Ethics / ELSI for research data

Context

As research becomes more data-driven and collaborative, ELSI (Ethical, Legal, and Social Implications) issues influence decisions far beyond basic legal compliance. Therefore, data stewardship requires looking beyond technical solutions and regulatory checklists to understand the human and societal context of data. While frameworks like the GDPR set the minimum requirements, ethical stewardship focuses on what should be done, not only what must be done. This distinction is vital; data can be legally compliant yet ethically complex, especially when working with vulnerable groups, indigenous knowledge, or dual-use data.

A robust ELSI framework ensures that the human context of the data is never lost in the digital architecture. Navigating these implications is an active process that spans the entire research lifecycle, from the drafting of informed consent to the decision-making process regarding long-term access.

Mismanaged ethical processes can cause harm to participants, erode public trust, and create institutional or legal vulnerabilities. Conversely, strong ethical foundations support transparency, enable responsible data reuse, and reinforce the credibility of research outputs. A mature ethical culture is established when policies are documented, consistently applied, and regularly reviewed. Data stewards play a crucial role in bridging the gap between researchers, ethics committees, and legal teams. They foster a culture where ethical reflection is normal, supported, and embedded into daily research practice.

Guidelines

Data stewards help translate ethical principles into actionable guidance and support researchers in navigating ethical responsibilities throughout the research lifecycle. Their mission is to promote awareness, encourage reflection, and enable responsible decision-making. Additionally, traditional research ethics committees typically focus on clinical or biomedical research - data stewards are well-positioned to contribute to the shaping of institutional ELSI policies by representing the research needs of other fields.

1. Promote awareness and visibility of ELSI support

✔ Strengthen visibility of ethical resources at the institutional level

• Contribute to the creation or revision of ethical guidelines, templates, and procedures by providing research-related feedback.
• Ensure institutional RDM and DMP guidance includes clear references to ethics, consent, data sensitivity, and responsible sharing.
• Embed ELSI information into onboarding materials and general training portfolios.
• Share reminders or updates on ethical requirements via newsletters, departmental meetings, or internal communication channels.
• Participate in research governance bodies or ethics-related events to increase visibility and build trust with different relevant stakeholders (e.g., researchers, clinical staff and community or patient representatives).

2. Foster a culture of ethical reflection and responsible decision-making

✔ Make it normal and safe to discuss ethical uncertainties or dilemmas

• Encourage researchers to ask questions about consent form, data reuse and identifiability.
• Integrate ELSI into formal interactions (e.g., project planning meetings, DMP reviews, consultations).
• Utilise everyday interactions (e.g., hallway conversations, coffee breaks, lab chats) to create a safe space for discussing dilemmas.

✔ Offer simple tools for everyday ethical decisions

• Provide checklists, prompts, or decision trees for common tasks such as consent, anonymisation, or assessing sensitive data.

✔ Track recurring issues and improve institutional support

• Keep a log of common ethical queries or pain points to identify systemic gaps.
• Use this information to refine templates, improve training, or flag recurring concerns to ethics committees or legal teams.
• Notify researchers specifically when updates are made as a direct result of their input, demonstrating the practical value of their feedback.

3. Integrate ELSI considerations into research workflows

✔ Position ethical checks at key research milestones

• Align ethical guidance with project proposal development, data collection, sensitive data handling, sharing decisions, and long-term stewardship.
• Ensure that consent processes, data minimisation, risk assessments, and participant protections are implemented at the relevant stages.

✔ Cultivate ethical competence

• Stay informed about emerging ethical principles (e.g., CARE, SEEDS) and actively advocate for their application in research planning and execution.
• Offer regular training on emerging ethical issues (e.g., AI/ML ethics, data linkage risks, indigenous data sovereignty).
• Integrate short ethics modules into the project’s lifecycle to maintain awareness throughout the project.

4. Establish strong collaboration with ethics committees and legal teams

✔ Clarify roles and expectations between data stewards, ethics committees, and legal experts

• Share domain-specific context to help ethics committees interpret requirements realistically within diverse research fields.
• Help assess the implications of new ethical or legal requirements for day-to-day research.
• Document collaboration frameworks and keep management informed of the shared responsibilities and outcomes.
• Provide feedback on draft policies to ensure they are practical.

✔ Collaborate on the introduction of new tools or frameworks

• Work with ethics, IT, and legal teams when adopting new systems for consent management, anonymisation, secure sharing, or controlled access.

✔ Establish open communication channels

• Formalise a documented communication pathway for raising ethical concerns or reporting issues.
• Forward potential ethical risks to the appropriate ethics or legal contact and monitor follow-up.