Emergency Preparedness

Business Continuity Planning (BCP) is the process of preparing for situations in which normal operations cannot continue, such as during natural disasters, infrastructure failures, or large-scale events like the COVID-19 pandemic.

The goal of a BCP is to help a department continue critical activities despite entering into a crisis and to support a return to normal operations as quickly as possible. In some situations, departments may also be expected to expand or adapt their activities to meet emerging needs.

Indiana University requires every department on every campus to maintain an active Business Continuity Plan and to be prepared to implement it when necessary. Please contact Emergency Management and Continuity at iuemc@iu.edu for additional guidance.

IU HRPP’s BCP will be followed when a situation impacting the HRPP has occurred, or in preparation for scenarios where a potential emergency situation is imminent, such as:

• Public health emergencies such as outbreaks or pandemics
• Cybersecurity incidents affecting research or HRPP systems
• Extreme weather events or other natural disasters
• Any event that limits HRPP/IRB operations or researcher access

The HRPP Emergency Preparedness Plan may be activated in two ways: 1) with activation of an Indiana University Emergency Preparedness Plan or 2) where an Emergency is uniquely impacting the IU HRPP.

In the event of an emergency, the University Director, HRPP, will work with the Vice President for Research (also the Institutional Official), Associate Vice President for Research Compliance, and other University leadership to develop and implement appropriate emergency response procedures. This plan aligns with and supplements the University’s overall emergency response.

The HRPP will follow the established communication channels to notify HRPP stakeholders of the activation of the emergency preparedness plan.

HRPP operations continue through:

• Remote operations:
  • HRPP staff work remotely whenever possible
  • IRB meetings continue virtually (Zoom or Microsoft Teams)
• Alternate onsite operations:
  • If remote access is unavailable, staff may transition to designated IU office locations in Indianapolis or Bloomington.
  • If virtual platforms are unavailable for IRB meetings, we will shift to in-person meetings or other options (teleconference, etc.) as appropriate.
• Review prioritization: HRPP prioritizes time-sensitive reviews, including:
  • Expanded access or treatment use
  • Interventional trials with potential direct benefit
  • Emergency-related research

Additional operational procedures relevant to HRPP staff are maintained internally to support implementation of this plan.

Federal regulations permit investigators to immediately implement changes without prior IRB approval only when necessary to eliminate an apparent immediate hazard to participants (45 CFR 46.108(a)(3)(iii); 21 CFR 56.108(a)(4)). Such changes must be reported to the reviewing IRB as soon as possible.

Additionally, researchers are expected to develop a study-level Business Continuity Plan (BCP) to protect participant safety and research integrity during emergencies. The need for BCP may be based on the type of research conducted and the degree of risk in the event a study could not continue.

BCP considerations may include, but are not limited to:

• Alternate drug dispensing options (e.g., home delivery via Investigational Drug Service when appropriate)
• Telehealth or virtual visits for study procedures
• Remote or telephone-based consenting processes
• Developing alternate mechanisms for safety monitoring.
• Transitioning participants to clinical care if investigational products become unavailable
• Following guidance from federal agencies (HHS, OHRP, FDA), Indiana University, and/or study Sponsors
• Periodically (at least annually) reviewing and keeping the BCP current.