Question

A large HMO has teamed up with several other large HMOs to study falls and footwear. The investigator proposes to review 5,000 medical records across 10 institutions of individuals injured during the last three years from a fall, so she has enough power to detect whether there is a greater number of falls among people who wear clogs. Because individuals wear so many different types of shoes, she will need to review a large number of records to find those few individuals who fit this category. From the medical records, she plans to extract the type of shoe the individuals wear. She will not re-identify the individuals and will not contact the individuals. Which of the following is likely to be the level of review determined as appropriate by the IRB?

a) Minimal risk
b) Moderate risk
c) High risk
d) No risk

Answer 1

The review likely to be determined as appropriate by the IRB for the study on falls and footwear is minimal risk, due to the non-invasive and data-focused nature of the research without patient re-identification.

Step-by-step explanation:

The level of review determined as appropriate by the Institutional Review Board (IRB) for a study examining the occurrence of falls among individuals wearing clogs would likely be a) Minimal risk. This determination is based on the study design, where the investigator plans to review medical records to extract data on the type of footwear worn by individuals at the time of their fall without re-identifying or contacting the individuals involved. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Considering the non-invasive nature of this study, it does not pose more than minimal risk to the participants.