Research in Clinical trials
Objectives
Understand the history behind the development of Human Subjects Protection guidelines
To identify and describe the three principles of ethical human subjects research identified in the Belmont Report
To identify risks associated with participation in research and appropriate protections against risks, vulnerable populations that need specific protections, and situations in which research involving humans is exempt from regulatory requirements
Identify the essential elements of an informed consent form
Describe the nurse’s role as patient advocate in research situations
submit a Word file that summarizes the essential elements of informed consent, special populations that require special legal and ethical research considerations, and the nurse’s role in advocating for the patient in research situations.
