390.673.01 ETHICAL AND REGULATORY ISSUES IN CLINICAL RESEARCH
- Franklin Adkinson
Explores and examines the ethical issues central to clinical research, reviews current regulations for clinical investigation, promotes understanding of the function and procedures of Institutional Review Boards, and better appreciation of the role of good clinical practices for clinical trials.
Upon successfully completing this course, students will be able to: • Observe the ethical underpinnings of human subjects research. • Identify good clinical practices for clinical trails, including the use of standard operating procedures. • Identify the requirements and procedures for IRB approval of human subject research, including recent HPPA regulations. • Integrate modern ethical standards and regulatory requirements into design of a clinical investigation.
- Monday 5:30 - 8:30