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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

14.2 Requirements for Reporting Problems (Adverse Events) to the IRB



Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

April 27, 2006

Revised: June 30, 2012

 



Policy

A.  PROMPT REPORTING  (10 DAYS)

Pursuant to federal regulations (45 CFR 46.103(b)(5) and 21 CFR 56.108(b)(1), problems  (adverse events) which fit all of the following three criteria must be promptly reported to the IRB (and to sponsors and/or a central or independent monitoring committee [i.e. DSMB] as applicable). 

Unless otherwise defined, “prompt reporting” should be made via the HSRO’s “Reportable Event” form within 10 working days after the investigator first learns of the problem (adverse event). 

The criteria for prompt reporting are: 

  1. (a) the problems (adverse events) are unanticipated (either in frequency, type, severity, scope or consequences)  from the nature of the research procedures and the subject population being studied; OR
    (b) the problems (adverse events) are expected but not fully addressed or specified in information provided to the IRB or to participants such as in the initial application or amendments, investigator brochures, scientific literature, product labeling, package inserts, IRB-approved informed consent documents or any existing documentation regarding the research conducted to date under the protocol); AND
  2. the problems (adverse events) are related, or have a reasonable possibility of being related, to the research procedures or to the subject’s participation in the research; AND
  3. the problems (adverse events) suggest that the research places subjects or others at greater risk of harm or discomfort than was previously known or recognized

One key to the above policy is “unanticipated”.  Problems that are anticipated (e.g. in a high risk sample or in high risk research) do not necessarily require prompt reporting.  But if such events are occurring at a significantly higher frequency or severity than expected, they constitute an unanticipated problem and must be promptly reported.    

Another key to the above policy is that a problem need not directly affect a subject to require prompt reporting.  For example, the loss of a computer containing identifiable and sensitive subject information must be promptly reported as an unanticipated problem.  Other examples of unanticipated problems which must be promptly reported include but are not limited to:

  1. findings that lab reports on blood or other samples were in error
  2. a drug dosing error
  3. hospitalization (initial or prolonged) due to (or possibly due to) the adverse event
  4. disability (i.e. a subject underwent a significant, persistent or permanent change, impairment, damage or disruption of bodily function/structure, physical activities or quality of life, which is related or possibly related to participation in the study
  5. congenital abnormality (i.e. the suspicion that exposure to a medical product prior to concept or during pregnancy resulted in or contributed to an adverse outcome in a child
  6. required intervention to prevent permanent impairment or damage (i.e. there is a suspicion that the use of a medical product resulted or may result in a condition requiring medical or surgical intervention to preclude permanent impairment or damage to a subject
  7. a research participant unexpectedly becomes pregnant in a study that includes interventions that may adversely affect pregnancy and/or pregnant women
  8. cessation of an investigational behavioral intervention
  9. inadvertent disclosure of confidential information (note—these are “serious” if they present an immediate risk to subjects such as from spousal or child abuse)
  10. an important medical event that jeopardizes the subject or requires medical intervention to prevent one of the outcomes listed above
  11. physical abuse for participating in the research
  12. unexpected violence by participants in a group counseling session

Federal regulations and IRB policies also require prompt reporting in each of the situations defined below: 

  1. any unanticipated adverse device effects occurring during the research (note – this must be reported to the HSRO and to the sponsor [if applicable] as soon as possible but no later than 10 working days after the investigator learns of the problem..  The sponsor shall immediately conduct an evaluation of the unanticipated device problem [21 CFR 812])
  2. any unanticipated internal drug problem associated with an IND-covered study (note – this must be reported to the HSRO and the sponsor [if applicable] within 10 working days after the investigator first learns of the occurrence. The sponsor shall notify the FDA and all participating investigators in a written IND safety report [21 CFR 312]
  3. any problem (even if it does not constitute an “unanticipated problem”  by the definition above)  if the protocol defines that problems (adverse events) are to be reported to a DSMB (note – such problems must be reported to the DSMB and HSRO within 10 working days after the investigator first learns of the occurrence)

B.  SUBJECT DEATH

The unanticipated death of a subject must be reported within 24 hours  if that death is suspected as being a direct outcome or possibly an outcome of the study intervention (If the cause of death is not available, this should not delay the report)

Reporting of a subject’s death is required only at the time of continuing review if that death fits any of the following criteria: 

  1. The death of a subject is due to the nature of the subject’s underlying disease or condition, or is identified as due to a possible risk of the study procedure/intervention as described in the protocol and consent form
  2. the death of a subject occurs more than 30 days after she/he has stopped or completed all study procedures/interventions and required follow-up
  3. the death is that of a subject who did not complete the protocol for whatever reason, including voluntary withdrawal or removal by the PI
  4. the death is that of a subject participating in a study which does not include a research intervention  (for example, an observational study tracking outcomes)

C.  LIFE THREATENING PROBLEM

A problem (adverse event) that is life-threatening must be reported within 24 hours.  Federal guidance defines “life-threatening” as being when a subject was at substantial risk of dying at the time of the problem or it is suspected that the use or continuance of the intervention/drug/device would result in the subject’s death



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