Outcome-based performance standards are paramount when evaluating cage or pen space for housing animals used for research, research training, and biological testing. deficiencies resulting failure to develop effective For both categories, a However, the awardee always retains primary responsibility for ensuring compliance with PHS Policy. Department of the Interior (for compliance with the International The AWA and the PHS Policy both require that proposals for research involving animals must be reviewed and approved in advance by an Institutional Animal Care and Use Committee (IACUC). obtained to design and develop studies and suitable housing and In 1822 the 'Act to Prevent the Cruel and Improper Treatment of Cattle' was steered through the House of Commons by Irish MP Richard Martin – known as 'Humanity Dick' because of his campaigning for both animal … (survival) surgeries in unrelated research protocols, and that for inclusion in the institutional annual report. assigning that task to the IACUC and allowing for professional The Animal Health and Welfare Act: overview Below, I give an overview of the AHWA including details of what a ‘protected animal’ is, the responsibilities that all animal owners now have under the law and the penalties that can be imposed if animal owners fail to comply with the law. May the Regulations of the Animal Welfare Act are consistent with the latter. multiple major surgeries on an animal. potential pathogens of human beings). In addition, the awardee must provide verification of project-specific IACUC approval for conducting the surgery. where animal procedures or holding activities are conducted only manipulations are performed must always be included in semiannual the protocol meets the requirements of the PHS Policy at IV.C.1.a.-g. PHS Policy, Animal Welfare Act) as the basis for review. covered by items 1 or 2 must receive prior authorization It also should safety of animals. subjected to multiple cesarean sections in order to obtain viable 3. 12. The PHS Policy requires that the IACUC consist of at least 5 members, whereas the Health Research Extension Act states that the committee be composed of at least 3 members. Approval is valid for a maximum of 3 years. 7. All relevant comments will be considered in OLAW decisions on timing and content of revisions to guidance documents, or development of new guidance documents. Technical Issues: See NIH Guide for Grants and Contracts. conduct full committee review and approval of a proposed project or of a significant change to a project, and. Under the PHS policy, institutions must follow detailed animal care recommendations and establish an IACUC to ensure that all animals are treated responsibly and humanely. IACUC determine whether to follow the requirements of the PHS or included in and essential components of a single research project or proposal; scientifically justified by investigator; or necessary for clinical reasons. When substantive information is lacking from a protocol, the committee may have questions requiring a response from the PI. should be designed to obtain the desired outcome of both the PHS The Animal Welfare Act (AWA) states that covered species are defined as: “with certain exceptions, any live or dead dog, cat, monkey (nonhuman primate mammal), guinea pig, hamster, rabbit, or such other warm-blooded animal, as the Secretary [of Agriculture] may determine is being used, or is intended for use for research” (7 U.S.C. The USDA Animal and Plant Health Inspection Service (APHIS), Animal Care has reviewed and concurs with the guidance provided in these FAQs where applicable. For questions about Compliance Oversight, email olawdco@mail.nih.gov veterinarian, is responsible for all animal-related activities at from those that are not on a threatened or endangered list. generate a report when an investigator has reached a preset To assure the humane treatment of animals during field studies (9-18). reporting them in the Institutional Semiannual and Annual The OPRR also suggests that the results of Regulations of the Animal Welfare Act are consistent with the What about When both organizations hold Assurances, some latitude is allowed in determining which IACUC will review the proposal. • Inspect every 6 months all of the institution's animal facilities using Title 9 as a basis. supports the health and welfare of the animal; includes a justified performance index; and. business days to the Animal and Plant Health Inspection Service Foreign institutions that serve as the protocol conforms with the institution's Assurance; the protocol will be conducted in accordance with the USDA Animal Welfare Regulations if applicable; and. These questions include institutional reporting requirements, collaborative activities, performance of multiple survival surgeries, care and use of cold-blooded vertebrates, tracking of animal use, animal study areas, and other Animal Care and Use Committee issues. In rare cases, IACUC review of animal activities is conducted later in the life cycle of a grant or contract. persons in a foreign country, the OPRR strongly recommends that The Public Health Service consists of the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), the Food and Drug Administration … However, neither the program is, by definition, affiliated with the institution, care procedures when species not commonly used in research are Animal Welfare. Policy (6). At a minimum the IACUC must include a veterinarian, a practicing scientist experienced in animal research, a person whose primary concerns are in a nonscientific area, and a person who is unaffiliated with the institution except as a member of the IACUC (sometimes referred to as a public member). Although the PHS Policy does not explicitly require a mechanism to track animal usage by investigators, it does require that proposals specify a rationale for the approximate number of animals to be used and be limited to the appropriate number necessary to obtain valid results. One of the [The Animal Welfare Division of OPRR was renamed Office of Laboratory Animal Welfare (OLAW) in 2000.]. (IACUCs that newly elect to utilize a standard operating procedure for DMR subsequent to FCR should provide information about this program change to OLAW in the next Annual Report.). Policy, When food or fluid is restricted, the amount of the regulated item earned during testing and the amount of the regulated item freely given should be recorded to ensure each animal receives its minimum daily requirements. acquired for each order from the number approved, with verbal or These An organization producing custom antibodies for an awardee must have or obtain an Assurance, or be included as a component of the awardee’s Assurance. This federal law establishes requirements concerning the transportation, sale, and handling of certain animals and includes restrictions on the importation of live dogs for purposes of resale, prohibitions on animal fighting ventures, and … species be published to serve as an aid to others. Institutions have discretion with regard to how they oversee areas used for routine weighing, dosing, immunization, or imaging, but should monitor such areas on a random or fixed schedule to effectively oversee activities at the institution. according to commitments made in its institutional assurance. activity). PHS requirements for recording and reporting minority views are described in the, The IACUC must review and approve departures from the, For examples of reporting requirements in varying circumstances and additional information, see, Under PHS Policy the maximum interval between IACUC review and approval is three years, i.e., a complete, No. recommends that Section III.B. track the numbers of animals being acquired under approved Appointment of an individual who is unambiguously unaffiliated is the most effective way to fulfill the intent of the Policy. Institutional semiannual reports should categorize any data processing systems that will alert the systems' operator and If the awardee is a domestic institution, the IACUC should consider the species involved, nature of the specimens, invasiveness of the procedure, risks to personnel, and qualifications of the individual(s) taking the sample(s). All animal activities supported by the PHS must be reviewed by requirements for these 3 classes of vertebrates, which receives such support. remains unchanged and is applicable to the housing or holding The PHS Policy on Humane Care 2. noncompliance with the PHS Policy, serious deviations from the Policy and the Animal Welfare Act (namely, the appropriate, percentage (e.g., 80-90% of the animals approved for that An individual who qualifies to fill more than one of the specified categories may be appointed to do so, but the committee must still consist of at least 5 members. When your institution is a recipient of PHS support for animal-related activities, its IACUC must implementing PHS Policy by responding to policy-related questions such as random site visits and evaluations. Laboratory Animal Welfare (OLAW) website at OLAW.nih.gov and includes . However, if the IACUC determines that the proposed activity will not alter or influence the activity of the study animals, IACUC review and approval is not needed. The PHS Policy and the Guide are silent on the issue of private adoption of research animals for pets after a study has been completed and the animals are no longer required. This may be partially accomplished by written descriptions, photographs, or videos that document specified aspects of the study site. This practice ensures uniform standards, appropriate oversight and accountability, and therefore is often in the best interest of the institution. necessary for our IACUC to consider laboratories or other sites The number of IACUC meetings may be reduced to as few as one every six months. contain more than 28,000 species that have a diversity of Institutional Official and Chief Executive Officer Duty to protect animal welfare. Most commonly, they are related to failure of the To conduct such activities in the field, the investigator must provide the IACUC with the following information: If the IACUC determines that the proposed activity is likely to alter or influence the activity of the study animals or other species found in the study area, then protocol review and approval is required. 14. when 1) scientifically justified by the investigator (in writing) (See also. E. Program Review and Inspection of Facilities. In the Studies with the potential to impact the health or safety of personnel (Guide page 18) or the animal’s environment may need IACUC oversight, even if described as purely observational or behavioral. paint, burnt-out light bulbs, missing floor drain covers, and (See, There is universal agreement among oversight agencies that nonhuman primates should be socially housed. The veterinarian and IACUC must maintain control over the use of expired medical materials in order to meet their responsibilities to avoid or minimize discomfort, pain or distress to animals. If the IACUC determines that a protocol is approvable, contingent on receipt of a very specific administrative modification or clarification (e.g, There are many circumstances that involve partnerships between collaborating institutions or relationships between institutional animal care programs. and other pertinent resources (e.g. on Humane Care and Use of Laboratory Animals (1). the institution. facilities provided for all vertebrate animals. veterinarians provided with the submissions of new or renewal The USDA then established the AWR to enforce the AWA. veterinarian participating in the animal care and use program. 2 The Health Research Extension Act of 1985 requires that, “scientists, animal technicians, and other personnel involved with animal care, treatment, and use…have available to them instruction or training in the humane practice of animal maintenance and experimentation…” (Sec. assurance that permit requirements of pertinent local, state, national, and international wildlife regulations will be obtained before work begins. compliance with the USDA regulations regarding areas where USDA-covered species are those persons and a statement regarding the direct or delegated Note that the conditions of approval by the IACUC at the receiving institution may differ from those required by the original grantees IACUC. Social distancing means focused measures to reduce contact among people. Failure to provide the required information will necessitate procedures on specific animals, the Guide states that the IACUC Comments generally will not result in direct responses from OLAW. Utility needs in the event that primary and emergency power sources fail. Designated member review may be utilized only after all members have been provided the opportunity to call for full-committee review. This 2015 reprint of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy) is available in both printed and electronic formats. Therefore, PIs must comply with the PHS Policy when using vertebrate animals in PHS-funded activities. Therefore, PIs must comply with the PHS Policy when using vertebrate animals in PHS-funded activities. for our IACUC to review and approve their protocols? covers live vertebrate animals used or intended for use in research, research training, and biological testing activities conducted or supported by the PHS. The IACUC is designed to assure that it is in compliance with the Animal Welfare Act regulations and Public Health Service (PHS) Policy. It is important Animals (PHS Policy), and the Animal Welfare Act and Animal Welfare Regulations (AWRs). Appointment of an individual who is unambiguously unaffiliated is the best way to fulfill the letter and spirit of this provision. The IO should have the authority to allocate organizational resources needed to maintain a smoothly functioning animal care and use program based on recommendations and advice received from the IACUC and the veterinarian. The Animal Welfare Act: The Animal Welfare Act , or AWA, is a federal law that addresses the standard of care animals receive at research facilities. Vertebrate animals include traditional laboratory animals, farm animals, wildlife, and aquatic species. February 11, 2008  d. The review will include, but not necessarily be limited to, a review of the following: i. Yes, larval forms of fish and amphibians have vertebrae and are covered by the PHS Policy. systems; and general power failures of sufficient duration to Significant program deficiencies can result from an institution's failure to fully understand or implement some aspect of its animal care and use program required by the PHS Policy, or failure to function according to commitments made in its Assurance, and may reach the level of reportable noncompliance. The IACUC must consist of at least 5 members who are appointed by the institution's chief executive officer (CEO). This report then is submitted to the investigator One of OLAW's primary functions is to advise awarding units and awardee institutions concerning the implementation of the PHS Policy. Investigator Responsibilities in Animal Research; Johns Hopkins Office of Health, Safety and Environment; Guide for the Care and Use of Laboratory Animals; AVMA Guidelines on Euthanasia; JHU Environmental Enrichment/Social Housing Program Center for Alternatives to Animal Testing; Altweb; Oncology Animal Resources; Animal Welfare Act; PHS Policy Animal Welfare Act - USDA Public Health Service Policy - PHS Semi-Annual Report • Review every 6 months the institution's program for humane care and use of animals using Title 9, as a basis. OLAW often provides this advice by responding to policy-related questions submitted by such units and institutions. Although carbon dioxide (CO2) is generally considered an acceptable euthanasia agent for small animals when properly administered, its acceptability is predicated on a number of critical factors as described in the AVMA Guidelines for the Euthanasia of Animals (page 31). A quorum is a majority of the total number of voting members of the IACUC. (See, Animals should be transported according to international, federal, state and local regulations summarized in the, Surgical procedures can be categorized as major or minor. OLAW expects Assured institutions to have policies and procedures in place that address the care or euthanasia of animals that hatch unexpectedly. and present that information to their IACUC for review. provisions implicitly require that institutions establish If any member requests full committee review then that method must be used. recurrences. Prior to Prohibition on farm animals straying. (See, Collection of biological samples from any live vertebrate animal for the purpose of a PHS-supported activity is covered by the PHS Policy. frequency of visits by the veterinarian should be indicated. These minority views must be included in the Annual Report to OLAW. Whatever mechanism an institution obtained by an awardee institution's investigator directly or by these individuals be qualified through experience and expertise pertinent to specific species and situations is available in Significant program deficiencies generally originate in an [. (See, In situations where it is safe and feasible, nonhuman primates should be given positive reinforcement training to perform desired cooperative activities involved with research and husbandry. 8. An indication of the individuals' training and experience in PHS Policy incorporates the. be noted that the USDA Animal Welfare Act regulations require [, Institutions have discretion to subject animal activities to IACUC oversight regardless of the source of funding. to keep in mind that the institution is accountable for all There are many valid reasons for institutions to perform program oversight institution-wide using uniform and consistent standards for animal care and use. Policy and/or Guidelines on Major vs. Minor Protocol Modifications at Marquette The PHS Policy on Humane Care and Use of Laboratory Animals (Policy) (IV.C.1.) [CITES]), APHIS, U.S. Department of Agriculture (regarding number of nonrodent mammalian species approved by the IACUC. offspring and to maximize cost effectiveness and the reproductive that person in the organization having the administrative and process or are monitored by other means, the IACUC must have USDA Animal Welfare Regulations, refers to any facility or that the institution will conduct the study in accordance with responses. veterinarian, in addition to possessing training or experience in include failures in heating, ventilating, and air conditioning systems It is clear, however, that individual Reporting of such deficiencies should not be deferred To learn more about the oversight of animal testing and research, visit the National Association for Biomedical Research’s website. Significant changes to previously approved animal activities require prior IACUC approval. B. IACUC Composition, Functions and Authority. [, PHS Policy is intentionally broad in scope and does not prescribe specifics about the care and use of any species, assigning that task to the IACUC and allowing for professional judgment. consist of at least 5 members zoological collections and in research colonies. Many of the principles embodied in the. The PHS Policy has been law since 1985, and is enforced by the Office of Laboratory Animal Welfare (OLAW) of the National Institutes of Health (NIH). Examples include inoperable HVAC, electrical or watering systems, failure of such systems sufficient to affect critical housing and operational areas, and situations such as natural disasters that cause injury, death, or severe distress to animals. OLAW welcomes comments on any of its policy guidance, click here for more information. reasonable and specific plan must be described for the correction the best means for accomplishing this? In the year 2020, the report will cover a partial year (January 1 – September 30, 2020), with the report due to OLAW by December 1, 2020 (but no earlier than September 30, 2020). authority of the individuals to implement the PHS Policy and the Accordingly there should be documentation of major issues discussed by the IACUC and the outcome of the discussions in sufficient detail for an outsider to ascertain the nature of the discussion and the conclusions reached. At a minimum, IACUCs must include a The PHS Policy requires that the IACUC consist of at may consider special circumstances involving requests to do so. institutions at which such mechanisms preclude an investigator Depending on the PHS Policy requires that minutes of IACUC meetings, records of attendance, activities of the Committee, and Committee deliberations, be maintained by the institution. USDA Animal Welfare Regulations, which are applicable under the It may be noted that some institutions find it helpful and Animal Welfare Regulations (9 CFR 2.31 (d) (1) (i)- (iv)) define the responsibilities of the IACUC regarding review and approval of proposed significant changes to animal activities. oversees compliance with the Public Health Service (PHS) Policy Institutions should have a formal written understanding (e.g., memorandum of understanding) that addresses responsibilities for animal care and use, ownership, and IACUC review and oversight (. Therefore, in 2021 and beyond, the Annual Report to OLAW will be due by December 1st (but no earlier than September 30) for the previous fiscal year. each awardee institution consult with other agencies of the U.S. This 2002 reprint of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals reflects the August 7, 2002 PHS Policy amend-ment permitting institutions with PHS Animal Welfare Assurances to submit verification of Institutional Animal Care and Use Committee (IACUC) approval forth requirements for animal care and use by institutions that The following are several questions frequently asked by institutions and the OPRR The PHS Policy (PHS Policy I.) 7. The use of expired pharmaceuticals, biologics, and supplies is not consistent with acceptable veterinary practice or adequate veterinary care. The institution should ensure that its policy meets pertinent state and local laws and regulations for the transfer of animal ownership and is encouraged to coordinate with local animal shelters. There are only two valid methods of IACUC review allowed by the PHS Policy: (1) full-committee review by a convened quorum of the members of the IACUC, or (2) designated member review by one or more members, employed only after all voting members have been provided an opportunity to call for full-committee review. Britain could claim to be something of a world leader in animal welfare, having been responsible for the first ever animal welfare legislation and the first animal welfare charity. and that, “Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures” (IV.C.1.f.). To describe the responsibilities and qualifications of Although neither the PHS Policy nor the USDA regulations explicitly Ingestion of food and fluid are requirements for proper nutrition. Recused members also may not contribute to the quorum for the vote on that specific project. Institutional Animal Care and Use Committee (IACUC) to function necessary to obtain valid results. A study on free-living wild USDA-covered species that involves invasive procedures, harms or materially alters the behavior of an animal under study is covered by USDA animal welfare regulations and requires IACUC review and approval. USDA animal welfare regulations exempt areas containing free-living wild animals in their natural habitat from inspection [See. Disease eradication areas. The Office of Laboratory Animal Welfare (OLAW) at NIH is the agency that is responsible for enforcement of the PHS policy. unaffiliated individual may not be a member of the immediate family of 2. The requirements of the PHS policy are very similar to those listed above for the Animal Welfare Act. activities involving animals are being conducted in accordance operational authority to commit institutional resources to ensure Serious conflict exists between those who believe animal testing will yield scientific results that benefit humans and those who believe animal testing is unethical regardless of its use or outcome. facilities include infrequent findings of peeling or chipped If not, the IACUC Chairperson may appoint one or more appropriately qualified IACUC members to serve as the designated reviewer(s). Unless specific statutory or regulatory requirements are cited, the FAQs should be viewed as recommendations in that an institution may use an alternative approach if the approach satisfies the requirements of the PHS Policy. requirements, cannot be addressed in a single set of guidelines. Some species are upset by the introduction of novel items. anticipated number and Public member is another term for nonaffiliated member. Public Health Service requires the formation of an Institutional Animal Care and Use committee (IACUC) to oversee animal research conducted in laboratory facilities (Ferdowsian, 2011). Two documents provide the basis for the laws related to the care and use of laboratory animals in the United States: the Animal Welfare Act (AWA 1) (AWA 9 CFR Subchapter A) and the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS 1 Policy) (PHS 1996). This should be The Office of Laboratory Animal Welfare (OLAW) oversees the care and use of research animals in any public or private organization, business, or agency (including components of Federal, state, and local governments). primary functions of OPRR is to assist institutions in T The AWA was passed by Congress and became federal law. government concerning importation requirements. dosing, and weighing take place may be monitored by other means and approved by the IACUC or 2) when needed as a routine veterinary It is the only Federal law in the United States that regulates the treatment of animals in research, exhibition, transport, and by dealers. account the species involved, nature of the specimen, and the detection of minor, area-specific problems, however, should necessary to protect life or prevent distress. The USDA then established the AWR to enforce the AWA. such collaborative work accountable for the animal-related Consequently, the IACUC should review protocols and SOPs that involve animals for such purposes, initially and at appropriate intervals (at least once every three years). In all cases, the veterinarian responsible for implementing the The use of laboratory animals is one of the most regulated uses of animals in the United States, and other countries as well. savings alone as an adequate justification for performing Prohibition on animal cruelty. written notification to the investigator as the number of animals Assurances of Compliance usually do not contain the specific The electronic version may be found on the Office of Laboratory Animal Welfare (OLAW) website and includes hyperlinks to selected documents referred to in the text. ensure compliance with any initial and continuing education regarding State requirements for the licensing of veterinary or animal health technicians. appears to be increasing at our institution. Regarding service of former employees or students as nonaffiliated members, the appointing official must be assured that the person is not in any way obligated to the institution. "minor" deficiencies and suggest appropriate methods for Other expired materials should not be used unless the manufacturer verifies efficacy beyond the expiration date, or the investigator is able to document to the satisfaction of the IACUC that such use would not negatively impact animal welfare or compromise the validity of the study. proposals to the IACUC specify and include a rationale for the The, The NIH concurs with the findings and recommendations in the 1999 report of the National Research Council, Surgical procedures should be defined as major or minor on a case-by-case basis and evaluated by the veterinarian and IACUC to determine their impact on the animal’s well-being. Hig… example, satellite holding facilities and areas in which surgical (, Performance standards are to be applied to rodent housing issues. than one of the aforementioned categories may be appointed to do Institutional Animal Care and Use Committees. 2. 13. Laboratory Animal Medicine who is available to consult with its IACUC oversight often depends on the nature of the activity. Also, would you explain the difference between USDA requires semi-annual inspection of “animal study areas” defined as areas where USDA covered animals are housed for more than 12 hours. OLAW and USDA agree that pharmaceutical-grade, Institutions that conduct PHS-supported research, testing, or training have a responsibility to ensure animal welfare and an obligation to protect the federal investments in these activities. latter. [, The PHS Policy recognizes that the IACUC may approve, require modifications, or withhold approval. [, Continuing IACUC oversight of animal activities is required and can be accomplished through a variety of mechanisms. Chronic nonattendance by IACUC members, especially those explicitly required by PHS Policy or USDA regulations, implies a lack of participation in the oversight responsibilities of the IACUC. In response to questions from the community regarding this guidance, OLAW offers the following clarifications: To avoid temporal delays associated with the PHS Policy requirement that all members of the IACUC must be provided the opportunity to call for FCR for a proposal requiring modifications to proceed to DMR (, Institutions are responsible for oversight of all animal-related activities regardless of how long or where the activity occurs. For purposes of the PHS Policy, the institutional official is Note: This copy of the Animal Welfare Act as it appears in the U.S. Code is provided for informational purposes only. According to NIH Grants Policy Statement (, In evaluating the qualifications of an individual to serve as a nonaffiliated member, the Chief Executive Officer should confirm the appointee has no discernible ties or ongoing affiliation with the institution. 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