CTA 5500 - Ethical and Legal Issues in Clinical Research

Generally, biomedical professionals are expected to learn the high standards of their chosen profession by example and experience. In the area of clinical trials that involve human volunteers, the assimilation of ethical standards cannot be left to chance. Personnel involved in clinical trials must balance the dual goals of scientific merit and ethical acceptability. Ethical principles (respect for autonomy, non-maleficence, beneficence, justice), and other ethical concerns (privacy, confidentiality, compassion, relationships among patients and professionals) are studied and applied to contemporary problems in medicine and clinical research. This course is designed to be practical, incorporating the use of case studies that illustrate problems arising in the design and conduct of research trials.

Credits: 3 hrs.