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UM Policies & Procedures - HSRO/IRB
1. Preface
2. Background Topics
3. Authorities and Responsibilities
4. Conflict of Interest
5. Institutional Review Boards
6. IRB Meetings
7. General Principles for IRB Reviews
8. Definition of IRB Review Types
9. IRB Review of Initial Studies
10. IRB Review of Continuing Studies
11. Amendments
12. Closing Studies and Final Reports
13. Suspension, Termination and Administrative Closure of IRB Approved Research
14. Unanticipated Problems and Adverse Events
15. Study Violations
16. Compliance Audits
17. Data Safety Monitoring Boards
18. Ancillary Committees
19. External IRB's
20. Policies Specific to Certain Types of Research
21. Informed Consent
22. Participant Recruitment Methods, Advertising Materials and Recruitment-Relevant Payment Arrangements
23. Vulnerable Populations
24. Privacy, Security, Confidentiality and HIPAA
25. Subcontracts/Agreements for UM-Initiated Studies that Engage or Involve non-UM Institutions or Investigators
26. International Research
27. Emergency Use
28. Record Retention
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eProst User Guide
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About the HSRO


Basic Folder Information

14.3 Reporting and Review of Unanticipated Problems



Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

August 27, 2007

Revised:

June 30, 2012

 



Policy

Pursuant to policy 14.2, Principal Investigators must promptly report  certain problems (adverse events) to the HSRO via the “Reportable Event” form in ePROST and to the sponsor and/or a central or independent monitoring committee (e.g., DSMB) as applicable.  Within these reports, the principal investigator shall assess the cause and seriousness of the problem (adverse event) and advise whether:

  1. a change in the protocol is necessary to minimize the risks to subjects
  2. the consent form should be revised to reflect the risk, and
  3. subjects in the study should be re-consented in light of the risk.

The HSRO shall promptly forward the principal investigator’s report to the IRB Chair or designee.  If immediate risks to subjects are involved, the report shall be forwarded to the Associate Vice Provost for Human Subject Research or the Assistant Provost for IRB Affairs or designees.  Any of the above individuals may take one or more actions which may include (but are not limited to):

  1. Implement immediate suspension of IRB approval to ensure the ongoing safety of subjects
  2. Call an emergency meeting of the convened IRB to act upon the report
  3. Request additional information from the Principal Investigator or others

All actions of the Associate Vice Provost, Assistant Provost, IRB Chair or designee regarding reportable problems or events shall be communicated to the Principal Investigator in writing and reported to the convened IRB.

Problems (adverse events) that fit the criteria for prompt reporting but that do not appear to require immediate action may be reviewed in an expedited manner by the IRB Chair or designee who may defer this review to the convened IRB when deemed appropriate.  Expedited review shall be limited to reported problems (adverse events) where only slight changes in risk have been reported, such that only minor changes in the study protocol or informed consent documents are required.  The IRB Chair or designee or the convened IRB may ask investigators and/or Data Safety Monitoring Boards or others for additional clarifying information and may require remedial actions (which shall be reported to the Principal investigator in writing) which may include:

  1. Modifying the inclusion or exclusion criteria to mitigate the newly identified risks
  2. Implementing additional monitoring procedures of subjects
  3. Modifying informed consent documents to include a description of newly recognized risks
  4. Revising the protocol
  5. Providing additional information about newly recognized risks to previously enrolled subjects
  6. Suspending enrollment of new subjects
  7. Suspending approval of the research
  8. Terminating approval of the study (convened IRB only)

Amendments submitted by Principal Investigators in response to reported problems (adverse events) shall be reviewed pursuant to policies governing reviews of other amendments.

The Associate Vice Provost for Human Subject Research shall be responsible for promptly communicating in writing to appropriate institutional officials including the Executive Vice President and Provost, the Dean of the School/College, and the Vice Provost for Research details and corrective actions or plans (as applicable) of:

  1. any reported unanticipated problems (adverse events) involving risks to subjects or others;
  2. any serious or continuing noncompliance with 45 CFR part 46, 21 CFR part 56 or the requirements or determinations of the IRB; and
  3. any suspension or termination of IRB approval pursuant the policies defined in Section 13. 

The Vice Provost for Research shall be responsible for promptly communicating in writing to supporting departments or agency heads (or designees) and the OHRP and/or FDA the details and corrective action plans related to any unanticipated problems involving risks to subjects or others; any serious or continuing noncompliance with 45 CFR 46, 21 CFR 56 or the requirements or determinations of the IRB and any suspension "for cause" or termination of IRB approval pursuant to the policies defined in Section 13.

NOTE: Reportable external problems (adverse events) need not be communicated by investigators to the UM IRB if UM is not the coordinating site in a multi-center study.

NOTE: If problems occur at a non-UM (or non-UM affiliated) site at which a UM investigator is responsible for the conduct of the research but the UM IRB does not serve as the IRB of record for that research, those problems need not be reported to the UM IRB unless the problem/event is unanticipated, related and places subjects at a greater risk than was previously known. 



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