生物医学技术高速发展时期提高对研究对象保护力度的挑战与思考

Challenges and Thoughts on Improving Subject Protection during the Period of Rapid Development of Biomedical Technology

随着基因编辑、人工智能、大数据等科学技术的发展,越来越多的前沿科技在客观上给生物医学研究带来的伦理风险不断加大,对研究对象的保护能力越来越显不足。然而,目前伦理治理手段相对薄弱,研究者伦理意识不强。反思现有伦理治理手段,已经不能很好应对新技术的发展。结合2022年3月中共中央办公厅、国务院办公厅印发的《关于加强科技伦理治理的意见》,提出需要从以下几个方面提高对研究者的保护力度:完善法规制度、加强伦理委员会建设、开展伦理治理手段的研究、提高伦理委员素质、构建区域伦理审查体系、提高研究者伦理素养等。开展上述工作,需要政府、伦理学专业组织、科研机构、生物医药企业、医疗机构等部门和社会大众一起,探索以“预防”的思想开展“伦理前置”性管理模式,从而在新型科技不断发展的现代社会提高对研究对象的保护力度。

With the development of technologies such as gene editing,artificial intelligence,and big data,cutting-edge technologies have brought increasing ethical risks in medical research,and the ability to protect subjects has become increasingly inadequate.However,the current means of ethical governance are relatively weak,the ethical awareness of researchers is not strong,and existing ethical governance methods can no longer meet the needs of new technological developments.Therefore,combined with the Guidelines to Strengthen Governance over Ethics in Science and Technology issued by the General Office of the CPC Central Committee and the General Office of the State Council in March 2022,this paper proposed that subject protection needed to be improved from the following aspects:improving regulations and systems,strengthening the construction of ethics committees,conducting research on ethical governance methods,raising the quality of ethics committees,constructing regional ethics systems,and improving the ethical literacy of researchers.To carry out the above work,it is necessary for the government,ethical professional organizations,research institutions,biomedical enterprises,medical institutions,and the public to explore the ethical pre-examination management model with the concept of prevention,so as to improve the subject protection in the modern society with the continuous development of new technologies.