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?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

Answer:

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

Explanation:

The research in conducting a focus group to learn about hygiene and disease prevention but the subject having a heart attack does't count as part of the research.

Answer 2

Answer:

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

Explanation: The Human and Health service department maintains that any research which involves human participants or subjects should be monitored by Institutional Review Board (IRB) in other to ensure the protection of participant's right and welfare.

However, in the scenario above, there is no need to report the incident to the Institutional Review Board as the incident is not related to participation in the study.