A subject of a research study involved in a motor vehicle crash sustains injuries. What should the investigator do upon learning of the incident?

When an investigator learns about an incident involving a subject in a research study, the appropriate action is to report all adverse events that occurred as a result of that incident. In this case, the subject sustained both a broken wrist and a mild concussion. Both of these injuries constitute adverse events that could potentially impact the subject's health and the overall integrity of the study.

Reporting both the broken wrist and the concussion is essential for several reasons. Firstly, from an ethical perspective, it is crucial to ensure participant safety and to monitor any health issues that arise during the course of a study. Secondly, from a regulatory standpoint, all adverse events need to be documented and communicated to relevant authorities, sponsors, or Institutional Review Boards (IRBs) to maintain transparency and oversight.

Furthermore, classifying the severity of adverse events can sometimes be subjective, and it is important to err on the side of caution. The broken wrist could require significant medical attention, rehabilitation, and may impact the subject’s ability to participate in the study activities. Meanwhile, even a mild concussion can have serious implications if not monitored, as symptoms may evolve over time.

Thus, comprehensive reporting of all adverse events is not just a best practice; it is a fundamental requirement in clinical research to safeguard participant health