Implementation of VHA Directive 1200.13: Financial Conflicts of Interest and Outside Compensation in VA Research

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The presentation discusses the implementation of VHA Directive 1200.13 concerning financial conflicts of interest and outside compensation for performance in VA research. It outlines key responsibilities for various roles, submission requirements for conflict of interest statements, training programs, and the background leading up to the directive's publication. The content also covers recent legislative changes impacting VA employees' ability to receive outside compensation for research projects.

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Implementation of VHA Directive 1200.13 Financial Conflicts of Interest and Outside Compensation for Performance in VA Research Presented By: C. Karen Jeans, PhD, CCRN, CIP Director of Regulatory Affairs Antonio Laracuente, MBA Director Field Operations Angela Angie Foster, MS, FAC-P/PM Senior Level Program Manager Christopher Britt, Ethics Attorney Office of General Counsel June 18, 2024

Objectives Objectives Describe the key responsibilities required by VHA Directive 1200.13 for the VA Medical Center Director, Chief of Staff, ACOS/R, R&D Committee, Financial Conflict of Interest (FCOI) Administrators, and VA Investigators; Identify key requirements for submission and review of the Research Financial Conflict of Interest (FCOI) Statement, OGE Form 450 Alternative-VA ( Alt-450 ); Describe how training for Financial Conflict of Interest Administrators review of the OGE Alt-450 forms will be conducted; and Identify training resources provided by the VHA Office of Research and Development (ORD) on the VAIRRS Research Conflict of Interest Module. For questions, please use Q&A box and address to All Panelists.

Background Background On December 28, 2004, VHA Handbook 1200.13 - Financial Conflicts of Interest in Research Handbook was published by ORD and rescinded shortly afterwards on February 1, 2005. Although no ORD policy existed, VA employees are required to adhere to federal ethics laws. The Research FCOI Statement, OGE Form 450 Alternative-VA ("Alt-450"), was developed and approved by the Office of Government Ethics (OGE) for VA Investigators to disclose financial conflicts of interest, allowing review by VA OGC Ethics. Implementation of the Alt-450 varied across VA Facility programs with a lack of a systematic approach for review and determination. Numerous attempts were made to develop a national research financial conflict of interest policy, but major challenges existed. For questions, please use Q&A box and address to All Panelists.

Background (cont.) Background (cont.) On December 29, 2022, the Joseph Maxwell Cleland and Robert Joseph Dole Memorial Veterans Benefits and Health Care Improvement Act of 2022 182 (2022), which is part of the Consolidated Appropriations Act, 2023 (P.L. 117- 328), was signed into law by President Biden. The Law included provisions for the VA employees to receive outside compensation from an academic affiliate or VA Nonprofit Corporation (NPC) to perform the VA-approved research project if certain conditions are met. VHA Notice 2023-09(1) was published on November 28, 2023, which included the implementation policies for the applicable provisions of the Law involving outside compensation. VHA Notice 2023-09(1) is now rescinded with the publication of VHA Directive 1200.13 on May 2, 2024; its policies are incorporated within the Directive. For questions, please use Q&A box and address to All Panelists.

Bottom Line Up Front The publication of VHA Directive 1200.13 codifies the process into formal policy that was implemented with the publication of the OGE 450 Alternative VA (Alt-450 Research Financial Conflict of Interest Statement) in November of 2013 and incorporates the policy requirements of VHA Notice 2023-9(1) (Outside Compensation for Performance of VA Research) published November 28, 2023 into one (1) ORD national Directive. 5

Moving Forward to Implement VHA Directive 1200.13 Moving Forward to Implement VHA Directive 1200.13 The new policy requirements of this Directive are required to be implemented by September 2, 2024 (no later than 4 months following publication date). Key implementation requirements: Appointment of a Financial Conflict of Interest Administrator Utilization of IRBNet (VAIRRS) for submission of and processing the Alt-450 Forms Approval process for outside compensation Including documentation of the decision by the Approving Official Note that this program is different than the affiliate university or VA NPC Conflict of Interest program and must be managed separately. For questions, please use Q&A box and address to All Panelists.

Who is Required to File the Alt Who is Required to File the Alt- -450 Forms 450 Forms All VA investigators (compensated, WOC or IPA), who meet either of the following criteria are considered to hold a position that requires them to complete and submit an Alt-450 Form as required by VHA Directive 1200.13: (1) Hold the position of VA investigator (i.e., principal investigator, co-principal investigator, investigator, co-investigator, sub-investigator or VA medical facility site investigator). NOTE: A VA medical facility site investigator in a multiple-site study can be a VA site principal investigator, co-principal investigator or sub-investigator. (2) All VA employees being proposed for the position of VA investigator. For questions, please use Q&A box and address to All Panelists.

Key Responsible Parties for Implementation of VHA Directive 1200.13 Key Responsible Parties for Implementation of VHA Directive 1200.13 Research & Development (R&D) Committee Financial Conflict of Interest (FCOI) Administrator Medical Center Director VA ACOS/R&D Chief of Staff Investigators For purposes of this presentation, the following individuals or groups will be discussed, but other individuals are also included in VHA Directive 1200.13 For questions, please use Q&A box and address to All Panelists.

VA Medical Facility Director Key Responsibilities for Implementation of VA Medical Facility Director Key Responsibilities for Implementation of VHA Directive 1200.13 VHA Directive 1200.13 VA Medical Facility Director (MCD) Approving Official Ensuring the VA medical facility s research FCOI program is not a combined program with that of the VA medical facility s Affiliate or other entity. Appointing, in writing, a VA medical facility FCOI Administrator who is responsible for the VA medical facility s research FCOI program and reviewing and certifying Alt-450s. Making final binding programmatic decisions in consultation with an OGC Deputy Ethics Official in situations in which an FCOI can be resolved. Terminating research or taking other appropriate actions upon receiving notification that a VA investigator is participating in VA research despite an FCOI that cannot be resolved. Serving as the Approving Official for requests for outside compensation from projects administered by the Affiliate or VA NPC and providing written approval as appropriate. For questions, please use Q&A box and address to All Panelists.

Chief of Staff and ACOS/R&D Responsibilities for Implementation of Chief of Staff and ACOS/R&D Responsibilities for Implementation of VHA Directive 1200.13 VHA Directive 1200.13 Chief of Staff (COS) Can be delegated by MCD to be approving official. Associate Chief of Staff for Research and Development (ACOS/R&D) Ensuring that all VA investigators (compensated, without compensation (WOC) or appointed or detailed to VA under the Intergovernmental Personnel Act (IPA), 5 U.S.C. 3371 et seq.) are assigned annual ethics training within VA Talent Management System (TMS) including tracking and verifying completion. Forwarding outside compensation requests to the Approving Official once the VA medical facility R&D Committee completes their review and provides a recommendation to approve or disapprove. Includes modifications. Providing the original approval to the VA employee upon receiving approval from the Approving Official. A copy of the letter must be placed in VA Innovation and Research Review System (VAIRRS) under the appropriate project. Notifying the VA Investigator if the Approving Official disapproves the outside compensation. For questions, please use Q&A box and address to All Panelists.

R&D Committee Responsibilities for Implementation of R&D Committee Responsibilities for Implementation of VHA Directive 1200.13 VHA Directive 1200.13 R&D Committee Reviewing outside compensation request recommendations by the VA medical facility FCOI Administrator and approving or disapproving the recommendation during the VA medical facility R&D Committee s initial review of the VA project. Ensuring that each review assesses the request with regard to project budget appropriateness, the effort required to conduct the project and the rationale for outside compensation (i.e., why the work cannot be completed during the employee s VA tour of duty). Reviewing the memorandum submitted by the ACOS/R&D if the ACOS/R&D is the employee conducting the research. Suspending or terminating an approved VA project if a VA Investigator is participating in an approved VA project despite an FCOI that cannot be resolved. Termination of a project can only be done by the VA medical facility R&D Committee during a convened meeting. For questions, please use Q&A box and address to All Panelists.

FCOI Administrator Responsibilities for FCOI Administrator Responsibilities for Implementation of VHA Directive 1200.13 VHA Directive 1200.13 FCOI Administrator Must be a VA paid employee who does not have an affiliate or NPC appointment or appointed as the Research Compliance Officer. Reviewing and documenting the review of the Alt-450 and accompanying documents of the project submissions and filing the signed Alt-450 within VAIRRS. Notifying both the OGC Deputy Ethics Official and the VA medical facility Director within 3 business days upon becoming aware that a VA investigator is participating in VA research despite an FCOI that cannot be resolved. Reviewing requests for outside compensation and providing a recommendation to the VA medical facility R&D Committee as part of the project approval process. Implementation of For questions, please use Q&A box and address to All Panelists.

VA Investigator Responsibilities for VA Investigator Responsibilities for Implementation VHA Directive 1200.13 VHA Directive 1200.13 Implementation of of VA Investigator: Ensuring that he or she discloses any financial conflicts that may impact the study. Filing initial and annual Alt-450 Forms in VAIRRS. Filing a new Alt-450 in VAIRRS if a VA investigator has a change in a financial interest that requires disclosure, such as when a new financial interest may result in a potential conflict, within 45 calendar days of the time the change occurred. Completing annual ethics training. Submits requests for outside compensation when warranted. Not participating or initiating research when an FCOI has been determined. For questions, please use Q&A box and address to All Panelists.

Required VA Investigator Training Required VA Investigator Training For questions, please use Q&A box and address to All Panelists.

Training Requirements for VA Investigators Training Requirements for VA Investigators Unless live training is provided by a qualified OGC instructor prior to first project submission and annually thereafter, the following TMS courses are required: For VA Investigators: Government Ethics The Essentials (TMS #3812493) For health professions trainees: VHA Mandatory Training for Trainees (TMS #3185966) and VHA Mandatory Training for Trainees Refresher (TMS #3192008) For questions, please use Q&A box and address to All Panelists.

Research Conflict of Interest Module Research Conflict of Interest Module For questions, please use Q&A box and address to All Panelists.

Utilization of IRBNet Utilization of IRBNet All Alt-450 Forms must be submitted via IRBNet utilizing the Conflict of Interest wizard. A project shell must be created to begin entering Alt-450 Forms Training is available in the Training Archives at: Conflict of Interest (COI) Module for Investigators and Committee Members (va.gov) VAIRRS Support is also available to host training webinars for the researcher community Outside Compensation memorandums may be entered into IRBNet in the R&DC workspace. Implementation of VHA Notice 2023-09, Outside Compensation for Performance of VA Research For questions, please use Q&A box and address to All Panelists.

FCOI Administrator (FCOIA) Role and FCOI Administrator FCOI Administrator (FCOIA) Role and FCOI Administrator Training Training Training for FCOI Administrators will be provided by OGC EST prior to the full implementation of the Directive and will be announced. Goal of the training is to ensure that FCOI Administrators understand their role in reviewing the Alt-450 Forms, including circumstances when the FCOIA should certify the Alt-450 Forms instead of assigning it to OGC Ethics. IRBNet will provide Conflict of Interest module training to FCOI Administrators upon notification the research office is ready to begin using the module. For questions, please use Q&A box and address to All Panelists.

Summary Summary Standardizing submission and review of research financial conflict of interest disclosures is critical to ensuring VA complies with the applicable federal ethics laws. The date for compliance with VHA Directive 1200.13's policies is September 2, 2024. For questions, please use Q&A box and address to All Panelists.

References References The Joseph Maxwell Cleland and Robert Joseph Dole Memorial Veterans Benefits and Health Care Improvement Act of 2022 182 (2022), VHA Directive 1200.13 Financial Conflicts of Interest and Outside Compensation for Performance in VA Research (May 2, 2024) located at VHA Publications Research Financial Conflict of Interest Statement OGE Form 450 Alternative-VA located at conflict_of_interest.pdf (va.gov) ORD Webpage: Outside Compensation Guidelines located at Outside Compensation Guidelines: Guidance under development (va.gov) Delegation of Authority from Secretary to the Under Secretary - Outside Compensation Delegation of Authority from Under Secretary to Facility Directors Matrix: Scenarios and Considerations for Outside Pay to VA Compensated Investigators and Staff Engaged in VA Research Sample Memo - https://www.research.va.gov/resources/policies/sample-memo-outside- comp.docx For questions, please use Q&A box and address to All Panelists.