What must be done when an unanticipated problem occurs that involves viral contamination?

In the context of research ethics and regulation, when an unanticipated problem such as viral contamination arises, it is essential to notify both the Institutional Review Board (IRB) and the Food and Drug Administration (FDA). This is necessary because such issues can have significant implications for participant safety, the integrity of the research, and the regulatory compliance of the study.

The IRB is responsible for reviewing and ensuring the protection of research subjects involved in clinical studies. When a participant's safety could be compromised due to viral contamination, the IRB needs to be informed to evaluate the situation, assess risks, and determine necessary actions. Additionally, if the research involves any investigational drugs or biological products that fall under FDA regulation, the FDA must be notified to assess the potential impact on public health and to take appropriate regulatory actions.

The importance of this notification emphasizes the ethical responsibility researchers hold for participant safety and communication with oversight bodies. Timely reporting is crucial for addressing any risks and implementing any necessary adjustments to the study protocol to protect subjects and ensure compliance with ethical and regulatory standards.