Collaborative research va research
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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

Collaborative ResearchVA Research

K. Lynn Cates, M.D.

Assistant Chief Research & Development Officer

Director, PRIDE

June 26, 2012


What is va research

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


Implications of a study s being va research

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


Implications of a study s being va research1

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


Which of the following is not a factor in determining whether or not a project is va research

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


Dual appointment investigators

Dual Appointment Investigators


Collaborative research va research

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


Va research

VA Research

What other information do you need?


Va research1

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


Collaborative research va research

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


Va research va form 10 1086

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)


Va research2

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


Should the va r d committee review her study

Should the VA R&D Committee review her study?

  • Yes

  • No

  • It Depends


Va research3

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


Collaborative research va research

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


Recruitment only studies

“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


Va research4

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


Va research record retention requirements

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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