What should a regulatory affairs professional do upon discovering an informed consent violation during a clinical investigation?

When a regulatory affairs professional identifies an informed consent violation during a clinical investigation, it is crucial for the integrity of the study and the protection of participants that the issue is addressed promptly and appropriately. The correct action involves ensuring that the study director discusses the issue with the investigator. This communication allows for a thorough evaluation of the violation, its implications, and the necessary steps to rectify the situation. It fosters accountability and ensures that those responsible for oversight are informed, so that mitigation strategies can be employed and future violations can be prevented.

This response aligns with regulatory requirements and best practices in clinical research, which emphasize the necessity of collaboration and communication among the study team to maintain compliance with ethical standards and protect participants’ rights. The study director, as a key figure in the research team, will have the authority and perspective to handle the situation correctly.

In contrast, alternative options such as predating informed consent, contacting patients directly to obtain consent without proper protocol, or solely reporting the deviation to the IRB may not adequately address the root of the issue or could even exacerbate the situation. Each of these would not guarantee compliance with ethical standards or regulatory requirements regarding informed consent and might lead to further complications.