To fulfil ethical and legal requirements SARAS project is aiming to reduce, refine and replace live animal experiments according to the 3Rs principle.

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An ethical imperative for the consortium of the SARAS Project is minimising the use of animals in experiments by reducing and replacing practices; this is why three members of the project Consortium are involved in the creation of a realistic and fully adequate Human Phantom for Surgical research as an alternative to animal experiments.

Replacing experiments, validation and training on living animals entirely is not always possible, firstly because hitherto no fully adequate alternative solution to replace these models is available and secondly because animal experiments constitute vitally important pre-clinical evidence with published acceptance in the field as pre-clinical validation models.

The principles of the 3Rs

The principles of the 3Rs (Replacement, Reduction and Refinement) were developed over 50 years ago providing a framework for performing more human animal research; since then they have been embedded in national and international legislation and regulations on the use of animals in scientific procedures, as well as in the policies of organisations that fund or conduct animal research.

The 3Rs principles are:

• Replacement: Replacing an animal experiment to the greatest possible extent, as long as adequate alternatives are available.
• Reduction: The reduction of animal experiments and the number of laboratory animals to the greatest possible extent. In so doing, it is important to use as many animals as are needed to obtain a statistically significant outcome. An adequate number of animals is required for the results to be sufficiently significant.
• Refinement: The methods and treatment of the animals during the experiments, and with regard to the way they are kept, should ensure that the distress caused to them is minimised to the greatest possible extent and that their well-being is taken into account as far as possible.

Partners involved

The Institute for Medical Science and Technology of the University of Dundee uses multiple medical imaging modalities as a resource for acquisition of clinical imaging data that used to create 3D virtual reconstruction models of patient anatomy.

From 3D reconstructed anonymised medical data and predominantly additive manufacturing fabrication technologies, ACMIT (antom models for training and benchmarking the SARAS system.

The phantoms realized for and used in the SARAS project were developed in order to meet the design specifications, with performance indicators, specific to the project’s target surgeries, i.e. Robotic Assisted Radical Prostatectomy and Laparoscopic Partial/Radial Nephrectomy, processes and tooling pathways, outlined thanks to the collaboration of the expert surgeons of the Urological Research Institute and the researchers of the center of Advanced Technology in Health & Well-Being of Ospedale San Raffaele (https://www.hsr.it/).

 

We strongly believe that research with human phantom offers the possibility of the substitution of animal experiments and it is of enormous value for research following ethic principles.