Protecting Patients During Clinical Research

Clinical research, once performed primarily at academic medical centers, now occurs in virtually every practice setting. These studies are funded by more than $18 billion per year from the National Institutes of Health and $17 billion per year from pharmaceutical companies.¹ As a result, most critical care nurses are likely at some point to provide care for patients enrolled in a clinical research study of a device or drug. Many critical care nurses are also performing their own nursing research in order to promote research-based nursing practice. Critical care patients are exceedingly vulnerable from a research perspective. Such patients are very ill, may have cognitive impairment, and depend on the healthcare team for their survival. Patients’ family members may be too anxious to consent objectively to enrolling their loved one in a research study. Therefore, critical care nurses must understand and use ethical principles and follow federal guidelines regarding...