OBJECTIVE:

To describe the requirement for emergency preparedness plans for human subjects research.

DESCRIPTION:

In order to strengthen the protection of human research subjects, an emergency plan is required for subjects who are involved in protocols that administer acute medical treatment but who might not be able to get the needed medical attention during a natural disaster (e.g., ice storm, hurricane).

All protocols that administer acute medical treatment to human research subjects must have a plan for how investigators would deal with this situation and ensure that research staff and subjects know what they should do in the event of an emergency situation.  Generally speaking, if a protocol is being conducted in the VCUMC, emergency medical coverage will be available and transportation to the hospital, if necessary, will be provided. If the protocol falls outside of these parameters, however, planning should be undertaken to ensure that subjects will be able to continue receiving their necessary care during such disasters. Emergency plans are not required to be included in protocol submissions but must be developed and disseminated to investigators, staff, and subjects so they will know what to do in the event of a natural disaster. The VCU IRB will verify that these plans have been developed and are in place during protocol site audits. If the protocol is taking place within the VCUMC, merely indicating the resources available through the hospital system for dealing with such emergencies will be sufficient for the plan.

RESPONSIBILITY:

It is the responsibility of the principal investigator to plan, develop and disseminate and emergency plan.

REFERENCE:

None listed.