Which document outlines broader confidentiality requirements related to medical records than those required by the FDA or HHS?

The ICH E6 guideline, titled "Good Clinical Practice," establishes comprehensive standards for the design, conduct, recording, and reporting of clinical trials involving human subjects. One of its important aspects is the emphasis on the protection of participant confidentiality and the handling of personal data. The ICH E6 outlines stricter and broader requirements for maintaining the confidentiality of medical records compared to the regulations set forth by the FDA or HHS.

This guideline addresses the various ways in which sponsors, investigators, and institutional review boards (IRBs) must ensure participant confidentiality and compliance with applicable laws and ethical standards. This includes ensuring that sensitive information is not disclosed without proper consent and that data integrity and privacy are maintained throughout the study.

When comparing it with the other documents listed, ICH E6 provides a more detailed framework for confidentiality practices, taking into account the ethical considerations and legal responsibilities that might extend beyond FDA or HHS requirements alone. This makes it particularly relevant for organizations conducting international clinical trials, where multiple legal frameworks may apply.

In summary, ICH E6's broader and more stringent confidentiality requirements reflect a commitment to protecting participant privacy and ensuring ethical research practices.