CLI 8501 Ethical and Legal Issues in Clinical Research
Although there has long been an emphasis on the conduct of ethical research, advances in genomics, in individualized precision medicine, and the globalization of clinical trials have resulted in an increasingly complex regulatory and legal structures to protect the rights and welfare of research participants. This course is intended to engage the students in consideration of the ethical and legal aspects of designing, conducting and reporting clinical research. They will review regulations, guidance statements and legal court decisions, as well as engage in discussions about how best to conduct research in respect of human subjects.