中国医学伦理学2024，Vol.37Issue(4)：420-427,8.DOI:10.12026/j.issn.1001-8565.2024.04.07
化妆品功效宣称评价试验的伦理审查
Ethical review of cosmetic efficacy claims evaluation trails
摘要
Abstract
The supervision of cosmetics started relatively late in China,and corresponding laws and regulations on ethical review are not yet perfect.The Cosmetics Supervision and Administration Regulations,which came into force on January 1,2021,had stricter requirements for cosmetic efficacy claims,requiring that cosmetic efficacy claims should have a sufficient scientific basis.Cosmetic efficacy claims evaluation trials include human efficacy evaluation trials,consumer use tests,and laboratory trials.Human efficacy evaluation trials and consumer use tests should comply with the requirements of ethical principles,the necessary product safety evaluation should be completed before the tests are carried out,to ensure that there is no harm to the human health of research participants(or consumers)under normal,foreseeable circumstances.The Regulations on the Administration of Registration and Filing Materials for Cosmetics required that product test reports should include microbiological and physical-chemical tests,toxicological trials,human safety trial reports,and human efficacy trial reports.The key points of the ethics committee's review of cosmetic efficacy claims evaluation trials include the reasonableness of the trial protocol,consumer survey and expert evaluation,selection of detection methods,study population and sample size,safety evaluation of the cosmetics,risk assessment of cosmetic raw materials,protection of privacy,and qualifications of the testing institutions and researchers.High-quality ethical review is conducive to safeguarding the safety and rights of research participants(or consumers),and will also promote the quality of cosmetic efficacy claims evaluation trails in China.关键词
化妆品/功效宣称/伦理审查/临床试验评价Key words
cosmetics/efficacy claim/ethical review/clinical trial evaluation分类
医药卫生引用本文复制引用
刘硕,周吉银..化妆品功效宣称评价试验的伦理审查[J].中国医学伦理学,2024,37(4):420-427,8.基金项目
2022年陆军军医大学人文社会科学基金重点项目"我市涉及人的健康相关研究伦理治理的现状与对策研究"(2022XRW02) （2022XRW02）
