Differentiating Roles of IRBs vs. Institutions IRB and R&D Committee Workshop August 20-21, 2019

1. Differentiating Roles of IRBs vs. InstitutionsIRB and R&D Committee WorkshopAugust 20-21, 2019

2. Objectives • Identify three major areas where IRBs or Institutions have difficulty with differentiating the roles of each in the review and approval of human subjects research. • Describe the role of ORD policy in differentiating the role of IRBs and VA Facilities in the review and approval of human subjects research with emphasis on the §.114 cooperative research provisions of the 2018 Requirements of the revised Common Rule. • Describe current and proposed model for adding IRBs to VA Facilities when VA Facilities request change in IRB arrangement for a multi-site study(ies).

3. What is the Role of the IRB according to the Common Rule? • An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy, including exempt research activities under §16.104 for which limited IRB review is a condition of exemption (under §16.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7), and (8)). Source: 38 CFR 16.109(a)

4. What is the Role of the IRB according to the Privacy Rule (HIPAA)? • IRBs gained authority to consider, and act upon, requests for a partial or complete waiver or alteration of the Privacy Rule's Authorization requirement for uses and disclosures of PHI for research. • If certain conditions are met, an IRB may grant a waiver or an alteration of the Authorization requirement for research uses or disclosures of PHI. Source: 45 CFR 164.512(i)(1)(i) and https:/privacyruleandresearch.nih.gov/irbandprivacyrule.asp

5. Are these IRB Responsibilities According to the Common Rule and HIPAA? IRB Review of Data Use Agreements Source: https://research.iu.edu/policies/human-subjects-irb/use-of-phi-in-research.html

6. Are these IRB Responsibilities According to the Common Rule and HIPAA? IRB Approval of HIPAA Authorization Language Source: https://research.umbc.edu/data-use-agreements/

7. Are these IRB Responsibilities According to the Common Rule and HIPAA? Determines Whether the Written Authorization Allows for Use and Disclosure of PHI to all Applicable Parties Source: https://smartirb.org/agreement/

8. In Order to Move Forward with Facilitating a Single IRB Review System, The Roles of the Institution and IRB Must Be Clearly Differentiated VA Facility Research Approval Process IRB

9. Back to Basics – Common Rule and §.114 Cooperative Research Provisions of the Revised Common Rule • Current version of VHA Directive 1200.05 removes a lot of the administrative burden that had been placed on VA IRBs and focuses on the required, basic functions of an IRB as mandated in the revised 2018 Common Rule. • ORD has also transferred some VA specific responsibilities the IRB was previously required to do as part of its approval of VA human subjects research to the R&D Committees and the Institution. • These changes were essential in order to facilitate use of non-VA IRBs for review of multi-site studies.

10. IRB Focus is on Protecting Human Subjects • Re-focus of VA IRBs on the ethical conduct of research and ensuring adequate human subjects protections Less time spent dotting i’s and crossing t’s on purely administrative issues that can be reviewed elsewhere • Single IRBs reviewing research for a VA will have to follow the Common Rule criteria VA IRB review requirements are much more closely aligned with the essential requirements of the Common Rule making review by a single non-VA IRB possible

11. Minefields and Pitfalls • Still some VA-specific research review requirements some of which include • Recruitment methodologies • Required informed consent language • Privacy and Information Security requirements • Use of vulnerable populations and non-Veterans • Research reporting requirements • Some these the IRB is still responsible for and some are now the responsibility of the Institution, whether through the R&D Committee or another mechanism

12. MOUs/IRB Reliance Agreements and SOPs • Reliance Agreements must clearly delineate the responsibilities of the Reviewing IRB and those of the Institution • Institution must have robust SOPs that clearly define how research is to be reviewed in that Institution to ensure all VA requirements are met; i.e., it can no longer all be left up to the IRB • Training is essential in order to fully embrace this cultural change

13. Possible Outcomes • Quicker IRB review times but longer R&D Committee review times and burden • Reviewing IRB may have to review amendment requests from multiple Institutions due to conditional R&D Committee approvals if VA requirements were not met • Initial increased monitoring and auditing on part of Institution to ensure quality reviews for the protection of Veterans • Development of more innovative and interactive oversight mechanisms

14. Problematic Issues Often Seen by VA Central IRB • Privacy and information security requirements regarding data and biologic specimen access, use, storage and transfer • Future use of data and specimens, as well as re-contact of participants • Use of unencrypted e-mail and cold calling to recruit participants • Understanding of how to request waivers (informed consent, waiver of documentation of informed consent, and HIPAA waiver)

15. VA Central IRB Structure is Changing! The VA Central IRB is adapting in the following way: • Adding an additional panel with the ability to add more panels based on workloads • Follow same SOPs, use same forms, and follow same meeting schedule • Transparent to investigators and study teams • Revised MOU will be released in mid-September and second panel must be added to facility FWAs • Dedicated Privacy Officer for ORD (50% time for VA CIRB)

16. January 20, 2020 and the §.114 Cooperative Research Provision: Impact on VA • Huge amounts of misinformation about what will happen on January 20, 2020 • Example below currently posted on a University’s website:

17. §.114 Cooperative Research Regulatory Text: A Critical Part of the Regulation Often Omitted (1) Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research. (2) The following research is not subject to this provision: (i) Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or (ii) Research for which any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context.

18. VA Process for Adding an IRB to a VA Facility’s Human Research Program: Implementation Issues of VHA Directive 1200.05, Paragraph 5.f.(8)a. • The facility’s IRB(s) of Record may include the facility’s own IRB(s), VHA Central Office IRB (VA Central IRB), an IRB of another VA facility, the IRB(s) of an affiliated medical or dental school, or the IRB of another Federal agency. A facility may also use for multi-site protocols an IRB from a non-affiliated medical or dental school if that IRB has been specifically designated by ORD as an IRB that may serve as a multi-site IRB for VA facilities. NOTE: A VA facility may not use a commercial IRB as an IRB of Record.

19. Process for Adding Non-Affiliated IRBs to a VA Facility’s Human Research Protection Program ORO Notifies VA Facility when FWA can be Updated with Submission of Addendum Query received by ORO or ORD Reliance Agreement Sent to Local Site and Reviewed by Institution ORPP&E Sends Application Form to VA Facility VA Facility Develops SOP and Sends to ORO Application Form Completed and Sent to ORPP&E Decision Sent by Dr. Klote to VA Facility. If Yes, Contact ORO ORPP&E Reviews Application and Consults with ORO

20. IRB Reliance Request Form – Pilot Phase

21. IRB Reliance Request Form – Pilot PhaseDifficulties with Obtaining Vetting Information

22. Proposed Model for Adding Non-Affiliated IRBs to a VA Facility’s Human Research Protection Program: (Requires Policy Changes) ORPP&E Notifies VA Facility When Reliance Agreement Executed – No FWA Update Query received by ORO or ORD Reliance Agreement Sent to VA Facility and Reviewed by Institution ORPP&E Sends Application Form to VA Facility VA Facility Works With ORPP&E for Reliance Agreement and Standardized SOPs Application Form Completed and Sent to ORPP&E Decision Sent by Dr. Klote to VA Facility. If Yes, site sent packet. ORPP&E Reviews Application and Consults with ORO

23. VA Implementation of the §.114 Cooperative Research Provisions • ORD supports the single IRB initiative • Issues affecting the ability for VA to implement • Policy issues • Information Security Issues • Legal Issues • Infrastructure issues • Relying IRBs varying interpretation of IRB responsibilities • Breakout Session #2 targets issues related to the single IRB initiative

24. Contact Information Annette R. Anderson, MS C. Karen Jeans, PhD, CCRN, CIP VA Central IRB Administrator Director, Regulatory Affairs, ORPP&E Annette.anderson3@va.govc.karen.jeans@va.gov 202-443-5649 202-443-5712 E-mail: va.central.irb@va.gov Toll Free Number: 877-254-3130 Website: http://www.research.va.gov/vacentralirb/default.cfm Current VA Central IRB Co-Chairs Fred Hendler, MD, PhD Stephen Bartlett, RPh, MSPH Fred.hendler@va.govStephen.bartlett2@va.gov 502-287-4000 ext. 55131 702-857-5709

25. Discussion