摘要
伦理倾销是指在伦理治理较宽松的中低收入国家开展不符合国际伦理准则的研究,该研究由于不符合伦理准则而无法在研究者所在国开展。伦理倾销主要发生在两个领域:第一,在高收入国家被禁止的研究在中低收入国家开展,导致受试者被有意剥削。第二,当研究者的伦理意识不足或所在国的伦理治理能力较低时,也可能引发伦理倾销。印度宫颈癌筛查、西非埃博拉疫苗、非洲智能手机应用软件等属于国际伦理倾销事件,也有俄国遏制伦理倾销的范例。中国最近几年的“换头术”“基因编辑婴儿”和“疟疾抗癌”等伦理倾销事件,持续引起国际社会的讨论和争议,暴露了监管的不完备。伦理倾销带来公正、剥削和科研廉正等方面的问题,欧盟为此制订了反伦理倾销准则。中国需遵守国际反伦理倾销准则,更要加快伦理治理能力建设,防范伦理倾销。具体措施包括:提升伦理规章的法律地位,完善伦理审查组织和架构,各部门联动和中省分层监管,增强委员辨识力以从源头遏制伦理倾销,培训研究者伦理意识和科普大众伦理知识。使伦理治理能力建设跟上中国科技发展的步伐,切实保护临床研究受试者的权益。
Ethics dumping refers to the study of non-compliance with international ethical standards in low-income countries with loose ethical governance,which can not be carried out in the country where the researchers are located due to non-compliance with ethical standards.Ethics dumping mainly occurs in two fields.Firstly,research banned in high-income countries is carried out in low-income countries,resulting in the intentional exploitation of subjects.Secondly,when the ethical awareness of researchers is insufficient or the ethical governance ability of the host country is low,it may also lead to ethics dumping.India’s cervical cancer screening,Ebola vaccine in West Africa and smart phone application software in Africa are international ethical dumping events.There are also examples of Russia’s efforts to curb ethical dumping.In recent years,China’s ethical dumping events,such as“head changing”“gene editing of infants”and“malaria anti-cancer”,have caused continuous discussion and controversy in the international community,exposing the inadequacy of regulation.Ethical dumping brings problems to justice,exploitation and research integrity.Therefore,the EU has formulated anti ethics dumping guidelines.China needs to comply with the international anti ethical dumping standards,accelerate the construction of China’s ethical governance capacity,and prevent ethical dumping.The specific measures include improving the legal status of ethical regulations,improving the organization and structure of ethical review,the linkage of various departments and the national and provincial level supervision,strengthening the identification of members to curb ethical dumping from the source,and training researchers’ethical awareness and popular ethical knowledge.The construction of ethical governance ability should keep pace with the development of science and technology in China,and protect the rights and interests of clinical research subjects in China.
作者
周吉银
刘丹
ZHOU Jiyin;LIU Dan(National Drug Clinical Trial Institution,The Second Affiliated Hospital of Army Medical University,Chongqing 400037,China)
出处
《中国医学伦理学》
2019年第12期1511-1517,共7页
Chinese Medical Ethics
基金
2019年陆军军医大学人文社会科学基金重点项目“伦理倾销对我国的危害及防范研究”(2019XRW04)
陕西省健康文化研究中心立项资助的“伦理倾销对我国的危害及防范研究”课题的一部分(JKWH2019-Q07)
关键词
伦理倾销
伦理审查
临床研究者
科技伦理
Ethics Dumping
Ethical Review
Clinical Researchers
Science and Technology Ethics
