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Changes to VHA Directives 1200.05 and 1200.01: Recap and Workshop

This recap highlights the new responsibilities and requirements outlined in VHA Directives 1200.05 and 1200.01, and provides a list of available resources for implementing changes in these policies.

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Changes to VHA Directives 1200.05 and 1200.01: Recap and Workshop

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  1. Recap of Changes to VHA Directives 1200.05 and 1200.01IRB and R&D Committee WorkshopAugust 20-21, 2019 Soundia Duche, MA, MS Chief, Education and Training ORPP&E

  2. Objectives • Highlight Significant New Responsibilities and Requirements outlined in VHA Directive 1200.05 • Highlight Significant New Responsibilities and Requirements outlined in VHA Directive 1200.01 • Provide a list of available ORD resources for implementing changes in VHA Directives 1200.05 and 1200.01 Policy that is under consideration for revision

  3. VHA Directives 1200.05 and 1200.01 • VHA Directive 1200.05: Requirements for the Protection of Human Subjects in Research (published January 7, 2019) • All requirements are enforceable • VHA Directive 1200.01: Research and Development Committee (published January 24, 2019) • All requirements enforceable as of May 1, 2019, except for the following which will be enforceable on January 20, 2020: • Establishment of a Research and Development Committee Conflict of Interest Committee for review of OGE Form 450 Alternative VA, Research Financial Conflict of Interest Statement • Completion of Information System Security Officer (ISSO) and Privacy Officer (PO) reviews of all research prior to final VA approval • Use of a Material Transfer Agreement (MTA) for transfer of biospecimens from VA in collaborative research activities

  4. VHA Directive 1200.05

  5. VHA Directive 1200.05: IRB Membership and Function • IRB Membership • Elimination of the requirement that VA staff from the facility must be appointed as voting members to an IRB other than its own, that serves as an IRB of record for the facility • IRB of Record • For multisite research, an IRB of a non-affiliated medical or dental school can serve as the IRB of record for a VA facility if that IRB has specifically been designated by ORD as an IRB that may serve as a multi-site IRB for VA facilities • Commercial IRB cannot be an IRB of Record

  6. VHA Directive 1200.05: Exempt Research VHA Directive 1200.05 revised to be in alignment with the exempt requirements in the revised Common Rule, except for certain restrictions on broad consent • Expansion of studies that may qualify for exemption • Increase in number of exempt categories • Broadening of scope of studies that may qualify for exemption • Introduction of “limited IRB review” • New review responsibility for IRBs reviewing exempt research • Required for exempt categories 2(iii); 3i(c); 7; and 8

  7. VHA Directive 1200.05: Broad Consent • Specific to research subject to the 2018 Requirements • Specific to the storage, maintenance, and secondary use of identifiable data/biospecimens • Applies to two new exempt categories (7 and 8) • VA-specific Limitations • Can only be used when data or biospecimens are collected solely for research purposes • Documentation of broad consent cannot be waived

  8. VHA Directive 1200.05: Continuing Review • A number of studies subject to the 2018 Requirements no longer require continuing review (CR) by the IRB • Research eligible for expedited review • Research that has progressed to the point that it involves only one or both of the following: • Data analysis, inclusive of analysis of identifiable private information or identifiable specimens, and/or • Access to follow-up clinical data obtained from procedures that subjects undergo as part of clinical care • Justification is required if the IRB elects to conduct CR on research that no longer requires it

  9. VHA Directive 1200.05: Removal of Certain VA-Specific Approval Criteria • IRB is no longer responsible for reviewing and approving the following: • Relevance of the research to the mission of the VA and the Veteran population that it serves • Inclusion of Non-Veterans • Ensuring that mechanisms are implemented to manage, reduce, or eliminate potential, actual, or perceived conflicts of interest (COI) related to the research • VA-specific approval criteria for inclusion of individuals with impaired decision-making capacity • Please note: Investigators must still inform the IRB of any COIs that may affect any aspect of the research

  10. VHA Directive 1200.05: Health Insurance Portability and Accountability Act (HIPAA) • The written HIPAA authorization may either be a standalone document or combined with the research informed consent form • If a standalone document is used, VA Form 10-0493, “Authorization for Use and Release of Individually Identifiable Health Information Collected for VHA Research” must be used • Combining the two documents is not advised by VHA Privacy in certain instances: • When there is optional future use of data and specimens • When legally authorized representatives (LARs) may consent on behalf of the subject

  11. VHA Directive 1200.5: Research involving Vulnerable Populations • Pregnant Women: Certification by the Facility Director is only required for interventional studies or invasive monitoring of pregnant women as subjects and for neonatal research • In Vitro Fertilization: Research involving the provision of in vitro fertilization services can be approved as VA-research • Fetal and Human Stem cells: Research involving a fetus can be approved as VA research • Research using human fetal tissue and human stem cells is governed by NIH policy for recipient of NIH research funding. • Multiple NIH restrictions exist on the use of human fetal tissue for NIH funded studies

  12. VHA Directive 1200.01

  13. VHA Directive 1200.01: R&D Committee Membership and Function • Voting members of the R&D Committee can now also be appointed to VA under the Intergovernmental Personnel Act (IPA) or a Without Compensation (WOC) appointment • R&D Committee meets on a regular schedule as needed (as opposed to prior monthly requirement) • R&D Committee meeting minutes must be documented and disseminated to the Quadrad (Director; Associate Director; Chief of Staff; and Associate Director for Patient Care Services) • R&D Committee approval can occur outside of the convened committee by designated review for certain specified activities • Requirement to establish a local R&D Conflict of Interest Committee (enforcement on hold)

  14. VHA Directive 1200.01: Continuing Review • Research not under the oversight of another subcommittee requires continuing review by the R&D Committee (e.g. exempt research) • R&D continuing review elements include: • Scientific Progress • Budget changes • Changes in space, personnel, equipment, supplies • Summary and impact of unanticipated problems • Any issues of non-compliance

  15. VHA Directive 1200.01: VA-Specific Approval Criteria • R&D Committee is now responsible for reviewing and approving the following for all research (exempt and non-exempt research): • Relevance of the research to the mission of the VA and the Veteran population that it serves • Inclusion of Non-Veterans • R&D Committee responsible for ensuring that Information System Security Officer (ISSO) and Privacy Officer (PO) review is complete before final VA approval • R&D Committee can approve contingent on ISSO and PO review

  16. VHA Directive 1200.01: Subcommittee Responsibilities • Clarifies that a subcommittee does not include committees established by a Memorandum of Agreement (MOU) or other agreement • R&D Committee responsible for reviewing all research-related committees and subcommittees at least annually • R&D Committee responsible for ensuring the adequacy of each subcommittee’s review procedures, including reviewing and approving all subcommittee SOPs • FAQ dated 6/5/19 clarifies that R&D Committee must have a way to ensure that each of it’s subcommittees has effective SOPs for protocol review

  17. VHA Directive 1200.01: External Committee Responsibilities • Multi-site studies: R&D Committee must determine whether the facility should participate in the multi-site study and ensure that the appropriate IRB agreements as required by VHA Directive 1200.05 and VHA Handbook 1058.03, Assurance of Protection for Human Subjects in Research, are in place prior to using the external IRB • R&D Committee must document • Research supports the VA mission • Is scientifically meritorious • Ensures the security of VA data and storage of data and specimens in accordance with all applicable requirements

  18. ORD Resources Supporting Implementation of VHA Directives 1200.05 and 1200.01 • Summary of Significant Changes to VHA Directive 1200.05: https://www.research.va.gov/resources/policies/guidance/SummaryChanges-VHADirective1200-05.pdf • ORD Guidance Documents: https://www.research.va.gov/resources/policies/default.cfm • ORPP&E Webpage: https://www.research.va.gov/programs/orppe/default.cfm • Moon Shoot Documents/Sample Documents: https://www.research.va.gov/programs/orppe/policy/draft/default.cfm • ORPP&E FAQs: https://www.research.va.gov/programs/orppe/policy/faq.cfm • ORPP&E Webinar Recordings: https://www.research.va.gov/programs/orppe/education/webinars/default.cfm • ORPP&E Regulatory Mailbox: vhacoordregulatory@va.gov

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