Which of the following is NOT a key goal of ICH E6?

Which of the following is NOT a key goal of ICH E6?

• A. Protection of trial subjects' rights
• B. Ensuring trial data credibility
• C. Maximizing profit for sponsors
• D. Ensuring confidentiality of trial subjects

Answer: (C)

One of the primary objectives of the ICH E6 guideline is to ensure the protection of the rights, safety, and well-being of trial subjects. This includes emphasizing the need for informed consent and safeguarding the confidentiality of trial subjects to maintain their privacy. Another critical goal is to ensure that the data generated from clinical trials is credible and reliable. This integrity is essential for regulatory authorities to make informed decisions regarding the safety and efficacy of new treatments or drugs. The idea of maximizing profit for sponsors does not align with the foundational principles of ICH E6. While sponsors certainly operate in a commercial context, the guideline prioritizes ethical conduct and the integrity of clinical trials over financial gain. The focus is on safeguarding participants and generating valid data rather than the financial interests of the sponsors. Thus, the notion that profit maximization is a key goal of ICH E6 stands in contrast to the core responsibilities and ethical considerations outlined in the guidelines.

One of the primary objectives of the ICH E6 guideline is to ensure the protection of the rights, safety, and well-being of trial subjects. This includes emphasizing the need for informed consent and safeguarding the confidentiality of trial subjects to maintain their privacy.

Another critical goal is to ensure that the data generated from clinical trials is credible and reliable. This integrity is essential for regulatory authorities to make informed decisions regarding the safety and efficacy of new treatments or drugs.

The idea of maximizing profit for sponsors does not align with the foundational principles of ICH E6. While sponsors certainly operate in a commercial context, the guideline prioritizes ethical conduct and the integrity of clinical trials over financial gain. The focus is on safeguarding participants and generating valid data rather than the financial interests of the sponsors. Thus, the notion that profit maximization is a key goal of ICH E6 stands in contrast to the core responsibilities and ethical considerations outlined in the guidelines.