Unified ethical principles and an animal research 'Helsinki' declaration as foundations for international collaboration

Abstract

Ethical frameworks are the foundation for any research with humans or nonhuman animals. Human research is guided by overarching international ethical principles, such as those defined in the Helsinki Declaration by the World Medical Association. However, for nonhuman animal research, because there are several sets of ethical principles and national frameworks, it is commonly thought that there is substantial variability in animal research approaches internationally and a lack of an animal research 'Helsinki Declaration', or the basis for one. We first overview several prominent sets of ethical principles, including the 3Rs, 3Ss, 3Vs, 4Fs and 6Ps. Then using the 3Rs principles, originally proposed by Russell & Burch, we critically assess them, asking if they can be Replaced, Reduced or Refined. We find that the 3Rs principles have survived several replacement challenges, and the different sets of principles (3Ss, 3Vs, 4Fs and 6Ps) are complementary, a natural refinement of the 3Rs and are ripe for integration into a unified set of principles, as proposed here. We also overview international frameworks and documents, many of which incorporate the 3Rs, including the Basel Declaration on animal research. Finally, we propose that the available animal research guidance documents across countries can be consolidated, to provide a similar structure as seen in the Helsinki Declaration, potentially as part of an amended Basel Declaration on animal research. In summary, we observe substantially greater agreement on and the possibility for unification of the sets of ethical principles and documents that can guide animal research internationally.

Keywords: 3Rs; 3Ss; 3Vs; 4Fs; 6Ps; AAALAC; Bioethics; Ethics; Harm-benefit-analysis; Morality; Regulation.

Graphical abstract

Fig. 1

Basel Declaration and unified sets of ethical principles. The 3S and 4F principles could be an important part of the Preamble to an animal research Basel Declaration. The 3Rs are the classical core, enhanced with guidance on the HBA by the 6Ps and the three validities (3Vs). The documents listed in Table 3 and others could be consolidated into a more complete Basel Declaration, modelled after the Helsinki Declaration on human research.