Which individual is responsible for handling incidents reported during research studies?

The Principal Investigator (PI) is the individual primarily responsible for the overall conduct of a research study and ensuring that all aspects of the study comply with regulatory and ethical standards. When incidents, such as adverse events or protocol deviations, are reported during a research study, it is the PI's duty to assess these incidents, address any immediate concerns, and report them to the appropriate oversight bodies, such as the Institutional Review Board (IRB) or regulatory agencies if necessary.

The PI's responsibilities encompass not only the scientific integrity of the research but also the safety and welfare of the participants involved. This includes managing risk, implementing corrective actions, and communicating with the research team and IRB about any issues that arise during the study. In contrast, other roles, such as the lead researcher or the chair of the IRB, may have specific responsibilities but do not have the same comprehensive authority and accountability for the study as the Principal Investigator.