Which responsibilities are NOT included for investigators under ICH E6?

Which responsibilities are NOT included for investigators under ICH E6?

• A. Qualifications and resources
• B. Compensation for subjects
• C. Informed consent of subjects
• D. Compliance with protocols

Answer: (B)

The responsibilities of investigators outlined in ICH E6 primarily focus on aspects of the clinical trial that pertain to oversight, ethics, and ensuring the integrity of the data collected. Investigators are tasked with ensuring that the study is conducted in accordance with the protocol, that subjects provide informed consent for participation, and that they possess the necessary qualifications and resources to conduct the trial effectively. Compensation for subjects, while an important aspect of clinical trial ethics and planning, is typically the responsibility of the trial sponsors rather than the investigators themselves. While investigators may facilitate the discussion about compensation, it does not fall directly under their regulatory responsibilities as per ICH E6. Therefore, this choice does not align with the core responsibilities expected from investigators within the framework established by ICH E6, making it the correct answer.

The responsibilities of investigators outlined in ICH E6 primarily focus on aspects of the clinical trial that pertain to oversight, ethics, and ensuring the integrity of the data collected. Investigators are tasked with ensuring that the study is conducted in accordance with the protocol, that subjects provide informed consent for participation, and that they possess the necessary qualifications and resources to conduct the trial effectively.

Compensation for subjects, while an important aspect of clinical trial ethics and planning, is typically the responsibility of the trial sponsors rather than the investigators themselves. While investigators may facilitate the discussion about compensation, it does not fall directly under their regulatory responsibilities as per ICH E6. Therefore, this choice does not align with the core responsibilities expected from investigators within the framework established by ICH E6, making it the correct answer.