Incident Report

Report of Incident


Report

Incidents are any unapproved changes or deviations in the research study or procedures that are within the investigator's control and not in accordance with the IRB approved protocol. 

Major incidents must be reported within 48 hours of awareness


REPORT AN INCIDENT

Unanticipated problems involving potential risk to participants or others must be reported. Lamar University IRB will conduct a complete of all violations. Additional information may be requested and subsequent action may follow.alert

Major Protocol Violations

Major protocol violations include but are not limited to the following:

  • Harm, significant or substantive risk to the research participant.
  • Change to the participant's clinical or emotional condition or status.
  • Damage to the scientific completeness or soundness of the data collected.
  • Serious or continuing noncompliance with federal, state, or local regulations.
  • Breach of privacy or confidentiality
  • Changes to eliminate or reduce an apparent immediate hazard to the safety of participants.
Minor Protocol Violations
Minor protocol violations include but are not limited to the following:
  • No harm or significant risk of substantive harm to the research participant.
  • No change in the participants clinical or emotional condition or status.
  • No damage to the completeness, accuracy and reliability of the data collection for the study.
  • No willful or knowing misconduct on the part of the investigator(s).
  • Non problematic or no significant potential harm to the research participants.
  •  Participant failure to initial every page of the consent form.
  • Study procedures conducted out of timeframe.