Inside the Role of Bio4HUMAN’s Ethics Officer
As part of Bio4HUMAN’s steadfast commitment to ensuring ethical and governance framework to oversee project activities in selected locations (the DRC and South Sudan) from an ethical standpoint, Bio4HUMAN appointed an Ethics Officer internal to the project consortium. The role of the Ethics Advisor is to support communication with the Ethics Advisory Board and ensure that all ethical, legal, and safety/security measures are taken, advising project partners whenever necessary.
To understand the role of the Internal Ethics Officer in more depth, and the fundamental principles behind ethical guidance, we have conducted an interview with Mr Dimitris Kokkalis, Bio4HUMAN’s Internal Ethics Officer.
Hi, Dimitris! As Bio4HUMAN’s Internal Ethics Officer, we would like to ask you some questions about your role and background. Firstly, for some context, what does your role as the Bio4HUMAN Internal Ethics Officer entail?
As the Ethics Officer for Bio4HUMAN, my role is to ensure that all research activities comply with Horizon Europe’s ethical standards and legal requirements. This includes monitoring ethical requirements, providing independent recommendations, and guiding the consortium in maintaining high ethical standards across all project dimensions. I oversee the ethical review of deliverables and advise project partners accordingly. In addition, I provide guidance on ethical and legal boundaries to the project coordinator and consortium members, actively participate in meetings with the Ethics Advisory Board (EAB) and the consortium, and contribute to the ethics sections of beneficiary reports. I also collaborate with the EAB to review and submit ethics overview reports to the European Research Executive Agency (REA) at key project milestones, ensuring that ethical integrity is upheld throughout the project.
Thank you very much for this clear explanation. Why do you believe that having an internal ethics officer is crucial for a project like Bio4HUMAN?
Having an internal ethics officer is important for a project like Bio4HUMAN due to its ethical challenges, including research with vulnerable populations, data protection, and operations in conflict zones. The project involves social science research with local communities, and informed consent procedures, participant safety, and ethical recruitment procedures are among the important aspects to be taken care of. Additionally, personal data collected in South Sudan and the Democratic Republic of Congo must be securely handled in compliance with GDPR and national regulations. The Internal Ethics Officer provides guidance to the project on adherence to Horizon Europe’s ethical standards and in conjunction with the important role of the Ethics Board, provides ongoing guidance to project partners.
Building on this, how has your experience of working with the Bio4HUMAN project been so far?
My experience so far has been very fruitful in a very professional environment with committed individuals to the activities of the project. Although as Ethics Officer I have no direct involvement in the technical implementation of the work packages, I have been closely engaged in reviewing the ethical dimensions of planned activities. I have appreciated the openness of the consortium to ethical guidance and their willingness to adapt procedures to meet high standards of ethical and legal compliance. The exchange has further enriched my knowledge, and I have also appreciated the expertise of the partners, their commitment to the objectives of the project, and their willingness to provide added value in their work. Collaborating with the EAB and supporting the preparation of the required ethics deliverables has also provided valuable opportunities to contribute meaningfully to the project’s integrity and impact.
You’ve held many previous roles in policy development and project preparation and implementation. How do your experiences in these areas inform your approach to ethical guidance within Bio4HUMAN?
My overall experience in developing and applying policies and my role as an evaluator, advisor, and monitor for European programmes such as Erasmus+ and Horizon Europe often involves interpreting policy frameworks, assessing alignment with EU objectives and standards, and advising on compliance and improvement. This work requires a solid understanding of policy processes and the ability to apply them in diverse project contexts, which directly informs my capacity to offer informed, practical ethical guidance in projects like Bio4HUMAN. It helps me look at both whether the project follows ethical rules on paper and how its activities affect people in real life—especially when working with vulnerable groups and handling sensitive data from conflict areas. Ethics isn’t just a formality, but an ongoing and useful part of the project that adds value and keeps it responsible.
Can you describe your approach to ethical guidance within the project? What are the key principles that you apply?
My approach to ethical guidance in projects is based on clarity, practicality, and ongoing support. I aim to make ethical principles understandable, helping teams integrate ethics into their daily work rather than treating it as a separate or administrative task. The key principles I apply in my approach include early engagement in addressing ethical issues from the beginning, continuous dialogue by maintaining constructive communication with project teams, and practical problem-solving by providing realistic solutions.
Lastly, what advice would you give to project partners to ensure that ethical considerations are integrated into every stage of the project?
My advice to project partners is to treat ethics as an integral part of the project from the very beginning, not just as a requirement to be addressed at specific checkpoints. Potential ethical risks need to be identified early. Ethics need to be always in mind when designing methodologies, engaging with participants, or handling data. Also, informed consent needs to be clear, culturally appropriate, and meaningful—not just a formality. The communication within the team and with external partners needs to be open and continuous in order to ensure that possible questions are quickly addressed, and any updates and new knowledge is taken into account for the work. It is important to carefully document decisions, approvals, and procedures, especially when working in sensitive contexts. Ethics should be considered as a continuous process that supports the quality, safety, and credibility of the work, and not as an administrative task that needs to be done. And, when in doubt, seek guidance—early and often.
The Bio4HUMAN Internal Ethics Advisor, Mr. Dimitris Kokkalis, is an independent adviser in education, training and research projects preparation and implementation. He is an experienced ethics adviser and reviewer actively contributing to HORIZON 2020 and HORIZON Europe projects. He has served as an external ethics adviser, focusing on ethics and data protection issues on various projects, while also contributing to the HORIZON 2020 and HORIZON Europe Ethics Appraisal Scheme. As a certified Data Protection Officer, he brings expertise in ethics and data protection within research and innovation contexts.