Animal Research: do we have ethics in mind

Animal Research: do we have ethics in mind by N. G. Kostomitsopoulos, DVM, PhD, Head, Laboratory Animal Facilities, Center for Experimental Surgery, Biomedical Research Foundation of the Academy of Athens, Athens, Greece as published in Lab Animal Europe (www.labanimaleurope.eu) in July 2008

The use of animals in research has a vital role in the development of new knowledge of the basic biological structure of life, as well as the improvement of the quality of life for humans and animals.

For many years, scientists have had to justify animal use solely by referring to the scientific value and biomedical importance. Nowadays, animal experimentation is considered to be an ethical issue. Ethical concerns about compromised animal welfare cannot be eased by claims of human benefit alone. The benefits of research must be achieved with minimal negative effects on the animals involved. Although there are no legal requirements in existing EU legislation, 16 out of 20 countries, members of the Federation of European Laboratory Animal Science Associations, confirm that they already have in force national mandatory controls that require ethical review of all regulated scientific uses of animals. Local, institutional or national ethical committees usually conduct the ethical evaluation of research projects that involve animal experimentation through a review process. It is within the scope of the revision of European Directive 86/609 to define and harmonize the ethical review process for the EU member states.

The application guidelines of the 7th Framework Programme of the EU also demands ethical documentation of projects involving animals. This clearly expresses the EU's interest in animal research ethics. From this perspective, scientists have a moral obligation to ethically justify the use of laboratory animals. No matter what ethical review process is in effect, scientists must realize the importance of ethics in animal research and of conducting ethical justification of projects from the initial design phase through the completion of the study and review of the results. It is also the responsibility of scientists to acquire knowledge about local laboratory animal welfare legislation and to conform to the spirit and the letter of the laws.

The main considerations that should be involved in this ethical justification are:

The precise definition of

1. a. the goals of the project and the existing probabilities for its success;
2. b. the selection of the appropriate animal model based on well-documented scientific knowledge, and the avoidance of duplication of experiments;
3. c. the possibility of obtaining the same results by using alternative methods that could completely replace animals by using, for example, in vitro or in silico approaches;
4. d. the benefits to science and society, with direct consideration of the harm caused to animals, including pain, suffering and distress;
5. e. whether and to what extent animal suffering may be minimized and animal welfare may be enhanced by implementing the 3Rs concept for replacement, reduction and refinement; and
6. f. the availability of the appropriate facilities, equipment and expertise to guarantee high standards of animal accommodation, husbandry, care and use.

Active collaboration between scientists of different specialisations within the research group is very important. Ethical justification for a project by scientists involves this type of teamwork and a sustainable ethical evaluation, rather than a one-time evaluation done mainly at the beginning of the project. In fact, ethical evaluation of the project should be made, not only at the beginning or during the design phase, but also during the study itself. This will give scientists the opportunity to evaluate and, if necessary, make improvements to the design (for example, if animal discomfort or distress is recognised). The biostatisticians should enquire about the optimum number of animals that can guarantee the best quality results, as well the minimum number of animals that can be used. Laboratory animal veterinarians can contribute to the refinement of experimental techniques by promoting use of the appropriate anaesthetic and analgesic protocols, recognition of the appropriate human endpoint and use of appropriate and humane euthanasia procedures. A layperson should also be involved in discussions about the aims of the project. This gives scientists an opportunity to receive feedback from the community about the research project.

The ethical justification should also prove that humane care and use of the animals is guaranteed from the beginning through the end of the experiment. Unfortunately, unlike in the US, where Institutional Animal Care and Use Committees (IACUCs) are required and they must have layperson representatives, the existing European Directive 86/609 includes no legal requirement for ethical justification of research protocols. Thus, it is up to the national legal requirements of every EU member state as to whether an ethical evaluation process is required at all, and, if it is, if the participation of a layperson is required in the ethical review process. As the use of animals in research is unavoidable at this time, the public should expect that research animals will be given the highest standards of care. The ethical justification for the laboratory animal research protocols reflects the interest and the responsibility of scientists for reduction and refinement of animal experimentation, and the communication of this responsibility to the public. This process builds trust between scientists and society. Of equal importance is the education of new generations of scientists to equate ethics and animal welfare with good science.

N. G. Kostomitsopoulos, DVM, PhD
Head, Laboratory Animal Facilities
Center for Experimental Surgery,
Biomedical Research Foundation of the Academy of Athens,
Athens, Greece

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