Research Data Availability & Sharing Policy

1. Purpose & scope

APALM supports transparent, reproducible research. This policy sets minimum requirements for data, code, and associated materials underlying articles we publish, and applies to all research submissions (including clinical, laboratory, imaging, computational, and observational studies). It complements our Human/Animal Ethics and Privacy policies and the ICMJE Recommendations.

2. Author obligations

  • A Data Availability Statement (DAS) in the manuscript (see Section 7 templates).

  • Persistent access to the minimal dataset necessary to reproduce the results (plus code, analysis scripts, and protocols where applicable). Apply the FAIR principles when preparing and describing data.

  • For clinical trials, include an ICMJE-compliant data sharing statement specifying what, when, for how long, and access criteria/mechanism. (“Undecided” is not acceptable.)

3. Where to share

Deposit data in a stable, recognized repository that issues a persistent identifier (e.g., DOI, Handle). Authors should prefer discipline-specific repositories; if none is suitable, use a general repository (e.g., institutional repository, Zenodo, OSF, Dryad). 

4. Preparing data (privacy, ethics, and consent)

  • Human participant data must be lawfully obtained, ethically approved, and de-identified according to local regulation and ethics approvals. Data sharing must remain consistent with ICMR National Ethical Guidelines and the WMA Declaration of Helsinki (current 2024 version).

  • Identifying information (e.g., names, hospital numbers, full dates, facial images) must not be shared publicly unless essential and participants (or guardians) have provided specific written consent for publication; even then, de-identification should be maximized. Follow ICMJE’s privacy guidance and archive consent per local rules.

5. What to share

Unless restricted by justified exceptions (Section 6), make available:

  • Raw or processed data underlying figures, tables, and key analyses.

  • Metadata and documentation (data dictionary, readme, methods) to enable reuse.

  • Analysis code or scripts and software environment details (version numbers, packages).

  • Study materials (questionnaires, image masks, protocols) where copyright permits.
    Cite shared resources formally in the reference list per the Joint Data Citation Principles.

6. Exceptions & access controls

Open sharing may be limited when: (a) participant privacy/consent or legal restrictions prevent open release; (b) third-party rights or contractual obligations apply; or (c) data are security-sensitive. In such cases, authors must:

  • Provide a justification in the DAS,

  • Use controlled access (e.g., Data Use Agreements, vetted request process), and

  • Share synthetic, aggregated, or redacted data where feasible.
    Clinical-trial data statements must still meet ICMJE requirements (e.g., access criteria, timing). 

7. Data Availability Statement (paste-ready templates)

Authors must include one of the following (edit as appropriate):

  • Open repository (preferred):
    “All data supporting the findings of this study are available in [Repository] at [DOI/URL], including a data dictionary and analysis scripts.”

  • Controlled access (privacy/ethics):
    “De-identified participant data and the data dictionary will be available [start date/duration] from [contact or repository link] for researchers who meet the access criteria (IRB/IEC approval and a signed data use agreement).”

  • Data available on request (justified):
    “Due to [legal/ethical/consent] restrictions, de-identified data are available on reasonable request from [contact or data access committee] subject to [conditions].”

  • No data shared (explain):
    “Data cannot be shared because [reason: non-consented identifiers/third-party rights/national security]; summary statistics and analysis scripts are provided at [link].”

  • Clinical trials (ICMJE-specific):
    “IPD sharing: [Yes/No; if No, justify]. What data: [describe IPD and documents]. When/for how long: [dates]. Access criteria and mechanism: [who/how/oversight; repository or request route].”

8. Licensing your data

To maximize reuse and clarity, APALM encourages CC0 for datasets (public-domain dedication), or where not possible, a permissive Creative Commons license (e.g., CC BY) for databases subject to copyright/database rights. Code may use widely adopted OSI-approved licenses. Always ensure the chosen license is consistent with participant consent and legal obligations.

9. File formats & documentation

Prefer non-proprietary, open formats (CSV, TXT, JSON, TIFF, PNG) or provide exportable equivalents. Include a README (study overview, variable descriptions, units, missing-data codes), data dictionary, and provenance details (instrument/software versions). Structure metadata to support FAIR discovery and reuse.

10. Timing of availability & retention

Unless constrained by justified exceptions, data should be available on publication and retained by the authors/repository for at least 5 years (preferably longer) to support verification and reuse. Clinical-trial statements must specify the availability window.

11. How editors and reviewers will assess compliance

At submission, authors declare repository links/DOIs and provide the DAS. Editors may request editorial/reviewer access to data and code during peer review. Before acceptance, the corresponding author must confirm that repository records and licenses match the manuscript’s statements and that any consents/approvals permit the planned sharing. 

12. Patient images and case reports (special note)

For identifiable images or case details, obtain specific, written consent for publication, ideally after showing the patient/guardian the material to be published. If consent is not obtainable and anonymity cannot be guaranteed, such content must not be shared publicly.

13. How to cite datasets

Cite datasets in the reference list with creator(s), year, title, repository, version, and DOI/identifier in line with the Joint Data Citation Principles. Example:
Doe J, Singh R (2025). Dataset: Histopathology patch tiles for X study (v1.1). Zenodo. https://doi.org/10.xxxx/zenodo.xxxxx. 

14. Questions & exceptions approval

Authors seeking exceptions should write to the editorial office before submission with a brief justification and proposed access mechanism. The Editor-in-Chief will decide, considering ethics approvals, consent language, and legal constraints.