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Practice and reflections on regional mutual recognition of clinical research ethics review——based on survey results from medical and health institutions in Jiangsu Province

  • Xiaolin Liu,
  • Qian Hong,
  • Jingzhi Huang,
  • Hongsen Zhu,
  • Qing Zhao,
  • Jun Bao

摘要

With the continuous advancement of medical research, the number of multi-center clinical studies has been steadily increasing, bringing about significant challenges to ethical review. Improving the efficiency and quality of ethical review has become a necessity driven by national policies and the development of the industry. Mutual recognition of ethical reviews is one of the most effective ways to enhance the efficiency of ethical review in multi-center clinical trials. The promotion of mutual recognition of ethical reviews is both feasible and practically significant; however, progress has been less than ideal. Through conducting surveys, this study attempts to understand the status of mutual recognition of ethical reviews in Jiangsu Province, identify the reasons hindering the implementation of mutual recognition, and propose possible solutions. The results indicate that while most medical and health institutions are aware of the policies related to mutual recognition of ethical reviews, the majority remain in a wait-and-see attitude. Ensuring policy guarantees and the high quality and homogeneity of ethical review across institutions are considered necessary conditions for achieving mutual recognition of ethical reviews.