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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

CBUB statement on the importance and necessity of local ethical evaluation in International research

Since there are numerous cases in which the field work and/or data collection for research projects are conducted outside Spain, the Bioethics Committee (CBUB) transmits the following considerations to the university community:

It is necessary to request and obtain the approval of a local ethics committee in the country where the research will be conducted. Various international organizations and institutions — such as the Council of Europe, the European Commission, the Council for International Organizations of Medical Sciences (CIOMS), the World Health Organization (WHO) and the Pan American Health Organization (PAHO) — agree that local ethical review helps acknowledge the diversity of regulations, sensitivities and social values, and contributes to building fairer and more equitable research relationships. From this perspective, obtaining approval from a local committee is not only a recommended practice, but a prerequisite for conducting ethically sound international research.

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. This includes ensuring that participants are well-informed and have given their consent, that their data is kept confidential and handled appropriately in accordance with local regulations, and that potential research risks are assessed with appropriate mitigation measures in place. It also involves respecting the historical, cultural, social and regulatory specificities of the country where the study is being conducted. Furthermore, approval by a local committee helps deepen the understanding of the social context in which the research takes place, promotes more equitable collaboration with the communities involved, and strengthens the ethical legitimacy and relevance of the project.

Not obtaining local ethical approval may compromise the ethical quality of the research and lead to dynamics that are disrespectful toward the communities involved. Several international institutions emphasize that validation by local ethics committees is a guarantee of respect toward participating communities, especially in vulnerable contexts or those marked by structural inequalities.

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. This assessment will take into account the type of research proposed, the methodology, the level of risk to participants, whether vulnerable populations or particularly sensitive data are involved, and other relevant contextual aspects or additional criteria depending on the specific case.

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.

In light of the above considerations, the CBUB deems it important to hold a favourable local ethics committee report in order to issue final approval for a research proposal, provided that this is applicable to the type of research and the context in which it will be conducted.

The communication can be downloaded as a PDF file:

CBUB statement local ethical evaluation