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

When new safety information is available from a Sponsor, what must the investigator do regarding informed consent?

1. File a report with the FDA

2. Submit a revised ICF to the IRB with the new safety information

3. Notify all participants by mail

4. Conduct an emergency briefing session

The correct answer is: Submit a revised ICF to the IRB with the new safety information

Informed consent is a fundamental component of ethical research practices, and obtaining consent from participants is an ongoing process throughout the study. When new safety information becomes available from a Sponsor, it directly impacts the participants' understanding of potential risks associated with their participation. Submitting a revised Informed Consent Form (ICF) to the Institutional Review Board (IRB) with the new safety information ensures that all participants have the most current and relevant information to make informed decisions about their continued participation in the study. This process is crucial for maintaining ethical standards and participant safety, as it allows for transparency and reassessment of risk in light of new findings. While notifying participants by mail or conducting an emergency briefing could be part of a broader strategy to communicate important updates, the primary requirement is to revise the consent documentation and get IRB approval to ensure that all participants are adequately informed and that their consent reflects the updated safety information. Filing a report with the FDA may be necessary in certain circumstances but is not a direct response to updating informed consent for participants, and an emergency briefing session would not replace the formal process of updating and obtaining consent.