推荐杏吧原创

3. Designation of IRB for Non-Exempt Human Research

Updated May 31, 2024

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 推荐杏吧原创 maintains registration of the 推荐杏吧原创 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 the IRB of Record (or reviewing IRB) for non-exempt research through a written IRB Authorization Agreement (IAA).

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

University IRB as the 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)
  • 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, the University IRB is the IRB of Record.

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 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 the University IRB for review and oversight of one or more research projects involving human participants. Requires an IAA.
  • An external investigator is planning to conduct non-exempt human research and her/his institution does not have an FWA. Requires an Independent Investigator Agreement.
  • 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 and Affiliate 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 must be AAHRPP-accredited.

In either case, the research cannot commence until:

  1. Research Integrity & Security or the IRB 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 established IAAs or Memoranda of Understanding (MOU) with institutions with whom University/Affiliate investigators have formal agreements and where they commonly conduct research:

  • Mountain View Hospital (under the Sunrise Health IRB) IAA
  • Sunrise Health IAA
  • University Medical Center Southern Nevada (UMCSN) IAA
  • University of Nevada, Las Vegas (UNLV) (MOU; reciprocal agreement)

The University also has an existing agreement with WCG IRB for review of sponsored, clinical investigations.

University/Affiliate investigators planning to use an external IRB of Record are advised to review IRB policy to use an external IRB.

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:

  • WCG IRB for review of sponsored, clinical investigations conducted by 推荐杏吧原创 School of Medicine faculty only, and
  • NCI Central IRB (CIRB) for Affiliate investigators wishing to enroll patients into NCI-sponsored clinical trials.

University/Affiliate investigators planning to use an external IRB of Record are advised to review IRB policy to use an external IRB.

External IRB of Record: No Existing IAA

When an IAA does not exist, on a case-by-case basis Research Integrity & Security 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).