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given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. • Phase IV: Studies are done after the drug or treatment has been marketed to gather information on thedrug’s effects in various populations and to assess any side effects associated with long-term use. Pharmaceutical companies are eager to bring new drugs to market. To reduce delays in the FDA approval process, in 1992 congress passed the Prescription Drug User Fee Act, which provided the FDA with funds to expedite the review process. As a result, the average drug approval time has decreased from 30 months to 12. H2: Clinical Research Study Design ELO: State the primary process and purpose of clinical research study design in pharmaceutical research. An appropriate experimental design is important to answer questions about drug safety and efficacy. Studies are designed to determine the effect of the independent variable (treatment, such as with a drug) on the dependent variable (outcome, such as clinical effect). Intervening (extraneous) variables are factors that may interfere with study results, and these may include age, sex, weight, disease state, diet, and the subject’s social environment. It is important to control for as many of the intervening variables as possible to increase study validity. The experimental group in drug trials is the group that receives the drug being tested. The control group in drug trials may receive no drug; a different drug; a placebo (pharmacologically inert substance); or the same drug with a different dose, route, or frequency of administration. H1: AMERICAN NURSES ASSOCIATION CODE OF ETHICS TLO: List the first nine provisions the American Nurses Association (ANA) Code of Ethics. The American Nurses Association (ANA) Code of Ethics “was developed as a guide for carrying out nursing responsibilities in a manner consistent with quality in nursing care and the ethical obligations of the profession.” It was first adopted in 1950 and most recently was revised with interpretive statements in 2015. The ANA Code of Ethics is founded on the principles first identified by Florence Nightingale, who believed that a nurse’s ethical duty wasfirst and foremost to care for the patient. It contains nine provisions (Box 1.3). The 2015 update addresses advances in nursing leadership, social policy and global health, and the challenges nurses face related to social media, electronic health records, and the nurse’s expanded role in clinicalresearch. BOX 1.3 Provisions of the AmericanNurses Association Code ofEthics Provision 1 The nurse practices with compassion and respect for the inherent dignity, worth, and unique attributes of every person. Provision 2 The nurse’s primary commitment is to the patient, whether an individual, family, group, community, or population. Provision 3 The nurse promotes,advocates for,and protects the rights,health, and safety of the patient. Provision 4 Thenursehasauthority,accountability,andresponsibility fornursingpractice; makes decisions; and takes action consistent with the obligation to promote health and to provide optimal care. Provision 5 The nurse owes the same duties to self as to others, including the responsibility to promote health and safety, preserve wholeness of character and integrity, maintain competence, and continue personal and professional growth. Provision 6 The nurse, through individual and collective effort, establishes, maintains, and improves the ethical environment of the work setting and conditions of employment Commented [SL20]: An ELO has been created and aligned with this H2. (p. 6) Commented [SL21]: A TLO has been created and aligned with this H1. (p. 6) 7 that are conduciveto theprofessionthroughresearch and scholarly inquiry, professional standards development, and the generation of both nursing and health policy. Provision 8 The nurse collaborates with other health professionals and the public to protect human rights, promote health diplomacy, and reduce health disparities. Provision 9 The profession of nursing, collectively through its professional organizations,
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