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

ABSTRACT 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. Keywords: Informed consent; Medical research; Disclosure; Comprehension; Voluntariness; Competence; International guideline

Development and validation of a tool to assess researchers’ knowledge of human subjects’ rights and their attitudes toward research ethics education in Saudi Arabia

Abstract Background Researchers must adhere to ethical and scientific standards in their research involving human subjects; therefore, their knowledge of human subjects’ rights is essential. A tool to measure the extent of this knowledge is necessary to ensure that studies with participants are conducted ethically and to enhance research integrity. Currently, no validated instrument is available for such an assessment. Therefore, the primary purpose of this study is to develop a reliable and valid instrument to assess researchers’ knowledge of human subjects’ rights in clinical settings, as well as a reliable and valid measure of their attitudes toward clinical research ethics education in Saudi Arabia. Methods The current study involves the development of a questionnaire about the rights of human subjects in research and the researchers’ attitudes toward research ethics education. The content was developed based on an extensive review of research ethics guidelines. A panel of experts tested the questionnaire for face validity (n = 5) and content validity (n = 8). The reliability of the questionnaire was established by a split-half reliability coefficient and item analysis among a sample (n = 301) of clinical researchers. Results Face validity demonstrated that the questionnaire was quick to complete and easy to answer. The global content validity indices (S-CVIs) were greater than 0.78 for all questionnaire sections; the split-half reliability coefficient was 0.755 for knowledge items; Cronbach’s alpha was 0.77 for researchers’ attitudes, showing good internal consistency. The difficulty index ranged from 12.0% to 98.7% for all knowledge items. Most questions were at an acceptable level of reliability and discrimination criteria. The final version of the questionnaire contained 89 items, distributed as 15 questions on demographic and professional characteristics, 64 questions items on knowledge, and 10 items on attitudes. Conclusions The questionnaire is a valid and reliable tool to assess biomedical researchers’ knowledge of human subjects’ rights and their attitudes toward research ethics education. This instrument could help address the gap in researchers’ knowledge of the rights and facilitate the development of educational intervention programs to set appropriate learning objectives