Editeur:: CRC Press/Taylor & Francis. Such experiments may have unquestioned scientific merit, but might not be justified because of the associated ethical cost. Examples include, but are not limited to, ethicist, lawyer, member of the clergy, librarian, etc. USDA animal welfare regulations exempt areas containing free-living wild animals in their natural habitat from inspection [See. Alternate members may be appointed to the IACUC as long as they are appointed by the IO or ot her official with authority to appoint members, and there is a specific one -to-one designation of IACUC members and . Ensure that the institutional security group works closely with local and state law enforcement to make certain that responses to illegal activities are prompt and adequate. properly constituted according to PHS IV.A.3 and the: Guide. IACUC Review : The IACUC conducts a review of proposed animal use (i.e., new protocol submissions, annual/triennial reviews, and/or significant changes proposed to approved IACUC protocols) and determines if it … If a member recusal reduces the number of IACUC members qualified to vote, for example, if the minimum number of eligible voting members present changes from 11 to 10, then the IACUC may not vote on that specific project. In the event of a pandemic, a properly constituted IACUC shall be defined as no fewer than five members to include: the IACUC Chair, the Attending Veterinarian, a scientist, a non-scientist, and a non-affiliated (community) member. ISBN 10: 1439849080. The generation of custom antibodies is an activity involving vertebrate animals and covered by PHS Policy. Ingestion of food and fluid are requirements for proper nutrition. For questions, please contact Cindy Corbett in … 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 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. Although the PHS Policy does not explicitly require a mechanism to track animal usage by investigators, it does require that proposals specify a rationale for the approximate number of animals to be used and be limited to the appropriate number necessary to obtain valid results. Prévisualiser. IACUC Staff 16. In order to prepare for this task, it is often necessary for one or both reviewers to consult the literature and discuss the protocol with the investigator. Crouse, For purposes of property standards under the uniform administrative requirements for HHS grant awards, animals purchased for research purposes are considered to be supplies. However, he has been more skeptical in recent memory, suggesting in July that Trump’s banter about delaying the election until people could vote “properly” constituted grounds for … A quorum is required to conduct official business at a convened meeting. Public Health Service Policy on Humane Care and Use of Laboratory Animals. Consequently, the IACUC should review protocols and SOPs that involve animals for such purposes, initially and at appropriate intervals (at least once every three years). it is frequently necessary to use non-pharmaceutical-grade substances such as investigational substances, pharmaceutical-grade substance is any active or inactive drug, biologic, reagent, etc., manufactured under Good Manufacturing Practices (GMP) which is approved, conditionally approved, or indexed by the Food and Drug Administration (FDA) or for which a chemical purity standard has been written or established by a recognized compendia (e.g., United States Pharmacopeia-National Formulary, U.S. Department of Health & Human Services, PHS Policy on Humane Care and Use of Laboratory Animals, Guide for the Care and Use of Laboratory Animals (PDF), AVMA Guidelines for the Euthanasia of Animals (external PDF), IACUC Composition, Functions and Authority, Program Review and Inspection of Facilities, Openness and Transparency and Biomedical Research Oversight, Guidance on Significant Changes to Animal Activities, International Guiding Principles for Biomedical Research Involving Animals, Guide for the Care and Use of Laboratory Animals, The 2016 Vertebrate Animals Section, Grants Policy, and Congruence, Quick Reference Guide: 9 CFR, Part 2, Section 2.31(c)(2), AVMA Guidelines for the Euthanasia of Animals, https://www.avma.org/KB/Resources/Reference/Pages/Compounding.aspx, U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training, Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research, ARENA OLAW Institutional Animal Care and Use Committee Guidebook, https://www.cdc.gov/coronavirus/2019-ncov/index.html, https://www.who.int/emergencies/diseases/novel-coronavirus-2019, https://medlineplus.gov/coronavirusinfections.html, https://distasterinfo.nlmnih.gov/pandemic-influenza, https://www.aalas.org/iacuc/iacuc_resources/disaster-preparedness#.VnrtDfkrJhE, https://medlineplus.gov/disasterpreparationandrecovery.html, PHS Policy on Humane Care and Use of Laboratory Animals, U.S. Department of Health and Human Services, PHS Policy on Humane Care and Use of Laboratory Animals, 2015, a brief description of how those procedures are likely to affect the biology and ecology of the study animals by describing the relationship of that species to the habitat and to other species found in the study area (including the nature and duration of potential effects); and. 3 The PHS Policy requires that institutions seeking an Assurance provide “a synopsis of training or instruction in the humane practice of animal care and use, as well as training or instruction in research or testing methods that minimize the number or animals required to obtain valid results and minimize animal distress, offered to scientists, animal technicians, and other personnel involved in animal care, treatment or use” (IV.A.1.g. 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. 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"). Both protocol approval and suspension of animal study protocols by the IACUC require a majority vote of a quorum of the IACUC. 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. The end points of procedures and the time frame must be clearly defined; and. Appointment of an individual who is unambiguously unaffiliated is the best way to fulfill the letter and spirit of this provision. Optimally, a research institution should appoint one or more expert peer review committees who are specifically charged with scientific merit review. In fact, the IACUC review of merit may have one advantage over reviews by external bodies. 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. 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.) The number of IACUC meetings may be reduced to as few as one every six months. 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. The IACUC Chair (or in his/her absence, the Vice Chair) retains the authority to I. H. Although members and alternates may not contribute to a quorum or act in an official IACUC capacity at the same time, alternates are encouraged to attend all IACUC meetings. Surgery conducted in response to a specific, custom request is covered by the PHS Policy. The value and humaneness of animal research was generally assumed regardless of the source of funding and whether or not the research was reviewed by peers. In this respect, the nonexpert members of the IACUC function essentially like jurors who, using the reasonable person standard, form their own evaluations of the case based upon evidence and evaluations presented to them by experts. It follows that animal-related activities without valid approval must be suspended until appropriate review and approval have … However, lack of IACUC expertise in the precise scientific field of research under review is not a reason for the committee to ignore merit and simply rubber stamp the proposal as ‘approved’ solely because its procedures are judged to be humane. Any IACUC member may submit a minority view to OLAW addressing any aspect of the institution’s animal program, facilities, or personnel training. 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. 1.4 Association for Assessment and Accreditation of Laboratory Animal Care, 5 . 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. 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. An IACUC Chair who isn't a member. When the awardee is a domestic institution (i.e., domestic award with a foreign component), PHS animal welfare requirements are applicable. Therefore, in 2021 and beyond, the Annual Report to OLAW will be due by December 1st (but no earlier than September 30) for the previous fiscal year. E. D., (IACUC). 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. The institution, however, must have a properly constituted IACUC in order for the IACUC to conduct valid official business. Continuation of animal activities in the absence of valid approval is a serious and reportable violation of PHS Policy. A free, online course primarily intended for persons sitting on an Institutional Animal Care and Use Committee (IACUC) who conduct mandated inspections of animal facilities for compliance with U.S. regulatory standards. Whereas review bodies other than the IACUC can, and ideally should, be charged with scientific merit review, it is the IACUC that must render the ultimate judgement on the acceptability of the research in terms of scientific merit balanced against animal welfare. A quorum is required to conduct official business at a convened meeting. Unless specific statutory or regulatory requirements are cited, the FAQs should be viewed as recommendations in that an institution may use an alternative approach if the approach satisfies the requirements of the PHS Policy. A properly constituted IACUC as set forth in PHS Policy (see subpar.IV.A.3b) and the Animal Welfare Act (see 7 U.S.C. In the event of a pandemic, a properly constituted IACUC shall be defined as no fewer than five members to include: the IACUC Chair, the Attending Veterinarian, a scientist, a non-scientist, and a non-affiliated (community) member. 3.11 Minimization of Pain and Distress 20 . To conduct such activities in the field, the investigator must provide the IACUC with the following information: If the IACUC determines that the proposed activity is likely to alter or influence the activity of the study animals or other species found in the study area, then protocol review and approval is required. An IACUC Chair who isn't a member. A. Oxford University Press is a department of the University of Oxford. The, Performance standards are to be applied to housing issues. The information in these FAQs is updated and supersedes previous guidance or commentary. If a protocol involves particularly complex issues, the PHS Policy states, ‘The IACUC may invite consultants to assist in the review of complex issues ( PHS, 1986a , P.8).’ However, as per the PHS Policy ‘Consultants may not approve or withhold approval of an activity or vote with the IACUC unless they are also members of the IACUC’ ( PHS, 1986a , P.8). (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. To learn more and for a sample annual report, see the Annual Report to OLAW. 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. 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. Comments generally will not result in direct responses from OLAW. Such an assessment obviously requires the reviewer to possess an adequate background in the scientific discipline of the protocol under review. This guidance is based on OLAW's experience with the subject matter and draws on best practices followed by the biomedical community regarding the use of research animals. (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.). It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. (Available from: Office for Protection from Research Risks, Building 31, Room 5B59, National Institutes of Health, Bethesda, MD 20892.). ); that medical care for animals will be provided by “qualified” veterinarians (IV.C.1.e.) 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