Ethical issues animal studies

Practical and ethical issues have impeded the analysis of biochemical influences on human behavior, and at present questions are more common than answers. However, in conjunction with more readily controlled animal studies, patterns of relationships between hormones and behavior have begun to emerge. 

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. 

From 1984 to 1997,1 was the director of computer systems in the Clinical Research Center (CRC) at Vanderbilt. I became aware of many ethical issues that I had not been forced to confront when my focus was on animal studies and mathematical models of research, including ... 

In in vivo studies, an important issue is the quality of ECG recordings and the methods used for the analysis. A few years ago, a survey reported on the practice in the pharmaceutical industry to assess the potential for QT prolongation and concluded that the majority view in the industry is not necessarily best practice [153]. After this publication, a lot of work has been done to improve the performance of in vivo models, although it should be acknowledged that their cost (together with some ethical considerations on the rational use of animals) makes them unsuitable for large-scale screening. 

Lund, V., Hemlin, S. and White, J. 2004b. Natural behaviour, animal rights or making money - a study of Swedish organic farmers view of animal issues. Journal of Agricultural and Environmental Ethics 17 157-179. 

The use of vertebrates to evaluate tolerability and absorption of drug administered via the vaginal route has been widely criticized on the basis of scientific and ethical considerations. Studies on animals can be substituted by validated in vitro tests as described in the guideline issued by Committee for Proprietary Medicinal Products (CPMP), now Committee for Medicinal Products for Human Use (CHMP) [112], Before an in vitro test can be considered valid, this test must undergo a procedure aimed at establishing its relevance and reliability. The relevance of the alternative test has to be compared with accepted in vivo standard methods. 

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