The nurse researcher reviews the proposed informed consent form for a futur
The nurse in the clinical research setting is knowledgable about ethical principles and protection of human subjects. What principle is demonstrated by ensuring the patient's right to self-determination? a. Beneficence b. Respect for persons c. Justice d. Informed consent - Correct Answer B The research nurse is meeting with a patient and determines, based on the assessment, that the patient meets inclusion criteria for clinical research. The patient agrees to participate in the clinical trial. The nurse advises the patient that which member of the health care team has the responsibility to explain the study and respond to questions? a. Registered Nurse b. Pharmacist c. Research associate d. Health care provider - Correct Answer D The clinical research nurse knows that only a small proportion of drugs survive the research and development process. An appreciation of the process and associated costs grows when the nurse is aware that approximately one in how many potential drugs is approved by the U.S. Food and Drug Administration? a. 100 b. 1,000 c. 10,000 d. 100,000 - Correct Answer C The nurse is interviewing a patient in a Phase I clinical trial. Which patient statement indicates an understanding of this trial phase? a. I am doing this to be sure this drug is safe. b. I am doing this to be sure this drug is effective c. I hope this drug is better than the current treatment. d. I can be part of demonstrating a cure. - Correct Answer A The foundation of clinical trials, Good Clinical Practice, is a helpful resource for nurses. The nurse is correct in choosing Good Clinical Practice as a reference for standards in which areas? (Select all that apply) a. Design b. Monitoring and auditing c. Analyses
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