Research Ethics Committee (CEI UNAV)
GOAL 
The committee of Ethics of the research has as mission statement to ensure compliance with ethical principles in the research in human beings. The IRB has been accredited by the General Administration of Health of the Government of Navarra since 2011.
Competences
The CEI has skill for the evaluation of research projects to be carried out in the centres dependent on the University of Navarra.
The ERC will evaluate those basic or applied research projects not yet initiated which require the participation as research subjects of persons (healthy or sick), involve the use of biological samples of human origin or require the use of personal data or clinical data.
The ERC will evaluate all research projects that comply with requirements above, irrespective of their design or purpose.
The REC is not accredited for the evaluation of research projects involving medicinal products or medical devices, the approval of which depends on the CEIC of Navarra.
In general
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Consider the methodological, ethical and legal aspects of project research.
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Weigh the balance of anticipated risks and benefits arising from the study.
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Assess the qualifications of the main researcher and the team researcher as well as the feasibility of the research project .
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Propose appropriate changes to investigators to ensure compliance of protocols with legal and ethical standards.
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Evaluate the protocols and issue the corresponding certificates.
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Establish and enforce ethical monitoring standards for approved protocols.
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Coordinate its activity with that of similar committees in other institutions.
In biomedical research
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Ensure compliance with procedures to ensure the traceability of samples of human origin from agreement to the law of biomedical research 14/2007 and RD 1716/2011, without prejudice to the provisions of the legislation on the protection of data of character staff.
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To report, after evaluation of the research project , on all biomedical research involving interventions on human beings or the use of biological samples of human origin, without prejudice to other reports that may be issued.
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Ensure confidentiality and exercise any other functions that may be assigned to them by rules and regulations of development of Law 14/2007.
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Develop codes of good practice for agreement in accordance with the provisions of ethical-legal documents.
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Manage the conflicts and files that non-compliance generates.
Since 25/05/2018, due to Regulation (EU) 2016/679 for the protection of personal data, it is necessary to use a new data protection clause, which you can consult in the documents of financial aid of the CEI for the elaboration of the Information and Informed Consent Sheet.
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The following documentation must be sent to the ERC Secretariat by e-mail(ceic@unav.es) to researcher when applying for ERC evaluation of a project research project:
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Complete documentation of project (protocol final of project, information and consent forms, report financial). All documents must be identified with a version and date.
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Document "Application for evaluation of research projects" duly signed by the main researcher . (For more information financial aid consult procedure "Evaluation of research projects").
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In the event that the documentation is incomplete or undated, the ERC secretariat will request the necessary documentation from the main researcher . A registration number will not be given to project until all documentation including the evaluation application form is complete, with version and date.
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The ERC ordinarily meets every two weeks on Thursdays in order to ensure the quality of the evaluations carried out; studies and/or research projects received by the ERC Secretariat will be evaluated in order of validation and with deadlines depending on demand.
President
Belén Sádaba (Clinical Pharmacology CUN)
Secretary
Carmen Berasain (CIMA)
Vowels
Elena Osácar (CUN Nursing)
Santiago Navas (Faculty of Pharmacy and Nutrition)
Gabriel Canel (UCEC)
Fernando Pérez de Gracia (School Economics)
Pilar León (Center for Medical Education)
Idoia Portilla (Faculty of Communication)
Charo Repáraz (FacultySchool Education and Psychology)
Luis Echarte (Faculty of Medicine)
Nerea Varo (School Sciences)
Felipe Garrido (Pediatrics, University of Cantabria)
María Jesús Álvarez (School of Engineering)
Juan Carlos Hernández (School Law)
Paloma L. Martín (Nephrology CUN)
Jaime Nubiola (External Member)
Amparo Zaragoza (Faculty of Nursing)
Gonzalo Arrondo Ostíz (Institute for Culture and Society)
María Calatrava Martínez (Institute for Culture and Society)
Technical advisors
Enrique Reina Martín (Protection of data)
Patricia Muleiro (Protection of data CUN)
Alberto García (CUN Information System)
Composition and functions
assessment of the projects of research and operation
Project monitoring research
Guidelines for the advertising of projects
Access to clinical records for retrospective projects
Annex I: Declaration manager
Annex II: Option A - application of a pseudonymized database via JIRA
Annex III: Option B - application via JIRA for pseudonymized access to the CUN System
Annex IV: Other Cases - Declaration manager
Research, like all other professional activities, has a significant impact on people's lives and on society. This calls for a clear awareness of professional responsibility on the part of researcher . Only this inner attitude can guarantee the soundness and reliability of the results of their work.
This section includes some documents that can guide researchers on the criteria of professional integrity and correctness in their work, which are fundamental in the development of the research activity carried out at this University.
REQUEST FOR EVALUATION
* If the research is based on the use of qualitative elements (interviews, surveys, focus groups, etc.), fill in the Social Sciences application form.
FREQUENTLY ASKED QUESTIONS
OTHER DOCUMENTS AND LINKS OF INTEREST
- financial aid for the elaboration of informed consent - Social Science Projects
- financial aid for the elaboration of the Information Sheet - project de Ciencias Biosanitarias
- Information Sheet and Informed Consent Templates - Biomedical Science Projects
- Scientific publications
- Shared use research
- General criteria for student surveys
- rules and regulations of the boards of trustees of the academic centers
- Ethical evaluation of TFG and TFM
- procedure of research in innovation projects professor
- Guidelines for the advertising of projects
- Information clause research projects
- Information clause for research projects (ENG)
In July 1998, the University of Navarra set up the committeede Ética para la Experimentación Animal (Ethics for Animal Experimentation) as a mandatory body enquirybefore using animals for experimentation or practice at the University.
The committeeis a body authorised by the Government of Navarra for the assessmentof experimentation and practices with animals, and can work for entities external to the University, invoicing the cost.
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:
- Euthanasia:
- Recommendations for euthanasia of animals, 1 (pdf)
Recommendations forthe Euthanasia of Animals, 2 (pdf)
AVMA Guidelines for the Euthanasia of Animals
- Recommendations for euthanasia of animals, 1 (pdf)
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.
2025report on agreement regarding the use of animals in scientific experimentation in Spain.
statement2022 of the Commission of the Confederation of Spanish Scientific Societies (COSCE).
The University of Navarra belongs to the associationEuropean Association for Animal research, EARA.
2025 activity report
The most notable actions committee by this committee during 2025 are described below:
1- Introduction
During 2025, the CEEA's actions have been aimed at adapting the research at the university to the framework that came into force in Spain on February 8, 2013 (RD53/2013).
During 2025, the CEEA met on 20 occasions, attempting to maintain a fortnightly schedule.
2- summary of protocols processed
During this year, a total of 132 new ethical protocols and 53 modifications to previously approved protocols (amendments) were reviewed. Fourteen of them did not complete their assessment. All protocols that were favorably evaluated by the CEEA and submitted to the Government of Navarra, if required, received authorization within approximately 30 days.
All protocols evaluated were submitted by researchers from CIMA, UNAV, or CUN, with the exception of one project by Navarrabiomed/IDISNA and 11 protocols submitted by external companies. As in previous years, most (62%) of the protocols and amendments came from CIMA researchers, particularly those submitted by staff the areas of Immunology and Immunotherapy. Twenty-three percent of the protocols and amendments came from the University. Most of these belong to department Pharmaceutical Sciences. In the case of those submitted by researchers linked to CUN, 8% of the total come mainly from area Cell Therapy. The remaining 7% of protocols belong to external applications.
3- Other activities carried out during 2025
Maintenance of our researchers' functions: The maintenance of functions in accordance with Order ECC/566/2015 requires training , as explained in the following guide by the Ministry of Agriculture, Fisheries, and Food: www.mapa.gob.es/dam/mapa/contenido/ganaderia/temas/produccion-y-mercados-ganaderos/bienestar-animal/en-la%20investigacion/20210217_guiasobremantenimientodelacapacitacion.pdf
Researchers who wish to continue in their roles must submit their application to the Livestock Service of the Government of Navarre, providing the necessary documentation. The CEEA provides information on this matter.
work supervision in accordance with Order ECC/566/2015: In 2025, a total of 50 researchers will have completed the work supervision required to obtain accreditation functions a, b, and c after passing the training courses. The Government of Navarre will issue the corresponding resolution on the functions acquired and astaff certificate ,staff will be sent to student.
Retrospective evaluations: Retrospective evaluations of the protocols in force since 2020 that required them, as established in RD53/2013, were sent to the Government of Navarre through the presentation a form by the Ministry of Agriculture, Fisheries, and Food.
Animal handling course: during the 2024-2025 academic year, doctorate students taking the Animal subject as a complementary training will receive training animal handling, in the absence of a work 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 training the CEEA: In order to provide training to help researcher their accreditation animal handling, the CEEA held three seminars and offered training activities through internal communications about online courses and training workshops related to animal experimentation, which are sent to the Government of Navarre for informational purposes. An 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 :
- The Office of laboratory Animal Welfare laboratory OLAW) reviewed and approved our institution's Animal Welfare Assurance. This Assurance is a core topic document core topic establishes the institution's responsibilities and procedures regarding the care and use of laboratory animals.
- agreement transparency agreement . The CEEA sent out the survey for institutions that work with animals, as stipulated in the fourth commitment of agreement transparency agreement to which the University of Navarra is a signatory.
- Membership of EARA (European Animal Research Association). The University of Navarra has renewed its membership of EARA for another year.
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.
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President, Professor of Bioethics
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administrative assistantand Animal Welfare Advisor, Animal Experimentation Service
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Coordinator and manageron site
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advisorexternal Animal Welfare, veterinary
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board member intern, researcherof the Gene Therapy Programme
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board member intern, researcher from department de Pediatría
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board member intern, professor at department of Environmental Biology
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board member intern, researcher of the Immunology and Immunotherapy Program.
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board member internal, researcherof laboratoryof researchMetabolic
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board member intern, professor at department of Biochemistry and Genetics
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2 Internal members, researchers from department de Pharmacology and Toxicology
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3 Internal members, researchers of the Cardiovascular Diseases Programme.
Forthcoming activities
Online courses in accreditation
Dates of the next Animalaria qualification courses:
Obtaining Functions (A, B, C, D, E, and/or F)
→January 9 to March 2
→ March 16 to May 11
→ May 25 to July 20
training maintenance
→ open enrollment
Designated Veterinarian
→ From March to July 2026
