临床科研项目知情同意过程存在问题及解决途径

Existing Problems and Solution of Informed Consent in Clinical Research

目的为规范我国临床科研项目知情同意现状,更好地发挥保护受试者权益的作用,以提高研究的伦理性。方法根据实际工作,并查阅国内有关临床科研项目知情同意过程存在的问题及解决途径方面的文献进行综合分析和讨论。结果结合临床科研项目知情同意过程中所面临的关于研究者、受试者和伦理委员会方面存在的问题,提出未来医学临床科研中关于规范知情同意的思考和建议。结论规范知情同意书,开展对受试者和研究者的医学理论知识培训,以改善知情同意现状,体现临床科研项目的科学性和伦理性,为临床医学事业的发展、进步作出贡献。

Objective： To standardize the present situation of informed consent in China＇s clinical research projects,and to better play the role of protecting the rights and interests of subjects,in order to improve the ethicality of research. Methods： According to the actual work,this paper reviewed literatures about the existing problems and solutions in the informed consent process in clinical research to carry out comprehensive analysis and discussion.Results： Combining with the problems about researchers,subjects and ethical committees faced in informed consent process in clinical research,this paper put forward thinking and suggestions on standardizing the informed consent for future medical clinical research. Conclusion： We should standardize the informed consent form and carry out the training of the subjects and researchers about medical ethics knowledge,so as to improve the status of informed consent,reflect the scientificity and ethicality of clinical research project,and to contribute to the development and progress of clinical medicine.