CPCSEA GUIDELINES 2014 PDF

The laws, regulations, guidelines, and standards on animal care and use for scientific purposes in the countries of Singapore, Thailand, Indonesia, and Malaysia, and India are described in this manuscript. For each of these five countries, a brief introduction is provided on the history of how the need for animal welfare in research, education, training, and testing came to being. This is followed by some background information leading to the current status of regulations and guidelines in each of the five countries. There is also a description of the responsibilities and functions of institutional animal welfare and ethics oversight bodies, enforcement agencies, penalties, and organizations supporting the industry.

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The laws, regulations, guidelines, and standards on animal care and use for scientific purposes in the countries of Singapore, Thailand, Indonesia, and Malaysia, and India are described in this manuscript. For each of these five countries, a brief introduction is provided on the history of how the need for animal welfare in research, education, training, and testing came to being.

This is followed by some background information leading to the current status of regulations and guidelines in each of the five countries. There is also a description of the responsibilities and functions of institutional animal welfare and ethics oversight bodies, enforcement agencies, penalties, and organizations supporting the industry. Finally, a conclusion with insights into the future of laboratory animal welfare and science in each of these five countries in Asia is provided.

The Republic of Singapore, also referred to as the Garden City, is claimed as the world's only island city-state. With a physical land area of just over square kilometers and a population of around 5. The literacy rate of the population for those aged 15 and above is While English is the official language in this cosmopolitan, multi-ethic, and multi-cultural environment, students are required to learn a second language, predominantly Malay, Mandarin, or Tamil.

Lee Hsien Loong, chairs the Research, Innovation and Enterprise Council RIEC , which comprises cabinet ministers and distinguished local and foreign members from the business, science, and technology communities.

The National Research Foundation NRF was also formed in under the Prime Minister's Office to support the RIEC in its work through the development and coordination of national policies to grow Singapore's research capability, support economic growth, and meet future national challenges. Deputy Prime Minister Mr. The NRF Strategic Research Programs supports investments in areas of research to create new industries and enable high growth. Multi-institutional flagship programs have been established in gastric cancer, eye disease, infectious diseases, metabolic diseases, and schizophrenia.

Although the Faculty of Medicine at the National University of Singapore had an Animal Research Ethics Committee in to review and approve proposals for the use of live animals for research and education purposes, there were no national guidelines or standards at that time.

One could say that the birth of Singapore's guidelines for the care and use of research animals took place in January when Mr. Yeo appointed members to form the National Advisory Committee for Laboratory Animal Research NACLAR , whose mission was to provide a set of national policies and guidelines for the acquisition, housing, and utilization of laboratory animals in biomedical research and address related scientific, ethical, and legal issues.

Within a few months of its appointment, NACLAR produced a draft of national guidelines in August , which was released to the public for general comment. These countries and organizations laid down stringent guidelines and procedures governing the care and use of animals in research. The NACLAR Guidelines set out responsibilities of all parties involved in the care and use of animals for scientific purposes, in accordance with widely accepted scientific, ethical, and legal principles.

The Guideline is organized into three sections, which should be read together as a complete document. The first section, Guiding Principles for the Care and Use of Animals for Scientific Purposes, describes the overall guiding principles to promote the humane and responsible care and use of animals for scientific purposes in Singapore.

The scope of the principles covers all aspects of the care and use of animals for scientific purposes including their use in teaching, field trials, environmental studies, research, diagnosis, product testing, and the production of biological products.

This section outlines the responsibilities of institutions, investigators, and persons involved in the care and use of animals for scientific purposes. The IACUC is responsible for the oversight and evaluation of the animal care and use program of an institution and for ensuring that the care and use of animals for scientific purposes and all animal experimental procedures are in compliance with the Guidelines.

Under the Guidelines, all institutions with research facilities are required to establish their own IACUC to assume this function. The third section, Training Guidelines, outlines the training scope and requirements for users of animals and animal facilities personnel.

This includes the scope of the core curriculum and the relevant core competencies, such as special courses for animal procedures. The Guidelines require all users of animals for research to undergo appropriate training before carrying out any experiments using animals. This required any research facilities that intend to use animals for scientific purposes to apply for and obtain a license from the AVA before commencement of work on animals.

The Rules provide a transitional period of 6 months for institutions to appoint an IACUC, 12 months to employ an Attending Veterinarian and for the completion of the required training as specified in the guidelines for all investigators and personnel in the care and use of animals for scientific purposes, and 18 months to comply with provisions in the guidelines relating to infrastructure in respect of those premises.

Similar to the United States, self-regulation is used as an enforcement mechanism in Singapore. Research facilities are licensed, but not individual researchers or their animal use protocols. Nevertheless, requirements imposed through AVA's licensing mechanism make each research facility accountable for the conduct of all live animals used for scientific purposes.

Each facility must put in place a program and a system of checks to ensure that animals are used responsibly. The IACUC is also required to conduct internal audits by reviewing the animal care and use program semiannually and by conducting facility inspections at least once a year. All animal research facilities are required to submit an annual report to the AVA, who will carry out inspections before licenses are considered for renewal. Special considerations for the care and use of nonhuman primates for scientific purposes are provided as an appendix to the NACLAR Guidelines.

As these animals have highly developed mental and emotional capacities compared to other species, environmental enrichment is emphasized. In addition, group housing is preferred due to their complex social hierarchy and interactions, although the potential for problems such as inappropriate dominance hierarchies, injury, and disease transmission would be considered. Housing enclosures should be designed in ways such that nonhuman primates can express specific behaviors such as gathering food, perching, swinging, and vertical flight.

It also advises that while interaction is encouraged, it should not be forced; direct physical contact should be minimized to prevent disease transmission as well as to avoid emotional attachment. The IACUC has a responsibility to determine if any mutant gene can result in a severely debilitating phenotype and if mitigating measures can be put into place to address them.

For example, modified husbandry measures or housing conditions can be of use, and general criteria for humane endpoints should be included in the project proposal. Specific clinical abnormalities that are known or suspected to occur in the development of a new mutant model should either be included at the start or made known to the IACUC when the information becomes available. SALAS was founded in and has held a conference annually since It has established links with regional Asian Federation of Laboratory Animal Science Associations and international International Council for Laboratory Animal Science associations to promote collaboration and awareness of recent developments in the field of laboratory animals.

It ensures that a facility's processes and the conditions in which laboratory studies using animals are planned, performed, monitored, recorded, reported, and archived meet international requirements. This enables Singapore's research laboratories to gain acceptance for their environmental health and safety data in OECD countries. There were six GLP registered facilities in Singapore in In the next 5 years from to , under the sixth science and technology plan for Singapore i.

With continued commitment to research, innovation, and enterprise, Singapore seeks to support and translate research, build up the innovation capacity of companies to drive economic growth, and leverage science and technology to address national challenges. Singapore continues to stay abreast with internationally recognized standards for the care and use of research animals.

The intent is to continue leading and staying ahead of its Southeast Asian neighbors in implementing laws and regulations using internationally recognized guidelines for animal research. The efforts to establish Sinagapore as an internationally recognized hub for biomedical research and the general culture of compliance with government regulations cultivated in this island has aided the implementation process and bodes well for its continued future in maintaining the highest standards of animal care and use in the region.

As in many countries, animals have played a vital role in the advancement of science in Thailand. Animals have been used for scientific purposes such as biomedical research, animal production research, teaching in sciences, and biological production.

Most of the scientists and researchers who use animals are in academic institutions and government organizations. Currently, animal research is still needed in Thailand; therefore, the regulation and legislation has evolved for ethical care and use. The Ethical Principles establish oversight of animal research at national and institutional levels. Training programs for animal users, IACUC, and animal care takers has been established where almost every year the NRCT offers training courses for improvement of competency.

However, the Ethical Principles and the Standards are not legislation; thus, the institutions have neglected to implement these standards at their institutions.

Legislation was considered by the NRCT for improvement of institutional and individual compliance with the guidelines. Initially there were divergent views about the necessity of law, but after long considerations, the animals for scientific purposes bill was ratified and became law in The act was enforced on September 14, , around days after it was published.

The act has 56 sections distributed in 6 chapters and transitional provisions. The sections 1 to 4 are an introduction and definitions. Animals in this act are defined as: any living organism or nonhuman vertebrate in the animal kingdom, which also covers a any fetus of the living organism developed after an egg is fertilized by a sperm until reaching half the period of conception or incubation of an egg, depending on the kind of animal; and b any cell, not a gamete, which is able to develop and multiply itself into a fetus or any part of organ without changing original genetic code;.

The third chapter sections 21—33 has two parts and addresses the control of procedures on animals. The first part defines the provisions requiring the establishment to be registered, and operating in accordance with the rules and guidelines. Included is the requirement to appoint an IACUC for review and approval of animal use protocols and oversight of procedures on animals.

The second part contains the provisions pertaining to procedures on animals and carcasses of animals for scientific purposes. This part is particularly important, as it clearly states that any person who wishes to use or breed animals for scientific purposes must be licensed.

The procedures on animals such as 1 breed improvement, 2 breeding, 3 production, 4 stem cell study, 5 genetic modification, and 6 cloning may be performed only after the Secretary-General of the NRCT is informed. This part establishes further requirements to advise the Secretary-General and comply with requirements created by the Committee for 1 sale, offer for sale, or possession for sale and 2 import, export, or transit.

Moreover, this part also includes the requirements for 1 transporting or transferring of an animal, 2 euthanasia of an animal, and 3 treatment of the carcass of an animal that must conform to the rules. The fourth chapter sections 34—38 relates to the provisions for the performance of duty and the authority of the competent officials who are appointed by the Prime Minister.

The fifth chapter sections 39—40 addresses administrative measures. The provisions in this chapter grant the authority to the Secretary-General of NRCT to order the responsible person of the establishment to improve or to comply with the regulations as well as to order suspension of the procedure of the animal users until there is an improvement in compliance with rules and regulations.

The sixth chapter sections 41—48 states the provision of penalties. Transitional provisions sections 49—56 are the provisions for enforcement of the act during days after the act entered into force. The Ethical Principles and Guidelines for the Use of Animals for Scientific Purpose Ethical Principles National Research Council of Thailand are comprised of five principles for which the scientists and institutions are responsible.

The value of life of animals Animals are to be used only for specific purposes, which have been carefully considered as beneficial and necessary for the development of the quality of life of both humans and animals and for the progress of science, where there are no other available options. The accuracy of the research outcome and the responsibility to minimize the number of animals on study Animal users are to consider that the objective and goal of the project can be achieved accurately with the fewest animals depending on the appropriate planning and techniques used in the experimental design.

The use of wild animals must not violate laws or policies for wildlife conservation The use of wildlife is to be restricted to scientific research that cannot be replaced by any other kind of animals, and it is to abide by the laws and policies for wildlife conservation.

Animals are living beings just as humans are living beings It should be considered that animals experience a sense of pain and respond to their surroundings in the same way that humans do. Animals are to be treated with caution to avoid stress, pain, and suffering by providing optimal conditions for transportation, animal husbandry, environmental enrichment, prevention of diseases, and appropriate experimental techniques.

Records for animal experimentsInvestigators must strictly follow the protocol described in their proposals, and all the details of the experiments are to be recorded in full and made available for public release or investigation at all times.

These Ethical Principles, by which animal users and animal breeders are to abide, provide a basis for ethics, virtue, humanity, and appropriateness as well as the universal standard of methodology. These Ethical Principles will be changed to the Ethics in Procedures on Animals for Scientific Purposes, which has more details and will come into force when published in the Government Gazette.

The IACUC has a vital role in the development of laboratory animal programs in their institutions as well as ensuring ethical care and use of laboratory animals in each research project.

The IACUC must be composed of at least seven members, and the chair has to be an executive or their representative. Thailand is in its early stages of the enforcement of the Animals For Scientific Purposes Act for animal breeders and anyone involved with animal procedures for scientific purposes. It is incumbent on the NRCT to inform and educate institutions and scientists as to their responsibilities under this legislation. It is necessary for those in the scope of this act to clearly understand the objectives and comply with the requirements.

Important will be the effective communication among regulators, scientists, institutions, and public and private stakeholders to identify and fill the gaps in programs, build trust, and improve and sustain cooperation in effecting the requirements.

In Indonesia, animal welfare legislation was enacted in with the release of the Law of Republic of Indonesia No.

This law was replaced in with Law No. Subsequently, this law was amended in with Law No.

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