Nakamura said. This, however, may have the counterproductive effect of limiting scientific gains from studies while increasing the costs. Because many medical needs remain unmet and much needs to be learned about living systems and disorders, Nakamura said the growth of welfare considerations and regulations must be constrained to allow some proportionality to the world outside of research (e.g., animals used for food, organisms displaced by humans or killed as pests). Nakamura suggested that animal welfare should not be considered in isolation from scientific goals or the larger needs of society.

The 3Rs are used when considering approval of animal research studies. However, the 3Rs are not a core principle, because as a core principle the 3Rs, specifically the principle of replacement, would translate into a goal to end animal research, Nakamura observed. If people are not ready to apply this to the world outside research, including the eating of meat or killing of pests, it should not be a core principle in research, Nakamura opined.

The key principle of animal regulation in research might be finding a balance among scientific progress, animal welfare, and cost effectiveness that is better than, yet proportionate to, the larger treatment of animals by humans, Nakamura concluded.

EUROPEAN REGULATORY PERSPECTIVE

Judy MacArthur Clark of the UK Home Office discussed core principles and considerations from a European regulatory perspective. She reiterated that a goal of regulatory balance might be to provide the public with confidence that animals will be appropriately protected and that science will not be inhibited from discovering solutions to many global health problems (see Chapter 2). While public opinion polls on animal research informed the development of the directive, MacArthur Clark noted that there is little direct support in the directive of high-quality science in Europe.

Core Principles

According to MacArthur Clark, three basic core systems are necessary in animal research regulations: a system of authorization of people, places, and projects; ethical, impartial, and independent evaluation of projects based on a cost-benefit balance; and impartial and independent verification of compliance involving some form of inspection.

MacArthur Clark referred participants to Chapter 7.8 of the World Organisation for Animal Health (OIE) Terrestrial Animal Health Code, which provides basic core principles of a regulatory system framework for use of animals (OIE, 2011). Per this code, components of the systems described above would include implementation of the 3Rs, evidence of



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