Aplicaciones anidadas

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research biological samples

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.

In programs of study , you must submit the research project research the manager approval to the CEI. Please note that a collection outside the Biobank regime can only be used in projects by the same researcher team, in the same line of research, unless new consent is requested from the participant to transfer the

It should be noted that a favorable opinion from the IRB does not automatically imply the possibility of using the samples in other projects. This depends on the consent given by the participants for future use and on how the samples are stored (project, collection, biobank). In addition, the IRB must evaluate the suitability of the research

For the use biobank samples, the biobank must confirm their availability.

A certificate Biobank must be included in the research project documentation research be sent to the CEI.

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.

Bloque 1 de FAQs

When should I go to committee research committee ?

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.

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Procedures, Deadlines, and management

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.

No, except in cases of unequivocal justification.

Researchers must assess the deadlines for presentation assessment the various calls for proposals and submit projects for assessment CEI with sufficient time for it to evaluate them and, where necessary, modify the documentation based on the assessment.

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).