Política de compartición de datos
The Boletín Epidemiológico Semanal promotes, in line with the FAIR principles (Findable, Accessible, Interoperable, Reusable) and the open science model advanced by the European Union and the Carlos III Health Institute, the responsible sharing of the data underlying published research findings. This policy is informed by the ICMJE position on Data Sharing Statements for Clinical Trials, the NIH recommendations on data management and sharing, and the EQUATOR Network guidelines applicable to each study design.
1. Data Sharing Statement
All manuscripts submitted to the Boletín Epidemiológico Semanal that report primary data or base their conclusions on primary data must include a Data Sharing Statement at the time of submission and in the final published article.
This statement must clearly and verifiably indicate which data are being shared, in what format, where they are deposited, within what timeframe, and under what access conditions. Where data cannot be shared, the statement must explain the reasons for this restriction (for example, protection of personal data without consent for disclosure, statistical confidentiality requirements, or third-party intellectual property rights) and, where appropriate, provide alternative resources, such as aggregated datasets, synthetic data, analysis code, or the statistical analysis plan.
2. Clinical Trials
The Boletín Epidemiológico Semanal requires that clinical trials whose participant recruitment began on or after 1 January 2019 include a Data Sharing Statement consistent with the ICMJE model. This statement must specify: whether de-identified individual participant data will be shared, exactly which data will be made available, which additional documents will be provided (such as the study protocol, statistical analysis plan, analysis source code, informed consent form, and data dictionary), when the data will become available and for how long, the access criteria (including who may access the data, for what types of analyses, and through what mechanism) and the repository or other channel through which the data will be made available.
Where the data-sharing plan declared in the trial registration differs from the final practice, the reasons for the discrepancy must be explained in the manuscript.
3. Observational, Surveillance, and Public Health Studies
For observational studies (including cohort, case-control, and cross-sectional studies), epidemiological surveillance studies, and public health research, the Boletín Epidemiológico Semanal also requires a Data Sharing Statement, tailored to the sensitivity of the information involved and the applicable legal bases for data processing.
Authors are encouraged to deposit data in trustworthy repositories, preferably institutional repositories of the Carlos III Health Institute (ISCIII), repositories within the ELIXIR European infrastructure, or repositories certified by CoreTrustSeal, and to assign a persistent identifier (DOI) to the dataset.
When data originate from national health information systems, the Data Sharing Statement must identify the procedure through which third-party researchers may request and obtain access to the data.
4. Personal Data and Legal Considerations
Data sharing must always comply with Regulation (EU) 2016/679 (GDPR), Organic Law 3/2018 of 5 December, and, where applicable, Regulation (EU) 2023/2854 on data.
Pseudonymization is not equivalent to anonymization. Therefore, the deposition or sharing of identifiable or re-identifiable individual-level data requires a specific legal basis authorizing such processing and disclosure.
Where there is a reasonable concern regarding the risk of re-identification, the Boletín Epidemiológico Semanal may request an independent expert opinion or require that the data be deposited in a controlled-access repository.
5. Data Associated with Data Papers
Manuscripts whose primary purpose is the description of a dataset (data papers) must deposit the complete dataset in a trusted public repository prior to acceptance of the article and assign it a persistent identifier, which must be cited within the manuscript.
The dataset description must provide sufficient information to enable validation of the dataset and its reuse by third parties, in accordance with the FAIR principles (Findable, Accessible, Interoperable, and Reusable).
6. Code, Scripts, and Supplementary Materials
When the analysis depends on scripts, source code, or non-commercial software, the Boletín Epidemiológico Semanal encourages authors to deposit the code in a public repository (for example, GitHub with archiving through Zenodo) under an open license and to cite it in the manuscript using a DOI.
Similarly, supplementary materials (such as questionnaires, sampling designs, and templates) should be described in sufficient detail to enable the reproducibility of the study.
7. Justified Exceptions
The Boletín Epidemiológico Semanal acknowledges that there may be legitimate reasons for not sharing data, including the protection of the privacy of vulnerable individuals, statistical confidentiality requirements, national security considerations, third-party intellectual property rights, and contractual embargoes.
In such cases, the Data Sharing Statement must explain the reason for the restriction and, whenever possible, provide alternative resources, such as aggregated data, the statistical analysis plan, or the analysis code.
8. Location of the Data Sharing Statement
The Data Sharing Statement must appear in a clearly visible section of the article, usually at the end of the main text and before the reference list.
When data have been deposited in a repository, the repository must be cited using its DOI or other persistent identifier and, whenever technically feasible, through an active hyperlink.
