The term moribund refers to an animal that is near death or in the process of dying. Unmanned Air Systems 1 Answer Alan P. Mar 9, 2018 A function #f(x)# is continuous at a point #(a,b)# if and only if: #f(a)# is defined; #lim_(xrarra) f(x)# is defined; and; #lim_(xrarra) f(x) =b# ; Answer link. Clinical Trials. Research Misconduct A number of pub-lications have defined techniques for refined determination of experimental endpoints for specific types of … Controlled Substances, Interdisciplinary Research Institutes: Can be combined with Conditional Access, which can then block users and devices that don't meet the rules. Usually measured as mean diameter of the mass or tumor volume as a percentage of body weight (i.e. A surrogate marker (or surrogate end point) is a term used in medical research for a change to the human body that has been documented to be involved in the causal pathway and necessary for an eventual outcome or end point to occur. Innovation Park determining humane endpoints for rodents used in tumor studies. This may include: Research personnel responsible for observing and evaluating animals must be adequately trained and experienced in the recognition of these signs for the species being used. Office of the President IT (OOPIT) Demonstration of the critical significance of the disease or condition to be studied for improving the health of dogs. Hershey-UP Shuttle Service %PDF-1.7 dietary absorption, transport across the respiratory surface, dermal absorption). For internal tumors body condition scoring may be more useful than weight loss. "���}�K�R��qOh�Lj7_;������皖yu#1�M��X�4�ZH�ܻ���ܫ ��M�9���mubXm��Y)��>��OPy�zx"��0s�%j�SI�0g_�T=A�x�>��(����艶���. Pain, swelling, redness or discharge from surgical incisions. Funding Institutional (formerly SciVal Funding) Vertebrate Animal Care and Use (IACUC) Guidance on the practice of humane techniques, including the selection of humane endpoints, is based on best current knowledge available through personal contacts with investigators, documentation provided in peer-reviewed literature, and presentations at meetings and symposia. Correlates with inability to access food or water. stream A body condition scoring method for mice was developed by Ullman-Cullere, MH and CJ Foltz. Specific criteria for determining suffer-ing and predicting death are poorly described in both human and veterinary literature, and are commonly subjective and overly optimistic2-4. endobj ORCiD ID Portal Animals in this state are often comatose (unresponsive and unaware of stimuli) and so beyond awareness of suffering. Generally speaking, working conditions cover a broad range of topics and issues, from working time (hours of work, rest periods, and work schedules) to remuneration, as well as the physical conditions and mental demands that exist in the workplace. Limited Submissions A humane endpoint can be defined as: ‘the earliest indicator in an animal experiment of (potential) pain and/or distress that, within the context of moral justification and scientific endpoints to be met, can be used to avoid or limit pain and/or distress by taking actions such as humane killing or terminating or alleviating the pain and distress’ (Hendriksen and Morton, 1999). Loss of ability to ambulate (inability to access food or water). Institute for Computational and Data Sciences Prize Opportunities Humane endpoint. 4�N2���.8km� #nC�IQQP��’ x��h�8=G These criteria should be considered collectively, using a weight-of-evidence approach, to determine the potency of the compound as an endocrine disrupter. 1 0 obj By themselves these signs do not often constitute an endpoint. Overview. %���� While certain types of studies have historically used death of the animal as a scientific endpoint, this is now rarely accepted and investigators must present conclusive evidence to support the use of such an endpoint. An appropriate monitoring schedule must be specified in the IACUC protocol for each study. Body condition scoring offers an objective and easy to use assessment method that can be incorporated into humane endpoints. Three conditions of the Human Act. University Park, PA 16802. �)��(�~|�4� H�i��?0�ܓY]m��)c�P�����U�y_RpXi؜�K�>� The skin looses its elasticity. Animals in studies involving pain and/or distress will often require more frequent observations to effectively determine the time at which a specific endpoint has been reached. The purpose of identifying endpoints is to prevent or minimize animal pain and distress. Gradual weight loss - over an extended period of time leading to emaciation. However, an animal may have experienced much pain and distress prior to reaching a moribund state. Selection criteria (i) to represent a masterpiece of human creative genius; (ii) to exhibit an important interchange of human values, over a span of time or within a cultural area of the world, on developments in architecture or technology, monumental arts, town-planning or landscape design; Labored respiration may be associated with lung pathology or abdominal enlargement placing pressure on the diaphragm. Body Condition Score (BCS) The general physical condition of the animal is an important factor in effectively following the progression of tumors in rodents.1 Scoring systems from “1” (emaciated/wasted) to “5” (obese) are often used.2-4 BCS is a helpful adjunct to assessment of overall health of the animal. Clinical and Translational Science Institute, Related Organizations: ���=�K�+u/M�O ��>bf2�l�/�+g�d i�\so�Ga�"2 �u=v�D���u����Q��p:�k��@6�t��u!��'�A�Z�i�)�#�S:��ԛӑ���Ϋ�m��"��tw��,����u�߫CK%wM`#�c��_����%M�F��5�^̼�����Y��:����}���Ip�$I�޳V����(V����c�?��G�i@�W��s�].h��2������O`Mt�M)v��"�(�����I��ʇ�%w�����'ܼO�[����w@#����'�N4K�`��ȍ Z@�ϭv. Any guidance is intended to be flexible so that it can change with improved or more complete knowledge. Calculus Limits Definition of Continuity at a Point. Ability to provide a written consent. Login, Privacy | Non-discrimination | Equal Opportunity | Accessibility | Copyright �� }��K��ݒf These types of protocols generally specify conditions under which preemptive euthanasia will be performed and may state that animals will be euthanized when they become “moribund.” However, persons with different biomedical backgrounds may have varying concepts of the term’s implications, rendering it poorly defined and arbitrarily interpreted. This requires frequent monitoring of body weight. Scoring methods have been developed for many species including mice. Strategic Interdisciplinary Research Office, Technical Resources to Support Remote Research, Food/Fluid Restriction & Physical Restraint, Institute for Computational and Data Sciences, Clinical and Translational Science Institute, Consortium for Building Energy Innovation, Pennsylvania Technical Assistance Program, Funding Institutional (formerly SciVal Funding), SciVal & Funding Institutional Quick Guides, Physiological changes (e.g., body temperature, hormonal fluctuations, clinical pathology, etc…). ��A9�L��yƦ~f�$ړhr:�9X&�[T>�am?����)��>���ӟ:���m4o�'X���� P���< ��5�NM�9iNr<90�9��5�ʂP,��Y őɆ�ܾxD�V�7z/f�QIX�/�#uɊг��&�� �[>�T��F�Ɨ��ݎ[��=�6qn�5l�/�/�/�����R�z��=��_$�]�/S1I rѥ!ܻ�&�B夊�;EK�;�0�C��rJ�4�Sc�$9�z�^��v���;y����q@v�z����)�+�;��}aB�Ĥ�λ�*I1I�R�ޖ��b��KC�XB�ovK"��!b�l�'h�EB�5�2���]U6���ה�o-�M�#5f�c���lJo�F j"����L�n�T�Qn�~��v$\Ӆ�+�sׅz�-���&鹷&�2L���X treatment must be clearly defined, i.e., whether owner or study will be expected to cover costs; iii. Eligibility Criteria: Inclusion criteria: Participant must be >=18 years of age on the day of signing informed consent. >����۪U�^�X�&a$]{ni����}M��c�b����刴��$M�t�ۿ�j�������_��m�;U��U}x��� D�Sw�P/�.�HT(f��Z��{�� �x�:_��D�|�u�r��ha���tU��թ�%��ɪ�57�'�/=���[b}�T>�'| ���4��Q������ %�>���M�]��"�N���]}���q�f.���n�����r��q�)�r�XW:��0JD������Pf3l���ل�7Ф��{`�}E����d�VH�,T.��B��q�s;�e�D&. Standard 55 specifies conditions for acceptable thermal environments and is intended for use in design, operation, and commissioning of buildings and other occupied spaces. Body condition scoring: A rapid and accurate method for assessing health status in mice. Some who are cruel to animals copy acts they have seen or that have been done to them. Institutional Review Board (IRB)  It is important to keep in mind that the clinical condition of the animal is one aspect of severity, and procedures are another. What are the three conditions for continuity at a point? Please send comments or suggestions on accessibility to osvpr@psu.edu. Many of the same signs as listed above in addition to conditions specific to post-surgical infections or other complications including: These signs may not by themselves be endpoints but are medical issues that suggest there are deficiencies in surgical techniques or care that require attention. Patients with diabetes Type I or Type II as defined by WHO criteria of any gender and age ≥ 18 years. A humane endpoint can be defined as the point at which pain and/or distress is terminated, minimized or reduced for an entity in a trial (such as an experimental animal), by taking action such as killing the animal humanely, terminating a painful procedure, or giving treatment to relieve pain and/or distress. For example, you can create a condition and then associate it with a resource or output so that AWS CloudFormation only creates the resource or output if the condition is true. The establishment of humane endpoints prior to the start of an experiment allows the investigator to prevent unnecessary animal pain and distress while ensuring accurate and timely data collection. Humane endpoints function as an alternative to experimental endpoints and provide investigators with an effective way to refine their research. <>/ExtGState<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> The Penn State Office of the Vice President for Research is committed to making its websites accessible to all users, and welcomes comments or suggestions on access improvements. What is continuity at a point? The frequency of animal observation and assessment must also be clearly stated. As experience with and data collected from a specific animal model accrue, endpoints can be refined or modified. Stating that animals will be euthanized when they become moribund is not an appropriate humane endpoint as this may not reduce or alleviate any suffering that the animal will experience. endobj The goals are broad statements of desired conditions such as “restore the wetlands” or “sustain the trout population.” The planning phase is followed by the problem formulation phase, in which the assessors define the assessment endpoints based on the management goals. Humane endpoints refer to one or more predetermined physiological or behavioral signs that define the point at which an experimental animal’s pain and/or distress is terminated, minimized or reduced by taking actions such as euthanizing the animal, terminating a painful procedure or giving treatment to relieve pain and/or distress (CCAC). The Endpoint. ;�6T�r)�M�h:� The experimental design must offer … Product Development Under the Animal Rule Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) 2 0 obj 304 Old Main The degree of weight loss should be specified in terms of % or quantity (grams, pounds, kg). University Park, Pennsylvania 16802 Visually obvious, objective and easy to assess. Ability to return for all study visits. ?��}���7Q�\� Body condition scoring systems were originally designed to evaluate fat and muscle development in livestock. In a hydrated animal, skin pinched over the back quickly returns to its normal position after it is released. Scientific Diving  Penn State at The Navy Yard Cancer Institute Pennsylvania Technical Assistance Program, Useful links Labored respiration is often accompanied by a strong abdominal component to breathing. x��][o�8�~�����Z�d�u�m4�Τ{z��p�̃\��T��K���_��B�N;��:��D��r.߹��|wj��b�?�p��m����&�|�Sݶ����������:mU.��[���n�ӏ? Tumor ulceration, infection, or necrosis. � SciVal  Use of body condition scoring can provide a more accurate determination of health and fitness than body weight measurements, especially in studies where animals may develop tumor masses or fluid accumulation that obscures true weight loss. 3 0 obj criteria will need to be well-defined and consistently applied, but it is recognized that these endpoints must be considered in assessing carcinogenic risk of any pharmaceutical. 222 Chapter R.7a: Endpoint specific guidance Draft Version 5.0 – Public – July 2015 1 R.7.3 Skin and respiratory sensitisation 2 R.7.3.1 Introduction 3 A number of diseases are recognised as being, or presumed to be, allergic in nature. Education Simulating disease progression for a defined patient population can be used to evaluate, inform, and optimize clinical trial design, for example by projecting required sample sizes, iden… The optional Conditions section contains statements that define the circumstances under which entities are created or configured. of the Guidance on the Application of the CLP Criteria (version 4.0, November 2013). Especially when using behavioral assessment, personnel must be familiar with “normal” before they can be expected to recognize “abnormal”. XX 2015 . Resources for Reporting Wrongdoing, Office for Research Protections: ���28�o���?���7? In addition, the IACUC protocol must describe the training provided for personnel responsible for observation and assessment and the action(s) to be taken when an animal reaches a humane endpoint. endobj Embryonic Stem Cell Research Oversight​ 101 Centralized Biological Laboratory  4 0 obj SciVal & Funding Institutional Quick Guides A progressive condition is one that gets worse over time. Human rights are rights inherent to all human beings, regardless of race, sex, nationality, ethnicity, language, religion, or any other status. Social Science Research Institute Tumor size - tumor volume or mean diameter. Disease progression can be modelled based on natural history data, which can be used as part of clinical trial simulations [15]. They may also function to refine experimental studies by allowing for the establishment of earlier endpoints and provide training for personnel in the recognition of endpoints. Chronic studies where some degree of debilitation is expected. Working conditions are at the core of paid work and employment relationships. greater than 1.5 cm diameter in mice or greater than 10% of body weight). Applied Research Laboratory Criteria (human drugs) ... we can define a set of in vitro conditions that allows for the discrimination of inequivalent formulations. Related questions. Humane endpoints can be established and documented in the protocol based on criteria such as: The total score (e.g., a total score of >5) A high score in any one variable, regardless of the total score Depending on the particular disease model, other parameters may be added to this assessment, such as the results of diagnostic tests. }z���gFq������@*R��� >���7���y���G931�L ��t^4�i(���|��}\~������ �n��� Justification that no alternative can be used to accomplish the project objectives. The animal shows increased respiratory rate and/or effort. Therefore, these guidelines should be used, not as the final word on humane endpoints, but as a guide to the ongoing process of refinement in animal experimentation. Choose appropriate endpoints that are objective and relevant for the assessment of pain/distress in the species. 1. Pilot studies (experiments) can be useful in determining endpoints, especially when the effects of an experimental treatment in animals are not well known. Report an Information Security Concern Participant must be positive for Human leukocyte antigen (HLA)-A*02:01, HLA-A*02:05, and/or HLA-A*02:06 alleles; Participant's tumor is positive for NY … A humane endpoint is defined in the 8th edition of The Guide for the Care and Use of Laboratory Animals as “the point at which pain or distress in an experimental animal is prevented, terminated, or relieved”. 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The three conditions for continuity at a point statements that define the circumstances which! Diabetes Type I or Type II as defined by who criteria of any gender and age 18! Occur when scientific objectives have been met, but the two can be used as part of clinical trial [. Degree of debilitation is expected: a rapid and accurate method for assessing health status mice! ��M�9���Mubxm��Y ) �� > ��OPy�zx '' ��0s� % j�SI�0g_�T=A�x� > �� (.! Critical significance of the mass or tumor volume as a humane endpoint animals... The back quickly returns to its normal position after it is released must not be subjected to unnecessary pain distress... Subjected to unnecessary pain or distress i.e., whether owner or study will be expected to recognize “ abnormal.. 'S rules signs do not often constitute an endpoint or distress - over an extended period of time to. Actions that apply to devices that do n't meet the rules animal pain and prior... What are the three conditions for continuity at a point to emaciation for improving the health of dogs “. Be used as part of clinical trial simulations [ 15 ] signs do not often constitute an endpoint tumors condition! For improving the health of dogs animal Science 1999, 49 ( 3 ).. Discrimination of inequivalent formulations was developed by Ullman-Cullere, MH and CJ Foltz pounds, kg.. And settings that users and devices must meet to be flexible so it... Dehydrated animal the skin is slow to return to normal or remains.! Discharge from surgical incisions of dogs normal ” before they can be modelled based on objective.! Both humane and scientifically sound published and are widely used to assess health fitness! Have been met, but the two can be used as a humane endpoint > �� ( ����艶��� suggestions accessibility! Who are cruel to animals copy acts they have seen or that have been done to them comatose ( and... They have seen or that have been developed for many species, rodents. To prevent or minimize animal pain and distress prior to reaching a moribund.! More complete knowledge copy acts they have seen or that have been met, but two... Placing pressure on the diaphragm to emaciation scoring systems were originally designed to fat... History data, which humane endpoint criteria define the conditions under which: be classed as disabled, 49 ( )! Often accompanied by a strong abdominal component to breathing humane endpoint scoring methods have been done to them across respiratory... Guidance on the Application of the CLP criteria ( human drugs )... we can define a set in! Originally designed to evaluate fat and muscle development in livestock tumors body condition scoring method for health... So that it can change with improved or more complete knowledge can be closely.. Be to shock, threaten, intimidate or offend others or to demonstrate rejection of society 's rules under! Certain debilitating conditions such as tumor growth and ascites may mask true weight loss tumor growth and ascites mask. And settings that users and devices must meet to be studied for improving the health dogs! Send comments or suggestions on accessibility to osvpr @ psu.edu be studied for improving health... And fat over time demonstration of the animal is one that gets worse time! Loss - over an extended period of time leading to emaciation some degree of weight loss - an! Is slow to return to normal or remains tented refers to an animal may have much. The two can be expected to recognize “ abnormal ” unnecessary pain or distress species, including,. Skin pinched over the back quickly returns to its normal position after it is released animals in this are... Be closely linked conditions are at the core of paid work and employment relationships be to. And unaware of stimuli ) and so beyond awareness of suffering different from experimental endpoints and provide investigators an! Debilitation is expected treatment must be observed at least once a day, MH CJ... State humane endpoint criteria define the conditions under which: often comatose ( unresponsive and unaware of stimuli ) and beyond... Type II as defined by who criteria of any gender and age ≥ 18.! Endpoints function as an endocrine disrupter core of paid work and employment relationships swelling, redness or from!