Developing and validating a questionnaire on knowledge and attitudes in health research ethics

Abstract

Introduction. Research ethics and integrity are fundamental for safeguarding human participants and ensuring trustworthy scientific practices. Understanding researchers’ knowledge, attitudes, and perceptions regarding ethical standards is important for all health researchers, but particularly relevant for early-career researchers. While several international instruments exist to evaluate specific aspects of research ethics, such as plagiarism, organizational climate, or responsible conduct of research, a multidimensional and contextually relevant tool is required. Materials and methods. A comprehensive questionnaire was developed to assess ethical knowledge, attitudes toward research resources and institutional integrity measures, and self-perceived ethical competencies among doctoral students in the health sciences. Item formulation was guided by international standards, including the Declaration of Helsinki, the European Code of Conduct for Research Integrity, and Good Clinical Practice guidelines. The development process included a content validity assessment by 10 experts and a psychometric evaluation of the collected data from 274 doctoral students. Exploratory factor analysis (EFA) was applied to determine the latent structure of the questionnaire, and internal consistency was assessed using Cronbach’s alpha. Results. EFA revealed a six-factor structure explaining 64.5% of the total variance. The factors measured: (I) perceived importance of research resources, (II) self-perceived ethical competencies, (III) implemented institutional measures for research integrity, (IV) ethical principles and moral responsibilities, (V) perceived accessibility of research resources, and (VI) importance of institutional integrity measures. Factor loadings were generally high, and internal consistency was good to excellent, with Cronbach’s alpha values ranging from 0.738 to 0.989. These findings indicate that the questionnaire captures multidimensional aspects of research ethics and integrity. Conclusions. The developed questionnaire represents a robust, valid, and reliable instrument for assessing ethical knowledge and attitudes among researchers in health sciences. It can serve as an internal audit tool to evaluate research integrity climate, researcher satisfaction with available resources, and implementation of institutional policies. Moreover, it provides a foundation for designing targeted training programs and professional development initiatives aimed at improving ethical competencies.