Data Sharing and Reproducibility Policy

Georgian Medical Journal · Publication Policy

Public Health Institute of Georgia (PHIG) · ICMJE · COPE Core Practices · FAIR Principles · CC BY 4.0 · editor@gmj.ge

The Georgian Medical Journal (GMJ) is committed to transparency, reproducibility, and the responsible sharing of research data. GMJ strongly encourages authors to make the data underlying their findings available to other researchers, subject to ethical, legal, and privacy constraints. This policy aligns with the ICMJE Recommendations, COPE Core Practices, FAIR Data Principles (Findable, Accessible, Interoperable, Reusable), and the Principles of Transparency and Best Practice in Scholarly Publishing endorsed by COPE, DOAJ, WAME, and OASPA.

1. Scope

This policy applies to all original research articles, systematic reviews, meta-analyses, and other manuscript types that report empirical findings submitted to GMJ. "Data" refers to the minimal dataset that would be necessary to interpret, replicate, and build upon the findings reported in the article, including raw data, processed data, statistical analysis code, study protocols, and other materials essential for reproducibility.

2. Data Availability Statement — Mandatory

All manuscripts reporting original research must include a "Data Availability" (or "Availability of Data and Materials") statement in the Declarations section of the article. This requirement is mandatory and applies regardless of whether the data can be shared openly.

The data availability statement must clearly describe:

— Where the data supporting the findings can be found or accessed
— Whether the data are publicly available or available on reasonable request
— Any restrictions on data access and the reasons for those restrictions
— Persistent identifiers (DOIs) or URLs for datasets deposited in repositories
— The name and version of any software, code, or analysis tools used

Manuscripts submitted without a data availability statement will be returned to the authors for completion before peer review can proceed.

Example Data Availability Statements

Data in a public repository: "The datasets generated and/or analysed during the current study are available in the [repository name] repository, [persistent URL or DOI]."

Data available on reasonable request: "The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request."

Data included in the article: "All data generated or analysed during this study are included in this published article [and its supplementary information files]."

Data sharing not applicable: "Data sharing is not applicable to this article as no datasets were generated or analysed during the current study."

Restricted data with justification: "The data that support the findings of this study are not publicly available due to [privacy/ethical/legal reason] but are available from the corresponding author on reasonable request and with permission of [institution/ethics committee]."

3. Encouraged Data Sharing Practices

While GMJ does not currently mandate open data deposition for all study types, the journal strongly encourages authors to make their data as open as possible and as closed as necessary. Specifically, GMJ encourages authors to:

— Deposit datasets in established, discipline-appropriate, publicly accessible repositories with persistent identifiers (DOIs)
— Share analysis code, statistical scripts, and software in public repositories (e.g., GitHub, Zenodo, Figshare)
— Use open, non-proprietary file formats where possible
— Follow the FAIR Data Principles — making data Findable, Accessible, Interoperable, and Reusable
— Cite datasets in the reference list using persistent identifiers, in addition to linking them in the data availability statement
— Provide study protocols, statistical analysis plans, and data dictionaries as supplementary materials

Making datasets publicly available before associated manuscripts are submitted will not preclude consideration by GMJ.

4. Clinical Trial Data Sharing

In accordance with the ICMJE data sharing policy, GMJ requires that all manuscripts reporting the results of clinical trials include a data sharing statement. The statement must indicate:

— Whether individual participant data (IPD) will be shared (de-identified)
— What specific data will be shared (e.g., individual participant data underlying published results, study protocol, statistical analysis plan, analytic code)
— When the data will become available (start and end dates, or "immediately following publication" / "no end date")
— With whom the data will be shared (e.g., anyone who wishes to access the data, researchers who provide a methodologically sound proposal, etc.)
— For what types of analyses the data will be available
— By what mechanism the data will be available (e.g., a publicly accessible repository, a data-sharing platform, upon request to the corresponding author)

GMJ encourages, but does not currently require, that clinical trial data be deposited in a controlled-access or open-access repository. Authors who are unable to share IPD should explain the reasons in the data sharing statement.

5. Recommended Repositories

GMJ recommends that authors deposit data in established, community-recognised repositories that assign persistent identifiers (DOIs). Appropriate repositories include, but are not limited to:

— General-purpose repositories: Zenodo (CERN/OpenAIRE), Figshare, Dryad, Harvard Dataverse, Open Science Framework (OSF)
— Discipline-specific repositories: GenBank and NCBI databases (for genomic/sequence data), Protein Data Bank (PDB), ClinicalTrials.gov (for clinical trial results), PANGAEA (environmental data), OpenNeuro (neuroimaging data)
— Institutional repositories: Authors may use their own institution's data repository if it meets the criteria of persistent identification, open metadata, and long-term preservation

A comprehensive registry of research data repositories is available at re3data.org. Where a widely established community expectation for data archiving in public repositories exists (e.g., nucleotide sequences in GenBank/ENA/DDBJ, protein structures in PDB), deposition in the relevant public repository is required.

6. Legitimate Restrictions on Data Sharing

GMJ recognises that there are legitimate reasons why data cannot always be shared openly. Acceptable reasons include:

— Participant privacy and confidentiality: Data that could enable re-identification of individuals, especially when de-identification is not feasible or when ethics committee conditions prohibit sharing
— Ethics committee or IRB restrictions: Where the informed consent obtained from participants did not include consent for data sharing, or where the ethics committee has explicitly restricted data access
— Legal or regulatory constraints: Data subject to national data-protection legislation (e.g., GDPR), third-party data-use agreements, or governmental restrictions on health data
— Indigenous and community data sovereignty: Where data governance is subject to the rights and interests of indigenous peoples or specific communities
— Proprietary or third-party data: Where the data are owned by a third party and the authors do not have the legal right to share them
— National security or public safety: Data that could pose risks if publicly available

When data cannot be shared, authors must clearly state the specific restrictions and the reasons in the data availability statement. Authors are encouraged to explore options for controlled-access sharing (e.g., sharing de-identified data upon reasonable request, or depositing in a controlled-access repository) even when fully open sharing is not possible. Inability to share data does not, in itself, preclude publication.

7. Code and Software Sharing

Authors are strongly encouraged to share custom analysis code, statistical scripts, and software that are central to the findings of the study. Code should be deposited in a publicly accessible repository (e.g., GitHub, GitLab, Bitbucket) with a persistent, archived version (e.g., via Zenodo-GitHub integration). The names and version numbers of all commercial and open-source software used must be reported in the Methods section of the manuscript.

8. Data Citation

GMJ endorses the Joint Declaration of Data Citation Principles and considers datasets as legitimate, citable scholarly objects. When datasets have been deposited in a repository and assigned a persistent identifier (DOI), they should be cited in the reference list of the manuscript using the following format:

Author(s). Title of dataset. Repository name. Year. DOI or persistent URL.

Example: Smith J, Doe A. Patient outcomes dataset for hypertension trial. Zenodo. 2026. https://doi.org/10.5281/zenodo.XXXXXXX

9. Post-Publication Compliance

After publication, authors must comply with the data availability statement included in the published article. If an author has stated that data are "available on reasonable request," the author is expected to respond to such requests in a timely manner, typically within 30 days. GMJ editors may follow up on data availability claims post-publication. Failure to comply with a published data availability statement without justifiable cause may result in a correction notice or, in serious cases, an expression of concern.

10. Peer Review of Data

Reviewers are encouraged to assess the adequacy and transparency of the data availability statement during peer review. Reviewers may request access to underlying data as part of their evaluation when this is necessary to verify the results. Any data accessed during peer review must be treated as confidential and must not be used for any other purpose.

11. Community-Mandated Data Types

Where a widely established community expectation for data archiving in public repositories exists, deposition is required as a condition of publication. These include:

— Nucleotide sequences → GenBank/ENA/DDBJ (accession numbers must be provided)
— Protein sequences → UniProt
— Macromolecular structures → Protein Data Bank (PDB)
— Gene expression data → Gene Expression Omnibus (GEO) or ArrayExpress
— Functional magnetic resonance imaging data → OpenNeuro or NeuroVault
— Clinical trial results → ClinicalTrials.gov or equivalent registry results database

Accession numbers or persistent identifiers for deposited data must be included in the manuscript at the time of final revision.

12. Supplementary Materials and Data Files

Authors may include datasets, analysis code, expanded tables, and additional figures as supplementary materials (additional files) accompanying the manuscript. Supplementary files are published alongside the article under the same CC BY 4.0 licence and are permanently archived. However, for large datasets or datasets requiring controlled access, deposition in an external repository with a persistent identifier is preferred.

13. Funder Compliance

An increasing number of research funders — including the NIH, Wellcome Trust, European Commission (Horizon Europe), and others — require that data generated through funded research be made publicly available. GMJ supports compliance with funder data sharing mandates and encourages authors to familiarise themselves with the data sharing requirements of their funders at the earliest stage of study design. Authors should describe how they have complied (or plan to comply) with relevant funder data sharing requirements in the data availability statement or funding section of the manuscript.

14. Reference Standards

— ICMJE Recommendations — Data Sharing Statements for Clinical Trials (icmje.org)
— FAIR Data Principles — Findable, Accessible, Interoperable, Reusable (go-fair.org)
— COPE / DOAJ / OASPA / WAME — Principles of Transparency and Best Practice in Scholarly Publishing (cope.org)
— Joint Declaration of Data Citation Principles (FORCE11)
— re3data.org — Registry of Research Data Repositories (re3data.org)
— NIH Data Management and Sharing Policy (2023)
— European Commission Horizon Europe — Open Research Data requirements

This policy will be reviewed periodically and updated as community norms, funder requirements, and best practices evolve. GMJ may strengthen data sharing requirements as the journal develops and as international standards advance.

Editorial Office — Georgian Medical Journal (GMJ) · Published by the Public Health Institute of Georgia (PHIG) · editor@gmj.ge · gmj.ge