Compassionate use in research.
Critical care nurses may be involved in clinical trials involving medications, devices, or treatments. Occasionally, there may be a patient who does not meet the inclusion criteria for the clinical trial and has a condition that is not responding to approval therapies. In these cases, compassionate use may be necessary. This article discusses the definition of compassionate use, when it is appropriate, how to gain approval, and the nurse's role in caring for these patients.
Miracle
Vickie A
VA
Bellarmine University School of Nursing, Louisville, Kentucky 40223, USA. vmiracle@aol.com
D000293:Adolescent; D000368:Aged; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence / Q000451:nursing; D003422:Critical Care / Q000941:ethics / Q000331:legislation & jurisprudence; D015507:Drugs, Investigational / Q000627:therapeutic use*; D004645:Empathy; D006801:Humans; D008297:Male; D024802:Nurse's Role; D018579:Patient Selection; D035703:Therapies, Investigational / Q000941:ethics / Q000451:nursing; D014481:United States; D014486:United States Food and Drug Administration
D015507:Drugs, Investigational