Clinical Investigators I: Basic GCP

At the end of the course, participants should be able to

• Explain the importance of conducting research involving human participants for the advancement of biomedical sciences and in the interest of public health
• Explain the importance of protecting human participants in the design, conduct and followup of research projects involving human beings
• Describe the fundamental principles of human research participant protection including autonomy, beneficence, non-maleficence and justice
• Identify and describe the basic documents of reference in research ethics (from Declaration of Helsinki to ICH-GCP) including the applicable law and regulation in Switzerland
• Describe how conflicts of interest may impact the design, conduct and follow up of a research project and what are the main measures to limit them
• Explain the negative impact of fraud and science misconduct and name measures to act against them
• Identify the basic rules of research ethics applicable in given situations and apply them to solve simple cases, in particular:
  • Assuring a proper balance of the risks and the benefits in a given research project (defining and assessing the risks) 
  • Obtaining a valid informed consent, including in situations where potential participants are legally incompetent (minors/incapacitated adults) or from a vulnerable group 
  • Respecting the privacy of the participants as well as the data protection requirements in collecting, processing and storing data/human biological materials
  • Obtaining ethical clearance from the competent Research Ethics Committee (REC)
• Describe the responsibilities of investigators in the protection of human participants and how they have the capacity to face them