Questions and Answers
A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it. This is an example of:
According to the authors, which response below contains the correct four common abuses that historically give rise to vulnerability?
In considering NBAC's analytic approach, what is an example of a high risk of harm for an otherwise competent person who is acutely ill?
Situational cognitive vulnerability
Which of the following was NOT included by NBAC as possibly leading to vulnerability?
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Identify the groups that are protected in federal regulations (45 CFR 46), specifically in Subparts B, C, and D.
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When an IRB is reviewing a research study, what should they consider regarding vulnerable populations?
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Subjects with a serious illness may be at risk for exploitation since they may be desperate for a possible cure. This is an example of:
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Inducements in research constitute an 'undue influence' if they alter a potential subject's decision-making processes, such that they do not appropriately weigh the risk-benefit relationship of the research.
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Study Notes
Economic Vulnerability
- Participation in drug studies due to treatment availability at reduced cost exemplifies economic vulnerability.
Historical Abuses Leading to Vulnerability
- Common abuses contributing to vulnerability include physical control, coercion, undue influence, and manipulation.
Situational Cognitive Vulnerability
- Individuals who are acutely ill may be deemed to have a heightened risk of harm due to situational cognitive vulnerability.
Research Vulnerability Concepts
- High potential for personal benefit from research participation is not recognized as a contributing factor to vulnerability.
Protected Groups Under Federal Regulations
- Subparts B, C, and D of 45 CFR 46 provide protections for specific populations: pregnant women, prisoners, and children.
IRB Considerations for Vulnerable Populations
- Institutional Review Boards (IRBs) must assess any existing power imbalances between researchers and potential subjects when evaluating vulnerability.
Medical Vulnerability
- Serious illness may lead to exploitation risks as affected individuals might be desperate for potential cures, representing medical vulnerability.
Inducements in Research Ethics
- Inducements can constitute undue influence if they compromise a subject's ability to make balanced decisions regarding risk and benefit assessment in research.
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Description
This quiz focuses on populations in research that require additional considerations and protections, emphasizing economic vulnerability and historical abuses. It will test your understanding of key concepts and definitions related to these vulnerable groups in clinical studies.
