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must articulate nursing values, maintain the integrity of the profession, and integrate principles of social justice into nursing and health policy. From American Nurses Association. (2015). Code of ethics for. org/DocumentVault/Ethics_1/Code-of-Ethics-for-Nurses.html H1: THE NURSES ROLE IN CLINICAL RESEARCH TLO: Explain the ethical role of nurses in the clinical research process. Nurses are at the forefront of clinical research. Regardless of the setting (inpatient or outpatient), nurses are likely to encounter patients who are eligible to participate, considering participation, or actively participating in clinical research. As such, nurses are responsible for both the safety of the patient and the integrity of the research protocol. NURSING PROCESS Patient-Centered Collaborative Care Clinical Research Assessment • Identify patients who are eligible to participate in or who are participating in clinical research. • Assess response to the study agent and identify adverse events (an unfavorable or unintended sign, symptom, or disease that was not present at the time of study enrollment and is associated with the treatment or procedure). Planning • Have a process in place to identify persons who are eligible to participate in a clinical research or to identify participants actively participating in clinical research studies. • Have a process in place to facilitate education and in- formed consent of eligible study participants. • Plan educational programming for staff who provide direct care to study participants. • Plan participant care to ensure integrity and compliance with study protocol. Nursing Interventions • Support the process of informed consent in a culturally competent manner. • Provide an interpreter when necessary. • Provide enough time for the person to read the consent and ask questions. • Serve as a witness to informedconsent. • After reviewing the study protocol, administer study agent(s). • Accurately document all participant care, assessment findings, and study agent administration. • Accurately and safely collectbiospecimens. • Act as advocate, educator, and collaborator in the research process. • Ensure safe care. • Ensure integrity of study data. • Communicate clearly. Evaluation • Determine if the potential participant understands what it means to participate in the study by asking open-ended questions. • Monitor response to the study agent or other interventions. • Determine whether participants understand how to take their study agents, what to do if they miss a dose, how to store the study agent, and when to call their health care provider. Commented [SL22]: To align with a TLO, this head was raised from an H2 to an H1. (p. 6) Commented [SL23]: If the author believes the content in this feature “Nursing Process” is core content, then the author would want to consider moving that content into the main text. (p. 8) Each of the four parts of the feature—Assessment, Planning, Interventions, and Evaluation—could be a second-level (H2) head with an accompanying ELO. This would help capture the content for digital transformation: H2: Assessment ELO: Identify the role of nurses in the assessment phase. H2: Planning ELO: Describe what nurses do in the planning phase. H2: Nursing Interventions ELO: Summarize nursing interventions during the clinical research process. H2: Evaluation ELO: List the ways in which nurses help in evaluation during the clinical research process. 8 H1: DRUG STANDARDS, LEGISLATION, AND REGULATION TLO: Summarize the standards, legislation, and regulation that guide drug development. This section addresses U.S. drug standards, federal legislation, as well as Canadian drug regulations. H2: U.S. Drug Standards ELO: Identify the authoritative source for drug standards in the United States. The set of drug standards used in the United States is the United States Pharmacopeia (USP). The United States Pharmacopeia and the National Formulary (USP-NF), the authoritative source for drug standards (dosage, forms, drug substances, excipients, biologics, compounded preparations, and dietary supplements), is published annually. Experts in nursing, pharmaceutics, pharmacology, chemistry, and microbiology all contribute.
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