Coming Soon! 

The Human Research Protection Program (HRPP) is developing tools and policies over the remainder of this year to support the development of emergency preparedness requirements. 

What is Emergency Preparedness 

Emergency preparedness is identifying and mitigating potential disruptions that could negatively impact research continuity and human subject safety. 

Why Emergency Preparedness Matters 

Emergency preparedness ensures that research teams can: 

  • Maintain continuity of critical studies 

  • Reduce risks to participants 

  • Respond quickly and effectively when disruptions occur 

  • Anticipate potential risks and define response strategies in advance 

June 2026 IRB Insights Session

The June IRB Insights session served only as an introduction, with more detailed guidance, tools, and policy updates expected in the coming months. The next steps over the remainder of the year will be to provide research teams with the resources needed to integrate preparedness into everyday study planning. 

View the slides and recording of the June IRB Insights. 

A Practical Framework for Preparedness

 

The session concluded with a simple checklist for getting started: 

  1. Identify risks (to participants, staff, and study integrity) 

  1. Map key contacts and backup communication pathways 

  1. Plan for continuity (what continues, what pauses, what adapts) 

  1. Document and report changes appropriately 

  1. Train and test the plan regularly 

This framework mirrors standard research practices but applies them through an emergency preparedness lens. 

Risk-Based Decision Making

Preparedness planning begins with understanding risk. Teams are encouraged to assess: 

  • Risks to human subjects 

  • Risks to research staff 

  • Risks to study integrity  

Higher-risk studies, such as clinical trials involving investigational drugs, require more robust contingency plans that include addressing: 

  • How will drugs be stored during power outages? 

  • What monitoring processes ensure safety if systems fail? 

  • What happens if supplies are interrupted  

During past disruptions like COVID-19, institutions prioritized higher-risk studies for continuation, while lower-risk research was paused—an approach that reinforces the importance of risk stratification.  

Moving Beyond Single-Event Planning

When considering preparedness, researchers should consider a wide range of possible disruptions, including natural disasters, power outages, cyberattacks, facility closures, or supply chain interruptions. The goal for planning it to identify how these events might affect staffing, communication, data access, and human subjects safety—and to plan accordingly. 

Communication Is Critical

Clear, reliable communication is at the heart of effective emergency preparedness. Research teams should identify key contacts (IRB, sponsors, pharmacy, study staff), backup contacts, and alternative communication methods if systems fail. 

Events such as internet outages or loss of system access can significantly disrupt coordination. Having redundant communication pathways and documented contact lists ensures teams can stay connected when it matters most.  

Additionally, plans should include communication strategies for human subjects, ensuring they are informed about any changes that affect their involvement or safety. 

Ensuring Continuity of Research Operations

Preparedness also requires planning for continuity of operations, including: 

  • Access to research records and data 

  • Secure backups in case of cyber incidents 

  • Defined workflows for emergency situations  

Teams should consider how research activities might shift during an emergency, including: 

  • Moving procedures to remote or virtual formats 

  • Modifying protocols to maintain safety 

  • Temporarily pausing activities when necessary  

Decisions should always be guided by participant safety and ethical considerations, with appropriate documentation and reporting to the IRB and sponsors.   

Defining Roles and Responsibilities

Successful response efforts depend on clearly defined roles. Preparedness plans should address: 

  • Who makes key decisions 

  • Who serves as backup leadership if the principal investigator is unavailable 

  • How responsibilities are delegated across the team  

While clinical trials often have structured delegation processes, other research settings may need to formalize these roles to ensure continuity. 

Training and Continuous Improvement

Creating a plan is only the first step. Research teams must also: 

  • Train staff on emergency procedures 

  • Practice scenarios or “tabletop exercises” 

  • Regularly review and refine plans  

Preparedness should be treated as an ongoing process—similar to other research practices—where teams continuously assess and improve their approach.  

After any disruption, teams should conduct debriefs to identify lessons learned and strengthen future responses.