Revised 2015 Show
PrefaceThis 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. 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. 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. Institutions with PHS Animal Welfare Assurances implemented the Eighth Edition of the Guide during 2012. (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). PHS Assured institutions implemented the 2013 AVMA Guidelines during the period from March 1, 2013, to September 1, 2013. (3) The OLAW mail address has been removed and electronic and fax contact information has been provided to facilitate efficient communication and conserve resources. (4) Footnotes 2, 7, 9, 11, and 13 have been modified to require PHS Assured institutions to comply with U.S. Department of Agriculture regulations that are applicable to their programs. (5) A change in format, but not content, was made to PHS Policy IV.B.3. (6) Grammatical corrections were made to reflect current writing standards. 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. 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 U.S. Principles were promulgated in 1985 by the Interagency Research Animal Committee and adopted by U.S. Government agencies that either develop requirements for or sponsor procedures involving the use of vertebrate animals. The Principles were incorporated into the PHS Policy in 1986 and continue to provide a framework for conducting research in accordance with the Policy. 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. For supplemental materials, please contact OLAW at the National Institutes of Health at , or visit the OLAW website at OLAW.nih.gov. Table Of Contents
Health Research Extension Act of 1985Public Law 99-158November 20, 1985, "Animals in Research" Sec. 495. (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.
Reports filed under subparagraph (C) shall include any minority views filed by members of the committee. "(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-
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. "(d) If the Director of NIH
determines that-
"(e) No guideline or regulation promulgated under subsection (a) or (c) may require a research entity to disclose publicly trade secrets or commercial or financial information which is privileged or confidential." U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training
*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. **Published in the Federal Register, May 20, 1985, Vol. 50, No. 97, by the Office of Science and Technology Policy [FR Doc. 85-12059]. Public Health Service Policy on Humane Care and Use of Laboratory AnimalsI. IntroductionIt 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" developed by the Interagency Research Animal Committee. This Policy is intended to implement and supplement those Principles. II. ApplicabilityThis Policy 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. 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. 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. This 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. III. Definitions
IV. Implementation by InstitutionsA. Animal Welfare AssuranceNo 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. 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. OLAW will provide the institution with necessary instructions and an example of an acceptable Assurance. All Assurances submitted to the PHS in accordance with this Policy will be 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. On the basis of this evaluation, OLAW may approve or disapprove the Assurance, or negotiate an approvable Assurance with the institution. 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. OLAW may limit the period during which any particular approved Assurance shall remain effective or otherwise condition, restrict, or withdraw approval. Without an applicable PHS-approved Assurance, no PHS-conducted or supported activity involving animals at the institution will be permitted to continue.
B. Functions of the Institutional Animal Care and Use CommitteeAs an agent of the institution, the IACUC shall with respect to PHS-conducted or supported activities:
C. Review of PHS-Conducted or Supported Research Projects
D. Information Required in Applications and Proposals for Awards Submitted to the PHS
E. Recordkeeping Requirements
F. Reporting Requirements
V. Implementation by the PHSA. Responsibilities of the Office of Laboratory Animal WelfareOLAW is responsible for the general administration and coordination of this Policy and will:
B. Responsibilities of PHS Awarding UnitsPHS awarding units may not make an award for an activity involving animals unless the prospective awardee institution and all other participating institutions have approved Assurances on file with OLAW, and unless the awardee institution has provided verification of approval by the IACUC of those components of the application or proposal related to the care and use of animals. 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. No award shall be made until all required Assurances have been submitted by the institution or institutions and approved by OLAW, and the institution or institutions have provided verification of approval by the IACUC of those components of the application or proposal related to the care and use of animals. C. Conduct of Special Reviews/Site VisitsEach 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. D. WaiverInstitutions may request a waiver of a provision or provisions of this Policy by submitting a request to OLAW. No waiver will be granted unless sufficient justification is provided and the waiver is approved in writing by OLAW. Footnote 1: Assurances should be sent to OLAW, NIH, by e-mail to or by fax to 301-451-5672. Footnote 2: 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. The Guide may differ from USDA regulations in some respects. Compliance with applicable USDA regulations is an absolute requirement of this Policy. Footnote 3: 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. However, each institution may identify the committee by whatever name it chooses. Footnote 4: As of the 2015 revision of this Policy, the only accrediting body recognized by the PHS is AAALAC. Footnote 5: 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. OLAW considers the CEO to be the highest operating official of the organization (such as the President of a University). If the CEO delegates authority to appoint the IACUC then the delegation must be specific and in writing. The CEO may or may not be the Institutional Official as defined by this Policy (see definition at III.G.). Footnote 6: Institutions may, at their discretion, represent the names of members other than the chairperson and veterinarian with program authority (see IV.A.3.) by using numbers or other symbols in submissions to OLAW. Sufficient information for OLAW to determine that all appointees are appropriately qualified must be provided. The identity of each member must be readily ascertainable by the institution and available to authorized OLAW or other PHS representatives upon request. Footnote 7: 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. The Guide may differ from USDA regulations in some respects. Compliance with applicable USDA regulations is an absolute requirement of this Policy. Footnote 8: The IACUC may, at its discretion, determine the best means of conducting an evaluation of the institution's programs and facilities. The IACUC may invite ad hoc consultants to assist in conducting the evaluation. However, the IACUC remains responsible for the evaluation and report. Footnote 9: 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. The Guide may differ from USDA regulations in some respects. Compliance with applicable USDA regulations is an absolute requirement of this Policy. Footnote 10: AVMA Guidelines for the Euthanasia of Animals: 2013 Edition or succeeding revised editions. Available at https://www.avma.org/KB/Policies/Documents/euthanasia.pdf. Footnote 11: 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. The Guide may differ from USDA regulations in some respects. Compliance with applicable USDA regulations is an absolute requirement of this Policy. Footnote 12: Institutions may, at their discretion, represent the names of members other than the chairperson and veterinarian with program authority (see IV.A.3.) by using numbers or other symbols in submissions to OLAW. Sufficient information for OLAW to determine that all appointees are appropriately qualified must be provided. The identity of each member must be readily ascertainable by the institution and available to authorized OLAW or other PHS representatives upon request. Footnote 13: 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. The Guide may differ from USDA regulations in some respects. Compliance with applicable USDA regulations is an absolute requirement of this Policy. Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files. Which of the following is true regarding the IACUC authority and responsibilities regarding research animal misuse mistreatment or noncompliance?A change in personnel. Which of the following is true regarding the IACUC's authority and responsibilities regarding research animal misuse, mistreatment, or noncompliance? The IACUC has regulatory authority to stop any animal activities to protect either animals or people.
Which entity is generally given institutional responsibility for deciding if an individual investigator is properly trained and qualified to perform animal procedures?Per PHS Policy and USDA Animal Welfare Regulations, the IACUC is given responsibility for ensuring that research personnel are properly trained to perform animal procedures.
Which of the following significant changes to a protocol could be administratively approved in principle by VVC quizlet?Which of the following significant changes to a protocol could be administratively approved (in principle) by VVC? With an existing policy approved by the IACUC, a change in analgesic agent could be approved by VVC.
Who if anyone supervises the treatment of laboratory animals?The attending veterinarian (AV) is responsible for the health and well-being of all laboratory animals used at the institution. The institution must provide the AV with sufficient authority, including access to all animals, and resources to manage the program of veterinary care.
|