A risk is a potential harm (injury) associated with the research that a reasonable person, in the subject's position, would be likely to consider important in deciding whether to participate in the research. To assess risk, be sure to consider all of the potential Types of Risk that could occur to subjects if they agree to participate in your study.
Federal regulation defines “minimal risk” as “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” The IRB considers both immediate and delayed risk. The estimated probability, severity, average duration, and reversibility of potential harm also are considered.
Generally, most people—including researchers—tend to underestimate risks involved in activities with which they are familiar and to overestimate the benefit of things that are important to them.
Use the Risk/Benefit Assessment Checklist to help in making this determination. Underlying the consideration of risk is the implicit moral imperative that all researchers do no harm while minimizing potential risk to the greatest extent possible.