临床试验性治疗的伦理挑战与规约

Ethical Challenges and Guidelines of Innovative Clinical Practice

作为一种临床技术创新形式,试验性治疗在推动医学发展、促进患者健康上做出了巨大贡献,但本身也存在技术创新路径不完全适用现代循证医学的研究范式、难以进行准确的风险评估、难以保证有效的知情同意、临床滥用危及患者安全等一系列伦理挑战。通过简要论证试验性治疗存在的道德合法性,重点指出临床试验性治疗应遵循保证科学基础、合理有效的知情同意、确保技术资质、公开治疗结果、控制利益冲突、适时进行规范研究等伦理准则,并建议医疗机构设立临床技术创新委员会,与机构伦理委员一同加强对临床试验性治疗的监管。

As a pathway of the development of clinical technology,innovative therapy has made significant contributions to the progress of clinical medicine and the promotion of patients＇ health.However,it also faces some ethical problems,such as in terms of failing to follow the evidence-based research paradigm,in obtaining valid consent and in making accurate evaluations of the quantified risks and benefits,all of which challenge the quality of patient care.Based on analysis of the legitimacy of innovative therapy,this paper proposes ethical guidelines for clinical innovative practices.The innovative treatments should be provided with appropriate and valid consent of the patients and should be performed by qualified and skilled practitioners in a protected clinical setting.The results of the treatments,either positive or negative,should be publicly reported.The innovators＇ conflicts of interests should be well managed and the innovative therapy itself should be subjected to formal research when it is necessary.Furthermore,the author suggests establishing a clinical innovative practice committee in medical institutions,together with the institutional review board,to regulate and oversee innovative clinical practices,thereby safeguarding the ethical application of new clinical technology and ensuring quality medical care.