Research Protections Policies
RP04 Care and Use of Vertebrate Animals (Formerly Policy RA15)
Policy Steward:Associate Vice President for Research, Director of the Office for Research Protections >
This policy provides the following assurances:
- Vertebrate animals involved in any research, testing or teaching procedures receive humane care and treatment.
- Animal research is conducted in a well-controlled research environment.
- Concerns regarding the care and use of vertebrate animals at the University are addressed in a professional and responsible manner.
- 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 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.
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. 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 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; a written memo must document all submission supplements or clarifications. 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 Vice-Dean for Research, 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 Vice-Dean for Research, 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.
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 approvals from both the cooperating institution and the University. 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.
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 slaughter houses (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.
Vertebrate Animal --
The University defines an animal as being any non-human organism possessing a well-developed nervous system as characterized by the presence of a dorsal notochord protected by a vertebral column. This policy applies to both live and dead animals.
These committees, one located at University Park and one located at the COM, are appointed to review all proposed research, testing or teaching activities involving vertebrate animals to be conducted under the auspices of the University. Projects are reviewed for compliance with the principals of humane animal care and use as set forth by policies and regulations promulgated by the United States Department of Agriculture and the Public Health Service. The membership of this committee provides for a balanced review of all submitted activities by inclusion of veterinarians, faculty, staff, and local community representatives.
Submission forms for all University campuses and colleges except for the COM can be accessed through the ORP website. Completed forms are submitted to the ORP through the electronic submission process or by email. Submissions received by ORP will be circulated to IACUC members.
Submission forms for Penn State College of Medicine can be accessed through the College of Medicine IACUC Office web site. Completed forms are submitted to the College of Medicine IACUC Office by email to IACUC@pennstatehealth.psu.edu and will be circulated to the IACUC members.
The IACUC has final authority to disapprove or suspend indefinitely an activity involving the use of vertebrate animals.
Appeals will be heard by the IACUC; however, by federal law the IACUC has final authority and disapprovals cannot be overruled by any administrator at the University.
Any IACUC submission involving a biohazardous agent or radioisotope also will require prior approval by the Institutional Biosafety Committee or theUniversity Isotopes Committee, respectively. The investigator is to include, in the IACUC submission, a safety protocol 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 Health Physicist 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 and Recombinant DNA Committee, Health Physicist or Chemical Hygiene Officer respectively. The Biosafety Officer, Health Physicist or Chemical Hygiene Officer, 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.
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.
Other Policies should also be referenced, especially:
SY20 - Hazardous Waste Disposal,
SY24 - Use of Biohazardous Materials in Research and Instruction, and
HM-15SPM – Biohazardous Materials, Use in Research and Instruction.
Effective Date: March 14, 2016
Date Approved: March 3, 2016
Date Published: March 14, 2016 (Editorial change, May 17, 2017)
Most recent changes:
- 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.
Revision History (and effective dates):
- 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.