Emergency and Disaster Planning for Human Research Protections
*Please note that this page is specific to researchers at HSC – researchers at other NTR IRB partnering institutions should contact the relevant officials/offices at their home institution for institution-specific emergency-preparedness planning.
However, ALL NTR IRB researchers are welcome to refer to and use the guidance documents provided below, which include the “Study-Specific Emergency-Disaster Risk Mitigation Planning” flowchart and the “Protocol-Specific Emergency-Disaster Risk Mitigation Planning” worksheet, provided below.
All NTR IRB researchers should also submit any necessary modifications to their research projects for IRB review and approval, ahead of implementation. This does not include situations in which an immediate change is needed in order to eliminate an apparent immediate risk or hazard to research participants – in those cases, please take action and notify the IRB within 5 business days of implementing the change.
The North Texas Regional IRB and the University of North Texas Health Science Center (HSC) are committed to the protection of human subjects involved in research. This commitment is especially important during emergencies and threats to the institution, such as extreme weather events, natural disasters, man-made disasters, and infectious disease outbreaks.
To prepare for these potential emergency or disaster events (as outlined above), the NTR IRB has collaborated with institutional leadership to develop, implement, and assess emergency preparedness procedures that are specific to the human research protection program (HRPP).
Depending on the nature of the event, NTR IRB leadership will collaborate with institutional leadership to determine the types of research that might continue and the types that the organization may need to temporarily postpone.
The IRB staff will work with IT resources and/or electronic system vendors (i.e., IRBNet) to ensure continuity of operations in the event that electronic systems are inaccessible or not operational for extended periods of time during an emergency/disaster. NTR IRB leadership will collaborate with the vendor of the IRB’s electronic system to ensure that records are maintained on a secure server that is accessible in the event of an emergency.
The organization will implement alternative review procedures, including leveraging online and virtual platforms, to ensure that IRB meetings can continue in scenarios where the IRB cannot meet in person. In instances where the convened IRB is unable to meet and IRB approval for a study may lapse, the IRB Chair can determine whether subjects can continue to participate in research activities if it is in the best interest of already enrolled subjects.
You can review Chapter 21 of the NTR IRB Manual which includes the following SOP, “Response Plan for Emergencies-Disasters Impacting the HSC HRPP”, for additional information.
Specific Guidance and Planning for Human Subject Researchers:
In order to assist investigators with appropriate emergency planning for your human subject research projects, the NTR IRB is also providing the following guidance and planning documents for our investigators:
- FLOWCHART – Study-Specific Emergency-Disaster Risk Mitigation Planning
- WORKSHEET– Protocol-Specific Emergency-Disaster Risk Mitigation Planning
This page was last modified on September 25, 2024