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Regulatory Approval

How do I get regulatory approval for animal subjects or basic research?

Animal subjects regulatory approval must be granted through Wake Forest’s Institutional Animal Care and Use Committee (“IACUC”). 

A Principal Investigator of the Wake Forest/VA protocol must adhere to the VA rules for the Use of Animals in Research. For guidance, please complete the Animal Research Tutorials for Animal Research funded by the U.S. Department of Veterans Affairs (VA) and by the Department of Defense

IACUC Protocol Review Requirements:

Primary Review: Researchers must submit a protocol via eIACUC to the Wake Forest (WF) IACUC and obtain approval from the WF IACUC.

Secondary Review: Researchers must then submit to the VA: 1) the WF approved protocol; 2) WF IACUC approval letter as evidence of WF IACUC approval; and 3) the VA Animal Component of Research Protocol (ACORP), which is the VA's version of an IACUC protocol. 

IACUC Amendments:

Submit all Wake Forest IACUC-approved amendments to the VA for approval (no work can start on an amendment until all approvals are granted).

How do I get regulatory approval for human subjects? 

Both the Wake Forest and VA IRBs must approve any human research study in which a Wake Forest researcher will be engaged at the VA. In order to meet federal regulations, investigators must report any unanticipated problems or non-compliance to both the Wake Forest and VA IRBs. The two IRBs will then work together to appropriately address the issues.

Submitting to the VA IRB

  • Your current research staff may prepare and submit your research proposal to the VAMC IRB if they have current Without Compensation (WOC) employee status with the VAMC. Review more information on the WOC employee status request process
  • Alternatively, you may request that VAMC research staff prepare and submit your IRB application to the VAMC IRB (a fee will apply). 
  • Once the VAMC IRB approves your study, the WFBMC IRB has an abbreviated application form that allows you to upload the VA IRB application documents rather than completing the entire WFBMC application. 

The IRB process you complete first will depend on the specifics of the study, the funding requirements, and the research plan. We can help you decide the best way to get started. 

VAMC IRB Coordinator 
Nathan Bledsoe
(704) 638-9000 ext 4299

WFBMC IRB Director  
Joseph Andrews, PhD
(336) 716-7658 

It is important to work with the IRB offices as you prepare your application so that all regulatory and site policy requirements are met. This will help in avoiding delays in approval. 

Additional VAMC resources are available on the internal VA website for WOC employees and faculty members with VA appointments.