Question

ICH E6 has broader requirements than FDA or HHS concerning confidentiality of medical record and access by third parties. if investigators are complying with ICH E6 guideline, they must:

Answer 1

Answer:

Investigators should  let the subjects know in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may be privy to the subject's medical records.

Explanation:

FDA stands for Food Drug and Administration that see to the regulation of food and drug in The U.S.

ICH E6 is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. These  guidelines are meant for standard practice globally.

Investigators should let the  subjects know in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject's medical records. Failure to do so is unethical and Subjects can pick up a case on this at the law court.