McCuistion Pharmacology A Patient-Centered Nursing Process Approach, 10th Edition

If a nurse suspects that a patient is being coerced to participate in the study, the nurse should report this to the principal investigator. When a patient verbalizes participation based on a financial reward, there is a potential element of coercion. DIF: Cognitive Level: Applying (Application) TOP: Nursing Process: Nursing Intervention MSC: NCLEX: Management of Client Care 7. Which is the characteristic of preclinical in vivo testing? a. A comparison of experimental and control data in animals b. A study conducted in a test tube in a laboratory c. A study that determines the effects of the placebo in human participants d. A study to assess the seriousness of the disease to be treated ANS: A Preclinical in vivo testing is performed in animals or other living organisms. In vitro studies occur in test tubes. Safe therapeutic dose studies are part of clinical research. Prior to clinical trials, an assessment is made of the disease and its seriousness. DIF: Cognitive Level: Understanding (Comprehension) TOP: Nursing Process: N/A MSC: NCLEX: Management of Client Care 8. Many drugs marketed in the 1980s may not be effective in a majority of the population. The nurse understands that this is because these drugs: a. did not pass through the appropriate phases of clinical trials. b. did not require human subject protections and are invalid. c. were not tested in women, minorities, or children. d. were tested on healthy subjNects only. ANS: C Drug research was historically performed only with Caucasian males, causing uncertainty as to the validity of the research results in the broader population. DIF: Cognitive Level: Understanding (Comprehension) TOP: Nursing Process: N/A MSC: NCLEX: Management of Client Care 9. The nurse is assisting with data collection in a study of drug effects in as mall group of healthy subjects. The nurse assists with blood and urine collection to determine serum drug levels and the presence of metabolites in urine. Which phase of drug development does this represent? a. Phase I b. Phase II c. Phase III d. Phase IV