Chapter 01: Drug Development and Ethical Considerations McCuistion: Pharmacology: A Patient-Centered Nursing Process Approach, 9th 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
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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) REF: p. 3 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