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Process Overview

1. Discuss Project Feasibility

Prior to beginning the process of research initiation at the VA Medical Center (“VAMC”), please contact Amy Morris, amy.morris3@va.gov, or Dr. Robin Hurley, robin.hurley@va.gov, to discuss the feasibility of conducting your research at the VAMC. For background information, please visit the US Department of Veterans Affairs Office of Research & Development.

Any individual wishing to serve as a PI for a study conducted at the VA must be a US citizen. 

2. Obtain a WOC Appointment

Every person working on a human, animal, or pure laboratory research project on the grounds of the VA Health Care System must have an appointment. If the investigator and/or any Wake Forest study staff does not already have any type of appointment at VAMC, s/he can get a WOC (Without Compensation) appointment. Learn more about WOC appointments

3. Receive Regulatory Approval

Animal subjects research at the VA must be approved through Wake Forest's Institutional Animal Care and Use Committee (IACUC). 

Human subjects research conducted at both Wake Forest Baptist Medical Center and the VA Medical Center must be approved by both sites' Institutional Review Boards.

Learn more about Regulatory Approval for VA projects.

4. Understand the Contracting Process for Clinical Trials

When working with the VAMC, in most cases, the VAMC functions as a separate site (i.e., not a sub site). In addition to the regulatory process, a contractual arrangement between a study sponsor and the VA is required. The contracting process varies according to type of clinical research funding, but generally a Cooperative Research And Development Agreement (“CRADA”) is established. The CRADA replaces the more familiar Clinical Trial Agreement (“CTA”) and is a legal agreement between a government agency (the VA in this case) and a private organization (the funder and/or sponsor of the study). Read more about General Contracting Considerations.

5. Set Up Award

VAMC funds are set up at the VA through the VAMC Foundation in the investigator’s name. Funds are to be used for research-related activities pursuant to the final CRADA or agreement that has been put in place for the conduct of the study.

Industry funds go directly to the VAMC foundation in the Principal Investigator’s name to be used for study-related activities.

6. Explore Options for Study Conduct

Wake Forest’s own study coordinators can conduct the research at the VAMC through an IPA. An IPA is a contract between the VAMC and WFMC that allows compensation for per hour salary + fringe. Any study staff conducting research-related activities must have an appointment (i.e., either paid or WOC) at the VAMC.

Investigators can opt to use VA staff to conduct research-related activities. Clinical services, administrative activities and laboratory activities can all be conducted at the VAMC. The payment for these activities can come right out of the study budget. Learn more about Study Conduct Options.

7. Closeout Study

When a study ends, there may be residual funds. Residual funds remain in the investigator’s name at the VA in an account managed by the VAMC Foundation. PIs may access and use residual funds in any research-related activity at the VA. Funds are to be used within one year of study closure. If the funds are not used, the funds are transferred out of the PI’s name and into the Foundation. In the event that the funds are placed into the general Foundation account, the PI can make a formal request to use the funds and any such request will be reviewed by VA leadership to determine if this request will be allowed/approved.