临床研究者对知情同意过程体验质性研究的Meta整合OA

Objective To integrate qualitative studies on clinical researchers'experiences in the informed consent process,and to pro-vide reference for clinical researchers to optimize the process.Methods Computer-based retrieval was conducted in databases includ-ing CNKI(National Knowledge Infrastructure),VIP Database,Chinese Medical Journal Full-text Database,China Biology Medicine Database(CBM),Wanfang Database,Embase,PubMed,Web of Science,Cochrane Library,and PsycINFO to collect qualitative studies on clinical researchers'experiences in the informed consent process.The retrieval period spanned from the inception of databases to July 2025.The quality of the included studies was evaluated using the Australian JBI Evidence-Based Health Care Center's quality ap-praisal standards for qualitative research.A convergent integrated approach was employed for result integration and summarization.Results Ten studies were included,from which 29 study findings were extracted,grouped into ten categories,and further integrated into five synthesized findings:ethical responsibility and role conflict,communication skills and quality of informed consent,emotional burden and ethical dilemmas,institutional constraints and resource support,and cultural adaptability and contextualized practice.Conclusion Clinical researchers'communication with potential participants during the informed consent process is affected by multi-ple factors,including research pressure,cultural concepts,barriers to information transmission and understanding,and imperfect sys-tems.Relevant institutions should strengthen researchers'ethical competence and provide systematic training,optimize the informed consent process and tool design,coordinate individual autonomy with family cultural context,and improve the practical guidance role of ethics committees.