In the oncological field, as well as in other areas of health-related research, animal experimentation is essential to evaluate the safety and effectiveness of new therapies, and its use is governed by regulatory frameworks designed to ensure ethical and scientific standards and is regulated by Directive 2010/63/EU of the European Parliament, implemented in Italy by Legislative Decree No. 26/2014.
Despite the advances in the use of alternative technologies and approaches, animal studies are still essential in cancer research to assess the complex effects of therapies on whole organisms. Although animals are not identical to humans, their genetic and molecular similarities allow researchers to study the safety and effectiveness of treatments, providing valuable data before progressing to human clinical trials. In this framework, adhering to the ethical principles of the 3Rs (Replacement, Reduction, and Refinement), as outlined in Directive 2010/63/EU of the European Parliament, is crucial to limit animal use, enhance their living conditions, and reduce stress during experiments.
Italian law recognizes the right to conscientious objection to animal experimentation. According to Law No. 413 of October 12, 1993, personnel who declare conscientious objection are not required to directly participate in experimental activities involving animals.
In full compliance with current ethical principles, research conducted at IFOM follows the 3Rs principle, which stands for Replacement, Reduction, and Refinement. This approach aims to replace and/or reduce the number of animals used in experimental protocols, optimize breeding and care techniques, and improve living conditions and experimental procedures to minimize animal stress while ensuring high standards of care and welfare.
To ensure the welfare of animals involved in research activities in compliance with applicable laws and ethical principles, as required by Article 25 of Legislative Decree No. 26/2014, IFOM relies on the Animal-Welfare Body (Organismo Preposto al Benessere Animale, OPBA) of Cogentech Società Benefit srl, a company directly controlled by the Institute.
The OPBA's responsibilities, as specified in Article 26 of Legislative Decree 26/2014, include:
The committee is also tasked with assessing research projects by considering factors such as their scientific significance, the rationale for using animals, and the suitability of the proposed methodologies.