Research Conductedin Aninternational Setting

Research conductedin anInternational Setting

18.6.1ReviewingInternationalResearch

AllhumansubjectresearchprotocolsthatinvolvethePIormembersoftheresearch team travelingoutsidetheUSAtorecruit,consent,conductresearchactivitiesand/or collectdataarerequiredtobepre-reviewedbytheInternationalResearchAdvisory Committee(IRAC)priortothenormalprotocolreviewasdetailedinthisdocumentfor initialfullboardorexpeditedprotocols.Additionally,anyresearchwhichisfundedbythe PI(orPI’sgrant),orresearchoccurringinanothercountryunderthedirectionofthePI (or thePI’sprotocol),mustbepre-reviewedbytheIRAC.

ReviewbyIRAC

COMIRBmustbeawareoflocalconditionsandsituationsthatmayaffectthedesignor implementationoftheresearch.Forexample;localregulationsgoverningresearchwith minorscanvaryfromcountrytocountry.Alsolocalsocialandpoliticalconditionsmay distortthewayinformedconsentdocumentsareviewedbyforeignparticipants,anda requestforasubject’ssignaturemaybeviewedwithsuspicion.Offeringmonetary

compensationoraccesstohealthcaremayalsobecoerciveincertainsettings.

COMIRBgenerallyrequirestheinvolvementofa localIRBthathasknowledgeofthelocal researchcontext.Thisisimportantbecausethelocalresearchenvironmentandthe characteristicsofthesubjectbeingenrolledcanvarygreatly.Thedegreeoflocal knowledgerequiredisbasedinpartonthedegreeofriskpresentedbytheresearch.

Becauseofthedetailedinformationneededforreview,internationalresearchshouldbe submittedontheCOMIRBapplicationform,evenifitisarequestforexemption.

COMIRBreliesonthePItoprovideacleardescriptionoftheresearchenvironmentand theplantoaddressculturalsensitivities.Thisplanshouldbesupportedbyexternal materialverifyingthisposition.COMIRBalsoneedstoverifythatthePIhasthe expertise andresourcestoconductaninternationalstudy.

AllresearchersconductingsuchresearcharerecommendedtocompletetheCITI

courseonInternationalResearchpriortoapprovaloftheprotocol.

IRACMembership:

 COMIRBexpedited/Exemptreviewers

 SeniorCOMIRBadministration

 RepresentationfromtheInternationalEducationOffice

 RepresentationfromtheGlobalHealthProgram

 Representationfromfaculty

 Adhocmembers:Expertswithworkingknowledgeofthelocalsitesatthe requestofthecommittee.

IRACProcedures:

ThiscommitteemeetsmonthlyandthePIandmentor/advisor(ifthePIisastudent)are

requestedtoattendinpersonorbyconferencecall.

TheIRACwillreviewtheprotocol,ApplicationwithattachmentB,andtheconsent form(s)toensurethatthestudyisculturallyappropriatetobeconductedinatthe locationsrequested.

Thecommitteeinconjunctionwiththeexpert(s)andbasedonconversationwiththePI

andmentor/advisor(ifapplicable)completetheIRACchecklist.

Thecommitteecanmakethefollowingrecommendations:

 Acceptableassubmitted

 Acceptablewithrecommendations

 Requireschangesandtobere-evaluatedbythiscommitteepriortoIRBreview

TheIRACmustconfirmincollaborationwiththePI(bycompletingAttachmentB), regionalexpertsandlegalcounsel:

 Toensurethatlocallawsarefollowed;

 Confirmtheresearchersandresearchstaffhastheappropriatequalifications fromconductingresearchinthatcountry;

 Ensurethatthereisappropriatepost-approvalmonitoring;

 Ensurethatthereisanappropriatemechanismforhandlingcomplaints, noncomplianceandunanticipatedproblemsinvolvingrisktosubjectsorothers.

TheIRACdocumentsitsfindingsusingtheIRACchecklist.

Acopyofthecommittee’srecommendationswillbesenttothePI,mentor/advisorand theIRBpanelorreviewer.

18.6.2Monitoringapprovedinternationalresearch

COMIRBreliesonthePItoassurereliableaccesstocollaboratinginvestigatorsinthe field.SuchstudiesmuststillbesubmittedtoCOMIRBforcontinuingreviewsoall appropriatedatamustbecollectedinthefield.Unanticipatedproblemreportingmust alsostillbemadeinatimelymanner.Anyproblemsencounteredbytheforeign investigatorortheresearchteaminthefieldshouldbereportedtothestudysponsor, relevantregulatoryagenciesandCOMIRB.

18.6.3ForVAregulatedinternationalresearch

Allparticipantswhoparticipateassubjectsinresearchatinternationalsitesmustbe providedappropriateprotectionsthatareinaccordwiththosegiventoresearchsubjects withintheU.S.aswellasprotectionsconsideredappropriatebylocalauthorityand customattheinternationalsite.

VHApolicystatesthatpermissionmustbeobtainedfromtheVACRADO(Chiefof ResearchandDevelopmentOfficer)ordesigneepriortoinitiatinganyinternational researchthatmeetsthefollowingdefinition:

ForthepurposeofVApolicy,InternationalResearchisdefinedasanyVA-approved humansubjectsresearchconductedatinternationalsites(notwithintheU.S.,its territories,orCommonwealths)ortoVA-approvedresearchusingeitherhuman biologicalspecimensorhumandataoriginatingfromaninternationalsitewhether identified,de-identifiedorcoded.Thispolicyappliesregardlessofthefundingsource (fundedorunfunded)andtoresearchconductedthroughanymechanismofsupport

includingagreements,MemorandaofUnderstanding(MOU),CooperativeResearchand

DevelopmentAgreements(CRADA),grants,orcontracts.Also,AllVA-approved researchmustbeapprovedbytheResearchandDevelopment(R&D)Committee.

Multi-sitetrialsareonlycoveredunderthisdefinitionif:

1.VAisthesponsor

2.VAfunctionsasthecoordinatingcenter

3.VAsubcontractstoaforeignsite

4.Theprincipalinvestigator(PI)forthetotalprojectisaVAinvestigator.

ThisDirectivedoesnotapplyifVAisonlyoneoftheparticipatingsitesandthetrialdoes notmeettheprecedingconditions.(VHADirective2005-050)

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