Unfortunately, there are no mathematical algorithms or related computer programs that can be used by an IACUC to perform an ethical cost-benefit assessment of animal research. 3.12 Standard Operating Procedure Review Criteria 21 . Assured institutions also have the option to amend their Assurance to cover performance sites that do not have an approved Assurance with OLAW, which effectively subjugates the performance site to the Assured institution and makes the Assured institution responsible for the performance site. The question of whether or not the average IACUC possesses enough expertise to perform a valid assessment of the scientific merit of all projects submitted to the committee has been raised by investigators and committee members alike. Typically, a valuable hypothesis gives insight towards a better understanding of normal physiology, biological mechanisms, disease processes, or the prevention or treatment of a disease or injury. If both the awardee institution and the performance site institution have Domestic Assurances, they may exercise discretion in determining which IACUC reviews animal activities and under which institutional program the research will be performed. Nevertheless, by inextricably linking ethical costs with scientific merit, animal research will not and should not be justified solely on the basis of whether or not the research is designed to pursue a significant and testable hypothesis. In the past, however, scientists may have planned and conducted animal experiments in relative isolation with little pre- or post-experimental ethical accountability. 2.2 Conflict of Interest 9 . tutes 1. a. For questions, please contact Cindy Corbett in … The IACUC must continue to be properly constituted. It is important to verify death after CO2 exposure, and CO2 narcosis must be followed by a secondary method of euthanasia where necessary. International (AAALAC) 6 . [2] The corresponding, parallel, and equivalent local ethical body responsible for overseeing U.S. federally funded research involving humans is the Institutional Review Board (IRB). Bad choices | Find, read and cite all the research you need on ResearchGate The following FAQs provide guidance that represents OLAW's current thinking on these topics. The institution, however, must have a properly constituted IACUC in order for the IACUC to conduct valid official business. Full Committee Protocol Review 20. The PHS Policy states, “An individual who meets the requirements of more than one of the categories detailed in, Guidance on reporting noncompliance is in the NIH Guide for Grants and Contracts, Sanctions imposed by the IACUC or by an institutional official due to serious or continuing noncompliance or serious deviations from the, Institutions must maintain records of minority views expressed (1) as recommendations to the Institutional Official and/or (2) during semiannual inspections. Institutional review of scientific merit becomes particularly important in a situation where an investigator, using in-house funds, initiates a research project whose review is pending at the NIH. PHS Policy requires that minutes of IACUC meetings, records of attendance, activities of the Committee, and Committee deliberations, be maintained by the institution. 1.3 United States Department of Agricultu re (USDA) 5 . The relative value of the study is a particularly important consideration in potentially painful experiments where there is an ethical imperative that the benefits of the research clearly outweigh any pain, discomfort, and distress experienced by the animals.’ We believe this is an appropriate qualification of scientific merit in an animal research context because societal values demand that the review include a judgement that takes into consideration the ethical costs of the research in terms of animal pain, morbidity, and mortality. 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. All relevant comments will be considered in OLAW decisions on timing and content of revisions to guidance documents, or development of new guidance documents. Key components in such organizations are the Institutional Official (IO), the IACUC, and the attending veterinarian. 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. We’d like to understand how you use our websites in order to improve them. When both organizations hold Assurances, some latitude is allowed in determining which IACUC will review the proposal. Ethics of animals welfare in research: The institution's attempt to achieve appropriate social balance. [, The PHS Policy recognizes that the IACUC may approve, require modifications, or withhold approval. A properly constituted IACUC obviously should have a broad based expertise, but it probably will not include experts in every field of research. Alternate members may be appointed to the IACUC as long as they are appointed by the IO. If there is no quorum, any business transacted and resolution passed is invalid. U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training. the protocol meets the requirements of the PHS Policy at IV.C.1.a.-g. IACUC SOP 01 - Committee Members A majority vote of the quorum present at a convened meeting is required for the IACUC to: Members may not participate in the review or approval of a project(s) in which they have a conflict of interest, except to provide information. Comments may be submitted to OLAW by email at: olaw@od.nih.gov (please insert the title of the specific guidance document in the subject field). Grant consideration cannot be given either to individuals or to organizations that do not have their nonprofit, tax-exempt 501(c)(3) status from the Internal Revenue Service. Usually, the investigator's response adequately addresses the questions of the committee and the use of animals in the research proposal will be approved. USDA requires semi-annual inspection of “animal study areas” defined as areas where USDA covered animals are housed for more than 12 hours. Optimally, a research institution should appoint one or more expert peer review committees who are specifically charged with scientific merit review. and/or telecommunications (see NOT-OD-06-052). The, Performance standards are to be applied to housing issues. (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. Awell-functioning animal care and use program (ACUP 1) is a dynamic system in which three distinct organizational entities, each staffed by highly trained and skilled personnel, work synergistically within a complex framework of animal welfare laws, regulations, policies, and guidelines to ensure the health and proper care of live vertebrate animals for humane use in essential biomedical research and teaching. D. A. Recused members also may not contribute to the quorum for the vote on that specific project. Based upon regulatory language, one may assume that the USDA was even less anxious than the PHS to take a concrete stand in writing on the issue of scientific merit. (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. and AWR §2.31(d)(6)). The articles of the company usually will specify the requisite number of members to constitute a quorum. However, if the IACUC determines that the proposed activity will not alter or influence the activity of the study animals, IACUC review and approval is not needed. IACUCs do not have authority to administratively extend approval beyond three years. Pages: 310. Written transcripts or tape recordings of meetings are not required. 1. Any member of this DMR sub-committee may request a FCR (see next) within five (5) business days if they deem it necessary. The IACUC can meet and conduct official business regardless of whether or not the non-affiliated member is present, so long as they are properly constituted (all 5 … Include a brief description of the experimental design and state the number and species/strain of animals per group/subgroup in each experiment/procedure; Describe sequentially, with a reasonable degree of detail, all procedures (surgical and nonsurgical) to be carried out on live animals. 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). Of Mice, Models and Men. An IACUC … If a trust has not been constituted correctly by a settlor, equity will not finish the job of setting up the trust correctly for them. the protocol conforms with the institution's Assurance; the protocol will be conducted in accordance with the USDA Animal Welfare Regulations if applicable; and. Table A. One of these members must be a Doctor … Provisions for conducting convened meetings via tele- or videoconferencing are addressed in the NIH Guide for Grants and Contracts, The Institutional Official (or another authorized official) may unilaterally halt, terminate, or impose sanctions on any animal activity, as this is not prohibited by the PHS Policy. Using this procedure, peer review by an IACUC is possible within the general limits of adequacy necessary to ascertain that the proposed research has an acceptable level of scientific merit. Despite the use of somewhat obtuse language, the PHS Policy unequivocally requires merit review by any institution that is the recipient of PHS funds. 2 The Health Research Extension Act of 1985 requires that, “scientists, animal technicians, and other personnel involved with animal care, treatment, and use…have available to them instruction or training in the humane practice of animal maintenance and experimentation…” (Sec. Significant changes to previously approved animal activities require prior IACUC approval. 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). Alternates receive the same training and orientation as IACUC When substantive information is lacking from a protocol, the committee may have questions requiring a response from the PI. The question of whether or not the average IACUC possesses enough expertise to perform a valid assessment of the scientific merit of all projects submitted to the committee has been raised by investigators and committee members alike. The original IACUC approval is void when the original grantee formally relinquishes the award. OLAW develops and monitors, as well as exercises compliance oversight relative to the Public Health Service Policy on Humane Care and Use of Laboratory Animals (the "PHS Policy"). 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. 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). 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. References are to previously published guidance or commentary in Dear Colleague Letters, Lab Animal Magazine, Contemporary Topics, and ILAR News which may provide additional elaboration or commentary. Dr. Prentice is a professor in the Department of Anatomy, and Associate Dean for Research in the Division of Graduate Studies and Research, at the University of Nebraska Medical Center, Omaha, Nebraska. See NIH Guide for Grants and Contracts. The, The NIH concurs with the findings and recommendations in the 1999 report of the National Research Council, Surgical procedures should be defined as major or minor on a case-by-case basis and evaluated by the veterinarian and IACUC to determine their impact on the animal’s well-being. face-to-face meetings not viable, the IACUC shall be authorized to conduct official IACUC meetings via telephone or video conference. Office of Laboratory Animal Welfare (OLAW). 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 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 (. Veuillez d'abord vous connecter à votre compte ; Avez-vous besoin d'aide? These minority views must be included in the Annual Report to OLAW. IACUC Approval Process . Organizations must be properly constituted and organized with a board of directors, by-laws, financial records, and controls. properly constituted according to PHS IV.A.3 and the: Guide. The IACUC must consist of at least 5 members who are appointed by the institution's chief executive officer (CEO). In our opinion, it is all of these to one extent or another. Outcome-based performance standards are paramount when evaluating cage or pen space for housing animals used for research, research training, and biological testing. 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.). To learn more and for a sample annual report, see the Annual Report to OLAW. Animal Welfare concerns should be reported to animalcare@wm.edu. Dresser (1989 ) is referring to this level of review when she observes that ‘…simply asking questions and demanding answers provides a crude merit evaluation. This certification means that the IACUC has approved those components of the application related to the care and use of laboratory animals. IACUC of another institution should not submit an IACUC Registration application. In fact, the IACUC review of merit may have one advantage over reviews by external bodies. A Critical Evaluation of Animal Research. “The Global Igbo Leaders had another Zoom meeting on 3rd January 2021 and further recommend that a properly constituted Ohanaeze Ndigbo Caretaker Committee be … Federal regulations and policy identify a minimum committee size of five individuals while also identifying specific roles which must be filled by voting members of the committee for an IACUC to be properly constituted. Certainly, no reputable scientist would deny the validity of the ethical imperative that all animal research should be scientifically and ethically justified. Cookies help us deliver our services. That approval certifies that the activity, as conducted at the foreign performance site, is acceptable to the awardee. (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. [, PHS Policy requires the IACUC to make this distinction in its semiannual reports to the Institutional Official. Indeed, in the case of very controversial protocols, the IACUC has sought consultation from several outside experts, as well as from other OPRR-sanctioned IACUCs. 3.10 Veterinary Consultation and Protocol Changes A ddressing Urgent Humane Issues 19 . The IACUC must continue to be properly constituted. (See, Collection of biological samples from any live vertebrate animal for the purpose of a PHS-supported activity is covered by the PHS Policy. For purposes of property standards under the uniform administrative requirements for HHS grant awards, animals purchased for research purposes are considered to be supplies. A significant deficiency is defined as one which is or may be a threat to the health or safety of animals. 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.). This judgement is not a recommendation for funding priority. (See. If, however, that is not possible because of the institution's size, bureaucratic complexity or other constraints, the obligation to perform scientific merit review falls by default to the IACUC. Significant program deficiencies can result from an institution's failure to fully understand or implement some aspect of its animal care and use program required by the PHS Policy, or failure to function according to commitments made in its Assurance, and may reach the level of reportable noncompliance. 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