Question 1The 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: Economic or social vulnerability Institutional vulnerability Physical vulnerability Cognitive or communicative vulnerabilityQuestion 2When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider: Are there adequate resources to conduct the study? Is there a power differential between researchers and subjects? Are the research procedures greater than minimal risk of harm? Has the researcher completed required training?Question 3A 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: Communicative vulnerability Economic vulnerability Social vulnerability Institutional vulnerabilityQuestion 4Which is true of inducements in research? Inducements 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. Inducements, like coercion, are always inappropriate, as they violate the ethical principle of respect for persons. Offering $10 for an hour long research study constitutes undue inducement. Like coercion, undue inducement is easy for IRBs to determine.Question 5In considering NBAC’s analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for: Capacity-related cognitive vulnerability Communicative vulnerability Situational cognitive vulnerability Economic vulnerability

QuizInstructions: Please provide an answer for all questions. Each question is one point. Click on the Submit button to register your answers. After submitting your answers, the correct answer to each question and an explanation will be displayed. Navigational links to the next module will also be provided.All quiz questions count towards your score. You should answer all questions.Question 1The 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: Economic or social vulnerability Institutional vulnerability Physical vulnerability Cognitive or communicative vulnerabilityQuestion 2When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider: Are there adequate resources to conduct the study? Is there a power differential between researchers and subjects? Are the research procedures greater than minimal risk of harm? Has the researcher completed required training?Question 3A 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: Communicative vulnerability Economic vulnerability Social vulnerability Institutional vulnerabilityQuestion 4Which is true of inducements in research? Inducements 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. Inducements, like coercion, are always inappropriate, as they violate the ethical principle of respect for persons. Offering $10 for an hour long research study constitutes undue inducement. Like coercion, undue inducement is easy for IRBs to determine.Question 5In considering NBAC’s analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for: Capacity-related cognitive vulnerability Communicative vulnerability Situational cognitive vulnerability Economic vulnerability

Which method is most associated with a lack of informed consent?Select one:a.In-depth interviewingb.Qualitative content analysisc.Covert observation d.Structured interviewing

Research on the informed consent process has revealed thatSelect one:a.the research process does not really benefit from giving participants the opportunity to review the nature of studies inb.most people do not bother to read the forms; they just take them home and forget about them.c.informed consent forms have become easier to understand after legal regulations were imposed.d.researchers who perceive Institutional Review Boards to be unjust often try to deceive the review board.

Which of the following is not needed by a participant in order to give informed consent to participate in a research study? A. Knowledge of the participants in the study B. Knowledge of the purpose of the research study C. Knowledge of the risks of the study D. Knowledge of the benefits of the study

As part of the consent process, the federal regulations require researchers to: Recommend that potential subjects discuss their decision to participate with family members. Provide potential subjects with information at the appropriate reading comprehension level. Describe penalties that may be imposed for non-participation. Provide a list of the IRB members who reviewed the protocol.