LAUSR

OBJECTIVES To describe the increasing complexity and scope of clinical trials research, convergent research, and the clinical nurse roles and responsibilities to ensure safe patient care and study data integrity. DATA SOURCES Textbooks, journal publications, federal regulations, US Food and Drug Administration documents, clinical practice guidelines. CONCLUSION The immune system, genetics, and molecular pathology are not new in the context of oncology treatments. The reliability and clinical validation of in vitro diagnostic medical devices is, however, becoming increasingly more important in the development of marker driven targeted therapies, immunotherapy, and adoptive T-cell transfer. Protecting patients and preserving the integrity of clinical trials is of utmost importance. IMPLICATIONS FOR NURSING PRACTICE The role and scope of oncology and research nurses will intersect and shift as clinical care continues to involve high-acuity patients who participate in complex in vitro diagnostic and therapeutics clinical trials. The expertise of oncology nurses may vary in skills and knowledge domain; however, all scopes of practice are underpinned by the nursing code of ethics to ensure accountability for all aspects of patient care.