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The Organization has a policy requiring prompt reporting of the death of a JHM participant to the JHM IRBs when the participant dies within 30 days of receiving a study intervention (Policy 103.6(b)(i)).
What does “JHM participant” mean?
A “JHM participant” is an individual enrolled in a research study that is either conducted at a Hopkins facility or conducted off-site under the direct supervision of a Hopkins Principal Investigator (PI) at a non-Hopkins site.
What do “unexpected” and “expected” mean with respect to a research participant’s death?
- An “unexpected” death is defined as the death of a participant that was 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 and/or study interventions.
- An “expected” death is defined as the death of a participant due to the nature of the participant’s underlying disease or condition, or identified as caused by a possible risk of the study procedure as described in the protocol and consent form
What does “prompt reporting” mean in the case of the death of a JHM participant?
1. Unexpected Death: Prompt reporting means the submission of a report to the IRB no later than 3 working days after the PI becomes aware of the death.
2. Expected Death: Prompt reporting means the submission of a report to the IRB as soon as possible after the PI becomes aware of the death, but in all cases no later than 10 working days.
A Further Study Action for Protocol Event Report in the eIRB system is the mechanism by which a prompt report of a death must be submitted to the IRB.
What are the exceptions to “prompt reporting”?
- When a JHM participant dies more than 30 days after s/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. In this situation, the death may be reported as part of the next Continuing Review application for IRB review.
- If the PI receives information of the death of a JHM 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.
- 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.
What is a study intervention?
A study intervention may include any of the following items:
- The administration of drugs, devices, biologics, dietary supplements, complementary and alternative medicines (CAMs), or physical procedures that are specified by the protocol; or
- Behavioral interventions (examples could include drug or alcohol counseling, delivery of mental health services, or psychiatric non-pharmacological interventions) that are specified by the protocol. The Organization recognizes that participants enrolled in research projects that include behavioral interventions often withdraw completely from a study and may not complete all study follow-up procedures. For such research projects, the PI should report promptly the death of a research participant for whom the behavioral interventions: a) have not been completed and/or b) the participant is still within the time period between the start of the study and the proposed last follow-up.
What should an investigator do if a sponsor’s requirement for reporting deaths of participants differs from the JHM requirement?
Sponsors (both federal and commercial) may have different reporting requirements for when a participant dies. The PI is responsible for meeting both the sponsor’s requirements and the JHM requirements. Investigators should check with their sponsors to ensure that all reports are submitted in compliance with the sponsor’s requirements.