VA Central IRB

1. VA Central IRB Annette Anderson, MS, CIP VA Central IRB Administrator Updated: July 19, 2019

2. Purpose of VA Central IRB • Primary Purpose • Improve human research protections in VA multi-site studies by ensuring: • Consistent expert ethical and scientific review • Local issues are still addressed • Secondary Purpose • Enhance efficiencies of IRB review in multisite studies

3. VA Central IRB Implementation • Established as part of the VHA Central Office Human Research Protection Program (HRPP) in 2008 • Institutional Official (IO) is a senior member of VHA Leadership • First study reviewed in August 2008 and approved in October 2008 • As of July 19, 2019, the VA Central IRB is overseeing or is in the process of reviewing a total of 244 multi-site studies involving a little over 1, 650 sites • The VA Central IRB also reviews some requests for Exemptions

4. VA Central IRB Composition • 14 voting members including 2 Co-Chairs and 2 non-scientists • 1 non-scientist alternate (Prisoner Rep) • 4 non-voting members • Ethics • Privacy with 1 alternate • Information Security with 1 alternate • Legal • Ad Hoc Consultants as needed

5. VA Central IRB Operations • Staffed by PRIDE • 1 VA Central IRB Administrator • 6 VA Central IRB Managers • 1 Technical Support Specialist • 2 Program Analysts • Meetings twice monthly via teleconference; two meetings a year in person in Washington, DC • SharePoint used for submitting and distributing documents and tasking Reviewers • CATS and shared drive data base for tracking and storing data

6. What Studies are Reviewed by VA Central IRB? • Studies that receive funding from the VA Office of Research and Development (ORD) in which multiple VA sites (2 or more) are engaged in human subjects research • Other designated studies funded by other sources, such as other government entities (DoD), pharmaceutical companies, and research networks • Currently no charge for use of VA Central IRB for VA-funded studies for studies funded by another federal entity.

7. Local VA Facility Requirements to Use the VA Central IRB Local VA Facilities must: • Amend Facility Federalwide Assurance to list the VA Central IRB as an IRB of Record; affiliated NPCs must amend FWAs as well • Enter into a Memorandum of Understanding (MOU) with the VHA Central Office and affiliated NPC if applicable • Develop Standard Operating Procedures (SOPs) for using the VA Central IRB as an IRB of Record

8. Memorandum of Understanding (MOU) • Spells out the respective authorities, roles, and responsibilities of the VHA Central Office HRPP, the VA Central IRB, the local VA facility, and the affiliated NPC if applicable • VA facilities that do not use the VA Central IRB will not be able to participate in studies reviewed by the VA Central IRB • As of July 19, 2019, the VHA Central Office HRPP has MOUs with 108 VA facilities with FWAs

9. Local Accountability for Research • The MOU requires the VA Facility Medical Center Director to Appoint local Site Representatives to: • Provide local comments to the VA Central IRB regarding the VA Central IRB’s review of the Principal Investigator New Project Application • Serve as the Local Site Liaison with the VA Central IRB

10. Engagement and Exemptions • Prior to submission of a new project for review by the VA Central IRB the PI may request if applicable: • An Engagement determination • An Exemption from IRB Review • A Human Subjects Research determination • Administrative Pre-Reviews are also available and highly recommended

11. Application Processes – 2 Types Principal Investigator (PI) Application – Based on IRB approval criteria • Co-PI and Coordinating Center Supplements • Protocol and other documents (i.e., surveys, scripts, investigator drug brochures) • Waiver requests • Vulnerable Population Supplements • Model Documents (i.e., informed consent form, recruitment materials, HIPAA Authorization) • COI statements from personnel in investigator roles only • CVs of investigators only • Local ACOS/R&D certification

12. Application Processes – 2 Types Local Site Investigator (LSI) Application –based on and mirrors PI/SC Application • Local study team • Local resources • Local recruitment practices • Local participant compensation practices • Customize model documents • All differences from PI Application must be justified • Signed by LSI and local ACOS/R certification

13. VA Central IRB Review Model – 7 Steps Step 1 - PI completes and submits PI Application • Contact VA Central IRB Administrator prior to completing application • Forms on VA Central IRB website • PI enlists local sites and lists them if known • Local Conflict of Interest determination if feasible • PI/SC signs form and obtains certification from local ACOS/R&D

14. VA Central IRB Review Model – 7 Steps Step 2 – VA Central IRB reviews PI Application • Initial Reviews • Administrative • Information Security • Privacy • Primary Reviewer System • Primary, Secondary, and Informed Consent Reviewers for studies reviewed at convened IRB Meetings • Primary Reviewer only for studies reviewed under expedited review procedures • VA Central IRB Co-Chair reviews and signs all approval letters for new PI Applications

15. VA Central IRB Review Model – 7 Steps Step 3 - Local Site Review and Submission of Local Site Investigator Applications 3a - Local Site Review VA Central IRB staff provide a copy of the approved PI/SC application to sites along with the VA Central IRB determination Sites have up to 15-days to submit comments for consideration by the VA Central IRB 3b - Submission of Applications Local Site Investigators complete the LSI Application for their site All site applications must be reviewed and submitted through PI/SC unless PI/SC indicates LSIs can submit directly to VA Central IRB Note: Local Review is not performed by local IRB Note: These two functions can take place simultaneously

16. VA Central IRB Review Model – 7 Steps Step 4 – Review of Local Site Comments and Local Site Investigator Applications Step 4a – The VA Central IRB reviews local comments and may do one of the following: • Refer comments to PI • Require changes in PI and/or LSI Applications • Administratively respond to comments Step 4b – Review Local Site Investigator Applications • Include modifications from step 4a if applicable

17. VA Central IRB Review Model – 7 Steps Step 5 – PI and LSI Submit Revisions as applicable • PI can submit answers to questions, clarifications, or a PI amendment for approval • LSIs submit revisions to their LSI Application Step 6 – VA Central IRB Makes Final Approval Decision on LSI Application • Approved documents made available on VA Central IRB Secure SharePoint system • E-mail sent to PI, LSIs, and VA Central IRB Liaisons

18. VA Central IRB Review Model – 7 Steps Step 7 – Local Site Final Approval • Local Site reviews and approves study in accordance with local policies and procedures (i.e., R&D Committee approval) • At local sites, approved application package consists of approved PI Application and the approved LSI Application Note: A study cannot begin at any given local facility until the PI and, if applicable, the LSI Application, has been approved by the VA Central IRB and the VA facility has complied with the requirements of VHA Handbook 1200.01

19. Amendments and Updates • PI Amendments • Made available to all sites through SharePoint • Local Site Investigator Amendments/Updates • Specific Site Amendment • Updates based on approved PI Amendments or change in model field (i.e., room or phone numbers) • Addition of a Site • Sites added after approval of PI/SC Application will not get 15-day comment period but still may make comments through local R&D process

20. Sites Subject to Continuing Review • Continuing Review date is set for overall study, not for each site • Two step application and submission process: • LSI submits a report to PI by PI established deadline • PI/SC submits summary report, along with copies of all LSI reports • Local Site Applications cannot be approved, even if no further modifications, until PI Application is approved

21. Studies Not Subject to Continuing Review • No continuing approval expiration date • Yearly status report will be required from PI site only indicating status of study and total enrollment • Routine RCO reports from all sites submitted with the status report • Notice will be sent approximately 30 days in advance Note: First notices will go out in late November/early December 2019 with further instructions

22. Transition of Pre-2018 Studies • Studies subject to the pre-2018 requirements may be considered for transition to the 2018 requirements at the time of Continuing Review if they are minimal riskand meet one of the below criteria: • The study is in data analysis only • The study does not involve any subject interventions • The VA Central IRB began transitioning studies submitted for continuing review after May 1, 2019 Note: FDA-regulated studies are not currently considered for transition.

23. Reportable Events • VA Central IRB Table of Reporting Requirements • Specific Reporting forms available on VA Central IRB website • Reported to VA Central IRB, not local IRB • Separate SharePoint site for uploading reports

24. RCO Audits and Other Local Site Audits or Reports • Submitted at Continuing Review: • Routine Research Compliance Officer (ROC) audits (informed consent and triennial) if no findings require review by the IRB; MVP exception – Quarterly summary from ORO Central Office • Submitted immediately (By RCO, PI, LSI) • Any reports of apparent serious noncompliance • Any other issues identified that require IRB review

25. Role of VA Central IRB Administrator • Main Point of Contact Prior to Submission • Maintenance of SOPs and Forms • Supervises VA Central staff • Assists VA Central IRB Co-Chairs with meeting management and IRB member management • Maintains website and provides training • Serves as POC for outside audits, site visits, and annual review of VHA Central Office HRPP

26. Role of VA Central IRB Managers • Serve as main point of contact after study is officially submitted to VA Central IRB and assigned a study number • Performs administrative review and coordinates all other required reviews, to include local site review • After initial approval, oversees all other study actions in coordination with Primary Reviewer and other staff processing CRs and SAEs/PDs)

27. Roles of Other PRIDE Personnel • Program Administrators • Management of MOU data base • Meeting and Member Logistics to include travel, training, and appointments • SharePoint and CATS system development and maintenance • Monitors SAE/PD review and reporting timelines • Technical Support Specialist • Answers toll free line • Processes new study actions and SAEs/Protocol Deviations • Fills in as needed for other staff • Maintains paper files for FDA-regulated studies

28. Contact Information Annette R. Anderson, MS VA Central IRB Administrator Annette.anderson3@va.gov or 202-443-5649 E-mail: vacentralirb@va.gov Toll Free Number: 877-254-3130 Website: http://www.research.va.gov/vacentralirb/default.cfm Note: See next slide for additional contact information.

29. VA Central IRB Managers and Other Staff Current VA Central IRB Managers and Regulatory Analyst Hector Ramirez 202-443-5656 hector.ramirez@va.gov Christie O’Brien 202-443-5660 christie.obrien@va.gov Kendra Clarke 202-443-5677 kendra.clarke@va.gov Michele McGee 202-443-5651 michele.mcgee@va.gov Mary Eckart Remotemary.eckart@va.gov Rishima Weston 202-443-5642 rishima.weston@va.gov SharePoint , CATS, MOUs, and Reportable Event Reporting Lindsey Martin 202-443-5653 lindsey.martin2@va.gov Erica Aulik Remote erica.aulik@va.gov Angela Foster 202-443-5822 angela.foster@va.gov