Ethics animal experimentation

Experimental use of animals is controlled under Good Laboratory Practice (GLP), and study protocols are submitted to the Animal Research Ethics Committee for approval. Studies using animals can only proceed with the approval of the Ethics Committee, which consists of technical personnel. 

The use of experimental animals and human subjects in the development of new medicines raises a number of ethical issues and is a source of concern to the European public in general. Animal experimentation and testing in human subjects are today a necessary part of the development of new medicines. New and... 

The Three Rs principle has been and still is a useful tool for engaging all stakeholders in the development of a common strategy in relation to animal experimentation. The establishment of a Three Rs principle pertaining to human experiments and thereby the introduction of a new and useful tool for engaging different stakeholders in developing a common strategy in relation to the future use of human subjects may help to solve some of the key ethical issues relating to clinical trials. 

Fox, M. A. (1986) Case for Animal Experimentation—An Evolutionary and Ethical Perspective. 

Apart from drugs, chemicals cannot ethically or legally be given to humans without safety evaluation, and hence, to confirm the third and fourth postulates, animal experimentation is usually required. For some chemicals information on the toxicity in animals may already exist. 

NOAELs) of t ie test compound via its expected routes and kinetic patterns of exposure. In the context of chemical toxicity testing, the reduction, refinement, and ultimately replacement (3Rs) of animal experimentations are often advocated for ethical reasons. In 1959 already, Russell and Burch, the fathers of the 3Rs precept, drew attention to the unavoidable infliction of distress on animals used for toxicity testing [ 1 ]. However, it is primarily with scientific concerns at heart that, throughout their book, they encouraged scientists to apply the 3Rs in order to improve the quality of their scientific output. 

In vitro assays to determine the action of human cytochromes and other DMEs have been developed in the last 10 years. In more recent times, their use in preclinical testing has increased rapidly in response to the pressures of prioritizing drug candidates and the ethical drive to reduce animal experimentation. As drug metabolism is better understood at the molecular level, it is proving possible to design assays to look at particular aspects of this complex process. There are still limitations which reflect the discrete nature of the tests with respect to each other, whereas the in vivo... 

The ethical concerns posed here are best comprehended with a clear understanding of what justifies research. Ultimately, no matter how much basic research and animal experimentation has been conducted on a given device, the risks and benefits it poses for humans cannot be adequately determined until it is actually used on humans. 

Considering the work load involved and the public concern on animal experimentation and ethics, it is unlikely that forthcoming research will completely fill the gaps. 

Some of the factors motivating the usage of simulation technologies are very well known. Ethical considerations and the risk of failure preclude the design and evaluation of therapeutics and devices in live humans, so that devices and treatments are often tested on computer and animal models first. In the past, animals have been the preferred choice, but this approach is continually being reevaluated. Whereas most researchers readily agree that animal experimentation has been and will continue to be necessary for the advancement of medical science, most would welcome methods and procedures that might reduce or even eliminate the use of animals. Furthermore, animals are rarely perfect models of human diseases and conditions. Thus, there has been and will continue to be a demand for alternative models and procedures. Desktop patients, if used to complement animal studies, can actually increase... 

Hecdth effects data come from three types of studies clinical, epidemiological, and toxicological. Clinical and epidemiological studies focus on human subjects, whereas toxicological studies are conducted on animals or simpler cellular systems. Ethical considerations limit human exposure to low levels of air poUutants which do not have irreversible effects. Table 7-1 lists the advantages and disadvantages of each type of experimental informahon. 

The environmental impact of a new product needs to be assessed before it can be released for general use. Chemicals released into the environment can enter the food chain and be concentrated in plants and animals. Aquatic ecosystems are particularly sensitive, in this respect, since chemicals, when applied to agricultural land, can be transported in the ground water to rivers and then to the lakes, where they can accumulate in fish and plant life. The ecokinetic model presented here is based on a simple compartmental analysis and is based on laboratory ecosystem studies (Blau et ah, 1975). The model is useful in simulating the results of events, such as the accidental spillage of an agrochemical into a pond, where it is not ethical to perform actual experimental studies. 

Ethical issues as well as difficulty in obtaining enough human nasal tissue specimens have called for the need to use alternative in vitro and in vivo methods. Various in vivo animal models and in vitro excised tissue models have been described in the literature for nasal drug transport studies. However, due to the difficulty in both controlling the experimental conditions in in vivo animal models and obtaining intact excised tissue samples, in vitro cell culture models are also being actively developed. 

The gold standard for human studies is called the randomized, controlled clinical trial. Such trials are close to experimental animal studies, but for obvious ethical reasons, they cannot be conducted to identify toxicity. They are, instead, designed to determine whether certain pharmaceutical or nutritional regimens, for example, reduce the risks of disease. They may provide information about adverse side effects, but they are not designed for studying toxicity. 

The 3R concept lies behind efforts to improve ethical standards for the use of experimental animals throughout the scientific community, including toxicity testing. A number of in vitro methods for genetic toxicology testing have been established as guideline methods for many years, e.g., the bacterial reverse mutation test, more popularly known as the Ames test. 

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