Questions and Answers
What are the three core ethical principles relevant to research involving human subjects?
Respect for persons, beneficence, and justice.
What does informed consent entail?
A mutual sharing of information, a process of communication, expressing respect for the person, and gaining the patient’s active involvement in their care.
Which phase of clinical experimentation tests a new drug for safety in a small group?
Justice in research requires that the selection of research subjects be fair.
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What is the role of nurses in clinical research?
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What does the acronym SAFER stand for regarding over-the-counter medications?
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Which of the following is NOT a responsibility of nurses regarding over-the-counter drugs?
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How does the FDA ensure the safety and efficacy of over-the-counter drugs?
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What is the primary goal of Phase I in clinical trials?
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The American Nurses Association Code of Ethics serves to promote quality in nursing care.
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In which phase of clinical trials do researchers primarily assess the drug's effectiveness in a larger group?
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The authoritative source of drug standards in the United States is the ______.
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Match the phases of clinical trials with their primary objectives:
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Which of the following is NOT typically assessed during Phase III of clinical trials?
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Nurses play a minimal role in clinical research.
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What is the purpose of Phase IV clinical trials?
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What is a brand (trade) name for a drug?
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The acronym SAFER stands for Speak, Ask, Find, Evaluate, Read.
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Name one example of an over-the-counter drug.
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OTC drugs must have labels that include the product's active ingredients, purpose, _____, warnings, dosage instructions, and inactive ingredients.
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Which of the following is a recommended consideration for patients when using OTC drugs?
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Match the term with its definition:
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Side effects from OTC drugs are common and should always be expected.
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What is the purpose of the SAFER acronym in relation to OTC drugs?
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What is a primary concern associated with counterfeit drugs?
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Informed consent requires that participants be aware of the benefits of the research.
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What is the purpose of disclosing alternative procedures to subjects in research?
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A _____ name describes a drug's chemical structure.
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Match the following terms with their descriptions:
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Which of the following is a reason for maintaining confidentiality in research?
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Participants in research can be penalized for refusing to participate.
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What information should be provided if research involves more than minimal risk?
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Study Notes
Ethical Principles in Research
- Three core ethical principles: respect for persons, beneficence, and justice.
- Originated from the Belmont Report and outlined in the WMA Declaration of Helsinki.
- Respect for persons entails treating patients as independent decision-makers and protecting those with diminished capacity.
Informed Consent
- Informed consent is a mutual information sharing process, emphasizing patient autonomy.
- Healthcare providers explain studies, while nurses advocate for patients and ensure understanding of study protocols.
- Essential for promoting participant safety and maintaining study integrity.
Beneficence
- Defined as the duty to protect research subjects from harm.
- Mandates that benefits of a study must outweigh risks, ensuring clarity in risk-benefit discussions.
Risk-Benefit Ratio
- Requires comprehensive analysis of potential consequences of clinical studies against inherent risks and expected benefits.
Justice
- Ensures fair and equitable selection of research subjects to prevent exploitation.
Phases of Clinical Research
- Good Clinical Practice (GCP) guidelines govern clinical trials involving human subjects.
- Preclinical trials assess drug properties such as genotoxicity and pharmacokinetics.
Human Clinical Experimentation
- Historically biased towards Caucasian males; raises questions about generalizability for women and other ethnicities.
- Four phases of human trials:
- Phase I: Safety evaluation, dosage range, and identification of side effects.
- Phase II: Effectiveness testing on a larger group while continuing safety assessments.
- Phase III: Confirmation of effectiveness and comparison with standard treatments in extensive populations.
- Phase IV: Post-marketing studies to monitor drug effects in diverse groups and long-term side effects.
American Nurses Association Code of Ethics
- Serves as a guide for nursing responsibilities, promoting ethical nursing practice and quality care delivery.
Role of Nurses in Clinical Research
- Nurses serve as frontline facilitators in clinical research, ensuring patient safety and adhering to research protocols.
- Responsible for conducting patient education, informed consent, and vigilance during study participation.
Drug Standards and Legislation
- The United States Pharmacopeia (USP) establishes drug standards for safety, efficacy, and quality control.
- Drugs that meet these standards display the “USP” designation.
Drug Names
- Chemical Name: Details the drug's chemical structure.
- Generic Name: Universal, non-proprietary name not owned by any company.
- Brand Name: Proprietary name chosen by the drug company, often trademarked.
Over-the-Counter (OTC) Drugs
- Considered safe for use without direct medical supervision.
- FDA labeling requirements emphasize active ingredients, uses, warnings, dosage instructions, and inactive ingredients.
Nursing Considerations for OTC Drugs
- Patients should read labels, adhere to dosing instructions, and consult professionals if symptoms persist.
- Awareness of potential side effects and interactions with other medications or health conditions is crucial.
Informed Consent Checklist
- Key elements include research purpose, duration of participation, procedures, risks, benefits, alternatives, confidentiality assurances, and voluntary nature of participation.
Initiatives Against Drug Counterfeiting
- Counterfeit drugs pose significant health risks, with estimates indicating over 10% of available drugs may be fake, containing incorrect or harmful ingredients.
Special Considerations for Pediatric OTC Use
- Parents must strictly follow dosage instructions based on age, avoid expired medications, and refrain from giving alcohol-containing drugs to children.
Four Phases of Clinical Trials
- Phase I: Initial testing of a new drug or treatment on a small group to assess safety, determine dosage, and identify side effects.
- Phase II: Involves a larger participant group to evaluate effectiveness and further assess safety.
- Phase III: Conducted on large groups to confirm effectiveness, monitor side effects, and compare with standard treatments.
- Phase IV: Post-marketing studies to gather data on the drug's long-term effects and side effects across diverse populations.
American Nurses Association Code of Ethics
- Established as a guiding framework for nursing responsibilities, ensuring quality care and ethical practices within the profession.
Nurse’s Role in Clinical Research
- Nurses are crucial in clinical research settings, ensuring participant safety and adherence to research protocols.
- They often encounter patients who may consider or are participating in clinical trials, emphasizing the importance of informed consent.
Drug Standards and Drug Legislation
- United States Pharmacopeia (USP): The official source for drug standards in the U.S., covering dosages, forms, drug substances, and compounded preparations.
- Generic Name: The universally accepted name of a drug, not owned by any company.
- Brand (Trade) Name: A proprietary name chosen by the drug company, often a registered trademark.
Over-The-Counter Drugs (OTC)
- OTC drugs are considered safe for use without healthcare provider supervision.
- Common OTC examples include pseudoephedrine and emergency contraception.
- Mandatory label information includes active ingredients, purpose, uses, warnings, dosage instructions, and inactive ingredients.
FDA Recommendations (SAFER)
- S: Speak up
- A: Ask questions
- F: Find the facts
- E: Evaluate your choices
- R: Read labels
Nursing Considerations Related to OTC Drugs
- Advise patients to read labels thoroughly and avoid exceeding recommended dosages.
- Encourage consultation with healthcare professionals if symptoms persist.
- Acknowledge variability in individual responses to medications.
- Ensure patients are informed on potential side effects and risks associated with any drugs being taken.
Clinical Research Participant Considerations
- Provide detailed information on potential risks, benefits, and confidentiality regarding participation in research studies.
- Explain voluntary nature of participation, non-penalizing refusal, and the right to withdraw at any time without penalty.
Drug Counterfeiting Initiatives
- Counterfeit drugs pose a global threat, with estimates indicating that over 10% of drugs may be counterfeit.
- Risks of counterfeit drugs include incorrect or insufficient active ingredients, impurities, and misleading packaging.
Drug Naming Conventions
- Chemical Name: Specifies the drug’s chemical structure, providing insight into its makeup.
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Description
This quiz focuses on Module 1 of NCM 106 Pharmacology in Nursing, covering drug development and ethical considerations. Participants will explore the three core ethical principles that guide nursing practice in pharmacology. Test your knowledge and understanding of these essential topics.
