[D161.0000] Emergency Preparedness

The UK HRPP will defer to the VPR, institutional leadership, and emergency response authorities and limit areas of human research studies that may interfere with or negatively impact the participants, research enterprise, or the emergency response.

The VPR (Institutional Official), Office of Research Integrity (ORI) leadership (Director and Associate Director), and Institutional Review Board (IRB) leadership (IRB Chairs) jointly respond to emergency/disaster situations according to this policy.

The ORI leadership is responsible for periodically evaluating and updating this plan as needed.

The ORI leadership and Education Team is responsible for creating, disseminating, and maintaining emergency response correspondence in coordination with Research Communications.

The ORI Education Team maintains email contact listservs for staff, IRB members, and researchers. The team disseminates announcements via Constant Contact and posts announcements and Frequently Asked Questions regarding emergency response on the ORI homepage. ORI maintains an alternate phone list for inter-office communication during emergencies.

The ORI will ensure research teams are notified that a response plan has been activated and what guidance to follow throughout the emergency/disaster.

Assess the nature of the event and the appropriate response.

Once the Vice President for Research (VPR), the President of the University, and/or Crisis Management and Preparedness (CMP) have determined the nature and level of the emergency, ORI will consult with the VPR regarding the potential impact on Human Subjects Research. Then, ORI will assist as needed in executing a specific plan to mitigate the effects on current and proposed human research protocols.

If applicable, ORI leadership will contact local authorities, oversight agencies, and/or accreditation organizations to solicit assistance and guidance regarding regulatory flexibility during emergency response.

The ORI may take some or all of the following steps in consultation with VPR and IRB:

• The ORI, IRB, and PIs will utilize remote systems to ensure all appropriate regulations and policies are followed for the protection of human subjects.
• In the event that in-person meetings become impossible due to an emergency and electronic systems have not been compromised, E-IRB and remote electronic meetings conducted by video conference will be utilized to ensure continuity of operations and accommodate time-sensitive reviews.
• Should an event result in temporary inability to access E-IRB, ORI, IRB, and researchers will resort to available systems (e.g., voice over internet protocol (VoIP), email, phone, hard-copy documents) to correspond and document status and determinations to permit tier I research to continue to serve and safeguard participants.
• Storage, handling, and control of investigational drugs will be maintained through UK’s Investigational Drug Service’s Emergency Preparedness Plan (PH08.05.230). Principal Investigators will work with the Investigational Drug Service (IDS) to coordinate alternate means of distribution of investigational products to research participants.  If necessary, for treatment purposes, IDS will assist with unblinding investigational products in coordination with the PI and study sponsor.
• Principal Investigators are responsible for maintaining medical device storage, handling, and control with guidance from commercial sponsors. A sample Device Accountability Standard Operating Procedure is available on the ORI website. The FDA provides guidance on Hurricane Emergency Preparedness and Medical Devices, which is applicable to natural disasters and other situations.
• UK security and police will maintain security of on-site research facilities as well as through normal distribution and surveillance of employee and/or student identification badges.
• The ORI will coordinate with the Center for Clinical and Translational Science (CCTS) to provide accurate outreach information for clinical research participants.
• The ORI will seek agreements with external IRBs if the emergency is local in nature so that new protocols can be approved in the event UK IRBs are unable to remain fully operational.
• The Vice President for Research, in conjunction with the ORI and IRBs, will advise using the criteria in each tier to determine which protocols may continue unimpeded, and those that need to be temporarily paused/postponed, or proceed following alternate mechanisms:
  • Tier I: Continue Unimpeded
  • Tier II: Modified to continue following alternate mechanisms

Research that presents a likelihood of direct benefit to participants, including:

• Clinical trials with treatment arms (e.g., oncology clinical trials, interventional studies for devices or therapies with significant benefit to subjects). Investigators should weigh the benefits of the treatment arm against the risks of added harm for study staff or research subjects when deciding about continuing these projects.
• Non-treatment intervention where stopping the intervention would cause harm. For example, studies that include supportive or palliative care, prevention, diagnostic, behavioral, or other non-treatment interventions.
• Research that does not involve interaction or intervention that creates increased risks.
• Research integral to the effects of or response to the disaster(s) if warranted and appropriate.

Note: Medical protocols may suspend recruitment/enrollment for individuals in the affected area, but may continue conducting research activities if the required facilities remain unaffected.

• Research that involves direct interaction or intervention but can manage risks by conducting study procedures via alternate mechanisms. For example, the use of remote study visits, conference calls, or video conferencing. Or canceling in-person gatherings of people involving research activities and holding meetings such as focus groups and research-related activities, such as community advisory boards and participant and support groups for study participants.
• Activities involving data collection that can be conducted remotely (e.g., EMR, previously collected) and studies that do not involve any direct subject contact (e.g., UK Healthcare Zoom, UK Telehealth, REDCap).
• Changes to protect the life and well-being of research subjects may be made without IRB approval. Federal regulatory agencies may also authorize global IRB approval of protocol changes without an individual modification request. This may include changes such as transitioning to remote contact to permit research to continue safely.
• For FDA-Regulated Research, changes to the protocol or investigational plan to eliminate apparent immediate hazards or to protect the life and well-being of research participants in an emergency may be implemented without IRB approval or before filing an amendment to the investigational new drug application (IND) or investigational device exemption (IDE), but are required to be reported afterwards.
  • Investigators for FDA-regulated research are advised to collect a list of contingency measures taken, list subjects affected by the study number, and indicate the impact on safety or efficacy results, if applicable.
  • For detailed guidance, see "FDA Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies: Guidance for Industry, Investigators, and Institutional Review Boards."
• Check with the study sponsor on reporting requirements. Investigators may submit an aggregate account of changes implemented without prior IRB approval on one protocol violation report.
• Include how participants will be informed of changes that may affect their willingness to continue, if applicable.
• Submit a Modification Request (MR) for changes to be permanent for any study that continues via alternate mechanisms after the emergency situation has resolved.
• Clinical trials that have paused recruitment due to a disaster should update their study status on ClinicalTrials.gov record accordingly (e.g., active, not recruiting).
  • For questions regarding ClinicalTrials.gov, see the Clinical Research Support Office (CRSO) ClinicalTrials.gov webpage.  

Studies that involve subject contact in-person or at affected facilities, which have no direct benefit to the subject, should be paused until further notice.

Examples of paused studies may include:

• Studies collecting human samples or imaging that require study subject contact (e.g., phlebotomy, surveillance biopsy, radiographic imaging, physical examination) without direct diagnostic or therapeutic benefit;
• Community-based studies involving group gatherings, which increase exposure risk;
• Studies that are not studying the effects of the disaster(s), if the IRB cannot determine that the research is integral/warranted/appropriate at that time;
• Any protocol that does not present the likelihood of direct benefit through clinical/therapeutic means to the participant;
• Protocols that require in-person interaction or intervention, especially those that create increased risk and/or where appropriate alternative facilities cannot be found;
• Protocols that require specific facilities affected by the disaster, where no other appropriate alternative facilities can be found;
• Protocols that will have an adverse impact on resources required to address and respond to the disaster/emergency;
• Protocols that require a convened IRB meeting/quorum when one cannot be held remotely.

The ORI will await a determination from the VPR and CMP regarding when and how research operations can return to normal and notify research teams accordingly.

Plans for resuming human research activities are based on CMP criteria for reopening public activities, available public health guidance, and federal or state government mandates.

Resumption may occur in a phased process.

• The phased approach provides a baseline framework from which additional variables may be considered.
• Policies and guidance will be dynamic and may accelerate or decelerate based on shifting recovery status and incidence data.
• Resuming human research operations must be parallel to and consistent with the institutional and VPR’s plan as well as specific facility, college, or unit mandates.
• The VPR may require principal investigator/researcher training and submission and review of a formal resumption plan to incorporate safeguards for participants and research staff. In addition, the implementation of precautions, controlled conditions, and safety principles is considered a prerequisite to resuming activities at all phases.
• Investigators may use judgment to continue pauses, modifications, and practices more stringent than allowed, to protect human subjects or research staff.

In order to prevent or minimize the suspension level of Human Subject Research, the following has been/will be implemented as needed:

Education & Training

The ORI will develop and distribute emergency preparedness information and education.

• Training Opportunities
• UK Division of Crisis Management and Preparedness

Departmental Network Drive

Departmental data is secured by allowing only certain groups access within the Active Directory. Departmental data is backed up nightly using the SpectrumProtect client.

E-IRB

IT support (Research Information Services (RIS)) holds shared responsibility with UK campus IT for the disaster recovery plan for data maintained on E-IRB’s UK server:

• Backup media is stored in a secure, geographically separate location from the original and isolated from environmental hazards.
• UK uses Spectrum Protect Storage Manager for its restore and backup needs.

Backup/Restores

• Servers (including shared network drives):
  • Backups will be performed daily via campus.
  • Restores will be performed within four (4) business hours.
• Databases:
  • Backups of production databases will be made both locally and via campus for 30 days according to the following schedule:
    • Locally:
      4 weeks of daily backups;
      4 weekly backups;
      1 monthly backup;
      2 weeks of transaction logs
    • Campus:
      30 days of daily full SQL backups
       

Restores of a complete database will be performed within four (4) business hours. Partial database restorations are dependent on data consistency issues and may take significantly longer.

Addressing missing functionality (e.g., bugs) and development of new features in E-IRB is ongoing and prioritized by user feedback received either through the E-IRB Support mailbox or by the E-IRB System Administrator. In coordination with the E-IRB Administrator, RIS implements an average of 10 system updates a year. 

Source: ORI D155 E-IRB Operations

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C-CERT Training

UK Police Department’s Division of Crisis Management & Preparedness now offers Campus Community Emergency Response Team (C-CERT) training for faculty and staff. UK C-CERT members will receive hands-on training in basic disaster response skills, such as fire safety and suppression, light search and rescue, disaster medical operations, team organization, disaster psychology, and terrorism.

Emergency Preparedness and Response Information

In any emergency, you are responsible for your safety. Think now about what you will do so you can take swift, decisive action when the time comes. The following information is intended to guide you in likely emergencies, but it cannot take all possibilities into account. If an emergency occurs during class, your instructor will provide further direction based on the university and department emergency plans.

Storm Sheltering/Sheltering in Place

During a severe storm, protect yourself from lightning and flying debris. Move to an interior room or hallway on the building's lowest level. Avoid outside doors and windows. Recommended shelter locations are marked on the emergency floor plans posted throughout the building. If a hazardous chemical release occurs outside the building, follow these same procedures. Shut all exterior doors and windows. Isolate yourself from outside air. View UK's Severe Weather Procedures.

Building Emergency Action Plan (BEAP) information is housed on the UK Crisis Management and Preparedness site. To access building-specific BEAPs, log in to the BEAP portal with your Link Blue credentials.

To Report an Emergency or Suspicious Activity

Call the University of Kentucky Police Department at 859-257-8573 (UKPD) from any mobile phone. If the line is unavailable or you are calling from another university location, dial 911.

Evacuation/Fire

We will always evacuate for a fire alarm or when university officials order us to do so. Gather your personal belongings quickly and move to the nearest exit. Evacuation routes are marked on the emergency floor plans posted throughout the building. If a hazardous chemical release occurs inside the building, follow these same procedures.

Active Shooter/Violence

In an active shooter situation or other attack, run – get away from the attacker. If you can't run, hide – barricade yourself in a safe place. If neither of these is possible, fight – do whatever you need to do to stop the attacker.

UK Alert

The university provides emergency notifications through UK Alert, which broadcasts to email, text message, building alarm systems, and outdoor sirens. If you receive a UK Alert message during class, notify your instructor and classmates immediately. Visit UK Alert for more information. 

The Division of Crisis Management and Preparedness is open every weekday. 

Staff members are also on-call after hours, weekends, and holidays. 

• E-mail CMP
• General Phone: 859-257-9665
• Fax: 859-257-4143

• UK Crisis Management and Preparedness
• UK Cooperative Extension Disaster Preparedness Resources
• UK Severe Weather Procedures
• U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR)
• Kentucky Emergency Management
• KY Weather Alerts
• KY Health Alerts
• Centers for Disease Control and Prevention (CDC)
• Ready.gov
  • National Preparedness Month