According to ICH GCP, where do the ethical principles stem from?

The correct answer is based on the foundational role that the Declaration of Helsinki plays in establishing ethical principles for medical research involving human subjects. Formulated by the World Medical Association, the Declaration of Helsinki provides a set of ethical guidelines for conducting clinical trials, emphasizing the importance of informed consent, the welfare of the research subjects, and the necessity to ensure that research is conducted with the utmost care for participant well-being.

This document specifically outlines the responsibilities of researchers and the ethical considerations that must be taken into account when designing and implementing clinical trials, making it a critical framework referenced in international guidelines, including the ICH Good Clinical Practice (GCP) guidelines.

Other documents like the Nuremberg Code and the United Nations Declaration contain important ethical principles as well, but the Declaration of Helsinki is crucial for its direct influence on the development of clinical research ethics, particularly in contexts regulated by ICH standards. The World Health Organization Guidelines also play a role in public health ethics but are not as specifically focused on the ethical principles pertaining to clinical trials as the Declaration of Helsinki.