Federal regulations require IRBs to establish written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and applicable regulatory agencies, of any unanticipated problems involving risk to human participants or others. Please note that these written procedures may be different than those established by sponsors and/or other institutions. The University of Texas Health Science Center San Antonio (UTHSCSA), Institutional Review Boards' (IRB) policy on prompt reporting of unanticipated problems involving risks to subjects or others (UPIRSO) and adverse events is contained within the UTHSCSA IRB SOP which can be accessed at: http://research.uthscsa.edu/irb/IRB-New/UTHSCSAUPIRSOPolicyandProce.pdf/. Reference: 45 CFR 46.103(b)(5), 21 CFR 56.108(b)(1). This letter addresses only the policy pertaining to unanticipated problems/adverse events that require Prompt Reporting to the UTHSCSA IRB. The criteria are as follows:
(1) Unanticipated AND (2) at least possibly Related to the study AND (3) suggests Greater Risk to participants or others (NOTE: Serious AE that is also both related and unanticipated would be considered to suggest greater risk),
Reporting must utilize the appropriate UTHSCSA reporting form/process within the following timeframes:
Prompt reporting required:
• All unanticipated AND at least possibly related events/problems that suggest that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized, must be reported within 7 calendar days of the investigator knowing of the event/problem if an “internal” event/problem or 14 days if an “external” (not within the UTHSCSA IRB jurisdiction) event/problem or follow-up report.
• The events above must be reported within 48 hours of the investigator's receipt of the information if the event involves an INTERNAL, life-threatening experience or death, (Submit only “Fatal toxicities”, if NCI).
Non-Prompt reporting:
• All events and problems that do not qualify for prompt reporting, must be included in the summary of problems/adverse events submitted to the IRB at the time of annual review (per the instructions provided in the Continuation Review report form). Refer to UTHSCSA "Policy on IRB Continuation Review Reporting"
If the problem/adverse event results in a revision to the informed consent document/process or to the protocol, the principal investigator must also submit an amendment.
Problems/adverse events that are submitted to the IRB on the prompt reporting form but are found by the IRB Chair or designated reviewer, to not meet the IRB's prompt reporting requirements, will be returned to the investigator without being reviewed by the IRB. The investigator will be asked to follow procedures for submission of reports to the IRB according to established policies. All investigators should follow policies for reporting unanticipated problems and adverse events established by their protocol, sponsor and/or FDA as appropriate.
OHRP advises that only a small subset of adverse events occurring in human subjects participating in research, will meet these three criteria for an unanticipated problem.
OHRP further advises that it is neither useful nor necessary under the HHS regulations at 45 CFR part 46, for reports of individual adverse events occurring in subjects enrolled in multicenter studies to be distributed routinely to investigators or IRBs at all institutions conducting the research. Individual adverse events should only be reported to investigators and IRBs at all institutions when a determination has been made that the events meet the criteria for an unanticipated problem [Unanticipated problem involving risk to subjects or others]. In general, the investigators and IRBs at all these institutions are not appropriately situated to assess the significance of individual external adverse events.
For additional information, please see the "UTHSCSA Investigator Handbook" Section M. For the reporting forms for events that require prompt reporting to the IRB and the optional form for tracking events that do not require prompt reporting to the IRB, please see: http://research.uthscsa.edu/irb/forms.asp.
If you have any questions, please feel free to contact me at (210) 567-2357. Thank you for your assistance in protecting human research participants at UTHSCSA.
Forms
- UPIRSO_Report_2007 (AE) (doc) - To report possible AE UPIRSO (e.g., Unanticipated possibly related event resulting in physical/psychological harm)
- UPIRSO_Report_2007 (Non-AE)
(doc) - To report possible NON-AE UPIRSO
(e.g., Unanticipated possibly related event which resulted in increased risk to subjects or others but no physical/psychological harm)
- Tracking Log (doc) – To track events/problems that do not require prompt reporting in order to make summarizing easier in annual progress report.
- UPIRSO Wizard - To help make a decision step-by-step about whether an event must be promptly reported as a possible UPIRSO. (Found on each of the above UPIRSO Reporting forms.)
Call Roy Estrada for specific questions not answered by one of these links at (210) 567-3083 or email at estradar3@uthscsa.edu |
