Ethics for the research at the University of Navarra
Research Ethics Committee (CEI UNAV)
The committeeof Ethics of the researchhas the task of mission statementto ensure that ethical principles are complied with in the researchin human beings.
The CEI has been accredited by the General Administrationde Salud del Gobierno de Navarra since 2011.
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.
Consider the methodological, ethical and legal aspects of project research.
Weigh the balance of anticipated risks and benefits arising from the study.
Assess the qualifications of the main researcher and the team researcher as well as the feasibility of the research project .
Propose appropriate changes to investigators to ensure compliance of protocols with legal and ethical standards.
Evaluate the protocols and issue the corresponding certificates.
Establish and enforce ethical monitoring standards for approved protocols.
Coordinate its activity with that of similar committees in other institutions.
In biomedical research
Ensure compliance with procedures to ensure the traceability of samples of human origin from agreement to the biomedical research law 14/2007 and RD 1617/2011, without prejudice to the provisions of the legislation on the protection of personal data.
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.
Ensure confidentiality and exercise any other functions that may be assigned to them by rules and regulations of development of Law 14/2007.
Develop codes of good practice for agreement in accordance with the provisions of ethical-legal documents.
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.
The following documentation must be sent to the ERC Secretariat by e-mail(firstname.lastname@example.org) to researcher when applying for ERC evaluation of a project research project:
Complete documentation of project (protocol final of project, information and consent forms, report financial). All documents must be identified with a version and date.
Document "Application for evaluation of research projects" duly signed by the main researcher . (For more information financial aid consult procedure "Evaluation of research projects").
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.
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.
Dr. Belén Sádaba (President)
Dr. Carmen Berasain (administrative assistant)
D. Luis Herrera (lay member)
Dr. Elena Osácar Crespo (CUN Nursing)
Dr. Santiago Navas (Fac. Pharmacy and Nutrition)
D. Gabriel Canel (UCEC)
Dr. María Pueyo (School de Enfermería)
Dr. Fernando Pérez de Gracia (Fac. Economics)
Dr. Pilar León (CEDM)
Ms. Patricia Muleiro (CUN Data Prot.)
Dr. Idoia Portilla (Fac. Communication)
Dr. Charo Repáraz (Fac. Educ. y Psic.)
Dr. Luis Echarte (Fac. Medicine)
Dr. Nerea Varo (School de Ciencias)
Dr. Felipe Garrido Martínez de Salazar (Paediatrics CUN)
Dr. María Jesús Álvarez (School of Engineering)
Dr. Juan Carlos Hernández Peñas (Law School)
Composition and functions
assessment of the projects of research and operation
Follow-up of the projects research
Access to medical 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.
Singapore Declaration on Research Integrity
REQUEST FOR EVALUATION
*If the research is based on the use of qualitative elements (interviews, surveys, focus groups, etc.), please fill in the form at application in Social Sciences.
OTHER DOCUMENTS AND LINKS OF INTEREST
- financial aid for the elaboration of informed consent - Social Science Projects
- financial aid for the elaboration of informed consent - Proyectos de Ciencias Biosanitarias
- financial aid for the elaboration of the Information Sheet - project de Ciencias Biosanitarias
- Scientific publications
- Shared use research
- General criteria for student surveys
- Ethical evaluation of TFG and TFM
- 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(email@example.com), 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.
- Experimental Design Assistant
- presentationInteractive: The Design and Statistical Analysis of Laboratory Animal Experiments. Michael Festing
- Guidelines for the Design and Statistical Analysis. Festing&Altman 2002
- 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)
- 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)
- Book: Statistical experimental design for animal research
- 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)
- 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:
- 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 anonymously send to knowledge of committee 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 by means of the following form :
The University of Navarra is adhered to the agreement of transparency on the use of animals in scientific experimentation in Spain.
reportannual report 2021 of agreementon 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.
report of activities 2022
The most outstanding actions that this committee has carried out during the year 2022 are described:
During the year 2022 the CEEA's actions have been directed to the adequacy of the research that is made in the university according to the legal framework that came into force in Spain last February 8, 2013 (RD53/2013).
During the year 2022, the CEEA met 24 times, trying to meet every two weeks.
2- summary of protocols processed
During this year, a total of 132 new ethical protocols and 57 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 in approximately 30 days deadline .
All the protocols that have been evaluated were submitted by researchers from CIMA, UNAV or CUN, with the exception of 4 projects submitted by Navarrabiomed and 15 protocols submitted by external companies. As in previous years, the majority (68%) of the protocols and total amendments came from researchers from CIMA, with those submitted by staff from the areas of Immunology and Immunotherapy standing out. Thirteen percent of the total protocols and amendments come from the University. Most of them belong to department of Pharmacology and Toxicology. In the case of those submitted by researchers linked to the CUN, 9% of the total, come, for the most part, from the area Cell Therapy area. The remaining 10% of protocols belong to external requests.
3- Other activities carried out during the year 2022
News related to the training continua: In 2022 the animal welfare service of the Government of Navarra issued the resolution for the maintenance of training of 104 researchers of our institution according to Order ECC/566/2015.
work under supervision according to Order ECC/566/2015: In 2022, a total of 44 researchers have completed the work under supervision, essential for obtaining the accreditation in functions a, b and c once the courses of training have been passed. The Government of Navarra issues the corresponding resolution of the functions acquired and a certificate staff which is sent to student.
Retrospective evaluations: retrospective evaluations of the protocols in force since 2017 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 academic year 2021-2022, the students of doctorate of MIDI and MIB who take the subject of Animal Experimentation as a complement of training, obtain the 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.
A total of 44 authorizations were requested to the Government of Navarra, after passing the work under supervision, for accreditation in the handling of animals. All of them were approved by the aforementioned competent authority.
Offering of training from the CEEA: In order to provide a continuous training to help the researcher in maintaining its accreditation in animal handling, the CEEA gave two seminars and offered continuous training activities through internal communications of online courses and workshops of training departmental related to animal experimentation, which are sent to the Government of Navarra for information purposes.
issuance42 researchers applied to the CEEA for a certificate to be submitted to different calls for projects at research, both national and international.
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.
Access to the CEEA forms at assessment is available to all users from the CEEA website. committee
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 of the department of Pediatrics board member intern, professor of the
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.
Online courses in accreditation
Dates of the next Animalaria qualification courses:
All functions and courses:
→ March 13 to May 8
→ May 22 to July 17
Role of Designated Veterinarian:
→ March 13 to July 17