Royal Decree 53/2013 of February 1st establishes the basic regulations applicable to the protection of animals used in experimentation and for other scientific purposes, including teaching. This Royal Decree on experimentation stipulates that, since August 2013, the responsibility for evaluating projects involving the use of animals has been assumed by the Authorized Bodies for Project Evaluation, which are bodies directly under the competent authority. In the case of the Autonomous Community of the Region of Murcia, the Authorized Bodies report to the Ministry of Water, Agriculture, Livestock, and Fisheries.

Taking into account current legislation in Spain and the European Union regarding these matters, as well as the Ethical Declarations of Helsinki and Tokyo and the recommendations of the World Health Organization, the following regulations are proposed for the operation of the UCAM Authorized Body.

Functions

In general, the functions of the UCAM Authorized Body are:

1. To review procedures that have already been evaluated or to propose the suspension of any experimentation already underway if there are objective reasons to believe that the requirements established in the project are no longer being met.
2. To ensure that the personnel participating in the procedures have the appropriate training to perform their assigned tasks.
3. To ensure compliance with good research and experimentation practices.
4. To evaluate projects involving the use of animals for scientific purposes and issue the required reports:
   • To verify that the project to be evaluated is justified and designed so that the procedures are humane and environmentally responsible.
   • It will include verification of: the purpose, the scientific or educational benefits, its compliance with the replacement, reduction, and refinement criteria, the degree of severity, damages and benefits, situations and exceptions provided for in Articles 6, 7, 9.1, 12, 20, 21, 22, 23, 25.3, 25.5, 26, and 29; and will determine whether the project should be evaluated retrospectively and, if so, when this should be carried out.
   • Expert advice may be sought in the fields deemed appropriate.
   • The evaluation will be transparent, impartial, and independent.
5. Retrospective evaluation of those projects that require it, in accordance with Article 35.1 of Royal Decree 53/2013. This retrospective evaluation will be carried out based on the required documentation submitted by the user and will assess the following: whether the project objectives have been achieved; the harm inflicted on animals, including the number and species of animals used, and the severity of the procedures; and any elements that may contribute to a better application of the replacement, reduction and refinement requirement.

Team Members