【中英文对照版】科技伦理审查办法(试行).docx

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1、科技部、教育部、工业和信息 化部、农业农村部、国家卫生 健康委、中国科学院、中国社 科院、中国工程院、中国科 协、中央军委科技委关于印发 科技伦理审查办法（试行）的通知（国科发监（2023） 167号）各省、自治区、直辖市及计划单列市、副省级城市有关部门，新疆生产建设兵团有关部科技伦理审查办法(试行)MeasuresforScientificandTechnologicalEthicsReview(forTrialImplementation)制定机关：科学技术部教育部工业和信息化部农业农村部国家卫生健康委员会中国科学院中国社会科学院中国工程院中国科学技术协会中央军委科学技术委员会发文字号：国

2、科发监2023167号公布日期：2023.09.07施行日期：2023.12.01效力位阶：部门规范性文件法规类别：科技综合规定与体改IssuingAuthority:MinistryofScience&TechnologyMinistryofEducationMinistryofIndustry&InformationTechnologyMinistryofAgricultureandRuralAffairsNationalHealthCommissionChineseAcademyofSciencesChineseAcademyofSocialSciencesChineseAcademyo

3、fEngineeringChinaAssociationforScienceandTechnologyScienceandTechnologyCommitteeoftheCentralMilitaryCommissionDocumentNumber：No.1672023oftheMinistryofScienceandTechnologyDateIssued：09-07-2023EffectiveDate：12-01-20231.evelofAuthority：DepartmentalRegulatoryDocumentsAreaofLaw：GeneralProvisionsandSystem

4、ReformofScienceandTechnologyNoticebytheMinistryofScienceandTechnology,theMinistryofEducation,theMinistryofIndustryandInformationTechnology,theMinistryofAgricultureandRuralAffairs,theNationalHealthCommission,theChineseAcademyofSciences,theChineseAcademyofSocialSciences,theChineseAcademyofEngineering,

5、theChinaAssociationforScienceandTechnology,andtheScienceandTechnologyCommissionoftheCentralMilitaryCommissionofIssuingtheMeasuresforScientificandTechnologicalEthicsReview(forTrialImplementation)(No.1672023oftheMinistryofScienceandTechnology)Therelevantdepartmentsofallprovinces,autonomousregions,muni

6、cipalitiesdirectlyundertheCentralGovernment,citiesunderseparatestateplanning,sub-provincialcities,andXinjiangProductionandConstructionCorps;allrelevantdepartmentsandallinstitutionsdirectlyundertheStateCouncil,andallrelevantentities:门，国务院各有关部门、直属机构，各有关单位：TheMeasuresforScientificandTechnologicalEthics

7、Review(forTrialImplementation),asapprovedbytheScienceandTechnologyCommissionoftheCentralMilitaryCommission,areherebyissuedtoyouforyourcomplianceandimplementation.科技伦理审查办法（试行）已经中央科技委员会同意，现印发给你们，请遵照实施。MinistryofScienceandTechnology科技部MinistryofEducation教育部MinistryofIndustryandInformationTechnology工业和信

8、息化部MinistryofAgricultureandRuralAffairs农业农村部NationalHealthCommission国家卫生健康委ChineseAcademyofSciences中国科学院ChineseAcademyofSocialSciences中国社科院ChineseAcademyofEngineering中国工程院ChinaAssociationforScienceandTechnology中国科协ScienceandTechnologyCommissionoftheCentralMilitaryCommission中央军委科技委September7,20232023

9、年9月7日科技伦理审查办法（试行）第一章总则第一条为规范科学研 究、技术开发等科技活动的科 技伦理审查工作，强化科技伦 理风险防控，促进负责任创 新，依据中华人民共和国科 学技术进步法关于加强科 技伦理治理的意见等法律法 规和相关规定，制定本办法。第二条开展以下科技活 动应依照本办法进行科技伦理 审查：（一）涉及以人为研究参与者 的科技活动，包括以人为测 试、调查、观察等研究活动的 对象，以及利用人类生物样 本、个人信息数据等的科技活 动；（二）涉及实验动物的科技活 动；（三）不直接涉及人或实验动 物，但可能在生命健康、生态 环境、公共秩序、可持续发展MeasuresforScientific

10、andTechnologicalEthicsReview(forTrialImplementation)ChapterIGeneralProvisionsArticle1TheseMeasuresaredevelopedinaccordancewiththeLawofthePeoplesRepublicofChinaonScientificandTechnologicalProgress,theOpinionsonStrengtheningtheGovernanceofScientificandTechnologicalEthics,andotherapplicablelawsandregul

11、ationsandrelevantprovisionstoregulatescientificandtechnological(usci-techn)ethicalreviewinscientificresearch,technologydevelopment,andotherscientificandtechnologicalactivities,strengthenthepreventionandcontrolofsci-techethicalrisks,andpromoteresponsibleinnovation.Article2Thefollowingscientificandtec

12、hnologicalactivitiesshallbesubjecttosci-techethicsreviewinaccordancewiththeseMeasures:(1) Scientificandtechnologicalactivitiesinvolvinghumanresearchparticipants,includinghumantesting,investigation,observation,andotherresearchactivities,andscientificandtechnologicalactivitiesutilizinghumanbiologicals

13、amplesandpersonalinformation,amongothers.(2) Scientificandtechnologicalactivitiesinvolvingexperimentalanimals.(3) Scientificandtechnologicalactivitiesthatdonotdirectlyinvolvehumansorexperimentalanimals,butmayposeethicalrisksandchallengestoareassuchaslifeandhealth,ecologyandenvironment,publicorder,an

14、dsustainable等方面带来伦理风险挑战的科development.技活动；(4) Otherscientificandtechnologicalactivitiesthatshallbesubjecttosci-techethicsreviewinaccordancewithlaws,administrativeregulations,andrelevantrulesissuedbythestate.Article3Inconductingscientificandtechnologicalactivities,peopleshalladheretotheunificationofin

15、novationpromotionandriskprevention,objectivelyassessandprudentlytreatuncertaintiesandrisksintechnologicalapplication,followtheprinciplesofimprovinghumanwellbeing,respectingtherighttolife,upholdingfairnessandimpartiality,reasonablycontrollingrisks,andmaintainingopenandtransparentsci-techethics,andcomplywiththeConstitution,lawsandregulations,andrelevantrulesissuedbythestate,aswellassci-techethicsstandards.Sci-techethicsreviewshalladheretotheprinciplesofbeingscientific,independent,impartial,andtransparent,disclosetothepublicthereviewsystemandreviewprocedures,objec