40. Emergency Preparedness and Response Plan

Updated February 23, 2026

This policy establishes written procedures for initiating a response to an emergency impacting the University of Nevada, Reno Institutional Review Board (IRB) and/or the University’s Human Research Protection Program (HRPP) operations. An emergency may include but is not limited to natural disasters, extreme weather events, man-made disasters, and public health crises. Both the scope and nature of the emergency will be considered when initiating a response. This policy is limited in scope due to the predominantly minimal risk nature of the research conducted at the University.

The below procedures establish HRPP-specific emergency planning and are intended to supplement, not replace, emergency response planning by the University’s leadership and/or institution-wide response measures. HRPP-specific emergency response planning and measures are limited only to those functions of the HRPP not otherwise covered by institution-level plans.

This policy is invoked once the Institutional Official (IO) has indicated an emergency has occurred or preparations are needed for an imminent emergency, and human research overseen by the University’s IRB has been or is likely to be adversely impacted.

Responsibilities: Execution of the procedures outlined in this policy involves the Research Integrity & Security Director, IRB staff, IRB members, and the IO.

Procedures

  1. Assess the nature of the risk and the potential impact to the HRPP.
    • Once an emergency or imminent emergency is identified, determine the response based on the nature of the event.
    • The Research Integrity & Security Director (or designee) shall contact the IO to determine whether there are University Emergency Disaster/Recovery Plans and/or Business Resumptions Plans already in place to address the event. If the IO is unavailable, the Associate Vice President for Compliance and Research Administration (AVPCRA) will be contacted. If University-wide plans are activated, proceed in accordance with those plans and determine whether and how communication with the human research community should commence.
    • If appropriate, communication will be initiated and directed by the Research Integrity & Security Director (or designee) using the following methods: email communications to researchers and research staff (employing the “ResearchNotes” Listserv maintained by the Vice President for Research and Innovation), email communications to other stakeholders (such as administrators in the research offices of the University of Nevada, Reno School of Medicine or affiliate hospitals), and website updates for broader communication (via the “Human Research” webpage of the Research Integrity & Security website). If these systems are unavailable, alternative modes of communication (such as mass text messaging, mailings, etc.) may be used.
  2. Assess whether the emergency may impact/has impacted IRB operations.
    • IRB meetings: If the emergency may prevent one or more IRB meetings from occurring, determine whether to cancel or reschedule the meetings to the earliest possible next date, being certain to identify currently approved human research that may expire prior to IRB review. If research will expire, follow the applicable provisions outlined in policies 562 (Continuing Reviews, Full Committee) and 563 (Continuing Reviews, Expedited) regarding lapses in continuing review. The University’s IRB will implement alternative review procedures, including leveraging if possible alternative virtual platforms or reverting to in-person meetings, to ensure that IRB meetings can continue.
    • Staff processing and review: If staff will be unable to complete submission processing and review responsibilities, or if capacity will be limited, the Research Integrity & Security Director (or designee) shall work with the staff to prioritize reviews. If research will expire, follow the applicable provisions outlined in policies 562 (Continuing Reviews, Full Committee) and 563 (Continuing Reviews, Expedited) regarding lapses in continuing review.
    • Data and records: If data/electronic records are unavailable during the current or anticipated emergency/disaster, consult with local information technology support and/or the vendor of the IRB’s electronic system to implement alternative procedures to access data/backup data. The University’s IRBNet vendor has affirmed that their cloud-based IRB management platform enforces strict standards and industry best practices in data backup policies and procedures, including:
      • The use of enterprise-grade database replication utilities to ensure the integrity of replicated data and backups performed across multiple servers and databases
      • The use of real-time database replication to “hot mirror” IRBNet data across multiple servers and databases that are geographically dispersed among multiple data centers
      • The creation and maintenance of daily database backups to enable multiple restore points for disaster recovery, and the periodic testing and validation of recovery processes
      • Active procedural monitoring to assure that data backup policies and procedures are properly followed and enforced, and to facilitate the timely update of backup technologies, policies and procedures in accordance with evolving industry best practices
    • Manual processing: If the electronic records administration system is unavailable, IRB staff will accept and review urgent submissions via alternative methods, such as University-owned cloud storage, email or hard copy.
  3. Assess whether the emergency could impact researchers’ ability to conduct research.
    • Notify the research community (via the communication procedures outlined above) of the potential need for modifications to their current IRB approved research, if appropriate. Some of these changes may include:
      • Alternative methods for in-person study visits/safety monitoring (virtual experimental sessions and data collection modalities, telemedicine, home visit, alternative location for specific assessments or labs);
      • Shipping investigational products directly to research participants (requires consult with Sponsor and FDA);
      • Implementing remote monitoring processes/programs in lieu of on-site monitoring.
    • Develop additional guidance, as necessary: for example, if the emergency impacts educational practices or clinical care standards which may in turn impact research, clarify what does and does not require IRB review.
    • Consider the types of research that may continue and the types of research that may need to be temporarily suspended or postponed; this consideration may include studies that present a likelihood of direct benefit to participants (or conversely, studies that include study interventions that may be harmful to participants if discontinued); and research involving direct interactions or interventions but can continue those interventions via alternate mechanisms (such as remote visits).
  4. Provide education and communication on expectations during an emergency.
    • Communications and education shall be developed and distributed based on roles/responsibilities within the HRPP. Specifically, researchers and research staff, IRB Chair/IRB members and IRB staff may each have differing needs with respect to effectively responding to emergency mitigation strategies.
    • IRB members and staff will receive education via new member/staff orientation and IRB or staff meetings.
    • Communications to researchers and research staff shall occur via standard communication routes, such as email, the Research Integrity & Security website and web-based platforms, if available. If the standard routes are not available, the Research Integrity & Security Director (or designee) and IO will determine alternate route(s).
    • Any necessary communications to the study sponsor will be initiated by the office of Sponsored Projects, as appropriate.
  5. The emergency response plan will be evaluated on an annual basis, during the process of assessing the adequacy of the University’s resources to protect the rights and welfare of human research participants. If necessary, additional improvements shall be implemented.

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