To submit a research project, the Principal Investigator must send to the OpBA ([email protected]) the following documents:

1. Project Proposal, in accordance with Legislative Decree No. 26 of 4 March 2014, Article 31(2);
2. Project Submission Template, in accordance with Annex VI of Legislative Decree No.26 of 4 March 2014;
3. Non-Technical Project Summary, in accordance with Annex IX of Legislative Decree No. 26 of 4 March 2014;
4. Self-Certified Declaration pursuant to Article 46, paragraph 1, letter aa, of Presidential Decree of 28 December 2000 (“Legislative provisions on administrative documentation”), certifying the absence of final judgments, or judgments issued pursuant to Article 444 of the Code of Criminal Procedure, concerning the offenses referred to in Articles 544-bis and 544-ter of the Italian Penal Code (Law 189/2004), as well as those referred to in Articles 4 and 5 of Law No. 201 of 4 November 2010; accompanied by a copy of an identity document, signed and dated;
5. Notification Form for the killing of Animals solely for the purpose of using their organs or tissues, pursuant to Article 1, paragraph 4, (Ministerial Note No. 0017710-P-26/10/2017);
6. Documentation from the Funding Body and/or Affiliated Institution, confirming the award of funding for the project and demonstrating financial coverage for the entire duration of the research.

The documentation for the authorization request, complete with the OpBA’s opinion, will be submitted to the Ministry, by the OpBA through the dedicated database, pursuant to Article 26 of Legislative Decree No. 26 of 04 March 2014. The OpBA will also inform the Principal Investigator of the outcome of the authorization request.

At the conclusion of the experimentation, the Principal Investigator must submit to the Ministry of Health — following review by the OpBA — the documentation concerning the experiments carried out, required for the retrospective assessment under Article 32 of Legislative Decree No. 26 of 04/03/2014. This documentation must specify:

1. the achievement of the project objectives;
2. the species and number of animals used, the harm inflicted, and the severity of the procedures employed;
3. the elements that contributed to strengthening the application of the principles of Replacement, Reduction, and Refinement.