Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

What action must an investigator take upon discovering new safety information about an investigational product?

1. Notify the funding agency

2. Submit a revised Informed Consent Form to the IRB/IEC

3. Inform all subjects immediately

4. Cease the trial immediately

The correct answer is: Submit a revised Informed Consent Form to the IRB/IEC

When an investigator discovers new safety information about an investigational product, it is essential to submit a revised Informed Consent Form to the Institutional Review Board (IRB) or Independent Ethics Committee (IEC). The informed consent process is critical in clinical research as it ensures that participants are fully aware of the potential risks and benefits associated with their involvement in the study. Updating the Informed Consent Form provides participants with the most current information regarding the safety profile of the investigational product. It empowers them to make informed decisions about their continued participation in the study based on the new findings. The IRB/IEC plays a crucial role in reviewing and approving any changes to the informed consent process to ensure that safeguards are in place for participants. While other actions, such as notifying the funding agency or informing subjects, may also be necessary depending on the context of the findings and regulatory requirements, the priority must be given to ensuring that the informed consent reflects the latest safety information. This helps to uphold ethical standards and supports participant autonomy in the research process.