Clinical research and the development of new drugs: issues for nurses.
Critical care nurses are frequently exposed to clinical trials for either new medications, equipment, or procedures. This article discusses the FDA regulatory requirements as well as the guidelines for conducting human research involving investigational new drugs. The role of the critical care nurse caring for patients enrolled in clinical trials is also discussed.
Holaday
Bonnie
B
Clemson University, E 106 Martin Hall, Clemson, SC 29634-5713, USA. holday@CLEMSON.edu
Mills
Debra M
DM
D035843:Biomedical Research / Q000941:ethics* / Q000458:organization & administration; D002986:Clinical Trials as Topic / Q000451:nursing*; D017277:Drug Approval / Q000379:methods / Q000458:organization & administration*; D015507:Drugs, Investigational; D026690:Ethics, Clinical; D004993:Ethics, Nursing; D006801:Humans; D012107:Research Design / Q000592:standards; D014481:United States
D015507:Drugs, Investigational