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?

a. No, this does not need to be reported since the subject had the heart attack when they were home, not at the focus group.b.No, this does not need to be reported since it is unrelated to participation in the study.c. No, this does not need to be reported because two weeks have passed.d. No, this does not need to be reported since the subject recovered.

Answer 1

b. No, this does not need to be reported since it is unrelated to participation in the study.

Step-by-step explanation:

The researcher should only report facts that are linked to the research objective and that can in any way influence the research data. The researcher should report these facts, so that some modifications can be made, making it possible for the research result to be as unbiased as possible.

In the case of the research reported in the question, the researcher need not report on the case of the patient who had a heart attack, as the research is on hygiene and disease prevention and the heart attack is irrelevant to the research results.