Journal of Clinical Research & Bioethics

Abstract

Informed Consent in Human Subjects Research: A Comparison of International and Saudi Arabian Guidelines

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 relevant regional and domestic laws. The objective of the study is to determine whether the compared regulations coincide regarding the requirements for a valid IC or whether they show significant differences, and to what extent such requirements are also present in Saudi Arabia’s regulations.

Methods: We conducted a content comparative analysis of the above-mentioned guidelines regarding five elements of IC: Disclosure, comprehension, voluntariness, competence, and form of consent. These five topics were subdivided into 44 subtopics. Then we compared and critically analyzed their similarities and differences.

Results: The similarities and differences observed in the seven guidelines are summarized under the five components of IC mentioned above and regarding 44 selected subtopics.

Conclusion: The analysis of the above-mentioned guidelines shows that while the most basic components of IC are present in all the compared documents, there are some differences between them. Specifically, the study found that the Saudi Arabian regulations include 26 of the 44 subtopics considered and that most of the elements that are missing relate to the disclosure of information to participants.

Published Date: 2023-12-11; Received Date: 2023-11-07