Under ICH E6 compliance, what must investigators clearly disclose in the informed consent form?

The requirement for investigators to disclose that monitors, auditors, IRBs/IECs, and regulatory authorities may access medical records is crucial for maintaining transparency and ensuring informed consent. This disclosure is essential because it informs participants that their data and medical records may not remain entirely confidential, as authorized personnel will need to review these records to ensure compliance with study protocols and regulatory standards.

This information empowers participants to make an informed decision about their involvement in the trial, as they understand that certain third parties will have access to their personal health information for the purposes of oversight, safety assessments, and research integrity. This aligns with the principles of ethical research practices, which prioritize participant autonomy and informed consent.

The other options touch on related themes but do not align with compliance requirements under ICH E6 in the same direct manner. For example, while it is true that confidentiality might not always be guaranteed, it is more important to explicitly communicate who will have access to sensitive data. Additionally, while regulatory bodies like the FDA may have the authority to inspect records, such stipulations are secondary to the more immediate need to confirm who will access the medical records while the trial is ongoing.