The answer is already given at the end of the question; solely by the magnitude or severity of expected harm
When assessing risks of harm associated with participation in a research study, the probability of harm and the risk of the severity of harm are two distinctive elements of risk that must be considered. In probability of harm, the fact that not all possible harms are equally probable should be considered. How these two elements occur is a crucial factor in determining the level of risk of harm in a study. Given the sensitivity of the information in the case scenario above, the probability that an individual subject could be identified is low while the magnitude of the possible risk of harm is high.
There are two important things that should be considered when assessing the risk of harm in a research study, the risk of the severity of harm and the probability of harm. In the probability of harm, there is a possibility that not all harms are possible in the research study.
However, the level of risk of harm in a study is determined by how these two elements occurred during the study. From the scenario painted in the research study, the probability that the subject in the research can be identified is very low while the probability that the research will poses a greater risk to the individual subject is very high.
A risk in a research can be described as the probability of harm that can happen to a research subject as a result of participation in a research study. Injury or harm could be physical, psychological, social or economic. The probability and magnitude of possible harm or injury vary. It can be from minimal to significant. However, the federal regulations only define Minimal risks.
Minimal Risks: a risk is said to be minimal when the probability or magnitude of harm or injury expected in a research study are not on the high side or not greater.
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