Question

Aresearcher 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?
1. no, this does not need to be reported because the subject had the heart attack when they were home, not at the focus group.
2. no, this does not need to be reported because the subject recovered.
3. no, this does not need to be reported because it is unrelated to participation in the study.
4. no, this does not need to be reported because two weeks have passed.

Answer 1

Answer:

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

Explanation:

As per the question, the given event must not be reported to IRB as 'the subject's heart attack, hospitalization, or recovery is not affiliated to his/her participation in the study'. The study aimed to assess the subject's attitudes towards hygiene or disease prevention which has no relation to a sudden heart attack of any of the subject. Thus, this would neither affect the results of the study nor its validity and hence, option 3 is the correct answer.