Unanticipated Problems and Noncompliance Reporting Requirements

Relevant IRB policies/procedures:

  • Unanticipated Problems Involving Risks to Subjects or Others (Policy 2.6) [pdf]
  • Noncompliance (Policy 1.9) [pdf]
  • Reporting Obligations for Principal Investigators (Policy 1.11)  [pdf]
  • Continuing Review (Policy 2.2) [pdf]

    [all IRB policies/procedures]

Unanticipated Problems

With respect to each research study he or she is conducting, the principal investigator must ensure that the following problems, events, and information involving risks to research participants or others are reported to the IRB no later than ten (10) calendar days after he or she first becomes aware of the problem, event, or information.

    

There are 4 Types of Unanticipated Problems Which form(s) must be completed and submitted to the IRB?

Adverse Event (AE) Biomedical

Submit the Expedited Reporting Form for Unanticipated Problems or Noncompliance and Adverse Event Reporting Form

Other Unanticipated Problems
(e.g. Breach of Confidentiality)
Submit only the Expedited Reporting Form for Unanticipated Problems or Noncompliance
3rd Party Safety Reports satisfying the Expedited Reporting Requirement

Submit the Expedited Reporting Form for Unanticipated Problems or Noncompliance and 3rd Party Safety Reporting Form

3rd Party Safety Reports not satisfying the Expedited Reporting Requirements but the Sponsor requires the reporting of  these
events to the IRB

Submit only the 3rd Party Safety Reporting Form  
Check box number 2. 

Adverse Events (AE) Biomedical   

All adverse events (whether occurring on-site or off-site), which in the opinion of the principal investigator are (1) unexpected, and (2) related or possibly related to the research and  (3) serious or suggests that the research places research participants or others at a greater risk of physical or psychological harm than was previously known or recognized must be submitted to the IRB within ten (10) calendar days.

Submission Instructions

Other Unanticipated Problems   

Other problems, events, or new information that are unexpected and indicate that research participants or others are at greater risk of harm must be submitted to the IRB within ten (10) calendar days.  The following are a few examples of Other Unanticipated Problems:

Submission Instructions

3rd Party Safety Reports   

The PI is responsible for making the assessment as to whether the adverse event(s) described in 3rd Party Safety Report(s) satisfies the expedited reporting requirement.  In other words, the adverse event(s) must be (1) unexpected, and (2) related or possibly related to the research and (3) serious or suggests that the research places research participants or others at a greater risk of physical or psychological harm than was previously known or recognized must be submitted to the IRB within ten (10) calendar days.

Submission Instructions for 3rd Party Safety Report satisfying the expedited reporting requirement

    

3rd Party Safety Report NOT satisfying the expedited reporting requirement but the Sponsor of the study requires the reporting of these events to the IRB 

If the research study is permanently closed to local accrual, and there are no local participants receiving interventions or long term follow-up, then adverse events described in third party safety reports do not need to be evaluated by the PI or submitted to the IRB.

Reporting Noncompliance to the IRB    

Principal investigators and their study staffs are required to report each event of serious or continuing noncompliance relating to human subjects research which they are conducting within ten (10) calendar days of learning of the event.

The following noncompliance items must be reported withing ten (10) calendar days to the IRB:

Examples of continuing noncompliance which should be reported promptly to the IRB:

The IRB will determine if the event constitutes serious or continuing noncompliance.

“Noncompliance" does not include protocol deviations that are beyond the control of the principal investigator and his or her study staff (e.g. delays caused by weather or by the acts or omissions of third parties such as outside labs).  However, this type of protocol deviation may constitute an unanticipated problem involving risks to research subjects or others reportable under IRB Policy 2.6, Unanticipated Problems Involving Risks to Subjects or Others.  

Submission Instructions

Monitoring Compliance

The IRB staff will be monitoring timely reporting of adverse events.  Investigators are accountable for timely reporting of unexpected and related adverse events. If the report is not timely, the first instance is noted in email correspondence with the PI and a justification is requested. A second instance involving the same study will be handled more formally by the IRO Director in communications with the PI. Should a third instance occur with the same study, accrual may be suspended pending a full IRB Committee review. Notification of the suspension will be forwarded to the appropriate Division Director as well as the President and Director of FHCRC and appropriate regulatory agency(ies).

Additional Reporting Requirements for

Certain Events

The occurrence of any one or more of the following events in connection with any study in which FHCRC is enrolling research subjects or is a participating site must be reported to the IRB as soon as possible but no later than ten (10) calendar days after the investigator or study staff learn of the event.  These events would be reported with a Research Modification Form.  See Modifications for further guidance and forms.

Questions and Comments

The IRB welcomes your input and comment on reporting requirements for unanticipated problems and noncompliance. Reporting and managing these events for the protection of human research participants is a shared responsibility. Please feel free to contact James Riddle, IRB Assistant Director at (206) 667-6501 with your comments on the recently revised policies or for assistance in identifying relevant federal regulations and/or funding agency specifications that may apply to your study.

    
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