Evolution of VA Research & Development Committee Responsibilities
The article discusses the changing roles of the VA Research & Development Committee in light of VHA Directive 1200.01. It covers the rationale behind revising committee responsibilities, strategies for exempt research functions, the importance of VA R&D Committee, and the major shift in responsibilities due to the Revised Common Rule. The focus is on enhancing governance for research oversight and the inclusion of non-Veterans in VA research.
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R&D Committee and VHA Directive 1200.01: Changing Roles of the R&D Committee IRB and R&D Committee Workshop August 20-21, 2019
Objectives Describe rationale for ORD s revision of the R&D Committee responsibilities in VHA Directive 1200.01. Discuss and identify process strategies for exempt research functions traditionally done by IRBs reviewing VA research Exempt determinations IRB approval of waiver of authorizations 2
Why Does the VA Research and Development Committee Exist? Serves a critical role as part of the institutional governance structure for the VA Facility s research activities. Approval of research studies Oversight of research-related subcommittees and committees Required by VA statutory regulation 38 CFR 17.85: VA medical facilities shall provide necessary medical treatment to a research subject injured as a result of participation in a research project approved by a VA Research and Development Committee and conducted under the supervision of one or more VA employees. Statute does not define its composition or approval process; ORD policy defines the R&D Committee responsibilities. 3
VA Research and Developments Responsibilities Vary Widely across VA Facilities Differences in the rigor of R&D Committee reviews both when it is the sole oversight committee or the research is overseen by other subcommittees or research-related committees. Some R&D Committees conduct review and approval functions not required by ORD policy Review of informed consent documents for IRB required basic elements of informed consent Approval of data use agreements and Material Transfer Agreements prior to signature by signatory official. Continuing review of research under IRB oversight 4
Major Shift in R&D Committee Responsibilities as a Result of the 2018 Requirements of the Revised Common Rule Increased governance for approval of research overseen by external IRBs. Need to ensure the VA Facility has an approval mechanism when non-Veterans are included in VA research. IRBs traditionally only have the scope of authority to review proposed subject recruitment as it relates to human subjects protections. Issues related to including non- Veterans in VA research are not solely human subject protection related. Need to streamline R&D Committee approval processes through creation of a R&D Committee designated reviewer approval process because of (a) the prior absence of a method for R&D Committee approval outside of a convened meeting, and (b) the greater number of human subject studies eligible for exemption requiring the R&D Committee to be the sole oversight committee. 5
Major Shift in R&D Committee Responsibilities: Exempt Research Process Anticipated Not Anticipated Increased volume workload for R&D Committee Members/Designated Reviewer Reluctance of some non-VA IRBs to approve waivers of HIPAA authorization when the activity does not involve the non-VA institution Increased workload of R&D Coordinator Reluctance of some non-VA IRBs to do exempt determinations when the activity does not involve the non-VA institution Need to develop worksheets or tools Some non-VA institutions refusing to permit use of some of the exempt categories permitted by ORD policy if the non-VA institution s IRB would do the limited IRB review; activity is reviewed by expedited review Investigators wishing to have studies approved as exempt since the activity meets one of the 2018 exempt categories Investigators wanting exempt studies that meet expedited categories reviewed by an IRB to eliminate continuing review 6
Should Consideration Be Given to Constituting a Privacy Board? ORD is not mandating that each VA Facility establish a Privacy Board. However, what would you do as the R&D Coordinator or R&D Chair if: You receive a retrospective chart review study from an investigator that would qualify under exempt category 4(iii), but Your primary IRB is your academic affiliate, and the academic affiliate will not agree to evaluate the proposed research for approval of a waiver of HIPAA authorization? 7
Would You Call the VA Central IRB? VA Central IRB E-mail Address: vacentralirb@va.gov No 8
Privacy Boards are not IRBs: Composition The Privacy Rule requires that a Privacy Board consist of at least two members and meet the requirements at section 164.512(i)(1)(i)(B). The members must have varying backgrounds and appropriate professional competencies as necessary to review the effect of a research protocol on the individual s privacy rights and related interests. At least one member of a Privacy Board must be an independent member who is (1) not affiliated with the covered entity that will use or disclose the PHI in connection with the research project, (2) not affiliated with the entity conducting or sponsoring the research, and (3) not related to any person who is affiliated with the covered entity or the entities conducting or sponsoring the research. Furthermore, no Privacy Board member may participate in the review of any project if that person has a conflict of interest. 9
Privacy Boards are not IRBs Source: NIH Publication Number 03-5448: Privacy Boards and the HIPAA Privacy Rule 10
Planned Role of ORDs Research Privacy Officer Dependent on Need: Privacy Boards Work with VHA Privacy on establishing standardized standard operating procedures if a VA Facility needed to establish a Privacy Board. Identify qualify assurance/quality improvement indicators a VA Facility may wish to use for assessing the Privacy Board operations. Identify policy and guidance deficits or needed clarifications or guidance for constituting and operating a Privacy Board. 11
What are Exempt Determination or Exempt Committees? Not a required subcommittee of the R&D Committee. R&D Committee can establish any subcommittee(s) deemed necessary for the efficient and effective management and oversight of the R&D Program (VHA Directive 1200.01, Paragraph 8.a.) They are subcommittees constituted to be responsible for having oversight of exempt research. Cannot be a committee of one. Must have standard operating procedures for its review and oversight. 12
Summary At the present moment in time, the implementation of the 2018 Requirements has placed a substantial amount of regulatory and process burden on the VA R&D Committee. The R&D Committee can choose to constitute subcommittees if needed, such as exempt determination committees. 13
Discussion 14
Contact Information C. Karen Jeans, PhD, CCRN, CIP Director, Regulatory Affairs ORPP&E Office of Research and Development Washington, DC c.karen.jeans@va.gov 15
References 38 CFR 17.85 Treatment of Research Related Injuries located at https://www.govregs.com/regulations/expand/title38_chapterI_p art17_subjgrp183_section17.85 VHA Directive 1200.01: Research and Development Committee (January 24, 2019) located at VHA Publications at https://www.va.gov/vhapublications/publications.cfm?Pub=1 NIH Publication Number 03-5448: Privacy Boards and the HIPAA Privacy Rule located at https://privacyruleandresearch.nih.gov/pdf/privacy_boards_hipaa_pr ivacy_rule.pdf 16
