Which laws mandate the formation of an iacuc

Monitoring of animal care and use is required by the PHS Policy. The Guide p. Continuing protocol review may consist of an annual update. The review must encompass all of the criteria in the Policy at IV. Animal work may not be administratively extended beyond the 3-year expiration date. Concerns may be raised by staff or employees of the institution, individuals in the community, or even members of the IACUC. It is a good idea for the IACUC to develop guidelines or procedures for handling allegations of mistreatment or noncompliance before such allegations are raised.

Suspension may occur only after review of the matter at a convened meeting of a quorum of the IACUC, and with the suspension vote of a majority of the quorum present.

The IO is required to take appropriate corrective action and report the action and the circumstances surrounding the suspension to OLAW. Another area that requires continual improvement will be education, whether for researchers, personnel involved in the animal research, or the lay public. There should be an active effort to collaborate with global peers with extensive experience and resources to advance care and use of animals in research.

The protection of experimental animals in India was established in law in when the Indian Parliament passed the Prevention of Cruelty to Animals Act Prevention of Cruelty to Animals Act To eliminate the potential for conflict, it was considered necessary to examine the international norms regarding the use of animals in scientific experiments, update regulations, and streamline and simplify procedures, while ensuring ethical use of animals and reduction of pain and stress on animals during experimentation.

Biomedical scientists have contributed to this national legislation system in their countries based on the public concern for animal welfare. The main objectives of Indian law, in the provisions in CPCSEA, are the opportunity for improving animal care and use and enhancing regulatory compliance in India.

Animals lowest on the phylogenetic scale i. Alternatives not involving animal testing should be given due and full consideration and sound justification provided, if the alternatives, when available, are not used.

Proper use of animals in experiments and avoidance or minimization when avoidance is not possible of pain and suffering inflicted on experimental animals should be an issue of priority for research personnel, and unless the contrary is scientifically established, investigators should process on the basis that procedures that cause pain or suffering in human beings will also cause similar pain or suffering in animals. Persons engaged in animal experimentation have a moral responsibility for the welfare of the animals after their use in experiments.

During the course of experimental procedure the animal has been left with a severe recurring pain and the animal exhibits obvious signs of long-term extreme pain and suffering. In situations where nontermination of the animal experimented upon would be life threatening to human beings or other animals. The living conditions of animals should be appropriate for their species and contribute to their health and comfort.

Animals used for biomedical purposes must be directed by a veterinarian or other scientist in a relevant discipline who is trained and experienced in the proper care, handling, and use of the species being maintained or studied.

In all circumstances, veterinary care shall be provided as necessary. Persons engaged in conducting scientific experiments on animals must act in conformity with the provisions of the Prevention of Cruelty to Animals Act, , and the Breeding of and Experiments on Animals Control and Supervision Rules, , as amended.

The purpose of the Prevention of Cruelty to Animals Act as amended in is to prevent unnecessary pain or suffering in animals. The IAEC is required to monitor the research throughout the life of the study, from periodic visits to the animals to completion and reporting of the data. The committee has to ensure compliance with all regulatory requirements, applicable rules, guidelines, and laws. The IAEC shall include eight members: 1 a biological scientist, 2 two scientists from different biological disciplines, 3 a veterinarian involved in the care of animal, 4 a scientist in charge of the animal facility of the establishment, 5 a scientist from within or outside the institute, 6 a nonscientific, socially aware member, and 7 a nominee of CPCSEA.

A specialist may be included while reviewing special projects using hazardous agents such as radioactive substance or infectious agents. The chairperson of the committee and member secretary are to be nominated by the institution from amongst the eight members.

It shall be the duty of the Committee to take all such measures as may be necessary to ensure that animals are not subjected to unnecessary pain or suffering before, during, or after the performance of experiments on them, and for the purpose it may, by notification in the Gazette of India and subject to the condition of previous publication, make such rules as it may think fit in relation to the conduct of such experiments.

The reports and other information which shall be forwarded to the Committee by persons and institutions carrying on exponents of animals. In particular, and without prejudice to the generality of the foregoing power, rules made by the Committee shall be designed to secure the following objects, namely: that in cases where experiments are performed in any institution, the responsibility therefore is placed on the person in charge of the institution and that, in cases where experiments are performed outside an institution by individuals, the individuals are qualified in that behalf and the experiments are performed on their full responsibility;.

In making any rules under this section, the Committee shall be guided by such directions as the Central Government consistently with the objects for which the Committee is set up may give to it, and the Central Government is hereby authorized to give such direction. All rules made by the Committee shall be binding on all individuals performing experiments outside institutions and on persons in charge of institutions in which experiments are performed. Penalties may be leveraged in the following situations: when a person contravenes any order made by the Committee under section 19; or.

Persons engaged in animal experimentation must comply with the provisions of the Prevention of Cruelty to Animals Act, , and the Breeding of and Experiments on Animals Control and Supervision Rules, , as amended. The IAEC may approve animal experiments, up to the phylogenetic level of rodents e. However, the IAEC is not empowered to clear research project proposals that involve experimentation on animals higher on the phylogenetic scale than rodents.

In such cases, IAEC may consider proposals for scientific experiments involving animals above the sentience level of rodents and forward its recommendations for consideration by the CPCSEA.

In terms of Rule 10 of the Breeding of and Experiments on Animals Control and Supervision Rules , as amended, 1 an establishment shall acquire animals for experiments from registered breeders only; 2 in case of nonavailability of animals from registered breeders, the animals may be procured from alternative legal sources; 3 in the case that the animal is procured from alternative legal sources, written permission is required from the competent authority under the law; and 4 alternatives to animals should be given due and full consideration, and sound justification must be provided in the case that alternatives are not available.

In terms of Rule 9 cc of the Breeding of and Experiments on Animals Control and Supervision Rules, , as amended, personnel using the experimental animals shall be responsible for the welfare of the animals during their use. In terms of Rule 9 cc of the Breeding of and Experiments on Animals Control and Supervision Rules, , as amended, investigators shall be responsible for the aftercare and rehabilitation of the animals after the experiment has ended.

This responsibility extends until the time the animal is able to resume a normal activities and extends to cover its natural life span. In terms of Rule 9 cc of the Breeding of and Experiments on Animals Control and Supervision Rules, , as amended, investigators shall not euthanize animals except in situations as defined below: When the animal is paralyzed and is not able to perform its natural functions or it becomes incapable of independent locomotion or it can no longer perceive the environment in an intelligible manner; or.

If during the course of experimental procedure the animal has been left with a recurring pain wherein the animal exhibits obvious signs of pain and suffering; or. Where the nontermination of the life of the experimental animal will be life threatening to human beings or other animals.

Rule 14 of the Breeding of and Experiments on Animals Control and Supervision Rules, , as amended, provides for the suspension or revocation of registrations. The IAEC receives reports from the member secretary or an authorized officer of the committee that details the results of an investigation of noncompliance.

The current regulatory frameworks in India establish guidelines and ethical principles for animals in biomedical research. In addition, the collaborative efforts on the training and workshops help biomedical scientists to enhance their skill sets and improve the understanding of animal welfare and ethical principles.

The application of ethical principles and values regarding animals of the countries of Singapore, Thailand, Indonesia, Malaysia, and India are shaped by several influences. The cultures and beliefs in each country have led to the evolution of rules and regulations for animals in biomedical research. In some of these countries, the laws and regulations have existed for over 50 years, while other nations are still trying to understand the impact of newly enforced regulations.

There is a diversity in the way that individual countries have established and implemented these laws, and the governing body varies by country. The effectiveness of the oversight and enforcement depends on the commitment of the governing bodies, institutions, and scientists to animal welfare and improvement of scientific standards. The establishment of ethical review bodies and AAALAC accreditation in these countries is seen as a measure of continuous improvement in animal welfare standards.

These steps will pave the way for these countries to become leaders in the biomedical sciences and advancement of global animal welfare. Laws of Malaysia. Animal and Birds Act. Agri-Food and Veterinary Authority of Singapore.

Animals for Scientific Purposes Act , B. Bhumibol Adulyadej, REX. March Conservation Law No. The Ministry of Forestry, Republic of Indonesia. Undang -Undang Konservasi Hayati No. Kementrian Kehutanan Republik Indonesia.

Laws, regulations, guidelines and principles pertaining to laboratory animals in Southeast Asia. In: Guillen J , ed. San Diego : Academic Press.

Google Scholar. Google Preview. Government of Republic of Indonesia's Regulation No. Sabah Lawnet. Law of Republic of Indonesia No. Undang-Undang Republik Indonesia No.

Law of the Republic of Indonesia No. The IACUC will need to know what the potential is for pain or distress associated with experimental manipulations, including clinical and behavioral abnormalities associated with spontaneous or induced animal models e.

By regulation, veterinary staff must be consulted in the planning of studies involving potential pain or distress; planning may involve both the preparation of the protocol for IACUC submission and training in the experimental methods.

Veterinary consultation is valuable for understanding:. Regulations also require that the PI consider alternatives to potentially painful or distressful procedures.

The IACUC, through the protocol review process, must determine that this has been done appropriately. Alternatives are taken to mean not just replacement of animals with non-animal methods, such as computer simulations, but also reduction of animal numbers to the minimum necessary to satisfy experimental objectives, and refinement of methods to minimize pain and distress. Current regulatory expectations are that, in most cases, the PI perform a literature search for alternatives.

Unfortunately, when done properly, this can be a time-consuming process. See the Alternatives section of this website for additional discussion and resources. One of the hardest jobs for both research staff and the IACUC is discussion and evaluation of methods to minimize pain and distress.

This involves an inevitable balancing act, or cost-benefit analysis, between the experimental objectives and animal welfare. When there is potential for pain or distress, researchers are expected to carefully monitor animals and relieve the pain or distress whenever possible.

One method to accomplish this is by administration of anesthetics or analgesics. By regulation, a specific scientific justification must be provided whenever anesthetics or analgesics are withheld in painful conditions; this might be necessary when the drugs would interfere with the interpretation of experimental data.

Pain and distress also can be reduced by euthanizing the animal, and defining so-called humane endpoints e. The AWARs require that research facilities file an annual report that accounts for numbers of animals used, by species and category of pain or distress see sidebar.

Some institutions use a different system for categorizing pain and distress. This determination is not always straightforward, as illustrated below in the Study Questions. Among other things, the Report must:. Difficult Issues in Protocol Review — Justification for using animals, species, and numbers used. Regulations require that the PI provide a justification for using animals, and for the specific species and numbers of animals to be used.

These are sometimes difficult issues to address, but involve basic questions that should be considered in the planning of any experiment using animals. Implicit in these questions is the notion that animals should not be wasted. It may sometimes seem obvious why animals are needed for a particular experiment, and in some cases, this may be so. However, the prevailing view is that animals should not be used in research, teaching or testing unless there is no other way to accomplish the objectives of the activity.

The need to use animals should be articulated in the protocol form. The species of animal to be used is relevant to protocol review because the characteristics of a particular species anatomy, physiology, behavior might be absolutely necessary for the success of a study. Conversely, use of the wrong species could prevent a successful outcome. Appropriate numbers of animals are also an important consideration in avoiding unnecessary or wasteful use of animals. There is a common misconception that this means that animal numbers must, as a priority, be minimized.

In fact, properly understood, the requirement to justify animal numbers means that there has been due consideration of the experimental design of an experiment, including determination of the optimal number of animals per treatment and appropriate use of controls. Use of too few animals in an experiment may fail to yield interpretable results and is therefore also potentially wasteful. Proper experimental design includes statistical considerations, and some IACUCs may have expectations for consultation with a statistician.

Some committees have statisticians as members, in order to provide advice in this area. The Animal Welfare Information Center has useful information and web links to assist with statistical considerations and animal numbers. Of course, not all use of animals e. IACUCs are still expected to determine that the numbers of animals requested are appropriate for the intended purpose. Even other scientists may have difficulty in understanding a description of animal use if written in highly technical language specific to a particular area.

One suggestion is for the PI to enlist support staff to help with this description. Difficult Issues in Protocol Review — Personnel qualifications and training more below. The IACUC must determine that personnel working with animals are adequately qualified to perform the procedures described in the protocol; this includes everything from basic animal handling to anesthesia support and surgery to euthanasia.

Thorough training of personnel is one of the most important refinements that can be made in studies using animals. Lab Anim 24 : 24 — Title 15, U. Van Zutphen B. Oxford University Press is a department of the University of Oxford. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide. Sign In or Create an Account.

Sign In. Advanced Search. Search Menu. Article Navigation. Close mobile search navigation Article Navigation. Volume Article Contents Abstract. Historical Overview. Institutional Responsibilities. International Considerations. Address correspondence and reprint requests to Dr. Oxford Academic. Cite Cite Lynn C. Select Format Select format. Permissions Icon Permissions. Abstract Training and instruction of personnel are important components of animal care and use programs because they help to ensure the health and welfare of the animals and the integrity of the research or testing results.

Table 1 U. The development of knowledge necessary for the improvement of the health and well-being of humans as well as other animals requires in vivo experimentation with a wide variety of animal species. Whenever U. Government agencies develop requirements for testing, research, or training procedures involving the use of vertebrate animals, the following principles shall be considered; and whenever these agencies actually perform or sponsor such procedures, the responsible Institutional Official shall ensure that these principles are adhered to: I.

The transportation, care, and use of animals should be in accordance with the Animal Welfare Act 7 U. Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society. The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results.

Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered. Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals.

Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. Surgical or other painful procedures should not be performed on unanesthetized animals paralyzed by chemical agents. Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of the procedure or, if appropriate, during the procedure.

The living conditions of animals should be appropriate for their species and contribute to their health and comfort. Normally, the housing, feeding, and care of all anmals used for biomedical purposes must be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied.

In any case, veterinary care shall be provided as indicated. Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. Adequate arrangements shall be made for their inservice training, including the proper and humane care and use of laboratory animals.