Module 5 Presentations

05/07/2024

Development of GCP Informed consent (1)

The idea of informed consent was firstly articulated in 12 th

century by Jewish scholar, physician and philosopher

Moses Maimonides (Rabbi Moshe Ben-Maimon or

Rambam), b1135-d1204, the most influential Jewish

thinker of the Middle Ages, in his work code of Jewish ora

l law, called the Mishneh Torah .

It was more than 700 years later, in the second half of the 20 th century, before any real actions to increase the protection of people who take part in clinical research were taken.

The Organisation for Professionals in Regulatory Affairs

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Development of GCP Informed consent (2)

First documented written informed consent from 1900 (Study with Yellow fever run by Dr. Walter Reed in Cuba)

The Organisation for Professionals in Regulatory Affairs

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