Reporting Adverse Events and Unanticipated Problems to the UAB IRB

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Reporting Adverse Events and Unanticipated
Problems to the UAB IRB

• Policy and Procedure Change
• September 22, 2006
• Amanda G. Murphy, RN, CIP
• Assistant Director, IRB

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From the Policy

• UAB Policy requires that unanticipated problems
  involving risks to research subjects or others
  must be promptly reported to the IRB, the
  Institutional Official, the sponsor, and
  appropriate federal agencies.

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Who Does What?

• The Investigator reports the problem/event to the
  Office of the IRB
• The IRB determines whether the problem/event
  alters the risk of the research, and must
  promptly report its determination and actions to
  the PI and the Institutional Official (IO)
• The IO is responsible for promptly reporting the
  IRB findings to the sponsor and applicable
  federal agencies

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From the Procedure

• Investigators, or their designees, must report
  REPORTABLE EVENTS to the OIRB for UAB IRB
  consideration

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All Reportable Events

• Must be reported promptly to the Office of the
  IRB
• The IRB has defined promptly as within 10 days of
  the study staffs knowledge of the event

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Four Types of REPORTABLE EVENTS

1. Adverse events that are serious, unexpected, AND
   related or possibly related to participation in
   the research
2. Serious adverse events that are expected in some
   subjects, but are determined to be occurring at a
   significantly higher frequency or severity than
   expected
3. Other adverse events that may alter the IRBs
   analysis of the R/B ratio and, as a result,
   warrant consideration of substantive changes to
   the protocol or consent document
4. Unanticipated problems not involving adverse
   events that occur and result in new circumstances
   which increase the risk of harm to subjects or
   others

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The Investigator/Study Staff

• Must submit reportable events to the OIRB on the
  revised Adverse Event Report
• Retain all reportable events for submission in a
  summary format at continuing review
• Report other adverse events in a summary format
  at continuing review

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GREAT NEWS!!!

• The change in IRBs Policy and Procedure will
  result in
• fewer Adverse Event Reports
• less time to prepare the Investigators Progress
  Report

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So What do You do??

• Complete the revised Adverse Event Report
  whenever you have knowledge of a reportable event

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You dont have to

• Submit as many Adverse Event Reports!

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The New FormWhat does the IRB want, where?
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Report Information
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Protocol Information
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Event Information
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Reporting and Actions
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Other Changes

• The OIRB will return to the investigator reports
  of events that do not meet the criteria for
  reportable events
• Each reportable event must be reported on a
  separate Adverse Event Report

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More Good News! The Summary Format

• At the time of continuing review
• For non-reportable events, youll use the Summary
  Log Sheet
• For reportable events, you can copy/paste the
  information from the report forms to the log
  sheet, instead of photocopying Adverse Event
  Reports

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Special Notes

• The revised form and summary tables do not have
  final IRB approval, so there may be some MINOR
  changes

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Questions?