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Work Package
WP11 — Ethics requirements (Lead: UL)
Goals & Objectives
- Assure that ethics design, informed consent and other ethics aspect provided in WP3 are consistent with EU regulations
Tasks
- Task 11.1: Requirement No1 (UL-EAB, M9) EAB will check the procedures and criteria that will be used to identify/recruit research participants must be submitted as a deliverable before the start of the relevant activities. The informed consent procedures that will be implemented for the research participants must be submitted as a deliverable before the start of the relevant activities. Templates of the informed consent/assent forms and information sheets (in language and terms intelligible to the participants) must be kept on file (submit confirmation) and provided upon request. For children and/or adults unable to give informed consent involved, details on how the consent of the legal representatives (and assent of the research participant, when applicable) will be obtained must be submitted as a deliverable before the start of the relevant activities. Adequate measures to protect vulnerable individuals/groups, prevent coercion and undue inducement, exacerbation of their vulnerability, and minimise the risk of harm and/or stigmatisation must be submitted as a deliverable before the start of the relevant activities.
- Task 11.2: Requirement No2 (UL-EAB, M12) EAB will check detailed information on the incidental/unexpected findings policy (including the disclosure policy in case of unexpected findings) must be submitted as a deliverable before the start of the relevant activities.. Copies of opinions/approvals by ethics committees and/or competent authorities for the research with humans must be obtained before the start of the relevant activities, kept on file (submit confirmation), and provided upon request.
- Task 11.3: Requirement No3 (UL-EAB, M12) EAB will check the clarification how all of the personal data that will be processed are relevant and limited to the purposes of the research project (in accordance with the ‘data minimisation ‘principle) must be submitted as a deliverable before the start of the relevant activities. A description of the technical and organisational measures that will be implemented to safeguard the rights and freedoms of the data subjects/research participants must be submitted as a deliverable before the start of the relevant activities. Description of the anonymization/pseudonymisation techniques that will be implemented must be submitted as a deliverable before the start of the relevant activities. When personal data are not anonymized/pseudonymized, a justification for not anonymizing/pseudonimizing the relevant data must be included. For the further processing of previously collected personal data, an explicit confirmation that the beneficiary has lawful basis for the data processing and that the appropriate technical and organisational measures are in place to safeguard the rights of the data subjects must be submitted as a deliverable before the start of the relevant activities.. The ethics risks related to the data processing activities of the proposal/project must be evaluated. This evaluation must include an opinion if data protection impact assessment should be conducted under article 35 General Data Protection Regulation 2016/679. The risk evaluation and the opinion must be submitted as a deliverable before the start of the relevant activities.
- Task 11.4: Requirement No4 (UL-EAB, M18) EAB will check if human right impact assessment covering the development, deployment and post-deployment phases, including detailed information on how respect for fundamental human rights and freedoms will be ensured, must be submitted as a deliverable before the start of the relevant activities. The beneficiaries are recommended to consult the ‘ASSESSMENT LIST FOR TRUSTWORTHY ARTIFICIAL INTELLIGENCE (ALTAI) for self-assessment’ and its relevant sections on fundamental rights impact assessment (FRIA)”. A detailed explanation on the measures taken to prevent, avoid and mitigate potential bias, discrimination and stigmatisation in input data and algorithm design and outcomes must be submitted as a deliverable before the start of the relevant activities. The beneficiaries must evaluate the ethics risks related to the AI and describe the measures set in place to prevent/mitigate any potential negative personal/social impacts during the research, deployment and post-deployment phase. The assessment and the risk mitigation plan must be submitted as a deliverable before the start of the relevant activities. A detailed explanation on how humans, e.g., border guards, will maintain meaningful control over the most important aspects of decision-making process must be submitted as a deliverable before the start of the relevant activities.
- Task 11.5: Requirement No5 (UL-EAB, M12) EAB will check the detailed explanation on how the research participants and/or end-users will be informed about: (1) their interaction with an AI system/technology; the abilities, limitations, risks and benefits of the AI system/technique; (3) the manner in which decisions are taken and the logic behind them (if relevant) must be submitted as a deliverable before the start of the relevant activities.
- Task 11.6: Requirement No6 (UL-EAB, M12) EAB will check if the risk assessment and details on measures to prevent misuse of research findings must be submitted as a deliverable before the start of the relevant activities.
- Task 11.7: Requirement No7 (UL-EAB, M14) An independent Ethics Board will be established and include members with expertise in artificial intelligence, personal data protection and human rights. They will give advice to the consortium on precise informed consent, people unable to give consent, possible pressure on participants (e.g., children and vulnerable people), processing of sensitive personal data and use in AI-based systems, unexpected findings (e.g., heartbeat), etc. Periodic reports from the Ethics Board must be provided at months 14, 24 and 36. The ethics reports should discuss how ethical issues were handled by the research team during the reporting period, whether any new issues emerged, and how they should be addressed (if applicable). All deliverables related to the above requirements should be reviewed as well as the project deliverables related the Ethical, legal and data protection specification (M6), GDPR compliance verification (M18), transparency, accountability, bias mitigation (M18), GDPR-compliant mobile app development (M16). Guidance for Ethics Advisors/Boards can be found under: https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/roles-and-functions-of-ethics-advisory-ethics-advisory-boards-in-ec-funded-projects_he_en.pdf
