Research Ethics Committee Assessment Toolkit …...2017/08/17 · Version 1.0. Baltimore Maryland...
Transcript of Research Ethics Committee Assessment Toolkit …...2017/08/17 · Version 1.0. Baltimore Maryland...
ResearchEthicsCommitteeAssessmentToolkit
(RECAT)
2017
Evaluatingtheneedsofresearchethicscommitteestoimproveoperationalqualityandefficiency
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TheResearchEthicsCommitteeAssessmentToolkit(RECAT)isdesignedtofacilitateevaluationoftheoperationalneedsofResearchEthicsCommittees(RECs)globallytoinformlocalqualityassuranceandqualityimprovementefforts.Thetoolkitispublishedopen-accessfornon-commercialuse.
TheRECATwasdevelopedbytheAfricanBioethicsConsortium(ABC)whosemembersincludetheJohnsHopkinsUniversity-FogartyAfricanBioethicsTrainingProgram,theUniversityofZambiaSchoolofMedicine,theUniversityofBotswanaOfficeofResearch&Development,andtheMakerereUniversityCollegeofHealthSciences.FinancialsupporttodeveloptheRECATwasprovidedtoJohnsHopkinsUniversityBloombergSchoolofPublicHealthandBermanInstituteofBioethicsthoughaUSNationalInstitutesofHealth,FogartyInternationalCenterandNationalInstituteofAllergyandInfectiousDiseasessupplementalgrantunderAwardNo.R25TW001604.ThecontentissolelytheresponsibilityoftheauthorsanddoesnotnecessarilyrepresenttheofficialviewsoftheNationalInstitutesofHealth.
Whilewemakethisfreelyavailable,weaskthatyoupleasereferencethefollowingcitationwhenusingoradaptingtheRECAT:
AfricanBioethicsConsortium.(2017)ResearchEthicsCommitteeAssessment Toolkit(RECAT). JohnsHopkinsUniversity.Version1.0.BaltimoreMarylandUSA.
WealsokindlyrequestthatyoushareyourexperienceswithusingtheRECATwithussowecanbetterunderstanditspotentialapplicationandcontinuetomakefutureimprovementsasnecessary.
Feedbackcanbesentviaemailto:[email protected]
Dateofpublication:�JuůLJ2017
Version:1.0�
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TableofContentsAbbreviations.................................................................................................................................................................................3
InstructionalGuide.........................................................................................................................................................................4
PurposeoftheRECAT........................................................................................................................................................4
KeyFeatures......................................................................................................................................................................4
ToolkitComponents..........................................................................................................................................................4
Procedures.........................................................................................................................................................................6
InstitutionalBriefingMemo.........................................................................................................................................................10
ImplementationChecklist............................................................................................................................................................11
AssessmentTool...........................................................................................................................................................................13
PartARECContext..........................................................................................................................................................14
PartBRECPolicies...........................................................................................................................................................19
PartCRECOperations.....................................................................................................................................................21
PartDRECMeeting.........................................................................................................................................................34
PartERECPerceptions....................................................................................................................................................ϰϬ
InterviewGuide-Dean/InstitutionalLeadership........................................................................................................40
FocusGroupGuide-RECMembers.............................................................................................................................41
FocusGroupGuide-ResearcherswhoSubmitProtocolstotheREC..........................................................................43
ReportingTemplate......................................................................................................................................................................44
SampleReport..............................................................................................................................................................................51
AbbreviationsABC–AfricanBioethicsConsortiumCIOMS–CouncilforInternationalOrganizationsofMedicalSciencesFABTP–FogartyAfricanBioethicsTrainingProgramFIC–FogartyInternationalCenterIRB–InstitutionalReviewBoardJHU–JohnsHopkinsUniversityNIAID–NationalInstituteofAllergyandInfectiousDiseasesNIH–USNationalInstitutesofHealthREC–ResearchEthicsCommitteeRECAT–ResearchEthicsCommitteeAssessmentToolkitSOP–StandardOperatingProceduresWHO–WorldHealthOrganization
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ResearchEthicsCommitteeAssessmentToolkit(RECAT)InstructionalGuide
PurposeoftheRECAT
TheResearchEthicsCommitteeAssessmentToolkit(RECAT)wascreatedforthepurposeofevaluatingtheneedsofResearchEthicsCommittees(RECs)–alsoknownasInstitutionalReviewBoards(IRBs)–inordertosupportefficient,highqualityethicsreviewofresearchprotocolsglobally.TheRECATcanbeusedbyinstitutionsandRECstoidentify:
1. baselineoperationalconditionsofaREC,2. areasforthedevelopmentoftargetedinterventionstoimproveRECfunctioning,and,3. changeinRECqualityandefficiencyovertimeacrossmultipledomains
KeyFeatures
v ConsistentwithinternationalRECstandards:Thetoolwasinformedbythe2011WHOStandardsandOperationalGuidancefortheEthicsReviewofHealthRelatedResearchwithHumanParticipants,whichreflectsthemostcurrentglobalguidanceforRECs.
v Mixedmethodsapproach:Thetooltriangulatesdatagatheredthroughvariousmethods,includinginterviews,focusgroups,documentreview,anddirectobservation.ThismixedmethodsapproachallowstheassessmenttocapturebothwrittenpoliciesandproceduresoftheRECaswellastheactualday-to-daypracticesoftheREC,andincorporatesperspectivesfrommultiplekeystakeholdersincluding:institutionalleadership,RECchairpersons,RECadministrators,RECmembers,andresearcherswhosubmitapplicationstotheREC.
v Internalorexternalassessment:Theassessmentcanbeadministeredbymembersoftheassessedinstitution(self-assessment)orbyindependentexternalassessors.
v Pilottested:ComponentsofthetoolandimplementationprocesswerepilotedintheUnitedStatesandthefulltoolkitwastestedintwoRECswithininstitutionsinZambiaandBotswana.
ToolkitComponents
1. ImplementationChecklist
TheImplementationChecklistprovidesabriefoverviewofallkeyactivitiesthatshouldbecompletedbytheassessmentteam.AdditionaldetailsabouteachstepareprovidedinthisInstructionalGuide.
2. InstitutionalBriefingMemo
TheInstitutionalBriefingMemoprovidesashortdescriptionoftheassessmentprocessandthetimeandresourcescommitmentneededfromtheinstitutionandRECbeingassessed.Priortotheassessment,thismemoshouldbesenttoinstitutionalleadershipresponsibleforoverseeingtheREC.
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3. AssessmentTool
TheAssessmentTooliscomprisedoffivepartsthatcollectinformationfromdifferentsources:
PartA:RECContext–InterviewwithRECAdministrator/Chair
ThissectionprovidestheassessorwithkeycontextualinformationaboutnationalandinstitutionalpoliciesandbackgroundoftheRECitself.TheinformationinthissectionisintendedtohelptheassessorunderstandtheworkingenvironmentoftheREC.
PartB:RECPolicies–Documentreview
ThissectionassessesthewrittenpoliciesandstandardoperatingproceduresoftheRECtodeterminethedegreetowhichtheyincludeinformationsuggestedbyinternationalstandards.
PartC:RECOperations–SitevisittoRECoffice
ThissectionassessestheregularpracticesoftheRECoffice.PartCiscompletedthroughobservationofRECofficeactivitiesandinfrastructure,capturinginformationrelevanttotheactualadministrativepracticesoftheREC.
PartD:RECMeeting–StructuredobservationofRECmeeting
Thissectionofthetoolsupportsassessmentofthenatureofcommitteedeliberations,theapplicationofethicsconsiderations,andtheextenttowhichmeetingdecisionsarefullycapturedinmeetingminutesandcommunicatedtoinvestigators.
PartE:RECPerceptions–InterviewsandfocusgroupswithRECstakeholders
PartEallowstheassessortofurtherverifyandexploretheREC’schallengesasperceivedbykeystakeholdersintheresearchethicsreviewprocessthroughinterviewsandfocusgroupdiscussions.Guidesareprovidedfora)afocusgroupdiscussionwithRECmembers;b)afocusgroupdiscussionwithresearchers;andc)anin-depthinterviewwiththeinstitutionalofficialresponsibleforoversightoftheREC(suchastheDeanorDirectorofResearch).Theopen-endednatureofquestionsinthisPartallowskeyRECstakeholderstovoiceissuesthatmaynothavebeencapturedthroughotherpartsoftheassessment,andadditionallytocontextualizethenatureofthesechallengesandtheirrelativepriority.
4. ReportingTemplate
AReportingTemplateisprovidedtohelpassessorssynthesizeinformationgatheredthroughtheassessment.ThetemplateshouldhelpgenerateacomprehensivesummaryoffindingsorganizedbykeydomainswhichcanbeprovidedtotheassessedRECandinstitution.Thereportingtemplateisnotmeanttobeexhaustiveandshouldnotrestricttheassessmentteaminitsidentificationofrelevantdomains,issuesandrecommendations.
5. SampleReport
TheSampleReportprovidesanexampleofthetypesofobservationsandrecommendationsthatonemightconveyusingthereportingtemplate.Thesampleismeanttoserveanillustrativepurposeonly.
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Procedures Thissectiondescribesrecommendedprocedurestoguideassessorsthroughthethreemainphasesofassessment:preparation,datacollection,andanalysisandreporting.PleaserefertotheseparateImplementationChecklistforasummaryofcoreprocedures.
A. Preparation
Institutionalconsultationandpermission
Priortoinitiatingassessmentactivities,relevantinstitutionalofficialsshouldbeconsultedabouttheirdesiresandpreferencesregardingtheRECassessment.TheInstitutionalBriefingMemocanbeadaptedandusedtohelpinformrelevantleadershipaboutthenatureoftheactivity.
Whileeachinstitutionmayhavedifferingrequirements,asageneralmatter,receiptofformalpermissiontoconducttheassessmentfromrelevantinstitutionalleadershipshouldsuffice.Ethicscommitteereviewandapprovalshouldbeconsideredfortheassessmentifassessorsintendtomakeinformationcollectedavailableoutsidetheinstitutionincludingforpublicationpurposes.Insuchcases,wherepossible,aRECotherthantheonebeingassessedshouldreviewtheproposedassessmentactivity.
Inadditiontoobtainingformalapprovaltoconducttheassessment,assessorsshoulddetermineiftheinstitutionwouldliketheteamtofollowanyparticularconfidentialitypracticesand/orwouldliketohaveaconfidentialityagreementsignedbymembersoftheassessmentteam.
Assessmentteam
Itisrecommendedthattheassessmentteaminclude1-3individuals(morethan1ispreferable).Inclusionofindividualsexperiencedwithqualitativedatacollectionandwithbasicknowledgeofresearchethicscommitteesisrecommended.
Thecompositionoftheassessmentteamshouldbeinformedbyanunderstandingoftheinstitutionalsettingandthewaysinwhichaparticipatoryapproachmayshapetheinformationcollectedduringtheassessment.WhereincludingamemberfromtheRECofficeontheassessmentteamisanticipatedtobiastheresultssuchthatthemostimportantbarrierstoRECcapacityarenotidentified,acompletelyexternalapproachmaybeappropriate.Wherethereisstronginstitutionalcommitmenttotheprocessandanopennesstoqualityassuranceandimprovement,anapproachthatincludesanRECmemberoradministratorontheassessmentteammayfacilitatenotonlytheidentificationofthemostimportantneeds,butcommitmenttoinvestinginsolutions.
Forexternallyconductedassessment,externalassessorsshouldidentifyaPointofContact(POC)attheinstitution,preferablysomeonewithknowledgeofRECand/orinstitutionaladministration,tofacilitatelocalcoordinationandtoservegenerallyasaresourceperson.
Scheduling/Timing
Theassessmentislikelytorequireapproximately1-2daysofadvancepreparation,3daysonsitetocollectinformation,and3-5daysforinitialanalysis.DatacollectiononsiteshouldbescheduledtooverlapwithaRECmeeting.Thecomponentsoftheassessmentcanbecompletedinanyorder,thoughitispreferabletobeginwithaninterviewwiththeinstitutionalofficialandreviewbackground
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documentationbeforeobservingacommitteemeeting.EffortshouldbemadetoavoidconductingtheassessmentatatimeofyearwheremanyRECmembersoradministratorsarelikelytobeunavailable.
Allactivities(officeobservation,meetingobservation,focusgroups,interviews)shouldbescheduledinadvancewithappropriateinvitationsprovided.Focusgroupsandinterviewsshouldbeconductedinaprivatespaceandusingtheprovidedinterviewguides.Schedulethefollowingsessionswellinadvance:
• Aninterview(approximately1hour)withaninstitutionalofficialwhoisresponsibleforoverseeingresearchactivitiesand/ortheREC(e.g.,Director/DeanorAssistantDirector/DeanofResearch).
• Twoseparatefocusgroupdiscussions(approximately1houreach):o Onefocusgroupwith6-8RECmembers,ifpossible,includingmemberswith6+months
experienceservingontheREC;eithercurrentmemberorrecentlyformermember.o Onefocusgroupwith6-8researchersattheinstitutionwhosubmittedprotocolstothe
RECwithinthepast2yearsandwhorepresentdifferentdepartmentsintheinstitution.
Documentcollectionandpreparation
AvailabledocumentsrelevanttotheRECshouldbecollectedandreviewedinadvancetopreparetheassessmentteamandsupportcompletionofPartsA&Boftheassessmenttool.Atleast2weekspriortoassessment,obtainthefollowingdocumentsfromtheinstitution,ifavailable:
• Relevantinstitutionalpolicies/procedures,nationallaws,policies,orguidelinesrelatedtoresearchwithhumanparticipants:
o Relevantinstitutionalpoliciesorproceduresrelatedtoresearchwithhumanparticipants
o AcopyofREC’sStandardOperationProcedures(SOPs)andanyotherrelevantRECpolicy/proceduredocuments
o Relevantnationallaws,policies,orguidelinesrelatedtoresearchwithhumanparticipants
• Templates,forms,andchecklistsusedbytheRECoffice:o Protocolsubmissionformsandtemplatesusedbyresearcherso Consentformtemplateso Checklistforsubmissiondocuments/screeningapplicationsforcompletenesso ChecklistforRECprotocolreviewo Meetingminutetemplateso Approvallettertemplateso Progressreportingformo Adverseeventreportingformo Amendmentformo Continuingreviewformo Studyclose-outformo MaterialTransferAgreement(MTA)templateo Otherkeyforms:__________________________
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PreparehardcopiesoftheAssessmentToolforeachmemberoftheassessmentteamanddeterminewhowillhaveresponsibilityforcollectingdifferentdatacomponents.Itisrecommendedthatatleast2assessorsparticipateintheRECmeetingobservationandfocusgroups/interviewstoallowforeasiernote-takingandreliabilityoffindings.Ifpermittedbyrespondents,assessorsshouldconsiderusingaudiorecordingdevicesduringfocusgroupsandinterviewstosupportdatacollectionandanalysis.
B. DataCollection
Foreaseofreference,datacollectionproceduresaresummarizedforeachPartoftheAssessmentToolinthefollowingtable.BriefinstructionsarealsoprovidedoneachPartoftheAssessmentToolitself.
AssessmentToolPart
Method SourceofInformation ExpectedDuration
Procedures
PartA:RECContext
Interview RECadministratororChair
1-2hourstotal CompletePartAoftheToolwithassistanceofanRECadministratorand/ortheRECchair.
PartB:RECPolicies
Documentreview
RECSOPs,institutionalandnationalresearchpolicydocuments,RECtemplatesandforms
2-4hourstotal CompletePartBoftheToolwhilereviewingcopiesofthewrittenpoliciesandprocedures.Canbecompletedinadvance.
PartC:RECOperations
SitevisittoRECadministrativeoffice
Assessorobservation,RECadministrator
6hourstotal(2hourvisiton3differentdaysrecommended)
CompletePartCoftheToolwhilephysicallypresentintheRECoffice.QuestionscanbeansweredthroughconversationwiththeRECadministratorandvisuallyverifyingoperationalcomponentsoftheofficethroughobservation.Observationwillfocusonverifyingadministrativeresources,filingandtrackingsystems,submissionpracticesanddocumentation,recordingofRECmeetingminutes,communicationswithresearchers,andchecklistsand/orothertoolsthatareusedtoenhancetheconsistencyofadministrativeprocesses.
PartD:RECMeeting
StructuredobservationofRECmeeting
Assessorobservation,RECmeeting
2-4hours CompletePartDoftheToolduringandaftertheRECmeetingselectedforobservation.ThisPartincludesthreesections:(D.1)whichcapturescontextualinformationrelatedtotheRECmeetingobserved;(D.2)whichprovidesaProtocolReviewChecklistthatshouldbecompletedbytheassessorduringtheobservedRECmeeting(onehardcopyofchecklistisneededforeachprotocolreviewedduringthemeeting);and(D.3)whichdescribesproceduresforreviewingtheoutputsoftheRECmeeting.ItisstronglyadvisedtoattempttoobserveanRECmeetingwhichincludes,ontheagenda,thereviewofdifferenttypesofprotocols–newprotocols,re-submissions,continuingreviews,etc….
PartE:RECPerceptions
Interviewsandfocusgroups
FocusgroupwithRECmembers,focusgroupwithresearchers,interviewwithinstitutionalofficialresponsibleforRECoversight
3-4.5hourstotal(1-1.5hoursforeachinterview/focusgroup)
Completetwoseparatefocusgroupdiscussionsandoneinterviewwiththelistedgroups/individual.Holddiscussionsinaprivatelocation.Identifyamoderatorandanotetakerfromwithintheassessmentteam.Itisimportanttoselectamoderatorwhowillhelpparticipantsfeelateasewithexpressingviews.Explainthepurposeofthediscussionandrequestpermissiontoproceed.Assureparticipantsthatconfidentialitywillbemaintained.Usetheprovidedsemi-structuredfocusgroupandinterviewguidesforeachsession.Takecomprehensivenotesandaudiorecordthesessionsforfuturereference,ifneeded,withpermission.Torespectrespondentprivacy,donotlogorwritedownparticipantnamesorotherpersonalidentifiers.Thankparticipantsandreiteratethepurposeoftheexerciseyouaredoingandhowtheviewswillbeused.
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C. AnalysisandReporting
Oncedatacollectioniscomplete,analysiscanbeginwithreviewingthevariousPartsofthecompletedtool,interview,focusgroupandothernotes.Notesshouldbetyped(ifnotalready)foreaseofanalysisandreporting.Ifaudiorecordingswerecollected,itmayalsobeusefultotranscribetheaudiointotypedtext.Thedomainsandsub-domainsnotedintheattachedReportingTemplatecanserveasapreliminaryguideforidentifyingthemesrelatedtoRECoperationsacrossthevariouspartsoftheAssessmentTool.Assessornotesandinterview/focusgrouptranscriptsshouldbereviewedtoidentifyanyadditionalthemes.Areviewofthe2011WHOStandardsandOperationalGuidancefortheEthicsReviewofHealthRelatedResearchwithHumanParticipantsmayalsohelpwiththeprocessofidentifyingthemesandcontextualizingfindingsfromtheevaluation.
Datashouldbereviewedseveraltimesandconsideredinlightofrelevantthemes.Whenthisiscompleted,asummaryofwhathasbeenlearnedfromtheevaluationshouldbeprepared.Thissummaryreportshouldcoverallfindingsfromthevarioussources/methods.Shoulddatasuggestconflictingviewsorpractices,assessorsmaydecidetoreportbothperspectives,ifthesourcesofinformationarereliable.
ItisrecommendedthattheReportingTemplatebeusedtogenerateasummarystatementanddetailedreportofkeyfindingsandrecommendationsbydomain.ASampleReportalsoincludedwiththistoolkitprovidesacompleteexampleofthetypesofobservationsandrecommendationsthatonemightconveyusingthereportingtemplate.AssessorsshouldnotfeelboundtothethemesorformatoftheReportingTemplate.AcoresetofRECneedsshouldbeidentifiedbasedonthesynthesisoffindings.Importantly,theassessmentshouldalsoattempttoidentifywhattypesofresourcesorinputsmayberequiredtoaddresstheidentifiedneeds.
AdraftreportshouldbeprovidedtotheinstitutionalpointofcontactandofficialresponsibleforoversightoftheRECforreviewandfeedbackpriortofinalization.Followingcorrectionofanymajorerrorsoromissions,thereportshouldbefinalized,signedbytheassessorandinstitution,anddelivered.Itisadvisabletoscheduleameetingbetweenrelevantinstitutional/RECstakeholdersandtheassessortoreviewthefindingstogether.
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ResearchEthicsCommitteeAssessmentToolkit(RECAT)
InstitutionalBriefingMemo
LeadAssessor:
Purpose:TheResearchEthicsCommitteeAssessmentToolkit(RECAT)isastructuredinstrumentthatprovides
researchinstitutions,particularlythosebasedinresourcelimitedsettings,withamethodtorigorouslyand
systematicallyassesstheneedsoftheirResearchEthicsCommittees(RECs)tosupportqualityassurance,
operationalefficiencyandbenchmarking.Thetoolwassystematicallydevelopedfrom2014-2016byresearchers
withintheAfricanBioethicsConsortium(ABC)whosemembersincludetheJohnsHopkinsUniversity-Fogarty
AfricanBioethicsTrainingProgram,UniversityofZambiaSchoolofMedicine,theUniversityofBotswanaOfficeof
Research&Development,andMakerereUniversityCollegeofHealthSciences.Thetool,whichcanbe
implementedbyinternalorexternalassessors,canhelpinstitutions:
• IdentifybaselinefunctioningofRECs
• CreateanorganizedlistofrecommendationsforRECqualityassurance/improvement
• DocumentchangeinthefunctioningofRECsovertime
AssessmentTeam:Theproposedassessmentteamwillinclude:
Activities:Theproposedassessmentincludesmultiplemodesofinformationcollection:documentreview,
interviews,focusgroups,andobservationofRECoperations.Theaboveassessmentteamwillimplementthese
activitiesusingtoolsandproceduresprovidedintheRECATToolkit.
Assessmentcomponents:
1. Aninterviewwithaninstitutionalofficialwhoisresponsibleforoverseeingresearchactivitiesand/orthe
REC(e.g.,Director/DeanorAssistantDirector/DeanofResearch),
2. AninterviewwithaleadRECadministrator,
3. AreviewofstandardoperatingproceduresandotheroperationaldocumentsoftheREC,
4. AsitevisittotheRECofficetoobserveadministrativepractices,
5. AnobservationofoneRECmeeting,and,
6. Twofocusgroupdiscussions–onewithresearchersandonewithRECmembers.
ManyinstitutionshaveconfidentialityrequirementsinplacerelatedtoRECpractices,communicationsand
documents.Theassessmentteamanticipatesandisfullycommittedtocomplyingwithanyconfidentiality
agreementsthatpertaintothisassessment.
Output:Acomprehensivesummaryoffindingsorganizedbykeydomainswillbeprovidedtotheinstitutionand
REC.Theinstitutionwillhaveanopportunitytoreviewthereportandcorrectanyerrorspriortofinalization.
Timeframe:TheprocessofcollectingrelevantRECinformationwilltakeapproximately3workingdays,scheduledaroundanRECmeeting.Wewillendeavortohaveadraftreportforinstitutionalreviewwithin
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ResearchEthicsCommitteeAssessmentToolkit(RECAT)ImplementationChecklist
Thischecklistprovidesanoverviewofkeyactivitiesthatshouldbecompletedbytheassessmentteam.AdditionaldetailsabouteachstepareprovidedintheInstructionalGuide.Priortoinitiatingtheseactivities,relevantinstitutionalleadershipshouldbeconsultedandshouldindicateadesiretocompleteanRECassessment.
A. Preparation
! ReviewthePreparationsectionoftheRECATInstructionalGuide.! IntroduceassessmenttoinstitutionalleadershipusingtheRECATBriefingMemo.! Determinewhatformalinstitutionalapprovalsarerequiredfortheneedsassessment.! ConfirmdatesofRECmeeting(s)thattheteamcouldobserveaspartoftheassessment.! Scheduleinterviewwithaninstitutionalofficialwhoisresponsibleforoverseeingresearchactivities
and/ortheREC(e.g.,Director/DeanorAssistantDirector/DeanofResearch).! Scheduletwofocusgroupdiscussionsofapproximately1houreach:
o FGD1:6-8RECmembers(ifpossible,recruitmemberswith6+monthsexperienceservingonREC,couldbeeithercurrentmemberorrecentlyformermember).
o FGD2:6-8researchersattheinstitutionwhosubmittedprotocolstotheRECwithinthepast2yearsandwhorepresentdifferentdepartmentsintheinstitution.
! Schedule4-5hoursoftime(canbesegmentedintotwovisitsduringtheassessment,ifneeded)forassessmentteammemberstovisitRECofficewiththeleadRECadministrator/coordinatorto:
o ReviewRECofficeoperations,ando InterviewtheRECadministrator
! Confirmthatallrelevantstakeholder/respondentsareinformedabouttheupcomingassessment.
Atleast2weekspriortoassessment,obtainthefollowingdocumentsfromtheinstitution,ifavailable:
1. Relevantinstitutionalpolicies/procedures,nationallaws,policies,orguidelinesrelatedtoresearchwithhumanparticipants:
! Relevantinstitutionalpolices/procedures,nationallaws,policies,orguidelinesrelatedtoresearchwithhumanparticipants
! AcopyofREC’sStandardOperationProcedures(SOPs)andanyotherrelevantRECpolicy/proceduredocuments
! Relevantnationallaws,policies,orguidelinesrelatedtoresearchwithhumanparticipants
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2. TemplatesusedbytheRECoffice:
! Protocolsubmissionformsandtemplatesusedbyresearchers! Consentformtemplates! Checklistforsubmissiondocuments/screeningapplicationsforcompleteness! ChecklistforRECprotocolreview! Meetingminutetemplates! Approvallettertemplates! Progressreportingform! Adverseeventreportingform! Amendmentform! Continuingreviewform! Studyclose-outform! MaterialTransferAgreement(MTA)template! Otherkeyforms:__________________________
B. Implementation
! ReviewtheDataCollectionsectionoftheRECATInstructionalGuide.! Priortoeachassessmentactivity,re-introducetheassessmentteamandthepurposeofthe
assessmenttoanyonebeingengaged.! UtilizetheAssessmentTools(PartsA-E)asappropriateforeachscheduledactivity.! Takedetailednotesduringeachactivity.! Ifanaudiorecordingisdesired,seekpermissionandaudio-recordinterviewsandfocusgroup
discussions.! Beavailableincasefurtherquestionsariseduringtheassessment.! Collectanypertinentdocumentsthatwerenotprovidedinadvanceoftheassessment.! Ifinstitutioniswillingandabletosharesuchdocuments,obtainacopyofmeetingminutesfromthe
meetingobservedduringtheassessmentexerciseandoflettersthecommitteesendstoinvestigatorsabouttheprotocolsreviewedduringtheobservedmeeting.
C. AnalysisandReporting
! ReviewtheAnalysisandReportingsectionoftheRECATInstructionalGuide.! Reviewnotes,audio-recordings(ifcollected)andcompletedAssessmentTools.! Asnecessary,requestanyclarificationorverificationoftheassessmentteam’sfindingsviafollow-up
callsandoremails.! SynthesizefindingsintoasummaryreportusingtheReportingTemplate.Reportinawaythatdoesnot
identifyindividuals,whereverpossible.! SharedraftsummaryreportwithRECChairand/orseniorRECAdministratorforcommentsand
feedback.! Incorporatefeedback,finalizesummaryreportandcompletesignaturepage.Makesuretheinstitution
receivesafinalcopyofthesummaryreport.
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ResearchEthicsCommitteeAssessmentToolkit(RECAT)AssessmentTool
NameofREC:
Institution:
Country:DatesofAssessment:
TypeofREC: �Regional�National�MultipleInstitution�SingleInstitution
NameofAssessor(s):
Interviews:
ParticipantsinAssessment:
InstitutionalOfficial:RECChair:RECAdministrator:FocusGroups: NumberofParticipants(N)RECMembers:Researchers:
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PartARECContext
Method:InterviewwithRECChairorAdministrator
ThequestionsinthissectionprovidebackgroundinformationonthenationalandinstitutionalcontextinwhichtheRECfunctions,aswellasthehistoryandcurrentworkportfoliooftheREC.ThissectionshouldbecompletedthroughaninterviewwiththeRECchairoradministrator.Informationcanbesupplementedifneededthroughdocumentreview.
A.1NationalContext1. Aretherenationalpolicies1inyourcountryabouthealthresearchand/orhumansubjectsresearch?
�Yes:(Listpolicynamesandaskforacopyand/orlinkifpostedonawebsite)�No�Don’tknow�Other:__________________________
a) Ifyes,donationalpoliciesrequireethicsreviewofallorsomehumansubjectsresearchprotocols?
�Yes,forALLhumansubjectsresearch�Yes,forSOMEhumansubjectsresearch(describewhichtypes)___________________�No�Don’tknow�Other:________________________________
b) Ifyes,donationalpoliciesrequirethatallorsomehumansubjectsresearchprotocolsbereviewedbyanationalethicscommittee,regardlessofpriorapprovalfromaninstitutionalREC?
�Yes,ALLhumansubjectsresearchmustbereviewedbythenationalethicscommittee�Yes,SOMEhumansubjectsresearchmustbereviewedbythenationalethicscommittee(describe):____________________________________________________________�No,thereisnorequirementforanyresearchtobereviewedbyanationalethicscommittee�Don’tknow�Other:
c) Ifyes,isthereanationalinstitution/agencythatmonitorsHumanSubjectsResearchActivitiesinyourcountrytoensurecompliancewithnationalpoliciesregardingethicsreview?
�Yes(describe):____________________________________________________�No�Don’tknow�Other:__________________________________________________________
1NotethatforallpartsofQuestion1,“nationalpolicies”canbeinterpretedasinclusiveoflaws,regulation,guidelines,executiveorders,etc.Therelevantfeatureisthattheyareapplicableatanationallevel.
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2. IsthereanationalentitythroughwhichRECsareregisteredinyourcountry?�Yes(nameofentity):�No�Don’tknow�Other:___________________________________________________________________
A.2InstitutionalContext3. Doestheinstitutionhaveawrittenpolicythatrequiresthathumansubjectsresearchprotocolsbereviewedbyan
ethicscommittee?
�Yes(askforacopy)
�No
�Don’tknow
�Other:_____________________________________________________________________
4. Doestheinstitutionauditapprovedhumansubjectsresearchactivitiesaftertheyareapproved?
�Yes(describeforwhatpurpose,e.g.,compliancewithinstitutionalpolicies?):__________________�No�Don’tknow�Other:________________________________________________________________
5. Isthereanindividual(Dean,AssociateDean,Director,etc.)whoservesasthe“InstitutionalOfficial”responsiblefortheformation,conduct,andoversightofhumanresearchattheinstitution?
�Yes(titleofindividual):____________________________________________________�No�Don’tknow�Other:_______________________________________________________________
6. DoestheinstitutionhaveapolicyorothermechanismsthatrequireRECstoregisterthroughsomeformalregistrationsystem,suchasnational,regional,orinternational?
�Yes:(describe)_________________________________________________________�No�Don’tknow�Other:_______________________________________________________________
7. ListallactiveregistrationscurrentlyheldbytheREC,includingnational,regional,orinternational:
NameofAgency/RegisteringBody RegistrationNumber Dateofregistration(mm/yyyy)
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A.3RECBackground8. WhenwasthisRECestablished?year_______
9. HastheRECbeenoperatingcontinuouslysinceitbegan?
�Yes�No(Explainanyperiodsofinactivity):�Don’tknow�Other:________________________
10. WhoappointsmembersoftheREC?
�DeanofResearchorequivalent�ChairofREC�Membersvolunteer�Don’tknow�Other(describe):________________________________________________
11. DoestheRECconductscientificreviewaswellasethicsreviewofresearchprotocols?
�Yes�No�Other:__________________________�Don’tknow
ResearchPortfolio
12. HowmanynewresearchproposalswerereviewedbytheRECinthemostrecentyearforwhichyouhavedata?
�10orLess�11-25�26-50�51-100�101-150�Morethan150Year:__________
13. OftheprotocolssubmittedtotheRECinthemostrecentyear,approximatelywhatpercentageofprotocolssubmittedtotheRECwere:
Studentprotocolsfromwithintheinstitution: _____________Faculty/staffprotocolsoriginatingfromwithintheinstitution: _____________Researchcollaborationswithotherinstitutionswithincountry: _____________Researchcollaborationswithinternationalinstitutions: _____________Other: _____________
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14. OftheprotocolssubmittedtotheRECinthemostrecentyear,approximatelywhatpercentagewerefundedby:
15. DoestheRECreviewclinicaltrialsinvolvinginvestigationaldrugsand/ormedicaldevices?�Yes�No�Don’tknow�Other:____________________________________________
16. DoesthisRECreviewsocialscienceandbehavioralresearchstudies?�Yes�No�Don’tknow�Other:____________________________________________
17. HowfrequentlyisRECscheduledtomeettoreviewresearchprotocols?�Weekly�Bi-weekly�Monthly�Don’tknow�Other(specify):_____________________________________
18. Howfrequentlyaremeetingcancelledorotherwisenotheld?�Almostnever�About25%ofmeetings�About50%ofmeetings�About75%ofmeetings�Almostalways�Other:_____________________________________�Don’tknow
FundingSource %ofProtocolsSubmittedThelocalornationalgovernment(ofcountrywheretheRECislocated)Non-governmentalOrganizations(localorinternational)Internationalfunders(e.g.WellcomeTrust,NIH,EDCTP,UNAIDs)Private,forprofitcompany(e.g.Multi-nationalPharmaceuticalCompany)Nofunding/self-funded(e.g.self-fundedstudentprotocolsorfacultyuseofdiscretionaryfunds)
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19. DoestheRECallowforexpeditedreview(byasingleRECmember)ofcertaintypesofresearchprotocols?
�Yes(describewhichtypesofprotocols):�No�Don’tknow�Other:_____________________________________
20. OftheprotocolssubmittedtotheRECinthemostrecentyear,approximatelywhat%were:Reviewedbyasinglememberofthecommittee:____________Requiredtohaveafullcommitteereview:_________________Determinedtorequirenoreviewbycommittee:____________
21. OftheprotocolssubmittedtotheRECinthemostrecentyear,approximatelywhatproportionofprotocolsreceivedthefollowingdecisionsafterfirstreview:
Fullapproval:____________________________________Returnedwithquestions(e.g.“tabled”):_______________Disapproval(e.g.rejection):_________________________Other(describe):_________________________________
22. IsthereanythingelseaboutthebackgroundofthisRECortheinstitutionalcontextthatwouldbeimportanttoknow?
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PartBRECPolicies
Method:DocumentreviewPleaseusethefollowingtablestodocumentwhethertheREChaswrittenpoliciesorwrittenstandardoperatingproceduresregardingeachofthefollowing:
B.1DoestheREChavewrittenpoliciesorstandardoperatingproceduresregardingthefollowingaspectsof
committeemembership?
Yes No Comments
1. Theselectionprocessofthechairandcommitteemembers
2. ThetermofappointmentofRECmembers
3. Thediversityofprofessionalbackgroundsthatshouldberepresentedonthecommittee
4. Thediversityofgenderthatshouldberepresentedonthecommittee
5. Therequiredmembershipofsomeonewithanon-scientificbackground
6. Therequiredmembershipofsomeonewithnoaffiliationtotheorganizationthatsponsors,funds,orconductsresearchreviewedbytheREC?
7. Therequiredquorumsizeforthecommitteetotakeactionsand/ormakedecisions
B.2DoestheREChavewrittenpoliciesorstandardoperatingproceduresregardingthefollowingaspectsof
committeeindependence?
Yes No Comments
8. Therequiredattendanceofsomeonenotaffiliatedwiththeinstitutionduringcommitteedeliberations
9. Theextenttowhichinvestigatorsmayparticipateincommitteedeliberationsabouttheirownresearch
10. Thedefinitionofaconflictofinterestformembersofthecommittee
11. Theproceduresthroughwhichconflictsofinterestwillbeaddressedwhentheyarise
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B.3DoestheREChavewrittenpoliciesorstandardoperatingproceduresregardingthefollowingaspectsof
trainingforcommitteemembers?
Yes No Comments
12. Therequiredresearchethicstrainingforcommitteemembers
13. Therequiredrefreshertrainingsforcommitteemembersduringtheirtermofservice
B.4DoestheREChavewrittenpoliciesorstandardoperatingproceduresregardingthefollowingaspectsof
committeedecision-making?
Yes No Comments
14. Thetypesofstudiesforwhichexpeditedreviewmechanismsareallowed(ifany)
15. Theprocessthroughwhichdecisionsaremade(e.g.voteorconsensus)
16. Theexistingethicalguidelines(e.g.DeclarationofHelsinki,TheBelmontReport,CIOMS,etc.)thatinformtheethicaldecision-makingofthecommittee
B.5DoestheREChavewrittenpoliciesorstandardoperatingproceduresregardingthefollowingaspectsof
administrativeoperations?
Yes No Comments
17. TheconfidentialityrequirementsofRECmembers
18. Thedocumentsthatarerequiredforsubmissionsforethicalreview
19. Thedocumentsthatmustbecirculatedpriortothemeeting
20. Theproceduresforrecordingmeetingminutes
21. Theapprovalprocessformeetingminutes
22. Theprocessforcommunicatingcommitteedecisionstoresearchers
23. Theprocessforpost-approvalmonitoringofprotocols(e.g.annualreviews)
24. Thesafetymonitoringrequirementsrequiredforprotocolsinvolvingmorethanminimalrisk
25. Theproceduresforarchivingcommitteedocumentsandcommunications
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PartCRECOperations
Method:SiteVisittoRECAdministrativeOffice
ThequestionsinthissectionprovideinformationontheactualpracticesoftheREC(incontrasttowrittenpoliciesorstandardoperatingprocedures).TheyincludebothquestionsaskedtotheRECAdministratoraswellas,whenpossible,visualverificationofthedocuments/systemsinquestion.Visualverificationshouldbenotedwhereindicatedonthisform.
C.1RECGovernance,Membership,andParticipation
1. WhatisthetypicallengthoftimesomeoneservesasanRECmember?
�Lessthan1year�1-3years�3-5years�Morethan5years�Don’tknow�Other:_______________________________________________
2. Isthereamaximumnumberofyearsamembercanserve?
�Yes(describe):_________________________________________�No�Don’tknow�Other:_______________________________________________
3. Doallmembersrotateatthesametime?
�Yes�No(describe):_________________________________________�Don’tknow�Other:_______________________________________________
4. WhatbackgroundsarerepresentedbycurrentmembersoftheREC?
MemberBackground Numberofmembers
PhysiciansPharmacistsNursesBiomedicalScientistsSocial&BehavioralScientistsLawyersBioethicistsReligiousrepresentatives/TheologiansCommunity/LayRepresentativesBiostatisticiansOther(describe)Other(describe)
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5. HowmanymembersoftheRECare:
Male Female
6. Atfullreviewmeetings,areRECactionsevertakenduringmeetingsintheabsenceofcommunity/layrepresentative?
�Yes(explain):____________________________________________________�No�Don’tknow�Other:_________________________________________________________
7. Atfullreviewmeetings,areRECactionsevertakenwhenlessthanhalfofRECmembersarepresentatameeting?
�Yes(explain):____________________________________________________�No�Don’tknow�Other:_______________________________________________
C.2RECresources
8. HowaretheoperationalcostsoftheRECfunded?(tickallthatapply)
�Institutionalfunding(allocatedfromtheregularbudget)�Applicationfeesandothercharges�ResearchSponsor�Othergrantsawardedtotheinstitution�Don’tknow�Other:(describe)___________________________________________
9. ApproximatelyhowmuchofRECoperationalcostsaresupportedbytheinstitution’sregularbudget?
�Lessthan50%�Morethan50%�N/A(noregularbudgetfundsallocatedtoRECoperation)�Don’tknow�Other:_______________________________________________
10. HowmanyadministrativestaffdoestheRECOfficehave?
Numberoffull-timestaff Numberofpart-timestaff
_________
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C.3TrainingofRECmembersandinvestigators11. AreRECmembersprovidedwithanysortoftrainingBEFOREtheirservice?
�Yes�No�Don’tknow�Other:_______________________________________________
a. Ifyes,whattype(s)oftrainingopportunitieshavebeenprovidedtoRECmembersbeforetheirservice?
�Workshop/Seminar�Onlinecourse(pleasespecify):_______________�Formalacademiccourse�Don’tknow�Other(describe):____________________________
b. Ifyes,whatdoesthetrainingtypicallycover?
�RECoperatingprocedures�Researchethicsprinciplesandconcepts�Bothoperatingproceduresandresearchethicsprinciplesandconcepts�Don’tknow�Other:____________________________
c. Ifyes,howlongistheaveragetrainingactivity?
�Lessthanonehour�Morethananhour,butlessthanonefullworkday�Onefullworkday�Morethanonefullworkday,butlessthanoneworkweek�Oneworkweek�Morethanoneweek�Other(describe):____________________________
12. AreRECmembersprovidedwithanysortoftrainingDURINGtheirservice?
a. Ifyes,whattype(s)oftrainingopportunitieshavebeenprovidedtoRECmembersduringtheirservice?
�Workshop/Seminar�Onlinecourse(pleasespecify):____________________�Formalacademiccourse�Don’tknow�Other(describe):____________________________
b. Ifyes,whatdoesthetrainingtypicallycover?
�RECoperatingprocedures�Researchethicsprinciplesandconcepts�Bothoperatingproceduresandresearchethicsprinciplesandconcepts�Don’tknow�Other:___________________________
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c. Ifyes,howlongistheaveragetrainingactivity?
�Lessthanonehour�Morethananhour,butlessthanonefullworkday�Onefullworkday�Morethanonefullworkday,butlessthanoneworkweek�Oneworkweek�Morethanoneweek�Other(describe):____________________________
d. Ifyes,howoftenaretrainingsofferedtoRECmembers?
�Severaltimesayear�Onceeveryyear�Onceeverytwoyears�Lessthanonceeverytwoyears
13. Approximatelywhat%ofthecurrentRECmembershavehadanytraininginresearchethics,fromanysource,inthepast2years?
�Lessthan50%ofmembers�Morethan50%ofmembers�Don’tknow�Other:______________________________
14. Areinvestigatorsprovidedwithanyresearchethicstraining?
�Yes�No�Don’tknow�Other:______________________________
a. Ifyes,whattype(s)oftrainingopportunitiesareprovidedtoinvestigatorsatyourinstitution?
�Workshop/Seminar�Onlinecourse(pleasespecify):____________________�Formalacademiccourse�Don’tknow�Other(describe):____________________________
b. Ifyes,whatdoesthetrainingtypicallycover?
�IRBoperatingprocedures�Researchethicsprinciplesandconcepts�Bothoperatingproceduresandresearchethicsprinciplesandconcepts�Don’tknow:�Other:____________________________
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c. Ifyes,howlongistheaveragetrainingactivity?
�Lessthanonehour�Morethananhour,butlessthanonefullworkday�Onefullworkday�Morethanonefullworkday,butlessthanoneworkweek�Oneworkweek�Morethanoneweek�Other(describe):____________________________
d. Ifyes,howoftenaretrainingsofferedtoinvestigators?
�Onlyonce,attimeofappointment�Onceevery5ormoreyears�Onceeverytwoyears�Onceeveryyear�Severaltimesayear
C.4RECTransparencyandAccountability.15. DoesyourREChaveadedicatedwebsite?�Yes(providewebaddress):__________________________________________________�No�Don’tknow�Other:_________________________
16. AreRECannualreportspubliclyavailable?
�Yes�No�Don’tknow�Other:_________________________
17. AreRECpoliciesandproceduresmadereadilyavailabletoresearchers?
�Yes(describe,e.g.,website,providedhardcopies,etc.):___________________�No�Don’tknow�Other:_________________________
18. HastheRECeverconductedaformalorinformalperformance/capacity/needsassessmentinthepast?
�Yes(requestcopyofreportifavailable)�No�Don’tknow�Other:________________________
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C.5DescriptionofRECAdministrativeResources
Note:thissectionincludesquestionstobeansweredthroughinterviewwiththeRECadministratoraswellasopportunitiestovisuallyverifyresponsesthroughobservationduringasitevisittotheRECOffice.Checkthe“observation”boxwhereinformationiscollectedthroughobservation.Checkthe“interview”ifresponseismadethroughinterviewonlyandnotvisuallyverified.Checkbothifboth“observation”and“interview”apply.
19. DoestheREChaveregularaccesstoaconfidentialmeetingspaceforcommitteemeetings?Response Method
�Yes �Observation�No �Interview�Other:____________
20. DoestheREChavededicatedofficespaceforitsadministrativestaff?Response Method
�Yes �Observation�No �Interview�Other:____________
21. DoestheREChaveasecureplaceforitsresearchfiles(e.g.alockablefilecabinet)?Response Method
�Yes �Observation�No �Interview�Other:____________
22. WhichofthefollowingresourcesdoestheRECOfficehaveavailable(tickallthatapply)?
Observation InterviewItem ü Ifpresent
dayofassessment
Alwaysavailablewhenneeded
Sometimesnotavailable
Neveravailable
Notneeded
ComputerInternetaccessPrinterEmailaddressTelephonesPhotocopierBasicofficesupplies(stationery,ink,paper,files,etc.)
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C.6FilingSystem23. DoestheREChaveafilingsystemforallapplicationsreceived?
Response Method
�Yes �Observation�No �Interview�Other:
a.Ifyes,isthefilingsystem:
Sufficientlysized(canaccommodateallfiles)
�Yes�No�Other:
�Observation�Interview
Consistentlyused �Yes�No�Other:
�Observation�Interview
Easilysearchable �Yes�No�Other:
�Observation�Interview
b. Ifyes,LOOKATFILESandnotewhatinformationiskeptinthefolderforeachprotocol?
�Originalapplicationform �Originalprotocoldocuments�Mostrecent/approvedprotocoldocuments(e.g.consentforms,recruitmentscripts)�Amendments�Progressreports �Ancillaryreviews(e.g.scientificreviews,biosafety,pharmacy&therapeutics)�RelevantGrants/contractsdocumentingfundingsourceoftheresearch�Minutesofmeetingswhenprotocolreviewed�Safetymonitoringreports,ifrelevanttotheprotocol�Problemevents �Researchethicstrainingcertificatesofresearchteam�Other:_________________________�Other:_________________________
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C.7TrackingSystem24. IsthereatrackingsystemavailableforofficestafftotracksubmissionstotheRECastheymovethroughtheapproval
process?Response Method
�Yes �Observation�No �Interview�Other:___________
a. Ifyes,whatformatisthetrackingdocument?
�Paper-based�Electronic�Other:_______________________
b. Ifyes,howconsistentlyisthetrackingsystemused?
�Trackingsystemisup-to-dateandconsistentlyused�Trackingsystemisregularlyused,butwithlargegapsoftimebetweenupdates�Trackingsystemisavailablebutisnotroutinelyused�Other:_______________________
c. Ifyes,LOOKATTRACKINGSYSTEMandnotewhichofthefollowingdatafieldsarerecorded:
�Dateofsubmission�Uniqueapplicationnumber�PIname�Studytitle�Initialsofpersonrecordingthesubmission�Submissiontype(e.g.new,amendment,progressreport)�Staffpersonassigned�Reviewerassignment�Processnotes�Datesenttoreviewer�Datereceivedback�Dateofmeetingwhereitwasreviewed�Finaldecision�Correspondencedateswithinvestigator�Other:___________________________
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C.8SubmissionandReviewPractices25. DoestheRECrequireinvestigatorstosubmitaresearchplanorprotocolwiththeirapplication?
�Yes�No�Other:_______________________
a. Ifyes,whatinformationistheinvestigatorexplicitlyrequiredtodescribeintheresearchplan?(tickallthatapply)
�Aimsofstudy�Rationaleforresearch�Studydesign�Participantsample�Recruitmentprocedures�Consentprocedures�Studyimplementation�Storageofdatacollected�Risksofthestudy�Benefitsofthestudy�Paymenttoparticipants,ifany�Other:____________________
b. Ifyes,doestheREChaveatemplateorchecklistforinvestigatorstouselistingtherequiredcomponentsoftheresearchplanfortheirapplication?
Response Method
�Yes �Observation�No �Interview�Other:___________
26. Whatareallofthedocumentsthatarerequiredtobesubmittedwitheachnewapplication?(tickallthatapply)
�Fullstudyprotocol�Protocolsummaryorresearchplan�Consentmaterials�Recruitmentmaterials�Researchinstruments(e.g.questionnaires,interviewguides)�Investigators’certificateofresearchethicstraining�CurriculumVitaeofPrincipalInvestigator�Detailedbudgetforstudy�Fordrug/devicestudies,productinformationforinvestigationalproduct�Other(describe):______________________________
27. Inthelast12months,approximatelywhat%ofapplicationsincludedallrequireddocumentationonthefirstsubmissionoftheapplication?�Morethan75%�About50%-75%�Lessthan50%
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28. DoesanystaffmemberoftheRECofficeconductapre-reviewofsubmittedapplicationstoseeiftheapplicationiscompletepriortoschedulinganapplicationforreview?�Yes(describewhodoesthereview):_________________________________________�No
29. DoesanystaffmemberoftheRECofficeconductpre-reviewofthesubmittedapplicationspriortoschedulinganapplicationforreviewforanyotherpurpose?�Yes,todetermineeligibilityforexpeditedrevieworexemptstatus�Yes,todeterminewhetherapplicationsqualifyasHumanSubjectsResearch�Other(describepurpose):_____________________________________________________�No,pre-reviewisnotconductedforanyotherpurpose.
30. Iseachapplicationassignedoneormoreprimaryreviewer(s)?�Yes�No�Other:___________________________
31. Iseachapplicationadditionallyassignedoneormoresecondaryreviewers?�Yes�No�Other:___________________________
32. HowregularlyareagendaitemsmadeavailabletoRECmembersinadvanceofRECmeeting?�Always�Often�Rarely�Never
a) Ifyes,howlonginadvanceofeachmeetingareagendaitemsmadeavailable?�Lessthan1week�1-weekormore
b) Ifno,arematerialsmadeavailableatthemeetingitself?�Yes�No
33. Howlong,onaverage,doRECmeetingsrun?
�Lessthan1hour�1-2hours�Morethan2hourbutlessthan3hours�3hours�Morethan3hours
34. Onaverage,howmanyNEWprotocolsarereviewedduringeachmeeting?
�0-2protocols�3-5protocols�6-10protocols�Morethan10protocols
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35. ApproximatelyhowmanyCONTINUINGprotocolsarereviewedduringeachmeeting?
�0-2protocols�3-5protocols�6-10protocols�Morethan10protocols
36. WhatistheapproximatelengthoftimebetweensubmissionofaprotocoltotheRECandthecompletionofthefirst/initialreviewbythecommittee?
�Lessthan1month�1-2months�3-4months�Morethan4months
C.9MeetingMinutes37. Aremeetingminutesrecordedforeachmeeting,eitherduringthemeetingitselfortypedupfromnotessoonafter
themeeting?
�Yes(describewhotakesminutesandwhen):______________________________�No�Other:______________________________
38. Isthereatemplateformeetingminutes?
�Yes:______________________________�No�Other:___________________________
a. Ifyes,LOOKATASAMPLEof3meetingminutesandnotewhatinformationisconsistentlyrecordedinmeetingminutes:
Meeting1 Meeting2 Meeting3MeetingdateandtimeAttendanceListofapplicationsreviewedIssuesofconcernordeliberationRegulatorydeterminations(e.g.fordevicesorexperimentaldrugs)Studyproductstatus(investigational,approved,etc.)?ReviewbyconsultantsReviewbypharmacologist,fordrugstudiesMentionofconsentproceduresActionstakenforeachprotocolreviewed(e.g.approval,conditionalapproval,table)
39. DoestheRECrequirememberstosigninonanattendancesheet?
�Yes�No�Other:_______________________________
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a. Ifyes,doesanyoneverifythattheattendancerecordedintheminutesmatchestheattendancesheet?
�Yes�No�Other:________________________________
b. Ifyes,doesanyoneverifythatthevotesrecordedintheminutesreflectthoseinattendanceduringthevote?
�Yes�No�Other:________________________________
C.10CommunicationPractices40. Areletters/emailsregularlysenttoinvestigatorsfollowingthemeetinginwhichtheirprotocolwasreviewed?
�Yes�No
a. Ifyes,howsoonfollowingmeetingsareletterssenttoinvestigators?
�Lessthan1weeklater�Within1-2weeks�Morethan2weeks
b. Ifyes,isthereatemplatefortheapprovalletterssenttoapplicantsfollowingthereviewofaresearchprotocol?Response Method
�Yes �Observation�No �Interview�Other:_____________________
c. Ifyes,LOOKATASAMPLEOFAPPROVALLETTERSSENTFROMTHERECOFFICE.Whatinformationisconsistentlypresentintheapprovallettersenttoapplicants?
Letter1 Letter2 Letter3ApprovaldecisionfromRECExpirationdateofapproval,ifgrantedRequirementthatanychangestotheapprovedresearchplanmustbesubmittedforreviewasanamendmentRequirementforthepromptreportingofanyadverseeventsorunanticipatedproblemsRequirementforthepromptreportingofprotocoldeviationsRequirementforinvestigatorstouseapprovedconsentanddatacollectionformsRequirementforinvestigatorstousestampedconsentanddatacollectionformsRequirementtosubmitcloseoutreportuponstudycompletion
41. Areinvestigatorsrequiredtosubmitprogressreportsaboutapprovedresearch?�Yes�No�Other:_______________________�Don’tknow
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a. Ifyes,howoftenareinvestigatorsrequiredtosubmitprogressreportsaboutapprovedresearch?�Morethanonceperyear�Onceperyear�Once,attheendofthestudy�N/A(progressreportsnotrequired)�Other:_________________________________________________________________
b. Ifyes,whataretheconsequencesforfailingtosubmitprogressreports?(tickallthatapply)�Investigatorwillreceivereminderletters�Ethicscommitteeordesigneewillconductasitevisit�Researchmaybestoppedorinterrupted�Other:__________________________________________________
42. Doestheethicscommitteeoritsdesigneeconductsitevisitstoprovidecontinuingoversightofapprovedresearchprotocols?�Yes,forallapprovedstudies�Yes,butonlyforsomestudies(describe):____________________________________�Notforanystudies�Other:__________________________________________________
a. Ifyes,howfrequentlydositevisitsoccur?
�Morethanonceayear�Onceayear�Atleastonceduringperiodofstudy�Other:__________________________________________________
C.11ProtocolReviewStructure43. DoestheREChaveachecklistofrelevantethicalconsiderationstoguidereviewersofresearchprotocols?
Response Method
�Yes �Observation�No �Interview�Other:_____________________
a. Ifyes,lookatthetemplateandidentifywhichofthefollowingethicsreviewcriteriaareonthechecklist?(tickallthatapply)
�ScientificValidity�BalancedRisksandPotentialBenefitstoParticipants�Appropriateconsiderationforstigmaandsocialriskstoparticipants�FairSelectionandRecruitmentofSubjects�JustifiableCompensationofSubjects�AdequatePrivacyandConfidentialityProtections�AdequateInformedConsentProcess�Adequateapproachestocommunicatingwithparticipantsandcommunitiesduringandafterresearch�ConsiderationforCommunityInterests(e.g.,inclusionofcommunityharmsinriskassessments,respectforcommunitystructuresduringinformedconsentprocess,etc.)�Responsivenessofresearchtolocalpriorities�Identifiedproceduresforhandlingadverseevents�Appropriatequalificationofresearchers�Other:____________________________________________________�Other:____________________________________________________
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PartDRECMeeting
Method:StructuredobservationofRECMeeting
ThisPartincludesthreesections:(D.1)whichcapturescontextualinformationrelatedtotheRECmeetingobserved;(D.2)whichprovidesaProtocolReviewChecklistthatshouldbecompletedbytheassessorduringtheobservedRECmeeting(onehardcopyofchecklistisneededforeachprotocolreviewedduringthemeeting);and(D.3)whichdescribesproceduresforreviewingtheoutputsoftheRECmeeting.ItisstronglyadvisedtoattempttoobserveanRECmeetingwhichincludes,ontheagenda,thereviewofdifferenttypesofprotocols–newprotocols,re-submissions,continuingreviews,etc….
D.1MeetingContextDate:StartTime:StopTime:NumberofNewProtocolsReviewed:NumberofContinuingReviewProtocols:
1. Didyou(observer)receiveacopyofagendaitems?�Yes
�No
2. Didyousignaconfidentialityagreementasaguest?�Yes
�No
3. IsyournameontheagendaORwereyouaskedtosignin?�Yes
�No
4. Didthemeetingoccurinaconfidentialroom?�Yes
�No
Notes
Notes
Notes
Notes
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5. Members:Member(notenamesduringmeeting–consultmeetingregister/attendancesheettoconfirm)
Background(clarifyaftermeetingifnecessary)
M/F
6. Wasthereanon-scientificmemberpresent?�Yes
�No
7. Wasthereacommitteememberunaffiliatedwiththeinstitutionpresent?�Yes
�No
8. Wasthereaquorumpresent(wereatleasthalfofthememberspresent)?�Yes
�No
9. Wereanynon-memberspresent(e.g.,investigatorswhoseprotocolsareunderreview,consultants,etc.)�Yes
�No
10. Wereconflictsofinterestdeclared?�Yes
�No
Notes
Notes
Notes
Notes
Notes
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11. Didmemberwhodeclaredconflictsofinterestparticipateindiscussionsoftheitemsforwhichtheyhaddeclaredconflicts?
�Yes
�No
�N/A
12. Werenotesorminutestakenduringthemeeting?
�Yes
�No
13. Wasachecklistusedtoensureconsiderationofrelevantethicaldecisions?
�Yes
�No
14. Howwasadecisionreached?
�Vote
�Consensus
�Other:___________________
15. Othernotesaboutthemeeting:
Notes:
Notes:
Notes(i.e.,howwereconflictsofinterestaddressed):
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D.2ProtocolReviewChecklistCompleteonechecklistforeachprotocolreviewedduringmeeting.Printoutasmanycopiesofthechecklistasthenumberofprotocolsbeingreviewedontheagenda.
REC:MeetingDate:Protocol:STARTTIME: ENDTIME:
1. TypeofProtocol:
□ NewProtocol,1streview□NewProtocol,2ndorlaterreview □Continuingreview□Administrativechanges□Other:____2. Presenter(tickallthatapply):
□ Primaryreviewer□Secondaryreviewer □Invitedresearcher□Invitedconsultant□Chair□Other:_____
Werethefollowingethicsconsiderationsmentionedand/ordiscussedinthereview?(M=Mentionedbyoneperson,D=Discussedbyatleasttwopeople,N=Neither)
Consideration M D N NotesScientificdesignandconductofstudy
Risksandpotentialbenefits
Selectionofstudypopulation
Recruitmentofresearchparticipants
Inducements,financialbenefits,andfinancialcosts
Protectionofparticipants’privacyorconfidentialityofdata
Informedconsentprocessorwording
Communityconsiderations(e.g.stigma,drainingcommunitycapacity,orpromotionofpositiveeffectsoncommunities)Other
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D.3PostMeetingFollow-upThefollowingquestionspertaintoRECpracticesthatoccurAFTERtheconclusionofameeting.Itrequireslookingatcopiesofmeetingminutesaswellasdecisionletterssenttoinvestigatorsdescribingtheoutcomeofthereview.Themeetingminutesandlettersreviewedshouldcorrespondtothesamemeeting.Thissectionmaybecompletedinoneoftwoways,dependingonthefeasibilityfortheassessorinthecontextoftheevaluation:
OPTION1:ProspectiveAssessment
Forthisoption,theassessorshouldreviewthemeetingminutesandletterssenttoinvestigatorspertainingtothesamemeetingthattheassessorobserved.UsethisoptioniftheassessorwillremainincontactwiththeRECadministratorandwillbeabletoobtaincopiesofmeetingminutesandcommunicationstoinvestigatorswhentheyaresentbytheRECOffice.
OPTION2:RetrospectiveAssessment
Forthisoption,theassessorshouldreviewmeetingminutesandletterssenttoinvestigatorspertainingtoapreviousmeetingthattheassessordidnotobserve.UsethisoptionifitwillnotbefeasiblefortheassessortoobtaincopiesoftheminutesandRECcommunicationstoinvestigatorsthataregeneratedfromthemeetingobservedbytheassessor.
Notewhichoptionisusedbelow:
�Option1:ProspectiveAssessment�Option2:RetrospectiveAssessment
DateofReferenceMeeting:_____________________________
MeetingMinutes
16. Howsoonafterthemeetingwereminutesapproved?
�Nominutesapproved�Within1weekafterthemeeting�Within2weeksafterthemeeting�Within1monthafterthemeeting�Morethan1monthafterthemeeting
17. Dotheminutesseemtoreflectanadequaterecordoftheconcerns,questions,anddecisionsvoicedattheRECmeeting?(Note:forprospectivefollow-up,theassessorcancompareminutesgeneratedagainsthis/herownnotesforthemeeting.Forretrospectiveassessment,theassessorshoulddeterminewhethertheminutescontaininformationaboutboththeconcernsandquestionsandwellasdecisionsmade,whethertheconcernsandquestionsreflectappropriateethicalconsiderations,andwhetherthedecisionsseemalignedwiththenatureofquestionsandconcernsdescribed.)
�Yes�Partially
�No
�N/A(meetingminutesneverproduced)
Notes:
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Notes:
CommunicationstoInvestigators:
18. Howsoonafterthemeetingwereletterssenttotheinvestigatorswhoseapplicationswerereviewedduringthemeeting?
�Withinoneweekafterthemeeting�Withintwoweeksafterthemeeting�Withinonemonthafterthemeeting�Morethanonemonthafterthemeeting
LOOKATALETTERSENTREGARDINGANUNCONDITIONALLYAPPROVEDPROTOCOLreviewedduringthemeeting.Ifnoprotocolwasapprovedduringthemeeting,checktheboxbelowandskiptoquestion21.
�Noprotocolwasunconditionallyapprovedduringthemeeting
19. Doesthestudyapprovaldecisionmatchwhatwasrecordedinmeetingminutes?
�Yes�No�N/A(nomeetingminutesproducedformeetingofreference)
20. Whatinformationispresentintheletter?
�ApprovaldecisionfromREC�ExpirationDateofapproval�Requirementthatanychangestotheapprovedresearchplanmustbesubmittedforreviewasanamendment�Requirementforthepromptreportingofanyadverseeventsorunanticipatedproblems�Requirementforthepromptreportingofprotocoldeviations�Requirementforinvestigatorstouseapproved,stampedconsentforms
21. LOOKATALETTERSENTREGARDINGAPROTOCOLTHATWAS“APPROVEDWITHCHANGES”or“TABLED”.Markwhichdecisionwasmadebelow.Ifnostudywas“ApprovedwithChanges”or“Tabled”duringthemeeting,checktheboxbelow.
�ApprovedwithChanges�Tabled�Noprotocolwas“ApprovedwithChanges”or“Tabled”duringthemeeting
22. Dotheconcernsandrequestedchangesdescribedintheletterreflectwhatwasrecordedintheminutes?
�Yes�Partially�No�N/A(nomeetingminutesproduced)
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PartERECPerceptions
Method:InterviewsandFocusGroupswithKeyStakeholders
Thissectionisintendedtobeopen-endedandprovideanopportunityforadditionalstakeholderstocommentontheneedsandprioritiesoftheREC.Werecommendengagingthreestakeholdergroupsinthispartoftheassessment:1)theDeanofresearchorequivalentindividualwhoisresponsibleforRECoversight,2)RECmembers,and3)investigatorswhosubmitapplicationstotheREC.Thefollowingsetsofquestionsaresuggestedinterview/focusgroupguidesthattheassessormayusetofacilitatediscussionamongdifferentstakeholdergroups.
E.1InterviewGuide-Dean/InstitutionalLeadershipThankyoufortakingtimetotalkwithmetoday.Asyouknow,IamhereaspartofaneedsassessmentexercisetohelpstrengthenyourREC.IaminterestedinyourperspectiveabouttheREC,itsroleintheinstitution,andthetopissuesyouperceiveasimportantforstrengtheningtheRECinthefuture.
1. WhatisthehistoryoftheRECatthisinstitution?a. WhatconsiderationswentintotheformationoftheREC?b. HowimportantdoyouviewtheroleoftheRECwithintheinstitutionnow?
2. WhatkindsofresourcesdoestheinstitutionmakeavailabletotheREC?a. Inyourview,aretheseresourcesadequate?Whyorwhynot?
3. WhatdoyouthinktheRECisdoingreallywell?
4. WhatdoyouthinkaresomeofthechallengesRECmembersexperienceinfulfillingtheworkofthecommittee?
5. WhatdoyouthinkaresomeofthechallengesRECadministrativestaffexperienceinfulfillingtheworkoftheoffice?
6. WhatdoyouthinkaresomeofthechallengesresearchersexperienceintheirinteractionswiththeREC?
7. WhataresomethingsyouthinktheinstitutioncoulddotoimprovethequalityandefficiencyoftheREC?a. First,whatdoyouthinkyoucoulddotoimprovetheQUALITYoftheREC?b. Now,whataresomethingsyouthinktheinstitutioncoulddotoimprovetheEFFICIENCYoftheREC?
8. WhatchangeswouldyouliketoseehappenwithrespecttotheREC?a. WhatwouldtheRECneedtomakethesechangeshappen?
9. IsthereanythingelsethatIhaven’taskedaboutthatyouwouldlikesayaboutresearchethicscommitteereviewatyourinstitution?
41
E.2FocusGroupGuide-RECMembersThankyoufortakingtimetotalkwithmetoday.Asyouknow,IamhereinaspartofaneedsassessmentexercisetohelpstrengthenLJŽƵƌ�Z��͘IaminterestedinyourperspectiveabouttheREC,itsstrengthsandweaknesses,andthetopissuesyouperceiveasimportantforstrengtheningtheRECinthefuture.
Background/Context
1. First,whatdoyoufeelaretherolesoftheREC?Doyouthinkitservesitsfunction(s)?Why/whynot?
2. DoyouthinkthewrittenRECpoliciesandprocedures(e.g.StandardOperatingProcedures)areadequate?Arethereanythatyouwouldchange?
3. Whatisyourcommittee’srelationshipwithothercommittee(s),ifanyothersexist?Doesanyonesitonmorethanoneofthecommittees?
4. WhatmajorchangeshastheRECseeninthepasttwoyears?Whatcausedthosechanges?
5. Howindependentdoyouthinkthecommittee’sdecisionsarefromtheinfluenceofoutsiders(e.g.high-rankinginstitutionalofficials,well-knownresearchers,etc.)?
RECComposition
6. IstheRECcapableofreviewinganytypeofresearchproposal?E.g.,clinicaldrugtrial,psycho-socialstudy,interventionalstudy,etc….DoyouthinkRECmembershipisadequatelydiverse?
a. Where,ifanywhere,iscontent-areaexpertiselackinginthecommittees?
7. IscommunityrepresentationontheRECvaluable?DoyouthinktheREChasappropriatecommunityrepresentation?HowdoestheRECrecruitcommunityrepresentatives?
8. DoyouthinktheREChasenoughmembers?Toomany?
9. HowisRECmembership‘turnover’?
QualityandEfficiencyofRECReview
10. I’dliketohearanythoughtsyoumighthaveonthequalityofRECreview.Doyoufeellikethereviewprocessaddssomethingtotheresearchbeingconducted?Ifyes,whatdoesitadd?Ifno,whatismissing?
11. Howwouldyoudescribethedeliberationsofthecommittee?Doyouthinkeveryonehasanopportunitytocontribute?Areinteractionsgenerallythoughtfulandrespectful?
12. Duringanaverageprotocolreview,whatdoestheRECspendmostofitstimereviewing?(e.g.science,ethics,budget,researcherqualifications,etc…)Whyarecertainthingsemphasizedoverothers?
13. HowefficientdoyoufeeltheREC’sadministrativeprocessesare?Whataresomeobstaclestoadministrativeefficiency?
42
RECResources
14. DoyouthinktheREChasadequateresourcestodoitswork?Whatdoesitneedandwhy?
a. Materialresources?
b. Supportstaff?
c. Compensationfortime?
Researchers
15. HowwouldyoudescribetheREC’srelationshipwithresearchers?
16. HowdoyouthinkresearchersunderstandtheroleoftheRECorwhatitdoes?
17. HowwellorpoorlydoyouthinkthatresearchersknowwhattheyneedtosubmittotheREC,howtosubmititand
whentosubmitit?Howwouldaresearcherlearnthisinformation?
18. DoyouthinkthatmostresearchproposalsthatshouldbesubmittedtotheRECareindeedsubmittedtotheREC?Are
thereanyreasonswhyyouthinkresearchersmightbehesitanttosubmitproposalstotheREC?
19. CouldyoutellmealittleaboutthequalityofthematerialsthataresubmittedbyresearcherstotheREC?Aretherepartsofthesubmissionsthataretypicallyoflowerquality(e.g.,informedconsentdocuments),andpartsthataretypicallyofhigherquality(e.g.,researchmethods)?Doesthequalitydifferbythetype/areaofresearch?
EthicsTraining
20. Whatsortofexperienceshaveyouhadinthepastwithethicstraining?Didthosetrainingexperiencesfocuson
thingsthatfacilitatedyourabilitytoconductethicsreview?
21. WhatadditionaltrainingmighthelpincreaseyourabilitytoconductRECreview?
22. DoestheREChelptrainresearchersinresearchethics?Ifso,how?
PerceptionofStrengths/Challenges
23. IfyoucouldasktheUniversityadministrationtodoonethingtoimprovetheREC’sabilitytooperate,whatwouldthat
be?
24. Whatdoyouseeasthecommittee’sgreateststrength?
25. Whatdoyouseeasthecommittee’sgreatestchallengesmovingforward?
26. IsthereanythingelsethatyouwouldliketosayabouttheRECorresearchatyourinstitutionthatIhaven’tasked
about?
43
E.3FocusGroupGuide-ResearcherswhoSubmitProtocolstotheRECThankyoufortakingtimetotalkwithmetoday.IamhereinaspartofaneedsassessmentexercisetohelpstrengthenyourREC.AsresearcherswhorelyontheRECtoconductyourwork,IaminterestedinyourexperiencesworkingwiththeREC,yourperceptionofwhatisgoingwellandwhatisn’t,andyoursuggestionsforstrengtheningtheRECinthefuture.
1. TellmeaboutyourinteractionwiththeREC?a. WhydoyousubmitprotocolstothisREC(e.g.institutionalrequirement,funderrequirement,personal
motivation)?b. Aretheretimeswhenyoudon’tsubmit?Ifso,whynot?c. DoyoueverconsulttheRECaboutastudybeforesubmittinganapplication?d. HowfrequentlydoyousubmitresearchprotocolstotheREC?e. Whatkindsofprotocolsdoyousubmit?
2. HowdoyouknowwhetheritisrequiredtosubmitanRECapplicationforyourresearchprojects?a. Whatkindsofresearchethicstraininghaveyoureceived?b. Areyoufamiliarwithinstitutionalpoliciesand/orguidelinesaboutresearchwithhumanparticipants?c. HaveyoueveraskedtheRECwhetheryoushouldsubmitaprotocolforreview?d. Whatdoyoudoifyou’renotsurewhetheryoushouldsubmitaprotocoltotheREC?
3. HowclearareRECsubmissioninstructions?a. Howdidyoufindoutwhatyouneededtosubmit?b. Wheredoyoulookforguidancewhenpreparingyourapplication?c. Whatkindsofchallenges,ifany,didyouexperienceinthesubmissionprocess?
4. Whatkindofcommentsandrequestedchangeshaveyoureceivedonyourprotocols?a. Didyouunderstandthem?b. Didtheyseemwelljustified?c. Didyouthinktheywerehelpfuland/orenhancedthequalityofthestudy?
5. Inyourexperience,approximatelyhowlonghasittakenfromthetimeyousubmitanapplicationtothetimeyoureceiveadecisionfromtheREC?
6. WhatchangestotheRECguidelinesoroperationswouldyourecommendtoimprovethequalityandefficiencyofethicsreviewatyourinstitution?
a. First,whatrecommendationsdoyouhavetoimprovetheQUALITYofethicsreview?b. Now,whatrecommendationsdoyouhavetoimprovetheEFFICIENCYofethicsreview?
7. IsthereanythingelsethatyouwouldliketosayabouttheRECorresearchatyourinstitutionthatIhaven’taskedabout?
44
ResearchEthicsCommitteeAssessmentToolkit(RECAT)ReportingTemplate
***NeedsAssessment
REPORT
DATESOFASSESSMENT____________________________________________________________________
ASSESSORS______________________________________________________________________________
PARTICIPANTS___________________________________________________________________________
ASSESSMENTMETHODS___________________________________________________________________
INTRODUCTION
SUMMARYOFFINDINGS
1. Qualityofethicsreview
Summary
Recommendations
2. Operationalefficiency
Summary
Recommendations
45
FULLREPORT
DOMAIN SUB-DOMAIN EXPECTATIONS OBSERVATIONS RECOMMENDATIONS
1
ESTABLISHMENTOFREC NationalContext Anationalenvironmentthatpromotes,supportsandrequiresethicalreviewandcontinuedoversight.
2
InstitutionalContext
Aninstitutionalenvironmentthatsupportsandrequiresethicalreview.
3RESOURCES Human Adequateresourcesto
supportoperations.
4Other Adequateresourcesto
supportoperations.
5
TOOLS SOPs SOPsavailablecoveringallessentialoperations.
6
Applicationforms RECshouldhavecomprehensiveapplicationformstoensurethatsubmissionsareuniformandmeetRECrequirements.
46
7
ReviewForm RECshouldhaveareviewchecklisttoensureconsistencyandthoroughnessofreview.
8
Otherforms RECshouldhaveformsforensuringconsistencyinhandlingrequestsorreports.
9
Approvalletters Comprehensivelettertemplatesforvariousreviewoutcomes.
10MEMBERSHIP Professional
backgroundsVariedbackgrounds.
11
Trainingonreview Memberstrainedinethicalreviewandotherrelevanttopics.
12
DOCUMENTATION Filingsystem Anefficientfilingsystemtoensureeasyretrieval.
13
Gooddocumentmaintenancepracticesforeachstudy/proposal.
14DocumentStorage Adequatespacefor
storage.
47
15
SERVICETOCLIENTS ClientSatisfaction RECshouldensurethatresearchersaregenerallysatisfiedbytheservicethatitprovides.
16
Guidancetoclients Adequateguidanceshouldbeprovidedtoresearchers.
17Communication Communicationsto
researchersshouldbetimelyandresponsive.
18
TraininginResearchEthics
Traininginresearchethicsshouldbeprovidedtoresearchcommunity.
19RESEARCHMONITORING
ActiveMonitoring RECshouldactivelymonitorapprovedstudies.
20
PassiveMonitoring RECshouldhaveasystemthatallowsforpassivemonitoringofstudies.
21
Trackingsystem RECshouldhaveatrackingsystemfortrackingallstudies.
48
22
RECMEETINGISSUES Reviewprocedures RECreviewproceduresshouldensurethoroughnessofreview.
23
Expeditedprocessing
RECshouldhaveefficientandtransparentexpeditedprocessingprocedures.
24
Preparationformeeting
Meetingshouldbeplannedaheadoftimeincludinginvitationsandavailingofagenda.
25
Meetingagenda AgendashouldcoverallessentialitemsthatreflectontheoperationsoftheREC.
26
Confidentiality RECshouldhavemeasurestoensureconfidentialityofmeetingdeliberations.
27
ManagingCOI RECshouldhavemeasuresformanagingCOIbyitsownmembers.
28Meetingspaceandatmosphere
Meetingspaceshouldbeavailableandconducive.
49
29
Content/
Discussion
RECmembersshouldbeknowledgeableandconversantaboutethicalandscientificissues;meetingsshouldprovideforadequatetimetodeliberateontheseissues.
30
Decisionmaking RECshouldhaveademocraticwayofreachingdecisions.
31
Proceedings RECmeetingsneedtobeconductedinanorderlymannerfollowingtheadoptedagenda.
32
Meetingminutes Minutesshouldbepreparedtimelyandshouldbedetailedenoughtoreflectondeliberations.
50
SIGNATURES:
InstitutionalRepresentatives Wetheundersigned,confirmreceiptofthisreportandaccepttheobservations.
Official1 Official2
Fullname ____________________ ______________________
Capacity ____________________ ______________________
Signature ____________________ ______________________
AssessmentTeamRepresentatives Wetheundersignedconfirmthatthisreportisbasedonourobservationsincludingdocumentsthatweremadeavailableduringtheassessmentexercise.
Assessor1 Assessor2
FullName ____________________ ______________________
Signature ____________________ ______________________
Date ____________________ ______________________
51
ResearchEthicsCommitteeAssessmentToolkit(RECAT)SampleReport
***
XYZResearchEthicsCommittee(XYZREC)NeedsAssessment
REPORT
DATESOFASSESSMENT 4th–7thMarch2017ASSESSORS Dr.NashwaBeatty(ExternalInstitution)andMr.JamesThompson
(IndependentConsultant/Offsite)PARTICIPANTS Prof.Apple(Dean,SchoolofHealthSciences),Dr.Button(DeputyDean,
SchoolofMedicine),Prof.Cello(Director,OfficeofResearch),Dr.Delta(Asst.Director,OfficeofResearch),Dr.Eagle(BiomedicalRECChair),Ms.Fiddle(RECAdministrator),Ms.Ginger(RECAdministrator),Mr.Hamper(RECAdministrator)
ASSESSMENTMETHODS Interviewswithinstitutionalleadership(Dean,DeputyDean,DirectorofResearch,AssistantDirectorofResearch,RECChair);FGDswith6researchersand9RECmembers;RECmeetingobservation;documentreview;RECofficeobservation
INTRODUCTIONBelowisareportbasedontheassessors’findingsfromcarryingoutanRECNeedsAssessmentexercisefocusedontheXYZUniversityResearchEthicsCommittee(XYZREC).WeacknowledgeandthankXYZRECmembersandadministrators,XYZleadershipsandresearchersfortheirtime,engagementandhonestfeedback.Thisexerciseisintendedasabenchmarkingactivity,providingabaselinethatwillallowstakeholderstoevaluatethestrengthsandchallengesfacedbytheXYZRECatthispointintimeandlatertorevisitthisprocesstomeasureprogressandanypersistentchallenges.ThisevaluationwaspartofapilottestofanRECNeedsAssessmentToolthatprovidesasystematicapproachtoassessandguideRECcapacitybuildingacrossavarietyofinstitutionalsettingsinlowandmiddle-incomecountries.TheseresultscanserveasabaselineforfutureworkwithXYZREC.Theassessorsnotethatthesefindingsaretheresultofarapidassessmentandmaynotfullycaptureallrelevantinstitutionalfactors.Thus,interpretationandsubsequentactionplanningshouldinvolvelocalexpertiseattheinstitutionallevel.Further,therecommendationslistedbelowarenottriagedaccordingtoimportance.Decisionsabouttheeaseofimplementationandurgencyofeachrecommendationmayvarybasedoninstitutionalcontext.
WefirstofferasummaryofourfindingswithinthreedomainsofinterestandrecommendationsforstrengtheningXYZRECcapacitybasedonafullreportprovidedinthetablefollowingthedomains.Thetableorganizesobservationsdocumentedduringtheassessmentunderkeydomainsanddescribesrecommendationsforaddressingcurrentgaps.
52
SUMMARYOFFINDINGS
1. Qualityofethicsreview
SummaryOverall,theethicalreviewprocessrunssmoothlyandXYZRECmeetingsinvolvesubstantiveandnuanceddiscussionsaboutscientificmeritandethicalconsiderationsofsubmittedresearchproposals.Assessorsfeltthatmembershadadequatetraininginresearchethicsandworkinanatmosphereconducivetothoughtfulreviews.EnsuringthatResearchEthicsCommittee(REC)ChairandViceChairhaveprotectedtimetocarryoutexpeditedreviewsaswellasstandardizedtemplatesandformsforalltypesofreviewandreportingareafewsuggestionsforimprovement,withfurthersuggestionslistedbelow.
Recommendationsa. NeedforXYZtoconsidersomeprotectedtimefortheRECChairandViceChairsincetheydealwith
avastamountofexpeditedrequests(seeRow2).
b. ThereisneedfortheRECtoadoptadditionaltoolssuchascontinuingreviewforms,amendmentrequestforms,SeriousAdverseEvent(SAE)reportingforms(seeRow8).
c. Approvallettersneedtoclearlystatereportingrequirements/expectations(seeRow9)
d. NeedtoconsideraddingmorefemalememberstoRECtoensuresomegenderbalance(seeRow10)
e. NeedtoensurethatResearchEthicsTrainingisprovidedtoallstaff(seeRow18)
f. RECneedstoschedulemoreandregularstudyinspections(seeRow19).
g. RECneedstoconsiderimposingpenaltiesforlateornon-renewals(seeRow20).
h. AgendatemplateneedsupdatingtocoverallRECactivities(seeRow25).
2. Operationalefficiency
SummaryXYZRECreceivesandprocessesover150proposalsubmissionsayear.ResearchersandRECmembersreportedbeinggenerallysatisfiedwithhowtheRECfunctions.However,researchers,RECmembersandtheassessorsdidnoteopportunitiestoimprovetheefficiencyandorganizationoftheadministrationoffice.
XYZREChasStandardOperatingProcedures(SOPs)thatcovermostoftheareasthatarecoveredbyinternationalstandardsforREC’s.SOPsarehowevertoobriefinsomeareastoensureconsistencyintheirapplication.Reviewchecklistsandapprovallettersarealsolargelyalignedwithinternationalstandards,thoughsomemodificationisrecommended.
Recommendationsa. NeedtostrengthenrelationswithnationalRECatMinistryofHealthtoensurenationaloversight
(seeRow1).b. RECreviewerchecklistneedstobeupdatedsoitbecomesmorecomprehensive(seeRow7).c. NeedtocreatepermanentinstitutionalRECpositions(seeRow3)d. RECsupportstaffneedtoundergotrainingthataddressesRECadministration(seeRow3).e. RECrequiresadedicatedwebpageforuploadingguidanceinformationandforms(seeRow4).f. RECSOPsneedstreamliningaswellastobemoredetailed.Guidanceforresearchersshouldbe
separatedfromSOPs(seeRow5).g. Filingsystemrequiresimprovementsothatitbecomeseasytolocatefiles(seeRow12).
53
h. Alldocumentsinstudyfilesneedtobenumberedconsecutively(folionumbering)toensuredocumentorderandsecurity(seeRow13).
i. Extracopiesofstudydocumentsshouldbedisposedappropriatelyafterapproval(seeRow14).j. RECshouldensurethatcommentstoresearchersaresentinasinglebatchsoastoavoid
inconveniencingresearchers(seeRow15).k. RECshouldmakearrangementstofacilitatepre-submissionconsultations(seeRow16).l. Detailedguidanceshouldbemadeavailabletoresearchers(seeRow16).m. RECneedstocreateanelectronictrackingsystemfortrackingstudiesandsubmissions(seeRow
21).
AllexpeditedissuesshouldbeformallyratifiedduringRECmeetingandthisshouldbedocumentedinRECmeetingminutes(seeRows23and31).
54
FULLREPORT
DOMAIN/SUBDOMAIN
SUB-DOMAIN EXPECTATIONS OBSERVATIONS RECOMMENDATIONS
1
ESTABLISHMENTOFREC
NationalContext
Anationalenvironmentthatpromotes,supportsandrequiresethicalreviewandcontinuedoversight
TheHealthResearchActof2011clearlystatesthatallhealthresearchissupposedtobereviewedandapprovedbyaREC.XYZRECisnationallyrecognizedandrelieduponbyotherinstitutionsastheRECofrecord.XYZRECisrepresentedonNationalCommitteeatHealthResearchBoard.MOHCommitteevisitedREConceinpastthreeyearstoconductaninspection.CommunicationbetweennationalBoardandXYZRECstillminimalsincestructuresarestillbeingestablishedatMOH.
EstablishandmaintainsystematiccommunicationbetweenXYZRECandtheNationalHealthResearchEthicsBoardtohelpensureadequatenationaloversightofresearchethicsreview.
2
InstitutionalContext
Aninstitutionalenvironmentthatsupportsandrequiresethicalreview
RECisrecognizedinstitutionallyasastandingcommittee,andissupportedbyinstitutionalpolicy.RECmembersareappointedbytheViceChancellor.RECoperatessemi-autonomouslywithnointerferencefrommanagement.ChairandViceChairprocessmanyrequestsforexpeditedprotocols.
ChairandViceChairneedprotectedtime,especiallyastheyprocessmanyrequestsforexpeditedreview.
3
RESOURCES Human Adequateresourcestosupportoperations
RECissupportedbyonefulltimestaffmemberwhohasnotreceivedadequatetrainingonRECadministration.RECadministratorisemployedbyalargegrant.Thefactthatthepositionissupportedbyanexternalgrantimpliesweakinstitutionalcommitment.Thisalsoimpliesthatthepositionmaydisappearintheeventofterminationoftheprojectprematurelyoratendofprojectlife.
XYZshouldconsidercreatingpermanentinstitutionalposition(s)forRECstafftoensurecontinuityofRECactivitiesbeyondtheendoftheprojectcurrentlyfundingtheRECAdministratorposition.XYZcouldconsiderotheroptionswhilelobbyingforpermanentinstitutionalpositions.RECsupportstaffmembersneedtoreceiverelevanttraining.
55
4
Other Adequateresourcesto
supportoperations
RECisprovidedwithresourcessuchasspace,
computers,internet,photocopieretc.
RECOfficewouldbenefitfroma
dedicatedwebpagefromwhichclients/researcherscandownloadall
up-to-dateformsneededforsubmissionandreportingon
proposalsandaccessinformation.
5
TOOLS SOPs SOPsavailablecovering
allessentialoperations.
SOPsVersionIIIof2015coveralltheessential
areasofRECoperationaspertheassessment
list.
SOPsareacombinationofguidance
forresearchersandSOPs.Needto
bestreamlinedanddetailedsoastopromoteconsistencyinoperations.
GuidanceforresearchersshouldbepresentedseparatelyfromRECSOPs.
6
Applicationforms
RECshouldhavecomprehensive
applicationformstoensurethatsubmissions
areuniformandmeetRECrequirements.
Applicationformsareavailableforresearchers,localstudentsandforeign
students
OK,althoughcreationofawebpagewhereresearchersandstudents
couldaccessformswouldbedesirable
7
ReviewForm RECshouldhaveareviewchecklistto
ensureconsistencyandthoroughnessofreview.
Reviewformisavailabletoguidereviewersinethicalandscientificreview.Formcapturesa
varietyofethicalissues,thoughnotallareaslistedininternationalstandards.
RECreviewerchecklistshouldbemodifiedtoincludeallimportant
scientificandethicalaspectsthatthereviewersneedtoconsiderduring
review,toensureeachproposalisthoroughlyandsystematically
reviewedanddocumented.Forexampleforscientificissues,needto
coverissuessuchasdesign,methods,samplesize,sampling
strategy,statisticalconsiderations,
datahandlingetc.
56
8
Otherforms RECshouldhaveformsforensuringconsistencyinhandlingrequestsorreports.
TheRECdoesnothavethefollowingformsthatcanassistresearchers:continuingreview,amendment,seriousadverseevent,protocoldeviation.
Itisrecommendedthatthecommitteeadoptadditionalreportingtoolsthatcanensureimprovedoversightofongoingresearchprojectsincludingcontinuingreviewform,amendmentform,seriousadverseeventreportingforms,etc.
9
Approvalletters
Comprehensivelettertemplatesforvariousreviewoutcomes.
Approvallettercoversessentialinformationsuchasreference,approvaldateandexpirydate.Butdoesnotcovertheneedforresearcherstoreportproblemeventssuchasprotocoldeviations,SAEsandunexpectedproblems.
Approvallettersneedtoclearlystateexpectationsonreportingof,protocoldeviationsandseriousadverseevents.Reviewtheinternationalstandardsforapprovallettersandconsiderincorporatingadditionalitemsintoapprovallettertemplates.
10
MEMBERSHIP Professionalbackgrounds
Variedbackgrounds Membersrepresentedvariousbackgrounds.Fivefemalemembersandtenmalemembers.Twocommunityrepresentativesattendedmeeting.
Needtoconsideraddingmorefemalememberstoensuregenderbalance.
11 Trainingon
reviewMemberstrainedinethicalreviewandotherrelevanttopics
Membersaretrainedonappointmentandarealsoprovidedwithcontinuingtrainingduringtheirtermofoffice.
OK
12
DOCUMENTATION Filingsystem Anefficientfilingsystemtoensureeasyretrieval
RECusesafilingsystemthatorders/numbersproposalbythemonthsubmittedandyear.InformationonsubmittedproposalsiskeptinMS-Wordworddocuments.
Filingsystemcanbeimprovedtomakeiteasyforadministratortoprovideinformationonsubmittedprotocolse.g.usingcontinuousnumbers.Becomeshardtofindaprotocolifcan’trememberwhenitwasinitiallyreviewed.Wouldbeverybeneficialtocreateacomprehensiveandsearchable
57
trackingsystemforprotocolsubmissions.
13
GooddocumentMaintenancepracticesforeachstudy/proposal
Eachproposalisfiledinaseparatefile.
Documentsdonothavefolionumberstoensureorderoffiling.
Needtoensurethatallstudydocumentsarenumberedconsecutively(folionumbering)intheorderinwhichtheyarereceived.Thisensuresdocumentorderandsecurityandispartofgooddocumentfilingpractices.
14
DocumentStorage
Adequatespaceforstorage
Additionalfilingspaceavailableinstoragecontainer.RECFilingroomissecure.
Noshredderandtoomanyduplicatedocumentskeptonfile.Insomestudyfiles,therewerethreeorfoursetsofthesameactioneddocuments(e.g.studyprotocols).
Needtoappropriatelydisposeunnecessaryduplicatedocumentsasawayofsavingspace.
Recommendpurchaseofshredder.
15
SERVICETOCLIENTS ClientSatisfaction
RECshouldensurethatresearchersaresatisfiedbytheservicethatitprovides.
ResearchersgenerallyexpressedsatisfactionregardingthequalityoffeedbackfromREC.EncouragethatRECshouldprovidefeedbackonceandavoidsendingadditionalcommentsafterresearcherhasresponded.
RECmembersandadminshouldavoidsendingadditionalcommentsafterresearcherhasrespondedtoinitialcomments.
58
16
Guidancetoclients
Adequateguidanceshouldbeprovidedtoresearchers
Abriefchecklistisavailabletoguideresearchersonsubmissionexpectations.NodetailedguidanceisavailabletoresearchersonwhatRECexpects.Fewfacultyhavereceivedtraininginresearchethics.
RECshouldbeavailableforpre-submissionconsultations,eitherthroughofficehours,appointments,orsomeothermechanism.
RECshouldfindawayofensuringthatinfoonitsexpectationsisdisseminatedtopostgradsandresearchers.
Detailedguidanceforresearchersshouldbepubliclyavailable.RECshouldpromote/facilitatetrainingoffacultyinresearchethics.
17Communication Communicationsto
researchersshouldbetimely.
Communicationstoresearchersareissuedinatimelymanner
OK
18
TraininginResearchEthics
Traininginresearchethicsshouldbeprovidedtoresearchcommunity
Trainingisprovidedtopostgraduatestudents.Notrainingisprovidedtofaculty/staff.
RECshouldfacilitate/organizeprovisionoftraininginresearchethicsforresearchersandtheirteams.
19RESEARCHMONITORING
ActiveMonitoring
RECshouldactivelymonitorapprovedstudies.
RECattimesengagesinsiteinspectionsforlargestudies.
RECcouldschedulemoresiteinspections.
20
PassiveMonitoring
RECshouldhaveasystemthatallowsforpassivemonitoringofstudies.
Nopenaltiesforlaterenewalornon-renewal. RECshouldconsiderimposingpenaltiesforlateornon-renewals.
21
Trackingsystem RECshouldhaveatrackingsystemfortrackingapprovedstudies.
TheRECdoesnothaveatrackingsystemanditisdifficultfortheAdmintoknowtoprovideinformationonprocessingofproposals.
RECshouldconsidercreatinganelectronicproposaltrackingsystem.
59
22
RECMEETINGISSUES
Reviewprocedures
RECreviewproceduresshouldensurethoroughnessofreview
EveryproposalissentforreviewtothreeRECmembersselectedbyChair.Reviewersarethoroughintheirreviewasconfirmedbydetailedcomments.
OK
23
Expeditedprocessing
RECshouldhaveefficientandtransparentexpeditedprocessingprocedures.
ExpeditedprotocolsareincludedinRECagendaitems,butarenotdiscussedandformallyratifiedbytheRECduringthemeeting.
NeedtoensurethatallexpeditedapprovalsareformallyratifiedduringtheRECmeetingforaccountability.Theformalratificationshouldalsobenotedintheminutes.
24
Preparationformeeting
Meetingshouldbeplannedaheadoftimeincludinginvitationsandavailingofagenda.
Meetinginvitationandagendaaresentmorethan1weekaheadofmeeting.
OK
25
Meetingagenda
AgendashouldcoverallessentialitemsthatreflectontheoperationsoftheREC.
Agendaisdevelopedusingatemplateandcoverssomeoftheessentialitems.
ThetemplatecouldbeimprovedsothatitreflectsalltheactivitiesoftheREC.Examplesofitemsthatneedtobeaddedtoagendatemplateincludetrainingopportunities,studyinspections,correspondence,RECstatistics,reportbackfrommeetings,seriousadverseevents,etc.ThismayassisttheRECinassessinghowitisperformingacrossitsfunctions/activities.
26
Confidentiality RECshouldhavemeasurestoensureconfidentialityofmeetingdeliberations.
Assessorscompletedconfidentialityagreementsandwereintroducedatstartofmeeting.AllRECmemberssignconfidentialityagreementsuponappointment.
OK
27
ManagingCOI RECshouldhavemeasuresformanagingCOIbyitsownmembers.
MembersdeclareconflictofinterestandrecusethemselvesfromthemeetingroomduringdiscussionofitemsonwhichtheyhadCOI.
OK
60
28Meetingspaceandatmosphere
Meetingspaceshouldbeavailableandconducive.
Meetingspaceisconvenientandmembersareservedwithrefreshmentsduringmeeting
OK
29
Content/
Discussion
RECmembersshouldbeknowledgeableandconversantaboutethicalandscientificissues;meetingsshouldprovideforadequatetimetodeliberateontheseissues.
Reviewersprovideddetailedcommentsonethicalandscientificissues.TheRECspentanaverageof8minutesdiscussingeachnewproposal(RECspent15minutesdiscussingoneoftheproposals).Issuesraisedanddiscussedrangedfrominclusioncriteria,lettersofpermission,confidentiality,specimenissues,useofjargoninICF,materialtransferagreements,justificationofstudy,statisticalissues,referencing,risksandbenefits,assent,communitybenefits,provisionofresults,reimbursements,translationofICF,communitybenefits,registrationofstudydrugwithNationalauthority.
OK
30
Decisionmaking
RECshouldhaveademocraticwayofreachingdecisions.
Decisionsarereachedbyconsensusandallmemberswereprovidedwithopportunitytocommentbeforereachingdecision.
OK
31
Proceedings RECmeetingsneedtobeconductedinanorderlymannerfollowingtheadoptedagenda.
Expeditedissueswerenotratifiedduringthemeeting.Focuswasmainlyonnewproposals.
AllexpeditedissueshandledbyChairshouldbeformallyratifiedbyRECduringthemeetingandthisshouldbedocumentedintheminutes.
32
Meetingminutes
Minutesshouldbepreparedtimelyandshouldbedetailedenoughtoreflectondeliberations.
Meetingminutesweredetailedandaccurateasevidencedbythefewcorrections.Minutesarepreparedusingatemplate.
OK
61
SIGNATURES:
InstitutionalRepresentatives Wetheundersigned,confirmreceiptofthisreportandaccepttheobservations.
Official1 Official2
Fullname ____________________ ______________________
Capacity ____________________ ______________________
Signature ____________________ ______________________
AssessmentTeamRepresentatives Wetheundersignedconfirmthatthisreportisbasedonourobservationsincludingdocumentsthatweremadeavailableduringtheassessmentexercise.
Assessor1 Assessor2
FullName ____________________ ______________________
Signature ____________________ ______________________
Date ____________________ ______________________