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25 April, 20:32

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 HHS regulations, should the researcher report this event to the IRB?

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  1. 25 April, 20:49
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    Answer:No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study.
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