RP04 Care and Use of Vertebrate Animals

Contents:

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

DEFINITIONS:

PURPOSE:

This policy provides the following assurances:

1. Animals involved in any research, testing, or teaching procedures receive humane care and treatment.
2. Animal research is conducted in a manner designed to obtain high quality results while minimizing the number of animals needed and utilizing the most appropriate model available (in vitro or in vivo).
3. Concerns regarding the care and use of 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 "Animal Welfare Assurance" with the 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 (ORP) at UP for all University campuses and colleges, except for COM, which holds its own assurance with OLAW.

APPLICABILITY:

This policy is applicable to all research, testing, or teaching activities involving animals except as excluded below, conducted under the auspices of the University and applies to all University locations and personnel, including the COM.

University projects involving the use of 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.  For collaborations between UP, COM, and/or any Commonwealth Campus, IACUC oversight (UP or COM) is determined by the performance location; institutional oversight (UP or COM) is determined by the funding location.

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 .
3. Animal tissues or parts* obtained from federal or state agencies per their internal policies and procedures. 
4. Animal tissues or parts* collected from roadkill or hunter harvest surveys.
5. Established cell lines, preserved carcasses and tissues, and biological fluids and foods available as standard inventory from a conventional commercial supplier.
6. The observation of animals in the absence of any human manipulation that could materially alter the behavior of the animals under study.

* UP and COM IACUC staff consult with investigators on the use of animal tissues and parts to verify whether they do or do not require IACUC approval for use. If the use of animal tissues or parts does not require IACUC approval, it is the responsibility of the investigators to consult with relevant institutional units (i.e., Institutional Biosafety Committee, Environmental Health and Safety) to ensure the acquisition, handling, and disposal of animal tissues and parts follow all University policies and procedures.

POLICY:

IACUC approval is required prior to the actual involvement of live animals 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 UP and all other campus locations except COM, the UP IACUC is the responsible committee. Animal research, testing, or teaching at COM is reviewed and approved by the COM IACUC. Any exceptions in oversight location must be agreed upon by both committees. Unless indicated otherwise by a sponsor, any 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 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. 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 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 anonymously through the Penn State Hotline (1-800-560-1637). All reports of concern will be handled confidentially, investigated by the appropriate IACUC, and resolved in a timely manner.

SUBMISSION PROCEDURE:

Applications for the use of animals in research, testing and teaching activities are submitted through the electronic protocol management system, CATS (Centralized Application Tracking System) IACUC.  Submission instructions: University Park IACUC.  Submission instructions (requires COM login): College of Medicine IACUC. The IACUC has final authority to disapprove or suspend indefinitely an activity involving the use of 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 UP 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) and the University Isotopes Committee (UIC), respectively. The investigator must obtain separate approvals by the IBC (see Policy RP11) and UIC (see Policies SY14 and SY15) as appropriate. 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 and related materials contaminated with biohazardous materials. The University Radiation Safety Officer will assist the University Biosafety Officer in the development of safety protocols involving the use of radioisotopes. For IACUC submissions involving hazardous chemicals, the University Biosafety Officer will work with animal care personnel and investigators to design safety protocols for the use of hazardous chemicals.

Any submission to the COM IACUC involving a biohazardous agent, radioisotope, or hazardous chemical will require prior approval by the COM IBC, 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:

SY14 - Use of Radioactive Materials

SY15 - Radiation-Producing Instruments

SY20 - Hazardous Waste Disposal

RP11 - Use of Biohazardous Materials in Research and Instruction

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

Most recent changes:

• May 28, 2024 - Expanded the definitions and applicability of the policy to include cephalopods. Based on guidance from USDA, IACUC approval is not needed for all animal tissues and parts; updated Applicability section and added additional items to Exclusions section to clarify. Updates to Applicability section to clarify UP vs COM oversight.  Updates to Biohazardous Agents and Radioisotopes section regarding ancillary reviews and processes. Reorganized sections for clarity and editorial changes throughout. 

Revision History (and effective dates):

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