POLICY
UTHealth Houston maintains a Human Research Protection Program (HRPP) emergency preparedness plan to ensure continuity of Human Research Protection and Institutional Review Board (IRB) operations during events that disrupt normal institutional or research activities. The plan applies to all research under the oversight of the UTHealth Houston IRB, including studies for which UTHealth Houston serves as the IRB of record.
The HRPP emergency preparedness plan helps ensure the protection of human research participants, continuity of ethical and regulatory oversight, and integrity of research conducted at the University during emergencies that disrupt normal clinical, academic, or research operations.
The HRPP follows the University emergency management and business continuity plan that addresses procedures to protect life, property, the environment, and the continuity of business operations at the University.
PROCEDURE
During an emergency, HRP leadership shall coordinate with the Institutional Official and other university leadership to implement procedures that support compliant and ethical conduct of human subject research and align with UTHealth Houston’s institutional emergency operations.
Training: HRP leadership shall collaborate with institutional officials to develop and implement training related to emergency preparedness and response for human research. The HRPP emergency preparedness plan shall be made available on the IRB website. The emergency preparedness plan will be shared with individuals involved in the conduct, review, or oversight of human subject research under the jurisdiction of the UTHealth Houston Institutional Review Board including research teams, IRB chairs and members, IRB staff, HRPP and research compliance staff.
UTHealth Houston shall notify research teams when the institutional emergency response plan is activated. IRB members and HRP staff shall receive periodic training to ensure alignment with institutional emergency operations and HRPP procedures. The HRPP will work with University leadership to establish mechanisms to notify investigators and research teams when emergency procedures are activated. Communications shall clarify which research activities may continue, required modifications or reporting expectations and institutional priorities related to clinical care.
When the emergency plan is activated, senior research leadership shall communicate relevant information to the UTHealth Houston research community. Updates shall also be posted on the IRB website.
IRB Operations: The IRB electronic systems is hosted in secure UTHealth Houston data centers with redundant power, uninterruptible power supplies, and backup generators. Systems are continuously monitored, and daily backups support full restoration when necessary. If system access is disrupted, the IRB office shall implement alternative procedures for receiving and processing time?sensitive IRB submissions until normal operations resume.
IRB meetings are conducted virtually and would be able to continue to be held during emergencies. If the primary virtual platform becomes unavailable, meetings may be transitioned to the secondary virtual platform or teleconference.
If quorum cannot be achieved and IRB approval for a study is at risk of lapsing, the IRB Chair may authorize continued participation of already?enrolled subjects when necessary to protect their welfare. If quorum cannot be restored for an extended period, HRP leadership shall evaluate transferring IRB oversight to an external IRB with which UTHealth Houston has an established IRB reciprocity agreement.
Research Study Triaging: The IRB will work with the Institutional Official and other University leadership to make decisions regarding continuation or postponement of research. The IRB will use a risk?based approach to determine how human subject research may proceed during an emergency. Research activities are categorized by risk level and aligned with institutional operational directives. The IRB shall consider whether the research:
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Offers a prospect of direct benefit to participants
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Minimizes in-person interactions or increased risk
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Can safely transition to remote or alternate procedures
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Competes for resources essential to emergency response
The IRB may implement graduated responses short of suspending all research, including:
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Identifying studies that may continue and those that must be paused, including studies offering potential direct benefit or where discontinuation may harm participants and studies that would divert resources needed for emergency response
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Temporarily suspending review of new protocols that are non?interventional or offer no direct benefit.
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Pausing recruitment or enrollment while allowing ongoing interventions to continue when appropriate.
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Approve using remote or online procedures for recruitment, consent, data collection, debriefing, and follow?up; modifying visit schedules when feasible.
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Implement equivalent participant?protection procedures, such as extending continuing review dates or allowing minor procedural changes without prospective IRB review.
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Use AAHRPP?accredited external IRBs, including commercial IRBs and SMART IRB partners, if UTHealth Houston IRB operations are disrupted.
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Expand use of documentation waivers for minimal?risk research involving participant interaction.
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When in-person visits are not feasible, the IRB shall evaluate alternate safety monitoring methods, including telehealth visits, phone follow-up, and assessments at alternate clinical sites. When feasible, research activities may continue using alternate mechanisms, including: Remote study visits, Telehealth platforms, Telephone or videobased assessments
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Use of local laboratories or imaging centers
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For research not subject to federal regulations, the IRB may implement flexible oversight measures during emergencies, including extensions of review periods and postimplementation reporting of minor changes.
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The IRB shall consider expanded use of waivers of documentation of consent for minimal risk research involving interaction with participants when appropriate.
Research Team Responsibilities
Research teams are responsible for determining whether an emergency response plan is required for their studies. Emergencies may affect study procedures, participant safety monitoring, communication, and access to investigational products. The scope of the plan shall reflect the nature of the emergency, the study design, and associated risks.
If a study does not involve in?person interactions or can continue as approved while complying with institutional emergency directives, a separate emergency plan may not be required. For sponsored research, investigators shall consult the sponsor regarding any sponsor?specific emergency procedures. UTHealth Houston requirements supersede sponsor procedures when more restrictive.
Emergency response plans shall address all locations where research is conducted. Any relocation of research activities in response to an emergency requires prospective IRB approval.
REFERENCES
If you find errors in this document, contact [email protected]
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Document Number: |
101-A04 |
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Document Name: |
Emergency Preparedness – Human Subjects Research |
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Reviewed by: |
Associate Vice President, Research Compliance |
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Effective: |
1 Jun 2026 |
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Revision History: |
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