KULeuvenX: Research Ethics: a guide for responsible research with human subjects

• What research ethics is
• Why ethics is necessary in research
• What are the main ethical issues in research
• How researchers can actively engage with ethics when undertaking research
• Which ethical considerations must be made in research involving human subjects
• What ethical codes and guidelines researchers must follow and the ethical principles that shaped them
• How to assess risks and benefits of research
• What the role of a Research Ethics Committee is
• What are the criteria for a valid informed consent
• How to do research with vulnerable individuals and populations
• How to protect participants’ privacy and confidentiality
• How to identify ethical misconduct in research and understand how to avoid it
• How to critically think of research and apply ethical reasoning

Module 0: Course introduction.
Introduction to the edX platform, the course team, the main topics and goals covered in this MOOC.

Module 1: Responsibility in research.
Discuss the importance of doing responsible research and the role of researchers in society.

Expert speakers module 1 :

• Dr. Rene Von Schomberg , Guest Professor at the Technical University of Darmstadt.
• Prof. Kim De Keersmaecker , Associate Professor at the Faculty of Medicine of KU Leuven, Head of the Laboratory for Disease Mechanisms in Cancer.
• Prof. Giselinde Kuipers , Professor at the Faculty of Social Sciences of KU Leuven, Coordinator of the Centre for Sociological Research.
• Prof. Séverine Vermeire , Full Professor at the Faculty of Medicine of KU Leuven, Research Coordinator of the Biomedical Sciences Group.
• Prof. Diether Lambrechts , Full Professor at the Faculty of Medicine of KU Leuven, Head of the Laboratory of Translational Genetics (VIB-KU Leuven).
• Prof. Liesbet Geris , Professor Faculty of Engineering Science and at the Faculty of Medicine of KU Leuven.

Module 2: Ethics Infrastructure and Governance.
Examine the ethical guidelines and the historical scandals that prompted them. Understand the importance of doing a risk and benefit assessment when designing a research project. Examine ethical challenges of clinical research. Learn about the role and mandate of Research Ethics Committees.

Expert speakers module 2 :

• Dr. Alice Cavolo , Senior Researcher at the Centre for Biomedical Ethics and Law at KU Leuven.
• Prof. Stefaan Callens , Full Professor of Health Law at the Faculty of Medicine of KU Leuven, Member of the Centre for Biomedical Ethics and Law at KU Leuven.
• Dr. Raffaella Ravinetto , Senior Researcher at the Institute of Tropical Medicine Public Health Department.
• Prof. Dieter Baeyens , Associate Professor at the Department of Parenting and Special Education of KU Leuven, Chair of the Social and Societal Ethics Committee (SMEC) of KU Leuven.
• Prof. Minne Casteels , Full Professor of Pharmacology at the Department of Pharmaceutical and Pharmacological Sciences of KU Leuven, Chair of the Ethics Committee Research UZ / KU Leuven.

Module 3: Informed consent: informing participants.
Focus on the information that researchers must provide to participants for consent to be valid. Identify key obstacles to an adequate informed consent and learn about the strategies to overcome them.

Expert speakers module 3 :

• Dr. David Kirchhoffer , Director of the Queensland Bioethics Centre at the Australian Catholic University’s Brisbane Campus.
• Prof. Pascal Borry , Full Professor of Bioethics at the Centre for Biomedical Ethics and Law at KU Leuven.
• Kamiel Verbeke , PhD candidate with an expertise on Deception Studies at the Center for Biomedical Ethics and Law at KU Leuven.
• Evelien de Sutter , PhD candidate with an expertise on Electronic Informed Consent at the Clinical Pharmacology and Pharmacotherapy unit of KU Leuven.
• Dr. Hélène Nobile , Associate Researcher at the Institute for Ethics, History and Philosophy of Medicine at the Medical School Hannover.
• Dr. Emilia Niemiec , Associate Researcher at Lund University.

Module 4: Informed consent: obtaining consent.
Understand the 'consenting' part of the informed consent and the voluntary nature of the decision to participate in research. Consider how pressures and incentives affect participants’ ability to consent. Reflect on the right to withdraw as a safeguard for voluntary consent.

Expert speakers module 4 :

• Dr. Hélène Nobile , Associate Researcher at the Institute for Ethics, History and Philosophy of Medicine at the Medical School Hannover.
• Dr. Emily Largent , Assistant Professor of Medical Ethics & Health Policy at the Perelman School of Medicine.
• Prof. Pascal Borry , Full Professor of Bioethics at the Centre for Biomedical Ethics and Law at KU Leuven.

Module 5: Vulnerable participants.
Understand what vulnerability means in the research context. Focus on the ethical challenges of including vulnerable individuals or groups in research.

Expert speakers module 5 :

• Prof. Chris Gastmans , Head of the Centre for Biomedical Ethics and Law at KU Leuven, Full Professor of Medical Ethics.
• Dr. Virginia Sanchini , Adjunct Professor of Clinical Ethics at University of Milan, Visiting Research Fellow at the Centre for Biomedical Ethics and Law at KU Leuven.
• Dr. Raffaella Ravinetto , Senior Researcher at the Institute of Tropical Medicine Public Health Department.
• Dr. Bege Dauda , Postdoctoral Fellow at University of Pennsylvania.
• Prof. Angus Dawson , Professor of Bioethics and Director of Sydney Health Ethics at the University of Sydney.

Module 6: Privacy and confidentiality.
Be aware of the challenges to maintain privacy and confidentiality in research. Identify the ethical concerns surrounding different types of data.

Expert speakers module 6 :

• Leonardo Cervera Navas , Director of the Office of the European Data Protection Supervisor.
• Dr. Griet Verhenneman , Data Protection Officer at UZ Leuven, Research Fellow at the Centre for IT and IP Law KU Leuven.
• Prof. Mahsa Shabani , Assistant Professor of Privacy Law at the University of Ghent.
• Dr. Effy Vayena , Professor of Bioethics at the Swiss Federal Institute of Technology, Visiting Professor at the Centre for Bioethics at Harvard Medical School, Faculty Associate at the Berkman Klein Center for Internet and Society.
• Prof. Maarten Larmuseau , Associate Professor of Genetic Genealogy at KU Leuven.
• Dr. David Resnik , Bioethicist at the National Institute of Environmental Health Sciences of the National Institutes of Health.

Module 7: Research integrity.
Understand the difference between research integrity and research ethics and recognize key values and principles in research integrity. Focus on identifying research misconduct practices and critically reflecting on grey areas of research integrity. Learn how conflict of interest is related to research integrity.

Expert speakers module 7 :

• Prof. Kris Dierickx , Full Professor of Medical Ethics at the Faculty of Medicine at KU Leuven, Member of the Centre for Biomedical Ethics and Law at KU Leuven.
• Dr. Steven de Peuter , Senior Researcher at the Faculty of Psychology and Educational Sciences at KU Leuven.
• Inge Lerouge , Research Integrity Coordinator at KU Leuven.
• Prof. Joeri Tijdink , Assistant Professor at the Philosophy Department and at the Ethics, Law and Humanities department of the Amsterdam UMC.

Module 8: Final exam.
Final multiple-choice quiz.