phs policy applies to which animals

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.). 3. 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 this Policy, unless the individual makes other arrangements with the PHS. and 2. of this Policy, and reports prepared in accordance with IV.B.3.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. 6. conduct site visits to selected institutions. Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered. (3) The OLAW mail address has been removed and electronic and fax contact information has been provided to facilitate efficient communication and conserve resources. 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. Problems identified included ineffective administrative organization and management of the animal use program, inadequate review of animal use procedures, substandard housing and sanitation in animal facilities, poor record keeping and occupational health programs, insufficient personnel training, inadequate provision of veterinary care, and deficiencies in supervision of anesthesia, analgesia, surgery, and postoperative care. At least once every 12 months, the IACUC, through the Institutional Official, shall report in writing to OLAW: a. any change in the institution's program or facilities that would place the institution in a different category than specified in its Assurance (see IV.A.2.of this Policy); b. any change in the description of the institution's program for animal care and use as required by IV.A.1.a.-i. "(A) the appropriate use of tranquilizers, analgesics, anesthetics, paralytics, and euthanasia for animals in such research; and. 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. USDA Animal Care, a unit within the Animal and Plant Health Inspection Service, administers the Animal Welfare Act (AWA). Adequate arrangements shall be made for their in-service training, including the proper and humane care and use of laboratory animals. 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. Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. 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. on Humane Care and Use of Laboratory Animals, hereinafter referred to as PHS Policy. g. Methods of euthanasia used will be consistent with the recommendations of the American Veterinary Medical Association (AVMA) Panel on Euthanasia, unless a deviation is justified for scientific reasons in writing by the investigator. 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. 8. 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 OLAW, which has responsibility for the general administration and coordination of the Policy, provides specific guidance, instruction, and materials to institutions that must comply with the Policy. All vertebrate species used in research, teaching or testing at institutions receiving PHS funds. 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. Procedures with animals will avoid or minimize discomfort, distress, and pain to the animals, consistent with sound research design. Institutions That Have an Approved Assurance, 3. Should institutions apply the PHS Policy to all animal activities regardless of the source of funding? 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) PHS Assured institutions implemented the 2013 AVMA Guidelines during the period from March 1, 2013, to September 1, 2013. (a) The Secretary, acting through the Director of NIH, shall establish guidelines for the following: Such guidelines shall not be construed to prescribe methods of research. Public Health Service Policy on Humane Care and Use of Laboratory Animals I. Sponsors a voluntary accreditation program for animal care and use programs. d. The living conditions of animals will be appropriate for their species and contribute to their health and comfort. Although this institution was able to correct their program deficiencies and submit Assurance Statements that allowed research to resume, such examples emphasize that insufficient attention to animal care programs can have severe consequences, and that grantee institutions must abide by existing guidelines. The PHS Policy on Humane Care and Use of Laboratory Animals became law with the enactment of the Health Research Extension Act of 1985. of this Policy. On the basis of this evaluation, OLAW may approve or disapprove the Assurance, or negotiate an approvable Assurance with the institution. Available at https://www.avma.org/KB/Policies/Documents/euthanasia.pdf. 1. Without an applicable PHS-approved Assurance, no PHS-conducted or supported activity involving animals at the institution will be permitted to continue. No waiver will be granted unless sufficient justification is provided and the waiver is approved in writing by OLAW. • Office of Laboratory Animal Welfare (OLAW) is responsible for administration of the PHS Policy (5) A change in format, but not content, was made to PHS Policy IV.B.3. In order to approve proposed research projects or proposed significant changes in ongoing research projects, the IACUC shall conduct a review of those components related to the care and use of animals and determine that the proposed research projects are in accordance with this Policy. "(1) The proper care of animals to be used in biomedical and behavioral research. e. a description of any euthanasia method to be used. Lab Animal. 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. If any one of these institutions does not have an approved Assurance on file with OLAW, the awarding unit will ask OLAW to negotiate an Assurance with the institution or institutions before an award is made. 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. OLAW will provide the institution with necessary instructions and an example of an acceptable Assurance. ), 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. This applies to all the animals covered under the AWA as well as purpose-bred rats, mice and birds … e. Medical care for animals will be available and provided as necessary by a qualified veterinarian. Consultants may not approve or withhold approval of an activity or vote with the IACUC unless they are also members of the IACUC. 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 … I. APPLICABILITY OF ASSURANCE . 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. 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. 4. For supplemental materials, please contact OLAW at the National Institutes of Health at [email protected], or visit the OLAW website at OLAW.nih.gov. ); (2) one practicing scientist experienced in research involving animals; (3) one member whose primary concerns are in a nonscientific area (e.g., ethicist, lawyer, and member of the clergy); and. 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. 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. Assurances shall be submitted to the Office of Laboratory Animal Welfare (OLAW), Office of the Director, National Institutes of Health (NIH).1 The Assurance shall be signed by the Institutional Official. Those organizations that accept Public Health Service (PHS) or National Science Foundation (NSF) funding. **Published in the Federal Register, May 20, 1985, Vol. The Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) applies to activities supported by any PHS agency. 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. Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files. (6) Grammatical corrections were made to reflect current writing standards.. Lab Animal. The Animal Welfare Act applies only to research institutions; PHS Policy applies to all organizations that house animals. The PHS endorses the "U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training" developed by the Interagency Research Animal Committee. All records shall be accessible for inspection and copying by authorized OLAW or other PHS representatives at reasonable times and in a reasonable manner. 7. Approval of an Assurance will be for a specified period of time (no longer than five years) after which time the institution must submit a new Assurance to OLAW. of this Policy. FAQ. Non-PHS funded activities. 1. review at least once every six months the institution's program for humane care and use of animals, using the, 2. inspect at least once every six months all of the institution's animal facilities (including satellite facilities) using the. As of the 2015 revision of this Policy, the only accrediting body recognized by the PHS is AAALAC. 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. The IACUC may invite consultants to assist in the review of complex issues. of this Policy shall include any minority views filed by members of the IACUC. At least once every 12 months, the IACUC, at an institution which has no changes to report as specified in IV.F.1.a.-c. of this Policy, shall report to OLAW in writing, through the Institutional Official, that there are no changes and shall inform OLAW of the dates of the required IACUC evaluations and submissions to the Institutional Official. 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. 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. 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. The Assurance Statement must describe the institution’s program for care and use of all animals used in research, research training, and biological testing. Reports filed under subparagraph (C) shall include any minority views filed by members of the committee. (PDF - 138 KB) Using privately owned animals in a study of human subjects. 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