Bioethics and Regulatory Issues in Clinical and Translational Research

Catalog description

This course provides a spectrum of trends with a broad base on the ethical, legal and regulatory aspects that govern the practice of clinical research. These aspects will be discussed based on the actual definitions and situations that will provide the par ticipants with perspectives of the research process in its multiple manifestations. The course will discuss the historic framework that supports the ethical, legal and regulatory aspects of research. The development, enactment, and enforcement of all applicable principles, regulations and laws that govern the research enterprise will be discussed, interpreted, and analyzed. The course will emphasize principle-based ethics. This course is offered through the online modality.