Human Research Protection Program

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Reportable Events

Requirements for Reporting to the IRB

The Federal regulations (45 CFR 46.1 03(b)(5) & 21 CFR 56.1 08(b)) require written procedures for ensuring prompt reporting of unanticipated problems to the IRB, appropriate institutional officials, any supporting department or agency head (or designee), and OHRP.

The purpose of prompt reporting is to ensure that appropriate steps are taken in a timely manner to protect subjects from avoidable harm. Investigators must promptly report any Unanticipated Problem Involving Risk to Subjects or Others (UPIRSO) associated with their research project in accordance with MCW IRB SOP: Requirements for Reporting to the IRB.

Events which meet MCW’s Prompt Reporting Criteria

a) Any Adverse Events (internal or external) that meet all of these criteria:

  • Unexpected
  • Possibly, probably, or definitely related to the research
  • Suggests the research places research participants or others at a greater risk of physical or psychological harm than was previously known or recognized.

Examples include but are not limited to the following:

  • Unanticipated adverse events (either occurring internally or at an external site) which meet the criteria above
  • Unanticipated adverse device effect
  • External Serious Adverse Events that meet the criteria above
  • A series of adverse events that meet the criteria above
  • New information that might affect adversely the safety of the participants or the conduct of the clinical trial
  • Any change significantly affecting the conduct of the clinical trial or increasing the risk to participants
  • New findings that result in premature closure of a study or are related to an unanticipated problem involving risks to subjects or others 

b) Follow-up reports to initially reported Adverse Events which meet all of the above criteria


c) Unanticipated Problems or any incident, experience, or outcome that meets all of the following criteria:

  • Unexpected with reference to procedure/risks defined in initial IRB application
  • Possibly, probably, or definitely related to participation in the research study, and
  • Suggests the research places subjects or others at greater risk of harm than was previously known or recognized.

Examples include but are not limited to the following:

  • Breach of privacy or confidentiality including lost or stolen study records that contain private identifiable subject information.
  • Any other problem that the investigator considers to be unanticipated and indicates that subjects or others are at increased risk of harm.
  • Incarceration of a subject in a protocol not approved to enroll prisoners.
  • Complaint of a subject when the complaint indicates unexpected risks or cannot be resolved by the research team.

d) Safety Notice/Report from Sponsor or Central Site if report describes new information regarding risks or unanticipated problems involving risks.
 

Examples include but are not limited to the following:

  • Sponsor imposed suspension for risk.
  • Change in FDA labeling or withdrawal from marketing of a drug, device, or biologic used in a research protocol.
  • Any safety reporting requirements specified by the IRB as a condition of approval.
  • A paper is published from another study that shows that the risks or potential benefits of the research might be different from those initially presented to the IRB.
  • Suspension or Termination of the Study by the Sponsor

e) Report from a Data Safety Monitoring Board (DSMB) or Equivalent if the report describes new information regarding risks or unanticipated problems involving risks.

Examples include but are not limited to the following:

  • An interim analysis or safety monitoring report indicates that the frequency or magnitude of harms or benefits might be different from those initially presented to the IRB.

f) Significant Protocol Deviation
 

Examples include but are not limited to the following:

  • Any departure from the protocol (deviation or violation) that harmed subjects or others; that indicates subjects or others might be at increased risk of harm; or that compromises the integrity of the research data.
  • Any change made to the research without prior IRB approval in order to eliminate apparent immediate harm

g) Planned Protocol Deviation which increases the risk to participants or others, decrease potential benefits of the study, or undermines the scientific integrity of the study. 
 

Examples include but are not limited to the following:

  • Enrolling a subject who does not meet eligibility criteria
  • Not performing a specific screening procedure for a patient as indicated in the protocol

h) Non-Compliance with IRB Policies and/or Procedures
 

Examples include but are not limited to the following

  • QI routine review reports which recommended immediate reporting of events
  • Any allegation of non-compliance with protocol requirements (including protocol deviations or violations) or IRB policies.

 

 

 

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Page Updated 02/11/2014