chapter  4
18 Pages

Enticement, Enrollment, and Engagement

The Informed Consent Process

The informed consent process is one of the most important elements in the conduct of clinical trials. Yet, historically, the compromise of the ethical principles underlying informed consent has been the cause of some of the most troubling and ethically challenged research studies ever conducted. In this chapter, we will discuss the informed consent process from recruitment to screening, enrollment, and throughout the duration of the study.