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

Answer 1

Answer: No it should not be reported because it is unrelated to the participation in the study.

Explanation:

The study was based on health and hygiene and disease prevention. Based on this study the diseases that can be taken into consideration which is related to health and hygiene.

The heart attack is not a disease which is caused by being into an unhygienic environment.

So, heart attack cannot be reported to IRB because the study was not based on this topic.