Office for Research Protections

Animal Welfare

Background
PSU Policies
Federal Policies
PowerPoint Presentations
Case Studies
Online Learning Tools
Articles

Background

The decision to use animals in research or testing is one that must be made with care. Significant advances have been made in scientific, behavioral, and medical research that are due to information gained from animal use, and there are still many research questions that can only be answered if animals are used. Recent technological advances have made many alternatives to animal use available, and these should be used whenever possible. If the decision is made to use laboratory animals in research, it must be understood that using animals for research is a privilege, not a right, and that only those agreeing to use animals responsibly are granted the privilege. Scientists must scientifically justify the use of animals in their study, and provide assurance that using animals will benefit human or animal health or advance general scientific knowledge before being granted the privilege to use them. If the privilege to use animals in research is granted, the scientist is responsible for complying with state, federal and local regulations.

Regulations and policies
The Animal Welfare Act, which was signed into federal law in 1966, regulates the treatment of certain animal species in research, exhibition, transport, and by dealers (1). The Act is administered by the U.S. Department of Agriculture (USDA). Research institutions are required to register with the USDA, comply with the minimum standards for animal care and use set forth in the Animal Welfare Act, and to submit to annual inspections by USDA personnel. It addresses topics such as research facilities, attending veterinarians and adequate veterinary care, stolen animals, records, confiscation and destruction of animals and access and inspection of records and property. The Animal Welfare Act has sections governing the care and use of various animals, although rats, mice, and birds used in research are specifically excluded from the Act's purview. Research that is funded by Public Health Service Agencies (such as the National Institutes of Health, or NIH) must also meet requirements set by the Public Health Service Policy on Humane Care and Use of Laboratory Animals (2). Animals covered by the policy include "any live, vertebrate animal used or intended for use in research, research training, experimentation, or biological testing or for related purposes." Federal regulations and policies ensure that the pain and distress experienced by research animals is minimized, and that all research animals are treated humanely. The regulations and policies require

  • Appropriate pain relieving medications such as sedatives, analgesia, or anesthesia must be used when painful procedures are conducted on animals;
  • Appropriate endpoints must be established prior to the start of an experiment to ensure that the researcher prevents unnecessary pain and distress, and that accurate and timely data can be collected;
  • Appropriate animal husbandry directed and performed by qualified persons;
  • Experimentation on living animals may only be conducted by, or under the close supervision of, qualified and experienced persons.

Institutions apply for an Animal Welfare Assurance from the Office of Laboratory Animal Welfare (OLAW), which maintains federal oversight of animal use. The Animal Welfare Assurance is like a contract between the institution and OLAW, stating that the institution agrees to comply with the PHS Policy as well as the Animal Welfare Act. If an institution fails to meet federal requirements, its Animal Welfare Assurance can be withdrawn. Moreover, while violation of the PHS policy forfeits the institution's funding eligibility, violation of the Animal Welfare Act is a criminal offense.

Penn State has policies and guidelines to ensure the safety and well-being of animals used in research. Policy RA15: Care and Use of Vertebrate Animals 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. PSU Policy RA15 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.

Penn State Policy SY23: Occupational Health and Safety Program for Animal Care Personnel ensures compliance with regulatory mandates for animal care personnel. These personnel may, in the course of their employment, research or education, be exposed to vertebrate animals and/or tissues, fluids, secretions, and excretions in a way that puts them at increased risk of an occupational illness or injury. Occupational Health Services (OHS) and Environmental Health and Safety (EHS) administer the Occupational Health and Safety Program (OHSP), in cooperation with the Office for Research Protections (ORP) and the Institutional Animal Care and Use Committee (IACUC).

Institutional Animal Care and Use Committees (IACUC)
The Animal Welfare Act and the PHS Policy on animal care and use require the appointment of an Institutional Animal Care and Use Committee (IACUC) to oversee the use of animal in research and teaching at the university. The IACUC is comprised of approximately twenty members and includes Penn State research scientists, administrators, veterinarians, and members of the local community. Researchers are required to submit a detailed description of proposed animal activities for review and approval by the IACUC, which will evaluate the proposal to ensure that

  • the research has clear benefit to humans, animals, or society in general;
  • the species selected and the number of animals to be used is justified;
  • pain and suffering will be minimized, and
  • the animals used will be treated humanely and will be well cared for.

Once approved, researchers may not deviate from the protocol without severe penalties. Principal investigators are responsible for seeing that personnel have received appropriate procedural and safety training.

Opposition to the use of animals in research
Some individuals and groups strongly oppose the use of animals in research, testing, and teaching, for various reasons. Some have a philosophical objection, on the grounds that animals have rights that prevent humans from using them in any way (including as pets or food). Others are concerned that animals used in research suffer needlessly, and believe that alternatives to animal research should always be used. Well-publicized cases of animal misuse or abuse have supported these arguments, and irresponsible investigators not only violate a moral code, but also risk their own research and jeopardize the public's willingness to permit the use of animals in research.

References

  1. Questions and Answers about the Animal Welfare Act and Its Regulations for Biomedical Research Institutions. United States Department of Agriculture, National Agricultural Library
  2. Public Health Service Policy on Humane Care and Use of Laboratory Animals

PSU Policies

  • Policy RA15: Care and Use of Vertebrate Animals

    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.

  • Policy SY23: Occupational Health and Safety Progeam for Animal Care Personnel

    To provide a safe work place and to comply with regulatory mandates for animal care personnel. These personnel may, in the course of their employment, research or education, be exposed to vertebrate animals and/or tissues, fluids, secretions, and excretions in a way that puts them at increased risk of an occupational illness or injury. Occupational Health Services (OHS) and Environmental Health and Safety (EHS) administer the Occupational Health and Safety Program (OHSP), in cooperation with the Office for Research Protections (ORP) and the Institutional Animal Care and Use Committee (IACUC).

  • Guideline RAG16: The Responsible Conduct Of Research

    The Pennsylvania State University is committed to fostering integrity in the conduct of research. All members of the research community, including faculty, research staff, students, fellows, adjunct faculty, and visiting researchers, are expected to adhere to the highest ethical and professional standards as they pursue research activities to further scientific understanding.

    The goal of the Guidelines is to offer a set of values, principles, and standards to guide decision-making and conduct throughout the research process. It is not intended to provide a set of rules that prescribe how researchers should act in all situations. Rather, the Guidelines are intended to increase awareness of research integrity and outline the University's expectations for ethical behavior amongst all researchers.

    The Guidelines discussed are not mutually exclusive. There are many circumstances when many of them apply to a single project or activity. The risks of non-adherence to the Guidelines can be both personally and institutionally great. Potential consequences of non-adherence are outlined in the University polices that form the foundation for these Guidelines.

Federal Policies

Resources

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Case Studies

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