E · Transparency & Reproducibility

Research Data, Availability & Reproducibility

Requires research articles to carry a meaningful Data Availability Statement identifying whether, where and under what conditions underlying data, code and materials may be accessed, or why they cannot be shared. Establishes author access to supporting data and protects analytical and publication freedom in sponsor agreements, recognises legitimate privacy, consent, legal, community-governance and third-party restrictions, and distinguishes transparency from guaranteed reproducibility.

Permanent identifier LMI-POL-019 Publisher + Journal Policy

Purpose and Scope

This policy establishes the minimum expectations of LMI journals concerning the data, code, protocols and materials underlying published research. It applies to research articles and to the evidence on which their conclusions rest.

Data Availability Statement

Each journal shall require, for research articles where relevant to the design, a Data Availability Statement that meaningfully informs a reader. The statement shall identify whether the data underlying the reported findings are available; where they are held, with a persistent identifier, accession number or DOI where deposited; the conditions of access, including any application process, approving body or licence; and, where data cannot be shared, the specific reason and any lawful route by which a legitimate request might nonetheless be considered.

A statement that data are “available on reasonable request” shall not be used as a default where deposit in a repository or a clearer access route is feasible. Where such wording is genuinely appropriate, the statement shall identify who holds the data and who decides requests. Statements shall be accurate: authors are accountable for honouring what their statement says (C1), and a statement known to be false when made may be assessed under C5.

Data, Code, Protocols and Materials

Where the reported findings depend on analytical code, scripts or computational workflows, authors shall be encouraged, and may be required by the journal, to make them available with sufficient documentation to be intelligible. Protocols, analysis plans and key materials shall be available as required by the study type, including as required for trials under D3. Deposited datasets and code shall be cited in the reference list with their persistent identifiers so that data are formally credited and traceable.

Author Access to Data and Sponsor Agreements

Authors shall have access to the data necessary to verify and take responsibility for the results attributed to them. For collaborations involving commercial sponsors or data-holding organisations, the research agreement shall expressly preserve appropriate author access to the primary data, independent participation in analysis, and freedom to publish an accurate account of the findings. At least one accountable author should have had sufficiently complete access to the data and analysis to answer questions about the reported results. Editors may require a statement identifying which authors had access and whether any agreement restricted access, analysis or publication.

Clinical-trial reports shall include the data-sharing statement required by the journal and, where applicable under current registration standards, a data-sharing plan in the public trial registry. Material changes to a registered data-sharing plan shall be updated transparently in the registry and explained in the manuscript.

FAIR Orientation

LMI encourages research outputs to be findable, accessible, interoperable and reusable in accordance with the FAIR Principles, with appropriate metadata, recognised formats and clear licensing. FAIR does not mean open without qualification: data may be findable and well described while access is properly controlled. LMI does not represent that all research data can or should be openly released.

Legitimate Restrictions

Sharing shall not occur where it would breach obligations owed to others. Recognised grounds for restriction include: participant privacy and the risk of re-identification; the limits of the consent actually obtained (D1); legal, regulatory or contractual restrictions; professional or commercial confidentiality; the governance rights of Indigenous peoples and other communities over data concerning them; national-security or dual-use considerations (D5); and third-party ownership of data or materials.

Restricted is not the same as undocumented. Where any of these grounds applies, the Data Availability Statement shall name the restriction and, where one exists, the lawful route to access — such as application to a data-access committee, a repository's controlled-access mechanism, or a data-use agreement. De-identification or aggregation should be considered as a means of enabling controlled sharing where full release is not permissible. Personal data within the publishing workflow remains governed by A5; publication of identifiable participant data requires consent under D1 and is not authorised by this policy or by the article licence (F1).

Reproducibility

Transparent availability of data and methods supports, but does not guarantee, reproducibility. Neither LMI nor its journals represents that any published study is reproducible, and availability of data is not a warranty of the validity of findings. Where reanalysis or replication raises credible doubt about a published work, the concern is handled under C5 and any resulting record action under G2; scholarly disagreement about reanalysis is properly pursued through post-publication discussion (G3).

Publisher and Journal Responsibilities

LMI establishes this minimum principle, requires journals to implement it, and supports the persistence of data citations and links within published metadata (G1). Each journal determines discipline-appropriate requirements: which repositories it recommends or requires, which article types must carry statements, acceptable formats, retention expectations, and the point in the workflow at which statements and deposits are verified.

Standards and Guidance

Informed by the FAIR Principles, the TOP Guidelines, and the ICMJE Recommendations on data sharing.