Which of the following statements about confidentiality of medical records is true according to ICH E6?

The statement that subjects must be notified about possible access to their records by third parties accurately reflects the principles outlined in ICH E6 regarding the confidentiality of medical records. This guideline emphasizes the importance of protecting the privacy of trial participants and ensuring that they are adequately informed about how their personal data will be handled.

Informed consent is a critical component of ethical research practices, and part of this process involves disclosing to participants any potential risks related to confidentiality, including the possibility that third parties may gain access to their records. By ensuring that subjects are aware of this potential access, researchers uphold the principles of transparency and respect for the autonomy of participants.

Other statements do not align with the directives of ICH E6. For instance, ICH E6 typically aims for harmonization and often adheres to certain protections that may align closely with or exceed those of regulatory bodies like the FDA, rather than suggesting less stringent requirements. Moreover, stating that FDA regulations afford greater confidentiality than ICH E6 does not reflect the goal of the ICH guidelines. Lastly, asserting that informed consent does not require confidentiality information contradicts fundamental ethical standards, as providing information about confidentiality is key to securing informed consent from participants.