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103.6bi Organization Policy on Reporting Death of a JHM Research Participant

April 2016

Deaths of JHM Research Participants

The death of a JHM research participant who dies within 30 days of receiving a study intervention, whether expected or unexpected, must be reported promptly to the JHM IRBs when the Principal Investigator (PI) learns of the death. (See Reporting Deaths of JHM Research Participants for additional information and exceptions to prompt reporting).  These reports will be reviewed by the JHM IRB of record for the study.  The IRB will notify the Institutional Official (IO) when it determines that the death was an unanticipated problem presenting risks to subjects or others, the result of non-compliance by the researchers, or otherwise necessitates immediate changes to the study protocol to address perceived safety issues.  The IO will evaluate such reports from the IRB to determine when the event must be reported to the OHRP and FDA.

Deaths of Research Participants at Non-JHM Sites if JHM is the Coordinating Center

If a JHM PI, who is the lead or coordinating investigator of a multi-center study, is informed that a participant has died within 30 days of receiving a study intervention at any site of the research (whether at JHM or at another site), the JHM PI must promptly inform the PIs at all of the participating study sites.