committee of Ethics for Animal Experimentation

enquiryon employmentof animals

In order to make enquiries for the employmentof animals, a system of enquiryhas been created using forms in Word documents, appropriate for each subjectof enquiry. Each time you wish to send a enquiryto committee, you only need to downloadthe document, save it with the name of the enquiryand open it to fill in the relevant data.

The forms can be found at downloadfrom the following links:

• Experiment or normal internship (financial aid to be completed). A non-technicalsummary also needs to be filled in (guide to be filled in).
• employmentof animals solely for the purpose of obtaining organs or tissues
• Animal husbandry
• Amendment to protocolC
• Amendment to protocolbreeding
• Change of degree scrollor staffresearcher

Once the enquiry is completed, it is sent, together with the non-technical summaryif applicable, by email to the email address of committee(ceea@unav.es), and the documents are kept for future reference. The consultantwill receive the comments of the committeeon its enquiryat the e-mail address provided.

In order to receive the approval finalfrom protocol, it will be necessary to send the latest version of the proposalon paper, signed as indicated on the form itself.

Once evaluated by the committee, the documentation is sent to the Government of Navarra for approval (if the animals are used only for organ or tissue procurement, this approval is not necessary).

Royal Decree 53/2013 of 8 February 2013 on the basic rules applicable to the protection of animals used for experimental and other scientific purposes, including teaching, classifies experiments according to the Degreeof pain, suffering, distress or lasting harm that the animal is expected to experience during procedure. This classification can be found in Annex IX, Section I of the Decree; examples can be found in Section III of that Annex, which can be consulted at linkbelow: Royal Decree 53/2013.

A number of resources are listed below at network, useful for considering the experimental design, finding alternative methods to employmentfor animals, or finding out about standardised procedures for attention.

designexperimental

• Experimental Design Assistant
• presentationInteractive: The Design and Statistical Analysis of Laboratory Animal Experiments. Michael Festing
• Guidelines for the Design and Statistical Analysis (article)
• Statistical experiment design for animal research (book)

Alternative methods

• Alternatives to Laboratory Animals (ATLA)
• Animal Welfare Information Center (AWIC)
• European Consensus-Platform for Alternatives (ecopa)
• European Union Reference Laboratory for alternatives to animal testing (EURL-ECVAM)
• Fund for the Replacement of Animals in Medical Experiments (FRAME)
• groupof the Working Group on Alternative Methods (WGEMA)
• Information Resources for Adjuvants and Antibody Production (in AWIC)
• NTP Interagency Center for the Evaluation of Alternative Toxicological Methods
• Monoclonal Antibody Production and The Production of Polyclonal Antibodies in Laboratory Animals
• PubMED (for general searches)
• Series on Testing Assessment / Adopted Guidance and Review Documents (programs of studyon toxicology) in Organisation for Economic Cooperation and Development (OECD)
• The Norwegian Reference Centre for Laboratory Animal Science & Alternatives (NORINA Database) ( especially for alternatives at teaching)

Statistics

• Recommendations for improving the use and presentation of statistical reports in animal experiments.
• Quantitative methods in Psychology
• Diagram on statistical methods (courtesy of Marta García-Granero)
• Calculation for the comparison of two averages
• Michael Festing's page on designexperimental and the 3Rs, especially paragraphs 6 and 7.
• issuemonograph on designexperimental and statistics in the researchbiomedical of the ILAR journal
• articlein The Lancet: Sample size calculations in randomised trials
• Sample size tables (including 1- and 2-variable ANOVAs)
• G*Power: free and very comprehensive programme of the University of Düsseldorf for sample size calculation.
• guidefor the calculation of the sample size with the G*Power programme (2-criteria ANOVA)

Standardised procedures

• Animal Welfare Information Center (AWIC)
• Blood collection using the saphenous vein
• Blood collections (pdf)
• Practice Guide to the Administration of Substances and Removal of Blood, Including Routes and Volumes
• End point criteria:

  Choosing endpoints (CCAC)
  Humanitarian endpoints

• Euthanasia:

  Recommendations for euthanasia of animals, 1 (pdf)
  Recommendations forthe Euthanasia of Animals, 2 (pdf)
  AVMA Guidelines for the Euthanasia of Animals

This brief information may leave doubts on various issues, such as other aspects of the committeeof Ethics for Animal Experimentation, or problems that may arise with the formof enquiryof Word. To resolve them, you can send an email to committeeby clicking here.

For further information on the procurement and employmentof experimental and practical animals, please contact the Animal Experimentation Service.

This committee must ensure the correctness of the procedures for the care and use of animals. If you wish to collaborate with this task, you can send to knowledge of committee, anonymously if you wish, any incidents or common ways of working that you have observed, that you consider incorrect, and that you think can be corrected with financial aid of committee. To do so, you can send this information through form of the University's internal information channel, checking the box "Animal abuse" in step 3, even if the incident does not strictly refer to animal suffering:

The University of Navarra is adhered to the agreement of transparency on the use of animals in scientific experimentation in Spain.

report 2023 of agreement for transparency on the use of animals in scientific experimentation in Spain.

statement2022 of the Commission of the Confederation of Spanish Scientific Societies (COSCE).

Institutional declaration.

The University of Navarra belongs to the associationEuropean Association for Animal research, EARA.

report of activities 2024

The most important actions carried out by this committee during the year 2024 are described:

1- Introduction

During the year 2024 the CEEA's actions have been aimed at adapting the research carried out at the university according to the legal framework that came into force in Spain on February 8, 2013 (RD53/2013).

During the year 2024, the CEEA met 22 times, trying to meet every two weeks.

2- summary of protocols processed

During this year, a total of 137 new ethical protocols and 46 modifications to previously approved protocols (amendments) were reviewed. All the protocols that have been favorably evaluated by the CEEA and submitted to the Government of Navarra, if required, received a resolution of authorization within approximately 30 days.

All the protocols that have been evaluated were submitted by CIMA, UNAV or CUN researchers, with the exception of one project submitted by Navarrabiomed/IDISNA and 10 protocols submitted by external companies. As in previous years, most (70%) of the total protocols and amendments came from CIMA investigators, highlighting those submitted by staff from the areas of Immunology and Immunotherapy. Sixteen percent of the total protocols and amendments come from the University. Most of them belong to the department of Pharmaceutical Sciences and Biochemistry and Genetics. In the case of those submitted by researchers linked to the CUN, 8% of the total, come mostly from the area of Cell Therapy and Orthopedic Surgery. The remaining 6% of protocols belong to external requests.

3- Other activities carried out during the year 2024

News related to the continuous training : The training with the old categories has expired in April 2023. Researchers who wish to maintain their functions according to the Order ECC/566/2015 issue the application personally to the Livestock Service of the Government of Navarra, providing the necessary documentation. The CEEA provides information in this regard.

work under supervision according to Order ECC/566/2015: In 2024, a total of 53 researchers have completed the work under supervision, essential to obtain the accreditation in functions a, b and c once the training courses have been passed. The Government of Navarra issues the corresponding resolution of the acquired functions and a certificate staff that is sent to the student.

Retrospective evaluations: Retrospective evaluations of the protocols in force since 2019 that so required were sent to the Government of Navarra, as established in RD53/2013, through the presentation of a form prepared by the Ministry of Agriculture, Fisheries and Food.

Animal handling course: during the 2023-2024 academic year, MIB doctorate students who take the Animal Experimentation subject as a training complement, obtain training in animal handling, in the absence of a work under supervision.

training courses in animal handling: in order to address the needs of training of staff researcher of the University of Navarra, CUN and CIMA, the University of Navarra maintains a agreement with Animalaria, training and management S.L. According to this, it is established that students and staff linked to the University, including those belonging to CIMA and CUN, can enroll in online courses issued by this business with advantageous conditions in the cost of the enrollment.

training offered by the CEEA: In order to provide continuous training to help the researcher in maintaining their accreditation in animal handling, the CEEA gave two seminars and offered continuous training activities through internal communications of online courses and departmental training workshops related to animal experimentation, which are sent to the Government of Navarra for information purposes. An internal training plan for the CEEA was also completed.

issuance: 30 researchers requested a certificate from the CEEA to be submitted to different national and international research project calls.

agreement COSCE of transparency and membership of EARA (European Animal Research Association): The CEEA sent the annual survey for institutions working with animals as stipulated in the fourth commitment of the agreement COSCE of transparency to which the University of Navarra is adhered.

Communications and reports from COSCE and EARA were shared with our researchers.

Media interviews were collected from our researchers related to the contribution to transparency on the use of research animals.

Researchers from our institution who wish to attend CEEA meetings may do so at attendance .

Contacts with the competent body: throughout this year, different issues that arise in the work of committee have been discussed with the Government of Navarra, mainly: (1) interpretation of the ministerial order ECC/566/2015, (2) homologation of trainings of staff working with animals, and (3) doubts that arise from protocols presented by researchers.

• President, Professor of Bioethics

• administrative assistantand Animal Welfare Advisor, Animal Experimentation Service

• Coordinator and manageron site

• advisorexternal Animal Welfare, veterinary

• board member intern, researcherof the Gene Therapy Programme

• board member intern, researcher from department de Pediatría

• board member intern, professor at department of Environmental Biology

• board member intern, researcher of the Immunology and Immunotherapy Program.

• board member internal, researcherof laboratoryof researchMetabolic

• board member intern, professor at department of Biochemistry and Genetics

• 2 Internal members, researchers from department de Pharmacology and Toxicology

• 3 Internal members, researchers of the Cardiovascular Diseases Programme.