Question

ICH E6 allows broader access to research records and to otherwise confidential medical records than is required by FDA regulations. TRUE OR FALSE

Answer 1

The assertion that ICH E6 provides broader access than FDA regulations to research records and confidential medical records is false. ICH E6 sets international standards for clinical trials but does not override local privacy laws enforced by agencies like the FDA.

Step-by-step explanation:

The statement that ICH E6 allows broader access to research records and to otherwise confidential medical records than is required by FDA regulations is FALSE. ICH E6, also known as the Good Clinical Practice (GCP) guideline, sets international standards for ethical and scientific quality in designing, conducting, recording, and reporting trials that involve the participation of human subjects. The guideline aims to ensure that the rights, safety, and well-being of trial subjects are protected, and that clinical trial data are credible.

However, the ICH G6 does not supersede local regulations such as those enforced by the FDA, which have strict rules to protect patient confidentiality and limit access to personal health information unless there are specific circumstances that warrant such access.