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OBJECTIVES

Trainees learn through case discussions how to identify and resolve common ethical dilemmas that arise in clinical research, how research on human subjects is regulated by the federal government, and what constitutes research misconduct. Trainees resolve the ethical considerations involved in the research protocol they develop in the Designing Clinical Research course. This course provides a more in-depth analysis of research ethics than the website course required by the UCSF Committee on Human Research.

PREREQUISITES

Possession of a MD, PhD, DDS or PharmD or equivalent doctoral degree. Exceptions to these prerequisites may be made with the consent of the Course Director, space permitting.

Required Assignments:
All students who have not already completed the on-line HIPAA training for research should do so as soon as possible.

All students must complete the on-line CHR human subjects training available at http://research.ucsf.edu/chr/Train/chrTrain.asp#citi as soon as possible. This on-line training provides an overview of the regulations that govern human subjects research and protocols that require CHR approval. We will not be covering this material in class, but you will need to understand these principles to complete the course assignment. You will need a login name and password to access the training. If you have completed the on-line course in the last two years, you do not have to complete it again.

New this year: online discussion group each week. Please go here for details on this course requirement.

FACULTY

TEXTBOOK

Ethical Issues in Clinical Research: A Practical Guide by Bernard Lo. Lippincott Williams & Wilkins. 2009.

GRADING

This course is offered on a Satisfactory/Unsatisfactory (S/U) basis only.

ENROLLMENT

To enroll please see the application section of the Summer Clinical Research Program.