TEST BANK FOR PHARMACOLOGY 10TH EDITION BY MCCUISTION / McCuistion: Pharmacology: A Patient-Centered Nursing Process Approach, 10th Edition; complete test bank, all the chapters

Chapter 02: Drug Development and Ethical Considerations McCuistion: Pharmacology: A Patient-Centered Nursing Process Approach, 10th Edition MULTIPLE CHOICE 1. The nurse is obtaining consent from a subject newly recruited for a clinical drug trial that will last for 6 months. All subjects will be given gift certificates for participating. One subject says, “Well, I guess if the drug doesn’t work, I’ll just have to put up with the symptoms for 6 months.” What will the nurse tell the subject? a. “Participation for the duration of the study is required.” b. “Participation may end at any time without penalty.” c. “Withdrawal from the study may end at any time, but the gift certificate will not be given.” d. “You can request placement in the treatment group.” ANS: B All participants have the right to autonomy, which is the right to self-determination. Patients have the right to refuse to participate or to withdraw from a study at any time without penalty. Patients generally are not allowed to choose participation in either the treatment or the control group. DIF: Cognitive Level: Understanding (Comprehension) TOP: Nursing Process: Nursing Intervention MSC: NCLEX: Management of Client Care 2. The nurse is assisting with a clinical drug trial in which the side effects of two effective drugs are being compared. A patient who would benefit from either drug has elected to withdraw from the study, and the nurse assists with the paperwork to facilitate this. This is an example of a. autonomy. b. beneficence. c. justice. d. veracity. ANS: A All participants have the right to autonomy, which is the right to self-determination. Patients have the right to refuse to participate or to withdraw from a study at any time without penalty even if the health care provider disagrees with that choice. DIF: Cognitive Level: Understanding (Comprehension) TOP: Nursing Process: N/A MSC: NCLEX: Management of Client Care 3. During a clinical drug trial for a new medication, researchers note a previously unknown serious adverse effect occurring in more than 50% of subjects. The study is discontinued. Which ethical principle is being exercised? a. Beneficence b. Justice c. Respect for persons d. Veracity TEST BANK FOR PHARMACOLOGY 10TH EDITION BY MCCUISTION TESTBANKWORLD.ORG N ANS: A Beneficence is the duty to protect subjects from harm. Once a serious adverse effect is noted and it is determined that the benefits do not outweigh the risks of the study, researchers have an ethical obligation to stop the study. DIF: Cognitive Level: Understanding (Comprehension) TOP: Nursing Process: N/A MSC: NCLEX: Management of Client Care 4. In a 5-year experimental clinical trial to investigate a new cancer treatment, researchers in the second year note overwhelming improvement in almost all of the subjects in the treatment group. It is decided to stop the trial early and report the findings due to the overwhelmingly beneficial effects. This decision was made based on which ethical principle? a. Beneficence b. Justice c. Respect for persons d. Veracity ANS: B The principle of justice requires that all people be treated fairly. Because the findings were overwhelmingly positive, an ethical decision was made to stop the study early and report findings so that additional people could gain benefit from the treatment. DIF: Cognitive Level: Understanding (Comprehension) TOP: Nursing Process: N/A MSC: NCLEX: Management of Client Care 5. The nurse is enrolling subjects for a double-blind experimental study. One patient asks the nurse to explain the role of the experimental group. The nurse will explain that subjects in the experimental group in this type of study: a. are selected for participation in that group. b. have unique baseline characteristics. c. receive a placebo. d. receive the experimental treatment being evaluated. ANS: D In a double-blind experimental study, subjects in the experimental group receive the treatment or drug under study. They are randomly assigned and not selected. They should have similar baseline characteristics to those in the control group. They do not receive a placebo. DIF: Cognitive Level: Understanding (Comprehension) TOP: Nursing Process: Nursing Intervention: Patient Teaching MSC: NCLEX: Management of Client Care 6. The nurse is obtaining signatures on consent forms for participation in a clinical drug trial. One patient says, “I’m not sure I want to do this, but I need the cash.” The nurse will take which action? a. Ask the patient to clarify concerns. b. Reinforce that cash is given to all subjects equally. c. Report this statement to the lead investigator. d. Review the elements of the study and obtain consent. ANS: C TEST BANK FOR PHARMACOLOGY 10TH EDITION BY MCCUISTION TESTBANKWORLD.ORG N 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 subjects 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 ANS: A Phase I drug trials are performed to assess safety and to identify the pharmacokinetics, such as metabolism and elimination, of drugs in healthy subjects. DIF: Cognitive Level: Understanding (Comprehension) TOP: Nursing Process: N/A MSC: NCLEX: Management of Client Care TEST BANK FOR PHARMACOLOGY 10TH ED