Ethical and Legal Issues in Clinical Research

2 units

This course prepares clinical researchers to critically evaluate ethical and regulatory issues in clinical research. The principal goal of this course is to prepare clinical researchers to identify ethical issues in clinical research and the situational factors that give rise to them, to identify ethics and compliance resources, and to foster ethical problem-solving skills. The course aims to deliver practical guidance for investigators through discussion of critical areas of clinical research ethics. An additional aim of the course is to enable participants to recognize the different ways in which research participants may be vulnerable and the ethical issues raised by including and excluding vulnerable participants. By the end of the course, participants will understand the regulatory framework that governs human subjects research and the distinction between compliance and ethics; be able to identify major ethical concerns in the conduct of clinical research, including situational factors that may give rise to ethical concerns; and be able to apply an ethical problem-solving model in clinical research. Please contact the MSCI Program for permission to enroll in this course.