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core ethical principles are relevant to research involving human subjects: respect for persons, beneficence, and justice. Derived from the Belmont Report, the World Medical Association Declaration of Helsinki set out ethical principles for medical research that involves human subjects. These ethical principles are integral to the issues of informed consent and risk-benefit ratio in such research. H2: Respect forPersons ELO: Summarize how respect is shown for patients. Patients should be treated as independent persons who are capable of making decisions in their own best interests. Patients with diminished decision-making capacity are entitled to protection. When making health care decisions, patients should be made aware of alternatives available to them as well as the consequences that stem from those alternatives. The patient’s choice should be honored Commented [SL5]: Ideally, for digital lessons, all key terms should be deployed in the context of a learning objective to better capture for digital consumption and lesson creation. (p. 17) Commented [SL6]: All figures should be referred to in the text. Figures should be placed immediately following their intext reference. (p. 18) Commented [SL7]: Ensure that all figures are given a clear and descriptive title. (p. 18) Commented [SL8]: Because this heading is a main (H1) heading, a Terminal Learning Objective (TLO) has been created and aligned with it. (p. 6) Commented [SL9]: Because this is a second-level (H2) heading, an Enabling Learning Objective (ELO) has been created and aligned with it. (p. 6) Note that the Bloom’s level of the ELO is always at or below the level of the TLO. (p. 7) 3 whenever possible. It is imperative that nurses recognize when patients are not capable of making decisions in their own best interest and are therefore entitled to protection. The nurse can assist with the determination of decision-making capacity through frequent assessment of the patient’s cognitive status. H3: Autonomy Autonomy is an integral component of respect for persons. Autonomy is the right to self-determination. In health care settings, health care personnel must respect the patient’s right to make decisions in their own best interest, even if the decision is not what the health care personnel want or think is best for the patient. Generally, patients can refuse any and all treatments (right of autonomy) except when the decision poses a threat to others—such as with tuberculosis, when taking medications is legally mandated. Autonomy is as relevant to the conduct of research as it is in health care decision making; Patients have the right to refuse to participate in a research study and may withdraw from studies at any time withoutpenalty. H3: Informed Consent Informed consent has its roots in the 1947 Nuremberg Code. The two most relevant aspects of the Code are the right to be informed and that participation is voluntary, without coercion. If coercion is suspected, the nurse is obligated to report this suspicion promptly. Informed consent has dimensions beyond protection of the individual patient’s choice: • It is a mutual sharing of information, a process of communication. • It expresses respect for the person. • It gains the patient’s active involvement in their care. • Itrespectsthe patient’sright to self-determination. It is the role of the health care provider, not the nurse, to explain the study and what is expected of the patient to the patient and to respond to questions from the patient. While giving written consent, the patient must be alert and able to comprehend; consent forms should be written at or below the eighth-grade reading level, and words should be kept to fewer than three syllables. Nurses are patient advocates. In collaboration with the health care provider and the pharmacist, the nurse must be knowledgeable about all aspects of a drug study—including all inclusion and exclusion criteria for participants(Box 1.1),study protocol, and studyrelated documentation—in order to promote participant safety and quality studyresults. BOX 1.1 Sample Inclusion and Exclusion Criteria Fig. 1.2 shows a sample of an informed consent form for a clinical drug trial, and Box 1.2 shows an informed consent checklist. Sample Informed Consent Form for
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