Question

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 1

This should not be reported to the IRB or the Institutional Review Board. Since it is not related to the research about hygiene and disease prevention that was conducted two weeks ago. And also, even though heart attack is a disease, it only happens if there is inadequate supply of oxygen-rich blood to a part of the heart muscle, then it suddenly becomes blocked and the heart can't get oxygen.