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IRB-HSR > Managing Protocol After Initial Approval >Unanticipated Problems

 

 

 

 

 

 

Unanticipated Problems

Definition
An Unanticipated problem is any event, experience, issue, instance, problem or outcome that meets all 3 of the following criteria:

  • Is unexpected in terms of the nature, severity or frequency given the research procedures that are described in the protocol –related documents AND in the characteristics of the population under study.
  • Is related or possibly related to participation in research.  This means that there is a reasonable possibility that the incident may have been caused by the procedures involved in the research study.
  • The incident suggests that the research places the subject or others at greater risk of harm (physical, psychological, economic or social) than was previously known or recognized OR results in actual harm of the subject or others.  An unanticipated problem generally required a change in policy or procedure , warrants consideration of substantive changes to the protocol/consent or other immediate corrective actions in order to reduce the risk or eliminate immediate hazard.

Unanticipated Problems that meet the definition of an Serious Adverse Events
A small number of Adverse Events are considered Unanticipated Problems. If an Adverse Event meets ALL 3 the criteria listed above, then the event is considered an Adverse event AND an Unanticipated Problem: Those events that meet the definition of both adverse event and unanticipated problem are reported to the IRB-HSR through the Adverse Event reporting system as previously described using IRB Online.

For additional information on Serious Adverse Events: http://www.virginia.edu/vpr/irb/hsr/adverse_events.html

Unanticipated Problems that meet the definition of Protocol Violation or Other Noncompliance Issue

A small number of Protocol Violations are considered Unanticipated Problems ONLY if they meet all 3 of the criteria listed above. Events that meet the definition of both protocol violation and unanticipated problem are reported to the IRB-HSR using the Protocol Violation/Noncompliance /Enrollment Exception Form.

For additional information on Protocol Violations and other Noncompliance Issues: http://www.virginia.edu/vpr/irb/hsr/managing.html 
Look under Protocol Violation/Noncompliance/Enrollment Exceptions section

Unanticipated Problems that meet the definition of Data Breach

A data breach may result from a violation of the Privacy Plan in the protocol (in which case it would be reported as a Protocol Violation.  However there may also be a data breach that does NOT result from a Protocol Violation and meets the criteria for an Unanticipated Problem.  If the Data Breach (not resulting from a Protocol Violation) meets all 3 of the following criteria below it would be reported using the Unanticipated Problem Reporting Form:

  • Is unexpected in terms of the nature, severity or frequency given the research procedures that are described in the protocol –related documents AND in the characteristics of the population under study.
  • Is related or possibly related to participation in research.  This means that there is a reasonable possibility that the incident may have been caused by the procedures involved in the research study.
  • The incident suggests that the research places the subject or others at greater risk of harm (physical, psychological, economic or social) than was previously known or recognized OR results in actual harm of the subject or others.  An unanticipated problem generally required a change in policy or procedure , warrants consideration of substantive changes to the protocol/consent or other immediate corrective actions in order to reduce the risk or eliminate immediate hazard.If the Data Breach meets the criteria of an Unanticipated Problem, the researcher must follow the IRB-HSR requirements for reporting an Unanticipated Problem

For more information on Data Breach:  http://www.virginia.edu/vpr/irb/hsr/data_breach.html

Reporting Timeline Requirement for Unanticipated Problems  

If an Unanticipated Problem should occur during the conduct of any study under the jurisdiction of the IRB-HSR, the PI should notify the IRB-HSR within 7 days from the time the PI/Study team receive knowledge of the event.

How to submit an Unanticipated Problem to the IRB

Events that meet the definitions of a Serious Adverse Event and unanticipated problem are reported to the IRB-HSR through the Adverse Event reporting system as previously described using IRB Online.

For additional information on Serious Adverse Events: http://www.virginia.edu/vpr/irb/hsr/adverse_events.html

Events that meet the definition of both protocol violation/noncompliance and unanticipated problem are reported to the IRB-HSR using the Protocol Violation/Noncompliance/Enrollment Exception Form.

For additional information on Protocol Violations and other Noncompliance Issues: http://www.virginia.edu/vpr/irb/hsr/managing.html 
Look under Protocol Violation/Noncompliance/Enrollment Exceptions

Unanticipated problems that that are not the result of an adverse event or protocol violation must be submitted to the IRB-HSR within 7 calendar days from the time the study team receives knowledge of problem using the Unanticipated Problem Report.

All submissions should be accompanied by a Routing Form

Documentation of IRB’s Receipt of Unanticipated Problem
The IRB will provide a stamped copy of the Unanticipated Problem Form OR the Protocol Violation/Noncompliance/Enrollment Form to document IRB receipt.  Stamped documents should be placed in the regulatory files. 

IF the Unanticipated Problem is an AE, then it will be reported using IRB OnLine and automatic emails will be returned to the study team do document receipt.  The emails should be printed and placed in the regulatory files.

IRB Review of the Unanticipated Problem
All reports of Unanticipated Problems are reviewed by the full board.  Once the board’s review is complete you will receive an assurance form for Full Board Determination:  Serious Adverse Event/Unanticipated Problem.  Any actions required by the board will be listed on this assurance.  Please complete any actions required by the board and file this Assurance Form in your regulatory files.

Mandatory IRB reporting of Unanticipated Problems
Per federal regulations the IRB must report Unanticipated Problem to OHRP and the FDA (if applicable). (If the Unanticipated Problem meets the definition of an Adverse Event, the sponsor is responsible for making the report to FDA)  Per IRB policy these reports are copied institutional officials involved in research oversight.  The PI, study coordinator and IRB Coordinator will receive a copy of this letter

The study team is responsible for reporting Unanticipated Problems to their sponsor.

Version Date :  9-04-14