Research ethics in Horizon Europe
Ethics in Horizon Europe (HEU)
To be eligible for funding from HEU, applicants must complete an Ethics Self-Assessment form. HEU adopts a comprehensive understanding of ethics, while the Danish ethics committee system primarily focuses on health research ethics. Consequently, aspects such as data management, GDPR, animal trials, plant materials, work environment, and AI at DTU are addressed within the framework of good scientific conduct and GDPR regulations. Notably, dual-use concerns are addressed separately under the security provisions of the Horizon Europe program. Read more about dual-use.
The EU has developed a guide for researchers on how to complete your required HEU Ethics Self-Assessment. This DTU Inside page serves as a supplement to EU’s guide. The page's structure mirrors the HEU’s guidelines and is divided into 10 thematic sections. While some sections mainly link to existing DTU Inside pages, others contain specific information relevant to the section not already covered on DTU pages.
Download the EU's guide 'How to complete your ethics self-assessment'.
When completing the HEU Ethics Self-Assessment, it is important to provide clear details on the need, relevance, and procedures for obtaining ethical national approvals, if necessary. If, after reading these pages, you are still uncertain about which ethical national approvals are needed, please contact the Danish National Committee on Health Research Ethics (NEC) (in Danish) for guidance.
Ethics approvals are not required at the application stage, but you cannot start the part of your project that raises ethical concerns until you have obtained the required approvals.
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Below DTU Inside pages inform you what to be aware of and which ethics committees may be relevant if you conduct research activities involving human embryonic stem cells and human embryos, humans and human cells or tissues (sections 1, 2, and 3 in the HEU form).
- Research involving human trial subjects and human biological material
- Requirements for clinical trials and testing of medical devices and drugs
The pages provide information on the Danish Ethics Committee System, relevant definitions, and an introduction to the individual Danish ethics committees and their mandate.
Below, the DTU Inside page informs you what to be aware of if you are processing personal data, the use of informed consent, and general GDPR compliance.
On the page, you will also find detailed information on DTU’s DPO that must be entered in the HEU form, as well as relevant definitions, such as the clarification of anonymized versus pseudonymized data.
Finally, the page covers authorization requirements when importing and exporting material, including personal data within and outside the EU.
Below, the DTU Inside pages inform you what to be aware of and where to apply for approval if you conduct animal research. The pages include information on requirements for animal experiments in Denmark and optimizing animal welfare (the 3R principles).
Collaborating with or using material from non-EU countries can be complex and time-consuming. Hence, it is advisable to start preparations well in advance.
The specific type of research you conduct will determine the ethical considerations to address when collaborating with non-EU countries. Therefore, you can find the necessary information by consulting the pages relevant to your type of research.
For projects involving local resources like animals, plants, microorganisms, or traditional knowledge, adherence to the Access and Benefit Sharing (ABS) regulation is required. Verification of the status and requirements of the relevant country can be done through the ABS clearing house. Further details are available on the DTU Inside page 'Utilization of non-human genetic resources for research (Nagoya protocol)'.
To assess whether your research raises ethical concerns regarding the environment, health, and safety please consider the following questions:
Environmental impact: Does your research involve the use of substances, processes or technologies that may cause harm to the environment, animals or plants?
Please consult the DTU lab you plan to use for your project to determine lab classification. In your self-assessment, you are advised to read and refer to DTU’s working environment actions and initiatives (Framework).
Protection of endangered species and areas: Does your research involve endangered fauna and/or flora and/or protected areas?
You must indicate whether specific authorizations are required in the HEU form. Please take note of restrictions for species listed in the EU regulation (no. 338/97) on the protection of species of wild fauna and flora as well as restrictions for animals captured in the wild (Bekendtgørelse om dyreforsøg, §7)
If uncertain, please contact The Animal Experiments Inspectorate.
Health and safety risks: Does your research involve the use of substances, processes or technologies that may cause harm to humans, including those performing the activity?
Please consult the DTU lab you plan to use for your project to determine lab classification and local guidelines on health and safety. Additionally, please ensure an assessment of safety precautions required for the project.
Note: blood is considered hazardous to human health.
Each department oversees the local implementation and compliance with national and EU regulations regarding health and safety. Please contact your department’s environment and health and safety coordinator for more specific information.
Approval from one of the Danish Ethics Committees is relevant for some research involving AI.
DTU refers to the EU’s ethics guidelines for trustworthy AI and to the EU’s ‘Living guidelines on the responsible use of generative AI in research’ to assess whether your research involves AI that requires ethical considerations.
EU Commission's definition of AI
The EU Commission defines artificial intelligence as:
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“…systems that display intelligent behaviour by analysing their environment and taking actions – with some degree of autonomy – to achieve specific goals. AI-based systems can bepurely software-based, acting in the virtual world (e.g. voice assistants, image analysis software, search engines, speech and face recognition systems)orAI can beembeddedin hardware devices (e.g. advanced robots, autonomous cars, drones or Internet of Things applications).” |
For AI to be ethical, it must be trustworthy. This entails complying with seven key requirements:
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Interaction with human decision-making
It is essential to assess whether your AI system or technique interacts with, replaces, or influences human decision-making processes. Securing informed consent and explaining how humans will retain meaningful control is crucial in such cases.
For additional guidance on informed consent and data protection issues, please visit the DTU Inside page Personal data - questionnaires, interviews and observations.
Research ventures into new and evolving fields may raise ethical questions not yet addressed by existing laws or guidelines. Nonetheless, it is crucial to address any concerns that arise proactively.
Exploration in fields such as neurobiology, man-machine interaction, nanotechnology, genetic enhancement, and the development of androids and cyborgs can raise ethical dilemmas.
Should you encounter other ethically significant issues during your research, it is vital to document and elaborate on them in your ethical self-assessment and detail your strategies for addressing these concerns.
In case of uncertainty or when confronted with complex ethical questions, please e-mail the Research Office at researchethics@adm.dtu.dk.
Addressing dual-use and security concerns
Certain research activities can generate materials, methods, technologies, or know-how with the potential for misuse, necessitating thorough ethical consideration.
Formerly integrated into the H2020 ethics checklist, security issues such as dual-use (technology or knowledge developed for civilian use that can be used for a military purpose or misused for criminal or terrorist purposes) are now covered in a separate ‘Security Issues Table’. This ethics checklist, therefore, serves as a complementary tool, focusing on areas not addressed under security concerns.
Further information can be read in DTU guidance on dual-use.