Topic: Ethics Requirements and Ethical Oversight in EU-Funded Projects

Overview

All projects funded by the EU, such as Horizon Europe, must meet stringent ethical standards and adhere to relevant EU, international and national laws. Addressing ethical considerations is therefore a crucial foundation of EU-funded research projects. This is reflected in the Horizon Europe Framework Programme, which sets high expectations in relation to scientific projects. This includes ethical standards, which ensures that research is conducted in a responsible manner and that the welfare of participants is safeguarded. Core EU values, such as respect for human dignity, freedom, democracy, equality, the rule of law and human rights, including the rights of minorities, need to be respected in projects.

Oversight of ethics in Horizon Europe-funded projects is rigorous, with a well-established process to ensure compliance throughout the project lifecycle through the Ethics Appraisal Scheme.  During the proposal stage of projects, applicants must identify and address arising ethical issues, providing details as to how they will be managed during the project through the Ethics Self-Assessment. Research projects concerning more sensitive themes, such as involvement of human participants or animal subjects, personal data or dual-use technologies, are subject to more scrutiny, often requiring ethics approvals from relevant bodies prior to the project commencing. Furthermore, regular monitoring is often part of the process, with reporting and audit requirements during the project in order to ensure ethical standards are upheld.

BBMRI-ERIC highly recommends that the ethical and legal components of projects are proactively planned for and incorporated at the design stage of projects. This requires a full understanding of the ethics requirements in EU-funded projects, as well as a collaborative and interdisciplinary approach from the outset in order to identify and address potential ELSI issues.  The Ethics Self-Assessment is designed to help you identify and address the ELSI issues in your project. Preparing for this early in the project lifecycle is crucial. It enables you to allocate appropriate tasks, expertise, and resources to address ethical considerations effectively. Delaying this can result in additional ethics requirements that are imposed by the EU. Proactive planning ensures smoother compliance and strengthens your project’s ethica and legal foundation. In the event that ethical issues have been flagged, BBMRI-ERIC also recommends including an Ethics Advisor or Ethics Advisory Board from the outset, in the proposal, if the ethics self-assessment has identified critical ethical issues.

Key Ethical, Legal and Societal Issues

To ensure that EU-project proposals are ethically compliant, applicants for EU Horizon funding must complete the Ethics Self-Assessment. Within this, there are key issues that need to be addressed. It is essential to flag potential ELSI issues in the Ethics Issue Table, followed by a comprehensive action plan as to how they will be managed in the Ethics Self-Assessment. These are found in the EU guidance document: EU Grants. How to complete your ethics self-assessment. The ELSI issues include:

Human Embryonic Stem Cells and Human Embryos

The use of hESCs or embryos in research is a highly sensitive topic due to the moral and ethical implications surrounding the origin and potentiality of these cells. Projects must ensure that such research is justified, legally compliant, and conducted with the utmost care to respect human dignity.

Note: Funding is not provided where the use of human embryonic stem cells or embryos is prohibited in a Member State.

Humans

Human participants must be protected during research activities. Concerns arise when research could impact the dignity, rights, or well-being of participants. As a result, robust safeguards are required. This includes respecting informed consent, privacy, as well as minimising any potential harm.

Human cells or tissues

Research involving human cells or tissues and cells must be handled with care and respect for the participants’ rights and dignity through the project, particularly in order to avoid any potential for exploitation. It is crucial that informed consent is obtained from participants, respecting their autonomy and privacy, as well as guaranteeing that collection, storage, and use of these materials comply with ethical and legal regulations

Personal Data

Biobanking and biomedical research involves collecting, processing, or storing sensitive personal data. As a result, the project must adhere to data protection laws, such as the GDPR. It is essential to ensure that data is handled securely and confidentially, respecting privacy and data rights.

Animals

Ethical concerns arise when research involves animals, particularly regarding their welfare and the necessity of their use. Researchers must demonstrate that the use of animals is essential, that alternatives have been considered, and that the highest standards of care and humane treatment are applied.

Non-EU Countries

Due to varying legal and ethical standards, as well as potential varying levels of protection for participants, it is necessary to ensure that research complies with both EU and domestic laws. It is important to ensure that participants’ rights, safety, and dignity are upheld to the same standards as within the EU.

Environment, Health and Safety

Research that could impact the environment, human health, or safety must address potential risks and implement measures to mitigate negative effects. It is necessary to ensure that research does not cause harm to ecosystems, individuals, or communities.

Artificial Intelligence

Research involving AI and other emerging technologies raises ethical issues around bias, fairness, transparency, and the potential for unintended consequences. Legal and ethical oversight is crucial to ensure that these technologies are developed and used in ways that respect individual rights, whilst also benefiting society. Ethically sound AI systems should be based on core principles, namely human agency and oversight; privacy and data governance; transparency; fairness, diversity and non-discrimination; societal and environmental well-being; and accountability.

Note: To learn more about AI and Biobanking, please click here.

Other Ethics Issues

Any outstanding ethical issues should also be addressed, particularly relating to novel developments such as in neurobiology, nanotechnology, genetic enhancement, etc.

Cross-Cutting Issue: Potential Misuse of Results

This refers to projects where there is a risk that research could be misused. Dual-use technologies would therefore fall under this category, given that they can have both civilian and military application. Given the potential that such research can be misused for harmful purposes, strict oversight is needed to prevent unintended consequences.

Relevant EU Legislation

As part of the Ethics Self-Assessment, applicants must also state relevant legislation and how they intend to comply with such legislation. Both domestic and EU-laws must be complied with, such as the:

General Data Protection Regulation (GDPR)

The GDPR provides a regulatory framework for lawfully processing personal data, including genetic data and any other health information.  While the GDPR does not directly address the management of incidental findings, it does nevertheless apply upon their discovery, given that incidental findings constitute sensitive personal data.

EU Artificial Intelligence Act (AI Act)

Approved in May 2024, the AI Act regulates the use of AI, adopting a tiered approach based on risk assessment: the greater the potential societal harm from an AI application, the stricter the regulations imposed. The AI Act applies to all sectors and industries, including the life sciences, imposing various obligations at every stage of the AI cycle.

Note: For further relevant EU legislation that may be applicable, please take a look here.

BBMRI Resources

The below resources have been developed within the BBMRI network:

ELSI Dialogues: ELSI Self-Assessment 

This webinar provides an overview on ethical issues to consider for EU grants.

Ethics Appraisal Process for EU-Funded Projects

This is a guide to assist researchers to navigate the Ethics Appraisal process for EU-funded projects. 

External Resources

The below resources have been developed outside of the BBMRI network:

EU Grants: How to complete your ethics self-assessment.

by the European Commission (V2.0 13 July 2021)

These guidelines assist applicants with the completion of the ethics self-assessment, which is a requirement in the proposal phase of EU-funded projects.

EU Grants: Horizon Europe Programme Guide. (Section 12: Ethics and Integrity) 

by the European Commission (Version 4.1 1 May 2024)

This document contains detailed guidance on the structure, budget, and political priorities of Horizon Europe, including how to prepare proposals. For ethics, section 12: Ethics and Integrity is recommended.

European Network of Research Ethics Committees (EUREC) 

EUREC is a network that brings together already existing national Research Ethics Committees (RECs) associations, networks or comparable initiatives on a European level.

EUREC Resources

by EUREC

EUREC has a collection of resources to support both ethics reviewers and researchers.

The European Code of Conduct for Research Integrity.

by ALLEA – the European Federation of Academies of Sciences and Humanities.

The European Code of Conduct for Research Integrity serves the European research community as a framework for self-regulation across all scientific and scholarly disciplines and for all research settings. The 2023 revised edition ensure that the Code remains fit for purpose and relevant to all disciplines, emerging areas of research, and new research practices.

Training and Resources in Research Ethics Evaluation 

By TRREE

TRREE is an international consortium that provides training on the ethics of health research involving human participants. In addition to E-learning modules, an overview of national regulatory frameworks is also provided.

Last Updated: October 2024