Ethics of Modeling of Cerebral Ischemia in Small Animals
Animal models of cerebral ischemia have deepened our insight into the pathophysiology of ischemic brain damage. Success rates in translation to the bedside, however, are low. This fact entails unmet hopes for patients and ineffective deployment of money a
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1. Introduction Important advances in human and animal medicine have been made by using animals in research. Animal models have provided us with deeper insight into the pathophysiology of ischemic brain damage, but so far their contribution to clinical practice in stroke therapy has been limited. To date, only one therapy for acute ischemic stroke, tPA initiated within 3 h of stroke onset, has been approved (1). However, there are many arguments explaining the failure to translate therapeutic benefit in animal stroke models into successful clinical trials. Very recently, an interesting debate on the usefulness of animal models of neurodegenerative diseases has been published in Nature (news feature (2) with comments (3, 4)) suggesting a more differentiated use of the term “animal model of disease X”. Potential problems with animal studies for acute stroke therapies are discussed by Fisher and Tatlisumak (5) and detailed information can be found in this handbook in Chaps. 17, 18, and 19. Poor success rates in the translation to bedside Ulrich Dirnagl (ed.), Rodent Models of Stroke, Neuromethods, vol. 47, DOI 10.1007/978-1-60761-750-1_16, © Springer Science+Business Media, LLC 2010
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cause ineffective employment of money and time and, in the end, leave the patients alone with their unmet hopes of ameliorating their symptoms. In addition, unsuccessful translation from bench to bedside also raises an important ethical issue when animals are used for stroke research (see Note 1). Consequently, close attention should be given in the planning phase to the quality of animal experiments. The approval of applications for permission to conduct animal research is based on national and international animal research laws and regulations. Those with broad validity for readers are listed in the following: 1. International regulation: Good Laboratory Practice (GLP): Compliance with GLP regulations is a critical requirement for certain types of research and testing involving laboratory animals. The principles of GLP deal mainly with responsibility, quality assurance, test facilities, and documentation. 2. USA: The Public Health Service issued the “Guide for the Care and Use of Laboratory Animals”, which is the primary reference in the United States for animal care and use programs. 3. European Union: European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes (1986, as amended on 2005). National and institutional regulations may differ in many details; but some important aspects seem to be held in common. This chapter helps design studies on animal experiments in stroke research at a high ethical level and thus provides important arguments for obtaining permission from regulatory authorities.
2. General Standards as Prerequisite for Considering the Ethical Viewpoint
2.1. Decision on the Model
In order to reduce, refine, or replace animal experiments whenever possible, avoid or minimize discomfort, stress, and pain for the animal and thus reduce suffering and
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