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Information for Research Participants
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Institutional Review Boards
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
Other Policies
UChart Forms & Guidance
HSRO Forms & Documents
University Fees
Ancillary Committee Information
eProst User Guide
Ethics, Federal Regulations & Guidance
HIPAA
Translations
Western IRB (WIRB)
About the HSRO


Basic Folder Information

14.1 Definitions



Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

April 27, 2006

Revised: June 30, 2012

 



14.1 Problems and Events that Require Prompt Reporting

1.  ADVERSE EVENT or PROBLEM

Federal documents and professional literature interchangeably refer to a “problem” or an “adverse event” as any undesirable physical or psychological experience to or within a human subject participating in research (note-.  FDA regulations define adverse events as any undesirable experience associated with the use of a medical product in a patient). 

2. INTERNAL VS EXTERNAL

Federal guidance differentiates between problems/ events that are “internal” (i.e. experienced by a research subject enrolled at a site under the jurisdiction of the University of Miami IRB for either multicenter or single center research projects) or “external” (i.e. experienced by subjects enrolled at a site external to the jurisdiction of the University of Miami IRB or in a study for which UM is not the coordinating center. 

3.  RELATED

An event is “related” if it is likely to have resulted from participation in the research study

4. SERIOUS ADVERSE EVENT

Federal regulations consider an adverse event to be serious when medical or surgical intervention is required to prevent any of the following: 

  1. Death
  2. A life-threatening situation
  3. Inpatient hospitalization
  4. Prolongation of existing hospitalization
  5. A persistent or significant disability/incapacity, or congenital anomaly/birth defect

Pursuant to federal regulations, adverse events that do not result in death or are not life threatening or require hospitalization should also be considered serious adverse events when, based upon appropriate medical judgment, they may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. 

5.  UNANTICIPATED

An event is unanticipated if it was unforeseeable at the time of its occurrence (i.e. it is not consistent with the current Investigator’s Brochure; or if an Investigator’s Brochure is not required or available, the event should be considered unanticipated if its specificity or severity is not consistent with the risk information described in the investigational plan or elsewhere in the IRB application.  Note- if adverse events occur at a greater frequency, severity or duration that was previously anticipated, these events should be considered “unanticipated” and must be promptly reported. 

6.  UNANTICIPATED PROBLEMS INVOLVING RISK TO PARTICIPANTS OR OTHERS

This defines any event that was:

  1. Unanticipated
  2. Related
  3. Places subjects or others at a greater risk of physical or psychological harm than was previously known or recognized

Examples of such unanticipated problems include but are not limited to:

  1. Breach of confidentiality
  2. Loss of research data stored without encryption
  3. Any change to the protocol made without prior review even if done to eliminate an apparent immediate hazard to subjects
  4. Subject complaints that indicate unexpected risks
  5. Sponsor-imposed suspensions

NOTE: Unanticipated problems involving risk to participants or others should be reported to the IRB regardless of whether the problems occur during the study, after study completion, after participant withdrawal or after study closure.



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