Emergency Preparedness /Continuity of Operations Plan (EP/COOP)

1.0 Emergency Preparedness /Continuity of Operations Plan (EP/COOP)

The UNMC Office of Regulatory Affairs (ORA) and the Human Research Protection Program (HRPP) is committed to the safety and protection of research participants, as well as ORA and HRPP staff, and investigators and research staff, and the operations and facilities of the research enterprise.

The purpose of this Emergency Preparedness /Continuity of Operations Plan (EP/COOP) is to provide the framework for restoring essential functions to the HRPP, ORA and the UNMC IRB in the event of an emergency that affects its operations. It is a supporting document to the UNMC/Nebraska Medicine (NM) enterprise COOP Plan. This document establishes the EP/COOP procedures for any operational disruption, including but not limited to:

The intent of this HRPP EP/COOP is to lay out procedures to allow the HRPP, in the event of an emergency, to implement actions to promptly begin continuity operations and to maintain essential functions until full operative capacity can be resumed.

This document applies to all personnel in the UNMC HRPP office and all locations where essential functions of the UNMC HRPP are conducted. It also applies to the array of emergencies and hazards that could threaten the performance of essential HRPP functions. The plan covers the Human Research Protection Program and the UNMC Institutional Review Board.

This plan does not apply to temporary disruptions of service including temporary disruptions in IT systems or power outages and any other scenarios where essential functions can be readily restored in the primary facility within 3 business days.

It is the responsibility of the entire team to ensure the success of the UNMC HRPP EP/COOP implementation during and after an emergency; however, there are specific roles that hold explicit responsibility and decision-making authority during implementation.

Implementation and operationalizing of the UNMC HRPP EP/COOP: The COOP Coordinator will act as the primary point of contact (POC) for all members of the HRPP team regarding day-to-day operations of the HRPP EP/COOP. The COOP Coordinator will initiate appropriate internal and external notifications, support the decision-making procedures of the Director of the ORA (Assistant Vice-Chancellor for Regulatory Affairs; AVCRA) and Institutional Official (IO), and maintain the UNMC HRPP EP/COOP for the duration of the emergency to ensure the essential functions of the HRPP.

In addition, the IO and designee, the Institutional Review Board (IRB) Executive Chair, Chairs, and Vice-Chairs; UNMC and NM leadership; and the Safety/Compliance team will all play critical roles in the EP/COOPs implementation.

Strategic Coordination and Communication: The AVCRA is responsible for providing strategic decision-making for all elements of UNMC HRPP EP/COOP operations. They will communicate with UNMC/NM incident command; coordinate communications with ORA and representatives of components of the HRPP, and principal investigators (PIs); and coordinate the release of information with UNMC Strategic Communications.

Research Stoppage: The IO, in consultation with the VCR and the AVCRA, is responsible for the final decision-making regarding the stoppage of any and all research activities, including new IRB reviews.

Periodic Evaluation of the Emergency Plan: The AVCRA is responsible for evaluating the UNMC HRPP EP/COOP and making changes, when appropriate. This evaluation shall occur at least annually.

Periodic Review of the UNMC HRPP EP/COOP Training and Education Plan: The AVCRA is responsible for ensuring the educational materials are reviewed and updated as necessary, based on the outcome of the periodic evaluation of the emergency preparedness plan.

The following assumptions have guided the development of this plan:

The institutions are vulnerable to a full range of hazards (man-made, natural, technological disasters and potentially hazardous materials (area/department dependent) that may constitute an emergency.

An emergency and any resulting impacts may occur during normal business hours and during off hours and may adversely affect the ability of the UNMC HRPP to initiate or sustain its essential functions.

The UNMC AVCRA has authority to implement the UNMC HRPP EP/COOP under emergency conditions affecting UNMC HRPP, even if the institution has not activated incident command or declared an emergency.

Critical personnel and other resources may be requested of the institution by the UNMC AVCRA and will be made available to the extent possible if required to sustain or recover essential functions.

Leadership and all personnel will continue to recognize their responsibilities to public safety and human subjects research protection and will exercise their authority to implement the UNMC HRPP EP/COOP in a timely manner when confronted with emergencies as described above.

All personnel have been trained in the UNMC HRPP EP/COOP and know and understand their role.


2. Implementation Procedures

Depending on the nature of the risk and the potential impact to the HRPP and the institution, the AVCRA, in consultation with the IO, the Executive Chair and IRB Chairs, and representatives from components of the HRPP as appropriate, will determine which actions need to be undertaken to minimize the impact on research activities and mitigate risk to research participants, study team members, and the institution.

Specific strategies:

Deviations and Modifications to Existing Research:

The AVCRA, in consultation with the IO as appropriate, may allow investigators to implement procedures to minimize burden on subjects and/or maintain research integrity without modification to the IRB application or formal IRB approval.

In-person interactions with research subjects: If studies involve in-person interactions with research subjects, investigators (in consultation with the ORA) will determine whether the studies may be conducted as written, or whether interactions need to be altered to adhere with emergency mitigation strategies.

In a manner similar to the way they perform scientific review of clinical research, Departments and/or Colleges should consider conducting a risk-analysis regarding the impact of emergencies on their planned research, and an emergency mitigation strategy for ensuring the safety of research participants.

Safety monitoring: If trial participants are unable to come to the investigational site for protocol specified visits, alternative methods for safety assessments must be considered. This may include utilizing phone contact, virtual/telehealth visits , alternative locations for assessment (including alternate laboratory sites, study visit sites, or imaging centers) to assure the safety of research study participants.

Sponsored research: When studies have an external sponsor, each PI must coordinate with the sponsor to confirm mitigation plans. The PI and study team must document any mitigation strategies that are implemented.

Clinical care and/or research facility considerations: If the emergency impacts clinical care standards which may in turn impact research, the PI must consult with the ORA regarding any changes to protocol activities, and document which do and do not require IRB review. Emergency response plans must be considered for each existing research location and any changes to research locations.

Regulatory Flexibility: When studies are not subject to the Common Rule or to FDA regulations, the ORA may employ “equivalent protections” in protecting the rights and welfare of research participants. For example, the IRB may consider extending continuing review dates during the emergency and allowing more widespread use of waivers of documentation of consent.

Halting existing research: The AVCRA and IO, in consultation with the VCR may consider halting enrollment of new subjects into active research, and/or stopping some or all study activities, for some or all active protocols. As noted above, specific criteria for halting research will be determined based on the nature of the emergency and its expected effect on IRB, ORA and clinical research infrastructure.

During the emergency, the IO, in consultation the AVCRA and the VCR, institutional stakeholders, may consider limiting acceptance for review of new protocols submitted to the IRB, based on the nature of the emergency and its expected effect on IRB, ORA and clinical research infrastructure.

If limiting acceptance is deemed necessary, priority for review will be based (in order of importance) on:

(1) potential for direct benefit to subjects of the research

(2) impact of protocol on research and clinical infrastructure

(3) number of potential subjects impacted

(4) importance of trial to the organization as determined by the IO; and

(5) contractual and/or funding requirements.

Research which is directly related to the operations or understanding of the emergency will also have priority.

As noted above, the AVCRA will have the authority to utilize the Rapid Response IRB, or any other institutional IRB, to conduct reviews of high priority studies. The IO shall have the authority to allow the use of external IRBs as needed to conduct reviews of high priority studies.

Following any emergency, the AVCRA will convene a team to collect information on critical issues requiring leadership attention, lessons learned, and best practices associated with the response. The review will focus on what did and did not facilitate response efforts and the findings will be used to develop recommendations to improve procedures for future event response operations.

The After-Action Review will be shared with the IO, appropriate stakeholders, and the UNMC Office of Emergency Management for inclusion in the overall incident file. Once developed, new or updated procedures should be evaluated for effectiveness in an exercise and any formal updates should be included in the amended UNMC HRPP EP/COOP document.


3. Plan maintenance

The AVCRA will periodically review and update the UNMC HRPP EP/COOP based on legislative changes, UNMC/NM guidance, departmental or personnel changes, and procedural changes based on lessons learned from exercises and actual events.


4. Training and Education

The ORA will provide targeted communications and education/training regarding the UNMC HRPP EP/COOP to researchers and research staff, IRB Chairs and IRB members, study team members and PIs. As appropriate, the ORA, in collaboration with the UNMC and NM Office of Emergency Management will conduct periodic exercises to assure validity and operability of the plan.


DOCUMENT HISTORY:

 Written: 8/14/2023 (Approved: 9/1/2023) - {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}


Revision #2
Created 5 September 2023 17:14:32 by Robert A Lewis
Updated 10 July 2024 15:50:47 by Robert A Lewis