Management of Clinical Trials - Ethical and Legal Aspects (2024)

Micro-credential

The micro-credentialed Short course Ethical and Legal Aspects corresponds to module 3 of the DAS in Management of Clinical Trials.

• Understand the principles of Human Subject research ethics.
• Demonstrate knowledge of the informed consent process.
• Recognise the importance of data protection and confidentiality in clinical studies.
• Explain the purpose and function of Research Ethics Committees (EC).
• Evaluate risks and benefits associated with research participation.
• Identify and address ethical considerations for vulnerable populations in clinical trials.
• Apply principles of Good Clinical Practice (GCP) in clinical trial management.
• Familiarise with the legal frameworks governing Human Subject Research, including interventional studies with investigational medicinal products and medical devices, in Switzerland, Europe, and the United States.
• Familiarise ethical issues related to biobanks in clinical research.

Healthcare professionals, researchers, and individuals involved in Human Subject Research, including clinical trial managers, coordinators, monitors, scientists, and regulatory affairs specialists.

• Ethical decision-making in clinical research and clinical trial management.
• Compliance with regulatory requirements and Good Clinical Practice standards.
• Effective communication with stakeholders regarding ethical considerations.
• Understanding of regulatory framework and processes.
• Critical thinking and problem-solving in addressing ethical dilemmas in biobanking and clinical research.

Director(s)

Prof. Youssef DAALI and Prof. François CURTIN, Faculty of Science and Faculty of Medicine, University of Geneva

The course is accredited by Swissethics, Swiss Association of Pharmaceutical Professionals (SwAPP), Swiss Society of Clinical Pharmacology and Toxicology (SGKPT-SSPTC), Swiss Institute for postgraduate and continuous medical education (SWIF-ISFM).

a) Holders of a university master’s degree or doctorate in science, medicine or pharmacy or a qualification deemed equivalent;
or a bachelor’s degree in nursing from a Swiss University of Applied Sciences;
or a qualification deemed equivalent or professional experience deemed equivalent by the programme directors.

b) Good oral and written comprehension of English (equivalent to level B2-C1)

• Prof. Gerrit Borchard, President of the Section of Pharmaceutical Sciences (ISPSO), Faculty of Science, University of Geneva
• Prof. Alexandra Calmy, Vice-Dean of clinical research, Director of the Clinical Research Centre (CRC), Head of HIV/AIDS Unit, Associate Physician, Department of Infectious Diseases, Geneva University Hospitals
• Prof. Youssef Daali, Head of the Pharmacological Investigation Unit, Geneva University Hospitals, Faculty of Medicine, University of Geneva
• Prof. Antoine Geissbuhler, Dean of the Faculty of Medicine, University of Geneva
• Dr Olivier Huber, President, Cantonal Commission on Human Research Ethics, Canton of Geneva
• Prof. Samia Hurst, Director, Institute of Ethics, History and Humanities (iEH2), Faculty of Medicine, University of Geneva
• Prof. Arnaud Perrier, Medical Director, Geneva University Hospitals

• Dr Emilie Alirol, Senior Director Clinical Affairs, FIND
• Dr Enrica Alteri, Pharmaceutical consultant, former Head of Human Medicine R&D Support Division, EMA
• Prof. Francois Curtin, Medical Director Personalised Health Programmes, Swiss Federal Institute of Technology in Zürich & Lecturer at Geneva University Hospitals, University of Geneva
• Prof. Youssef Daali, Head of the Pharmacological Investigation Unit, Geneva University Hospitals, Faculty of Medicine, University of Geneva
• Dr Patricia Delaite, Chief Medical Officer, Nouscom, Basel
• Dr Catherine Deloche, Chief Operating Officer, Solid Drug Development, Geneva
• Prof. Jules Desmeules, Faculty of Medicine, University of Geneva
• Prof. Philippe Ducor, Faculty of Law, University of Geneva
• Prof. Marc Froissart, Full Professor Clinical Research, Faculty of Biology & Medicine - FBM, UNIL, Lausanne
• Prof. Angèle Gayet-Ageron, Head of the Methodological Support Unit, Clinical Research Centre (CRC), Geneva University Hospitals, Faculty of Medecine, University of Geneva
• Prof. Angela Huttner, Associate Professor, Department of Infectious Diseases, Geneva University Hospitals, Faculty of Medicine, University of Geneva
• Dr Cyril Jaksic, Statistician, Methodological Support Unit, Clinical Research Centre (CRC), Geneva University Hospitals
• Dr Françoise Lascombes, External Consultant
• Dr Guillaume Perriard, PhD, Lead patient Engagement, Novartis, Basel
• Dr Victoria Rollason, Division of Clinical Pharmacology and Toxicology, Geneva University Hospitals and Faculty of Medicine, University of Geneva

• Copy of identity document
• Passport photo
• Curriculum Vitae
• Copies of relevant university degrees
• Covering letter
• Two reference letters
• Written authorisation from their employer, if applicable