【中英文对照版】科技伦理审查办法(试行).docx

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&InformationTechnologyMinistryofAgricultureandRuralAffairsNationalHealthCommissionChineseAcademyofSciencesChineseAcademyofSocialSciencesChineseAcademyofEngineeringChinaAssociationforScienceandTechnologyScienceandTechnologyCommitteeoftheCentralMilitaryCommissionDocumentNumber：No.1672023oftheMinistryofScienceandTechnologyDateIssued：09-07-2023EffectiveDate：12-01-20231.evelofAuthority：DepartmentalRegulatoryDocumentsAreaofLaw：GeneralProvisionsandSystemReformofScienceandTechnologyNoticebytheMinistryofScienceandTechnology,theMinistryofEducation,theMinistryofIndustryandInformationTechnology,theMinistryofAgricultureandRuralAffairs,theNationalHealthCommission,theChineseAcademyofSciences,theChineseAcademyofSocialSciences,theChineseAcademyofEngineering,theChinaAssociationforScienceandTechnology,andtheScienceandTechnologyCommissionoftheCentralMilitaryCommissionofIssuingtheMeasuresforScientificandTechnologicalEthicsReview(forTrialImplementation)(No.1672023oftheMinistryofScienceandTechnology)Therelevantdepartmentsofallprovinces,autonomousregions,municipalitiesdirectlyundertheCentralGovernment,citiesunderseparatestateplanning,sub-provincialcities,andXinjiangProductionandConstructionCorps;allrelevantdepartmentsandallinstitutionsdirectlyundertheStateCouncil,andallrelevantentities:门，国务院各有关部门、直属机构，各有关单位：TheMeasuresforScientificandTechnologicalEthicsReview(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MeasuresforScientificandTechnologicalEthicsReview(forTrialImplementation)ChapterIGeneralProvisionsArticle1TheseMeasuresaredevelopedinaccordancewiththeLawofthePeople'sRepublicofChinaonScientificandTechnologicalProgress,theOpinionsonStrengtheningtheGovernanceofScientificandTechnologicalEthics,andotherapplicablelawsandregulationsandrelevantprovisionstoregulatescientificandtechnological(usci-techn)ethicalreviewinscientificresearch,technologydevelopment,andotherscientificandtechnologicalactivities,strengthenthepreventionandcontrolofsci-techethicalrisks,andpromoteresponsibleinnovation.Article2Thefollowingscientificandtechnologicalactivitiesshallbesubjecttosci-techethicsreviewinaccordancewiththeseMeasures:(1) Scientificandtechnologicalactivitiesinvolvinghumanresearchparticipants,includinghumantesting,investigation,observation,andotherresearchactivities,andscientificandtechnologicalactivitiesutilizinghumanbiologicalsamplesandpersonalinformation,amongothers.(2) Scientificandtechnologicalactivitiesinvolvingexperimentalanimals.(3) Scientificandtechnologicalactivitiesthatdonotdirectlyinvolvehumansorexperimentalanimals,butmayposeethicalrisksandchallengestoareassuchaslifeandhealth,ecologyandenvironment,publicorder,andsustainable等方面带来伦理风险挑战的科development.技活动；(4) Otherscientificandtechnologicalactivitiesthatshallbesubjecttosci-techethicsreviewinaccordancewithlaws,administrativeregulations,andrelevantrulesissuedbythestate.Article3Inconductingscientificandtechnologicalactivities,peopleshalladheretotheunificationofinnovationpromotionandriskprevention,objectivelyassessandprudentlytreatuncertaintiesandrisksintechnologicalapplication,followtheprinciplesofimprovinghumanwellbeing,respectingtherighttolife,upholdingfairnessandimpartiality,reasonablycontrollingrisks,andmaintainingopenandtransparentsci-techethics,andcomplywiththeConstitution,lawsandregulations,andrelevantrulesissuedbythestate,aswellassci-techethicsstandards.Sci-techethicsreviewshalladheretotheprinciplesofbeingscientific,independent,impartial,andtransparent,disclosetothepublicthereviewsystemandreviewprocedures,objectivelyandprudentlyassesstheethicalrisksofscientificandtechnologicalactivities,conductreviewsaccordingtotheapplicableprovisions,andconsciouslyacceptthesupervisionofrelevantparties.Ifnationalsecurity,statesecrets,tradesecrets,orsensitiveissuesareinvolved,relevantworkshallbeconductedeffectivelyinaccordancewiththeapplicablelawsandregulations.ChapterIlReviewers（四）依据法律、行政法规和 国家有关规定需进行科技伦理 审查的其他科技活动。第三条开展科技活动应 坚持促进创新与防范风险相统 一，客观评估和审慎对待不确 定性和技术应用风险，遵循增 进人类福祉、尊重生命权利、 坚持公平公正、合理控制风 险、保持公开透明的科技伦理 原则，遵守我国宪法、法律法 规和有关规定以及科技伦理规 范。科技伦理审查应坚持科学、独 立、公正、透明原则，公开审 查制度和审查程序，客观审慎 评估科技活动伦理风险，依规 开展审查，并自觉接受有关方 面的监督。涉及国家安全、国 家秘密、商业秘密和敏感事项 的，依法依规做好相关工作。第二章审查主体第四条高等学校、科研 机构、医疗卫生机构、企业等Article 4 Institutionsofhigherlearning,scientificresearchinstitutions,medicalandhealthinstitutions,andenterprises,amongothers,arethepartiesresponsibleforadministeringtheirsci-techethicsreview.Entitiesengagedinlifescience,medicine,artificialintelligence,andotherscientificandtechnologicalactivitiesshallestablishasci-techethics(review)committeeiftheresearchcontentinvolvessensitivefieldsofsci-techethics.Otherentitiesthatneedtoconductthesci-techethicsreviewmayestablishasci-techethics(review)committeeaccordingtotheiractualcircumstances.Entitiesshallprovidethesci-techethics(review)committeewithstaff,officepremises,funds,andotherconditionsnecessaryforperformingtheirdutiesandtakeeffectivemeasurestoensurethatthesci-techethics(review)committeeconductsethicsreviewindependently.Theestablishmentofprofessionalandregionalsci-techethicsreviewcentersshallbeexplored.Article 5 Themajordutiesofthesci-techethics(review)committeeinclude:(1) developingandimprovingmanagementrulesandworkstandardsofthesci-techethics(review)committee;(2) providingsci-techethicsconsultation,guidingscientificandtechnologicalpersonneltoconductthesci-techethicsriskassessmentofscientificandtechnologicalactivities;是本单位科技伦理审查管理的 责任主体。从事生命科学、医 学、人工智能等科技活动的单 位，研究内容涉及科技伦理敏 感领域的，应设立科技伦理 （审查）委员会Q其他有科技 伦理审查需求的单位可根据实 际情况设立科技伦理（审查） 委员会。单位应为科技伦理（审查）委 员会履职配备必要的工作人 员、提供办公场所和经费等条 件，并采取有效措施保障科技 伦理（审查）委员会独立开展 伦理审查工作。探索建立专业性、区域性科技 伦理审查中心。第五条科技伦理（审 查）委员会的主要职责包括：（一）制定完善科技伦理（审 查）委员会的管理制度和工作 规范；（二）提供科技伦理咨询，指 导科技人员对科技活动开展科 技伦理风险评估；（三）开展科技伦理审查，按 要求跟踪监督相关科技活动全 过程；(3) conductingsci-techethicsreviewandtrackingandsupervisingtheentireprocessofrelevantscientificandtechnologicalactivitiesasrequired;(4) makingjudgmentsonwhethertheproposedscientificandtechnologicalactivitiesareincludedinthelistdeterminedinArticle25oftheseMeasures;(5) organizingtrainingonsci-techethicsreviewforcommitteemembersandtrainingonsci-techethicsknowledgeforscientificandtechnologicalpersonnel;(6) acceptingandassistingintheinvestigationofcomplaintsandreportsinvolvingsci-techethicsissuesinrelevantscientificandtechnologicalactivities;and(7) registeringandreportinginaccordancewiththerequirementsofArticles43,44,and45oftheseMeasures,andcooperatingwithlocalandappropriateindustrydepartmentsinconductingrelatedworkinvolvingsci-techethicsreview.Article6Thesci-techethics(review)committeeshalldevelopitsbylaws,andestablishandimprovethereview,supervision,confidentialitymanagement,archivesmanagement,andotherrulesandstandards,workprocedures,andthemechanismforthemanagementofconflictsofinteresttoensurethatthesci-techethicsreviewiscompliant,transparent,andtraceable.（四）对拟开展的科技活动是 否属于本办法第二十五条确定 的清单范围作出判断；（五）组织开展对委员的科技 伦理审查业务培训和科技人员 的科技伦理知识培训；（六）受理并协助调查相关科 技活动中涉及科技伦理问题的 投诉举报；（七）按照本办法第四十三、 四十四、四十五条要求进行登 记、报告，配合地方、相关行 业主管部门开展涉及科技伦理 审查的相关工作。第六条科技伦理（审 查）委员会应制定章程，建立 健全审查、监督、保密管理、 档案管理等制度规范、工作规 程和利益冲突管理机制，保障 科技伦理审查合规、透明、可 追溯。第七条科技伦理（审 查）委员会人数应不少于7 人，设主任委员1人，副主任 委员若干。委员会由具备相关 科学技术背景的同行专家，伦 理、法律等相应专业背景的专 家组成，并应当有不同性别和Article7Thesci-techethics(review)committeeshallconsistofatleastsevenmembers,includingonechairmanandseveraldeputychairmen.Thecommitteeshallconsistofpeerexpertswithrelevantscientificandtechnologicalbackgrounds,andexpertswithcorrespondingprofessionalbackgroundsinethicsandlaw,amongothers,anditshallhavemembersofdifferentgendersandmemberswhoarenotfromtheentityitself.Inethnicautonomousregions,thereshallbememberswhoarefamiliarwithlocalconditions.Thetermofofficeofamembershallnotexceedfiveyearsandamembermaybere-elected.Article8Membersofthesci-techethics(review)committeeshallhavethecorrespondingabilityandcompetenceinsci-techethicsreview,goodscientificresearchintegrity,andcomplywiththefollowingrequirements:AbidingbyChina'sConstitution,laws,regulations,andrulesandregulationsonsci-techethicsandthebylawsofthesci-techethics(review)committee.(2) Attendingsci-techethicsreviewmeetingsontimeandindependentlyandimpartiallygivingtheirreviewopinions.(3) Strictlyabidingbyconfidentialityprovisions,andshallnotdivulgeoruseforotherpurposesanystatesecret,personalprivacy,personalinformation,technicalsecret,andundisclosedinformation,amongothers,towhichtheyhaveaccessduringthesci-techethicsreview.(4) Complyingwiththerequirementsforthemanagementofconflictsofinterestandwithdrawinginaccordancewiththerelevantprovisions.非本单位的委员，民族自治地 方应有熟悉当地情况的委员。 委员任期不超过5年，可以连 任。第八条科技伦理（审 查）委员会委员应具备相应的 科技伦理审查能力和水平，科 研诚信状况良好，并遵守以下 要求：（一）遵守我国宪法、法律、 法规和科技伦理有关制度规范 及所在科技伦理（审查）委员 会的章程制度；（二）按时参加科技伦理审查 会议，独立公正发表审查意 见；（三）严格遵守保密规定，对 科技伦理审查工作中接触、知 悉的国家秘密、个人隐私、个 人信息、技术秘密、未公开信 息等，未经允许不得泄露或用 于其他目的；（四）遵守利益冲突管理要 求，并按规定回避；（五）定期参加科技伦理审查 业务培训；(5) Regularlyparticipatingintrainingonsci-techethicsreview.(6) Completingotherworkassignedbythecommittee.ChapterIIIReviewProceduresSection1ApplicationandAcceptanceArticle9Sci-techethicalriskassessmentshallbecarriedoutinscientificandtechnologicalactivities.Thesci-techethics(review)committeeshall,inaccordancewiththerequirementsoftheseMeasures,developmeasuresfortheassessmentofsci-techethicalrisksanddirectscientificandtechnologicalpersonneltoassesssci-techethicalrisks.IftheactivitiesfallwithinthescopespecifiedinArticle2oftheseMeasuresuponassessment,thepersoninchargeofscientificandtechnologicalactivitiesshallapplytothesci-techethics(review)committeeforasci-techethicsreview.Theapplicationmaterialsshallmainlyinclude:(1) anoverviewofscientificandtechnologicalactivities,includingbutnotlimitedtothename,purpose,significance,andnecessityofscientificandtechnologicalactivities,andprevioussci-techethicsreviews;(2) theimplementationplanforscientificandtechnologicalactivitiesandrelevantmaterials,includingbutnotlimitedtotheplanforscientificandtechnologicalactivities,possiblesci-techethicalrisksandpreventionandcontrolmeasuresandemergencyresponseplans,andtheformsofreleaseofachievementsofscientificandtechnologicalactivities;（六）完成委员会安排的其他 工作。第三章审查程序第一节申请与受理第九条开展科技活动应 进行科技伦理风险评估。科技 伦理（审查）委员会按照本办 法要求制定本单位科技伦理风 险评估办法，指导科技人员开 展科技伦理风险评估。经评估 属于本办法第二条所列范围科 技活动的，科技活动负责人应 向科技伦理（审查）委员会申 请科技伦理审查。申请材料主 要包括：（一）科技活动概况，包括科 技活动的名称、目的、意义、 必要性以及既往科技伦理审查 情况等；（二）科技活动实施方案及相 关材料，包括科技活动方案， 可能的科技伦理风险及防控措 施和应急处理预案，科技活动 成果发布形式等；（三）科技活动所涉及的相关(3) thelegalqualificationmaterialsofrelevantinstitutionsinvolvedinscientificandtechnologicalactivities,therelevantresearchexperienceoftheparticipantsandtheirparticipationinsci-techethicstraining,thesourcesoffundsforscientificandtechnologicalactivities,andthedeclarationofconflictsofinterestinscientificandtechnologicalactivities,amongothers;(4) theinformedconsent,explanatorymaterialsonthesourceofbiologicalsamples,datainformation,andexperimentalanimals,amongothers;(5) aletterofcommitmenttocomplywithsci-techethics,scientificresearchintegrity,andotherrequirements;and(6) othermaterialsasrequiredbythesci-techethics(review)committee.Article 10 Thesci-techethics(review)committeeshalldecidewhethertoaccepttheapplicationornotaccordingtotheapplicationmaterialsforsci-techethics(review)andnotifytheapplicantoftheresult.Ifitdecidestoaccepttheapplication,itshallspecifytheapplicablereviewprocedures,andifthematerialstobesupplementedareincomplete,itshallinformtheapplicantoftherequiredsupplementsatonetime.Article 11 Inprinciple,sci-techethicsreviewshallbeconductedthroughmeetings,exceptasotherwiseprescribedintheseMeasures.机构的合法资质材料，参加人 员的相关研究经验及参加科技 伦理培训情况，科技活动经费 来源，科技活动利益冲突声明 等；（四）知情同意书，生物样 本、数据信息、实验动物等的 来源说明材料等；（五）遵守科技伦理和科研诚 信等要求的承诺书；（六）科技伦理（审查）委员 会认为需要提交的其他材料。第十条科技伦理（审 查）委员会应根据科技伦理审 查申请材料决定是否受理申请 并通知申请人。决定受理的应 明确适用的审查程序，材料不 齐全的应一次性完整告知需补 充的材料。第十一条科技伦理审查 原则上采取会议审查方式，本 办法另有规定的除外。第十二条国际合作科技 活动属于本办法第二条所列范 围的，应通过合作各方所在国 家规定的科技伦理审查后方可Article 12 WhereinternationalcooperativescientificandtechnologicalactivitiesfallwithinthescopespecifiedinArticle2oftheseMeasures,theymaybecarriedoutonlyafterpassingthesci-techethicsreviewprescribedbythecountrieswhereallthecooperatorsarelocated.Article 13 Wherethesci-techethics(review)committeeofanentityisunabletosatisfytherequirementsfortheethicsrevieworanentityfailstoestablishasci-techethics(review)committeeorhasnopersonneltoconductscientificandtechnologicalactivities,theentityshallentrustinwritinganotherqualifiedsci-techethics(review)committeetocarryouttheethicsreview.Section2GeneralProceduresArticle 14 Thesci-techethicsreviewmeetingshallbepresidedoverbythechairmanorthedeputychairmandesignatedbythechairman.Thereshallbenotlessthanfivememberspresentatthemeeting,anditshallincludemembersofdifferentcategoriesaslistedinArticle7.Asrequiredforthereview,theapplicantmayberequiredtoexplaintheplanorexplainspecificissuesatthemeeting,andadvisoryexperts,amongothers,whohavenodirectinterestintherelevantfieldsmaybeinvitedtoprovideadvice.Advisoryexpertsshallnotparticipateinthevotingatthemeeting.Ifameetingisheldinavideoform,therequirementsofthesci-techethics(review)committeeontheconditionsfortheapplicationofvideomeetings,meetingrules,andotherrelevantrulesshallbecompliedwith.开展。第十三条单位科技伦理 （审查）委员会无法胜任审查 工作要求或者单位未设立科技 伦理（审查）委员会以及无单 位人员开展科技活动的，应书 面委托其他满足要求的科技伦 理（审查）委员会开展伦理审 查。第二节一般程序第十四条科技伦理审查 会议由主任委员或其指定的副 主任委员主持，到会委员应不 少于5人，且应包括第七条所 列的不同类别的委员。根据审查需要，会议可要求申 请人到会阐述方案或者就特定 问题进行说明，可邀请相关领 域不存在直接利益关系的顾问 专家等提供咨询意见。顾问专 家不参与会议表决。会议采用视频方式的，应符合 科技伦理（审查）委员会对视 频会议适用条件、会议规则等 的有关制度要求。第十五条科技伦理（审 查）委员会应按照以下重点内 容和标准开展审查：Article 15 Thesci-techethics(review)committeeshallcarryoutthereviewaccordingt