Ethical Principles in Clinical Research and GCP

This document discusses the ethical foundations of Good Clinical Practice (GCP) and the importance of protecting human participants in clinical research.

It highlights historical unethical research scandals, such as the Nazi experiments, Tuskegee Syphilis Study, and Willowbrook Study, which led to the development of ethical guidelines like the Nuremberg Code (1947) and the Declaration of Helsinki (1964).

These guidelines emphasize voluntary consent, minimizing harm, and ensuring that risks are proportional to benefits.

The document also presents case studies to illustrate ethical considerations in modern clinical research, such as informed consent, participant rights, and the balance between scientific goals and participant welfare.