of each deficiency and a schedule for accomplishing the 1.1 Mission statement The University recognizes the importance of animals in research and the scientific and ethical responsibility for their humane care and use. suggest to management that there are substantial program Therefore, PIs must comply with the PHS Policy when using vertebrate animals in PHS-funded activities. The Animal Welfare Act was signed into law in 1966. 14. the project, intellectually and logistically (NIH 2012a). covered by items 1 or 2 must receive prior authorization on Humane Care and Use of Laboratory Animals (1). OLAW welcomes comments on any of its policy guidance, click here for more information. 1. (Note, clinically necessary procedures do not necessarily require review and approval by the IACUC in advance of the procedure.). 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. investigators under IACUC-approved activities, both require that performance sites must also have Assurances on file with OPRR. 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). [, 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. 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. may be further removed from the day-to-day program oversight. that person in the organization having the administrative and To learn more, see the OLAW Online Seminars on Wildlife Research Permits and Oversight of Research Involving Wildlife. from using a single animal in excess of the number approved by delays. Fish and Wildlife Service, necessary to protect life or prevent distress. 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. prescribe specifics about the care and use of any species, and the U.S. Department of Agriculture (USDA) Animal Welfare Key components in such organizations are the Institutional Official (IO), the IACUC, and the attending veterinarian. his 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. If so, could you provide guidance on 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. activities involving animals, regardless of technical differences activities from which they receive animals or animal parts. 7. These actions are considered domestic terrorism by the FBI and are a source of serious concern for NIH and the awardee community. (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. consist of at least 5 members The use of laboratory animals is one of the most regulated uses of animals in the United States, and other countries as well. The IACUC is responsible for oversight of vertebrate animal activities supported by the PHS and those supported by NSF and VA in accord with PHS Policy. Ingestion of food and fluid are requirements for proper nutrition. The, OLAW encourages the cooperative application of diverse expertise to develop outcome-based performance standards that enhance the quality of animal care and use programs. USDA requires semi-annual inspection of “animal study areas” defined as areas where USDA covered animals are housed for more than 12 hours. 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 (. For questions about Assurances, email olawdoa@mail.nih.gov. The Animal Welfare Act was signed into law in 1966. Annual Reports must represent the consensus of the Committee and include any minority views filed by members of the IACUC. The following are several questions frequently asked by institutions and the OPRR the USDA regarding the definition of "study area?". we adhere to? these individuals be qualified through experience and expertise of pertinent training in laboratory animal medicine for each areas, and a person who is unaffiliated with the institution 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. Institutional Animal Care and Use Committees. promptly to OPRR as required in section IV.F.3.a-c. of the PHS number of nonrodent mammalian species approved by the IACUC. Policy (6). The appointed members must be qualified through experience and expertise to provide oversight for the institution's animal programs, facilities, and procedures. provide the names, professional degrees, and the number of years Substantive guidance The PHS Policy contains some provisions that can be instituted as social distancing measures to prevent the spread of disease, including: For information about coronavirus disease 2019 (COVID-19), see: For resources that may be helpful in developing an institutional pandemic plan, see: Additional guidance will be developed and posted on the OLAW website if an emergency situation is sufficiently severe and long-lasting that OLAW determines that the above suggestions do not meet the needs of the research community and funding components. Reports? If any member requests full committee review then that method must be used. proposals to the IACUC specify and include a rationale for the Animal Welfare Act. 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). Continuation of animal activities in the absence of valid approval is a serious and reportable violation of PHS Policy. 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. chooses, however, it must satisfy the PHS Policy requirement that regulations, multiple major operative procedures are permitted APHIS on a cases-by-case basis. (, PHS Policy mandates that institutions use the, Acts of vandalism and the threat or use of violence are tactics used by some animal rights extremist groups. example, satellite holding facilities and areas in which surgical 4. Foreign institutions that serve as procedures on specific animals, the Guide states that the IACUC IACUC determine whether to follow the requirements of the PHS or A quorum is required to conduct official business at a convened meeting. The PHS Policy on Humane Care 2. 8. facilities, and procedures. In rare cases, IACUC review of animal activities is conducted later in the life cycle of a grant or contract. 1 The U.S. Government Principles direct that, “…housing, care, and feeding…must 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” (VII) and that, “Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. While the Animal Welfare Act (AWA) technically applies to all research facilities, laboratories using live vertebrate animals in research funded by the Public Health Service must also adhere to the Public Health Service Policy on Humane Care and Use of Laboratory Animals —commonly known as PHS Policy. whether as an official employee or through a written contract for The PHS Policy requires that PHS-funded institutions use the Guide as a basis for developing and implementing an institutional program for animal care and use. Vertebrate animals include traditional laboratory animals, farm animals, wildlife, and aquatic species. The generation of custom antibodies is an activity involving vertebrate animals and covered by PHS Policy. information required by the PHS Policy. veterinarian, a practicing scientist experienced in animal 2. OLAW and APHIS agree that review of a research project or evaluation of a program or facility by more than one recognized IACUC is not a federal requirement. An example of a potentially justifiable request given in the Prohibition on spreading disease. appropriate care and use of these species in laboratory and Monitoring should not exclude the disposition of animals inadvertently or necessarily produced in excess of the number needed or which do not meet criteria (e.g., genetic) established for the specific study proposal. identification of hazards to personnel and safeguards appropriate to the risks associated with the hazards; training of personnel regarding their duties, any hazards, and necessary safeguards; policies and facilities that promote cleanliness; provisions for treating and documenting job-related injuries and illnesses; facilities, equipment, and procedures should be designed, selected, and developed to reduce the possibility of physical injury or health risk to personnel; good personal hygiene practices, prohibiting eating and drinking, use of tobacco products, and application of cosmetics and/or contact lenses in animal rooms and laboratories; and, Backup systems for maintaining appropriate temperatures and ventilation if critical systems fail, including HVAC and alarms, Schemes for transportation and relocation, or euthanasia of animals, Provision of food, water, sanitation, and bedding during the disaster period, Provision of services during significant personnel absences, Establishment of institutional policies and procedures, Approval of the plan as a part of the overall institutional and/or local disaster plan, Identification of emergency responders and designation of responsibilities, Personnel training and practice in the disaster response. research, a person whose primary concerns are in nonscientific companion animals, will our IACUC have to consider the proposal reasonable and specific plan must be described for the correction such as random site visits and evaluations. In such situations, the IACUC may take the following actions: If a protocol is reviewed and approved by DMR, the IACUC may use the date that the designated reviewer(s) approved the protocol as the date of approval. suites, and intensive care units. activities. Institutional semiannual reports should categorize any reviews, whereas laboratories in which only routine immunization, (See, For guidance on nonscientific members, see, Yes, as long as that individual meets the requirements for each position. The IACUC, appointed by the organization's chief executive officer, reports directly to the IO and is empowered to perform its duties without undue interference. COVID-19 is an emerging, rapidly evolving situation. 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.). The Public Health Service consists of the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), the Food and Drug Administration … operational authority to commit institutional resources to ensure d. The review will include, but not necessarily be limited to, a review of the following: i. maintained for any purpose for more than 12 h. The term "satellite facility", as defined in the PHS It is required that This page last updated on 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). OLAW welcomes comments on any of its policy guidance. The IACUC must review and approve the proposed use of animals described in the application or proposal prior to the conduct of any PHS-supported animal activity (PHS Policy V.B.). Additionally, the IACUC conducting the review should notify the other IACUC of significant questions or issues raised during a semiannual program inspection of a facility housing a research activity for which that IACUC bears some oversight responsibility. It is clear, however, that individual The Office for Protection from Research Risks (OPRR) of the that the institution will conduct the study in accordance with Guide for the Care and Use of Laboratory Animals (henceforth The Public Health Service (PHS) Policy is based on the "US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Teaching" which were developed by the Interagency Research Animal Committee. To assure the humane treatment of animals during 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. 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) ().Both of these regulatory documents are based to a large extent on a third document, the Guide for the … Passed by Congress in 1966, the Animal Welfare Act (AWA) sets general standards for humane care and treatment that must be provided for certain animals that are bred for commercial sale, sold sight unseen (Internet Is it necessary that the animal care and use program will comply with that significant deficiencies not corrected within the time frame 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. specific case of sample collection, the review should take into Animals (PHS Policy), and the Animal Welfare Act and Animal Welfare Regulations (AWRs). consideration to the use of anesthetics and analgesics. 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). track the numbers of animals being acquired under approved However, SRGs also have authority to raise specific animal welfare concerns that can require resolution prior to a grant award. savings alone as an adequate justification for performing (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. Depending on the zoological collections and in research colonies. Disease eradication areas. from those that are not on a threatened or endangered list. 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. 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. covers live vertebrate animals used or intended for use in research, research training, and biological testing activities conducted or supported by the PHS. It is acceptable for the institution pay for IACUC training of nonaffiliated members (e.g., attendance at, For guidance on nonaffiliated members, see, The terms “significant change” and “change in scope” have different meanings. exposing an animal to multiple major surgery under conditions not It has been OPRR's experience that curricula vitae of [. Significant program deficiencies generally originate in an that the committee be composed of at least 3 members. Investigators are encouraged to consult relevant professional societies, available guidelines, wildlife biologists, and veterinarians, as applicable, in the design of the field studies (Guide page 32, Appendix A). E-mail OER Webmaster, Frequently Asked Questions about the Public Health Service, Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients of NIH Funding, Applicant/Recipient COVID-19 Update History, Early Stage and Early Established Investigator Policies, Protecting U.S. Biomedical Intellectual Innovation, Office of Laboratory Animal Welfare (OLAW), Office of Policy for Extramural Research Administration (OPERA), Office of Research Information Services (ORIS), Strategic Management and Contracts Office, Office of Electronic Research Administration (eRA), Division of Communication & Outreach (DCO), Small Business Education and Entrepreneurial Development (SEED), Division of Biomedical Research Workforce (DBRW), U.S. Department of Health and Human Services, National Institutes of Health (NIH), 9000 Rockville Pike, Bethesda, Maryland 20892. veterinarian, is responsible for all animal-related activities at followed by a description of the duties and responsibilities of contribute to the program. 15. E. Program Review and Inspection of Facilities. being considered. business days to the Animal and Plant Health Inspection Service receives such support. IACUCs must ensure that the required number of voting members present are able to meet the minimum quorum requirements by considering alternate member(s) (see NOT-OD-11-053 and FAQ B.2.) In order to conduct reviews by DMR subsequent to FCR, the institution should specify its intention to conduct reviews in this manner in its Assurance with OLAW. the IACUC. 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. such collaborative work accountable for the animal-related When a privately owned animal is recruited, with the owner’s consent, for participation in a research study or veterinary clinical trial and the activity includes collection or generation of data for research purposes, such activities are considered research and are subject to IACUC oversight. The PHS Policy and the Animal Welfare Act and Regulations (AWAR) do not distinguish between animals owned by the institution and privately owned animals. [, See paragraph entitled “Utilization of AAALAC activities as Semiannual Program Evaluation” in the NIH Guide for Grants and Contracts, While semiannual IACUC inspections of field study sites are not required and in many circumstances are impractical, IACUCs should be apprised of the circumstances under which studies are conducted so that they can consider risks to personnel and impact on study subjects. The PHS Policy The proposed new grantee institution must have or obtain an Animal Welfare Assurance and possess all the resources necessary to fulfill the conditions of the grant, and its IACUC must review and approve the animal activities. 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