老虎机攻略

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Research

Adverse Event(s) and Reporting

Reporting significant and unanticipated adverse events (AEs) is essential to maintaining institutional credibility, fostering a culture of care, and ensuring animal welfare. Principal Investigators (PIs) are required to seek guidance from the Attending Veterinarian (AV) when adverse events occur. The AV will help assess the situation, seek resolutions, and assist in reporting when needed.

Consultation with the AV is mandatory if:

  • Pain or distress exceeds the approved animal use protocol.
  • Intervention, such as administering analgesics, is not possible.

Completion of the Adverse Event Form is required to report any unforeseen or negative incidents affecting animals involved in research, testing, or educational activities.

adverse event information

Definitions and Examples

Adverse Event (AE)

An adverse event is any unanticipated occurrence not consistent with IACUC-approved expected outcomes that results in animal welfare concerns, such as distress, increased pain, disease, or death.

Examples of Reportable Adverse Events for both Lab Animal and Wildlife Research:

  • Unexpected animal deaths or injuries during approved activities.
  • Distress, disease, or death due to equipment failure or natural disasters.
  • Unexpected injuries or adverse reactions (e.g., allergic reactions, broken limbs, complications during recovery, unanticipated reactions to experimental compounds, or sudden death).
  • Life-threatening or debilitating birth defects discovered after breeding genetically modified animals.
  • Increased death rates beyond approved protocol expectations.

Expected Outcomes (Not Reportable)

Expected outcomes are events anticipated in the approved protocol and do not require reporting if:

  • They occur within the expected frequency.
  • Animal monitoring and humane endpoint determinations outlined in the protocol are followed.

Examples include:

  • Expected morbidity or mortality from specific procedures (e.g., surgery, disease models). All animal deaths, whether reportable as an Adverse Event (AE) or not, MUST be reported to the Attending Veterinarian (AV).
  • Common conditions like ulcerative dermatitis or barbering unrelated to the study.
  • Anticipated breeding-related outcomes.

 

Reporting Procedure

  1. Notification by LAR Staff
  • If an AE is identified by Laboratory Animal Resources (LAR) staff, the PI and contact listed on the cage card will be notified via email.
  • The PI/research staff must complete the 老虎机攻略 Online Adverse Event Form within 24 hours of notification.
  • The IACUC Manager and AV will be copied on the initial email.
  1. Notification by PI/Research Staff
  • If the AE is identified by the PI or research staff, the Adverse Event Form must be completed within 24 hours of discovery.
  • Research staff may contact the AV by phone for immediate assistance if necessary.
  1. Follow-Up
  • Upon submission of the AE form, the IACUC Manager and AV will be notified electronically and follow up with the PI/research staff.
  • The AV and IACUC Manager will determine if the AE requires reporting to external agencies (e.g., OLAW, USDA, AAALAC).
  1. Filing Reports
  • AE reports will be stored in the PI’s designated online BOX folder for future reference.
  • If the AE is deemed reportable, the IACUC Manager will notify the PI and collaborate with the AV and PI to generate the required report for federal or accrediting agencies.
  1. Protocol Amendments
  • If necessary, the AV and IACUC Manager will work with the PI to modify or amend the approved animal use protocol to address issues related to the AE.

 

Commitment to Compliance and Care

By adhering to this policy, researchers demonstrate their dedication to the ethical treatment of animals, the integrity of their work, and the credibility of the institution. For guidance or further assistance, contact the Attending Veterinarian or IACUC Manager.