In the event of unexpected risks discovered during a study, what is an investigator's primary duty?

When unexpected risks are discovered during a study, the primary duty of the investigator is to report those risks immediately to the Institutional Review Board (IRB). The IRB plays a crucial role in ensuring the safety and welfare of research participants. By informing the IRB, the investigator enables the board to assess the new information and determine if any modifications to the study protocol are necessary to protect participants.

Prompt reporting to the IRB allows for timely evaluation and, if needed, the implementation of measures such as revising informed consent documents or halting certain procedures to mitigate the risk. The integrity of the study and the safety of participants are paramount, and the IRB is responsible for overseeing ethical standards in research.

Other options, while they may seem relevant, do not prioritize the immediate action required in response to unexpected risks. Abandoning the study without consulting the IRB would be premature, and notifying participants of risks afterward does not align with the obligation to act swiftly. Reassessing the study's goals can be an important step, but it typically follows the IRB’s guidance and is not the first course of action in response to new risks.