In general, all research programs of study research human subjects, their samples, or their staff data must be submitted for review by an accredited IRB.

This includes collecting data for research or unfunded research projects, as well as for thesis publications, or presentations at conferences or in scientific journals.

If the data have already been collected, it will not be possible to obtain the CEI's opinion.

programs of study data are completely anonymous from the outset must be evaluated to ensure the voluntary nature of participation and to verify the method of collection.

CEI-Unav is not accredited to assess projects involving the evaluation of drugs (clinical trials and programs of study ) or medical devices, nor for research projects research human pluripotent cells obtained through cell reprogramming.

Multicenter projects in which UNAV staff students or CUN patients participate as researchers and/or research recruited as research subjects must be evaluated by the UNAV Institutional Review Board (IRB).

The project documentation project be adapted to the UNAV center, especially the Participant Information Sheet (PIS), which must clearly state the contact person contact the data Protection Officer data the University of Navarra, Clínica Universidad de Navarra, IESE, or CIMA, as appropriate.  

Any certificate approval from another CEI must be included in the documentation to be submitted to the CEI.

For aC project C another CEI/CEIm, the following is required:

• certificate approval of project research project research another IRB/IEC.
• Documents approved by the CEI/CEIm (version appearing in the ruling).
• IC by the other CEI/CEIm, without modification.
• IC with the data : data researcher at the University of Navarra center, including their contact data , and data data Protection Officer data University of Navarra center, as well as information on data participants at the relevant center data withdraw their consent for the research exercise their data protection rights.

The researcher (PI) must notify the IRB of any modifications to project apply for approval whenever there is a substantial change. For example: change in degree scroll, change of PI, incorporation of new centers, change in the recruitment system, issue groups of patients/participants recruited, change or incorporation of new samples, etc.

Yes, but it should be noted that the CEI can only evaluate, and therefore issue an opinion on, research is going to be carried out, and under no circumstances on research been carried out.

In principle, this is not research, therefore, its assessment the CEI would not be necessary.

However, since journals can apply for approval a committee, the case to be published is evaluated and a certificate is issued.

If it is possible to obtain it, an information and consent form for publication must be prepared.

Yes, the IRB must evaluate any study that collects information or samples from patients, even if they were collected during attendance , since the samples or data used for research purposes, not for care.

You must submit all documentation in agreement requirements , as indicated on the application form .

Once the documents have been checked, the CEI will issue a certificate assessment project is in the assessment process, signed by the CEI's administrative office , which you will receive by email.

Yes, since data will be collected data the center's employees. If no clinical or healthcare data is collected from patients, it will be presented as project social research project .

You must submit approval from the center or department .

In the event that anonymous collection of questionnaires is proposed, the IRB will verify this method of collection. 

TFGs or TFMs require assessment the CEI if they use data for research purposes or for publication.

No assessment is required assessment the purpose of project exclusively professor.

The tutor these projects is manager that they are carried out in compliance with fundamental requirements , the protection of information confidentiality, and all other rules and regulations .

The TFG and TFM submitted for assessment include the identity of tutor work tutor , who assumes the role of researcher , and of the student.

Please note that data obtained for professor purposes cannot be used professor any other purpose, such as a research project , without their consent.

A professor project with a professor purpose professor PID) does not require approval by the CEI; its implementation depends on each School .

However, research possible subsequent publication using project data project be submitted assessment the IRB assessment . In this case, the IRB will evaluate:

• The application consent to use data research, which should be completed before starting the PID.
• The recruitment process must avoid any coercion, especially in cases where a teacher of the subject invites participation. Measures to prevent coercion must make it clear that the decision to participate cannot influence grade .
• The participant information and consent form must include information on confidentiality and data protection measures.

It is important to note that participation in a research professor project professor voluntary, so only the data students who decide to participate in the research project will be used for research purposes.

Any research involves the collection of data health data and is conducted for any of the following purposes is considered an observational study involving medications under Royal Decree 957/2020:

1. To determine the beneficial effects of medications, as well as the factors that influence them—including the patients’ perspective—and their relationship to the resources used to achieve them.

2. To identify, characterize, or quantify adverse drug reactions and other risks to patient safety associated with their use, including potential risk factors or effect modifiers, as well as to measure the effectiveness of risk management measures.

3. Gather information on medication use patterns in the population.

The UNAV IRB is not accredited to review programs of study drug programs of study ; these must be reviewed by an IRB (in Navarre).

The UCEC at CUN provides support for this process. You can contact email contact : eomcun@unav.es.

Access to data for purposes other than patient attendance the subject’s prior consent (Law 41/2002, Art. 16). If it is not possible to obtain this consent, a justification must be provided. The CEI will evaluate the project this application access without consent.

data may only be accessed if it is justified that consent cannot be obtained and the following can be confirmed:

1. The research should be research general interest.

2. The research should research conducted by the same institution that requested the initial consent.

3. The research less effective or impossible without the source subject's data .

4. There is no record of an explicit objection on the patient’s part (it can be verified that the patient has not objected to the use of their data research the CUN’s data protection clauses).

5. The confidentiality of staff data must be guaranteed.

In any case, in the absence of consent, the IP must sign a manager declaration form. The process for accessing data without consent must be carried out in accordance with the relevant PNT and its annexes.

Profiling refers to the processing of data to evaluate, analyze, or predict aspects such as a person’s professional performance, status , health, preferences, interests, consumption trends, reliability, behavior, location, movements, etc.

A simple classification of people based on basic characteristics—such as their age, sex, and weight—is not considered profile.

Advertisements intended to promote recruitment—both the text and the method of dissemination—must be reviewed by the CEI. Once authorization has been obtained, they may be published in the designated media, indicating the issue the project and the date of project approval. A document explaining the requirements for these advertisements is available on the CEI’s website.

A project to be conducted at CUN/UNAV will require approval from the CEI-Unav, including the project consent project(ICFs). The CEI will assess, among other things, whether the ICF clearly identifies the project manager project CUN/UNAV and provides contact, as well as local information on how to exercise data protection rights.

data registries data research purposes research approval from the IRB. The IRB will review a project create a registry that will serve as the basis for future research, as well as the informed consent form.

The use of data an existing C registry C a research project research the one in which the registry was created requires assessment the CEI. The CEI will evaluate each research project research that data; in such cases, it will not be necessary to submit a HIP, but rather to provide reference letter C registry.

Phone calls made solely for research purposes are research considered commercial calls and therefore fall outside the scope of the LSSI and the General Telecommunications Law. Consequently, calls for surveys related to research projects may be made research the restrictions imposed by these two laws.

They must comply with data protection laws data therefore, when using an existing list of phone numbers to make calls, there must be a legitimate basis for using it for this purpose. Furthermore, at the beginning of the call, relevant information regarding data processing must be provided (including who the manager is, the legal basis and purpose of data retention periods data the rights of data and how to exercise them).

If students are to participate in the study, the“General Guidelines for StudentSurveys” must be followed.

If other groups, such as employees, teachers, etc., are to participate, prior authorization must be obtained from the appropriate governing body.

Yes, it is possible to do so, but it is important to note that images and voice recordings constitute data ; therefore, you must first obtain the express consent of all individuals affected by the recording, including the interviewer, when applicable.

To apply for assessment project assessment project complete the application form , which can be found on the CEI website:

https://www.unav.edu/investigacion/nuestra-investigacion/etica-para-la-investigacion

There are two forms: form social science projects and another for health science projects. Health projects that only involve the use of assessment recording tools, without data , should complete the social form .

The form all project documentation project to your assessment report, assessment registration tools, information sheets, availability certificates, approval certificates, etc.) must be sent to the CEI at the following address: ceic@unav.es

If you have any questions, please contact contact the same email address.

The date refers to the final date of creation of the document under assessment corresponds to the version, which is the issue identifies the document under assessment. For example, if today is April 3, 2026, the document version would be 1 and the date would be April 3, 2026.

It is very important that when you submit another modified version to the CEI, it is modified. For example, if we have requested clarification and you submit the new version of the document, and today is April 24, 2026, the new version will be version 2, and the date will be April 24, 2026.

The rulings should include a list of the approved documents for a project, with version and date. For this reason, it is important that each document submitted to the CEI includes the version and date. Otherwise, it will not be possible to issue a ruling with this information.

It is also important to maintain document traceability and know which version is current at all times.

Each IP must submit a project to the CEI project a degree scroll , preferably including the objectives/tasks for which assessment is requested. For example: degree scroll project task to be performed.

Each project will be processed project , with issue different issue . The application form application specific information on the work of this PI within the project the particular ethical considerations of their participation (recruitment of patients/participants, data, samples, sample analysis, etc.).

It is advisable for each PI to indicate that another researcher the University of Navarra is participating in the same project.

grade: This is a status when one IP replaces another, for example, because it is transferred to another center, or for any other reason. In this case, it will be a modification to an C project .

grade: The status the same project has an IP and a CoIP is also different. In this case, both participate in the same project. A single certificate will be issued, with information on both IPs.

The committees' opinions on research programs of study research be substantiated.

Any clarification regarding these rulings may be requested from the administrative office (ceic@unav.es).

No, unless there are clear justifications. Researchers must take into account the presentation assessment deadlines assessment the various calls for proposals and submit their projects assessment CEI for assessment well in advance so that the CEI can evaluate them and researchers have time to modify the documentation based on the assessment.

apply for must apply for assessment , specifying the recruitment method, the data collection process data the use of assessment recording tools to evaluate compliance with requirements .

Participation must be voluntary, without coercion. In the case of UNAV students, the rules and regulations must also be followed, and profiling must be avoided.

The survey instruments should inform participants of goal (without influencing their responses), who is responsible for the study and data contact data contact an email address, for example), what participation in the study entails (duration, tasks to be performed, etc.), and ensure that participation is voluntary and anonymous. 

If any sensitive information is also collected, subject must be notified in advance and given the option to decline to answer. 

Anonymization involves converting data into data cannot be used to identify an individual.

In some cases, even if data directly identify individuals (such as name, email address, National Identity Card number, etc.) are removed, it is still possible to re-identify them by combining other data (for example, weight, gender, age, ZIP code, date of birth…), either on their own or in conjunction with data from other sources.

Therefore, the use of anonymization techniques is recommended to reduce the risk of re-identification.

Further information is available in theguide to Anonymizationprepared by the National data Protection Authority data Singapore and translated by the Spanish data Protection Agency data English version) or in the bibliography .

These are two ways to store the data the individual separately from the rest of the data (typically data such as weight, gender, age, ZIP code, etc.), so that the individual can be contacted at a later date.

data is replaced with a code or pseudonym. The code is stored in a separate table alongside the data .

If the mapping between thedata code anddata is held by a person other than the researchers—who do not have access to that mapping—this is referred to as pseudonymization.

If the relationship is maintained by aresearcher team member ,researcher referred to as coding.

Pseudonymization and encryption are different from anonymization, since anonymization involves the complete removal of data .

Anonymization techniques that reduce the risk of re-identification through the combination of data or other data should also be applied to data or data , when necessary.

You have two options:

• They can be stored in a biobank. You can contact the UNAV Biobank.

You must submit the research project research Biobank approval to the CEI.

In programs of study with these samples, the CEI will evaluate each project, sample Biobank must also provide the availability sample .

• A sample collection can be created, and the researcher manager will have to register the collection in the ISCIII National Biobank Registry.

In the project , the collection issue and the researcher manager must be communicated to the CEImanager be evaluated.

For programs of study , you must submit the research project research the manager approval to the CEI. Please note that a collection outside the Biobank system may only be used in projects by the same researcher team and within the same line of research, unless new consent is obtained from the participant to release the samples.

It is important to note that a favorable decision by the IRB does not automatically mean that the samples can be used in other projects. That depends on the consent participants have given for their future use and on how the samples are stored (project, collection, biobank). In addition, the IRB must evaluate the appropriateness of the research.

It will be necessary apply for modification to project , including the new information, as well as the documents corresponding to the origin of those samples (ICmodel , availability BB or manager , cell lines, etc.).

The samples may be used in another project the same line of research, with the participation of researcher team researcher that line and with the authorization of manager , provided that the project obtained a favorable opinion from the CEI-Unav.

To use samples from the biobank, the biobank must confirm their availability. This certificate the biobank must be attached to the research project documentation research be submitted to the CEI.