3. Designation of IRB for Non-Exempt Human Research

Updated June 4, 2026

The terms of a Federalwide Assurance (FWA) for the protection of human research participants 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 the Office for Human Research Protections (OHRP).

The University of Nevada, Reno maintains registration of the University of Nevada, Reno Institutional Review Board (listed as the U of Nevada - Reno IRB #1 Biomed in the DHHS OHRP online FWA/IRB database): IRB00000215.

Federal regulations allow institutions to designate an IRB from another FWA-holding institution as an IRB of Record (or reviewing IRB) for non-exempt research through a written IRB Authorization Agreement (IAA).

Designation of the University IRB as an IRB of Record for Non-exempt Research

University IRB as an IRB of Record: Existing IAAs

Through written Memoranda of Understanding (MOU), local institutions that do not have IRBs have designated the University IRB as an IRB of Record for review and oversight of non-exempt* human research in which the institution or their employees or representatives is engaged (see Policy Manual Definitions). Termed "Affiliates," institutions with an established MOU with the University IRB as the IRB of Record include:

  • Desert Research Institute (a component of NSHE)
  • Truckee Meadows Community College (a component of NSHE)
  • Western Nevada 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
  • Barton Health

*Under these existing MOUs, Research Integrity & Security or the IRB also reviews exempt research conducted by Affiliate investigators.

NOTE: For all human research studies (including exempt research) that involve at least one UNR faculty, staff, or student as PI or a research team member (engaged in the human research study in their capacity as a UNR faculty, staff, or student), the University IRB is the IRB of Record.

Affiliate investigators are subject to the same submission requirements as University investigators.

University IRB as an 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 research. The researcher's institution has an IRB that agrees to rely on the University IRB. Requires an IAA.
  • Federal regulations, state laws, or local policies require use of a specific IRB. Requires an Independent Investigator Agreement.

See IRB policy for external IRB and independent investigator agreements.

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 investigators must use the University IRB unless the sponsor requires review by a central or independent IRB, or the external site will not cede review to the University IRB, or federal regulations, state laws, or local policies require use of a specific IRB. When the sponsor requires use of a central or independent IRB, the IRB is generally required to be AAHRPP-accredited (usually required for greater than minimal risk research and preferred for minimal risk research).

In either case, the research cannot commence until:

  1. The IRB office confirms or establishes an IAA between the two institutions and acknowledges review by the external IRB, and
  2. the external IRB approves the research.

External IRB of Record: Existing IAAs or Memoranda of Understanding

The University has a master services agreement with WCG IRB for review of sponsored, clinical investigations. This agreement permits reliance on WCG IRB without execution of a study-specific reliance agreement.

When an IAA does not exist, on a case-by-case basis IRB staff will assist University investigators in establishing an agreement between the UNR IRBs and the external IRB. University investigators planning to use an external IRB of Record are advised to review the IRB policy that addresses external IRBs and reliance agreements.