Events and Information that Require Prompt Reporting to the IRB

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Note: Submit a narrative summary of all adverse events, (previously reported or not, serious or not), and submit routine, periodic reports (e.g. DMC reports that indicate no changes, sponsor annual progress reports) to the IRB at Continuing Review (renewal).

Reportable information should always be reported by the PI directly to the IRB within 5 working days from when the PI learns of the event or new information.  

• Use the IRB Reportable Events Form found at www.med.nyu.edu/irb
• Reporting an unanticipated problem involving risks to participants or others (UAP):
  • If PI is the only monitoring entity:
    Items in section I below must be reported immediately.  
    Items in section II below should be reported directly to the IRB within 5 working days
  • If there is a monitoring entity in addition to, or other than, the PI: Report to the IRB using this form within 10 working days from receiving an assessment from monitoring entity. Only when an event has been assessed by the monitoring entity to be a UAP should the PI report it to the IRB.

I. UNANTICIPATED PROBLEMS INVOLVING RISKS TO PARTICIPANTS OR OTHERS (UAPS)

UAPs are events (including internal or external events, deaths*, life-threatening experiences*, injuries, breaches of confidentiality, or other problems) that occur any time during or after the research study, which in the opinion of the Monitoring Entity or the PI are:

1. a. Unanticipated - not in the consent form, investigator brochure, protocol, package insert, or label; or unanticipated in its frequency, severity, or specificity,
   AND
2. Related to the research procedures - caused by, or probably caused by research activity, or, if a device is involved, probably caused by, or associated with the device,
   AND
3. Harmful - caused harm to participants or others, or placed them at increased risk of harm

In other words, to qualify as a UAP, an event must be Unanticipated AND Related AND Harmful.

*Unanticipated deaths or life-threatening experiences related to the research (at NYUMC or when NYUMC is the coordinating institution in a multi-site study) must be reported within 5 working days from when the research team learns of the event.

II. OTHER REPORTABLE EVENTS AND INFORMATION (other than UAPS)

1. New Information indicating a change to the risks or potential benefits of the research, in terms of severity or frequency. [e.g., Analysis indicates lower-than-expected response rate or a more severe or frequent side effect; Other research finds arm of study has no therapeutic value; FDA labeling change or withdrawal from market]  
2. Protocol Deviation or Violation. Only if:
   • Intended to eliminate apparent immediate hazard to a research participant, or
   • Harmful (caused harm to participants or others, or placed them at increased risk of harm, or
   • Possible serious or continued noncompliance
3. Complaint
   • unresolved by the research team, or
   • that indicates increased or unexpected risks.
4. Incarceration when in the opinion of the PIit is in the best interest of the participant to remain on the study.
5. Unanticipated adverse device effect. New information about the effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.