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?
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

The correct answer is 3. No, this does not need to be reported because it is unrelated to participation in the study.

Explanation:

The Department of Health and Human Services (HHS) in the U.S. aims at preventing and protecting the health of U.S. citizens, including participants of research studies. In these cases, the HHS provides regulations and guidelines on how to carry research without risking participants' health and well-being. Besides this, it establishes health issues during the research should be reported to the IRB or Institutional Review Board that checks conditions in research are ethical and safe.

In the case presented, it is not necessary to report this event because the heart attack is not related to the participation of the individual as the researcher was only studying the attitudes of participants towards hygiene and disease prevention, and it is highly unlikely this has caused a heart attack. This is supported by the HHS that establishes unexpected incidents during the research should be reported only if they are possibly related or in the cases, there are many possibilities the research caused the incident.