What is the required action if an investigational biologic is not properly screened for viral contaminants?

The required action in the scenario where an investigational biologic is not properly screened for viral contaminants is to notify the subjects and potential partners of increased risk. This approach is crucial because it prioritizes the safety and informed consent of the individuals involved in the research. Participants have the right to know about any potential risks associated with the investigational product they are receiving, especially when there is a concern regarding viral contamination that could pose health risks.

In situations involving investigational biologics, ensuring transparency and maintaining trust with research subjects is paramount. When subjects are informed about possible risks, they can make better decisions about their participation, which is a fundamental principle of ethical research practices.

On the other hand, conducting further studies before notifying the Institutional Review Board (IRB) can delay necessary communication and action, possibly further endangering participants. Ignoring a screening error if no infections are found undermines ethical obligations and could lead to serious repercussions if any unforeseen consequences arise. Ceasing all ongoing trials immediately could be excessive unless there is a confirmed immediate risk, as it may disrupt research progress without targeted justification. Overall, the emphasis should always be on proactive communication to safeguard participant health and uphold ethical research standards.