Navigating the ethical world of clinical researchers in China: challenges and pathways for improvement.

BACKGROUND

Over the past decade, China has witnessed a sharp increase in clinical trials, exceeding 4,000 in 2023. Yet, this growth has brought emerging ethical challenges and concerning researcher misconduct. Despite growing scholarly attention to clinical trial regulation, a critical knowledge gap remains regarding the ethical world of clinical researchers. This study investigates ethical challenges in clinical research, their contributing factors, and pathways for improvement.

METHODS

The research design involved mixed methods, specifically a nationwide questionnaire survey (quantitative) and semi-structured interviews (qualitative). Using stratified random sampling from China's Clinical Trial Registry (ChiCTR), 1,800 questionnaires were distributed and 287 valid responses analyzed descriptively with SPSS 22 to identify key challenges. Subsequently, 37 clinical researchers were interviewed, and transcripts thematically analyzed with NVivo 11 to explore underlying causes and triangulate the survey findings, thereby identifying potential pathways for improvement.

RESULTS

The descriptive analysis of the questionnaire results, triangulated with interview findings, reveals that general misconduct is common despite the rarity of severe violations; ethical behavior often lags behind ethical cognition and attitude; researchers show blunted moral sensitivity; and most adopt a passive stance toward ethical compliance rather than active engagement. The thematic analysis identifies two core contributors to these challenges: individual factors-including personal traits, dulled moral sensitivity, limited ethical knowledge, and low ethical awareness; and environmental factors-including weak ethical oversight, an inadequate ethical climate, unhealthy research competition, and researcher-subject knowledge asymmetry.

CONCLUSIONS

Ethical challenges in China's clinical research persist due to the interaction of personal ethical limitations and structurally weak oversight systems. To mitigate these challenges, a dual approach is proposed, integrating internal moral cultivation and external oversight. Internally, efforts should focus on creating an ethical space for dialogue, promoting moral consensus, fostering ethical identity and sensitivity, and cultivating a sense of ethical responsibility through moral practice. Externally, improvements are needed in post-approval ethical monitoring, targeted training programs, research climate, and public understanding of clinical trials and ethics.