3.11 Minimization of Pain and Distress 20 . Some species are upset by the introduction of novel items. Full Committee Protocol Review 20. For questions about Compliance Oversight, email olawdco@mail.nih.gov If there is no quorum, any business transacted and resolution passed is invalid. Additional OLAW Guidance regarding IACUC review of grant applications can be found at FAQ D10, previous OLAW Commentary, and OLAW Online Seminar The 2016 Vertebrate Animals Section, Grants Policy, and Congruence. 2. (IACUC) REGISTRATION APPLICATION AND FILING INSTRUCTIONS This application form is used for the registration of a new Institutional Animal Care and Use Committee (IACUC) or to update an existing IACUC with the Health Research Governance Department (HRGD), Ministry of … 2.1 Committee Composition 7 . 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. Finally, Principle IX states, ‘Where exceptions are required in relation to the provisions of these Principles, the decisions should not rest with the investigators directly concerned but should be made, with due regard to Principle II, by an appropriate review group such as the institutional animal care and use committee’ ( PHS, 1986b ). data collection) are conducted. Adequate arrangements shall be made for their in-service training, including the proper and humane care and use of laboratory animals” (VIII). (, 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. The IACUC should develop a plan for conducting official business during a pandemic event, taking into account the following: The IACUC must continue to be properly constituted. Admittedly, there are cases of research with questionable merit and incidents of animal abuse in the name of science ( Rowan, 1984 ), but these are extremely rare given the tremendous volume of animal research. Translation for 'properly constituted' in the free English-Swedish dictionary and many other Swedish translations. IACUC of another institution should not submit an IACUC Registration application. Search for other works by this author on: Ingredients of a successful grant application to the Horrobin, D. F. 1990, The philosophical basis of peer review and the suppression of innovation. Webster's New Universal Unabridged Dictionary, © Institute for Laboratory Animal Research, Behavioral Management is a Key Component of Ethical Research, Moving Beyond the Absence of Pain and Distress: Focusing on Positive Animal Welfare, Micro- and Macroenvironmental Conditions and Stability of Terrestrial Models, The Role of Feed in Aquatic Laboratory Animal Nutrition and the Potential Impact on Animal Models and Study Reproducibility, About the Institute for Laboratory Animal Research, Responsibility for Scientific Merit Review, Receive exclusive offers and updates from Oxford Academic, Copyright © 2021 Institute for Laboratory Animal Research. M. D. Prentice, U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training. 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). Just-In-time (JIT) Review 22. That approval certifies that the activity, as conducted at the foreign performance site, is acceptable to the awardee. 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. 3.9 Review of Modifications to Approved P rotocols 19 . One can interpret Principle IX to mean that the PHS considers the IACUC an appropriate review committee to determine if any exceptions should be granted. The end points of procedures and the time frame must be clearly defined; and. There are only two valid methods of IACUC review allowed by the PHS Policy: (1) full-committee review by a convened quorum of the members of the IACUC, or (2) designated member review by one or more members, employed only after all voting members have been provided an opportunity to call for full-committee review. 3.8 Range of IACUC Actions 16 . (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. In general, society appears to support valuable animal research that is humanely conducted. Maintenance of Properly Constituted IACUCs Tutorial: PHS Policy on Humane Care and Use of Laboratory Animals—The IACUC Membership Sample Animal Welfare Assurance for Domestic Institutions —describes how to fill out IACUC member’s roles when writing the assurance document. In addition, the USDA indirectly addresses one aspect of scientific merit by stating, ‘The principal investigator has provided written assurance that the activities do not unnecessarily duplicate previous experiments’ (9CFR2.31). Any member of this DMR sub-committee may request a FCR (see next) within five (5) business days if they deem it necessary. It is interesting to note that the U.S. Department of Agriculture (USDA) Animal Welfare Regulations are for the most part silent with regard to the institution's responsibility for scientific merit review. [, Institutions have discretion to subject animal activities to IACUC oversight regardless of the source of funding. 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. For questions, please contact Cindy Corbett in … The appointed members must be qualified through experience and expertise to provide oversight for the institution's animal programs, facilities, and procedures. Animal facilities must be maintained at a level to ensure animal welfare. A quorum (i.e., one person more than one half of the total number of voting members of the IACUC) of a properly constituted IACUC (as defined in PHS Policy IV.3.b) must be present to proceed with any official business requiring a quorum. If an institution does not have an animal care and use program, facilities to house animals, and an IACUC, the awardee institution will conduct the animal activity at an Assured institution (performance site). Annual Reports must represent the consensus of the Committee and include any minority views filed by members of the IACUC. It is our contention that any trained biomedical scientist with an understanding of scientific methodology can judge the merit of a protocol at the fundamental level, given adequate responses to the six points above. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. 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. IACUC review may be delayed if the animal activities will not occur until a year or later in the award period as part of the research design described in the grant application or contract proposal (e.g., the initial development of a drug or device with subsequent animal testing projected into the future). If an institution does not have a separate peer review committee that is charged with reviewing scientific merit, we suggest that it is incumbent upon the IACUC to assume this responsibility. In fact, the IACUC review of merit may have one advantage over reviews by external bodies. If a protocol is assigned more than one designated reviewer, the reviewers must be unanimous in any decision. Institutions have adopted a variety of administrative, electronic, and manual mechanisms to meet institutional needs and PHS Policy requirements. Examine its portfolio of research and determine those activities that may be potentially targeted. An organization conducting custom surgery for an awardee must have or obtain an Assurance, or be included as a component of the awardee’s Assurance. 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. Editeur:: CRC Press/Taylor & Francis. An institution may also have non-voting members which can assist the function of the committee by … Plans should consider appropriate staffing levels, cross-training to cover critical operations, and adequate inventories of essential supplies (e.g., feed, bedding, personal protective equipment, cagewash supplies). Institutions have discretion with regard to how they oversee areas used for routine weighing, dosing, immunization, or imaging, but should monitor such areas on a random or fixed schedule to effectively oversee activities at the institution. I. H. One member who is not affiliated with the university in any way other than as a member of the IACUC. NIH Grants Policy Statement on Written Agreements (, Guidance on what is considered a significant change to an ongoing animal activity that requires IACUC review can be found in NIH Guide Notice, Yes. 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