RP04 Care and Use of Vertebrate Animals

Contents:

• Purpose
• Policy
• Applicability
• Exclusions
• Definitions
• Submission Procedure
• Biohazardous Agents and Radioisotopes in Animals
• Further Information
• Cross References

PURPOSE:

This policy provides the following assurances:

1. Vertebrate animals involved in any research, testing, or teaching procedures receive humane care and treatment.
2. Animal research is conducted in a well-controlled research environment.
3. Concerns regarding the care and use of vertebrate animals at the University are addressed in a professional and responsible manner.
4. Research involving the use of live animals is performed in an ethical manner, designed to minimize pain and distress, and comply with applicable federal and state regulations.

This policy enacts certain necessary provisions of the University's "Assurance of Compliance with Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals," an agreement with the Office for Laboratory Animal Welfare (OLAW) at the National Institutes of Health (NIH) which provides eligibility for receipt by University investigators of funding from various federal agencies. One assurance is held by the Office for Research Protections at University Park  ("UP") for all University campuses and colleges, except for the College of Medicine / Milton S. Hershey Medical Center (“COM”), which holds its own assurance with OLAW.

POLICY:

Approval by the appropriate Institutional Animal Care and Use Committee (IACUC) is required prior to the actual involvement of a vertebrate animal in any University research, testing or teaching activities. These activities must be managed by a Principal Investigator, who is responsible for the work. For animal activities at University Park and all other campus locations except COM, the University Park IACUC is the responsible committee. Animal research, teaching or testing at the COM is reviewed and approved by the Penn State Hershey IACUC. Any such project involving an external sponsor must be reviewed and approved by the responsible IACUC before funding is accepted.

IACUC records and housing and use facilities are subject to regular unannounced inspections by representatives of the United States Department of Agriculture (USDA). USDA inspection reports describe any institutional deficiencies or apparent IACUC record violations, and are accessible to the public under the Freedom of Information Act. For this reason, all IACUC submissions must be carefully prepared and detailed. The Office for Research Protections (ORP) is responsible for coordinating IACUC reviews and approvals for all University campuses and colleges except for the COM.  The Office of the Vice Dean for Research and Graduate Studies is responsible for coordinating IACUC reviews and approvals at the COM.

Concerns regarding the proper care and use of vertebrate animals in a University project are to be reported to the ORP; Office of the Vice Dean for Research and Graduate Studies; Attending Veterinarian; Institutional Official; IACUC Chair; or Penn State Hotline (1-800-560-1637). All reports of concern will be handled anonymously, investigated by the appropriate IACUC, and resolved in a timely manner.

APPLICABILITY:

This policy is applicable to all research, testing, or teaching activities involving vertebrate animals (live or dead*) or animal parts except as excluded below, conducted under the auspices of the University and applies to all University locations, including the COM. University projects involving the use of vertebrate animals at other institutions must receive IACUC approval. If IACUC approval from the other institution’s IACUC is accepted, a Memorandum of Understanding (MOU) between the other institution and the University must be established.  The COM will serve as the cooperating institution during a collaborative effort between the COM and any other University college or campus location.

* The IACUC reviews the use of dead animals to verify that they originate from a reputable source and are disposed of appropriately.

EXCLUSIONS:

The following materials are excluded from this policy and are exempt from IACUC review:

1. Animal tissues or parts collected from animals euthanized under an approved IACUC protocol.

2. Animal tissues or parts collected from USDA-inspected slaughterhouses (except at COM where IACUC review and approval may be required).

3. Established cell lines, as well as biological fluids and foods available as standard inventory from a conventional commercial supplier.

DEFINITIONS:

SUBMISSION PROCEDURE:

Applications for the use of animals in research, testing and teaching activities are submitted through the electronic protocol management system, CATS IACUC.  Submission instructions: University Park IACUC.  Submission instructions: College of Medicine IACUC. The IACUC has final authority to disapprove or suspend indefinitely an activity involving the use of vertebrate animals.The IACUC has final authority to disapprove or suspend indefinitely an activity involving the use of vertebrate animals.

Appeals will be heard by the UP IACUC/COM IACUC; however, the respective IACUC has final authority and disapprovals cannot be overruled by any administrator at the University. 

BIOHAZARDOUS AGENTS AND RADIOISOTOPES IN ANIMALS:

For University Park and all other campus locations except for COM, any IACUC submission involving a biohazardous agent or radioisotope also will require prior approval by the Institutional Biosafety Committee (IBC) or the University Isotopes Committee (UIC), respectively. The investigator must submit a separate safety protocol to the IBC describing procedures for work with biohazardous materials used with animals. The University Biosafety Officer, in consultation with animal care personnel, will aid investigators in designing appropriate safety protocols for the handling and disposal of animals contaminated with biohazardous materials. The University Radiation Safety Officer will advise investigators in the development of safety protocols involving the use of radioisotopes.

Any submission to the COM IACUC involving a biohazardous agent, radioisotope, or hazardous chemical will require prior approval by the COM Institutional Biosafety Committee, Health Physicist, or Program Manager of Chemical and Environmental Safety, respectively [see https://infonet.pennstatehershey.net/web/institutional-animal-care-use-committee/resources for links to the appropriate offices]. The Biosafety Officer, Health Physicist, or Program Manager of Chemical and Environmental Safety, in consultation with the Department of Comparative Medicine staff, will assist investigators and research staff in designing appropriate safety protocols for the handling and proper disposal of animals contaminated by any hazardous agent.

FURTHER INFORMATION:

For questions, additional detail, or to request changes to this policy, please contact the Office of the Associate Vice President for Research, Director of the Office for Research Protections.

CROSS REFERENCES:

Other Policies should also be referenced, especially:

SY20 - Hazardous Waste Disposal,

RP11 - Use of Biohazardous Materials in Research and Instruction, and

HM-15SPM – Biohazardous Materials, Use in Research and Instruction.

Most recent changes:

• September 1, 2023 - Updated Subject Matter Expert to Debra Thurley, Associate Vice President for Research.  

Revision History (and effective dates):

• May 23, 2022 - Updated submission process for CATS IACUC; updated Chemical Hygiene Officer to Program Manager of Chemical and Environmental Safety; minor editorial edits.
• November 18, 2019 - Clarified use of MOU in APPLICABILITY and added Principal Investigator to DEFINITIONS. 
• October 2, 2018 - SUBMISSION PROCEDURE section updated to reflect the current processing for submission forms.
• May 17, 2017 - Editorial changes made; the second paragraph of the SUBMISSION PROCEDURE section has been updated to reflect the current processing for submission forms.
• March 14, 2016 - Revisions have been made throughout the policy to include the IACUC at the College of Medicine and other references relating to the College of Medicine, to have a unified policy for the University.
• June 8, 2015 - This policy was previously a Research Administration policy, RA15. It has been moved from the Research Administration section to the Research Protections section to reflect the reorganization, and links/cross references have been edited as appropriate.
• August 12, 2010 - Editorial changes made; updated address and website links were revised in the POLICY and SUBMISSION PROCEDURE sections, respectively.
• May 24, 2007 - Major revisions to entire policy, as approved by the Institutional Animal Care and Use Committee (IACUC).
• February 23, 2005:
  • Responsibility moved from Office for Protection from Research Risks to Office for Laboratory Animal Welfare.
  • Under the section BIOHAZARDOUS AGENTS AND RADIOISOTOPES IN ANIMALS, the procedure was rewritten.
  • Under the APPROVAL PROCEDURE, upon completion of the IACUC review, ORP prepares letters of approval for proposals.
  • Under the section DISAPPROVALS, "lack of availability of adequate animal housing or care" was changed to "inadequate animal housing or care."
  • Lack of compliance with federal regulations was added as a reason for disapproval.
  • Changes to several office names.
• February 20, 1998 - Relocated and renumbered Policy RA15 from SY23, and clarified "Exclusions."
• September 1, 1994 - Office addresses updated.
• March 24, 1992 - New policy.