title: Ethical issues in clinical trials.
abstract: The oncology nurse may assume many different roles in clinical trials, including direct care provider, educator, advocate, data collector, primary investigator, and member of the IRB. Regardless of the role, the nurse is in a key position to promote the interests of the individual subject as well as helping to assure that the clinical trial is conducted with scientific and ethical integrity. The nurse can help to assure that the subject is adequately informed and facilitate rational decision making. The nurse can also assure that the requirements of the protocol are consistently attended to and that subjects are well monitored and data precisely collected. "In oncology, perhaps more than in any other medical specialty, there is a blurring of the distinction between research, therapeutic innovation, and medical practice. The frontiers of knowledge in cancer are continuously advancing. The final step in the process of procuring usable knowledge is the clinical trial, a meeting place of the practice of medicine and clinical research. Because of this there are many ethical considerations which must be attended to in the justification of and conduct of a clinical trial.
authors.affiliation: Collaborative Intramural Program, National Center for Nursing Research, National Institutes of Health, Bethesda, MD 20892.
authors.forename: C
authors.initials: C
authors.lastname: Grady
mesh_terms: D026686:Beneficence; D002986:Clinical Trials as Topic; D004992:Ethics, Medical; D035082:Federal Government; D033161:Government Regulation; D007258:Informed Consent; D009369:Neoplasms / Q000451:nursing / Q000628:therapy*; D009859:Oncology Nursing / Q000379:methods / Q000592:standards; D010344:Patient Advocacy; D026684:Personal Autonomy; D016032:Randomized Controlled Trials as Topic; D035842:Research Subjects; D018570:Risk Assessment; D012380:Role; D012935:Social Justice; D036302:Therapeutic Human Experimentation; D035501:Uncertainty