How should the risk of harm be evaluated in a research study?

Evaluating the risk of harm in a research study is essential to ensure the safety and well-being of participants. The correct approach involves assessing both the magnitude of potential harm and the probability of its occurrence. This dual consideration allows researchers to understand not only how severe the harm could be (magnitude) but also how likely it is to happen (probability).

For instance, a study might have a high-magnitude risk, such as severe psychological distress, but if the probability of experiencing that distress is very low, the overall risk might still be acceptable. Conversely, a high-probability event with low magnitude might be deemed unacceptable if it occurs frequently. Evaluating risk in this comprehensive manner ensures that researchers can make informed decisions about the ethical implications of their studies and implement appropriate safeguards to minimize harm.

Other factors mentioned in the incorrect options, such as the financial cost of the study, the duration of the study, or the number of participants, do not directly address the ethical considerations related to participant safety and risk assessment. While these factors can impact the design and feasibility of a study, they should not replace the primary focus on the risks participants might face.