VA Research is research that is conducted by investigators (serving on VA compensated, WOC (Without Compensation), or IPA (Intergovernmental Personnel Act) appointments) while on VA time or on VA property, or using a VA program (example: Whole Health). The research may be funded by the VA, by other sponsors, or be unfunded.  

When questions arise whether an activity falls under Truman VA Hospital research, the local VA research office will be consulted.  

Truman VA Hospital entered into a Memorandum of Understanding to utilize the MU IRB for IRB services. It does not preclude Truman VA from using another IRB. If planning to use another IRB besides MU, you must obtain approval first through the Truman VA research office, and the MU IRB will not be involved with the review.   

See our Truman VA SOP for additional information.  

Prior to conducting VA research, there are multiple steps that must be followed. Full documented MU IRB approval and VA R&D approval must be received prior to conducting any research activities.  

  1. Truman VA Feasibility Review Process – All Truman VA research must go through a feasibility review process. This process must be completed before submitting the project to the MU IRB. The MU IRB will return the project to you until this is complete, and the feasibility review letter has been uploaded. If you have not done this, you must contact Lane Nelson, the Truman VA HRPP Health System Specialist, to obtain instructions for completing the feasibility review process. His contact information is: lane.nelson@va.gov or (573) 814 -6000 ext. 53714.  
  2. Additional VA Training – There are additional training requirements for VA research. The Truman VA Research Office will work with you to ensure all additional training has been completed.   
  3. MU IRB Application – Submit the MU IRB application in eCompliance indicating on the form this is VA research where asked. There is a Truman VA Research subform at the end of the application that must also be completed.  
  4. VA R&D Application & other VA Forms - If you are conducting VA research, please contact the VA Research Office at 573-814-6550 to complete the appropriate paperwork to avoid delays in the VA review process. This includes, but is not limited to, the VA R&D Application, Information Security and Privacy Checklists, Privacy and Security Plan for Principal Investigators, VA CITI Training, etc.  

 

Yes. You will need to contact the VA Research Office for a current copy of their consent template.  

No, the HIPAA authorization does not need to be separate. The VA Research office will work with you to embed the appropriate VA HIPAA authorization language if you do not use their separate form. If you use the separate form, it does not get uploaded or reviewed by the MU IRB. It is only submitted to the VA R&D application. If it is a combined consent and HIPAA authorization, it will need to be uploaded for MU IRB review. Contact the VA Research Office for guidance.  

For expedited and full board studies, MU will review the HIPAA waiver or alteration request in conjunction with your IRB application. The MU IRB does not review Truman VA exempt studies; therefore, the Truman VA will guide you through their review and approval process.

No. Truman VA Quality Improvement Projects, Case Reports, and Exempt Studies go through the Truman VA Research Office for review and approval.

Contact Lane Nelson, the Truman VA HRPP Health System Specialist, to obtain instructions for completing their VA exempt application since they utilize a separate online system. His contact information is: lane.nelson@va.gov or (573) 814 -6000 ext. 53714. 

Yes. Although this likely will not require VA Research R&D committee approval, you must reach out to the Truman VA Research Office for guidance on the approval process to share recruitment information at the VA. There is a separate, formal process for recruitment only activities at the VA.  

The MU IRB application must indicate this is a multi-site study involving populations at both MU and VA. You have the option to complete two separate IRB applications (one for MU and one for VA) or just one combined. When combined, this requires separate consent forms required by each institution and roles will need to be clearly defined regarding VA time and MU time for researchers with dual appointments.   

You must work with the Truman VA to ensure all agreements, such as a CRADA or Data Use Agreement, are in place before the research can commence.  

See VA 1200.05 section 15 for additional information regarding collaborative research requirements.  

This would be considered VA research that needs to go through the normal submission and review steps discussed above in FAQ #2. In addition to that process, you will need to work with the Truman VA to ensure a Data Transfer/Use Agreement is in place before any study materials leave the VA. You cannot remove any VA research data from the VA without appropriate agreements in place.  

This would be considered VA research that needs to go through the normal submission and review steps discussed above in FAQ #2. In addition to that process, you will need to work with the Truman VA to ensure an agreement is in place utilizing MU space and resources.