Informed Consent Policy
The Boletín Epidemiológico Semanal ensures, in all its articles, respect for the right to privacy and the protection of the personal data of patients, research participants, and third parties mentioned in manuscripts. This policy follows Section II.E of the ICMJE Recommendations and complies with Regulation (EU) 2016/679 (GDPR), Organic Law 3/2018 of 5 December, and Law 41/2002 of 14 November, which establishes the basic regulations governing patient autonomy.
1. When informed consent for publication is required
Authors must obtain written informed consent, specifically for publication, whenever a manuscript contains information, images, videos, audio recordings, or any data that could directly or indirectly allow the identification of a person. This includes, but is not limited to, names, initials, medical record numbers, clinical photographs (even when the eye region has been masked), pedigrees, detailed descriptions of rare clinical cases, surgical videos, ultrasound images containing metadata, genomic sequences, and combinations of sociodemographic data that are sufficiently specific.
Informed consent for publication is distinct from, and additional to, any consent that may have been obtained for clinical care or participation in a research study. The individual concerned, or where appropriate their legal representative, must be given the opportunity to review the manuscript before agreeing to publication and must be informed that the article will be made openly available on the Internet, with the consequent possibility of indefinite discoverability through search engines.
2. Retention of Consent Documentation
The signed copy of the informed consent for publication must be retained by the authors and by the institution responsible for the research for the period required under applicable local regulations governing the retention of clinical and research records. As a rule, the Boletín Epidemiológico Semanal does not retain copies of consent forms.
At the time of manuscript submission, authors must sign a declaration confirming that they have obtained the required consent and undertake to provide an anonymized copy to the editorial team upon request. Where required by applicable legislation, the Boletín Epidemiológico Semanal may request that the consent form be submitted directly for archiving.
3. Anonymization and Non-Essential Data
Identifying details that are not essential to the scientific understanding of the work must be omitted. Where anonymization requires the modification of identifying characteristics, authors must ensure, and editors must verify, that such modifications do not alter the scientific meaning or validity of the study.
Simple partial masking (for example, placing a bar over the eyes in a clinical photograph) is not considered sufficient anonymization.
4. Cases in Which Consent Is Not Required
Individual consent for publication is not required when a manuscript uses data that have been irreversibly anonymized, aggregated population-level data, or data processed under a specific legal basis that permits such use (for example, data obtained through the National Epidemiological Surveillance Network under the provisions of the General Public Health Act).
In such cases, authors must describe in the Methods section the legal basis for the processing of the data and the measures adopted to ensure confidentiality.
5. Statement in the Published Article
When informed consent has been obtained, this must be explicitly stated in the article, usually at the end of the Methods section or within the Ethics Statement section.
6. Minors and Persons with Impaired Legal Capacity
In the case of minors or persons whose legal capacity has been modified by a court decision, consent must be provided by their legal representative. For minors who possess sufficient maturity and understanding, their assent should also be obtained. These circumstances must be reported in the manuscript.
