What must researchers do in response to an adverse event that presents greater risks?

When an adverse event occurs that presents greater risks in a research study, it is critical for researchers to inform all subjects involved in the study as part of their ethical responsibility to ensure participant safety and autonomy. This notification allows participants to make informed decisions about their continued participation, especially if the risks have changed. In addition to informing the subjects, researchers often need to implement close monitoring of the participants involved in the research to ensure their well-being and to gather information on the event's impacts.

By keeping participants informed, researchers uphold the principles of respect for persons and beneficence outlined in ethical guidelines, such as those by the Belmont Report. These principles emphasize that individuals should be treated as autonomous agents, with the right to make informed choices in the context of research participation. Monitoring also allows researchers to adjust the study protocols or interventions promptly to address new safety concerns.