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

August 2010

Death of JHM participant when a JHM participant dies within 30 days of receiving a study intervention, whether expected or unexpected, must be reported promptly to the IRB and other participating sites (if JHM is the coordinating center of a multi-center study) when the PI learns of the death, with three exceptions.  A report of the death of a JHM research participant will be reviewed by the JHM IRB of record for the application.  The JHM IRBs will notify the Institutional Official (IO) when the review of death of a participant causes immediate changes to a protocol to address perceived safety issues.  The IO shall evaluate such reports to determine when the event must be reported to the OHRP and FDA.

Definitions

  • A “JHM Participant” is defined as an individual enrolled in a research study either that is conducted at a Hopkins’ facility or that is conducted off-site under the direct supervision of a Hopkins’ principal investigator at a non-Hopkins site.
  • “Prompt reporting is defined by the Organization. 
    • Prompt reporting for death of a JHM participant that was unexpected (e.g., not related to a risk of participation that was listed in the protocol or consent document, and was more likely than not caused by the research procedures/study interventions), must be reported to the IRB no later than 3 working days of when the PI receives the report of death.  
    • Prompt reporting for death of a JHM participant which was expected due to the nature of the participant’s underlying disease or condition, or identified as caused by a possible risk of the study procedure/intervention as described in the protocol and consent form, must be reported to the IRB as soon as possible after the PI learns of the event, but in all cases no later than 10 working days.

Exceptions to Prompt Reporting

  1. When a JHM participant dies more than 30 days after she/he has stopped or completed all of the study procedures, interventions, and/or required follow-up the PI does not have to report the death promptly when the PI learns of the event.  In this situation, the death may be reported as part of the next Continuing Review application for IRB review.   
  2. If the PI receives information of the death of a former participant who did not complete the protocol for whatever reason (including voluntary withdrawal or removal by the PI) the PI is to report to the IRB the former participant’s death as part of the next Continuing Review application for IRB review.
  3. PIs of protocols that do not include a research intervention and are only tracking outcomes in an observational study design do not have to promptly report deaths of JHM participants.  These deaths may be reported to the IRB in the Continuing Review application.

Death of a Research Participant at another Research Site

When the JHM PI, as the lead researcher of a multi-center study, is informed that a participant has died within 30 days of receiving a study intervention at another site, the JHM PI must promptly disseminate the relevant information to all of the participating study sites.



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