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In the ever-evolving field of public health, statistical analysis serves as a cornerstone for understanding and managing disease outbreaks. By leveraging various statistical tools, health professionals can predict potential outbreaks, analyze ongoing situations, and devise effective responses to mitigate impact. For that to happen, there are a few possible stages of the analysis:
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Disease surveillance is the systematic collection, analysis, and interpretation of health data essential to the planning, implementation, and evaluation of public health practice. This process integrates data dissemination to entities responsible for preventing and controlling disease, injury, and disability. Surveillance systems provide crucial information for action, helping public health authorities make informed decisions to manage and prevent outbreaks, ensure public safety, optimize...
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Developing a Rapid Response Single IRB Model for Conducting Research During a Public Health Emergency.

Abigail E Lowe1, Colleen Kraft2, Mark G Kortepeter3

  • 1Abigail E. Lowe, MA, is an Assistant Professor, Global Center for Health Security, College of Allied Health Professions, University of Nebraska Medical Center, Omaha, NE.

Health Security
|May 11, 2022
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Summary

Developing a rapid response single Institutional Review Board (IRB) is crucial for ethical clinical research during public health emergencies. Preparedness exercises, like workshops and tabletops, help refine these essential processes for emerging pathogens.

Keywords:
COVID-19Investigational drugsPublic health preparedness/responseRapid reviewSingle IRB review

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Area of Science:

  • Public Health
  • Clinical Research Ethics
  • Emergency Preparedness

Background:

  • Evidence-based patient care relies on clinical research, which is often too slow for public health emergencies.
  • Established processes for rapid, multi-site ethical review of human subject research during emergencies are lacking.
  • The University of Nebraska Medical Center (UNMC) aimed to create a rapid review resource for emerging pathogen research.

Purpose of the Study:

  • To address operational gaps in multi-site human subject research during public health emergencies.
  • To identify procedural needs for a rapid response single Institutional Review Board (RR-sIRB).
  • To develop and test the RR-sIRB model using preparedness exercises.

Main Methods:

  • Conducted preparedness exercises, specifically workshops and tabletops, to simulate emergency research scenarios.
  • Utilized these exercises to develop, refine, and test the RR-sIRB model and its review functions.
  • Validated the readiness of regulatory research processes for rapid response.

Main Results:

  • The preparedness exercises provided a unique method for testing and refining rapid IRB review functions.
  • The study identified specific procedural needs for operationalizing RR-sIRB for multi-site research.
  • The exercises validated the readiness of regulatory processes for timely and ethical research.

Conclusions:

  • Preparedness exercises are effective for developing and testing rapid review capabilities for single Institutional Review Boards (sIRBs).
  • Establishing robust RR-sIRB processes in advance is critical for conducting ethical and sound clinical research during public health emergencies.
  • This model enhances the ability to initiate and conduct multi-site clinical research rapidly and ethically when needed.