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


Al-Madaney, May M; Fässler, Margrit (2023). Development and validation of a tool to assess researchers’ knowledge of human subjects’ rights and their attitudes toward research ethics education in Saudi Arabia. BMC Medical Ethics, 24(1):94.

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.

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.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > Institute of Biomedical Ethics and History of Medicine
Dewey Decimal Classification:610 Medicine & health
Scopus Subject Areas:Health Sciences > Issues, Ethics and Legal Aspects
Social Sciences & Humanities > Health (social science)
Health Sciences > Health Policy
Uncontrolled Keywords:Health Policy, Health (social science), Issues, ethics and legal aspects, Attitudes; Clinical researchers; Knowledge; Questionnaire development; Research ethics; Saudi Arabia; Validation study
Language:English
Date:2 November 2023
Deposited On:29 Nov 2023 16:55
Last Modified:31 Mar 2024 03:39
Publisher:BioMed Central
ISSN:1472-6939
OA Status:Gold
Free access at:Publisher DOI. An embargo period may apply.
Publisher DOI:https://doi.org/10.1186/s12910-023-00968-z
PubMed ID:37919701
  • Content: Published Version
  • Language: English
  • Licence: Creative Commons: Attribution 4.0 International (CC BY 4.0)