This course consists of 3 modules.
Module 1: Introduction into research ethics
In this module, students are introduced in the ethical and regulatory aspects of clinical trials involving human subjects. Starting from an historical overview of cases, the major ethical legal issues in clinical research will be explored. Second, the continuous need for good regulation and practice will be illustrated. Finally, students will be introduced in the ethical and legal frameworks that apply to clinical research in Belgium and Europe. The module will also inform students on how to submit an application at the relevant ethics committee.
Module 2: Protocol writing
In this module, students are introduced in the basics of protocol writing. The key questions that students are faced with when writing a protocol will be addressed: What should a protocol look like? What choices are to be made with regard to the design, recruitment, analysis, risk-management, return of results, incentives? How should be formally complied with ethical guidelines and regulatory requirements? What are the tips and tricks for writing the patient information and consent forms? Students can bring an own research proposal for exploring how to deal with the before named issues in practice.
Module 3: Informed consent
The process of informed is complex. Everything starts by drafting understandable participant information and consent forms. In this module, students will exercise in writing participant information forms and consent forms, starting from their own research. Once the written documents have been drafted, exercises in the oral consent discussion will be performed. Key questions will come to the surface: How do researchers deal with (unexpected) questions from research participants? What does a good consent discussion look like? Which tips and tricks will enhance the practice?
This course will be given by Prof. dr. Wim Pinxten.
If you follow the three modules, this is eligible for 1 course (Transferable skills) within the miminal requirements of the DS M&LS.
- Module 1: May 2, 2016; 13:00-15:30
- Module 2: June 23, 2016; 13:00-15:30
- Module 3: September 13, 2016; 13:00-15:30
- To be determined
- Registration closed since April 3.
- Max. 20 participants
- As places are limited, registration does not automatically imply that you will be able to participate. You will be contacted by e-mail in due time.