Office of Research and Innovation
University of Louisville
Louisville, Ky. 40202
502.852.6512, 502.852.2594 (Fax)
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Unanticipated Problem Involving Risk to Subjects or Others (UPIRTSO): Any incident, experience, or outcome that meets all of the following criteria:
UPIRTSO events must be reported regardless of whether they occur during the study, after study completion, or after participant withdrawal or completion. If the study has been closed with the IRB, please notify the IRB via email at hsppofc@louisville.edu.
An event that is determined to be a UPIRTSO must be reported to appropriate entities under the HHS regulations at 45 CFR 46.103(a) and 46.103(b)(5). Additional regulatory requirements for reporting unanticipated problems involving risks to subjects and others may be found in 45 CFR 46.103(b)(5)(i) and 21 CFR 56.108(b)(1).
The following Venn diagram summarizes the general relationship between adverse events and unanticipated problems:
The diagram illustrates three key points:
A protocol deviation is any change, divergence, or departure from the study design or procedures of a research protocol that is under the investigator’s control and that has not been approved by the IRB.
Upon discovery, the Principal Investigator is responsible for reporting protocol deviations to the IRB. Any change, divergence, or departure from the study design or procedures of a research protocol that affects the subject's rights, safety, or wellbeing and/or the completeness, accuracy and reliability of the study data constitutes a protocol violation. Changes or alterations in the conduct of the trial which do not have a major impact on the subject's rights, safety or well-being, or the completeness, accuracy and reliability of the study data are considered minor protocol deviations.
If sponsored attach correspondence with sponsor and their response in IRIS.
Local Adverse Events |
When to Report |
iRIS Form |
---|---|---|
Local Adverse Event PI determines to be:
|
Report within 5 working days of UofL site awareness |
Complete the Serious Adverse Event (SAE) Reporting Form within the iRIS system |
Unanticipated Problems (UPIRTSOs) |
When to Report |
iRIS Form |
Local Event PI determines to be:
|
Report within 5 working days of UofL site awareness |
Complete the UPIRTSO Reporting Form within the iRIS system |
Deviations/Violations/Misc. |
When to Report |
iRIS Form |
Major Deviations/Violations/Misc.
|
Report within 5 working days of UofL site awareness
|
Complete the Deviation/Violation/Misc. form in iRIS. Attach notification of deviation to the study sponsor (if applicable) in iRIS |
Minor Deviations/Violations/Misc.
|
Report with the next continuation review application |
Attach documentation with the continuation review application: These can be combined on one document (e.g. an excel file) |
External Safety Reports |
When to Report |
iRIS Form |
The majority of IND Safety Reports, MedWatch Reports do not need to be reported to the UofL IRB. The only reports that must be reported are those that reveal an unanticipated problem involving risks to participants and others. We understand that some sponsors require submission of all reports to the board regardless of the nature of the event reported. If you are submitting to fulfill such a requirement, please indicate this in your submission. |
Not Required |
Amendment-Other |
The principal investigator will report to the IRB using the appropriate reporting process outlined above.
If, in response to the report, the IRB chair/vice-chair/member/alternate, conducting the initial review, believes that immediate action is needed to ensure research subject safety; the reviewer may request that the investigator suspend research procedures or take action to suspend research procedures pending discussion of the event at the next convened meeting of the IRB. Suspensions suggested by the reviewer, and in concurrence with the IRB chair/vice-chair, will follow IRB policies and procedures regarding suspensions.
Each report will have initial review by a primary reviewer (usually an IRB chair or vice chair) to determine if the report may be an unanticipated problem involving risks to subjects or others (UPIRTSO). If the reviewer recommendation is to report the event to the full board, the HSPPO staff will schedule IRB review at the next convened meeting whose agenda has not been finalized. The primary reviewer will discuss the report. Should the primary reviewer be unavailable, the IRB chair for the meeting will lead the discussion. The board members will also have access to all of the event documents through the electronic submission system.
The primary reviewer will present a summary of the problem and make a recommendation to the IRB about whether the event represented a UPIRTSO. The IRB will deliberate and vote to determine whether the event represented a UPIRTSO. The determination of whether an event represents a UPIRTSO is based on whether the event represents all of the following:
If the board determines all three criteria are met, the reviewer will make a recommendation to the IRB about proposed actions. The IRB will deliberate and vote to approve these or any other appropriate actions. Actions the primary reviewer and IRB may consider include, but are not limited to:
All determinations from reported events will be communicated through the electronic submission system. The principal investigator will receive a written response from the IRB upon review of the reported event.
Any principal investigator who conducts research under the auspices of the University of Louisville IRBs must adhere to this policy. The University’s IRBs must follow this policy. Failure of investigators to report problems as required by this policy could result in a range of penalties.
HSPPO staff will follow the University of Louisville IRB Report of Findings policy for reporting unanticipated problems involving risks to subjects or others to the Executive Vice President for Research and Innovation. This policy is located here.