IRB Member Checklist: Unanticipated Problems

This page provides a guidance for members of the ED/SBS IRB when reviewing Reportable Events that are presented as Unanticipated Problems.

If the IRB Director or IRB Chair determine that a Reportable Event appears to constitute a potential unanticipated problem involving risks to participants or others, the report will be referred to the full IRB for review at the first possible IRB meeting.

The report is added to the IRB agenda, and IRB members are provided the Reportable Event via the ARROW portal.

After reviewing the report, the IRB must determine:

Does the report constitute an unanticipated problem, per UW-Madison Unanticipated Problems Policy?
(To qualify, the problem must be unanticipated AND reasonably related to the research)
If the IRB determines that the event reported does constitute an Unanticipated Problem, per campus policy, the IRB must further determine:
A. What action is appropriate in response to the report?  Although not all inclusive, actions may include:
  • modifications to the protocol and/or consent documents
  • providing additional information to past or current participants
  • requiring additional training for investigators or staff
B.  Is suspension or termination of approval warranted?

(NOTE:  Any suspension or termination of research by the IRB must be promptly reported to the Institutional Official.)

C. Is further reporting to university officials, federal agencies and department heads required, pursuant to the UW-Madison Reporting to Institutional and External Authorities Policy?
The IRB will notify the investigator in writing of its decision(s).

Keywords:unanticipated problems, reporting, UAP   Doc ID:57944
Owner:Casey P.Group:Education and Social/Behavioral Science IRB
Created:2015-11-03 14:27 CSTUpdated:2019-06-10 09:48 CST
Sites:Education and Social/Behavioral Science IRB, VCRGE and Graduate School
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