How often should researchers reassess risks to participants during a study?

Researchers should regularly reassess risks to participants throughout a study to ensure their ongoing safety and well-being. This continuous evaluation is essential because participant circumstances, the study environment, and potential risks can change over time. Such ongoing assessments help researchers identify any emerging issues or heightened concerns that may affect participants, allowing for timely adjustments in procedures or protocols to minimize harm.

For example, if a new side effect or unexpected situation arises during the course of a study, or if participants express new concerns that weren't anticipated in the initial risk assessment, researchers must be prepared to modify their approach. Ensuring that these assessments occur regularly fosters ethical research practices and maintains the trust of participants, which is foundational in conducting responsible and scientifically valid research.