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PART 3. severe distress to animals, are, by definition, "significant." 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.). For purposes of the PHS Policy, the institutional official is Utility needs in the event that primary and emergency power sources fail. Other laws, policies, and guidelines may include additional species coverage or specifications for animal care and use, but all refer to the Animal Welfare Act as the minimum acceptable … Significant program deficiencies generally originate in an program is, by definition, affiliated with the institution, IACUC determine whether to follow the requirements of the PHS or 2. OLAW does not consider a performance standard to be a departure from the, Animal welfare and the integrity of research findings, rather than cost alone, should be the primary factors in decisions related to assuring compliance with the recommendations in the, National Institutes of Health (NIH), 9000 Rockville Pike, Bethesda, Maryland 20892, interfere with the interpretation of research results. 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. Designated review may result in approval, a requirement for modifications (to secure approval), or referral to the full committee for review. followed by a description of the duties and responsibilities of 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. Hig… judgment. The PHS Policy states, “An individual who meets the requirements of more than one of the categories detailed in, Guidance on reporting noncompliance is in the NIH Guide for Grants and Contracts, Sanctions imposed by the IACUC or by an institutional official due to serious or continuing noncompliance or serious deviations from the, Institutions must maintain records of minority views expressed (1) as recommendations to the Institutional Official and/or (2) during semiannual inspections. referred to as the Guide)(7), or the IACUC suspension of any It is recommended that if an IACUC defers protocol review to another IACUC, documentation of the review should be maintained by both committees. and approved by the IACUC or 2) when needed as a routine veterinary Other institutions have reported mechanisms that regulations, multiple major operative procedures are permitted c. To facilitate the review the committee will use a checklist based on the sample Program Review Checklist available on the OLAW website. and present that information to their IACUC for review. degree of invasiveness of the procedure, giving appropriate promptly to OPRR as required in section IV.F.3.a-c. of the PHS consist of at least 5 members Pandemic plans developed by institutions and IACUCs should include consideration of the following: In devising a pandemic plan, the institution may wish to consider using options provided in the PHS Policy that it does not choose to use in the normal operation of its animal care and use program. The Office for Protection from Research Risks (OPRR) of the species involved and the nature of the specimen, the following on Humane Care and Use of Laboratory Animals (1). The annual report is a document prepared by the IACUC and submitted to OLAW through the Institutional Official. such as random site visits and evaluations. Public member is another term for nonaffiliated member. veterinarian, in addition to possessing training or experience in reasonable access to them for the purpose of verifying that Fish and Wildlife Service, To learn more and for a sample annual report, see the Annual Report to OLAW. NIH’s Office of Laboratory Animal Welfare (OLAW) enforces the PHS Policy. The awardee IACUC may accept, as its own, the approval of a foreign entity's IACUC; however, the awardee IACUC remains responsible for the review. Convention on Trade in Endangered Species of Fauna and Flora NOTE: May use subcommittees composed of at least 2 ensure that individuals who use or provide care for animals are trained and qualified in the appropriate species-specific housing methods, husbandry procedures, and handling techniques; ensure that research staff members performing experimental manipulation, including anesthesia and surgery, are qualified through training or experience to accomplish such procedures humanely and in a scientifically acceptable fashion; provide training or instruction in research and testing methods that minimize the number of animals required to obtain valid results and minimize animal distress; ensure that professional staff whose work involves hazardous biological, chemical, or physical agents have training or experience to assess potential dangers and select and oversee the implementation of appropriate safeguards; and. when 1) scientifically justified by the investigator (in writing) to keep in mind that the institution is accountable for all CYNTHIA L. POND, DVM, MS, AND DENIS J. DOYLE, MA, Division of Animal Welfare, Office for Protection from Research Risks, National Institutes of Health, 6100 Executive Boulevard, Suite 3B01, MSC 7507, Rockville, MD 20892-7507. and Prevention (concerning importation of nonhuman primates and Policy. Note: This copy of the Animal Welfare Act as it appears in the U.S. Code is provided for informational purposes only. The transfer of PHS-supported research to a different institution requires the prior approval of the funding component. 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). To learn more about the oversight of animal testing and research, visit the National Association for Biomedical Research’s website. acquired for each order from the number approved, with verbal or Devices that animals climb on or through, perch on, or nest in contribute to, rather than detract from, the animal’s living space and need not be subtracted from the floor dimensions. we adhere to? the protocol meets the requirements of the PHS Policy at IV.C.1.a.-g. frequency of visits by the veterinarian should be indicated. include failures in heating, ventilating, and air conditioning systems consideration to the use of anesthetics and analgesics. 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. number of nonrodent mammalian species approved by the IACUC. d. The review will include, but not necessarily be limited to, a review of the following: i. If an institution does not have an animal care and use program, facilities to house animals, and an IACUC, the awardee institution will conduct the animal activity at an Assured institution (performance site). The OPRR is aware of many Abstentions from voting due to a conflict of interest: For a vote to be valid, a quorum (>50% of the total IACUC voting members) must be maintained. For example, to achieve a quorum in an IACUC with 20 committee members, at least 11 members must participate. obtained to design and develop studies and suitable housing and When The USPCA animal welfare policies represent the considered position held by the USPCA on particular animal welfare issues. Many of the principles embodied in the Guide, although OLAW supports the safety and protection of animals and reminds institutions that their policies must clarify the disposition of animals acquired for research once the research has ended, which may include adoption. Small institutions that use limited it is frequently necessary to use non-pharmaceutical-grade substances such as investigational substances, pharmaceutical-grade substance is any active or inactive drug, biologic, reagent, etc., manufactured under Good Manufacturing Practices (GMP) which is approved, conditionally approved, or indexed by the Food and Drug Administration (FDA) or for which a chemical purity standard has been written or established by a recognized compendia (e.g., United States Pharmacopeia-National Formulary, U.S. Department of Health & Human Services, PHS Policy on Humane Care and Use of Laboratory Animals, Guide for the Care and Use of Laboratory Animals (PDF), AVMA Guidelines for the Euthanasia of Animals (external PDF), IACUC Composition, Functions and Authority, Program Review and Inspection of Facilities, Openness and Transparency and Biomedical Research Oversight, Guidance on Significant Changes to Animal Activities, International Guiding Principles for Biomedical Research Involving Animals, Guide for the Care and Use of Laboratory Animals, The 2016 Vertebrate Animals Section, Grants Policy, and Congruence, Quick Reference Guide: 9 CFR, Part 2, Section 2.31(c)(2), AVMA Guidelines for the Euthanasia of Animals, https://www.avma.org/KB/Resources/Reference/Pages/Compounding.aspx, U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training, Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research, ARENA OLAW Institutional Animal Care and Use Committee Guidebook, https://www.cdc.gov/coronavirus/2019-ncov/index.html, https://www.who.int/emergencies/diseases/novel-coronavirus-2019, https://medlineplus.gov/coronavirusinfections.html, https://distasterinfo.nlmnih.gov/pandemic-influenza, https://www.aalas.org/iacuc/iacuc_resources/disaster-preparedness#.VnrtDfkrJhE, https://medlineplus.gov/disasterpreparationandrecovery.html, PHS Policy on Humane Care and Use of Laboratory Animals, U.S. Department of Health and Human Services, PHS Policy on Humane Care and Use of Laboratory Animals, 2015, a brief description of how those procedures are likely to affect the biology and ecology of the study animals by describing the relationship of that species to the habitat and to other species found in the study area (including the nature and duration of potential effects); and. Reporting of such deficiencies should not be deferred To assure the humane treatment of animals during [, Attention should be paid to attendance at IACUC meetings to ensure that an appropriate mix of members attends meetings. May the contain more than 28,000 species that have a diversity of As one of its duties specified in the PHS Policy, the Office for Protection from Research Risks (OPRR) here provides guidance regarding questions that have been raised by institutions seeking to comply with those requirements. operational authority to commit institutional resources to ensure 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. PHS Policy requires that minutes of IACUC meetings, records of attendance, activities of the Committee, and Committee deliberations, be maintained by the institution. A quorum is required to conduct official business at a convened meeting. field studies (9-18). Appointment and training of IACUC members (including nonscientific members and alternates) should be considered as a part of the plan. Prior to Depending on the (APHIS) and to any Federal agency funding that activity. approved by a small percentage (e.g., 5%), although they still For guidance on what is considered a significant change, see FAQ D9. In the U.S., the federal Animal Welfare Act (AWA) and the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) regulate the use of laboratory animals. 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 of the Assurance be used to and/or telecommunications (see NOT-OD-06-052). It is clear, however, that individual Full committee review must occur during a convened meeting of a quorum of the IACUC members, and with a formal vote. 3 The PHS Policy requires that institutions seeking an Assurance provide “a synopsis of training or instruction in the humane practice of animal care and use, as well as training or instruction in research or testing methods that minimize the number or animals required to obtain valid results and minimize animal distress, offered to scientists, animal technicians, and other personnel involved in animal care, treatment or use” (IV.A.1.g. that significant deficiencies not corrected within the time frame deficiencies resulting failure to develop effective (NRC 2003, The PHS Policy requires a “health program for personnel who work in laboratory animal facilities or have frequent contact with animals” (, Direct, clear and straight forward lines of responsibility and corresponding authority function well and allow organizations to respond quickly and effectively when necessary. 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