PI with Comments Role of user: PPHS Macro Analyst Prerequisite: The PPHS Analyst who is performing intake has assigned this submission to the Macro Analyst. The Macro Analyst made a cursory review, and determined that this submission is not complete or requires significant material revisions. 1. If needed, the Analyst enters field-level comments. Red marks the tabs and subtabs where comments were added. 2. If needed, you can enter general comments into this field. 3. Select Return to PI from the Action drop-down menu, and click the Submit button. This task will be removed from the Analyst’s To-do List, and a Modification task will appear on the submitter’s To-do List. Click to go back to Analyst’s Steps

7 Assigning Offices Role of user: PPHS Macro Analyst Prerequisite: The PPHS Analyst who is performing intake has assigned this submission to the Macro Analyst. The Macro Analyst made a cursory review, and determined that this submission is complete and ready for review. 1. Select Assign Offices from the Action drop-down menu, and click the Submit button. This Macro task will remain on the Analyst’s To-do List, and the screen will refresh to show the PPHS/Micro review. 2. Because this is an Exempt submission, the only office to whom it will be sent for review is the PPHS. Click to go back to Analyst’s Steps

8 Adding a Review, to Set the Result of PPHS Analyst’s Review or to Assign an Additional Reviewer Role of user: PPHS Micro Analyst Prerequisite: The PPHS Macro Analyst assigned this submission to the PPHS office for review. The system automatically advanced to this page, showing the PPHS Micro Review. 1. PPHS Micro Analyst has clicked through the tabs, left appropriate field-level comments, and entered appropriate General Comments. The review is done and the Micro Analyst has either arrived at a decision, or, decided to add another PPHS Analyst to review the submission. 2. After reading and possibly leaving review comments, click the Add Review button. A new row will be added to the list of reviews. That new row will begin with a red X. In that row, the Analyst will enter the decision. Click to go back to Analyst’s Steps

9 Set the Result of PPHS Analyst’s Review to Revisions Required and Return to PI Role of user: PPHS Micro Analyst Prerequisite: The PPHS Micro Analyst reviewed the submission, added comments, and added a review. 1. PPHS Micro Analyst added this review. When you see the red X next to a review, that indicates that you created this review. 3. From the Motion drop-down list, select Revisions Required. 4. Click the Set Result button. This Micro Review task will be removed from the Analyst’s To-do List, and a Modification task will be added to the submitter’s To-do List. Click to go back to Analyst’s Steps 2. Select Administrative Review for an exempt submission. 5. [Add instruction for the develop response submission here.]

10 Set the Result of PPHS Analyst’s Review to Approved Role of user: PPHS Micro Analyst Prerequisite: The PPHS Micro Analyst reviewed the submission, added comments, and added a review. 1. PPHS Micro Analyst added this review. When you see the red X next to a review, that indicates that you created that review. 2. From the Motion drop-down list, select Approved. 4. Click the Set Result button. This Micro Review task will be removed from the Analyst’s To-do List, and a new task will be added, reading All Micro Reviews Complete. 3. Enter 365 or the appropriate period for Review Frequency. The Approval Start and End will then populate. Check and, only if needed, correct those values. Click to go back to Analyst’s Steps

11 Frame this off, include the screnshot from next slide, and compress these into one page. Add a Macro Review Role of user: PPHS Micro Analyst Prerequisite: The PPHS Micro Analyst reviewed the submission, added comments, and added a review. Under that review, the Analyst set the decision to Modifications Required or Approved. Setting the decision in the Macro review is the final step. When several offices are involved, this process is done after all the individual offices have completed their reviews. For an exempt submission, only the PPHS office conducted a review. However, the steps must still be completed. 1. Note that “All Micro Office reviews are complete.” This message appears, even when the PPHS office was the only one to do a Micro Office review. Which, for an exempt submission, is the case. 2. Go to the Review Dashboard tab and click the Add Review button. A new row will be added to the list of reviews. That new row will begin with a red X. In that row, the Analyst will enter the decision, just as in Part 1 of this process. Click to go back to Analyst’s Steps

12 1. PPHS Micro Analyst added this review. When you see the red X next to a review, that indicates that you created that review. 2. From the Motion drop-down list, select Approved. 4. Click the Set Result button. This Micro Review task will be removed from the Analyst’s To-do List, and a new task will be added, reading All Micro Reviews Complete. 3. Enter 365 or the appropriate period for Review Frequency. The Approval Start and End will then populate. Check and, only if needed, correct those values. Set the Result of Macro Review to Approved Role of user: PPHS Micro Analyst Prerequisite: All micro reviews were completed and a macro review was added. Click to go back to Analyst’s Steps [Make the same changes here that we are making to slide 13]

13 1. PPHS Micro Analyst added this review. When you see the red X next to a review, that indicates that you created that review. 2. From the Motion drop-down list, select Modifications Required. 3. Click the Set Result button. This Micro Review task will be removed from the Analyst’s To-do List, and a new task will be added, reading All Micro Reviews Complete. Set the Result of Macro Review to Modifications Required Role of user: PPHS Micro Analyst Prerequisite: All micro reviews were completed and a macro review was added. Click to go back to Analyst’s Steps Note: Until Ideate is fully implemented, there might be additional data entry in eRAP required as a reminder. 2. Select Administrative Review for an exempt submission. [Add clicking the check box to expand the review as the first step.]

14 Replacing the PI 1. Click the replace link. A popup window will display the pick list of all personnel in the system. If the new PI is not on that list, go to and submit a request to have the PI added as a new user After selecting the new PI, check the Primary Department and make sure it’s correct for the new PI. Role of user: Current PI, or any personnel with Signature Authority for this protocol. Prerequisite: You must be working on an Initial Application of Modification, and it must have the status of Under Development.