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to make a reasoned decision about participation, normally involve signing a consent form to document voluntary and informed participation. Situation: Mr. Jake proposed to conduct research on the utilization of a revised self-care guide for patients diagnosed with rheumatoid arthritis. 10. Mr. Jake believes that he must abide by the ethical conduct in research, which code of ethics requires informed consent in all studies involving human subjects? A. ICN code of ethics B. Belmont report C. Nuremberg code D. Helsinki declaration Answer is C. Nuremberg code - the first international document which advocated voluntary participation and informed consent. D: ethical principles for medical research involving human subjects C: a set of ethical research principles for human experimentation; states that human subjects must be able to withdraw from a research study at any time; developed after Nazi atrocities were made public as an international effort to establish ethical standards; the FIRST international document which advocated voluntary participation and informed consent. B: statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects A: a statement of the ethical values, responsibilities and professional standards of nurses 11. Which of the following codes of ethics differentiate whether the research study has a therapeutic value, or which essentially yields new knowledge and has no therapeutic value? A. Nuremberg code B. Belmont report C. Helsinki declaration D. ICN code of ethics The answer is A. Nuremberg code. According to code no. 2: The experiment should be such as to yield fruitful results for the good of the society, unprocurable by other methods or means of study, and not random and unnecessary in nature. To be able to stay true to this code, the study’s therapeutic value or non-value must be first differentiated and determined. The ICN code of ethics does NOT state that it differentiates whether the research has therapeutic value or not. A: Called for voluntary consent, assessment of risks and benefits, and assurance of competent investigators. B: Standards of ethical research are based on: beneficence, respect for human dignity, and justice. C: The World Medical Association’s (1964) Declaration of Helsinki reiterated the Nuremberg Code’s emphasis on voluntary and informed consent to research as well as other factors important to ethical conduct in scientific investigations involving communities and individuals. The Declaration of Helsinki, revised most recently in 2000, is universally recognized as a foundational guideline for ethical behaviour in scientific research. (WHO) D: The ICN Code of Ethics for Nurses is a statement of the ethical values, responsibilities and professional accountabilities of nurses and nursing students that defines and guides ethical nursing practice within the different roles nurses assume. 12. Some characteristics are considered vulnerable as subjects for clinical research, which is NOT considered as vulnerable? A. Adult woman B. Mentally or emotionally disabled people C. Children D. Institutionalized people The answer is A. Adult woman. If someone becomes institutionalized, they gradually become less able to think and act independently, because of having lived for a long time under the rules of an institution (Cambridge Dictionary) 13. During the study, one of the subjects expressed his intention to disengage from the research. Which of the following is the appropriate action to take? A. Motivate him to sustain his participation B. Entice him by giving him stipends C. Explain to him that such would affect the validity of the study
D. Allow the subjects to withdraw anytime The answer is D. Allow the subjects to withdraw anytime. Researchers should treat participants as autonomous agents, capable of controlling their own activities. The principle of self-determination means that prospective participants have the right to decide voluntarily whether to participate in a study, without risking penalty or prejudicial treatment. It also means that people have the right to ask questions, to refuse to give information, and to withdraw from the study. A person’s right to self-determination includes freedom from coercion of any type. Coercion involves explicit or implicit threats of penalty from failing to participate in a study or excessive rewards from agreeing to participate. (Polit & Beck) 14. To prevent manipulation of vulnerable groups, which of the following is the best measure? A. Ensure confidentiality of data described to prospective subjects the nature B. Protect privacy of patients C. Payment of stipends for the subjects D. Secure informed consent The answer is D. secure informed consent. The consent of parents/ guardians and assent of children must be obtained. Written consent must be obtained from legal guardians of mentally or emotionally disabled people as individuals with disability make it impossible for them to weigh the risks and benefits of participation and making informed decisions. Institutionalized people may feel constrained in their ability to give free consent as they might feel that their treatment would be jeopardized by failure to cooperate. Researchers studying institutionalized groups need to emphasize the voluntary nature of participation. C: can be considered mild coercion. B/A: privacy and confidentiality alone cannot assure the prevention of manipulation of vulnerable groups. 15. To ensure the study and the subject’s rights, Mr. Jake adheres to which of the following procedures? A. Covert data B. Informed consent C. Full disclosure D. Debriefing The answer is B. informed consent. Informed consent ensures the participant has right to both self- determination and full disclosure. D: Means providing information about the research to participants AFTER they have given their informed consent to participate, and usually AFTER their participation is completed. It is required if the research involves deception of the participants. (University of Mary Washington) C: Means that the researcher has fully described the nature of the study, the person’s right to refuse participation, the researcher’s responsibilities, and likely risks and benefits. The right to self- determination and the right to full disclosure are the two major elements on which informed consent is based. B: Means that participants have adequate information regarding the research, comprehend the information, and have the power of free choice, enabling them to consent to or decline participation voluntarily. A: An investigative strategy in which the researcher's professional identity and academic intentions are hidden, either partially or fully, from those involved in the study. Therefore, research is conducted without the knowledge or consent of those being studied. (Sage Publications) 16. The study is considered to be accomplished when Mr. Jake has achieved which of the following activities? A. Submitted the research report to the CEO B. The result of the study is used by the nurses in the hospital C. Presented the study in research forum D. Published the results in a nursing journal The answer is B. The result of the study is used by the nurses in the hospital. The final step of conducting research is utilizing the findings in practice. Communicating the findings (D, C) is the second to the last step. Situation: Rosa, a new research staff of a tertiary hospital is tasked to conduct a research study about the increased incidence of hospital-acquired infections in the workplace 17. Which of the following is the best tool for data gathering? A. Observation

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