CONTENTS
- Scope and purpose
- Definitions
- General principles: FAIR data and open science
- Data Availability Statement: general requirements
- Data Availability Statement: wording templates
- Data categories: primary, secondary and derivative data
- Recommended repositories: general and discipline-specific
- Sensitive and restricted data in gynecological and obstetric research
- Embargo: conditions, maximum duration, and request procedure
- Clinical trial data: ICMJE alignment
- Code and software availability
- Protocol and materials sharing
- Dataset citation
- Licensing of research data
- Compliance with funder data management requirements
- Post-publication data access and dataset updates
- Peer review and editorial assessment of data availability
- Non-compliance and consequences
- GDPR provisions for research data sharing
- Annual review and compliance reporting
- Cross-references within the EGO Editorial Policy Framework
- Normative references
- SCOPE AND PURPOSE
This Data Availability and Sharing Policy (hereinafter: the Policy) establishes the requirements governing the availability, sharing, archiving, and citation of research data associated with manuscripts submitted to and published in European Gynecology and Obstetrics (EGO). It applies to all authors, reviewers, editors, and the Publisher.
The Policy operationalizes the data governance commitments established in Section 7 of the Editorial Policy Statement. In the event of inconsistency between this Policy and the Editorial Policy Statement on matters of data availability, this Policy governs.
The Policy applies to all manuscript types that generate, analyze, or use research data, including original research articles, systematic reviews and meta-analyses, case reports, clinical trial reports, study protocols, and data notes. It does not apply to opinion pieces, editorials, letters, and commentaries that contain no original or reanalyzed data; authors of such articles are required to complete the standard wording template for non-applicable articles (Section 5.7).
The Publisher issues the Policy on behalf of the European Society of Gynecology (ESG), and it enters into force on the date of adoption. It applies to all manuscripts submitted from that date.
- DEFINITIONS
For this Policy, the following definitions apply. Definitions already established in the Research Ethics Policy - including anonymized data, pseudonymized data, secondary use of data, and biobank - retain their meaning as defined in the Research Ethics Policy (Section 2) and are incorporated here by reference.
Research data: all data, whether quantitative or qualitative, that are generated, collected, processed, or analyzed in the course of the research reported in a manuscript, and upon which the results, conclusions, and claims of the article depend. Research data includes primary, secondary, and derived datasets; processed data; statistical outputs; images; clinical measurements; genomic sequences; survey responses; and any other material that substantiates the findings of the published work.
Primary data: data generated directly by the authors in the conduct of the study reported in the manuscript, including experimental measurements, clinical observations, patient records (de-identified), biological assay results, imaging data, and survey responses.
Derived data: data produced by applying analytical, computational, or statistical processes to primary or secondary data, including calculated variables, summary statistics, and outputs of bioinformatics pipelines or statistical models.
Data Availability Statement (DAS): a mandatory, standardized declaration published in the article that specifies where the data underlying the article's findings can be accessed, under what conditions, and under which license, or that explains why the data are not publicly available. The DAS is a formal component of the published record.
Data Management and Sharing Plan (DMSP): a document required by many research funders - including the National Institutes of Health (NIH), Horizon Europe, Wellcome Trust, UKRI, and Gates Foundation - describing how scientific data generated during a funded project will be managed, preserved, and shared during and after the project period. The DMSP is a funder requirement and is not submitted to the Journal; however, its content must be consistent with this Policy.
Repository: a digital infrastructure that provides storage, persistent identification, metadata management, and access services for research data, and that assigns a persistent identifier (typically a DOI) to each deposited dataset. Repositories may be general-purpose, institutional, or discipline-specific.
Controlled-access repository: a repository that restricts access to deposited data to authorized users who have submitted a formal access request and met defined eligibility criteria. Used for sensitive data that cannot be deposited in open-access repositories due to privacy, consent, or ethical constraints.
Embargo period: a defined period of time following publication during which access to a deposited dataset is restricted, after which the dataset becomes publicly available. Embargoes are exceptional and subject to the conditions defined in Section 9.
FAIR Data Principles: the Findable, Accessible, Interoperable, Reusable principles for research data management and sharing, as defined by Wilkinson et al. (2016) and subsequently adopted by the European Commission, NIH, and the major international publishers as the framework for responsible data sharing.
Code availability: the requirement to make available the computer code, scripts, algorithms, and analytical pipelines used in the generation of the reported results, in accordance with Section 11.
- GENERAL PRINCIPLES: FAIR DATA AND OPEN SCIENCE
3.1 FAIR Data Principles. European Gynecology and Obstetrics (EGO) endorses and promotes the FAIR Data Principles as the foundational framework for research data management and sharing. Consistent with the Journal's commitment to diamond open access and scientific transparency, data underlying published articles should be: (a) Findable, meaning deposited in a searchable repository and assigned a persistent identifier such as a DOI; (b) Accessible, meaning retrievable under clearly defined conditions, even if subject to controlled access; (c) Interoperable, meaning stored in standard, machine-readable formats with documented metadata; and (d) Reusable, meaning accompanied by sufficient metadata and a clear licence statement to enable reuse by others.
3.2 Open science commitment. The Journal recognizes data sharing as a component of scientific integrity and reproducibility. Making underlying data available enables independent verification of results, reduces redundant data collection, supports evidence synthesis, and advances the quality of evidence-based medicine in gynecology and obstetrics. Consistent with the Journal's zero-embargo model for articles and the open data requirements of major public funders, the Journal encourages maximum data sharing within ethical, legal, and privacy constraints.
3.3 Balance with participant protection. The Journal recognizes that research in gynecology and obstetrics involves categories of data - including health data, reproductive data, genetic and genomic data, and data concerning minors - that are subject to heightened privacy protection under the GDPR and under ethical standards including the Declaration of Helsinki 2024. The requirements of this Policy are applied in a manner that respects and preserves the privacy and dignity of research participants, and that is consistent with the provisions of the Journal's Research Ethics Policy. The obligation to share data does not supersede the obligation to protect participants.
3.4 Relationship to funder mandates. The requirements of this Policy align with, and in most cases satisfy, the data management and sharing requirements of the major public research funders. Funder-specific provisions are addressed in Section 15. Authors whose funders impose data management requirements more stringent than those of this Policy must comply with their funder's requirements in addition to those of this Policy.
- DATA AVAILABILITY STATEMENT: GENERAL REQUIREMENTS
4.1 Mandatory requirement. All manuscripts submitted to the Journal that generate, reanalyze, or use existing research data must include a Data Availability Statement. The DAS is a mandatory element of all original research articles, systematic reviews and meta-analyses, case reports, clinical trial reports, study protocols, and data notes. For article types to which the DAS is not applicable - including opinion pieces, editorials, letters, and commentaries containing no original or reanalyzed data - the standard template for non-applicable articles (Section 5.7) must be completed. No manuscript is accepted for publication without a completed DAS.
4.2 Content of the DAS. The DAS must clearly specify: (a) whether the data underlying the article's findings are available; (b) where the data are available (repository name, URL, and DOI or accession number of the dataset); (c) the conditions under which the data are accessible (open, controlled-access, or on reasonable request); (d) the license under which the data are made available (Section 14); and (e) whether any part of the underlying data is restricted, and if so, the reason for the restriction and how access may be requested.
4.3 Placement in the manuscript. The DAS is placed as a standalone section immediately before the References section, under the heading "Data Availability Statement". It may not be embedded in the Methods section, acknowledgments, or any other section of the manuscript. For clinical trial reports, the DAS must also include a statement regarding the data-sharing plan registered with the trial registry, consistent with Section 10.
4.4 Supplementary information. Please do not provide large datasets as supplementary information files attached to the article; this will not substitute for deposit in a recognized repository. Where data are provided as supplementary material, the DAS must state this and must specify that the supplementary data files are available through the Journal's platform. Supplementary data provided on the Journal's platform are subject to the CC BY 4.0 license applicable to the article and are consistent with the Open Access Policy (Section 7).
4.5 Data notes. Data notes - structured articles whose primary purpose is the description of a dataset of scientific interest - must include a DAS pointing to the described dataset in a recognized repository. The dataset DOI must be included in the article metadata and in the DAS. Data notes that do not include a link to a deposited, publicly discoverable dataset record are not accepted for publication. Where the dataset contains sensitive data, a controlled-access arrangement may satisfy this requirement, provided that the repository record, metadata, access procedure, and applicable restrictions are publicly described.
4.6 Consistency with the manuscript. The DAS must be consistent with the manuscript content, particularly the Methods section and the funding statement. Any discrepancy between the DAS and the registered data sharing plan (where applicable) must be explained and justified in the cover letter. Inconsistencies identified during peer review or post-publication may trigger an investigation.
4.7 Human subjects research. All articles reporting research involving human participants must confirm in the DAS whether data sharing is consistent with the informed consent obtained from participants, in accordance with the Open Access Policy (Section 7). Where the consent does not cover open data sharing, the DAS must indicate the applicable restriction and specify the conditions under which the data may be accessed.
- DATA AVAILABILITY STATEMENT: WORDING TEMPLATES
Authors must use one of the following standard wording templates for the DAS, adapting the placeholders in square brackets as appropriate. The use of these standard templates supports consistency, editorial assessment, and discoverability, including downstream metadata handling and CrossRef/DataCite linking where technically implemented by the Publisher. Authors may supplement the standard template with additional explanatory text but may not replace it.
5.1 Data available in a public repository:
Template 5.1 The data that support the findings of this study are openly available in [Name of Repository] at [URL], DOI: [DOI of dataset]. The dataset is licensed under [CC0 1.0 / CC BY 4.0].
5.2 Data available in a public repository with access accession code:
Template 5.2 The data that support the findings of this study are available in [Name of Repository] under accession number [accession number] at [URL].
5.3 Data available from the corresponding author upon reasonable request:
Template 5.3 The data that support the findings of this study are available from the corresponding author ([name or ORCID]) upon reasonable request. Data are not publicly available due to [ethical/legal / privacy] restrictions. Access requests should be directed to [email address or institutional data access contact].
5.4 Data available in a controlled-access repository (sensitive data):
Template 5.4 The data that support the findings of this study are available in [Name of Controlled-Access Repository] at [URL / accession number]. Access is subject to approval by [data access committee/ethics committee / institutional authority]. Requests for access should be submitted to [contact / URL].
5.5 Data deposited with embargo (see Section 9 for conditions):
Template 5.5 The data that support the findings of this study will be available in [Name of Repository] at [URL / DOI] from [date or event]. During the embargo period, access requests may be directed to the corresponding author at [email address].
5.6 All data contained within the article and/or supplementary materials:
Template 5.6 All data generated or analyzed during this study are included in this published article [and its supplementary information files]. [Supplementary data are available through the Journal's platform at [URL].]
5.7 Not applicable (opinion pieces, editorials, letters with no original data):
Template 5.7 No datasets were generated or analyzed during the current study. This article does not report original or reanalyzed research data.
Authors should use the template that best describes their data availability. Where a combination of templates applies - for example, where some data are publicly available and others are restricted - both relevant templates should be included, with clear identification of which data each template refers to.
- DATA CATEGORIES: PRIMARY, SECONDARY AND DERIVATIVE DATA
6.1 Primary data. Authors reporting original research are expected to make all primary data underlying the results, tables, and figures of the article available in a recognized repository, subject to the exceptions defined in Sections 8 and 9. This includes quantitative measurements, clinical data (appropriately de-identified in compliance with Research Ethics Policy (Section 19) and the GDPR), imaging data, genomic sequences, survey responses, and any other material that substantiates the findings.
6.2 Secondary data. Research based on secondary use of existing data - including administrative databases, disease registries, birth registries, assisted reproduction databases, and national health surveys - must include in the DAS a reference to the source dataset and, where applicable, the accession number or repository link to the original data. Where the secondary data are proprietary or subject to access restrictions, the DAS must explain the conditions under which the data were accessed and how other researchers may request access. Provisions governing ethics committee approval for secondary data use are set out in the Research Ethics Policy (Section 8).
6.3 Derived and processed data. Derived data, processed datasets, statistical analysis outputs, and the outputs of bioinformatics pipelines that are necessary to reproduce the main findings of the article must be deposited in a repository or made available as supplementary material, with full documentation of the processing steps applied. Where derived data are substantial in size, a representative or minimum dataset sufficient to reproduce the key results is acceptable.
6.4 Metadata. All deposited datasets must be accompanied by sufficient metadata to ensure their findability and reusability, consistent with the FAIR principles. Metadata must include at minimum: dataset title; authors; date of deposit; associated publication DOI; description of variables, units, and data collection methods; access conditions; and license. The use of standard metadata schemas (including DataCite Metadata Schema, Dublin Core, or discipline-specific schemas where available) is strongly encouraged.
6.5 Data not generated in this study. Where an article does not generate any new data but reanalyses, reproduces, or draws upon previously published datasets, the DAS must include a reference to the source dataset and, where applicable, to the article in which the dataset was first published. The DAS must confirm whether the data were accessed in exactly the form in which they were originally published or whether any transformation was applied.
- RECOMMENDED REPOSITORIES: GENERAL AND DISCIPLINE-SPECIFIC
7.1 Selection criteria. The Journal recommends that authors deposit research data in repositories that: (a) assign a persistent identifier, preferably a DOI, to each deposited dataset; (b) are registered in re3data.org or FAIRsharing.org; (c) are committed to long-term data preservation; (d) provide machine-readable metadata; and (e) support open licenses or provide a mechanism for controlled access with documented access procedures. Authors are encouraged to use community-endorsed, discipline-specific repositories, where available, for their data type.
7.2 General-purpose repositories. The Journal recognizes the following general-purpose repositories as meeting the criteria of Section 7.1:
- Zenodo (zenodo.org, operated by CERN and OpenAIRE) - free, open-access, accepts all data types, assigns DOIs, CC0 and CC BY 4.0 supported; designated repository for Horizon Europe compliance;
- Figshare (figshare.com) - free for individual researchers, accepts all data types, assigns DOIs, CC BY 4.0 and CC0 supported;
- Dryad (datadryad.org) - journal-integrated repository for data underlying published articles, assigns DOIs, CC0 default;
- Open Science Framework / OSF (osf.io, Center for Open Science) - free, supports pre-registration and open materials in addition to data, assigns DOIs;
- Harvard Dataverse (dataverse.harvard.edu) - open-access, multi-disciplinary, assigns DOIs, supports diverse data types.
7.3 Discipline-specific and clinical repositories. For specific data types arising in biomedical and clinical research, the Journal recommends the following discipline-specific repositories:
- PhysioNet (physionet.org, MIT) - for clinical physiological data, waveform data, and databases from critical care and obstetric monitoring; controlled-access available;
- ISRCTN Registry (isrctn.com) - a clinical trial registration and results-reporting platform; may be used to register trial information, data sharing plans, protocols, and summary results. It is not a data repository for underlying research datasets and does not replace deposition of primary data in an appropriate repository where such deposition is required or feasible;
- ClinicalTrials.gov Results Database - a results-reporting platform for trials registered on ClinicalTrials.gov; may host structured summary results, protocols, and data sharing plans, but does not substitute for deposition of underlying research datasets in a dedicated data repository;
- Gene Expression Omnibus / GEO (ncbi.nlm.nih.gov/geo, NCBI) - for gene expression data;
- European Nucleotide Archive / ENA (ebi.ac.uk/ena) - for nucleotide sequences generated in genomic research.
7.4 Controlled-access repositories for sensitive data. Where data cannot be deposited in an open-access repository due to privacy, consent, or ethical constraints (see Section 8), the Journal recommends the following controlled-access repositories:
- European Genome-phenome Archive / EGA (ega-archive.org, EMBL-EBI and CRG) - for human genetic and genomic data from European research, with data access committee review; aligned with GDPR requirements;
- dbGaP (ncbi.nlm.nih.gov/gap, NCBI/NIH) - for human genotype and phenotype data from NIH-funded studies;
- UK Biobank (ukbiobank.ac.uk) - for data derived from the UK Biobank resource.
7.5 Institutional repositories. Authors affiliated with institutions that operate a recognized open repository may deposit data in their institutional repository, provided the repository assigns a persistent identifier and meets the criteria of Section 7.1. The institutional repository may be combined with a general-purpose repository for redundancy.
7.6 Repository selection guidance. Authors may consult re3data.org or FAIRsharing.org to identify appropriate repositories for their data type. Authors who are uncertain about the appropriate repository for their data are encouraged to contact the Editorial Office before submission.
- SENSITIVE AND RESTRICTED DATA IN GYNECOLOGICAL AND OBSTETRIC RESEARCH
8.1 Scope. Research in gynecology and obstetrics regularly involves data subject to heightened privacy protections, including health data; data related to reproductive function; genetic and genomic data; data derived from assisted reproduction procedures; data concerning pregnant women and their fetuses; data concerning neonates; and data concerning minors. These categories are special categories of personal data under Article 9 GDPR and require additional safeguards when sharing is contemplated. The provisions of this Section apply to all such data.
8.2 Patient-level clinical data. Individual-level clinical data that could directly or indirectly identify participants may not be deposited in open-access repositories. Such data must be de-identified in accordance with GDPR standards and the definitions of Research Ethics Policy (Section 2) before public deposit, or deposited in a controlled-access repository. Where de-identification is not feasible without loss of scientific value, data must be made available on reasonable request via the corresponding author (Template 5.3) or through a controlled-access mechanism (Template 5.4). Authors must confirm in the DAS that data sharing is consistent with the informed consent obtained from participants (Section 4.7).
8.3 Genetic and genomic data. The deposit of raw genetic and genomic data in open-access repositories is not required by the Journal when such a deposit is not covered by participant consent, in recognition of the particular re-identification sensitivity of genetic data. Consistent with the Research Ethics Policy (Section 15.3), a summary data deposition, an aggregate data statement, or a controlled-access arrangement in an appropriate repository, such as EGA or dbGaP (Section 7.4), may satisfy the data availability requirements of this Policy in such cases. Authors must confirm in the DAS: (a) whether raw genomic data have been deposited in a controlled-access repository and, if so, the repository name and accession number; or (b) why deposit was not feasible and what alternative access arrangement is in place. The consent conditions and any ethics committee authorization for the deposit of genomic data must be declared as required by the Research Ethics Policy (Section 15).
8.4 Assisted reproduction and fertility data. Data derived from assisted reproduction procedures, fertility treatments, and reproductive medicine practice are treated as health data and reproductive data subject to heightened protection under GDPR. Such data may not be deposited in open-access repositories in individually identifiable form. De-identified aggregate data are not subject to this restriction.
8.5 Data concerning minors and neonates. Data derived from research involving minors (persons under 18 years of age) or neonates are subject to the protections applicable to vulnerable populations under Research Ethics Policy (Sections 9, 10, and 11). Such data may not be deposited in a form that enables identification of individual participants. Controlled-access arrangements are strongly recommended where individual-level data are scientifically necessary.
8.6 Dual-use data. Where data could be misused to cause harm - for example, data on pharmaceutical manipulation of reproductive function, reproductive toxicology, or genetic modification technologies - the Editor-in-Chief, in consultation with Edikta S.r.l., may impose additional restrictions on data availability, including requiring deposit only in a controlled-access repository or restricting access pending review. Dual-use concerns are evaluated on a case-by-case basis consistent with Research Ethics Policy (Section 18.3).
8.7 Re-identification risk. Authors depositing ostensibly anonymized datasets must confirm in the DAS that they have assessed and minimized the risk of re-identification, in accordance with the Research Ethics Policy (Section 8.4) and the GDPR data minimization principle. The editorial leadership may request a description of the de-identification methodology applied.
- EMBARGO: CONDITIONS, MAXIMUM DURATION, AND REQUEST PROCEDURE
9.1 General position. Consistent with the Journal's zero-embargo model for articles and with the recommendations of major public funders, data embargo is exceptional. It is permitted only in the circumstances defined in this Section. Authors seeking a data embargo must submit a formal request to the Editorial Office as part of the manuscript submission and must provide a written justification for the embargo.
9.2 Permitted grounds for embargo. A data embargo may be granted by the Editor-in-Chief only in the following circumstances:
- Pending patent application: where the data contain information that is the subject of a patent application that has been filed but not yet granted, and where premature disclosure would prejudice the patent rights of the authors or their institution;
- Third-party data agreements: where a binding agreement with a data owner, funding body, or regulatory authority requires a defined period of data exclusivity after publication;
- Graduated data release: where a large-scale dataset is being released in stages according to a pre-defined data release plan registered in a public repository or trial registry;
- Technical preparation: where the dataset requires a short period of final preparation, curation, or de-identification before public deposit, and the deposit will be completed within 90 days of publication.
9.3 Prohibited grounds. The following do not constitute grounds for a data embargo: the general expectation of future publications based on the same dataset; competitive concerns not associated with a filed patent application; or the authors' preference to retain exclusive access.
9.4 Maximum duration. Data embargoes are granted for a maximum period of 12 months from the date of online publication. An embargo of more than 6 months requires an exceptional justification and is subject to review by the Editor-in-Chief. Embargoes may not be renewed beyond the initial approved period without a new request and exceptional justification.
9.5 Embargo request procedure. Authors requesting a data embargo must: (a) indicate the request in the cover letter at the time of submission; (b) specify the grounds for the embargo from the list in Section 9.2; (c) identify the specific datasets or data elements subject to the embargo; and (d) indicate the planned date of public data release. The Editor-in-Chief reviews the request and communicates the decision to the authors before acceptance. Approval of a data embargo does not affect the editorial assessment of the manuscript.
9.6 Disclosure during embargo. Where an embargo has been approved, the DAS must use Template 5.5 and must specify the date or event upon which the data will become publicly available. The Editor-in-Chief may share embargoed data with peer reviewers in confidence for the review process, subject to the reviewer confidentiality obligations of the Peer Review Policy.
9.7 Embargo and funder requirements. Authors must verify that any approved embargo is consistent with their funder's data-sharing requirements. In particular, NIH-funded research is subject to the 2023 NIH Data Management and Sharing Policy, which requires that data-sharing expectations be maximized; similarly, Horizon Europe Article 17 MGA and Wellcome Trust policies impose immediate or prompt data-sharing requirements. Any embargo that conflicts with funder requirements must be resolved by the author with their funder; the Publisher cannot waive funder data sharing requirements.
- CLINICAL TRIAL DATA: ICMJE ALIGNMENT
10.1 ICMJE requirement. Consistent with the ICMJE policy effective from 1 July 2018, all manuscripts reporting the results of clinical trials submitted to the Journal must include a Data Availability Statement. Clinical trials that began enrolling participants on or after 1 January 2019 must have included a data sharing plan in the trial's registration record at the time of registration. The DAS published with the article must be consistent with the registered data sharing plan.
10.2 Content of the DAS for clinical trials. The DAS for clinical trial reports must specify: (a) whether individual participant data (IPD) will be shared; (b) which IPD will be shared; (c) what additional related documents will be available (study protocol, statistical analysis plan, analytical code); (d) when the data will be available and for how long; (e) by what access criteria data will be shared; and (f) what mechanisms will be used (e.g., repository name with DOI, access request procedure, name and contact of data access committee). In accordance with ICMJE requirements, an “undecided” response regarding IPD sharing is not acceptable. Authors must explicitly state whether IPD will be shared and provide the required details accordingly.
10.3 Discrepancy with the registered plan. Where the DAS published with the article differs from the data-sharing plan registered in the trial registry, the authors must explain the discrepancy in the cover letter and, where applicable, update the trial registry record before submission. Unexplained discrepancies may be treated as inconsistencies requiring investigation.
10.4 IPD sharing and participant consent. The sharing of individual participant data from clinical trials must be consistent with the informed consent participants provided. Where participant consent does not cover open IPD sharing, data must be made available only through a controlled-access mechanism or on reasonable request, consistent with Sections 8 and 5. Authors must confirm in the DAS that IPD sharing is consistent with participant consent and with applicable ethics committee approval.
10.5 Clinical study reports and protocols. Authors are encouraged to make available the full clinical study report, the study protocol, the statistical analysis plan, and the case report forms alongside the data. These documents are not a substitute for the dataset but complement its reusability for systematic reviewers and regulators.
- CODE AND SOFTWARE AVAILABILITY
11.1 General requirement. When computer code, scripts, algorithms, statistical analysis pipelines, or bioinformatics workflows were used to generate the results reported in an article, and the results depend on the correct execution of such code, authors are strongly encouraged to make the code available alongside the data. For articles where the code is central to the reported findings - including computational studies, machine learning analyses, and AI-based diagnostic tools evaluated in a clinical or gynecological context - code availability is required.
11.2 Code availability statement. Authors providing code must include a Code Availability Statement immediately following the Data Availability Statement, specifying: (a) the repository or platform where the code is available (e.g., GitHub with a permanently archived version on Zenodo, GitLab, or an institutional repository); (b) the DOI or permanent identifier of the archived version; (c) the programming language and version; and (d) the license under which the code is released.
11.3 Licensing of code. Creative Commons licenses, including CC BY 4.0, are not designed for executable software and do not apply to code in the ordinary sense. Authors releasing code are strongly encouraged to select a recognized open-source software license such as MIT, BSD 2-Clause, Apache 2.0, or GPL v3, consistent with Copyright and Licensing Policy (Section 6.5). The selected license must be clearly identified in the repository and in the Code Availability Statement. Where the authors specify no license, the Journal will note this limitation in the article metadata.
11.4 AI-generated code. Where AI-assisted tools were used to generate or substantially modify code used in the analysis, this must be disclosed in the Methods section in accordance with the Artificial Intelligence Policy. AI-generated code must be reviewed, tested, and validated by a human author before use and made available as supplementary material or in a designated open repository, consistent with the Artificial Intelligence Policy (Section 8) and this Policy.
11.5 Relationship to data. Code and data availability are complementary requirements. The availability of code without data, or of data without the code used to analyze it, limits the reusability and reproducibility of the reported findings. Authors are encouraged to deposit code and data together in the same repository, or to provide cross-links between separate deposits.
- PROTOCOL AND MATERIALS SHARING
12.1 Protocol sharing. Authors who have pre-registered a study protocol in a public registry (ClinicalTrials.gov, ISRCTN, WHO ICTRP, OSF, or an equivalent registry) are encouraged to make the full protocol available to reviewers and, upon publication, to readers. The registry number must be included in the abstract and in the Methods section, consistent with Research Ethics Policy (Section 14). Where a protocol was pre-registered, the DAS should indicate whether the data-sharing plan in the registry was adhered to or whether any deviations occurred (Section 10.3).
12.2 Unpublished protocols. Where a detailed study protocol exists but has not been formally registered, authors are encouraged to deposit it as supplementary material or in a repository such as OSF, and to provide a link in the Methods section. This is of particular value for methodologically innovative studies and for systematic reviews and meta-analyses.
12.3 Biological materials. Where unique biological materials - including cell lines, animal models, plasmids, reagents, or clinical specimens - were used in the research and are central to its replicability, authors are encouraged to declare their availability in the Materials and Methods section, specifying any restrictions on access and the conditions under which materials may be requested.
12.4 Reporting checklists. Completed EQUATOR Network reporting checklists (CONSORT, STROBE, PRISMA, CARE, STARD, ARRIVE, SAGER, and others as applicable) must be submitted as supplementary material at the time of manuscript submission. These are not research data for this Policy but are required by the Submission Guidelines. Provisions governing methodological reporting standards are established in the Statistical Reporting and Reproducibility Policy.
- DATASET CITATION
13.1 Datasets as citable objects. Research datasets deposited in recognized repositories and assigned a persistent identifier are citable scholarly outputs. The Journal treats datasets as primary research outputs, equivalent in status to published articles for citation purposes.
13.2 How to cite datasets. Datasets referenced in an article - whether generated by the authors or used from existing sources - must be cited in the References section of the article using the DataCite recommended citation format or an equivalent discipline-standard format, including: dataset author(s); dataset title; year of deposit; repository name; version (where applicable); persistent identifier (DOI). Example: Smith J, Jones A (2024). Gynecological outcome dataset from randomized trial of [intervention]. Dryad. https://doi.org/[DOI].
13.3 DAS and reference list alignment. The DOI of the deposited dataset cited in the DAS must match the DOI included in the References. Authors must ensure consistency between the DAS, the Data Availability Statement wording template, the Funding Statement, and the reference list.
13.4 CrossRef and DataCite. When DataCite assigns DOIs to datasets, and the article is registered with CrossRef, the Journal will include dataset citation metadata in the CrossRef deposit to create a bidirectional link between the article and the dataset. This link supports discoverability and enables citation counting of datasets by data metrics systems.
- LICENSING OF RESEARCH DATA
14.1 Recommended licenses. Consistent with Open Access Policy (Section 7) and the FAIR Data Principles, the Journal recommends that authors license research datasets deposited in repositories under: (a) CC0 1.0 Universal (Public Domain Dedication) - the preferred option for datasets, as it imposes no legal or attribution restrictions on reuse and maximizes interoperability; or (b) Creative Commons Attribution 4.0 International (CC BY 4.0) - where attribution is required or preferred by the authors or by repository policy. The Data Availability Statement must specify the license under which the dataset is made available.
14.2 Repository default licenses. Where a repository assigns a default license to deposited data, the DAS must specify the license applied by the repository. Authors should confirm that the repository's default license is acceptable before deposit. Where CC0 or CC BY 4.0 is not the default license of the selected repository, authors are encouraged to explicitly select one of these licenses if the repository permits it.
14.3 Restricted and non-open licenses. Where data are deposited in a controlled-access repository and are not publicly available, the license applicable to data access is that of the data access committee or institutional authority governing the repository. In such cases, the DAS must specify the controlled-access conditions rather than an open license (Template 5.4).
14.4 Software licenses. The licensing of code and software is governed by Section 11.3 and the Copyright and Licensing Policy (Section 6.5). Creative Commons licenses do not apply to executable software.
14.5 Third-party data. Where an article reanalyses third-party data, the license applicable to the reanalyzed dataset is the license under which those data were originally published. Authors must confirm that their reanalysis and any derived data outputs are consistent with the original dataset's license.
- COMPLIANCE WITH FUNDER DATA MANAGEMENT REQUIREMENTS
15.1 NIH Data Management and Sharing Policy (2023). The NIH Policy for Data Management and Sharing, effective 25 January 2023, requires all NIH grant applicants to submit a Data Management and Sharing Plan (DMSP) with their application. The DMSP must address: (a) data types generated; (b) standards and formats; (c) data preservation and access; (d) access, distribution, and reuse considerations; (e) privacy and intellectual property; and (f) oversight. The Journal's requirements are aligned with the NIH DMS Policy. NIH-funded authors must ensure that the DAS published with the article is consistent with the approved DMSP for their grant. From 25 May 2026, NIH will require use of a new, simplified DMSP format (Notice NOT-OD-26-046).
15.2 Horizon Europe - Article 17 MGA. Research funded by Horizon Europe or the European Research Council (ERC) is subject to the open data requirements of Article 17 of the Model Grant Agreement (MGA), which requires open access to underlying research data "as open as possible, as closed as necessary". Authors funded by Horizon Europe are encouraged to develop a Data Management Plan (DMP) for their project and to make data available in a repository consistent with the DMP. The Journal's diamond OA model and FAIR data provisions are aligned with Horizon Europe open data requirements.
15.3 Wellcome Trust. The Wellcome Trust requires a Data Access Statement for all funded publications. Wellcome requires that data underlying original research publications be made available to other researchers at the time of publication, as well as any original software required to view datasets or to replicate analyses. Where research data relates to public health emergencies, researchers must share quality-assured interim and final data as rapidly and widely as possible, and in advance of publication. Summary trial results must be posted in the applicable trial registry within 12 months of primary study completion. The Journal's DAS requirement is designed to support compliance with the Wellcome data access statement requirement.
15.4 UKRI. UKRI requires a Data Access Statement for all in-scope publications that specifies how the underlying data may be accessed. The Journal's DAS requirement is designed to support compliance with the UKRI Data Access Statement requirement. Authors funded by UKRI are encouraged to deposit data in a repository that is consistent with UKRI research data management expectations.
15.5 Gates Foundation. The Bill and Melinda Gates Foundation Open Access Policy requires a Data Availability Statement for all funded publications. The Journal's DAS requirement is designed to support compliance with the Gates Foundation requirement. Data sharing is expected to the maximum extent possible consistent with ethical and legal constraints. For Gates Foundation-funded work, authors should not rely solely on an informal “available from the corresponding author upon reasonable request” statement where repository or managed-access deposition is feasible. Where legal, ethical, or privacy constraints prevent open deposit, the DAS must specify the managed access route, access criteria, responsible body or institution, and conditions for reuse.
15.6 Other funders. Authors funded by organizations not listed above - including the Australian Research Council, Canadian Institutes of Health Research, Agence Nationale de la Recherche, Deutsche Forschungsgemeinschaft, Swiss National Science Foundation, and Italian MUR/PNRR - are encouraged to confirm that their DAS is consistent with their funder's data management requirements. The Publisher will provide reasonable assistance to authors in navigating funder-specific requirements upon request.
- POST-PUBLICATION DATA ACCESS AND DATASET UPDATES
16.1 Duration of data availability. Authors who have committed to making data available - whether in a public repository, through a controlled-access arrangement, or on reasonable request - are expected to honor this commitment for a period of not less than 10 years from the date of publication, or for the minimum period required by their institution or funder, whichever is longer. This commitment is consistent with the retention obligations applicable to primary research documentation under standard research governance frameworks.
16.2 Responding to data access requests. Where data are made available on reasonable request via the corresponding author (Template 5.3), the corresponding author is expected to acknowledge requests within 30 working days of receipt and to provide a decision within 60 working days, unless legal, ethical, contractual, or technical constraints require additional time and are documented. Legitimate grounds for declining a request include: inconsistency with participant informed consent; identified privacy or re-identification risk; absence of ethics committee approval for the requested secondary use; conflict with a data transfer agreement or binding institutional obligation; or a request that lacks a scientifically valid purpose. Where access is granted, a data use agreement may be required by the data controller or the institution. Unreasonable refusal to provide access to data declared available on request may be treated as a breach of the DAS commitment and investigated under the Complaints, Appeals and Whistleblowing Policy.
16.3 Dataset version updates. Where a dataset is updated after publication - for example, to correct errors, to add data from a follow-up period, or to release data that were previously under embargo - the authors must: (a) deposit the updated version in the same repository, under a new version identifier; (b) notify the Editorial Office; and (c) request a post-publication update of the DAS to reflect the new version. Dataset corrections that affect the interpretation of the published article may trigger a Corrigendum under the Corrections and Retractions Policy.
16.4 Repository unavailability. Where a repository in which data were deposited becomes unavailable or ceases operation, the corresponding author must notify the Editorial Office. The Publisher will make reasonable efforts to update the DAS to reflect the data’s new location. Authors are encouraged to deposit data in multiple repositories for redundancy and to use repositories committed to long-term preservation.
16.5 Data related to retracted articles. Where an article is retracted, the dataset associated with it is not automatically retracted. The Journal will update the article record to indicate the retraction and will note any implications for the integrity of the associated dataset. Where the retraction arises from data fabrication or falsification that affects the dataset, the Publisher will notify the relevant repository and request an appropriate annotation of the dataset record, consistent with the Corrections and Retractions Policy.
- PEER REVIEW AND EDITORIAL ASSESSMENT OF DATA AVAILABILITY
17.1 Assessment of the DAS during peer review. The Data Availability Statement is assessed as part of the peer review process. Reviewers are asked to evaluate: (a) whether the DAS is present and complete; (b) whether the stated data availability is consistent with the Methods section and the study design; (c) whether the data provided or described are sufficient to support the conclusions of the article; and (d) whether the stated reasons for any restriction are plausible and appropriate. Consistent with the Peer Review Policy (Section 9), the completeness and accuracy of the DAS are criteria for the review report.
17.2 Data review during peer review. Where data are available in a repository at the time of submission, reviewers are encouraged to access and review the deposited dataset as part of their assessment of the manuscript. Reviewers who identify discrepancies between the manuscript and the deposited data must report these in their review report. Embargoed data may, with the author's consent, be made available to reviewers in confidence for the review.
17.3 Editorial pre-screening. Before a manuscript enters peer review, the editorial office conducts a pre-screening check that includes verification of the DAS's presence and formal completeness, using the templates in Section 5. Manuscripts that do not include a DAS, or that include a DAS in a non-standard format that cannot be assessed, are returned to authors for correction before entering peer review. This does not constitute editorial assessment of the scientific content of the DAS.
17.4 Post-publication data audit. The Journal may, at its discretion, request that authors provide a copy of the underlying dataset post-publication, particularly where concerns about data integrity, data fabrication, or inconsistencies between the DAS and the manuscript arise. Authors must comply with such requests within a reasonable timeframe. Non-compliance may be treated as a breach of the terms of publication and investigated under the Complaints, Appeals and Whistleblowing Policy.
- NON-COMPLIANCE AND CONSEQUENCES
18.1 Failure to provide a DAS. Manuscripts submitted without a DAS are returned to authors for correction before peer review. Failure to provide a DAS upon request from the editorial office may result in rejection of the manuscript without further assessment.
18.2 False or misleading DAS. A DAS that falsely states that data are available when they are not, that provides an inaccessible or invalid repository link, or that omits material restrictions on data access, is treated as a breach of the publication terms and may constitute research misconduct. Such cases are managed under the Corrections and Retractions Policy and, where appropriate, under the Complaints, Appeals and Whistleblowing Policy.
18.3 Non-provision of data on request. Where data declared available on reasonable request (Template 5.3) are not provided within a reasonable time without legitimate justification, the Editor-in-Chief may: (a) contact the corresponding author for an explanation; (b) issue an Expression of Concern; or (c) initiate a formal investigation under the Complaints, Appeals and Whistleblowing Policy.
18.4 Data integrity concerns. Where the editorial leadership or a third party identifies a substantive discrepancy between the dataset and the published article, or where there are credible allegations of data fabrication or falsification affecting the dataset, the Corrections and Retractions Policy and Complaints, Appeals and Whistleblowing Policy apply. Investigation may result in Correction, Retraction, or Expression of Concern, as appropriate.
18.5 Dataset retraction. Where a dataset deposited in a repository is found to be substantially unreliable - due to fabrication, falsification, serious error, or violation of participant consent - the Publisher will notify the relevant repository and request that the dataset be annotated or retracted, consistent with established practices for dataset retraction.
- GDPR PROVISIONS FOR RESEARCH DATA SHARING
19.1 Legal basis. The sharing of research data through repository deposit or on-request mechanisms must comply with EU Regulation 2016/679 (GDPR) and applicable national data protection law. Where research data constitutes personal data under the GDPR - including pseudonymized data, which remains personal data - the sharing of such data requires a valid legal basis under Article 6 GDPR or, for special categories of data (health data, genetic data, biometric data, data concerning a person's sex life or sexual orientation), under Article 9 GDPR. Reproductive and fertility-related data may constitute health data and/or data concerning a person's sex life under Article 9 GDPR, depending on their content and context; they are not a separately named category under the Regulation but are subject to the same heightened protection as the explicitly listed special categories. Where the scientific research derogation under Article 89(1) GDPR is relied upon as the legal basis for data processing or sharing, authors must confirm that appropriate safeguards - including data minimization, pseudonymization where feasible, and technical and organizational measures proportionate to the re-identification risk - have been implemented. Authors must confirm that a valid legal basis exists for any data sharing contemplated in the DAS. Detailed provisions on the legal bases applicable in the research context are contained in Research Ethics Policy (Section 19). The EDPB Guidelines 1/2026 on the processing of personal data for scientific research purposes (adopted on 15 April 2026 and currently under public consultation) provide further regulatory guidance on the application of Article 89 GDPR in the research context and will be incorporated into future revisions of this Policy upon finalization. The processing of personal data of authors, reviewers, and website users by Edikta S.r.l., in its capacity as data controller, is governed by the Privacy and Data Protection Policy, a separate document within the EGO Editorial Policy Framework, to which this Section does not apply.
19.2 Anonymization as prerequisite for open deposit. Only truly anonymized data - data from which re-identification is irreversible and not reasonably possible - may be deposited in open-access repositories. Pseudonymized data remain personal data under the GDPR and may only be shared through a controlled-access mechanism with appropriate access controls and data processing agreements. The distinction between anonymized and pseudonymized data is defined in the Research Ethics Policy (Section 2).
19.3 Data minimization. Where a dataset contains elements that are not directly necessary to support the article's findings, authors must apply data minimization before deposit, removing any data elements whose inclusion would increase re-identification risk without a corresponding scientific benefit. The DAS may note the application of data minimization without identifying the specific elements removed.
19.4 Third-country data transfers. Where data sharing involves the transfer of personal data from the European Economic Area to a third country - for example, deposit in a repository operated outside the EEA - authors must confirm that the transfer was conducted in compliance with the applicable GDPR transfer mechanism (adequacy decision, standard contractual clauses, or binding corporate rules) or an applicable derogation under Article 49 GDPR. Repository-level data processing agreements may serve as the applicable transfer mechanism where the repository operator has implemented the required GDPR safeguards.
19.5 GDPR and funder requirements. Authors must ensure that the data-sharing arrangements described in the DAS are consistent with both the GDPR and their funder's data-sharing requirements. Where funder requirements mandate data sharing that is not feasible under GDPR constraints applicable to the specific dataset, the restriction must be documented and justified in the DAS.
- ANNUAL REVIEW AND COMPLIANCE REPORTING
20.1 Annual review. This Policy is reviewed annually by the Editor-in-Chief and Edikta S.r.l. The review considers: (a) updates to the FAIR Data Principles, ICMJE data sharing requirements, NIH DMS Policy, Horizon Europe MGA, and other relevant standards; (b) developments in repository infrastructure and best practice; (c) the Journal's experience in applying this Policy, including recurring patterns of non-compliance, requests for embargo, or difficulties encountered by authors; and (d) any updates to the GDPR regulatory framework or national data protection law.
20.2 Compliance reporting. The Journal's annual editorial transparency report (consistent with Editorial Policy Statement (Section 25) and DOAJ transparency criteria) includes summary information on DAS compliance, including: (a) the proportion of articles with an open-access DAS, a controlled-access DAS, a request-based DAS, and a not-applicable DAS; (b) the number of embargo requests received and approved; (c) any post-publication investigations related to data availability. This report is published on the Journal's website.
- CROSS-REFERENCES WITHIN THE EGO EDITORIAL POLICY FRAMEWORK
This Policy is part of the EGO Editorial Policy Framework and must be read in conjunction with the following documents:
- Editorial Policy Statement, Section 7: establishes the foundational data governance commitment of the Journal, including the requirement for a Data Availability Statement for all original articles and the adoption of the FAIR Data Principles. In the event of inconsistency between the Editorial Policy Statement (Section 7) and this Policy, this Policy governs.
- Research Ethics Policy (Sections 2, 8, 15, and 19): provides the definitions of anonymized data, pseudonymized data, secondary use of data, and biobank incorporated by reference in Section 2 of this Policy; governs ethics committee requirements for secondary data use and genetic data deposit (Research Ethics Policy Sections 8 and 15); and establishes the GDPR framework applicable to research data (Research Ethics Policy Section 19). Research Ethics Policy Section 15.3 specifically authorizes controlled-access or aggregate data arrangements to satisfy the requirements of this Policy for genetic and genomic data where open deposit was not covered by participant consent.
- Open Access Policy (Section 7): establishes the licensing framework for datasets deposited in external repositories (CC0 or CC BY 4.0 recommended); requires the DAS to specify the licenze of the dataset; and identifies the repositories recognised by the Journal for article deposit (Zenodo, OpenAIRE, institutional repositories, PMC), which overlap with those recommended for data deposit in Section 7 of this Policy.
- Copyright and Licensing Policy (Section 6.5): governs the licensing of software code and scripts, providing that CC BY 4.0 applies only to textual components of code and that recognized open-source licenses (MIT, BSD, Apache, GPL) should be applied to executable software. Section 11.3 of this Policy implements this cross-reference for code availability.
- Artificial Intelligence Policy (Section 8): requires that AI-generated code used in analysis be made available as supplementary material or in an open repository, in accordance with this Policy. Section 11.4 of this Policy implements this cross-reference.
- Peer Review Policy (Section 9): lists the declaration of data availability among the criteria systematically evaluated by reviewers in the peer review report. Section 17 of this Policy operationalizes this requirement.
- Complaints, Appeals and Whistleblowing Policy: governs formal investigation of breaches of this Policy, including false or misleading DAS, refusal to provide data on request, and post-publication data integrity concerns.
- Corrections and Retractions Policy: applies to post-publication corrections related to dataset errors, dataset retraction, and expressions of concern arising from data availability investigations.
- Statistical Reporting and Reproducibility Policy: complements this Policy with provisions on statistical reporting transparency, analytical code requirements, and computational reproducibility.
- Conflict of Interest Policy (Section 5): governs conflicts of interest arising from sponsor access to study data, including provisions on the independence of academic authors in data access and analysis, which complement the data availability requirements of this Policy.
- NORMATIVE REFERENCES
- Wilkinson M.D. et al. (2016). The FAIR Guiding Principles for scientific data management and stewardship. Scientific Data, 3, 160018. https://doi.org/10.1038/sdata.2016.18
- ICMJE. Data Sharing. International Committee of Medical Journal Editors. Available at: www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html (data sharing requirements effective 1 July 2018).
- National Institutes of Health. Final NIH Policy for Data Management and Sharing. Notice Number NOT-OD-21-013, effective 25 January 2023. Updated DMS Plan format: Notice NOT-OD-26-046, effective 25 May 2026.
- National Institutes of Health. 2024 NIH Public Access Policy. Notice Number NOT-OD-25-047, effective 1 July 2025.
- European Commission. Horizon Europe Model Grant Agreement, Article 17 (Open Science: open access and open data). Version applicable from 2021.
- Wellcome Trust. Open Access Policy (updated January 2025). Available at: wellcome.org/grant-funding/guidance/open-access-guidance.
- UK Research and Innovation (UKRI). Open Access Policy. Available at: ukri.org/funding/information-for-award-holders/open-access.
- Bill and Melinda Gates Foundation. Open Access Policy (updated 2021). Available at: gatesfoundation.org/about/policies-and-resources/open-access-policy.
- DOAJ - Directory of Open Access Journals. Principles of Transparency and Best Practice in Scholarly Publishing, Version 4 (September 2022). COPE/DOAJ/OASPA/WAME. Available at: doaj.org/apply/transparency/. Guide to Applying, Version 2.6 (November 2025). Available at: doaj.org/apply/guide/.
- DataCite Metadata Working Group. DataCite Metadata Schema Documentation for the Publication and Citation of Research Data and Other Research Outputs, Version 4.7 (2026). DataCite e.V. https://doi.org/10.14454/qdd3-ps68
- European Parliament and Council. Regulation (EU) 2016/679 (General Data Protection Regulation - GDPR), OJ L 119/1, 27 April 2016.
- European Data Protection Board (EDPB). Guidelines 1/2026 on the processing of personal data for scientific research purposes (adopted 15 April 2026; under public consultation until 25 June 2026). Available at: edpb.europa.eu. Note: these are draft guidelines pending finalization; the Policy will be updated upon adoption of the final version.
- WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, 2024 Revision (WMA, 75th General Assembly, Helsinki, October 2024).
- WMA Declaration of Taipei on Ethical Considerations Regarding Health Databases and Biobanks (2016).
- re3data.org - Registry of Research Data Repositories. Available at: re3data.org.
- FAIRsharing.org - A curated, informative and educational resource on data and metadata standards, inter-related to databases and data policies. Available at: fairsharing.org.
- COPE - Committee on Publication Ethics. Core Practices (2022). Available at: publicationethics.org.
- EQUATOR Network. Reporting guidelines for health research. Available at: equator-network.org.