Except in cases of tacit consent (silenzio-assenso) expressly provided for under Article 33 of Legislative Decree No. 26/2014 — namely, projects that do not involve the use of non-human primates, are required to meet regulatory requirements with established methods, and are classified as “non-recovery,” “mild,” or “moderate” — research projects involving the use of animals may be carried out only after obtaining ministerial authorization, within the time limit set forth in Article 31(7) (40 working days from the date of receipt of the application) (Legislative Decree No. 26/2014, Articles 31–33).

Pursuant to Article 2 of Legislative Decree No. 26/2014, all research projects involving the use of animals conducted at authorized facilities must first be reviewed and approved locally, and subsequently submitted to the Ministry of Health by the Animal Welfare Body (OpBA), which every user establishment is required to establish.

Therefore, all research projects involving the use of animals conducted at the “G. d’Annunzio” University must be submitted to the Animal Welfare Body (OpBA, [email protected]), established in compliance with the above provisions.

The OpBA conducts an initial assessment of the project to ensure formal compliance with the provisions of the aforementioned Legislative Decree. The project is then reviewed by the OpBA Scientific Coordinator, who may: 1. decide on its immediate submission to the Ministry of Health; 2. determine the need for an in-depth ethical and scientific evaluation by the Inter-Institutional Ethics Committee for Animal Experimentation (CEISA); 3. request CEISA’s evaluation upon explicit request by the Principal Investigator of the research project.

The CEISA operates under mandate from the Rectors as an advisory body, with the aim of improving the quality of scientific research involving animals. Through dialogue with researchers, it promotes the reduction of animal use whenever it is not strictly necessary for achieving research objectives, while ensuring that projects submitted to the Ministry of Health comply with applicable regulations. For this reason, the ethical-scientific evaluation may involve requests for clarifications and subsequent modifications, intended to improve the project prior to ministerial review. 

Furthermore, CEISA may issue ethical-scientific compliance opinions, also in English, whenever such documents are required for submission to national and international funding bodies or for the publication of research involving animal experimentation in scientific journals. Researchers with such needs may, in any case, request a CEISA opinion at the time of project submission. 

Projects deemed suitable for ministerial evaluation will be submitted to the Ministry of Health by the OpBA, together with the reasoned opinions of both CEISA and the OpBA. In accordance with Legislative Decree No. 26/2014, the Ministry is required to issue a binding final decision within 40 working days from the date of project submission. Projects approved by the Ministry may then be carried out in the manner and within the timeframe established. Any modifications that may become necessary for scientific or technical reasons must be promptly communicated to the OpBA, which will, where required by law, notify the Ministry of Health.

At any stage of project design or execution, the Principal Investigator may consult the OpBA and CEISA for clarifications of a technical or ethical-scientific nature relating to the project. Likewise, CEISA and the OpBA are accountable to civil society for ensuring the integrity and ethical-scientific value of animal-based research conducted at the University.