Cayuse IRB Overview

Cayuse IRB Overview Objectives Describe the function and purpose of Cayuse IRB Outline Human Subjects Research requirements and process for gaining access to Cayuse IRB Describe Cayuse user Roles Provide instructions for navigating the Dashboard Clarify whose approval is required for different submission types Describe pre-review, review, and post-review processes

Cayuse IRB Cayuse IRB is a cloud-based system that allows investigators to securely submit protocols via the web. Cayuse IRB is accessible from anywhere with internet access and works best in Google Chrome. It uses smart forms that are easy to navigate and require only the completion of relevant questions/sections. The system offers electronic routing for approval (i.e., by study PI, division heads, department chairs, etc.) All submissions and their relevant documents requiring review by the IRB are submitted, reviewed and approved via Cayuse IRB. Initial Applications, Modifications, Renewals, Incident Reports, and Closures are all submitted under the umbrella of the “Study Details”

Purpose of Cayuse IRB Application The Cayuse IRB application should capture the conduct of the study at Lurie Children’s with a protocol provided (if available) for background. Cayuse IRB features relevant links to our Policies & Procedures, Regulatory Information, applicable templates and helper text to make it a learning tool and means for ongoing education. The description of the protocol within the Cayuse IRB application must present an interpretable enough description of the study design and reflect the conduct of the study at this institution to allow for a valuable IRB review. Information included in the Cayuse IRB application may be based on the protocol, but it must be summarized and condensed by the PI/study team to ensure that it is comprehensible enough to a general audience to allow for the IRB to review the ethical and safety considerations of the study while having the background available for reference. This should not involve directly copying and pasting from the study protocol. Before certifying the submission, the PI should review this application to ensure that it is written for a general audience and does not rely on terminology specific to this field of study with all acronyms and complex terms defined at their first use.

Cayuse IRB Access/HSR Education All Cayuse IRB users are required to have completed and provided documentation of Human Subjects Research (HSR) Education training as outlined on the IRB Education page. HSR Education Documentation must be submitted to IRB@LurieChildrens.org with a HSR Education Certification Form for all Cayuse users or staff engaged in research at the institution. The Office of Research Integrity and Compliance will either respond with a request for correction/clarification or with Cayuse login information. When Cayuse login information is provided, the user is now available to be added to studies within Cayuse IRB. A list of research personnel with current HSR Education Certification is available in the 6/30/18 Education Database. Collaborators completing study procedures or engaged in the study conduct at Lurie Children’s must be in this education database, please refer to OHRP Guidance on Engagement for more details on engagement.

HSR Continuing Education All research personnel must complete continuing education in human subjects approximately every two years with all Lurie Children’s staff given the same date of HSR Education expiration (6/30/18). The Office of Research Integrity will provide global guidance for renewing HSR education when institution-wide HSR Education expiration is approaching. Options and articles for re-certification will be provided via the IRB Education page.

My Role Due to the variety in user needs within Cayuse IRB, there are several different roles available. Please ensure that the correct selection is made for your task. Researcher: Select this role if you are the PI or Primary Contact on the study. If you are the PI on a study and need to certify the submission, as prompted by an email from Cayuse, you will only be able to do so by selecting this role. Org Approver: Select this role if you are the organizational approver for studies in your department. If you are the departmental approver for studies and need to certify a submission created by another PI, you will only be able to do so by selecting this role. Reviewer: Select this role if you are an IRB member completing an assigned review.

Study Status In Draft: Submission has been started in Cayuse, but is still open for edit by the study team. Study has not yet been marked complete or routed for PI certification. Awaiting Approval: Submission has been marked complete and is awaiting PI Approval and Organizational Approval (required for Initial submissions only) Pre-Review: Submission has been approved as required and is with a Research Compliance Coordinator (RCC) for pre-review. Pre-Review issues are communicated to the study team via the comments in Cayuse IRB. Under Review: Pre-Review has been conducted and all responses found by RCC to be satisfactory. Submission is now under review with the IRB or IRB Vice Chair.

Dashboard Tiles My Studies: Any studies in any status on which you are listed as study personnel in any role. My Tasks: Any submissions currently requiring action on behalf of the study team. Submission by Type: This shows how many pending submissions of each type you currently have open. Approved Studies: Approved studies on which you are listed as study personnel in any role. Studies Expiring In…: By clicking the dropdown menu, this tile shows you any studies expiring in the next 30, 60, or 90 days. It is advised that renewals are submitted at least 30 days prior to expiration. Expired Studies: This tile shows any currently approved studies on which you have a role. This tile should be empty!

Dashboard Overview My Role: make the correct selection for the pending task Click to start a new study details page, all subsequent submissions under a study are submitted independently from the Study Details page. Study Status Dashboard Tiles

PI/Organizational Approval Because the PI is ultimately responsible for all conduct of his/her study at Lurie Children’s, PI certification is required for all submissions. If rejected by the PI, the submission is routed back to the Primary Contact(s). See IRB Policies & Procedures Manual Section 5 PI Responsibilities for details. When new studies are submitted for IRB review, the IRB requires the initial application be certified by the PI followed by the Division and Department Head(s) represented by the faculty listed as study personnel. Following PI certification, the Division Head(s) may first certify or reject the study followed by the Department Head(s). If rejected by either, the study is routed back to the PI and Primary Contact(s). See Division/Department Routing for Organizational Approval for details. A submission only needs to be certified by the PI/Org Approvers at the initial submission – it will not have to return for approval following the IRB analyst pre-review. The PI remains responsible for all requests/comments from the pre-review and has access to view/edit them as needed. For more information about the IRB Submission Process, IRB Tracking, required approval and Cayuse IRB tasks, see the Cayuse IRB Submission Process.

PI Certification

Pre-Review An RCC pre-reviews all incoming submissions before they are routed for IRB review to ensure that all regulatory criteria are met and all questions have adequate responses to allow the IRB/Vice Chair to conduct a robust review focused on the patient safety and ethical consideration of the study. For studies requiring review at the full board, a pre-review comment will be included with a tentative meeting date and pre-review response deadline. Please see the IRB Meeting Schedule when planning full board submissions. Pre-Review issues are communicated to the study team via the Comments within Cayuse and will be noted with speech bubbles.

Pre-Review Comments Sections including pre-review comments will have a small speech bubble with a number to indicate where comments may be found. Click on the section and scroll through to find a black speech bubble. Open this bubble to see the comment. Revise the application as requested, Reply to the comment, and mark the comment Addressed. Once all pre-review comments are revised, replied and addressed, Cayuse IRB will allow the submission to be routed back for ongoing IRB review. The RCC conducting the pre-review will be noted on the Submission Details page and in the comments as the “analyst.”

Pre-Review Comments (1) Locate speech bubble(s) indicating comments in the list of sections. Click to bring you to that section. Scroll through section to find comments to expand. Click to expand and view comment.

Pre-Review Comments (2) REVISE the application as requested in the comment. REPLY to the comment. Mark the comment ADDRESSED. Look for green checkmark in “Sections.” Mark submission “Complete” to route back.

Post IRB Review Approval If your submission is approved, you will receive an email noting its approval. While the e-mail itself contains approval information, the official approval letter can be found by (1) logging into Cayuse IRB and open the study's overview page; 2) clicking on the reviewed submission; and 3) clicking on the "Letters" tab.  All official correspondence relating to that submission may be found here and is available to download or print by clicking on the letter. If the study included consent forms, these may be downloaded by (1) logging into Cayuse IRB and navigating to the Study Documents page of the approved submission, (2) opening any of the comments by clicking on the speech bubbles, and (3) downloading the stamped and approved consent forms from the open comment. All IRB approval documents should be maintained in the study regulatory binder or a note-to-file should be put in the regulatory binder to indicate that these documents are available electronically in Cayuse IRB.

Post IRB Review Contingencies / Deferral If the IRB or an IRB Vice Chair reviews a submission and determines that there are issues upon which study approval is contingent, these issues will be returned in the comments in the same manner as the pre-review. If the IRB reviews a submission at a full board meeting and finds that it is not adequate for review and approval, the submission will be returned with comments indicating the reason for deferral. The study will be rescheduled for another meeting once the deferral issues have adequate responses.

Cayuse IRB Contact Information The banner at the top of the Cayuse dashboard at login includes the current week’s downtown office schedule as well as a brief description of upcoming meetings and suggested date of receipt for submissions to be scheduled. Cayuse specific questions may be directed to Eriika Etshokin at the Office of Research Integrity and Compliance: eetshokin@luriechildrens.org; 773-755-7424 IRB Research Center Hours: 8:30-4:30 Monday – Friday IRB Hospital Office (19-376) Hours: 9-4:00 Tuesdays and Thursdays General IRB Inquiries may be sent to the IRB Inbox, IRB@LurieChildrens.org

ORIC Staff Contact Information Office of Research Integrity and Compliance Staff: Tricia Eifler (Associate Director) Eriika Etshokin (Coordinator, PIs S-Z) Jackie Hoyt (Coordinator, PIs A-F) Erin Lynch (Coordinator, PIs P-R) Jessica Macha (Assistant Director) Jessica Olsofka (Senior Administrative Assistant) Kyle Potter (Coordinator, PIs G-K) Cathy Powers (Director) Kim Rowan (Coordinator, PIs L-O)

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