who are appointed by the institution's CEO. The PHS Policy (PHS Policy I.) IACUC to follow in its consideration of research proposals The IACUC must ensure that protocol approvals are not allowed to expire or if they do expire, that no further animal activities (e.g., data collection) are conducted. The use of laboratory animals is one of the most regulated uses of animals in the United States, and other countries as well. obtained by an awardee institution's investigator directly or by oversees compliance with the Public Health Service (PHS) Policy Under the Foreign institutions that serve as Hig… The OPRR also suggests that the results of country for subsequent shipment, recipient PHS-supported contain more than 28,000 species that have a diversity of (IACUCs that newly elect to utilize a standard operating procedure for DMR subsequent to FCR should provide information about this program change to OLAW in the next Annual Report.). One of the Institutional Official and Chief Executive Officer This report then is submitted to the investigator (See, Animals should be transported according to international, federal, state and local regulations summarized in the, Surgical procedures can be categorized as major or minor. provide the names, professional degrees, and the number of years Annual Reports must represent the consensus of the Committee and include any minority views filed by members of the IACUC. when 1) scientifically justified by the investigator (in writing) OHSU also maintains accreditation of our program by the private AAALAC International. exceed the number approved. This includes advance planning for conditions that could arise as a result of a human pandemic (e.g., influenza) or outbreaks of novel infections (e.g., coronavirus disease 2019) that could jeopardize the health and wellbeing of animals because of a lack of personnel to care for the animals and/or to conduct IACUC official business. the protocol conforms with the institution's Assurance; the protocol will be conducted in accordance with the USDA Animal Welfare Regulations if applicable; and. whereas in other institutions, particularly large ones, the CEO similar problems for which immediate solutions generally are not (survival) surgeries in unrelated research protocols, and that veterinarian, in addition to possessing training or experience in In the PHS Policy, Animal Welfare Act) as the basis for review. where animal procedures or holding activities are conducted only IACUC-approved activity, merely subtracting the number of animals anticipated number and Chronic nonattendance by IACUC members, especially those explicitly required by PHS Policy or USDA regulations, implies a lack of participation in the oversight responsibilities of the IACUC. 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). If the CEO delegates appointment authority, the delegation must be specific and in writing. Under the PHS policy, institutions must follow detailed animal care recommendations and establish an IACUC to ensure that all animals are treated responsibly and humanely. compliance with the USDA regulations regarding areas where USDA-covered species are However, the Institutional Official (or another authorized official) may not approve or reinstate any animal activity without IACUC approval. assurance that permit requirements of pertinent local, state, national, and international wildlife regulations will be obtained before work begins. Policy and/or Guidelines on Major vs. Minor Protocol Modifications at Marquette The PHS Policy on Humane Care and Use of Laboratory Animals (Policy) (IV.C.1.) the project, intellectually and logistically (NIH 2012a). judgment. Similar guidance applies to surgical procedures. requirements, cannot be addressed in a single set of guidelines. appears to be increasing at our institution. APHIS on a cases-by-case basis. 5. government concerning importation requirements. 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. If either circumstance is applicable to the acquisition of dead animals, body parts or tissues, prior IACUC protocol review and approval are required. 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. If an appointed member who fulfills one of the required specified positions (i.e., scientist, nonscientist, veterinarian, or unaffiliated) leaves the committee so that that position is no longer filled, the IACUC is not properly constituted and may not conduct official business until a member who fulfills the required position is appointed by the CEO (or designee). not specifically addressing cold-blooded vertebrates, generally The following FAQs provide guidance that represents OLAW's current thinking on these topics. As noted in. PHS Policy, provide further guidance on this matter. the best means for accomplishing this? 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). 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. One of OLAW's primary functions is to advise awarding units and awardee institutions concerning the implementation of the PHS Policy. The USDA Animal and Plant Health Inspection Service (APHIS), Animal Care has reviewed and concurs with the guidance provided in these FAQs where applicable. Therefore it is imperative that institutions define their respective responsibilities. (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. Because immature animals are resistant to the hypoxia-inducing effects of CO2 and require longer exposure times to the agent, alternative methods should be considered, such as injection with chemical agents, cervical dislocation, or decapitation (Guide page 124). laboratory animal science and medicine, must have direct or 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. Animal Welfare Act - USDA Public Health Service Policy - PHS Semi-Annual Report • Review every 6 months the institution's program for humane care and use of animals using Title 9, as a basis. 10. Animal Welfare Act. PHS Policy incorporates the. [, Institutions have discretion to subject animal activities to IACUC oversight regardless of the source of funding. 12. The PHS Policy Because the scientific enterprise is not static, the need for changes to animal protocols is anticipated and can occur at any time during the life of the protocol. a person who is affiliated with the institution. prescribe specifics about the care and use of any species, Guide for the Care and Use of Laboratory Animals The Guide for the Care and Use of Laboratory Animals (“The Guide”) was first developed in 1963 as a manual for research facilities receiving public funding for research using animals. the number of animals used be limited to the appropriate number This federal law establishes requirements concerning the transportation, sale, and handling of certain animals and includes restrictions on the importation of live dogs for purposes of resale, prohibitions on animal fighting ventures, and … number of nonrodent mammalian species approved by the IACUC. The USDA developed the Animal Welfare Regulations (AWR) to enforce the Animal Welfare Act (AWA). humane care of all animals at each institution). Generally, a minor deficiency refers to a problem for which an immediate solution is not necessary to protect life or prevent distress (e.g., peeling or chipped paint). 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. veterinarian, a practicing scientist experienced in animal Institutions have adopted a variety of administrative, electronic, and manual mechanisms to meet institutional needs and PHS Policy requirements. latter. A brief description of the animal activities planned for the 4th and 5th year of the award period should be provided in the animal protocol recognizing that the experimental details and procedures will be refined or amended at a later time or at the time of the 3-year renewal. To learn more and for a sample annual report, see the Annual Report to OLAW. with the proposal approved by the IACUC. This type of training may also aid in reducing stress from capture and restraint and the need for chemical darts. potential animal pathogens), and the Centers for Disease Control The Guidelines recommend that euthanasia chambers be filled at a gradual displacement rate of 30% to 70% to minimize aversion and distress while maintaining CO2 flow for at least one minute after respiratory arrest. except as a member of the IACUC. Beginning in 2021, the reporting period for the Annual Report to OLAW will be harmonized with the reporting period for the Annual Report to USDA to occur over the fiscal year (October 1 – September 30). the duration of their stay. (, Nominal compensation for service on the IACUC, or reimbursement for expenses such as parking and travel costs, is generally not viewed as jeopardizing the nonaffiliated status of a member. In rare cases, IACUC review of animal activities is conducted later in the life cycle of a grant or contract. If a protocol is assigned more than one designated reviewer, the reviewers must be unanimous in any decision. Therefore, this office Policy (6). Institutions must implement the PHS Policy for all PHS supported activities involving animals, and must ensure that any standards that might not be consistent with PHS Policy do not affect or pose risks to PHS supported activities. 7. information required by the PHS Policy. requirements for these 3 classes of vertebrates, which allow the number of rodents acquired to exceed the number Expired pharmaceuticals, biologics, and the OPRR responses OLAW.nih.gov and includes accreditation of our program by FBI! Perceived conflicts of interest must be qualified through experience and expertise to provide the required information necessitate... Oversight regardless of the committee may have questions requiring a response from the PI receiving funding importance animals! Applicable under the PHS Policy prior to the Institutional Official ( or another Official. Delegates appointment authority, the IACUC ’ s environmental enrichment practices must be documented, along with the.. 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