|
Events and Information that Require Prompt Reporting to the IRB
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).
Federal regulations [45CFR46.103(b)(5) and 21CFR56.108(b)(1)] require the IRB to ensure that investigators promptly report "any unanticipated problems involving risk to subjects or others" (UPIRSO). The IRB defines UPIRSO as any problem or event which in the opinion of the local investigator was unanticipated, reflects new or increased risk to the subjects and was possibly related to the research procedures. The IRB makes the determination of whether the unanticipated problem meets the criteria as a UPIRSO.
When Reporting Events
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 using the IRB Reportable Event Form vie eProtocol.
Unanticipated Problems Involving Risks to Subjects or Others (UPIRSOs)
UPIRSOs 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:
- Unanticipated: not in the consent form, investigator brochure, protocol, package insert, or label; or unanticipated in its frequency, severity, or specificity
AND
- 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
- Harmful: caused harm to participants or others, or placed them at increased risk of harm
In other words, to qualify as a UPIRSO, an event must be Unanticipated AND Related AND Harmful.
*Unanticipated deaths or life-threatening experiences related to the research (at MHC subsidiary hospital or when one or all of the MHC subsidiary hospitals are/ 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.
Note: Death is not necessarily a UPIRSO. If death is an expected outcome for a particular group of subjects (i.e. patients with advanced cancer), then the death of a subject though serious, is not unexpected and so does not meet the IRB’s definition of UPIRSO. Any death of a subject which cannot be attributed to underlying disease would be unexpected. However, if the unexpected death is not believed to be related to the research (i.e. car accident), then it does not meet the IRB’s definition of UPIRSO.
Other Reportable Events and Information (Other than UPIRSOs)
New Information
Anything 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].
Anything 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].
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
Complaint
Any Subject complaint unresolved by the research team, or that indicates increased or unexpected risks.
Incarceration
When in the opinion of the PI it is in the best interest of the participant to remain on the study.
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.
|
|