June 2007
The Organization has a policy requiring prompt reporting of the death of a JHM research participant when a JHM participant dies within 30 days of receiving a study intervention (Policy 103.6(b)(i)) . A “JHM participant” is defined as an individual enrolled in a research project that is either conducted at a Hopkins’ facility, or conducted off site under the direct supervision of a Hopkins’ principal investigator at a non-Hopkins site. If the protocol does not include any research intervention and is only to track outcomes using an observational study design, there isn’t an obligation to report the death of a JHM participant. What does “prompt reporting” mean in the case of the death of a JHM participant? 1. Unexpected Death: Prompt reporting for a death of a JHM participant at any JHM site, or at any site where the research conducted under the direct supervision of a Hopkins PI, 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 (possibly, probably or definitely)], must be reported to the IRB within 3 working days of when the PI receives the report of death. 2. Expected Death: Prompt reporting for a 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 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.”
Reports of death of a JHM participant must be submitted to, and reviewed by, the JHM IRBs. Reports should be submitted to the JHM IRB of record using the form R.F. 2: Report of Death of a JHM Research Participant for paper studies OR using the Problem/Event Report Form in eIRB for eIRB studies. What is a study intervention? A study intervention may include any of the following items:
- drugs, devices, biologics, 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 followup.
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 when a participant dies. The PI is responsible for meeting both the sponsor’s requirements and the JHM requirements. Check with the sponsor to assure all reports are submitted in compliance with the sponsor’s requirements.
| 
