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- Bioethics Commission of University of Barcelona
- CBUB Technical Secretary
- Juliana Morell Building
- EASI Space, 2nd floor
08028 Barcelona - How to arrive
- Tel. 93 403 5 463
- cbub@ub.edu
- Office of the Vice Chancellor for Research
FAQ's
Do I need to submit my project to the CBUB for assessment?
As stated in the Code of Integrity in Research of the University of Barcelona, and following the directives of the European Code of Conduct for Research Integrity, if the research directly involves the use of people, material of human origin or personal data, it must observe internationally recognized human rights and the four principles of medical ethics: autonomy, beneficence, non-maleficence and justice. When the research involves this type of activity, the researcher is responsible for requesting approval from the University of Barcelona Bioethics Committee, which will issue a favourable report if the relevant conditions are satisfied.
In addition, as stipulated in Spanish Law 14/2007, of 3 July, on biomedical research (Official State Gazette no. 159, 4 July 2007), all research involving human subjects, biological samples of human origin and the collection of personal data must be approved by the ethics committee of the centre at which the work will be carried out.
As such, if your research involves one or more of the above activities, it must be assessed by the CBUB before work can begin.
In the case of Bachelor's theses, Master's theses, or doctoral thesis that are part of a research project already approved by the CBUB, please contact the Technical Secretary (cbub@ub.edu) before submitting your application.
How do I submit my project?
Full information on submitting projects for assessment can be found on the CBUB website. The specific documents to be submitted for each type of research project are detailed in the corresponding form. To make sure that you have submitted all the necessary documentation, use the online Checklist.
All documents should be sent via NorayDocs. Instructions on how to register and how to send your documents can be found in the online handbook.
The CBUB is not responsible for your registration on NorayDocs. You should register with enough time to submit your project before the deadline in the assessment calendar.
Which form do I submit?
You should submit the form corresponding to your research:
- Form 1, for projects or theses that involve experimentation with human subjects or the use of biological samples of human origin.
- Form 2, for projects or theses that involve behavioural or observational studies, field work or archaeological studies, interviews, life histories, questionnaires or other analogous forms of research.
- Form 3, for projects or theses involving experimentation with human subjects or the use of human samples of human origin, and those involving observational studies or social interactions.
Can I submit my project to the CBUB if I have already begun the field work or the collection of samples/data?
The CBUB cannot assess projects if the field work or the collection of human samples or data has already begun, since it cannot guarantee that the work has been carried out in compliance with the applicable ethical standards. CBUB approval must always be obtained in advance.
As indicated above, according to the Code of Integrity in Research of the University of Barcelona, and following the directives of the European Code of Conduct for Research Integrity, if the research directly involves the use of people, material of human origin or personal data, it must observe internationally recognized human rights and the four principles of medical ethics: autonomy, beneficence, non-maleficence and justice. When the research involves this type of activity, you as the researcher are responsible for requesting approval from the University of Barcelona Bioethics Committee, which will issue a favourable report if the relevant conditions are satisfied.
In addition, as stipulated in Spanish Law 14/2007, of 3 July, on biomedical research (Official State Gazette no. 159, 4 July 2007), all research involving human subjects, biological samples of human origin and the collection of personal data must be approved by the ethics committee of the centre at which the work will be carried out.
How can I obtain a preliminary report from the CBUB for submission with funding calls?
To request a report from the CBUB for funding calls that require it, an application must be processed through the Noraydocs platform (Request for certificates for submission to funding calls with pending resolution), in which the following documentation must be attached:
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Annex 1 of the corresponding guide document (Form), duly completed and signed.
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Document of specific commitments signed, following the indications of point 6 of the guide document (Form).
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Draft of the project report (alternatively, a summary of the project can be submitted following the indications of the guide document).
Once we receive this documentation through the platform, we will issue a certificate stating the following 3 points:
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That the researcher has sent the required documentation.
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That the evaluation of the methodological, ethical, and legal aspects is pending.
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That, in the event that the researchers are beneficiaries of the grant, they will inform the CBUB to proceed with its evaluation - perceptive and prior to the start of the research - to obtain, if applicable and as indicated by the call, the favorable report.
As reflected in point 3 of the certificate, once the project is granted, you should contact us to submit all the documentation so that the project can be evaluated to obtain the favorable report.
Do I need to submit the documents in a particular language?
All documents submitted for assessment by the CBUB must be in one of the UB's three official languages: Catalan, Spanish or English.
When will my project be assessed?
The assessment calendar can be consulted on line. Your documents must be submitted to the Technical Secretary via NorayDocs by the stated deadline. If the Technical Secretary recommends making changes, you will be notified via NorayDocs and should submit the amended documents by the new deadline to ensure that your project can be assessed during the next scheduled meeting
If my research was carried out outside Spain, are any other documents required?
For research outside Spain involving the collection of human samples or data or requiring human interventions, it is necessary to request and obtain the approval of a local ethics committee in the country where the research will be conducted. This validation is essential to ensure the protection of the rights of study participants, as local committees ensure that the research complies with the ethical, legal and cultural framework of the specific context, and that the safety and well-being of participants are properly protected. In cases where the research is conducted within the European Economic Area (EEA), the need to present a favourable report from a local committee will be determined by the CBUB based on the specific characteristics of the research project.
To obtain a favourable report from a local committee, the CBUB suggests considering the following options:
- Initial step: Contact ethics or bioethics committees of universities in the country where the research is being conducted.
- Alternative or complementary option: In the case of doctoral theses or projects funded by a local entity, you may request information from that entity regarding local committees that are authorized to issue a favourable review.
- In case of difficulties: If neither of the above options are viable — due to committee refusals, the lack of appropriate committees, or other obstacles — we recommend contacting the Technical Secretary at the CBUB (cbub@ub.edu), providing a description of the situation and supporting evidence. The CBUB will analyse the situation and provide guidance on exploring appropriate alternatives or solutions.
Submission of a favourable report is essential to receive final approval from the CBUB, although it is not a prerequisite for initiating the evaluation process.
For more information we recommend you to check CBUB statement on the importance and necessity of local ethical evaluation in International research
If I have the approval of a corresponding CEIC/CEIM/European Ethics Committee, what procedure should I follow?
In these cases, when the project for which the CBUB approval is requested is exactly the same as that approved by this committee, you should submit the following documentation for review:
- Approval Letter from the CEIm/c or Bioethics Committee: Official document certifying the committee's approval, duly signed and dated.
- Study Protocol Report: Final version of the approved protocol, including any approved modifications.
- Information Sheet and Informed Consent: Copy of the information sheet and informed consent approved by the committee.
- Additional Documentation: Any other relevant documentation requested by the CEIm or bioethics committee.
- CBUB Documentation: Annex 1, Annex 4, and specific commitments (point 6 of the CBUB form), duly signed.
In case of doubt, contact the Technical Secretary (cbub@ub.edu) before submitting the documentation
Is there a document for declaring the specific commitments referred to in point 6 of the form?
There is no model document for declaring specific commitments. You must submit a separate document declaring any specific commitments that apply to your work. This must be signed by the principal investigator or your supervisor/tutor (as applicable).
Once my project has been assessed in a full committee meeting, is there a specific deadline for submitting the amended documents in response to the CBUB's comments?
Once you have received the committee's comments and observations, you have one month to submit the amended documents, incorporating any changes required. If a response to the comments is not received by the end of this month, the Technical Secretary will send a reminder to confirm that you are working on the amendments. A second reminder will be sent one month after the first:
- If you do not send confirmation within two weeks, the project will be rejected.
- If you confirm that you are working on the necessary amendments, you will be given an additional month in which to complete and send the documents. If the documents have not been received by the end of this month, the project will be rejected.
If the project is rejected, the submission process must be repeated in full.
How do I make changes to a project that has already been approved by the CBUB?
If you wish to amend a project that has already been approved, you should write to the Technical Secretary (cbub@ub.edu) to explain the nature of the amendment and why it is necessary. Once the Technical Secretary has reviewed the proposed changes, you will receive an email indicating how to proceed and what documents are required.
Where can I find information about data management and protection for my project?
Full information is provided in the data protection handbook Guide for researchers at the University of Barcelona on the protection of personal data, provided by the Data Protection Office.
What is considered a special category of data under the GDPR?
According to the General Data Protection Regulation (GDPR), special categories of data include:
- Genetic data: Information about a person's inherited or acquired genetic characteristics.
- Biometric data: Data obtained from specific technical processing, such as fingerprints or facial recognition, that uniquely identify a person.
- Health data: Information about a person's physical or mental health.
- Ethnic or racial origin.
- Political opinions.
- Religious or philosophical beliefs.
- Trade union membership.
- Data concerning a person's sex life or sexual orientation.
These data require additional protection due to their sensitive nature.
If you have any other doubts, write to us at cbub@ub.edu or call 934 03 54 63.