The PHS policy applies to all live vertebrate animals used in teaching, research and testing. Research labs required to abide by PHS Policy include: 1. 1. The reports must contain a description of the nature and extent of the institution's adherence to the. All records shall be accessible for inspection and copying by authorized OLAW or other PHS representatives at reasonable times and in a reasonable manner. (5) A change in format, but not content, was made to PHS Policy IV.B.3. For applications and proposals covered by this Policy from institutions that do not have an approved Assurance on file with OLAW, the signature of the official signing for the applicant organization shall constitute a declaration that the institution will submit an Assurance when requested by OLAW. PHS Policy section IV.A. All of the institution's programs and facilities (including satellite facilities) for activities involving animals have been evaluated by the IACUC. 1. request and negotiate, approve or disapprove, and, as necessary, restrict or withdraw approval of Assurances; 2. distribute to Scientific Review Administrators of initial review and technical evaluation groups, and to PHS awarding units, lists of institutions [domestic and foreign] that have an approved Assurance; 3. advise awarding units and awardee institutions concerning the implementation of this Policy; 4. evaluate allegations of noncompliance with this Policy; 5. have the authority to review and approve or disapprove waivers to this Policy (see V.D. If some or all of the institution's facilities are accredited by AAALAC or another accrediting body recognized by the PHS, the report should identify those facilities as such.). The PHS Policy on Humane Care and Use of Laboratory Animals became law with the enactment of the Health Research Extension Act of 1985. 5. and 2. of this Policy, and reports prepared in accordance with IV.B.3.of this Policy. Prior to the review, each IACUC member shall be provided with a list of proposed research projects to be reviewed. Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered. The IACUC shall notify investigators and the institution in writing of its decision to approve or withhold approval of those activities related to the care and use of animals, or of modifications required to secure IACUC approval. "(c) The Director of NIH shall require each applicant for a grant, contract, or cooperative agreement involving research on animals which is administered by the National Institutes of Health or any national research institute to include in its application or contract proposal, submitted after the expiration of the twelve-month period beginning on the date of enactment of this section-. Humane Care and Use of Laboratory Animals by Awardee Institutions, now entitled Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, incorporates the changes in the Public Health Service Act (PHS Act) mandated by 2. Each institution receiving PHS funding is required to file an Animal Welfare Assurance Statement to the Office of Laboratory Animal Welfare (OLAW) and the National Institute of Health (NIH) for approval. No waiver will be granted unless sufficient justification is provided and the waiver is approved in writing by OLAW. The Guide for the Care and Use of Laboratory Animals B. PHS Policy C. Animal Welfare Act Regulations D. AVMA Guidelines on Euthanasia D. AVMA Guidelines on Euthanasia 24 T or F: Dry ice is an acceptable form of carbon dioxide for euthanizing rodents. Sponsors a voluntary accreditation program for animal care and use programs. For competing applications or proposals only, such verification may be filed at any time prior to award unless specifically required earlier by the funding component. Intramural and extramural laboratories run by the Public Health Service (including NIH itself, the Food and Drug Administration, and the Centers for Disease Control and Prevention) (6) The Guide may differ from USDA regulations in some respects. All facilities receiving Public Health Service grants, contracts, or cooperative agreements involving research on animals—the majority of which are granted by the National Institutes of Health (NIH) 2. If the IACUC suspends an activity involving animals, the Institutional Official in consultation with the IACUC shall review the reasons for suspension, take appropriate corrective action, and report that action with a full explanation to OLAW. However, those officials may not approve an activity involving the care and use of animals if it has not been approved by the IACUC. The use of laboratory animals is one of the most regulated uses of animals in the United States, and other countries as well. covers live vertebrate animals used or intended for use in research, research training, and biological testing activities conducted or supported by the PHS. The 2015 reprint of the PHS Policy reflects the following changes from the 2002 reprint: (1) On January 1, 2012, OLAW adopted the Guide for the Care and Use of Laboratory Animals: Eighth Edition (Guide), an update of the 1996 Seventh Edition, released by the National Academy of Sciences Institute for Laboratory Animal Research (ILAR) in 2011. Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy). If full committee review is not requested, at least one member of the IACUC, designated by the chairperson and qualified to conduct the review, shall review those research projects and have the authority to approve, require modifications in (to secure approval), or request full committee review of those research projects. 3. prepare reports of the IACUC evaluations conducted as required by IV.B.1. c. Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be painlessly killed at the end of the procedure or, if appropriate, during the procedure. Introduction 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 Institutions that seek funds from federal agencies for research with any vertebrate animals must follow the PHS Policy on Humane Care and Use of Laboratory Animals. Applications and proposals that have been approved by the IACUC may be subject to further appropriate review and approval by officials of the institution. The PHS Policy, frequently referred to as the NIH Policy, requires each institution receiving PHS funds for research involving animals to submit detailed information regarding the institution’s program for the care and use of animals (including farm animals, mice, and rats) to … AVMA Guidelines for the Euthanasia of Animals: 2013 Edition or succeeding revised editions. Compliance with applicable USDA regulations is an absolute requirement of this Policy. 2014; 43(4). "(3) The organization and operation of animal care committees in accordance with subsection (b). "(1) The proper care of animals to be used in biomedical and behavioral research. The PHS Policy on Humane Care 2. Public Health Service Policy on Humane Care and Use of Laboratory Animals Reports filed under IV.F. OLAW considers the CEO to be the highest operating official of the organization (such as the President of a University). 4. of this Policy. Institutions may, at their discretion, represent the names of members other than the chairperson and veterinarian with program authority (see IV.A.3.) Each awardee institution is subject to review (including unannounced site visits) at any time by PHS staff to assess the accuracy of the institution’s compliance statement. 1. All of the institution's programs and facilities (including satellite facilities) for activities involving animals have been evaluated and accredited by AAALAC, or another accrediting body recognized by the PHS.4 All of the institution's programs and facilities (including satellite facilities) for activities involving animals have also been evaluated by the IACUC and will be reevaluated by the IACUC at least once every six months, in accordance with IV.B.1. The housing, feeding, and nonmedical care of the animals will 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. Also included in this reprint are the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training (Principles). The PHS Policy incorporates the U.S. Government Principles, the Guide, and the AVMA Guidelines. Each awardee institution is subject to review at any time by PHS staff and advisors, which may include a site visit, to assess the adequacy or accuracy of the institution's compliance or expressed compliance with this Policy. PHS Policy on Humane Care and Use of Laboratory Animals (Policy) requires institutions to establish and maintain proper measures to ensure the appropriate care and use of live vertebrate animals involved in biomedical and behavioral research testing or training activities conducted or supported by the PHS. Lab Animal. Applicability of the PHS Policy Documents Relevant to the PHS Policy Guide for the Care and Use of Laboratory Animals U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training FAQ. Does the PHS Policy apply to animal research that is conducted in the field? Category 2 - Evaluated by the Institution. "(b) (1) Guidelines of the Secretary under subsection (a)(3) shall require animal care committees at each entity which conducts biomedical and behavioral research with funds provided under this Act (including the National Institutes of Health and the national research institutes) to assure compliance with the guidelines established under subsection (a). b. (2) On February 26, 2013, the American Veterinary Medical Association (AVMA) Panel on Euthanasia released the AVMA Guidelines for the Euthanasia of Animals: 2013 Edition (Guidelines). Upon such request, the institution shall prepare the Assurance as instructed by OLAW and in accordance with IV.A. and 2. of this Policy, and submit the reports to the Institutional Official; The reports shall be updated at least once every six months upon completion of the required semiannual evaluations. Procedures that may cause more than momentary or slight pain or distress to the animals will be performed with appropriate sedation, analgesia, or anesthesia, unless the procedure is justified for scientific reasons in writing by the investigator. The awardee institution shall maintain: a. a copy of the Assurance which has been approved by the PHS; b. minutes of IACUC meetings, including records of attendance, activities of the committee, and committee deliberations; c. records of applications, proposals, and proposed significant changes in the care and use of animals and whether IACUC approval was given or withheld; d. records of semiannual IACUC reports and recommendations (including minority views) as forwarded to the Institutional Official; and. of this Policy shall include any minority views filed by members of the IACUC. The reports must distinguish significant deficiencies from minor deficiencies. This reprint includes the Health Research Extension Act of 1985, Public Law 99-158, “Animals in Research” (November 20, 1985), which provides the statutory mandate for the PHS Policy. Compliance with applicable USDA regulations is an absolute requirement of this Policy. All vertebrate species used in research, teaching or testing at institutions receiving PHS funds. Researchers who use animals in research, including observational research, or teaching, can come under the jurisdiction of the USDA animal welfare regulations and/or the PHS Policy on Humane Care and Use of Laboratory Animals (hereafter, PHS Policy), which carries out the provisions of the 1985 Health Research Extension Act. e. records of accrediting body determinations. 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. 2. These programs and facilities will be reevaluated by the IACUC at least once every six months, in accordance with IV.B.1. I. APPLICABILITY OF ASSURANCE . Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy), section . If program or facility deficiencies are noted, the reports must contain a reasonable and specific plan and schedule for correcting each deficiency. The IACUC may invite ad hoc consultants to assist in conducting the evaluation. PHS Assured institutions implemented the 2013 AVMA Guidelines during the period from March 1, 2013, to September 1, 2013. (PDF - 138 KB) Using privately owned animals in a study of human subjects. Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. If the CEO delegates authority to appoint the IACUC then the delegation must be specific and in writing. of this Policy); and. The PHS Policy has been modified only once, in 2002, while the Guide, now in its 8th edition, was last revised in 2011. Compliance with applicable USDA regulations is an absolute requirement of this Policy. e. Medical care for animals will be available and provided as necessary by a qualified veterinarian. Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. • Office of Laboratory Animal Welfare (OLAW) is responsible for administration of the PHS Policy of this Policy. This Policy requires that Assured institutions base their programs of animal care and use on the Guide for the Care and Use of Laboratory Animals and that they comply with the applicable regulations (9 CFR, Subchapter A) issued by the U.S. Department of Agriculture (USDA) under the Animal Welfare Act. Institutions That Do Not Have an Approved Assurance. U.S. Department of Health and Human Service Office of Research Integrity ~ 1101 Wootton Parkway ~ Suite 240 ~ Rockville MD 20852 Noncompeting applications and contract proposals for other than full and open competitions need not repeat the information required by IV.D.1.a.-e. if the information was complete in the last competing application or proposal and there are no significant changes to that information. The Health Research Extension Act of 1985 requires the IACUC to be appointed by the Chief Executive Officer (CEO) of the entity for which the committee is established. Compliance with applicable USDA regulations is an absolute requirement of this Policy. The PHS Policy requires compliance with the USDA regulations regarding areas where USDA-covered species are maintained for any purpose for more than 12 h. The term "satellite facility", as defined in the PHS Policy, remains unchanged and is applicable to the housing or holding facilities provided for all vertebrate animals. If verification of IACUC approval is submitted subsequent to the submission of the application or proposal, the verification shall state the modifications, if any, required by the IACUC. 3. of this Policy; d. notice of the dates that the IACUC conducted its semiannual evaluations of the institution's program and facilities and submitted the evaluations to the Institutional Official. The Chief Executive Officer shall appoint an IACUC, qualified through the experience and expertise of its members to oversee the institution's animal program, facilities, and procedures. 8. It must also explain in detail the training available to scientists, technicians, and other personnel involved in animal care, treatment, or use. 2. The Assurance Statement must describe the institution’s program for care and use of all animals used in research, research training, and biological testing. All institutions that accept PHS funding. (6) Grammatical corrections were made to reflect current writing standards.. Consultants may not approve or withhold approval of an activity or vote with the IACUC unless they are also members of the IACUC. 6. The IACUC may invite consultants to assist in the review of complex issues. Failure to comply with PHS Policy can lead to various actions, including the termination of PHS service for all projects involving animals. c. any suspension of an activity by the IACUC. Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. As of the 2015 revision of this Policy, the only accrediting body recognized by the PHS is AAALAC. Notwithstanding subsection (a)(2) of section 553 of title 5, United States Code, regulations under this subsection shall be promulgated in accordance with the notice and comment requirements of such section. 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. 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 this Policy. The PHS Policy and the Animal Welfare Act and Regulations (AWAR) do not distinguish between animals owned by the institution and privately owned animals. 4. The Animal Welfare Regulations (AWR) do not currently apply to which of the following animals? As an example, an unannounced NIH site visit to a major university research center in 1986 resulted in suspension of funding for all animal research except that involving rodents and blocked future funding for all research involving animals. The most recent semiannual report of the IACUC evaluation shall be submitted to OLAW with the Assurance.​. The Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) applies to activities supported by any PHS agency. 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: *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. ). The PHS Policy (PHS Policy I.) However, each institution may identify the committee by whatever name it chooses. The verification shall be signed by an individual authorized by the institution, but need not be signed by the Institutional Official. The Assurance Statement indicates that the institution is committed to compliance with standards detailed in the Animal Welfare Act, the NIH Guide for the Care and Use of Laboratory Animals, and all other applicable laws and regulations. OLAW: Office of Laboratory Animal Welfare, Site Search | Site Index | Feedback | Staff Directory, For guidance on maintaining continuity of research and sponsored program activities during the COVID-19 crisis, please see ORSP’s, Research, Scholarship, Innovation, and Creativity, Office of Laboratory Animal Welfare (OLAW), Public Health Service Policy on Humane Care and Use of Laboratory Animals, OLAW: Office of Laboratory Animal Welfare, Chapter 4 - UM Institutional Animal Care and Use Committee ›. The PHS Policy is applicable to all PHS- supported activities involving animals, whether the activities are performed at a PHS agency, an awardee institution, or other institution (PHS Policy at I., II., III., and V.B. The name Institutional Animal Care and Use Committee (IACUC) as used in this Policy is intended as a generic term for a committee whose function is to ensure that the care and use of animals in PHS-conducted or supported activities are appropriate and humane in accordance with this Policy. Use of Laboratory Animals and the Guide for the Care and Use of Laboratory Animals (the Guide). Written descriptions of research projects that involve the care and use of animals shall be available to all IACUC members, and any member of the IACUC may obtain, upon request, full committee review of those research projects. The IACUC may, at its discretion, determine the best means of conducting an evaluation of the institution's programs and facilities. by using numbers or other symbols in submissions to OLAW. The Animal Welfare Act applies only to research institutions; PHS Policy applies to all organizations that house animals. This Policy requires that Assured institutions base their programs of animal care and use on the Guide for the Care and Use of Laboratory Animals and that they comply with the applicable regulations (9 CFR, Subchapter A) issued by USDA under the Animal Welfare Act. (4) one individual who is not affiliated with the institution in any way other than as a member of the IACUC, and is not a member of the immediate family of a person who is affiliated with the institution. Applications or proposals (competing and noncompeting) covered by this Policy from institutions that have an approved Assurance on file with OLAW shall include verification of approval (including the date of the most recent approval) by the IACUC of those components related to the care and use of animals. 2. 85-12059]. USDA Animal Care, a unit within the Animal and Plant Health Inspection Service, administers the Animal Welfare Act (AWA). Such exceptions should not be made solely for the purposes of teaching or demonstration. "(A) review the care and treatment of animals in all animal study areas and facilities of the research entity at least semiannually to evaluate compliance with applicable guidelines established under subsection (a) for appropriate animal care and treatment; "(1) assurances satisfactory to the Director of NIH that-, "(A) the applicant meets the requirements of the guidelines established under paragraphs (1) and (2) of subsection (a) and has an animal care committee which meets the requirements of subsection (b); and. As an agent of the institution, the IACUC shall with respect to PHS-conducted or supported activities: Applications and proposals (competing and noncompeting) for awards submitted to the PHS that involve the care and use of animals shall contain the following information: a. identification of the species and approximate number of animals to be used; b. rationale for involving animals, and for the appropriateness of the species and numbers used; c. a complete description of the proposed use of the animals; d. a description of procedures designed to assure that discomfort and injury to animals will be limited to that which is unavoidable in the conduct of scientifically valuable research, and that analgesic, anesthetic, and tranquilizing drugs will be used where indicated and appropriate to minimize discomfort and pain to animals; and. National Institutes of Health (NIH), 9000 Rockville Pike, Bethesda, Maryland 20892, PHS Policy on Humane Care and Use of Laboratory Animals, 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), Office of Laboratory Animal Welfare (OLAW) website, Public Law 99-158, November 20, 1985, "Animals in Research ", U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training, Public Health Service Policy on Humane Care and Use of Laboratory Animals, Functions of the Institutional Animal Care and Use Committee, Review of PHS-Conducted or Supported Research Projects, Information Required in Applications and Proposals for Awards Submitted to the PHS, Responsibilities of the Office of Laboratory Animal Welfare, Animal Welfare Act (7 U.S.C. Reports filed under subparagraph (C) shall include any minority views filed by members of the committee. 4. review concerns involving the care and use of animals at the institution; 5. make recommendations to the Institutional Official regarding any aspect of the institution's animal program, facilities, or personnel training; 6. review and approve, require modifications in (to secure approval), or withhold approval of those components of PHS-conducted or supported activities related to the care and use of animals as specified in IV.C. of this Policy; 7. review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the use of animals in ongoing activities; and. c. PHS Policy covers mice, rats, and birds. Those organizations that accept Public Health Service (PHS) or National Science Foundation (NSF) funding. Institutions in foreign countries receiving PHS support for activities involving animals shall comply with this Policy, or provide evidence to the PHS that acceptable standards for the humane care and use of the animals in PHS-conducted or supported activities will be met. IV.B.1.-2., requires the Institutional Animal Care and Use Committee (IACUC) to review the institution's program for humane care and use of animals and inspect all of the institution's animal facilities at least once every 6 months using the c. An individual who meets the requirements of more than one of the categories detailed in IV.A.3.b. This Policy requires that Assured institutions base their programs of animal care and use on the Guide for the Care and Use of Laboratory Animals and that they comply with the regulations (9 CFR, Subchapter A) issued by USDA under the Animal Welfare Act. 7. a list of every branch and major component of the institution, as well as a list of every branch and major component of any other institution, which is to be included under the Assurance; the lines of authority and responsibility for administering the program and ensuring compliance with this Policy; the qualifications, authority, and responsibility of the veterinarian(s) who will participate in the program and the percent of time each will contribute to the program; the membership list of the Institutional Animal Care and Use Committee(s) (IACUC) established in accordance with the requirements set forth in IV.A.3. a. The PHS Policy requires institutions to use this guide as a basis for developing and implementing institutional programs for research involving animals. of this Policy. b. PHS Policy requires conformity with the Guide for the Care and Use of Laboratory Animals; the Animal Welfare Act does not. ), Guide for the Care and Use of Laboratory Animals, Code of Federal Regulations (CFR), Title 9, Chapter 1, Subchapter A, Parts 1, 2, and 3, https://www.avma.org/KB/Policies/Documents/euthanasia.pdf, U.S. Department of Health and Human Services, PHS Policy on Humane Care and Use of Laboratory Animals, 2015. The IACUC shall conduct continuing review of each previously approved, ongoing activity covered by this Policy at appropriate intervals as determined by the IACUC, including a complete review in accordance with IV.C.1.-4. The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results. 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. In making this determination, the IACUC shall confirm that the research project will be conducted in accordance with the. Public Health Service (PHS) Policy (also known as NIH Policy) applies to all live vertebrate animals, including mammals, amphibians, reptiles, fish, and birds used or intended for use in PHS supported research. The PHS requires institutions to use the Guide for the Care and Use of Laboratory Animals  (Guide) as a basis for developing and implementing an institutional program for activities involving animals.2 The program description must include the following: Each institution must assure that its program and facilities are in one of the following categories: Category 1 - Accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC). 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