General Information and Questions on Salisbury VAMC Research
- Are there human resource considerations if I am a Wake Forest employee and I want to do research at the VA?
Human resource considerations vary by individual situation. Please discuss human resource considerations with Dr. Robin Hurley or Amy Morris before initiating the research process at the VA. A principal investigator (PI) must be a US citizen to conduct research at the VA.
- What are the types of grants offered by VHA?
VHA has Merit Review awards (similar to R01); Career Development Awards (similar to K awards); special calls for special interest subjects that appear intermittently throughout a year; and center grants.
- What does the term "5/8ths" mean?
"5/8ths" refers to the VA requirement that to be awarded a VA Merit Award, the PI must become a 5/8ths paid VA employee. The required commitment is to work 25 hours a week for VA or 50 hours in an 80-hour, two-week pay period. Wake Forest is working on a plan for how a Wake Forest employee can count these hours toward their work-effort at Wake – for purposes of calculating Wake Forest benefits. It may also be possible to collaborate with a WF investigator who has an existing 5/8ths appointment at the VA. For information pertaining to WF investigators with VA appointments, please contact Dr. Robin Hurley or Amy Morris.
- What are the citizenship eligibility requirements to apply for VA grants?
All Principal Investigator (PI) applicants for VHA funding MUST be United States citizens. There are no exceptions to this rule at the current time. If the PI is a clinician, they must hold an active unrestricted license to practice medicine within a US territory or state and be at least board eligible in his/her field of specialty. Finger printing and a federal background check are also required.
- If I have a clinical trial in process at Wake Forest, can I add the Salisbury VAMC as a site?
Generally, the answer is yes. However, it depends on the study sponsor and details of the study. The VA website lists all of the pharmaceutical companies that have standard agreements (i.e., Master CRADA's) ready for use with VA hospitals and their parent universities. The Wake Forest Research office and Dr. Hurley will be delighted to assist if an investigator is interested in this partnership. For this option, a principal investigator is not required to be a paid employee of VA. The investigator can be a without-compensation VA employee. Read more about WOC Appointments.
- Can I use the Wake Forest IRB for VA studies?
No, not at this time. An investigator will need to complete a submission to the Salisbury VA IRB. VA IRB focuses on human subjects protections only. Prior to or in conjunction with VA IRB, there may need to be a safety committee or a pharmacy committee review of the protocol. VA Research staff can tell the PI if these committee approvals will be needed. Once approved at this level, the proposal will go to a second-level committee (Research and Development). This second-level review looks more globally at research design, feasibility to complete the study, budget, etc. All of the VA forms and checklists are on the VA service directory, available to all WOC employees with computer access. Salisbury Research staff will be happy to answer any questions that an investigator has regarding these forms or the VA IRB process. Please call the office for assistance. 704-638-9000 extension 14295.
- What are the IRB and R&D Committee turn-around times?
Both the VA IRB and R&D Committees meet monthly. In most cases, review is completed for all packages submitted during the prior month. All fully completed packages for review are due to the IRB coordinator two weeks before the meeting deadline. Email Nathan Bledsoe, the Salisbury VA IRB Coordinator at email@example.com when you are close to packet completion and he can tell you next deadlines.
- Can I get funding for animal studies from VHA?
Yes, the Salisbury VAMC uses the Wake Forest IACUC as its IACUC of record and can engage in animal research funded by VHA.
- What is the difference between how PhDs and MDs apply for salary as principal investigators on a VHA grant?
All MDs (and MD/PhDs) in VA are funded by monies designated for clinicians, thus, an MD-principal investigator doesn't write his/her salary into the grant. If an MD writes a grant, then, he/she first makes arrangements with the local VAMC Chief of Staff office for the protected time in the event the grant is funded. PhDs do write their salaries into a Merit Review Grant.
- What is the lead time in order to be ready to apply for Merit Review funding?
To be ready for the twice-annual submission cycle, we suggest starting the process six months before due date. Due dates for Merit Reviews are posted to the Wake Forest Research website.
- What if I am a resident, fellow or student interested in research?
Residents, fellows, and students are welcome and encouraged to participate in VA research. However, they cannot be the Principal Investigator (PI) on a study. VA regulations necessitate that a VA staff member (either a WOC or paid-staff member) be the PI. Additionally, the resident/fellow/student must complete all required research training (including research ethics, CITI, etc.) before participating in the project. If you are a resident/student/fellow and would like to participate in research at the VA, please contact Dr. Frank Labagnara, Director of Medical Education at Frank.Labagnara@VA.gov or by telephone at 704-638-9000 ext. 4156 for more information and guidance.
- What else do I need to consider?
Due to the VA's requirements pertaining to PHI security, there will likely be increased data encryption requirements that need to be considered prior to beginning research at the VA. Please discuss these topics with Dr. Robin Hurley or Amy Morris.
For the most helpful advice, please read the wealth of information for investigators at the VA's Office of Research and Development website.
For any questions, please email Dr. Hurley at firstname.lastname@example.org for assistance.