Research involving human subjects: ethical and regulatory issues.

A history of past abuses on research with human subjects has led to various sets of rules that are designed to insure ethical practices to protect research subjects appropriately. To understand these rules, it is important to appreciate the significant differences between being a patient, where protecting the best interests of that patient is the primary goal, and being a research subject, where that is generally not the case. In the research setting, there can be a conflict between attempting to answer the research question, and doing what is best for the subject. The rules for conducting research with human subjects attempt to manage this conflict in an ethically acceptable manner. This chapter provides an overview of those rules, including a somewhat extended discussion of the U.S. "Common Rule" as a particular example.