Ethical and Legal Aspects of clinical trials
Planned for Autumn 2020
University of Basel
The implementation of clinical research projects requires conscientious review of research projects not only in terms of their scientific quality but also in regard to their ethical adequacy and appropriateness. How can we balance the risk benefit of our projects? Given the importance of ethics for the conduct of drug development and research, it should come as no surprise that many different professional associations, government agencies, and universities have adopted specific codes, rules, and policies relating to research ethics.
Each of these aspects will be carefully considered and discussed in the context of international and national principles and guidelines. These issues need to be carefully adhered to strengthen the health of the clinical trial enterprise to the benefit of patients and the overall health of the public. During our course, representatives from different institutions will introduce and discuss the most important concepts, tools, principles, and methods that can be useful in approaching and resolving ethical dilemmas. Realworld examples and case studies will be introduced and discussed.
By the end of the course, students will be able to:
Name key principles of ethical considerations during clinical research and development
Discuss ethical concerns for designing, conducting and reporting the results obtained through the conduct of clinical trials
Understand international and national principles and guidelines which have to be followed when performing clinical trials
All pharmaceutical and health care professionals who are interested to get a deeper understanding of ethical and legal aspects in medicines development
The course incl. assessment provides 2 ECTS credits.