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Veterans Affairs and Human Subjects Research

Human Research Protection Requirements for VA Research

The University of Nevada, Reno (the University) Institutional Review Boards (IRB) serve as the “IRBs of Record” for the VA Sierra Nevada Healthcare System (VASNHCS). As such, the University IRBs oversee all human subjects research conducted at the VASNHCS or by researchers affiliated with VASNHCS.

Investigators planning to conduct research involving veterans are advised to consult the University IRB policies and procedures for information about the additional regulatory requirements for human research that may be subject to VHA regulations.

If you are interested in conducting VA research, contact Elizabeth Hill at elizabeth.hill@va.gov or (775) 328.1752 about research project procedures.

Getting Started with VA Research

Although the following instructions are specific to the University and VASNHCS, the approval processes apply to all VA-regulated research involving human subjects.

1. Prepare a University of Nevada, Reno application for human subjects research, for exempt, expedited and full board review, whichever is appropriate for the research.

2. Assemble all protocol-related documents for submission with the application (e.g., IND/IDE, recruitment materials, consent forms).

   Note: VA-approved templates for consent forms and HIPAA authorizations or waiver of same may be found in the VASNHCS Forms section of the Investigators Forms page of this website.

3. Submit two copies of the complete protocol to the Program Support Assistant (PSA) for Research Service (Steve Olsen).

4. The PSA will create an internal protocol file and send two copies of the complete protocol to the University IRB.

5. The PSA will forward a copy of the protocol to the VA Protocol Review Subcommittee (PRS) for review at the committee’s next meeting (on the fourth Tuesday of the current or following month).

6. Following PRS review, the PSA will provide the IRB with a copy of the scientific review report for placement in the protocol file.

7. The University IRB will review the protocol and make one of four determinations:

   1. approve as submitted,

   2. request minor directed revisions as a condition for approval,

   3. defer because substantive changes are required, or

   4. disapprove.

8. If the protocol is approved as submitted or approved following resolution of the conditions for approval, the IRB will send a certification of approval to both the investigator and the PSA.

9. Upon receipt of certification of IRB approval, the PSA will arrange for review by the VA Research and Development Committee (RDC), and the Privacy (PO) and Information Security Officers (ISO).

10. Upon completion of the PO and ISO post-IRB reviews, the PSA will send copies of these officers’ reports to the IRB for the protocol file.

Human Research Protection Training Requirements for VA Researchers

All investigators and research team members who propose to conduct research at the VASNHCS must satisfy VA training requirements. For information about VA training requirements, contact the VASNHCS Research Office at (775) 328-1486.

VA Regulations and Publications for Human Subjects Research

• 38 CFR 16 Code of Federal Regulations, Department of Veteran’s Affairs “Protection of Human Subjects”
• VHA Handbook 1058.01 Requirements for Reporting Research Events to Facility Oversight Committees and the Office of Research Oversight
• VHA Handbook 1200.05 Requirements for the Protection of Human Subjects in Research
• Guidance: “VHA Policy is more restrictive than NIH guidance regarding recruitment of study subjects under the HIPAA Privacy Rule”