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Legal indicators: Ethics

This indicator assesses the extent to which ELSI (Ethical, Legal, and Social Issues) principles are integrated into research data management practices. It examines whether ethical considerations are addressed proactively or reactively, the existence and application of institutional guidelines, and the consistency of related procedures such as ethics review, consent, and data handling. The level of maturity reflects the organisation’s ability to promote ethical awareness, provide clear guidance and training, and ensure continuous compliance with established ethical standards.

Level 1 – Ethical considerations for RD are minimal and reactive. There are no formal guidelines or processes for ensuring ethical compliance in research.

  • Reactive: Ethical questions are addressed only when required by funders or external review boards.
  • Unclear responsibilities: No designated roles or guidelines exist for managing or advising on ELSI issues in RDM.
  • Limited researcher awareness: Researchers rely on personal judgment or external requirements to assess ethical implications.

Impact: Research integrity practices rely heavily on individual initiative, increasing the risk of ethical breaches, participant harm and reputational damage.

Level 2 – Basic ethical guidelines are established, but not consistently applied. Awareness of ethical issues is growing, and some training is provided.

  • Basic guidance: Ethical principles for RDM are defined but lack detail and specificity.
  • Fragmented application: Different parts of the organisation develop their own ethical processes independently, with no centralised system in place.
  • Raising awareness: Some ethics training sessions are provided, often as part of broader RDM or research integrity training. No specific ethics training is in place, resulting in inconsistent or ad hoc approaches.

Impact: Ethical awareness is growing, but inconsistency in implementation creates uncertainty and potential compliance gaps.

Level 3 – Ethical guidelines regarding RD are well-defined and consistently applied. Regular training and monitoring ensure compliance, and there is a clear process for addressing ethical issues.

  • Clear framework and procedures: Organisational ethics policies cover all stages and most types of research topics.
  • Designated support: Ethics committees, legal advisors and data stewards work together with each role having specific tasks.
  • Regular training and monitoring: Researchers and staff receive recurring ethics and ELSI training. Adherence is monitored through reviews and audits.

Impact: Ethical standards are integrated into research, ensuring compliance, reducing risk, and improving participant trust.

Level 4 – Ethical standards regarding RD are fully integrated into the research process. Continuous improvement and proactive measures are in place, with advanced training and robust mechanisms for ensuring ethical integrity.

  • Regular updates and maintenance: Ethics and ELSI policies are regularly updated to reflect evolving norms, technologies and societal expectations.
  • Proactive integration: Ethical review checkpoints are embedded in key processes, including DMPs, data sharing and project registration.
  • Advanced training and reflection: Regular, targeted and mandatory training encourages reflection on emerging ethical challenges.
  • Continuous improvement: Feedback loops, monitoring and auditing ensure policies remain relevant and effective.

Impact: A mature ethics culture fosters trust, transparency, and responsible innovation. Ethical reflection is an integral part of research planning, execution and data stewardship.

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