Protocol Submission Policy
Virginia Tech must provide assurance to several federal agencies that the acquisition, care, and use of vertebrate species in research and teaching is in accordance with applicable laws, regulations, guidelines, and policies (i.e., the federal Animal Welfare Act and AWA Regulations, Public Health Service Policies, U.S. Government Principles, and the Guide for the Care and Use of Laboratory Animals - the Guide). Virginia Tech is a Registered Research Facility with the USDA Animal and Plant Health Inspection Service Animal Care organization. We also have an approved Animal Welfare Assurance on file with the NIH Office for Laboratory Animal Welfare (OLAW).
While the University must provide regulatory compliance assurance, it is the responsibility of faculty, staff, and students, both as individuals and collectively, to provide appropriate animal care and handling in their use of vertebrate species in teaching and research, and to adhere to Virginia Tech policies governing the use of animals as well as adhering to applicable federal regulations and guidelines. Inappropriate handling or use of animals by a single individual could jeopardize federal authorizations to house and use animals, and could also result in withdrawal of federal funding for all animal research at the University. Thus it is in everyone's best interest to ensure not only personal compliance, but also compliance by faculty peers, staff, and students. Signs describing contact procedures for reporting misuse or abuse of animals used in teaching or research have been prominantly posted in animal holding facilities across the campus.
As required by the Animal Welfare Act and PHS Policies, Virginia Tech has an Institutional Animal Care and Use Committee (the Animal Care Committee), to provide oversight and assessment of regulatory compliance by the University as a whole, and also by individuals who care for and use animals in research and teaching.
The University Veterinarian, assisted by staff within the Office of the University Veterinarian and Animal Resources, provides oversight of compliance assurance, delivery and documentation of training, clinical and surgical care, and guidance on research methodologies which enhance and maintain animal well-being.
The federal "Laboratory Animal Welfare Act" was passed by Congress in 1966, in response to vocal public concerns about the theft and sale of pet animals for research purposes, and concerns about the housing and treatment of animals in research facilities. The Department of Agriculture (USDA), through its Animal and Plant Health Inspection Service (APHIS), was given the responsibility for implementing the Act. Animal dealers and research facilities were required to be licensed by or registered with USDA.The AWA requires that minimum standards of care and treatment be provided for certain animals bred for commercial sale, used in research, transported commercially, or exhibited to the public. Individuals who operate facilities in these categories must provide their animals with adequate care and treatment in the areas of housing, handling, sanitation, nutrition, water, veterinary care, and protection from extreme weather and temperatures. Although Federal requirements establish acceptable standards, they are not ideal. Regulated businesses are encouraged to exceed the specified minimum standards.
The original Act provided coverage of only six animal species under the definition of "animal": dogs, cats, rabbits, hamsters, guinea pigs, and nonhuman primates. To this date, the Act does not provide coverage of those species which comprise 90% of all animals used in research, teaching, and testing - namely rats and mice.
The Act was amended in 1970, at which time it was renamed the "Animal Welfare Act" [AWA] (P.L. 91-579), and provided for regulatory coverage of animal use prior to, during, and after experimentation. That amendment also extended coverage to wild, warm-blooded vertebrate species used in research. The AWA was again amended in 1976, setting standards for and licensure of common carriers involved in the transport of covered animal species. Finally, in 1985 the AWA was amended by the "Improved Standards for Laboratory Animals Act" (P.L. 99-198), with a number of significant advancements/requirements:
- A requirement for the CEO to appoint an Institutional Animal Care and Use Committee [IACUC];
- Mandatory IACUC review/approval of all proposals involving covered species;
- IACUC inspection of animal facilities every 6 months;
- The provision of training of all personnel handling/caring for or using animals;
- Establishment of a Program of Veterinary Care;
- Implementation and documentation of programs for assuring adequate exercise for dogs; and,
- Implementation and documentation of programs for assuring the provision of "environmental enrichment" for nonhuman primates.
Farm animals used for biomedical research were included in a subsequent amendment (refer to USDA-APHIS-Animal Care Policy #26 and Policy #29 here). USDA-APHIS-AC has adopted two guides, the "Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching", published by the Federation of Animal Science Societies, and the "Guide for the Care and Use of Laboratory Animals", published by the Institute for Laboratory Animal Research (ILAR), as the basis for provision of husbandry and veterinary care for farm animal species used in biomedical research).
In addition to providing the required standards of veterinary care and animal husbandry, regulated research facilities must provide dogs with the opportunity for exercise and promote the psychological well-being of primates used in laboratories. Researchers must also give regulated animals anesthesia or pain-relieving medication to minimize the pain or distress caused by research if the experiment allows. The AWA also forbids the unnecessary duplication of a specific experiment using regulated animals. Research facilities must establish an institutional animal care and use committee [IACUC] to oversee the use of regulated animals in teaching, testing, and research. This committee is responsible for ensuring that the facility remains in compliance with the AWA and for providing documentation of all areas of compliance to APHIS. The committee must be composed of at least three members, including one veterinarian and one person who is not affiliated with the facility in any way.
You can view the chapters of the Animal Care Regulations (01-01-2006 Edition, Title 9 CFR - Animals and Animal Products) that pertain to the IACUC, USDA regulatory compliance, animal welfare, and animal housing in research and teaching institutions, by clicking on the links below:
- Part 1 - Definition of Terms
- Part 2 - Regulations
- Part 3 - Standards
- Part 4 - Rules of Practice Governing Procedures under the Animal Welfare Act
You can view a copy of the Title 7 Animal Welfare Act pertaining to recordkeeping, registration, transportation, and identification of animals by dealers, exhibitors, research facilities, intermediate handlers, and carriers (Chapter 54 - Transportation, Sale and Handling of Certain Animals, Sec. 2131, updated January 27, 2006) by clicking here.
At least once annually, Virginia Tech undergoes an unannounced federal inspection by a veterinarian from USDA-APHIS-AC. This will occur during normal business hours. The inspector must be granted full access to all facilities which house or use regulated animal species, and has the authority to take photographs of animals or facilities to document deficiencies. In addition to inspecting animal facilities, the inspector reviews records of the Institutional Animal Care and Use Committee, animal acquisition records for dogs and cats, and applicable clinical records for regulated species.
If an inspection reveals deficiencies in meeting the AWA standards and regulations, the inspector will instruct the facility to correct the problems within a given timeframe. If deficiencies remain uncorrected at the unannounced followup inspection, APHIS documents the facility's deficiencies and considers possible legal action. APHIS also conducts reviews and investigates alleged violations. Some cases are resolved with Official Notices of Warning or agency stipulation letters, which set civil penalties for the infractions. Civil penalties include cease-and-desist orders, fines, and license suspensions or revocations. If APHIS officials determine that an alleged AWA violation warrants additional action, APHIS submits all evidence to the USDA for further legal review.
Annual Report Submission
A description of the "Annual Report for Research Facilities" is provided in Policy #17 (link here) of the USDA-APHIS-AC Policy Manual. Virginia Tech must submit an annual report detailing the use of animal species regulated by the Animal Welfare Act to the USDA-APHIS-AC regional office in Raleigh, NC on or before December 1 of each year. The Research Compliance Office, assisted by the University Veterinarian, compiles information related to numbers of animals used, by species and pain category, for the reporting year (October 1 through September 30). As per the above referenced policy, animals are to be counted only once, regardless of the number of proposals in which they were used. If an animal was used in more than one proposal, it must be counted in the most painful category. Animals used in multi-year studies will be counted once each fiscal year. Specific components and assurances contained within the Annual Report are described in the AWA Regulations at Section 2.36 here.
The Annual Report is reviewed and signed by the designated Institutional Official (the Vice Provost for Research) before submission to the USDA-APHIS-AC regional office.
It is the Policy of the Public Health Service (PHS) to require institutions to establish and maintain proper measures to ensure the appropriate care and use of all animals involved in research, research training, and biological testing activities (hereinafter referred to as activities) conducted or supported by the PHS. The PHS endorses the "U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training" [provided below] developed by the Interagency Research Animal Committee. The PHS Policy is intended to implement and supplement those Principles.
The PHSPolicy is applicable to all PHS-conducted or supported activities involving animals, whether the activities are performed at a PHS agency, an awardee institution, or any other institution and conducted in the United States, the Commonwealth of Puerto Rico, or any territory or possession of the United States. No PHS support for an activity involving animals will be provided to an individual unless that individual is affiliated with or sponsored by an institution which can and does assume responsibility for compliance with the Policy, unless the individual makes other arrangements with the PHS. The Policy does not affect applicable state or local laws or regulations which impose more stringent standards for the care and use of laboratory animals. All institutions are required to comply, as applicable, with the Animal Welfare Act, and other Federal statutes and regulations relating to animals.
No activity involving animals may be conducted or supported by the PHS until the institution conducting the activity has provided a written Assurance acceptable to the PHS, setting forth compliance with the PHSPolicy. Assurances are submitted to the Office of Laboratory Animal Welfare (OLAW), Office of the Director, National Institutes of Health. All Assurances submitted to the PHS in accordance with this Policy are evaluated by OLAW to determine the adequacy of the institution's proposed program for the care and use of animals in PHS-conducted or supported activities. Without an applicable PHS-approved Assurance, no PHS-conducted or supported activity involving animals at the institution will be permitted to continue. Individual investigators at Virginia Tech do not have to submit an Assurance. A single assurance for the entire university has been submitted by the Research Compliance Office.
A full-text copy of the PHS Policy can be viewed by clicking here. A copy of the Health Research Extension Act of 1985 (Public Law 99-158, November 20, 1985 "Animals in Research") can be viewed by clicking here. A copy of the Animal Enterprise Protection Act of 1992(Public Law 102-346--Aug. 26, 1992) related to disruption, terrorist or criminal acts committed against research facilities can be viewed by clicking here.
An on-line tutorial for new animal care and use committee members, institutional administrators, investigators, animal care personnel, veterinarians, or others who are interested in learning about the PHS Policy on Humane Care and Use of Laboratory Animals can be viewed by clicking here.
The development of knowledge necessary for the improvement of the health and well-being of humans as well as other animals requires in vivo experimentation with a wide variety of animal species. Whenever U.S. Government agencies develop requirements for testing, research, or training procedures involving the use of vertebrate animals, the following principles shall be considered; and whenever these agencies actually perform or sponsor such procedures, the responsible Institutional Official shall ensure that these principles are adhered to:
- The transportation, care, and use of animals should be in accordance with the Animal Welfare Act (7 U.S.C. 2131 et. seq.) and other applicable Federal laws, guidelines, and policies.*
- Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society.
- The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results. Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered. IV. Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals. V. Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. Surgical or other painful procedures should not be performed on unanesthetized animals paralyzed by chemical agents. VI. Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of the procedure or, if appropriate, during the procedure. VII. The living conditions of animals should be appropriate for their species and contribute to their health and comfort. Normally, the housing, feeding, and care of all animals used for biomedical purposes must be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied. In any case, veterinary care shall be provided as indicated. VIII. Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. Adequate arrangements shall be made for their in-service training, including the proper and humane care and use of laboratory animals. IX. Where exceptions are required in relation to the provisions of these Principles, the decisions should not rest with the investigators directly concerned but should be made, with due regard to Principle II, by an appropriate review group such as an institutional animal care and use committee. Such exceptions should not be made solely for the purposes of teaching or demonstration.
*For guidance throughout these Principles, the reader is referred to the Guide for the Care and Use of Laboratory Animals prepared by the Institute of Laboratory Animal Resources, National Academy of Sciences, referenced in the next section below.
The “Guide for the Care and Use of Laboratory Animals” (the Guide) was first published in 1963, and was subsequently revised in 1965, 1968, 1972, 1978, 1985 and 2010. It is widely accepted as a primary reference on animal care and use. The purpose of the Guide is to assist institutions in caring for and using animals in ways judged to be scientifically, technically, and humanely appropriate. The Guide is also intended to assist investigators in fulfilling their obligation to plan and conduct animal experiments in accord with the highest scientific, humane, and ethical principles. The recommendations are based on published data, scientific principles, expert opinion, and experience with methods and practices that have proved to be consistent with high-quality, humane animal care and use.
The Guide is organized into four chapters on the major components of an animal care and use program: institutional policies and responsibilities; animal environment, housing, and management; veterinary medical care; and physical plant. Responsibilities of institutional officials, institutional animal care and use committees, investigators, and veterinarians are discussed in each chapter.
The Guide provides the basis for semiannual inspections and assessments of the Program of Animal Care at Virginia Tech by the Animal Care Committee. Its recommendations regarding animal housing, husbandry, veterinary medical care, preventive medicine, surgery, anesthesia and analgesia, and euthanasia provide the basis for review/assessment of research and teaching protocols by the ACC.
- To download the new guide FREE (2010 edition 8)
- To purchase the book
In the mid-1970s, Food and Drug Administration (FDA) inspectors uncovered disturbing evidence of widespread carelessness and fraudulent or questionable practices in the conduct of preclinical drug safety studies. Those problems included:
- poorly conceived experiments that were carelessly executed and/or inaccurately evaluated and reported;
- cases where technical/support personnel were unaware of the importance of standardized protocols, and the necessity for accurate observations, proper administration of test articles, and accurate record keeping;
- failure for test lab management to ensure proper supervision of personnel and critical review of procedures and test data;
- personnel involved in the studies had insufficient scientific qualifications and inadequate training to perform the job reliably/effectively; and,
- repeated evidence of improper laboratory procedures, animal care, and data management.
The FDA asked Congress to increase their statutory authority, and to outline for industry minimum guidelines for the conduct of these important safety studies. Congress promulgated the “Good Laboratory Practices Act” in 1977, and subsequently amended it in 1987 (21 CFR Part 58 - Good Laboratory Practice Regulations; Final Rule).
GLPs serve two purposes:
- they are a set of regulations published by the federal government to facilitate regulatory oversight and establish minimum standards for internal assessment of compliance assurance; and,
- they are a set of operational procedures common to and necessary for labs which produce drugs and devices intended for pre-clinical studies, or who test the safety and efficacy of drugs or chemicals.
A copy of the GLP regulations can be viewed on-line by clicking here. In that on-line reference, Section 792.90 (Animal and other test system care) of 40CFR97 provides the basis for animal care practices. It should be noted that the GLP regulations require that animal care and use practices be in compliance with the “Guide for the Care and Use of Laboratory Animals.”
An active GLP Quality Assurance Unit (QAU) exists within the Virginia-Maryland Regional College of Veterinary Medicine (VMRCVM). Contact the University Veterinarian to determine if GLP studies proposed by researchers in departments/colleges/centers outside of the VMRCVM can utilize the services of the QAU in study design and auditing.
The Animals (Scientific Procedures) Act of 1986 regulates "any experimental or other scientific procedure applied to an animal which may have the effect of causing that animal pain, suffering, distress or lasting harm."
The "Code of Practice for the Housing and Care of Animals Used in Scientific Procedures" can be viewed on-line by clicking here.
The aim of this international agreement between governments is to ensure that international trade in specimens of wild animals and plants (including their use in research) does not threaten their survival.
Additional information about CITES can be viewed on-line by clicking here.
The European Convention for the protection of vertebrate animals used for experimental and other scientific purposes applies to any animal used or intended for use in any experimental or other scientific procedure where that procedure may cause pain, suffering, distress or lasting harm. It does not apply to any non-experimental agricultural or clinical veterinary practice.
A copy of the European Convention can be viewed on-line by clicking here.