IRB-01 is the the Institutional Review Board (IRB) of record for the North Florida/South Georgia Veteran’s Health System (NF/SG VHS or VAMC). Although the NF/SG VHS is considered an affiliated campus of the University of Florida, it is a separate federal institution that has its own additional requirements for conducting research. In order to conduct research at the NF/SG VHS researchers must obtain prior approval from both IRB-01 and the appropriate offices in the NF/SG VHS.

In particular, researchers are required to obtain approval from the VA Research & Development (R&D) Committee and its appropriate subcommittees reviews for all research studies that (1) utilize VA resources or facilities, (2) involve VA patients (including their medical information or PHI), (3) involve VA staff, including part-time staff, without compensation employees (WOC), and/or fee-basis, contract and consultants.  No research project may commence at the NF/SG VHS prior to final approval by the R&D Committee.  These procedures apply to all research projects regardless of funding source.

Contact the Research Service Office if you are considering conducting research at the VAMC. The telephone number is (352) 376-1611, extension 5955.

Conducting clinical research at the NF/SG VHS has additional considerations separate from UF:

• The VAMC grants PI status independently from UF - Permission to conduct research at UF does not automatically grant permission to perform research at the VAMC.  In order to conduct any research at the VA, you must: (1) at least one full- or part-time VA compensated staff member serving as an investigator on each protocol, or (2) receive separate express written permission from the VA R&D to conduct your project at the VA (for more detailed information read "Who May Conduct Research at the VA”). (3) The VA also requires researchers to complete additional, annual training on human subjects protections (see below).
• There is a separate approval process at the VAMC; If the study will be conducted all or in part at the VA, even if you have IRB approval, the study must also be reviewed and approved by the VA’s Subcommittee for Clinical Investigation (SCI) and the R&D Committee. These committees oversee all human subjects research activity under the auspices of the NF/SG VHS, including adverse events, revisions and continuing review.  The R&D Committee may disapprove an IRB approved research activity or may have additional requirements, conditions, or modifications. (NOTE: if the VA committees require any changes you may not implement any changes until you also obtain IRB approval for them).
• There are training, credentialing and documentation requirements for all persons working with human subjects, human tissue or human subject data at the VAMC.
• Some research appropriate at UF is not appropriate for the VAMC, or may need significant additional approvals (e.g., research involving minors and prisoners) or documentation (incompetent persons) prior to VA approval.
• The consent document for use at the VAMC requires a specific form (VA Form 10-1086) and additional language that is required by VHA. If both affiliate and VA subjects are going to be enrolled, you will need to submit two versions, UF and VA, for type of consent you intend to use..
• The VAMC may have additional charges depending on the services and facilty support needed to conduct the research.

If you are affiliated with the VAMC: You must submit your materials to both the VA Research Service Office and IRB-01.  You may submit to the VA & IRB at any time (simultaneously, to the IRB first, or to the VA first). You must obtain approval from both the IRB and VA R&D before you may initiate your research.

If you are not affiliated with the VAMC: You will need to identify a full or part-time VA compensated Investigator who will accept responsibility for the conduct of the work at the VA. Please submit all materials to the VA Office of Research and Development at the same time you submit to IRB to avoid unnecessary delays. Both offices work closely together, but it It is the PI’s responsibility to ensure the VA  receives all materials in a timely manner.
For more information, please refer to the Subcommittee for Clinical Investigation (SCI) website.

Links:

VA Researcher Web Page

SCI Meeting and Deadline Dates (2008)

R&D Meeting and Deadline Dates (2008)