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1、RegulationforEthicalReviewofClinicalResearchofTraditionalChineseMedicineChapter1GeneralPrinciples1.ThisregulationispromulgatedtoregulatetheethicalreviewofclinicalresearchoftraditionalChinesemedicine,torespecttherightsandprotectsafetyofthehumansubjectsinvolvedinclinic
2、alresearch,inaccordancewith‘LawofthePeople'sRepublicofChinaonProgressofScienceandTechnology’,‘RegulationsofthePeople’sRepublicofChinaTraditionalChineseMedicine’,‘RegulationsonManagementtoMedicalInstitutions’.2.EthicalreviewofclinicalresearchoftraditionalChinesemedici
3、neinvolvinghumansubjectsshouldabidebythisregulation.Chapter2EthicsCommittee3.StateandprovincialregulatoryauthorityoftraditionalChinesemedicinesareresponsibleforestablishingexpertethicscommittees.Asrequestedandentrustedbyregulatoryauthoritiesrespectively,throughdiscus
4、sion,theexpertethicscommitteesprovideadviceonpolicymakingforcriticalethicsissues,conductethicalreviewforimportantresearchprojects,supervisetheethicscommitteeswithinrespectiveareas,organizeworkshopandseminaronresearchethics.4.Institutionsthatconductclinicalresearchoft
5、raditionalChinesemedicines,includinghealthcaresectors,researchinstitutes,medicalcolleges,areresponsibleforestablishinginstitutionalethicscommittees(EC)andprovidingessentialresourcestosupporttheECsforcarryingouttheirresponsibilities.TheestablishmentofECsshouldreportto
6、therelatedhealthauthorityforkeepingonrecord.5.ThecompositionandoperationofECsshouldbeindependent,competent,multidisciplinaryandtransparent.Thereviewdecision-makingshouldnotbeinfluencedbyanyindividualorentitythatconducts,sponsors,orhoststheresearchitsreviews.6.ECsshou
7、ldbecomposedofatleast5membersincludingindividualswithexpertiseinmedicalscience(includingtraditionalChinesemedicine)andlegalmatters,laypeoplewhoseprimarybackgroundisnotinhealthandmedicine,andpeoplewhoarenotaffiliatedwiththeinstitutewhichwillconducttheresearchunderther
8、eview,withbalancedgenderdistribution.TheECmemberscouldbeselectedviarecruitmentorrecommendation.7.MembersofECsshouldbewillingtopubli
