ELSI refers to the early anticipation of, and rapid response to all non-technical (Ethical, Legal and Societal) Implications that may arise when developing emerging scientific knowledge and technologies and implementing them in society.

We do we need ELSI initiatives?
Scientific research and innovation processes and outcomes can significantly affect the world around us (directly or indirectly, in the short or long-term, at the individual, institutional or global levels). Clinical and translational research directly involves humans, personal data, and potentially transformative technologies and regulations for healthcare, and so comes with high social responsibility. Ignoring ELSI can lead to harm, mistrust, or legal issues that undermine both the science and its societal value.

ELSI Checklist for GIMM (CARE) Researchers:

Key Ethical Questions

• Does my research maximize potential benefits and minimize potential harms to participants, communities, and other stakeholders?
• Do I personally benefit from the results of my work? If so, is that benefit ethically justifiable and transparently managed?
• Is it ethical to use the chosen resources (e.g., plastics, public funding, unpaid interns) for this purpose? Have I considered sustainability and fairness in resource use?

Key Legal Questions

• Is my research fully compliant with all applicable legal instruments at the national, European, and international levels (laws, regulations, directives, conventions)?
• Are there relevant non-binding frameworks—such as policy guidelines, codes of conduct, or best practices—that I should follow?
• Do I have all required documentation (e.g., ethics approval, data protection agreements, consent forms) to demonstrate compliance?

Key Societal Questions

• Who are the end users of my research? Do I understand how the wider public and patient groups perceive both the research process and its potential outcomes?
• Does my research align with the priorities and needs of the target patient group or intended beneficiaries?
• Has a study been conducted to assess the social acceptability or socioeconomic impact of this research?
• How can I ensure broad accessibility of research outcomes? Have I considered open science, data sharing, and public dissemination strategies?
• Have I addressed diversity and inclusion in both the research design and dissemination to ensure equitable access and representation?

Need help?

EU Ethics and Data Protection Decision Tree here
(More information on Portuguese Law, Rules and Recommendations coming soon)

Training Resources
Download our Equitable Research Methods presentation here.

Curated Catalogue of External ELSI Tools
• BBMRI-ERIC ELSI Helpdesk
For researchers and staff using Biobanks. A centralized mailbox and curation team to track enquiries. Once resolved, all helpdesk requests are anonymized and feed into the ELSI Knowledge Base, which is then made available to the scientific community (via guidelines, trainings, and reading materials).

• European infrastructure for translational medicine (EATRIS)
For researchers conducting clinical studies and clinical trials. Advice for EMA, pre-clinical and clinical plan development, access to EATRIS Regulatory Database.

• The European life-sciences Infrastructure for biological Information (ELIXIR)
For project coordinators. Includes ELIXIR ELSI guidelines on managing life sciences data, best practices of sustainable software development, FAIR training courses and demonstration of impact.

• International Agency for Research on Cancer (IARC/WHO)
For researchers. Collection of ethics guidelines in cancer and links to materials.

• Microbial Resource Research Infrastructure (MIRRI)
For researchers in the public domain, companies, and policy makers. Includes a public forum, interaction with expert cluster, and advisory services concerning legal/regulatory issues.

• Oncology Compass (Switzerland)
For researchers and healthcare staff. A library of selected key publications which can be filtered and searched by clinical characteristics.

• Care Across (Europe)
For cancer patients. Offers personalized support for cancer patients to improve quality of life, tailored for each type of cancer and moment of treatment.

• European Cancer Patient Coalition (ECPC)
For researchers, the general public and patient advocates. Offers information on current policy issues, articles, and videos.

• European Clinical Research Infrastructure Network (ECRIN)
For staff and researchers involved in clinical trials. Provides access to regulatory information.

• CERA ElsiHub
For researchers in the fields of genetics and genomics. Users can search by topic (to understand if anyone had similar project issues), by people (to understand who may be able to advise), browse resources (including ELSI Hub Collections – curated reading lists on emerging topics), snapshot case studies and/or contribute to working groups.

Would you like to share a recommendation for inclusion in this catalogue? Contact us at care@gimm.pt and help others to benefit from your experience.