Data Sharing Policy

2.1 Mandatory Data Availability

All clinical trial manuscripts must include:

  1. Data Availability Statement specifying:
    • Where data are deposited (repository name, DOI/accession number)
    • Conditions for access (open, restricted, or on request)
    • Any ethical/legal restrictions
  2. Preferred Repositories:
    • Global South-focused: INDEPTH Data Repository, WHO Data Collections
    • General: Dryad, Figshare, Zenodo, Open Science Framework
    • Discipline-specific: ClinVar, GenBank

2.2 Data Types to be Shared

  • De-identified individual participant data (IPD)
  • Statistical analysis plans
  • Study protocols
  • Case report forms
  • Analytic code

2.3 Timeline for Sharing

  • At publication: Minimum dataset required to reproduce results
  • Within 6 months: Full dataset (unless justified otherwise)

2.4 Acceptable Restrictions

Data may be restricted if:

  • Contains identifiable participant information
  • Subject to national security laws
  • Involves indigenous/traditional knowledge protections
  • Has commercial confidentiality constraints (must be declared at submission)

3.0 Compliance and Verification

3.1 Pre-Submission Checklist

Authors must confirm:
☑ Trial registration number and date
☑ Consistency between registered and reported outcomes
☑ Data repository details
☑ Ethical approval for data sharing

3.2 Editorial Verification Process

Global South Health Horizons will:

  • Cross-check registration numbers in original registries
  • Confirm outcome reporting consistency
  • Spot-check data repository accessibility
  • Require corrections for non-compliance before publication

4.0 Consequences of Non-Compliance

Violation

Action

Unregistered trial

Immediate rejection

Outcome switching

Require correction/explanation

No data sharing statement

Manuscript held until provided

False data availability claims

Retraction + institutional notification

5.0 Global South Considerations

5.1 Capacity Building

Global South Health Horizons offers:

  • Fee waivers for registry fees in low-income countries
  • Guidance documents in multiple languages
  • Workshops on data management for LMIC researchers

5.2 Ethical Flexibility

Special provisions for:

  • Studies in conflict zones
  • Resource-limited settings without digital infrastructure
  • Community-owned health data

6.0 Templates for Authors

6.1 Data Availability Statement Examples

  1. Open access:
    "De-identified participant data are available in [Repository Name] under DOI [Number]"
  2. Managed access:
    "Data are available upon reasonable request to [Institution] Ethics Committee (contact@email) after signing a data use agreement"
  3. Restricted:
    "Data cannot be shared publicly due to [reason]. Requests may be sent to [PI Email]"

6.2 Registry Statement Format

"This trial was registered prospectively at [Registry Name] (ID: [Number]) on [DD/MM/YYYY]. The full protocol can be accessed at [URL]."

7.0 Appeals Process

Requests for exemptions must:

  1. Be submitted during manuscript submission
  2. Include ethical/legal justification
  3. Be approved by Global South Health Horizons' Ethics Review Panel

Contact

For queries:
team.gshh@cecr.com.ng
+234-806-195-6031

Policy Effective Date: [30/04/2025]
Next Review Date: [29/04/2030]