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adverse effects with the appropriate defi nition. Rang, H. P., Chapter 1: Drug Development and Ethical Considerations OBJECTIVES • Explain the three core ethicalprinciples in using human subjects in the drug development process. • Describe the objectives of each phase of human clinical experimentation. • List the nine provisions of the 2015 American Nurses Association Code of Ethics. • Explain the ethical role of nurses in the clinical research process. • Summarize the standards, legislation, and regulation that guide drug development. • State how nursing practices are established and regulated. • Describe the problem posed by counterfeit drugs and initiatives being implemented to combat it. • Describe the names and types of drugs used in the United States and resources to learn about them. OUTLINE Core Ethical Principles Respect for Persons Beneficence Justice Objectives and Phases of Pharmaceutical Research Preclinical Trials Human Clinical Experimentation Clinical Research Study Design American Nurses Association Code of Ethics The Nurse’s Role in Clinical Research Nursing Process: Patient-Centered Collaborative Care—Clinical Research Drug Standards, Legislation, and Regulation U.S. Drug Standards Federal Legislation Controlled Substances in the United States Canadian Drug Regulation Nurse Practice Acts Initiatives to Combat Drug Counterfeiting Drug Naming and Resources Drug Names Over-the-Counter Drugs Drug Resources Critical Thinking Case Study NCLEX Study Questions KEY TERMS American Nurses Association (ANA) Code of Ethics, p. 6 autonomy, p. 3 beneficence, p.4 brand (trade) name, p. 11 chemical name, p. 11 controlled substances, p. 8 Critical Path Initiative, p. 2 dependent variable, p. 4 Commented [SL1]: The list of objectives has been revised so that each Terminal Learning Objective (TLO) listed here aligns one-to-one with a main (H1) heading in the chapter. (p. 6) Commented [SL2]: Each objective should start with a clear and measurable verb that aligns with the intended student learning outcome. (p. 3) Commented [SL3]: The chapter outline has been adjusted to align with changes made to the headings. (p. 9) Commented [SL4]: Key terms are a critical component to measure, evaluate, and help remediate student understanding in digital lessons. All key terms listed should be essential to student understanding of the core chapter content. (p. 17) 2 generic name, p. 11 genotoxicity, p. 4 Good Clinical Practice (GCP) Consolidated Guideline, p. 4 independent variable, p. 4 informed consent, p. 3 justice, p. 4 over-the-counter (OTC), p. 11 placebo, p. 6 respect for persons, p. 3 risk-benefit ratio, p. 4 U.S. Food and Drug Administration (FDA), p. 2 Approval of new drugs by the U.S. Food and Drug Administration (FDA) has been steady since the early 2000s, reaching an all-time high in 2014 with the approval of 44 new drugs. To facilitate this increase, in 2004 the FDA established its Critical Path Initiative, a national strategy “to drive innovation in the scientific processes through which medical products are developed, evaluated, and manufactured.” One focus of this initiative is on “improving the prevention, diagnosis, and treatment of rare and neglected disorders.” Initiative successesinclude developing biomarkers and other scientific tools, streamlining clinical trials, and ensuring productsafety. The process of drug discovery and manufacturing takes 10 to 12 years, with a cost of more than $1 billion for each drug. Out of every 5000 to 10,000 compounds that begin preclinical testing, only one makes it through the FDA approval process. The steps of the process are shown in Fig. 1.1. Drug research and development is a complex process that is of particular interest and importance to professional nursing practice. FIG. 1.1 The Food and Drug Administration (FDA) Drug Approval Process. From Belluz, J. (2015). This new bill would add $9 billion for medical research. Here are 5 reasons critics are terrified. VOX Science & Health. This chapter is devoted to a description of basic ethical principles that govern drug development and the nurse’s role in this process. H1: CORE ETHICAL PRINCIPLES TLO: Explain the three core ethical principles in using human subjects in the drug development process. Three
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