【Educational Lecture 1】 US FDA proposal of GLP regulation amendment -Animal Welfare IssueE1-1
○ Tsutomu Miki Kurosawa Visiting Professor, Kagoshima University, Representative, Animal Welfare Research
US FDA is a regulatory body to regulate not only drugs but also medical devices, biological products, cell therapy products, cosmetics and food additives. The largest laboratory animal users are laboratories that follow the government requirement for safety testing and the amendment of GLP regulation is interested in by laboratory animal industry. In USA, GLP is regulated by law instead of ministry order which is ruled in Japan. The summary did not include animal welfare, however the animal welfare issue is largely added and this issue is not stringently regulated in Japan, therefore US GLP Regulation amendment should be carefully observed by Japanese laboratory animal industry. The significant amendments in terms of animal welfare are as follows. Addition of attending veterinarian to the definition. The study director must defer to the attending veterinarian when decisions regarding animal welfare arise, particularly when animals are in
pain or distress. The sponsor must ensure the study protocol provides for the humane care of animals. The new study director responsibilities affecting the welfare of test animals is added and the study director must consult with the attending veterinarian during review of proposed study protocols to determine potential animal welfare concerns and appropriate responses to likely contingencies. The most significant change is that FDA proposes removing the phrase“provided that such treatment does not interfere with the study”, and replacing this phrase with“as deemed necessary by the study's attending veterinarian.”FDA removes the premise for the study integrity which are appeared in Japanese regulation. FDA understands the protocol deviation is necessary to prevent a potential hazard to animal welfare or study integrity and proposes requiring that final study reports contain the names of all study attending veterinarians.
Anatomy of an AAALAC-accredited Large Animal Surgical Research Program E1-2
○ McCrackin MA Surgical Research Laboratory, Department of Comparative Medicine, Division of Laboratory Animal Resources, Medical University of South Carolina, Charleston, SC, USA.
Large animal surgical experimentation continues to be an important step in translational research and medical training in the United States. Academic institutions and private industry must meet the requirements of federal law (Animal Welfare Act) and funding organization regulations (for instance, National Institutes of Health). Many programs voluntarily meet expectations of AAALAC International as an endorsement of quality veterinary care and to meet standards of some nongovernmental funding organizations (for instance, American Heart Association). Veterinarians and veterinary technicians with specialized training or experience in surgery, anesthesia, laboratory animal medicine and clinical care are the foundation of a strong surgical research program. Veterinarians and veterinary surgical support staff partner with scientists and industry sponsors in many aspects of large animal surgical research projects, such as hypothesis development, animal model selection, animal purchasing,
anesthetic induction and maintenance, multi-modal analgesia, surgical assistance, and postoperative clinical care until the study endpoint. Members of the veterinary team work with scientists to solve problems that arise during execution of the project, such as incisional infection, treatment of expected model complications (for instance, heart failure after induction of myocardial infarction), unexpected adverse events, and determination of humane endpoints. The surgical research laboratory veterinarian and veterinary staff provide training in aseptic technique, comparative anatomy and the clinical care of large animals to users of the laboratory. Finally, medical records are important in documenting animal care and research data. Surgical research laboratory staff maintain detailed records of anesthesia, analgesia, surgical recovery, postoperative treatments, imaging, and necropsy records. Thorough records not only support current projects but also allow retrospective data collection in the future.
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【Educational Lecture 2】
E-2
Overview of United Kingdom Legislation Relating to the use of Laboratory Animals, Animals (Scientific Procedures) Act 1986 - Amendment Regulations 2012 ○ Martin Heath MSc, FRSB, FIAT, FIScT, RAnTech, PTLLS, U.K
Laboratory animal science in the United Kingdom is very highly regulated with great emphasis on animal welfare, this compliments and enhances the science. Since 1986, the legislation concerned with using animals in scientific research has constantly changed and improved, the last update being in 2012. Several licences are required in order to be able to carry out regulated procedures, thus being an Establishment Licence ensuring the facilities and staffing are adequate, secondly, a Project licence to justify the work involving animals and a protocol to explain the detail of the experiments and thirdly, a Personal licence that authorises competent
individuals to carry out specified procedures on specified species. Although highly regulated, and sometimes bureaucratic , the Animals (Scientific Procedures) Act 1986 - amendment regulations 2012, has been able to justify, regulate and produce very high quality research while providing animals with a significant level of protection. Training and competency are high on the agenda for good animal research and my next presentation will explain and discuss these requirements.
【Educational Lecture 3】
E-3
Training and Competency Requirements of the Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012 ○ Martin Heath MSc, FRSB, FIAT, FIScT, RAnTech, PTLLS Learning Curve (Development) Ltd., U.K.
The animals (Scientific Procedures) Act 1986 amendment regulations 2012, requires that a person working with laboratory animals is fully trained and competent. After completing a Home Office accredited course, a scientist or animal technician should have proof of training and proof of competence by way of training records either in a paper format or, even better, an electronic format, before being able to carry out regulated procedures. Post course training is carried out under the direction of the Named Training and Competency Officer (NTCO), which every facility must have as a condition of the Establishment Licence. It is in the interest of animal welfare and good science that staff cause minimal harm to an animal
in order to pursue their science. Training with nonanimal alternatives such as models, watching others and using cadavers is the first step; using a live animal to gain competency is currently not allowed under United Kingdom legislation. Procedures such as injections, blood sampling and surgery for example, will require satisfactory evidence of training and this includes the correct attitude towards the animals involved. Failure to comply with these requirements may result in losing their Personal Licence and their authority to work with laboratory animals. This talk will explain the theoretical and practical training aspects of a newly qualified person wishing to pursue a career in laboratory animal science.
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2017/05/17 16:29
○ Tsutomu Miki Kurosawa Visiting Professor, Kagoshima University, Representative, Animal Welfare Research
US FDA is a regulatory body to regulate not only drugs but also medical devices, biological products, cell therapy products, cosmetics and food additives. The largest laboratory animal users are laboratories that follow the government requirement for safety testing and the amendment of GLP regulation is interested in by laboratory animal industry. In USA, GLP is regulated by law instead of ministry order which is ruled in Japan. The summary did not include animal welfare, however the animal welfare issue is largely added and this issue is not stringently regulated in Japan, therefore US GLP Regulation amendment should be carefully observed by Japanese laboratory animal industry. The significant amendments in terms of animal welfare are as follows. Addition of attending veterinarian to the definition. The study director must defer to the attending veterinarian when decisions regarding animal welfare arise, particularly when animals are in
pain or distress. The sponsor must ensure the study protocol provides for the humane care of animals. The new study director responsibilities affecting the welfare of test animals is added and the study director must consult with the attending veterinarian during review of proposed study protocols to determine potential animal welfare concerns and appropriate responses to likely contingencies. The most significant change is that FDA proposes removing the phrase“provided that such treatment does not interfere with the study”, and replacing this phrase with“as deemed necessary by the study's attending veterinarian.”FDA removes the premise for the study integrity which are appeared in Japanese regulation. FDA understands the protocol deviation is necessary to prevent a potential hazard to animal welfare or study integrity and proposes requiring that final study reports contain the names of all study attending veterinarians.
Anatomy of an AAALAC-accredited Large Animal Surgical Research Program E1-2
○ McCrackin MA Surgical Research Laboratory, Department of Comparative Medicine, Division of Laboratory Animal Resources, Medical University of South Carolina, Charleston, SC, USA.
Large animal surgical experimentation continues to be an important step in translational research and medical training in the United States. Academic institutions and private industry must meet the requirements of federal law (Animal Welfare Act) and funding organization regulations (for instance, National Institutes of Health). Many programs voluntarily meet expectations of AAALAC International as an endorsement of quality veterinary care and to meet standards of some nongovernmental funding organizations (for instance, American Heart Association). Veterinarians and veterinary technicians with specialized training or experience in surgery, anesthesia, laboratory animal medicine and clinical care are the foundation of a strong surgical research program. Veterinarians and veterinary surgical support staff partner with scientists and industry sponsors in many aspects of large animal surgical research projects, such as hypothesis development, animal model selection, animal purchasing,
anesthetic induction and maintenance, multi-modal analgesia, surgical assistance, and postoperative clinical care until the study endpoint. Members of the veterinary team work with scientists to solve problems that arise during execution of the project, such as incisional infection, treatment of expected model complications (for instance, heart failure after induction of myocardial infarction), unexpected adverse events, and determination of humane endpoints. The surgical research laboratory veterinarian and veterinary staff provide training in aseptic technique, comparative anatomy and the clinical care of large animals to users of the laboratory. Finally, medical records are important in documenting animal care and research data. Surgical research laboratory staff maintain detailed records of anesthesia, analgesia, surgical recovery, postoperative treatments, imaging, and necropsy records. Thorough records not only support current projects but also allow retrospective data collection in the future.
― S30 ―
JALAS英文版.indd 30
2017/05/17 16:29
【Educational Lecture 2】
E-2
Overview of United Kingdom Legislation Relating to the use of Laboratory Animals, Animals (Scientific Procedures) Act 1986 - Amendment Regulations 2012 ○ Martin Heath MSc, FRSB, FIAT, FIScT, RAnTech, PTLLS, U.K
Laboratory animal science in the United Kingdom is very highly regulated with great emphasis on animal welfare, this compliments and enhances the science. Since 1986, the legislation concerned with using animals in scientific research has constantly changed and improved, the last update being in 2012. Several licences are required in order to be able to carry out regulated procedures, thus being an Establishment Licence ensuring the facilities and staffing are adequate, secondly, a Project licence to justify the work involving animals and a protocol to explain the detail of the experiments and thirdly, a Personal licence that authorises competent
individuals to carry out specified procedures on specified species. Although highly regulated, and sometimes bureaucratic , the Animals (Scientific Procedures) Act 1986 - amendment regulations 2012, has been able to justify, regulate and produce very high quality research while providing animals with a significant level of protection. Training and competency are high on the agenda for good animal research and my next presentation will explain and discuss these requirements.
【Educational Lecture 3】
E-3
Training and Competency Requirements of the Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012 ○ Martin Heath MSc, FRSB, FIAT, FIScT, RAnTech, PTLLS Learning Curve (Development) Ltd., U.K.
The animals (Scientific Procedures) Act 1986 amendment regulations 2012, requires that a person working with laboratory animals is fully trained and competent. After completing a Home Office accredited course, a scientist or animal technician should have proof of training and proof of competence by way of training records either in a paper format or, even better, an electronic format, before being able to carry out regulated procedures. Post course training is carried out under the direction of the Named Training and Competency Officer (NTCO), which every facility must have as a condition of the Establishment Licence. It is in the interest of animal welfare and good science that staff cause minimal harm to an animal
in order to pursue their science. Training with nonanimal alternatives such as models, watching others and using cadavers is the first step; using a live animal to gain competency is currently not allowed under United Kingdom legislation. Procedures such as injections, blood sampling and surgery for example, will require satisfactory evidence of training and this includes the correct attitude towards the animals involved. Failure to comply with these requirements may result in losing their Personal Licence and their authority to work with laboratory animals. This talk will explain the theoretical and practical training aspects of a newly qualified person wishing to pursue a career in laboratory animal science.
― S31 ―
JALAS英文版.indd 31
2017/05/17 16:29
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