3. Designation of IRBs for Non-Exempt Human Subject Research
The terms of an FWA for the protection of human subjects require assured institutions to designate at least one committee (or board) to review and oversee non-exempt research involving human participants and to register the committee/board with OHRP.
The University of Nevada, Reno maintains registration of two internal Institutional Review Boards (IRBs) for this purpose:
- Biomedical IRB for biomedical research and clinical trials: IRB00000215
- Social Behavioral IRB for social, behavioral, and educational research: IRB00000216
Federal regulations allow institutions to designate an IRB from another FWA-holding institution as the IRB of Record (or reviewing IRB) for non-exempt research through a written IRB Authorization Agreement (IAA).
Designation of a University IRB as the IRB of Record for Non-exempt Research
University IRB as the IRB of Record: Existing IAAs
A few local institutions that do not have IRBs designated at least one University IRB as the IRB of Record for review and oversight of non-exempt human subjects research in which the institution or their employees or representatives is engaged (see Policy Manual Definitions). Termed "Affiliates," institutions with an established agreement with a University IRB as the IRB of Record include:
- Desert Research Institute (a component of NSHE)
- Truckee Meadows Community College (a component of NSHE)
- VA Sierra Nevada Health Care System
- Saint Mary's Regional Medical Center
- Nevada Department of Health and Human Services
- Renown® Health
Under these existing agreements, the Research Integrity Office (RIO) or the IRB also reviews exempt research conducted by Affiliate investigators.
Affiliate investigators are subject to the same submission requirements as University investigators.
University IRB as the IRB of Record: No Existing Agreement
The University may agree to be the IRB of Record under the following conditions:
- An external researcher is collaborating with a University or Affiliate PI on non-exempt human subject research. The researcher's institution has an IRB that agrees to rely on the University IRB. Requires an IAA.
- A local institution has an FWA but does not have an IRB and wishes to engage the services of a University IRB for review and oversight of one or more research projects involving human subjects. Requires an IAA.
- An external investigator is planning to conduct non-exempt human subject research and her/his institution does not have an FWA. Requires an Independent Investigator Agreement.
Designation of an External IRB as the IRB of Record
By the authority of the Vice President for Research and Innovation and in compliance with accreditation standards, University and Affiliate investigators must use a University IRB unless the sponsor requires review by a central or commercial IRB, or the external site will not cede review to a University IRB. When the sponsor requires use of a central or commercial IRB, the IRB must be AAHRPP-accredited.
In either case, the research cannot commence until
- the RIO or the IRB confirms or establishes an IAA between the two institutions and acknowledges review by the external IRB, and
- the external IRB approves the research.
At its discretion, the University may require a dual review, in which case the research may not commence until both IRBs approve the research.
External IRB of Record: Existing IAAs
The University established IAAs with a few institutions with whom University/Affiliate investigators have formal agreements and where they commonly conduct research:
- Mountain View Hospital (under the Sunrise Health IRB) (biomedical research only)
- Sunrise Health (biomedical research only)
- University Medical Center (UMC) (biomedical research only)
- University of Nevada, Las Vegas (UNLV) (social behavioral and biomedical research; agreement is reciprocal)
The University has existing agreements with two other external IRBs:
- Western IRB for review of sponsored, clinical investigations conducted by UNSOM faculty only, and
- NCI Central IRB (CIRB) for Affiliate investigators wishing to enroll patients into NCI-sponsored clinical trials.
External IRB of Record: No Existing IAA
When an IAA does not exist, on a case-by-case basis the RIO will assist University/Affiliate investigators or student researchers in establishing an agreement between the IRBs (see IRB policies for external IRB agreements and using an external IRB