HRPP/IRB Continuity of Operations Plan – Important Information for Researchers
The HRPP/IRB has developed a Continuity of Operations (COOP) Plan in order to be prepared for potential emergencies that may affect the conduct of human research at VCU. This notice is to inform the research community regarding the relevant details of the plan as they impact researchers. The following are questions the research community may have regarding the HRPP/IRB COOP Plan.
What is the COOP Plan?
The COOP Plan is a document that outlines procedures for the HRPP/IRB in the event of an emergency. The plan provides the framework for restoring essential functions in the event of an emergency that affects departmental operations. The HRPP/IRB COOP Plan is a supporting document to VCU’s overall COOP Plan.
The HRPP/IRB COOP Plan may be activated for any type of emergency, including loss of facility access, loss of service due to reduced workforce, or loss of service due to equipment or systems failure. The COOP plan can be activated by an emergency that comes with notice, without notice during business hours, or without notice outside business hours.
What Should Researchers Know About the COOP Plan?
Researchers should be aware that the HRPP/IRB has a COOP Plan, should be aware of how studies may be impacted by potential emergencies, and should be aware of the channels of communication that will be used by the HRPP/IRB to communicate with the research community in the event of an emergency. These topics are covered below in the following sections.
How Might Studies be Affected by an Emergency, and How Does the COOP Plan Manage Studies in an Emergency?
When the HRPP/IRB COOP Plan is activated, the HRPP Director will work with other stakeholders to determine the impact of the emergency on research studies. If studies are impacted, the HRPP/IRB will use a data-driven approach to determine if and how studies may continue.
Data points from the RAMS-IRB SmartForm will be used to assist in data-driven categorization of studies. Examples of data points that may be used include, but are not limited to:
- Project type (research, HUD, expanded access, FDA-regulated, etc.) and review type (exempt, expedited, full board)
- Benefit type (direct benefit to participants; scientific benefit; etc.)
- Risk level (minimal risk/greater than minimal risk)
- In-person or remote participation and/or ability to convert to remote procedures
- Locations and facilities used by the project
- Whether or not the project is researching the disaster/emergency
Categorization of studies will support making determinations about how studies should proceed. The HRPP/IRB may take the following actions regarding study continuation:
- advise studies they may continue according to current approved protocols
- advise studies that they may continue after a contingency protocol with temporary alternative procedures is submitted to and approved by the IRB
- request that studies voluntarily pause some or all research activities
- request that VPR institutionally require that studies pause research activities
- suspend and/or terminate studies according to procedures in WPP VIII-8
If contingency plans are needed as a part of the emergency response, the “Contingency Plan” Page in the RAMS-IRB SmartForm will be activated. On that page, additional information and/or questions for researchers may be released, to assist with the development of contingency plans. In addition, contingency plan template(s) will be released by the HRPP/IRB when RAMS-IRB is patched to activate the Contingency Plan page.
How Will the HRPP/IRB Communicate With Researchers During an Emergency?
The HRPP/IRB will utilize the following communication strategies in an emergency:
- Internet (including email, both individual or mass), video meeting service, chat, TelegRAM, and the RAMS systems
- Phone, including voice, text and video chat
- Websites, including the VCU Alert webpage, the HRPP website and blog, social media, and other OVPRI websites
- Television or radio announcements, and newspaper ads, as needed depending on the nature of the emergency.
Investigators are therefore encouraged to proactively seek out channels of communication with the HRPP/IRB, so that they may receive information in a timely manner. Investigators may subscribe to the HRPP/IRB blog by following this link, and entering their email address into the relevant field on the right side of the screen.
Investigators may subscribe to the HRPP/IRB listserv by following this link, and scrolling to the bottom of the page for instructions for subscribing.
Note: Investigators with Reliance Agreements are responsible for notifying other sites relying on VCU, and/or the external reviewing IRB for the study, of pertinent changes that are made to the study during an emergency.