Research Data Policy

The Herald of the National Children's Medical Center supports responsible management, preservation, accessibility, verification, and, where ethically and legally appropriate, sharing of research data underlying published findings.

Research data should be managed in a manner that supports scientific integrity, transparency, reproducibility, participant protection, confidentiality, and appropriate reuse.

The journal recognizes that unrestricted public sharing is not appropriate for all research data. In particular, data concerning children, adolescents, patients, vulnerable participants, genetics or genomics, rare diseases, clinical images, and other potentially identifiable health information may require restricted or controlled access.

Accordingly, data should be made as accessible as reasonably possible while remaining as protected as necessary.

COPE identifies data availability and reproducibility as a core publication-ethics responsibility and recommends that journals establish clear policies on data availability and the possible inspection of underlying study data.

Scope

For the purposes of this policy, research data may include, where applicable:

  • numerical and statistical datasets;
  • clinical and observational data;
  • laboratory measurements;
  • survey and questionnaire data;
  • imaging data;
  • biological and molecular data;
  • genetic and genomic data;
  • registry and administrative datasets;
  • extracted data used in evidence syntheses;
  • protocols and statistical analysis plans;
  • data dictionaries and metadata;
  • analytic code, algorithms, and computational procedures;
  • other materials necessary to understand or verify the reported results.

Not every research output must be made publicly available. The appropriate level of access depends on the nature of the data, consent, ethical approval, applicable law, intellectual-property considerations, contractual restrictions, and risks to participants.

Data Availability Statement

Manuscripts reporting research based on collected or analysed data must include a Data Availability Statement.

The statement should explain clearly:

  • whether data underlying the results are available;
  • what data are available;
  • where the data can be accessed;
  • whether access is open, controlled, restricted, or available on reasonable request;
  • any applicable conditions or restrictions;
  • the repository name and persistent identifier or accession number, where applicable;
  • whether relevant code, protocols, data dictionaries, or other supporting materials are available.

A statement such as “data are available upon reasonable request” should, where possible, identify who may be contacted and explain any material conditions governing access.

If data cannot be shared, authors must provide an appropriate reason rather than simply stating that the data are unavailable.

Where no research dataset was generated or analysed, the Data Availability Statement may indicate that data sharing is not applicable.

Examples of Data Availability Statements

Depending on the study, appropriate statements may include:

Openly available data:
“The data supporting the findings of this study are available in [repository] at [persistent identifier/accession number].”

Controlled or restricted access:
“The data are not publicly available because they contain potentially identifiable or sensitive participant information. Access may be considered under applicable ethical, legal, and institutional requirements.”

Available on reasonable request:
“The data supporting the findings of this study are available from the corresponding author on reasonable request, subject to ethical approval, participant-consent limitations, and applicable data-protection requirements.”

No new data:
“No new research data were generated or analysed for this article.”

Authors must select wording that accurately reflects the actual status of the data.

Data Repositories

Where data can appropriately be shared, authors are encouraged to deposit them in a trusted, sustainable repository that:

  • provides persistent identifiers where possible;
  • preserves data over time;
  • provides stable access conditions;
  • allows appropriate metadata;
  • clearly states access restrictions;
  • supports versioning or provenance where relevant.

A recognized discipline-specific repository should be used where one is established and appropriate.

Where no suitable subject repository exists, an appropriate institutional or general research-data repository may be used.

Personal websites, temporary cloud links, or file-sharing links that do not provide reliable preservation should not normally be treated as long-term research-data repositories.

Sensitive Pediatric and Health Data

The journal does not require authors to place identifiable or inadequately de-identified patient data into an unrestricted public repository.

Particular caution is required for data involving:

  • newborns, infants, children, and adolescents;
  • rare diseases or rare combinations of clinical characteristics;
  • vulnerable participants;
  • direct or indirect patient identifiers;
  • dates, locations, or detailed clinical histories capable of enabling re-identification;
  • facial or other identifiable clinical images;
  • genetic and genomic information;
  • family pedigrees;
  • linked datasets;
  • small populations from a specific institution or geographical area.

Removing names alone does not necessarily make data anonymous.

When combinations of variables could permit re-identification, authors should use appropriate de-identification, pseudonymization, controlled-access procedures, or other safeguards.

Data-sharing decisions must remain consistent with the journal’s Research Ethics Policy, Privacy and Confidentiality requirements, Informed Consent provisions, and policies concerning Human Biological Materials and Genetic Data.

Consent and Data Sharing

Consent for participation in research does not automatically constitute consent for unrestricted public data sharing.

Authors should consider:

  • what participants were told about data use;
  • whether consent covered future or secondary use;
  • whether public deposition was contemplated;
  • whether data may be shared only in de-identified or controlled-access form;
  • whether an ethics committee imposed conditions;
  • whether applicable law restricts disclosure.

Where proposed sharing is inconsistent with the original consent, ethical approval, or applicable legal requirements, the journal does not require public disclosure of the data.

Ethics Committee and Institutional Requirements

Data sharing must comply with applicable ethics committee or IRB decisions, institutional policies, legal requirements, and valid agreements governing the study.

Authors must not use a journal data-sharing policy to override restrictions imposed for legitimate participant-protection reasons.

Conversely, vague references to “privacy” or “institutional policy” should not be used to conceal data where no genuine restriction exists.

Editors may request clarification or supporting information where a restriction appears unclear or inconsistent with the study documentation.

Authors’ Access to Data

Authors should have sufficient access to the data supporting the reported results to take responsibility for the integrity of the work.

In collaborations between academic and non-academic organizations, appropriate arrangements should protect academic authors’ ability to access and analyse the data.

For sponsored research, agreements should not prevent authors from accessing supporting data or independently assessing the results.

ICMJE’s January 2026 Recommendations state that all authors should be able to review data supporting the study results and that, in academic–non-academic collaborations, at least one author from the academic institution should have accessed the primary data and be able to participate in the analysis.

Sponsor Agreements and Data Control

Sponsors, funders, contract research organizations, technology providers, or other external partners must not impose arrangements that prevent appropriate scientific access to study data or undermine authors’ responsibility for the published findings.

Authors should disclose relevant sponsor involvement in:

  • study design;
  • data collection;
  • data management;
  • statistical analysis;
  • interpretation;
  • manuscript preparation;
  • decisions concerning publication or data sharing.

Where a sponsor owns or controls the data, this should be disclosed where relevant to understanding data access and author independence.

Clinical Trial Data Sharing

Manuscripts reporting clinical trial results must comply with the journal’s Clinical Trials Policy and applicable ICMJE data-sharing requirements.

ICMJE requires manuscripts reporting clinical trial results to contain a data-sharing statement.

For clinical trials that began enrolling participants on or after 1 January 2019, the trial registration must include a data-sharing plan. If that plan changes, the change should be reflected both in the manuscript’s data-sharing statement and in the registry record.

For clinical trials, the Data Sharing Statement should indicate, as applicable:

  • whether de-identified individual participant data will be shared;
  • which data will be shared;
  • whether data dictionaries will be available;
  • whether related documents such as the protocol or statistical analysis plan will be available;
  • when data will become available;
  • for how long;
  • who may obtain access;
  • for what purposes or analyses;
  • by what mechanism access will be provided.

The journal does not interpret data sharing as requiring unrestricted release of identifiable pediatric or clinical data.

Consistency with Trial Registration

For registered clinical trials, the data-sharing statement in the manuscript should be consistent with the data-sharing plan recorded in the trial registry.

Material changes should be transparently updated and explained where necessary.

A data-sharing plan must not be retrospectively altered merely to avoid commitments that were publicly declared during trial registration.

Secondary Use of Shared Data

Researchers using data generated by others must comply with applicable access terms, consent conditions, ethical approvals, data-use agreements, licenses, and repository requirements.

Secondary analyses should appropriately cite and identify the original dataset using a persistent identifier where available.

Authors should clearly distinguish the new analysis from previously published analyses based on the same dataset.

ICMJE requires secondary users of shared clinical-trial data to comply with agreed terms, credit the source data appropriately, and explain how their analyses differ from previous analyses.

Data Citation

Datasets that materially support the research should be cited where appropriate in a manner that allows readers to identify and locate them.

Data citations should include available persistent identifiers and should recognize the contribution of those responsible for generating and curating the dataset.

Data citations should not be manipulated for the purpose of artificially increasing citation metrics.

Data and Code Needed to Verify Results

Where appropriate, authors should retain and be prepared to provide the journal with data, analytic procedures, code, or other supporting materials reasonably necessary to verify reported results or investigate a credible integrity concern.

The journal may request underlying data during peer review or after publication when:

  • results cannot be adequately evaluated from the manuscript;
  • serious statistical or methodological concerns arise;
  • possible data fabrication or falsification is suspected;
  • image or result integrity is questioned;
  • a correction or post-publication investigation requires verification.

Any such request should respect participant confidentiality, legal restrictions, and legitimate data-security requirements.

COPE specifically identifies the ability of journals to request appropriately anonymized underlying data for inspection or verification as part of good data and reproducibility practice.

Data Retention

Authors and responsible institutions should preserve the primary data and analytic procedures supporting published findings for an appropriate period consistent with applicable law, institutional requirements, funder requirements, research ethics, and disciplinary standards.

The journal follows the ICMJE recommendation that investigators maintain the primary data and analytic procedures underlying published results for at least 10 years, unless a longer period is required by law, regulation, contract, institutional policy, or the nature of the research.

ICMJE also encourages preservation in an appropriate data repository to support longer-term availability.

Data Integrity

Research data must be accurate, traceable, and managed in a manner that preserves the integrity of the scientific record.

Authors must not fabricate, falsify, selectively alter, suppress, or misleadingly manipulate data.

Cleaning, exclusion, transformation, imputation, normalization, and other analytical processing should be scientifically justified and reported where material to interpretation.

The journal may investigate substantial discrepancies between published results and the underlying data according to its Publication Ethics Policy.

Missing, Lost, or Unavailable Data

Loss of original data does not automatically establish misconduct, but it may affect the ability of the journal to verify published findings.

Authors should promptly inform the journal if supporting data are lost, corrupted, inaccessible, or materially different from what was represented during submission.

The editorial response will depend on the seriousness of the issue and its effect on the reliability of the article.

This may result in clarification, correction, an Expression of Concern, retraction, or another appropriate editorial action.

Data Changes After Publication

If an error is discovered in data supporting a published article, authors should notify the journal promptly.

Material corrections to datasets, analyses, or results should be handled transparently and, where necessary, accompanied by an appropriate correction or other post-publication notice.

Published data or files should not be silently replaced when the change materially affects interpretation or reproducibility.

Data Availability and Peer Review

Availability of data may support peer review but does not replace scientific evaluation.

Where reviewers require access to non-public data for legitimate evaluation, the journal may arrange appropriate confidential or controlled access when feasible and ethically permissible.

Reviewers must treat any data supplied for peer review as confidential and comply with the journal’s Reviewer Policy and Artificial Intelligence Policy.

Artificial Intelligence and Research Data

Use of artificial intelligence does not remove authors’ responsibility for the accuracy, provenance, confidentiality, security, and lawful use of research data.

Identifiable or sensitive participant data must not be uploaded to external AI systems without an appropriate ethical, legal, institutional, and data-protection basis.

AI-generated, AI-transformed, or AI-assisted datasets and analyses should be documented sufficiently to allow appropriate assessment where their use materially affects the research.

No Universal Requirement for Unrestricted Open Data

The journal supports responsible data sharing but does not apply a universal rule requiring all research data to be openly accessible without restriction.

Reasons that may justify controlled or restricted access include:

  • participant confidentiality;
  • inability to adequately de-identify the data;
  • pediatric or vulnerable-participant protections;
  • genetic or genomic privacy;
  • ethics committee restrictions;
  • limitations of informed consent;
  • applicable data-protection law;
  • legitimate third-party rights;
  • valid contractual or intellectual-property restrictions.

Restrictions should be proportionate and should be stated transparently in the Data Availability Statement.

Editorial Assessment and Non-Compliance

Editors may request clarification where a Data Availability Statement is absent, misleading, inconsistent with the manuscript, inconsistent with trial registration, or unsupported by the actual availability of the data.

Fabrication of data, false repository links, misrepresentation of access conditions, intentional concealment of data relevant to published findings, or submission of falsified supporting material may constitute serious research or publication misconduct.

Such matters are handled under the journal’s Publication Ethics, Research Ethics, Corrections and Retractions, and Ethical Non-Compliance and Editorial Action policies.

Policy Application

This policy applies to research data underlying manuscripts submitted to and published by the journal, subject to the nature of the article and applicable ethical, legal, and disciplinary requirements.

The journal seeks to balance transparency and reproducibility with participant rights, pediatric safeguards, confidentiality, responsible data governance, and scientific integrity.

ISSN 2181-3353 (Print)
ISSN 2181-3353 (Online)