LJUBLJANA, SLOVENIA (18-19 NOVEMBER 2021)28th NEC FORUM
SPEAKERS & MODERATORS
Marjeta Terčelj Zorman
Vice Chair of the Commission of the Republic of Slovenia for Medical Ethics, UMC Ljubljana
Associate Prof. Marjeta Terčelj Zorman, PhD, internist and pneumologist, is currently vice president (2010-2021) of KME RS and a head of the Clinical Department of Lung Diseases and Allergy UKCL until 2020. She completed medical studies in 1978, specializing in internal medicine and in pneumology in 1984. In 1991, she defended a master’s thesis and in 2001, she successfully defended the doctoral thesis entitled at the University of Ljubljana, Faculty of Medicine.
In 1998, she moved to the newly established Department for patients with lung disease and allergy in the University Medical Centre Ljubljana (UMCL), which it until then did not exist. After several years, with its expert clinical and research work, it became the Clinical Department for Respiratory and Allergic Diseases, UMCL.
In 1998, she was elected to the title of assistant to the subject of internal medicine and pulmonology at the Faculty of Medicine of the University of Ljubljana and she became Associate Professor in 2012. She conducted research and introduced several methods for early detection of lung cancer, she introduced many new diagnostic and therapeutic methods of interventional bronchology in Slovenia. She has researched in the field of sarcoidosis in the last 15 years. She has over 40 published original scientific articles, 2 chapters, 3 invited lectures, over 35 published abstracts. She was coordinator of postgraduate seminars in the field of difficult intubation using endoscopy with bronchoscope for residence, specialists for anesthesiologist and run the school of bronchology for doctors in intensive care.
She lectured on ethics in biomedical research in postdoctoral study for several years. She has been a delegate for DH-BIO for many years and for the NEC Forum.
Deputy Director-General in DG Research and Innovation (R&I) at the European Commission
Joanna Drake has been the Deputy Director-General of the European Commission’s Directorate-General for Research and Innovation since October 2021. Her main responsibilities include managing the Horizon Europe Cancer Mission, synergies between Horizon Europe and other EU programmes, and as the Commission’s representative on the Group on Earth Observation.
Previously, she held the same position in the Commission’s Environment Directorate-General since 2016, and in this role was responsible notably for the coherence between anvironmental and other EU policies, with a view to mainstreaming the main pillars of the European Green Deal.
She also chaired a cross-cutting Task Force spear-heading strategic positions for the DG on the post-2020 Commission financial framework negotiations, Brexit co-ordination, the urban agenda and the future-proofing of the EU’s environmental acquis.
By training, Joanna is a doctor of laws from the University of Malta, where she also lectured full time in the Department of European and Comparative Law. She acquired a post-graduate degree in Advanced European Legal Studies from the College of Europe in Bruges, Belgium.
She held various legal and management posts in the private and public sector before joining the European Commission as head of the European Commission Representation in Malta in 2005. She also had a key role in the Malta-EU accession negotiations as member of the Malta-EU Steering and Action Committee.
Between 2010 and 2015 she was director for SME’s and Entrepreneurship in the European Commission’s Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs. During her tenure in DG GROW she also led the Commission’s Task Force on The Collaborative Economy, New Business Models And SME’s.
Chair of the Commission of the Republic of Slovenia for Medical Ethics
Božidar Voljč, MD, PhD is a former DG of the Primary Health Care Centre Kočevje-Ribnica and of the National Institute of the Transfusion Medicine. Between 1992 and 1997 he served as Minister of Health of Republic of Slovenia, he was also member of the Standing Committee at the WHO EURO and of the WHO Executive Board. Today he is a Chair of the National Committee for Medical Ethics, member of Task Forces at the Age Platform Europe and member of the Slovenian Medical Academy.
Head of Clinical Institute for genomic genetics, UMC Ljubljana
Borut Peterlin is head of the Clinical Institute of Genomic Medicine and has received Neurology and Medical Genetics training. He is a professor of Human genetics at the universities in Ljubljana, Belgrade, Rijeka and Osijek.
Currently, he is elected president and a past member of the Public and Professional Policy Committee of the European Society of Human Genetics. He is a member of the Board of Member States for European Reference Networks, European Commission, member of the Scientific Panel for Neurogenetics at European Association of Neurology. In addition, he is a past member of EUCERD (European Union Committee of Experts on Rare Diseases) and SCHER (Scientific Committee for Health and Environmental Risks) at DG Sanco, EU Commission.
His main professional and research interests include translation of genomic technologies into health systems and discovering new mechanisms of monogenic and complex disorders.
Application of Genomic Testing in Clinical Practice
Genomic technologies, especially new generation sequencing (NGS), has revolutionised diagnostics of rare genetic diseases. Systematic application of NGS in clinical practice resulted in significantly increased diagnostic yield, discovering new disease mechanisms, and designing novel therapeutic approaches. On the other hand, novel technologies often provide genetic information which is not linked to diagnostic hypotheses and has been incidentally revealed during the diagnostic process or could be potentially intentionally discovered in genetic data available in the diagnostic process. While such genetic information might pave the way to practical applications of personalised medicine, the medical information not directly linked to diagnostic questions raises several ethical issues regarding the provision of identified genetic risks. Similarly, genomic screenings in preconceptional, prenatal, neonatal and adult periods provide potentially helpful medical information. Nevertheless, the consensus about selecting targeted genetic information and the way of offering the screening is still a matter of active debate.
The Chair of Clinical Biochemistry, Faculty of Pharmacy, University of Ljubljana
Matjaž Jeras graduated at and received his master’s degree from the Faculty of Pharmacy, and his Ph.D. from the Faculty of Medicine, University of Ljubljana. He was first employed at the Institute of Pharmacy and Drug Research and then at the Blood Transfusion Centre of Slovenia (BTC), where he was acting as researcher, the head of the national Tissue Typing Centre and finally the Director of BTC. During this time he co-founded Slovenian unrelated bone-marrow donor registry, the national cord blood bank and the Cell and Tissue Engineering Society of Slovenia. In 2010 dr. Jeras moved to the Department of Clinical Biochemistry at the Faculty of Pharmacy, University of Ljubljana, where he is currently a full professor lecturing immunology, immunogenetics and histocompatibility, advanced therapies, as well as ethics and legislation in biomedicine. Since 2017 he is the president of the Faculty’s Steering Committee and since 2020 a deputy member of the Commission of the Republic of Slovenia for Medical Ethics. Dr. Jeras has lead 6 national and participated in 18 national and 4 international research and development projects. He published over fifty original and review scientific papers, mainly in the fields of cellular immunology, immunogenetics and histocompatibility, transplantation, biotechnology, and advanced therapies.
Ethical Aspects of Genetic Data Acquisation, Management and Dissemination
The expanding use of whole genome and exome sequencing, propelled by the next generation sequencing techniques (NGS) following the publication of human genome in 2001, has increasingly “geneticized” medicine and research (basic and clinical) in recent years. Even more, personal genomic and related health data are becoming invaluable assets for both public-funded and pro-profit entities involved in developing new drugs, therapies and diagnostics. Increasing collection of genomic-linked personal medical and biological information raises several ethical questions (e.g. privacy, security) and challenges a traditional concept of informed consent. Nowadays, in order to access large genomic datasets and health-related databases needed for genome-wide association studies (GWAS) and other research, pharmaceutical and biotech companies are developing partnerships with public (e.g. national biobanks and genomic medicine services) and private (direct-to-consumer genetic testing companies) entities which collect such data from research participants and customers. While individuals mostly support the sharing of their genetic data for research purposes (personal ethical obligation, fairness) providing that proper protective conditions are met, the for-profit nature of such information raises several questions regarding the rights of individuals, fairness and data sharing benefits, which have been innovatively addressed by the new generation sequencing and genomic data sharing startups. The identified ethical questions and tensions will be presented and discussed.
Michael P. Walsh Professor of Bioethics, Theology Department, Boston College, USA
Andrea Vicini, S.J. is Michael P. Walsh Professor of Bioethics and Professor of Moral Theology in the Boston College Theology Department. Alumnus of Boston College (S.T.L. and Ph.D.), M.D. and pediatrician (University of Bologna), he also holds an S.T.D. (Pontifical Faculty of Theology of Southern Italy, Naples). He taught in Italy, Albania, Mexico, Chad, and France. He is co-chair of the international network Catholic Theological Ethics in the World Church, lecturer, and member of associations of moral theologians and bioethicists in Italy, Europe, and the U.S. His research interests include theological bioethics, genetics, global public health, biotechnologies, environmental issues, and fundamental theological ethics. He authored Genetica umana e bene comune (2008) and co-edited: Ethics of Global Public Health: Climate Change, Pollution, and the Health of the Poor (2021); Reimagining the Moral Life: On Lisa Sowle Cahill’s Contributions to Christian Ethics (2020); Building Bridges in Sarajevo: The Plenary Papers of CTEWC 2018 (2019); Just Sustainability: Technology, Ecology, and Resource Extraction (2015). He also published: “Correcting the Genome with CRISPR: Ethical Challenges,” La Civiltà Cattolica (2021); “Reflecting on CRISPR Gene Editing,” Health Progress (2020); “Ethical Challenges of Human Genetics Today: From the Lab, through the Clinic, to the Pews,” Studia Moralia (2012).
Reflecting on Human Genetics Today: Bioethical Contributions
Human genetic research, and its clinical applications to promote diagnosis, screening, and therapy, should contribute to foster a holistic approach to human health that considers the health of individuals, families, communities, nations, and of the whole planet. Such a comprehensive and integral focus on human and planetary health is strengthened by a threefold bioethical approach that: first, encompasses a vision of human beings (anthropology) that is centered on human dignity and respect, and that aims at empowering all moral agents, particularly those who are disempowered and marginalized. Second, it requires a vision of science (epistemology) that, while searches for knowledge, strives to promote personal and social flourishing. Third, it embraces a vision of society (social ethics) that aims at eliminating social inequities and engages in promoting the common good in inclusive ways.
Vice President Head GSK Office of the Chief Medical Officer and Privacy Risk Owner for R&D
Tatjana Poplazarova is Vice President and Head of the GSK Office of RD Risk Management and Bioethics, based in Wavre, Belgium. Trained in Bioethics, she is leading the company bioethics programme that is key to upholding the highest medical and research ethics standards and decision-making in research and development. During her industry experience she has covered several roles in scientific writing, clinical operations, publications and quality and risk management. She is one of the founders of the clinical disclosure team at GSK and has been spearheading both strategic and operational aspects related to transparency of human subject research. She is an invited lecturer for Biopharmaceutical Bioethics as part of the Unesco Bioethics Curriculum and an independent ethics expert evaluator for the H2020 programme of the European Commission.
Tatjana holds an MSc degree in Biochemistry from the Zagreb University, Croatia and a joint Erasmus Mundus MA degree in Bioethics from the KU Leuven, Nijmegen and Padova Universities.
Privacy Protection of Genetics Data in Biopharmaceutical R&D
Large volumes of personal information (PI) is collected for performing R&D work, such as research subjects and patients. The genetic information is considered unique relative to other medical information that increases its sensitivity, and in particular the risk related to the protection of data privacy. The presentation will consider measures undertaken in R&D to mitigate the privacy risk and the role of Ethics Committees to ensure the ethics oversight.
Chair of the Ethics Department, Faculty of Philosophy, University of Warsaw; Chair of Committee on Ethics in Science at Polish Academy of Science
Paweł Łuków is professor of philosophy and ethics. He is the Dean of the Faculty of Philosophy, University of Warsaw, Poland, where he chairs the Department of Ethics, and the Center for Bioethics and Biolaw. He works as an ethics expert for domestic and international institutions. He has published on I. Kant’s ethics, bioethics, and philosophy of medicine. His current research focuses on human dignity and human rights in bioethical regulation and policy-making in a democratic society, equal access to health care, the ethical and legal status of the human body in transplant medicine, protection of human dignity and vulnerability in biomedical research, and ethics education of medical professionals. He is the PI of three research projects, including a Humanities in the European Research Area (HERA) project “Healthcare as a Public Space: Social Integration and Social Diversity in the Context of Access to Healthcare in Europe”. His recent publications include: “Bioethics, policy compromise, and religious pluralism”, Ethics, Medicine and Public Health 5 (2018): 99-109; “A Difficult Legacy: Human Dignity as the Founding Value of Human Rights”, Human Rights Review 19 (3) 2018: 313-329; “Pure Altruistic Gift and the Ethics of Transplant Medicine”, Journal of Bioethical Inquiry 17 (1) 2020: 95-107.
Gemma Galdon Clavell
Founder and CEO of Eticas Consulting, University of Barcelona, Spain
Dr. Gemma Galdon-Clavell is a leading voice on technology ethics and algorithmic accountability. She is the founder and CEO of Eticas Consulting, where she is responsible for leading the management, strategic direction and execution of the Eticas vision. Her multidisciplinary background in the social, ethical, and legal impact of data-intensive technology allows her and her team to design and implement practical solutions to data protection, ethics, explainability, and bias challenges in AI. She has conceived and architected the Algorithmic Audit Framework which now serves as the foundation for Eticas flagship product, the Algorithmic Audit. Her academic work has been published in Science and Public Policy, Information Policy, Ethics and Information Technology, Citizen Science Theory and Practice or Urban Studies, and in leading academic publishers such as Routledge, Springer, and Sage. Under Galdon-Clavell’s leadership, Eticas has forged the development of a new market in digital ethics and trustworthy AI, reaching all verticals including social services, healthcare, finance, government, education, cybersecurity, and more. Through the Eticas Foundation, she is also a leading voice in policy circles, having advised international organizations such as the OECD, EU FRA, the UN, or the European Parliament on issues related to applied ethics and responsible AI, and is a tech ethics adviser at international, regional and national public and private organizations. Her contributions combine academic rigor, policy experience, and a commitment to protect people in technology processes by pioneering solutions and services that translate rights and values into technical specifications. She has appeared in Forbes, Computer Weekly, Wired, El País, La Vanguardia, or Cinco Días, and is a sought-after keynote speaker and media contributor with the mission to shift the way we think about technology.
A Practical Ethics to Protect Rights and Values in AI Systems
The session will review how recent technological advances are impacting on human rights and values, and how these rights and values are changing under the impact of AI, robotics and advanced machine learning. The session will present a summary of the practical ethics solutions that are emerging in order to address the new challenges posed by such technologies.
TechETHOS Project Coordinator, Austrian Institute of Technology
Eva Buchinger is a sociologist working at the Austrian Institute of Technology (AIT), Austria’s largest contract research organization. She specializes in social systems theory and innovation policy. Her tasks include research, teaching, research management, and policy consulting. Presently, she works on “ethics of technology” and “demand-driven innovation policy”. Her long-time experience include among other roles, thematic coordinator “societal futures” at the AIT, board member of the Austrian Journal of Sociology (ÖZS) and the Interdisciplinary Journal Science & Environment (W&U), associate editor of the journal SYSTEMA, lecturer at the Vienna University of Technology and the Vienna University of Economics, president of the Research Committee on Sociocybernetics (RC51) of the International Sociological Association (ISA), board member of the Austrian Sociological Association (ÖGS) and the Viennese Sociological Association (WGS), and serving as a consultant for the Austrian government and EU institutions (ERAC, Commission).
Ethics by Design for Technologies with High Socio-Economic Impact
TechEthos aims to facilitate “ethics by design”, namely, to bring ethical and societal values into the design and development of new and emerging technologies from the very beginning of the process. The project will produce operational ethics guidelines for users such as researchers, research ethics committees and policy makers, covering technologies such as “climate engineering”, “digital extended reality”, and “neurotechnologies”. To reconcile the needs of research and innovation and the concerns of society related to these technologies, the project will explore the awareness, acceptance and aspirations of academia, industry and the general public alike and reflect them in the guidelines. TechEthos is an EU-funded project that deals with the ethics of the new and emerging technologies anticipated to have high socio-economic impact. The project involves ten scientific partners and six science engagement organizations and runs from January 2021 to December 2023. TechEthos receives funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 101006249.
Co-founder of the AI Transparency Institute
Eva Thelisson studied Economics and International Business Law at the University of Lyon III (Lyon), Humboldt Universität (Berlin) and ESSEC Business School (Paris). She obtained her Ph.D from the University of Freiburg (Switzerland). Eva’s research expertise is the in area of European Data Protection, Digital Ethics and Responsibility, Public Policy and Digital Technologies. She reflects on business incentives to generate positive business models aligning the interests of all stakeholders. She is Founding Editor of the AI Ethics Journal which is published by Springer. She launched the AI Governance Forum in March 2019 as well as the first Special Issue on AI Governance in 2020.
She co-founded the AI Transparency Institute, which is dedicated to a safe, efficient and human-centred AI. In 2021, she organised her first digital art exhibition, namely “Data Blossom” with artworks from Refik Anadol. Eva Thelisson is Fellow of the Royal Society for Arts, Manufactures and Commerce (UK).
AI Technologies in Digital Health: Benefits and Ethical Challenges
How to build an ecosystem of trust in digital health? The availability of large amounts of personal data, from multimodal sources, combined with AI and ML capacities, Internet of Things and strong computational platforms have the potential to transform healthcare systems in a disruptive way. The emergence of personalized medicine offers opportunities and raises new legal, ethical and societal challenges. A silent transformation towards a data-driven preventive and personalized medicine may improve diagnosis and therapies while reducing the cost of public health policy. In order to build an ecosystem of trust, the risks of harm and misuses such as data breaches, privacy issues, discrimination, eugenics must be addressed. This talk presents the disruptive nature of AI and ML technologies in healthcare, and makes specific recommendations to build a trustworthy digital health system. Special attention is given to the governance of AI systems by international institutions (EU Proposal on AI Regulation, OECD, Council of Europe, etc) but also on key principles like transparency, accountability and decision-making processes in a medical context.
General Director of the Norwegian National Research Ethics Committees
Helene Ingierd is the General Director of The Norwegian National Research Ethics Committees. She has been a Director of The Norwegian National Committee for Research Ethics in Science and Technology and the Ethics Committee in Patent Cases (2011- 2019), and the Director of The Norwegian National Committee for Research Ethics in the Social Sciences and the Humanities and the National Committee for Research Ethics on Human Remains (2008-2011). Ingierd holds a Ph.D. in political science from the University of Oslo and has been a Research Fellow at the Peace Research Institute, Oslo (2001-2008). She has edited several anthologies on research ethics, including Internet Research Ethics, 2015, (w/Hallvard Fossheim) and Interessekonflikter i forskning (Conflicts of Interest in Research), 2019, (w/Ingrid Bay Larsen and Kjellrun Hiis Hauge). Currently she is an Expert Group member in a project on research integrity in international research collaborations in OECD Global Science Forum.
School of Law, Ewha Womans University, Member of UNESCOS’s International Bioethics Committee (IBC)
Kyungsuk Choi was graduated from Michigan State University in U.S.A. for his Ph.D. in Philosophy (2003) and from Seoul National University in Korea for his M.A. (1996) and B.A. in Aesthetics (1991). He is working at Ewha Womans University, School of Law and Bioethics Policy Studies, as a Professor of bioethics. He is a member of Korea National Bioethics Committee and a member of UNESCO International Bioethics Committee.
He published several English papers, “Legal and Ethical Issues Regarding End-of-Life Care in Korea” (Development and Society, Vol. 45, No. 1, June 2016, 151-164), “The Ideal of Autonomy and Its Misuse” (in Family-Oriented Informed Consent: East Asian and American Perspectives, Ruiping Fan, ed., Springer, 83-91, 2015 March 5), and other Korean papers.
The Role of Ethics During the Pandemic in Republic of Korea
University of the Witwatersrand, South Africa; Member of UNESCO’s International Bioethics Committee (IBC)
Pamela Andanda is a Professor of Law at the University of the Witwatersrand (Wits), Johannesburg where she coordinates Intellectual Property Law and lectures Cyber Law and Research Methodology courses. Her research interests are in the areas of intellectual property, data protection, research integrity and ethics, biotechnology, health law and governance of research. Pamela is a member of the following international, regional and national committees: UNESCO’s International Bioethics Committee; The African Academy of Sciences – Data and Biospecimen Governance Committee; Academy of Science of South Africa (ASSAf) Standing Committee on Biosafety and Biosecurity; the Ethics Advisory Council of the International COVID-19 Data Alliance (ICODA); Strathmore University’s institutional ethics review committee and The Data and Biospecimen Access Committee of the Human Heredity and Health in Africa (H3Africa). She chairs Wits University’s advisory committee on ethics, has acted as an expert for the World Intellectual Property Organization’s Standing Committee on the Law of Patents (WIPO/SCP) and was an external expert reviewer of the World Health Organization’s Guidance document on the Ethics and governance of artificial intelligence for health, 2021.
Increasing the Impact of International Cooperation: Engaging and Involving Local Communities in the Co-production of Technology for Health Research
International cooperation in global health research has become urgent during the ongoing pandemic, which has highlighted the inequalities between countries at different stages of development. Countering these inequalities requires the active involvement of all stakeholders and co-production of technology for health research. To achieve these goals, engaging and involving local communities should be made integral to research planning and implementation to build public trust (AESA, 2020) and integrate the results with local needs (Chatfield et al., 2018). Communities should not be engaged in a tokenistic way that is only aimed at meeting regulatory requirements. A paradigm shift from doing research on the community to doing research with the community will ensure the co-production of technology for health research in a way that prioritises the needs of all stakeholders and benefits due to them. This presentation highlights the challenges of achieving more impact from international cooperation in global health research. It proposes suitable ethical approaches to engaging and involving local communities to ensure co-production of technology for health research, give communities greater control over the research process (Durose et al., 2012) and enable their collaborators to learn from them as equal partners.
University of Central Lancashire, UK
Doris Schroeder is Professor of Moral Philosophy and Director at the Centre for Professional Ethics, UCLan UK and Professor in the School of Law at UCLan Cyprus. Her academic background is in philosophy, politics and economics. Doris’ specialist areas of expertise are global research ethics, benefit sharing and inclusive research and innovation. She is the lead author of the Global Code of Conduct for Research in Resource-Poor Settings (2018) which is a mandatory reference document for Horizon Europe and now used in around lower income 50 countries. She currently leads the Wellcome Trust funded project “Leaving no-one behind in research” (2021-2025).
Equitable Research Collaborations with Partners in Resource-Limited Settings: The TRUST Code
International research collaborations are more important today than they have ever been given the growing number of global challenges. Yet, international research is still often biased towards high-income countries, from one-sided research agenda setting to unfair publication practices. At its worst, inequitable research collaborations can even lead to ethics dumping, i.e. off-shoring of unethical research from higher to lower income settings. The Global Code of Conduct for Research in Resource-Poor Settings, the TRUST code, opposes all forms of inequities in international research and guides its users to equitable research partnerships and the prevention of ethics dumping. The short, clear and jargon-free code is now applied in around 50 countries world-wide, with the European Commission being the lead adopter for Horizon 2020 and Horizon Europe. The Lead Author of the TRUST code is joined by three co-authors from Africa to provide the NEC Forum with up-to-date information on the code and its successes. This includes information on the sister code, the San Code of Research Ethics.
Partners for Health & Development in Africa, Kenya
Dr Joshua Kimani is the Clinical Research Director at the University of Manitoba/ University of Nairobi field office in Kenya (Partners for Health and Development in Africa- PHDA), implementing HIV programming/ research activities. He has the responsibility for the medical patient care of almost 40,000 marginalized sex workers has a strong and longstanding interest in research ethics and community engagement. He is a co-author of the Global Code of Conduct for Research in Resource-Poor Settings (2018).
Joyce Adhiambo Odhiambo
Partners for Health & Development in Africa, Kenya
Joyce Adhiambo Odhiambo works at the University of Manitoba/ University of Nairobi field office in Kenya (Partners for Health and Development in Africa- PHDA) supporting the implementation of HIV programming/ research activities. She represents the interests of the sex worker community, for whom she is also a peer educator. Her human rights activism is focused on access to live-savings medicines for marginalised populations in Kenya. She is a co-author of the Global Code of Conduct for Research in Resource-Poor Settings (2018).
San Council, South Africa
Leana Snyders is the Director of the South African San institute and a co-author of the Global Code of Conduct for Research in Resource-Poor Settings (2018). The San community are one of the most researched communities world-wide. Her responsibility is the liaison with researchers who would like to involve San members in research, from medical research to social science research to the transfer of traditional knowledge.
Senior Expert in the Unit D.1 Combatting Disease, DG Research & Innovation, European Commission
Katja Neubauer holds a master degree (Diplom) in biology from the University of Konstanz, Germany. She is a Senior Expert at the European Commission and has spent most of her career in the Commission’s Directorate-General for Health, in different positions both in the food safety and health area, including the one of deputy Head of Unit for Healthcare Systems during a period of more than 4 years. Katja moved recently to DG Research and Innovation where she worked on the mission on cancer, and since beginning of this year on pandemic preparedness and the R&I aspects of the newly established Health Emergency Preparedness and Response Authority (HERA). In this position, she leads a team in charge of developing the Horizon Europe partnership on pandemic preparedness, and coordinating preparedness research with HERA.
Pandemic Preparedness in the European Union, Way Forward
The European Health Emergency preparedness and Response Authority (HERA) has been established on 16 September as an internal structure of the European Commission, to become fully operational at the beginning of 2022. HERA will anticipate threats and potential health crises, through intelligence gathering and building the necessary response capacities. HERA’s scope is large in addressing serious cross-border health threats in an all-threat approach (including chemical, biological, environmental, radiological and nuclear threats of natural, accidental or intentional origin). When an emergency hits, HERA will ensure the development, production and distribution of medicines, vaccines and other medical countermeasures – such as gloves and masks – that were often lacking during the first phase of the coronavirus response. HERA is a key pillar of the European Health Union announced by President von der Leyen in her 2020 State of the Union address and will fill a gap in the EU’s health emergency response and preparedness. There is a strong role for research and innovation in achieving HERA’s objectives, in particular for horizon scanning and foresight, support of innovation, development and selection of most promising candidates for medical countermeasures, and R&I support in their production.
Vrije Universiteit, Amsterdam, The Netherlands
Lex Bouter has a tenured chair in Methodology and Integrity at the Department of Epidemiology and Data Science of the Amsterdam University Medical Centers and the Department of Philosophy of the Faculty of Humanities of the Vrije Universiteit. He is currently involved research and teaching on research integrity topics. He was professor of Epidemiology since 1992 and served his university as its rector between 2006 and 2013. Professor Bouter has supervised 77 PhD students, of whom to date 17 were appointed as professor. He is the founding chair of the World Conferences on Research Integrity Foundation.
Project Coordinator, Danish Centre for Studies in Research and Research Policy, Aarhus University
Niels Mejlgaard is a Professor at the Department of Political Science and Associate Dean at the Aarhus School of BusinessandSocial Sciences, Aarhus University. His work focuses on research policy and governance, with particular interest in issues related to responsibility and integrity in research practices. He did his PhD at Aalborg University on the notion of scientific citizenship. From 2011-18, he was the director of the Danish Centre for Studies in Research and Research Policy. He has led or participated in several European and national research projects (including MASIS, STEPE, ResAGorA, MoRRI, HEIRRI, ENERI, SUPER MoRRI, and NewHoRRIzon). He has advised the EC, national governments, and institutions on issues related to research policy, RRI, evaluation, and development of indicators of RRI and public understanding of science and controversial technologies. He presently serves on the editorial board of Public Understanding of Scienceand his work has appeared in leading field journals, including Science and Public Policy, Science and Engineering Ethics, Science as Culture, Research Evaluation, Environmental Communication, Public Understanding of Science, Journal of Informetrics, and Journal of Science Communication.
Standard Operating Procedures for Research Integrity
Organisations play an important role in promoting responsible conduct of research. By developing, implementing, and maintaining appropriate structures, policies, and procedures, organisations enable research practices that align with fundamental principles of research integrity. Based on an extensive empirical research programme, the “Standard Operating Procedures for Research Integrity” (SOPs4RI) project emphasizes the relevance of having organisational ‘Research Integrity Promotion Plans’ that outline the steps that an organisation takes to foster research integrity within the context of its mission and disciplinary orientation.
This presentation will highlight the topical areas that should be addressed in a Research Integrity Promotion Plan for research performing organisations and research funding organisations respectively. It will also discuss approaches to develop and implement a Research Integrity Promotion Plan, based on the work carried out in the SOPs4RI project.
Mariëtte Van Den Hoven
INTEGRITY Project Coordinator, University of Utrecht, The Netherlands
Prof. dr. Mariëtte vd Hoven is appointed at Amsterdam University Medical Centre and at Utrecht University. She is coordinator of INTEGRITY, an H2020 project on educational tools on research integrity and has helped built a mandatory program for PhD’s at Utrecht University. Within the Netherlands, she chairs a network group of educational developers on the topic. Next to integrity topics, she has built expertise in public health ethics and professional ethics and is (and has been) a member of medical RECs, an ethics review committee at the humanities faculty.
Empowering Students Through Evidence-Based, Scaffolded Learning of Responsible Conduct in Research (RCR)
This H2020 funded program, started in Jan 2019, has as its core focus to develop educational tools in an evidence-based manner. To this purpose, a survey was developed to get more grip on the knowledge and needs students have on research integrity topics. The results of the survey were, next to literature reviews on RCR education, used to develop a teaching philosophy on RCR education (a so-called competence profile), that takes ‘empowerment’ as a central focal point. In this presentation, I will describe what this core idea of empowerment entails and how the building blocks in the project have been used to build educational tools in a empowering and evidence-based manner.
University of Ljubljana, Faculty of Theology, member of the Commission of the Republic of Slovenia for Medical Ethics
Assoc. Prof. Dr. Roman Globokar holds the Chair of the Department of Moral Theology at the Faculty of Theology, University of Ljubljana, Slovenia. He holds courses in the field of theological ethics, bioethics and social ethics. He is a member of the National Medical Ethics Committee and participates in the National Experts Council for general education in Slovenia. He collaborates in the H2020 project INTEGRITY on educational tools on research integrity.
Research Integrity Among High School and University Students
In this presentation, we will present the results of a large-scale survey in 9 European countries on the main issues concerning research integrity among high school, undergraduate, and Ph.D. students. We will highlight the main challenges, which are plagiarism, proper citation of sources, distribution of tasks and credit in group work (collaborative practice), helping others in research, and practices related to collecting, analyzing, and presenting data, including avoiding falsification and fabrication. In particular, we will pay attention to the correlation between training in the field and ethical responsibility in research. A brief presentation of the tools developed by our partners in the Integrity project (H2020) for high school and university students will also be given.
Institute of Oncology Ljubljana, Slovenia
NAME: Branko Zakotnik, born September 14th, 1954 in LJUBLJANA, SLOVENIJA
Medical faculty: University of Ljubljana, Medical School – graduated February 1979
Postgraduate education Medical faculty Ljubljana: Cell biology and molecular biology, 1997-98
Doctoral theses 29.12.1999: Treatment of inoperable head and neck carcinoma with radiochemotherapy.
POSITIONS AND APPOINTMENTS:
Specialist of Internal Medicine and Medical Oncology, Medical Oncology Department, Institute of Oncology, Ljubljana, from December 1988
Consultant in Medical Oncocology, Institute of Oncology Ljubljana
Professor, Medical faculty Ljubljana,
President of the institutional Ethics committee at the Institute of Oncology Ljubljana¸1991-2003
President of Cancer Society of Slovenia 1994-2004
European Society of Medical Oncology (ESMO) National representative 1996-2002
Member of ESMO Educational committee 2002-2007
Coordinator of Slovenian National Cancer Plan from 2010-
MEMBER OF MEDICAL SOCIETIES:
Slovene Medical Society
ESMO (European Society of Medical Oncology)
Institutional Responsibility in Oncological Research
It is not ethical not to research in medicine, even more true in case of cancer. My focus will be on clinical studies (with patients).-
Participating entities (institutions) in the journey of clinical studies and their ethical responsabilities:
- All health institutions/clinics treating cancer patients must offer them participation in clinical studies when appropriate (if available)
- All tertiary health institions treating cancer patients should have trained personnel and facilities to perform clinical studies applying GCP. For studies in rare cancers and phase III studies collaboration between health institutions is essential (accrual time).
- Most clinical trials in oncology are witrh new drugs, pharmaceuthical companies have bocome an important partner/sponsor (impact on protocol design).
- Reaserch organisatrions are an important bridge between these partners (international research teams, design of protocols, contracts with pharma, data manegement, …). . Example: EORTC.
- Medicine agencies (EMA, FDA, national agencies) are responsable for giving green light for public use of drugs based on clinical studies (criteria, indipendence)
- Professional associations publish treatement guidelines (ex. ESMO Clinical gudelines) or even more precisely for drugs (ESMO-Magnitude of Clinical Benefit Scale)
HTA agencies – entry of new treatments into payment systems of individual countries (predefined criteria)
EnTIRE Project Coordinator, Amsterdam University Medical Centers, VU University, Amsterdam
Guy Widdershoven (1954) is emeritus Professor of Medical Philosophy and Ethics at Amsterdam UMC and VU university Amsterdam. He is a former Scientific Director of the School for Public Health and Primary Care (Caphri) of Maastricht University, and the Dutch National Research School for Primary Care Research (CaRe). He was president of the European Association of Centers for Medical Ethics (EACME).
He published on clinical ethics, especially moral case deliberation, and the theory and methodology of empirical ethics. He also published on ethical aspects of chronic care, including psychatric care and care around the end of life, particularly palliative care and euthanasia. Currently he coordinates two Horizon 2020 projects on Research Integrity: Mapping the Research Integrity Framework (EnTIRE) and Virtue based ethics and Integrity of Research: Train-the-Trainer program for Upholding principles and practices of the European Code of Conduct for Research Integrity (VIRT2UE), which initiated a platform for Research Integrity: The Embassy of Good Science.
The Embassy of Good Science
The Embassy is a grassroots approach, collecting information about good science and making it available and accessible to all researchers and other stakeholders involved in research. The Embassy is based on community work: a) Contributors add themes, resources, and training materials and tools; b) Projects showcase their activities, products, and results; c) Ambassadors promote and disseminate the platform. The information on The Embassy is constantly updated and improved by the use of Wikimedia methodology. The Embassy aims to be the go-to platyform for reserch integrity and ethics in Europe and beyond.
President of the French National Ethical Consultative Committee for Life Sciences and Health (CCNE)
Immunologist, he is a specialist in HIV and emerging viruses. He was director of the ANRS (France Recherche Nord&sud Sida-hiv Hepatites) and of the Institute of Immunology and Infectious Diseases (Aviesan-Inserm) until the end of 2016. In 2014, he was appointed interdepartmental coordinator of the response to the Ebola epidemic. He was Head of the Department of Internal Medicine at the Paris Sud University Hospital (AP-HP), and Professor at the University of Paris Sud Saclay. Prof. Delfraissy has chaired several international scientific councils on HIV/AIDS as well as a series of international congresses dedicated to infectious disease research such as the IAS World Conference in July 2017 in Paris. He has published more than 500 articles in the field of immunology, internal medicine and HIV infection. He has established close collaborations with HIV associations in France and in the South. He was named Officer of the National Order of the Legion of Honor in 2010. In 2018, as President of the CCNE, he led the Etats généraux de la bioéthique, which resulted in a summary report and an opinion 129 of the Committee. These documents are intended to enlighten French decision-makers in charge of revising the Bioethics Law which was adopted at the end of June 2021.
In 2019, he was appointed co-chair “of the Collaborative Group on Social Participation (WHO)”. He received the INSERM Honorary Award in 2019. Since March 2020, he is the President of the Covid-19 Scientific Council.
Jean-Francois Delfraissy has been president of the National Consultative Ethics Committee (CCNE) since January 2017.
Chair of the Hellenic National Commission for Bioethics & Technoethics, Greece
Effy Vayena is Professor of Bioethics at the Swiss Federal Institute of Technology (ETHZ) and renowned expert at the intersection of medicine, data, and ethics. Her work focuses on how emerging technologies in biomedicine and data analytics affect our society and what ethical safeguards we should put in place to avoid negative consequences. To address these questions, she uses different research methodologies. She founded and directs the Health Ethics and policy Lab, an interdisciplinary research lab including philosophers, social scientists, lawyers, biologists and engineers.
Vayena has been Faculty Associate at the Berkman Klein Center for Internet & Society at Harvard University, where she was previously a Fellow. She has published over a hundred peer-reviewed articles and book chapters and co-edited several books. Vayena is also an elected member of the Swiss Academy of Medical Sciences. She chairs the Ethical, Legal and Societal Implications advisory group for the Swiss Personalized Health Network, a national infrastructure and research program which aims to advance personalized healthcare in Switzerland. She co-chaired the WHO’s expert advisory group on Artificial Intelligence health ethics and governance and she was a member of the Swiss COVID19 Science Task. In May 2021 she was named chair of the Hellenic National Bioethics and Technoethics Commission. Vayena frequently advises governments and public policy organizations on matters of digitization and ethics.
National Ethics Committees; current challenges and future directions
Based on recently published research by the World Health Organization, I present the current landscape of challenges faced by national ethics committees globally. I discuss the role of national ethics committees in the COVID era and how this crisis may have affected the role of national committees. In additional I am discussing how broader technological trends such as artificial intelligence and automation will pose challenges for national committees and I suggest some directions for the future in order to ensure their sustainability and impact.
Research Ethics Coordinator, Vienna University of Technology, Austria
Marjo Rauhala (PhD, MSSc, BA) is the research ethics coordinator at TU Wien and responsible for establishing the research ethics advisory and review procedures for the entire university. With a background in philosophical and biomedical ethics and social sciences, Marjo Rauhala has broad experience in the field of research ethics. This experience encompasses academic research, ethics management and advisory tasks in engineering projects, as well as ethics review in the research funding programs of the European Union. Since FP7, Marjo Rauhala participates in the European Commission’s working groups on ethics guidance and expert panels in ethics screening, review and check/follow-up of European funded research for the European Commission’s Ethics and Integrity Sector and the European Research Council.
Exploring Alternatives: Caring Rather Than Clearing
Traditional research ethics review that is rooted in the biomedical research ethics regulation has long been considered ill-fitting in particular for social science research. Some critiques have gone as far as to question its benefits outside its original realm. In contexts where there is little experience in addressing ethical issues in research, establishing ethical review faces additional challenges. Both reviewers and researchers need to learn to identify and address ethical issues in research. In introducing the biomedical review model to other contexts, in which the awareness of experience in examining the ethical implications of research may just be evolving, an ethics committee may be misinterpreted as an instance that not only approves of research but clears the researcher from their responsibilities. In this presentation, an alternative way to set up ethics review, based on the ideas of peer review, dialogue, and mutual learning will be introduced. One of the core messages is that ethics review needs more care, and less clearance.
Edward Stellwagen Dove IV
University of Edinburgh, United Kingdom
Edward Dove is Lecturer in Health Law and Regulation at the School of Law, University of Edinburgh. He is Deputy Director of the J Kenyon Mason Institute for Medicine, Life Sciences and Law, and Director of Ethics and Integrity at the Law School. Edward’s primary research interests are in the areas of confidentiality and data protection law in the biomedical context, research ethics governance, and health research regulation. He is author of the open access monograph, Regulatory Stewardship of Health Research: Navigating Participant Protection and Research Promotion (Edward Elgar, 2020), and co-author of one of the leading medical law textbooks in the UK, Mason and McCall Smith’s Law and Medical Ethics (11th edn, Oxford University Press, 2019). Edward is Co-Chair of the Regulatory and Ethics Work Stream of the Global Alliance for Genomics and Health (GA4GH), a member of the National Data Guardian’s Panel, and a member of the Scientific Programme Committee for the European Society of Human Genetics (ESHG). He is Associate Editor of the journal Research Ethics, and an Editorial Board member of the journals Asian Bioethics Review and the European Journal of Health Law. Edward is the UK National Contact for the European Association of Health Law (EAHL) and the UK representative for the European Network of Research Ethics Committees (EUREC).
Ethics Committees: Are They Still Fit for Purpose?
As is well known, the principal aim of research ethics committees (RECs) is to protect the rights, interests, and welfare of prospective (and current) participants and to minimise risk of harm to them. Another aim is to promote ethical and socially valuable research. This phenomenon of evaluating the ethics of proposed research involving humans, and determining whether the research may proceed – and on what grounds – largely has been in existence in its current form for approximately half a century. Originally designed for review of clinical research involving healthy human volunteers, research ethics review has since expanded to cover all fields of research, including (but certainly not limited to) social science-driven health research such as qualitative studies investigating patient experiences with a disease or treatments that they receive. Given their central role in determining the bounds of ethical research, it is unsurprising to learn that RECs have been subject to sustained scrutiny; in many quarters, this has resulted in criticism within the research community that the process of research ethics review is no longer fit for purpose, particularly with respect to 21st century scientific endeavours. In this presentation, I consider the merits of this charge. I argue that RECs have become regulatory entities in their own right and are a form of social control of science. At the same, I also argue that while RECs are far from perfect in terms of regulatory design and performance, they do perform, at least in principle, a valuable role in helping to steward research projects towards an ethical endpoint; and while some modifications to their design and performance are warranted, on the whole, RECs do remain fit for purpose in the 21st century.
Marcel Jeroen van den Hoven
Rapporteur for the EGE Statement “Values for the Future: The Role of Ethics in European and Global Governance”, Member of the outgoing European Group on Ethics in Science and New Technologies (EGE)
Jeroen van den Hoven was the rapporteur of the statement European Group on Ethics (EGE) “Values for the future: the role of ethics in European and global governance” (2021). He is a University Professor at Delft University of Technology and Editor in Chief of the journal Ethics and Information Technology (Springer Nature). He served on the WHO taskforce that drafted the Ethics Guidelines for AI in Health (2021). He recently published Evil Online (with Dean Cocking, Wiley, 2018) and Designing in Ethics (with Miller and Pogge (eds), Cambridge University Press, 2017).
Values for the Future: The Role of Ethics in European and Global Governance
The Statement of the EGE on Values for the Future of Europe provides perspectives on the role of ethics in human societies and their governing institutions. It emphasizes the importance of ethics for the future of Europe, the need for a more ambitious and proactive type of ethics and stresses the close links between ethics and participatory governance and democratic principles. The talk will clarify what such an ambitious and proactive ethics entails and which challenges it will face.
Head of the Ethics and Research Integrity Sector, DG Research & Innovation, European Commission
Isidoros Karatzas is a biochemist and psychologist by training. After joining the European Commission, he was responsible for the ex-post evaluation of the Framework Programme. Isidoros managed the risk governance research file and was the scientific secretary of the European Research Advisory Board (EURAB), a high-level body that advised the Commission on research policy and research priorities. Currently, he is the head of the Research Ethics and Integrity Sector in DG Research and Innovation. As head of the Sector, he established the Ethics Appraisal process for the research Framework Programmes, initiated advanced training courses on research ethics for Commission staff and the research community and has set up the first European system on ethics checks and follow-up. In addition, the sector oversees the research integrity policy activities, including the relations with relevant stakeholders such as ALLEA, LERU, Science Europe and the business community.