Procedure for requesting authorisation to animal testing

Unless tacit consent in the specific cases provided for by art. 33 of Legislative Decree No. 26/2014 (projects that do not include the use of non-human primates needed to satisfy the regulatory requirements with established methods and procedures classified as ‘non-recovery’, ‘mild’ or ‘moderate’), the research projects that require the use of animals can be carried out ONLY after obtaining ministerial approval, in accordance with the time limit foreseen in paragraph 7 article 31 (40 working days from the date of receipt of application) (Legislative Decree. No. 26/2014, arts. 31-33).

Legislative Decree. No. 26/2014, art. 2 requires that all research projects that require use of animals held at various authorised establishments must be previously inspected and approved locally, and then sent to the Ministry of Health by the Committee for Animal Care, which each facility is required to adopt. Therefore, all research projects involving the use of animals held at the ‘G. D'Annunzio’ University must be sent to the Committee for Animal Care (OpBA, [email protected]), established in compliance with the requirements above.

OpBA makes a preliminary examination of the project for formal adherence to the requirements of the said Legislative Decree. The project is then examined by the scientific representative of OpBA, who can: 1. decide for immediate sending to the Italian Ministry of Health; 2. recognise the need for a thorough ethical and scientific evaluation by CEISA - Interuniversity Ethics Committee for Animal Experimentation; 3. request CEISA assessment on the express request of the head of the research project.

CEISA acts on behalf of the Rector as counselling body, which aims to improve the quality of scientific research involving animals, reducing, through dialogue with the investigator, the recourse to the use of animals when they are not required to achieve the objectives of the research, and ensuring adherence to the regulations of the projects submitted to the Ministry of Health. For this reason, the ethical-scientific evaluation may lead requests for clarification, and amendments, aimed at improving the project before ministerial judgment. CEISA will also issue ethical and scientific compliance opinions, also in English, if they are needed for sending projects to national and international funding agencies or for the publication of research that requires animal testing in scientific journals. The researcher who has these needs can apply to have, anyway, CEISA opinion when presenting the project.

Projects considered suitable to ministerial evaluation will be transmitted to the Ministry of Health, together with the reasoned judgment of CEISA and OpBA, directly by OpBA. The Ministry, as provided in the Legislative Decree. No. 26/2014, must express binding final opinion within 40 working days from the date of shipment of the project. The projects approved by the Ministry will then be conducted in the foreseen way and on schedule. Any changes that may be necessary for scientific or technical reasons must be promptly communicated to OpBA, which will then inform the Ministry of Health, where this is deemed necessary under the rules of law.

The person in charge of a project may, at any stage of the design and execution of the experiments, contact OpBA and CEISA for clarification of technical and scientific ethics nature inherent to the project. Equally, CEISA and OpBA respond to civil society about the fairness and the ethical and scientific value of the research that requires the use of animals conducted in the University.