Organization Policy on Reporting Death of a JHM Research Participant (Policy No. 103.6(b)(i))
June 2007

Death of JHM participant, whether expected or unexpected, must be reported promptly to the IRB when the PI learns of the death, with two exceptions.  A report of the death of a JHM research participant will be reviewed by the JHM IRB of record for the project.  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 project that is either 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 within 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 within 10 working days.

Exceptions to Prompt Reporting:

1. When an individual dies more than 30 days after she/he has stopped or completed all of the study procedures/interventions and required follow-up, the PI does not have to report the death promptly when he/she learns of the event.  In this situation, the death may be reported on the Continuing Review Application submitted for the next IRB review.   Subjects who do not complete the protocol for whatever reason, including voluntary withdrawal or removal by the PI, are to be included in this reporting requirement if the PI receives information that the former participant has died.
   
2. 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 research participants.  These deaths may be reported to the IRB in the Continuing Review Application as part of the progress report.