NU investigators are required to report deaths of NU* participants to the IRB office if the death was:
- not anticipated and
- possibly related to participation in the study.
The investigator should contact the IRB Office as soon as possible via phone or email.
Depending on the circumstances, the IRB may need to take immediate action to minimize further harm to participants such as halting the enrollment of additional participants or suspending approval of the research.
Formal notification to the IRB of the event is still required and accomplished through a New Information Report submission under the applicable study in eIRB.
* NU participant includes participants enrolled at NU’s affiliate sites (RIC, NMH, NMG) or sites for which NU has agreed to serve as the IRB of Record through a signed IRB Authorization Agreement (IAA).