Question

Consent to participate in research is an ongoing processA 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

Answer 1

Answer:

No, the researcher does need to report this event to IRB

Explanation:

The researcher only need to report the event if there is a direct correlation between the study and the said event. Heart attacks are mostly influenced dietary habit and genetics disposition rather than hygiene. Because of it, this does not need to be reported since it is unrelated to participation in the study.