Reporting Requirements to Regulatory Authorities and Accreditation Agencies
Number: IACUC-POL-009
Responsible Office: Office of Research and Creative Scholarship (ORCS)
Applies to: All animal research and teaching activities involving live vertebrate animals conducted under the 91次元 (UM) IACUC
1. Purpose
The 91次元 is required to submit documentation and reports to federal regulatory agencies and accrediting bodies to ensure compliance with animal welfare standards. This policy establishes the reporting responsibilities of the IACUC, the Institutional Official (IO), and the IACUC Coordinator to the Office of Laboratory Animal Welfare (OLAW), the U.S. Department of Agriculture (USDA), and AAALAC International.
2. Policy
UM will submit all required reports, registrations, notifications, and compliance documents to regulatory and accreditation authorities in accordance with federal laws, Public Health Service (PHS) Policy, Animal Welfare Act Regulations (AWAR), and AAALAC International requirements. Records of all submissions will be maintained for a minimum of three years.
3. Reporting Procedures
Internal Reporting Policies
Semiannual Program Reviews and Facility Inspections
A draft of the report to the IO will be written by the IACUC Office and approved by the IACUC within one month of the inspection. The report must contain a description of the nature and extent of the institution's compliance with the Public Health Service (PHS) Policy and Guide for the Care and Use of Laboratory Animals; any departures must be identified and modifications proposed, with a plan and timetable for correction. Minority views of IACUC members must be included. Final reports must be submitted by the IACUC to the IO semiannually and kept for at least three years.
External Reporting Policies
Office of Laboratory Animal Welfare (OLAW)
Assurance of Compliance with PHS Policy
Assurances are approved for a period of up to five years, after which time the institution must submit a new request for a Letter of Assurance. The IACUC Coordinator will provide a written agreement to the IO that fully describes the institution's program and commits the organization to comply with the PHS Policy, and in which the institution outlines in detail its policies and procedures. The IO will submit the document to OLAW and an Assurance number is assigned by OLAW to the 91次元.
Complaints, violations, and suspension of activities
The designee of the IACUC Chair (currently the IACUC Manager) must report promptly (telephone call or written report) to the Compliance Officer and Oversight at OLAW (once the assurance number has been issued), through the IO, stating the circumstances and corrective actions taken and any minority views filed in the following instances: suspension of any activity by the IACUC; serious or continuing non-compliance with the PHS Policy; significant deviation from the provisions of the Guide for the Care and Use of Laboratory Animals. The contents of the PHS Suspension/Noncompliance Report will include: a full explanation of circumstances; description of corrective action taken; and minority views filed by IACUC.
Annual Reports
The IACUC Manager will draft the annual report that is submitted to OLAW, through the IO, at least once every 12 months. The Annual Report to OLAW is due on December 1st and includes activities during the Federal fiscal year (October 1 - September 30). OLAW website, . All reports are kept in the office of the IACUC Manager for a minimum of 3 years.
USDA
USDA Research Facility Registration
The research facility will maintain USDA registration in compliance with federal regulations. A research facility shall notify the Deputy Administrator in writing of any change in the name, address, or ownership, or other change in operations affecting its status as a research facility, within 10 days after making such change. The Notification of Change form (APHIS Form 7033) may be used to provide the information.
Complaints, violations, and suspension of activities
If the IACUC suspends any activities involving USDA-regulated animals, the IO will file a prompt report with the Western Regional Director of Animal Care and any federal agency funding the activity. Prompt reporting may be done by telephone, noting the date of suspension.
Annual Report
On or before December 1, each facility registered with USDA must submit an annual report to the USDA/APHIS, describing activity during the previous Federal fiscal year (October 1 - September 30). The final report is retained for a minimum of 3 years.
AAALAC
Program Description
Triennial submission as directed by AAALAC prior to site visit. The program description is prepared by the IACUC Office and is reviewed by the IO prior to being sent to AAALAC by the unit contact.
Prompt Reporting
Depending on the severity of this noncompliance or the applicable regulatory framework for the institution, this adverse event might warrant a prompt report to AAALAC International.
Annual Report
The institution must submit an Annual Report every year. The online report becomes available in mid-December. There is no set due date, but the report must be submitted within three months after the end of our chosen reporting period (e.g., calendar year or fiscal year). Each report must follow the previous one without any gaps in dates.
The report should include:
- Changes in key program contacts (Institutional Official, Attending Veterinarian, IACUC Chair, Unit Contact)
- Changes to animal care or research facilities
- Follow-up actions on AAALAC Suggestions for Improvement
- Changes in program structure or organization
- Animal use information
- Protocol violations that could affect animal welfare
- Animal use that was not approved by the IACUC
4. References
- Public Health Service Policy on Humane Care and Use of Laboratory Animals
- Office of Laboratory Animal Welfare
- Animal Welfare Regulations Animal Welfare Act and Animal Welfare Regulations
- AAALAC International
5. Review, Approval and Version History
|
Version |
Date |
Description of Changes |
Approved By |
|---|---|---|---|
|
1.0 |
February 16, 2006 |
Initial policy creation |
IACUC |
|
2.0 |
September 13, 2017 |
Review |
Heivilin |
|
3.0 |
November 25, 2025 |
Review and rewrite |
Hicks |