CITI IRB Populations and Unanticipated Problems well solved.

CITI IRB Populations and Unanticipated Problems well solved.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 -ANSWER Medical Vulnerability Which is an example of a situation where deferential vulnerability might be a factor? -ANSWER A physician recruiting his patients Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, D and D with additional protections: -ANSWER Pregnant women, prisoners, children 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 -ANSWER Economic vulnerability When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider: -ANSWER Is there a power differential between researchers and subjects? According to OHRP, a problem is an "unanticipated problem" when it meets which of the following criteria: -ANSWER Unexpected, related or possible related to the research, suggests the research puts subjects or others at greater risk A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. One of the subjects is in an automobile accident two weeks after participating in the research study. Is this an example of an unanticipated problem that requires reporting to the IRB? -ANSWER No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study. A researcher conducts a focus group to learn about attitudes towards hygiene and disease prevention. Two weeks after the focus group, the researcher learns one of the subjects had a heart attack at home and was hospitalized, but made a full recovery. Based on DHHS regulations, should the researcher report this event to the IRB? -ANSWER No, this does not need to be reported since it is unrelated to participation in the study. A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. The data are stored on a laptop computer without encryption, and the laptop computer is stolen from the researcher's car on the way home from work. This is an unanticipated problem that must be reported because the incident was (a) unexpected (i.e., the researchers did not anticipate the theft); (b) related to participation in the research; and (c) placed the subjects at a greater risk of psychological and social harm