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Roberto Andorno
Research Center, King Fahad Medical City, Riyadh Second Health Cluster, P.O. Box. 59046, 11525 Riyadh, Kingdom of Saudi Arabia
Publications
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Research Article
Informed Consent in Human Subjects Research: A Comparison of International and Saudi Arabian Guidelines
Author(s): May M. Al-Madaney*, Roberto Andorno and Margrit Fässler
Objective: Informed Consent (IC) is an essential requirement for the conduct of medical research involving human subjects. Since the Nuremberg Code was adopted in the aftermath of the Second World War, various international guidelines have specified the conditions for a valid IC for medical research. Among the most relevant guidelines are the World Medical Association’s Declaration of Helsinki, the guidelines of the Council of International Organization of Medical Sciences (CIOMS), and the Good Clinical Practice Guidelines of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH-GCP). This paper aims to compare the above-mentioned international guidelines with Saudi Arabia’s Law of Ethics of Research on Living Creatures regarding the requirements for IC. The comparison also includes some r.. View more»