CITI Training, Modules 1-24 (Biomedical Research) 2023

CITI Training, Modules 1-24 (Biomedical Research) 2023 The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? Which of the following are the three principles discussed in the Belmont Report? When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider: Which is an example of a situation where deferential vulnerability might be a factor? In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for: Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, C, and D with additional protections: The NBAC looks at characteristics individuals might have that would prevent them from being able to provide voluntary informed consent. The traits may be thought of as falling into six broad areas: cognitive or communicative, institutional, deferential, medical, economic, and social. Prospective research subjects who are not able to comprehend information, deliberate, and make decisions about participation in a proposed research study have a: The use of prisoners in research is a concern under the Belmont principle of Justice because: Which of the following is included in the Nuremberg Code: Which of the following brought increased public attention to the problems with the IRB system? Informed consent is considered an application of which Belmont principle? The National Research Act of 1974 How long is an investigator required to keep consent documents, IRB correspondence, and research records? According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB? Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if: IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must: A general requirement for the informed consent form is that it may not include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language?