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Collaborative Research VA Research

Collaborative Research VA Research. K. Lynn Cates, M.D. Assistant Chief Research & Development Officer Director, PRIDE June 26, 2012. What is “VA Research”?*.

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Collaborative Research VA Research

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  1. Collaborative ResearchVA Research K. Lynn Cates, M.D. Assistant Chief Research & Development Officer Director, PRIDE June 26, 2012

  2. What is “VA Research”?* VA Research is research that has been approved by the Research & Development (R&D) Committee and conducted by VA investigators including principal investigators (PIs), Co-PIs, and Site Investigators (serving on compensated, Without Compensation (WOC), or Intergovernmental Personnel Act (IPA) appointments) while on VA time, utilizing VA resources, and/or on VA property including space leased to, and used by, VA. The research may be funded by VA, by other sponsors, or be unfunded. *VHA Directive 1200

  3. Implications of a Study’s Being“VA Research” VA R&D Committee approval makes the study “VA Research” and, therefore, VA is responsible for • The ethical conduct of the research • Ensuring the research is carried out in accordance with all VA and other requirements

  4. Implications of a Study’s Being“VA Research” VA medical facilities must provide necessary medical treatment to a research subject injured as a result of participation in a research study approved by a VA R&D Committee and conducted under the supervision of one or more VA employees.* *38 CFR 17.85 & VHA Handbook 1200.05 § 60a

  5. Which of the following is not a factor in determining whether or not a project is VA Research? • Source of funding • Whether or not subjects are Veterans • R&D Committee approval • All of the above • None of the above

  6. Dual Appointment Investigators

  7. A VA investigator uses non-VA funding to conduct research entirely at a non-VA facility with Veteran subjects. Is this VA Research? • Yes • No • It Depends

  8. VA Research What other information do you need?

  9. VA Research Is the VA investigator working on VA time or using other VA resources (e.g., VA laptop, VA office space, etc.)? • If YES, then it is VA Research • If NO, then it is not VA Research

  10. If research is being conducted at a non-VA facility and the participants are not Veterans, does the investigator need to use a VA informed consent form (VA Form 10-1086)? • Yes • No • It Depends

  11. VA ResearchVA Form 10-1086 • YES – they have to use a VA informed consent form (VA Form 10-1086) if it is VA Research (e.g., if the investigator is using VA time, equipment, etc) • NO – if it is not VA Research (e.g., if the investigator is not using any VA resources)

  12. VA Research A VA investigator is conducting non-VA funded research at a non-VA facility, on her affiliate time, and she is using no VA resources. The non-VA facility’s IRB has approved the study. The subjects include Veterans and non-Veterans. More

  13. Should the VA R&D Committee review her study? • Yes • No • It Depends

  14. VA Research VA R&D Committee approval makes the study “VA Research” and, therefore, VA is responsible for • The ethical conduct of the research • Ensuring the research is carried out in accordance with all VA and other requirements • Providing care for research-related injuries

  15. Does VA permit its R&D Committees to approve studies in which the VA’s sole involvement is to solicit participation of Veterans in research conducted by non-VA personnelat a non-VA entity? • Yes • No • It depends

  16. “Recruitment Only” Studies • A VA investigator must have a substantive role in any VA Research (not just recruiting Veterans for a non-VA study) • VA R&D Committee approval makes the study “VA Research” and obligates VA to provide care for research-related injuries

  17. VA Research A project is VA Research if • It has been approved by the R&D Committee • It uses any VA resources, such as • VA funding • VA time • VA equipment • VA property

  18. VA Research Record Retention Requirements • VA research records must be maintained in accordance with Federal records retention and other requirements • Currently, there is no applicable Records Control Schedule therefore all VA research records must be kept for the foreseeable future

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