CITI GCP Practice Exam – Complete Study Resource 2025

According to the ICH E6 guidelines, the informed consent form must disclose the access to a subject's records by regulatory authorities. This is critical because regulatory authorities play an essential role in ensuring that clinical trials are conducted ethically and that participant safety is prioritized. Informing subjects about this access allows them to understand that their data may be reviewed by independent entities tasked with overseeing compliance with ethical standards and regulations.

Such transparency helps to ensure that participants are fully aware of who may have access to their personal health information and reinforces their trust in the clinical research process. This understanding is a key component in promoting informed decision-making among potential participants when they are considering involvement in a study. Ensuring that subjects know their rights and the entities involved is an integral part of protecting their welfare in clinical research.

The other options related to access by insurance companies, research sponsors, or family members do not align with the required disclosures under the ICH guidelines, which focus on regulatory oversight as a primary concern in maintaining the integrity and ethical management of clinical trials.