research ethics committee assessment toolkit (recat)...v consistent with international rec...

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.1NationalContext

1. 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.2InstitutionalContext

3. Doestheinstitutionhaveawrittenpolicythatrequiresthathumansubjectsresearchprotocolsbereviewedbyanethicscommittee?

�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.3RECBackground

8. 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:Documentreview

PleaseusethefollowingtablestodocumentwhethertheREChaswrittenpoliciesorwrittenstandardoperatingproceduresregardingeachofthefollowing:

B.1DoestheREChavewrittenpoliciesorstandardoperatingproceduresregardingthefollowingaspectsof

committeemembership?

Yes No Comments

1. Theselectionprocessofthechairandcommitteemembers

2. ThetermofappointmentofRECmembers

3. Thediversityofprofessionalbackgroundsthatshouldberepresentedonthecommittee

4. Thediversityofgenderthatshouldberepresentedonthecommittee

5. Therequiredmembershipofsomeonewithanon-scientificbackground

6. Therequiredmembershipofsomeonewithnoaffiliationtotheorganizationthatsponsors,funds,orconductsresearchreviewedbytheREC?

7. Therequiredquorumsizeforthecommitteetotakeactionsand/ormakedecisions


committeeindependence?

Yes No Comments

8. Therequiredattendanceofsomeonenotaffiliatedwiththeinstitutionduringcommitteedeliberations

9. Theextenttowhichinvestigatorsmayparticipateincommitteedeliberationsabouttheirownresearch

10. Thedefinitionofaconflictofinterestformembersofthecommittee

11. Theproceduresthroughwhichconflictsofinterestwillbeaddressedwhentheyarise

20


trainingforcommitteemembers?

Yes No Comments

12. Therequiredresearchethicstrainingforcommitteemembers

13. Therequiredrefreshertrainingsforcommitteemembersduringtheirtermofservice


committeedecision-making?

Yes No Comments

14. Thetypesofstudiesforwhichexpeditedreviewmechanismsareallowed(ifany)

15. Theprocessthroughwhichdecisionsaremade(e.g.voteorconsensus)

16. Theexistingethicalguidelines(e.g.DeclarationofHelsinki,TheBelmontReport,CIOMS,etc.)thatinformtheethicaldecision-makingofthecommittee


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

21

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.3TrainingofRECmembersandinvestigators

11. 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):____________________________


�RECoperatingprocedures�Researchethicsprinciplesandconcepts�Bothoperatingproceduresandresearchethicsprinciplesandconcepts�Don’tknow�Other:___________________________

24



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):____________________________


�IRBoperatingprocedures�Researchethicsprinciplesandconcepts�Bothoperatingproceduresandresearchethicsprinciplesandconcepts�Don’tknow:�Other:____________________________

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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


21. DoestheREChaveasecureplaceforitsresearchfiles(e.g.alockablefilecabinet)?Response Method


22. WhichofthefollowingresourcesdoestheRECOfficehaveavailable(tickallthatapply)?

Observation Interview

Item ü Ifpresentdayofassessment

Alwaysavailablewhenneeded

Sometimesnotavailable

Neveravailable

Notneeded

ComputerInternetaccessPrinterEmailaddressTelephonesPhotocopierBasicofficesupplies(stationery,ink,paper,files,etc.)

27

C.6FilingSystem

23. DoestheREChaveafilingsystemforallapplicationsreceived?

Response Method

�Yes �Observation�No �Interview�Other:

a.Ifyes,isthefilingsystem:

Sufficientlysized(canaccommodateallfiles)

�Yes�No�Other:

�Observation�Interview

Consistentlyused �Yes�No�Other:


Easilysearchable �Yes�No�Other:


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:_________________________

28

C.7TrackingSystem

24. IsthereatrackingsystemavailableforofficestafftotracksubmissionstotheRECastheymovethroughtheapprovalprocess?

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:___________________________

29

C.8SubmissionandReviewPractices

25. 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%

30

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

31

35. ApproximatelyhowmanyCONTINUINGprotocolsarereviewedduringeachmeeting?

�0-2protocols�3-5protocols�6-10protocols�Morethan10protocols

36. WhatistheapproximatelengthoftimebetweensubmissionofaprotocoltotheRECandthecompletionofthefirst/initialreviewbythecommittee?

�Lessthan1month�1-2months�3-4months�Morethan4months

C.9MeetingMinutes

37. Aremeetingminutesrecordedforeachmeeting,eitherduringthemeetingitselfortypedupfromnotessoonafterthemeeting?

�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:_______________________________

32

a. Ifyes,doesanyoneverifythattheattendancerecordedintheminutesmatchestheattendancesheet?

�Yes�No�Other:________________________________

b. Ifyes,doesanyoneverifythatthevotesrecordedintheminutesreflectthoseinattendanceduringthevote?

�Yes�No�Other:________________________________

C.10CommunicationPractices

40. 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 Letter3

ApprovaldecisionfromRECExpirationdateofapproval,ifgrantedRequirementthatanychangestotheapprovedresearchplanmustbesubmittedforreviewasanamendmentRequirementforthepromptreportingofanyadverseeventsorunanticipatedproblemsRequirementforthepromptreportingofprotocoldeviationsRequirementforinvestigatorstouseapprovedconsentanddatacollectionformsRequirementforinvestigatorstousestampedconsentanddatacollectionformsRequirementtosubmitcloseoutreportuponstudycompletion

41. Areinvestigatorsrequiredtosubmitprogressreportsaboutapprovedresearch?

�Yes�No�Other:_______________________�Don’tknow

33

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.11ProtocolReviewStructure

43. 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:____________________________________________________

34

PartDRECMeeting

Method:StructuredobservationofRECMeeting

ThisPartincludesthreesections:(D.1)whichcapturescontextualinformationrelatedtotheRECmeetingobserved;(D.2)whichprovidesaProtocolReviewChecklistthatshouldbecompletedbytheassessorduringtheobservedRECmeeting(onehardcopyofchecklistisneededforeachprotocolreviewedduringthemeeting);and(D.3)whichdescribesproceduresforreviewingtheoutputsoftheRECmeeting.ItisstronglyadvisedtoattempttoobserveanRECmeetingwhichincludes,ontheagenda,thereviewofdifferenttypesofprotocols–newprotocols,re-submissions,continuingreviews,etc….

D.1MeetingContext

Date: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

35

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

36

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):

37

D.2ProtocolReviewChecklist

Completeonechecklistforeachprotocolreviewedduringmeeting.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 Notes

Scientificdesignandconductofstudy

Risksandpotentialbenefits

Selectionofstudypopulation

Recruitmentofresearchparticipants

Inducements,financialbenefits,andfinancialcosts

Protectionofparticipants’privacyorconfidentialityofdata

Informedconsentprocessorwording

Communityconsiderations(e.g.stigma,drainingcommunitycapacity,orpromotionofpositiveeffectsoncommunities)Other

38

D.3PostMeetingFollow-up

ThefollowingquestionspertaintoRECpracticesthatoccurAFTERtheconclusionofameeting.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:

39

Notes:

CommunicationstoInvestigators:

18. Howsoonafterthemeetingwereletterssenttotheinvestigatorswhoseapplicationswerereviewedduringthemeeting?

�Withinoneweekafterthemeeting�Withintwoweeksafterthemeeting�Withinonemonthafterthemeeting�Morethanonemonthafterthemeeting

LOOKATALETTERSENTREGARDINGANUNCONDITIONALLYAPPROVEDPROTOCOLreviewedduringthemeeting.Ifno

protocolwasapprovedduringthemeeting,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,checkthe

boxbelow.

�ApprovedwithChanges�Tabled�Noprotocolwas“ApprovedwithChanges”or“Tabled”duringthemeeting

22. Dotheconcernsandrequestedchangesdescribedintheletterreflectwhatwasrecordedintheminutes?

�Yes�Partially�No�N/A(nomeetingminutesproduced)

40

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?Arethere

anythatyouwouldchange?

3. Whatisyourcommittee’srelationshipwithothercommittee(s),ifanyothersexist?Doesanyonesitonmorethan

oneofthecommittees?

4. WhatmajorchangeshastheRECseeninthepasttwoyears?Whatcausedthosechanges?

5. Howindependentdoyouthinkthecommittee’sdecisionsarefromtheinfluenceofoutsiders(e.g.high-ranking

institutionalofficials,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.Doyoufeellikethereviewprocessadds

somethingtotheresearchbeingconducted?Ifyes,whatdoesitadd?Ifno,whatismissing?

11. Howwouldyoudescribethedeliberationsofthecommittee?Doyouthinkeveryonehasanopportunityto

contribute?Areinteractionsgenerallythoughtfulandrespectful?

12. Duringanaverageprotocolreview,whatdoestheRECspendmostofitstimereviewing?(e.g.science,ethics,budget,

researcherqualifications,etc…)Whyarecertainthingsemphasizedoverothers?

13. HowefficientdoyoufeeltheREC’sadministrativeprocessesare?Whataresomeobstaclestoadministrative

efficiency?

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?Arethere

partsofthesubmissionsthataretypicallyoflowerquality(e.g.,informedconsentdocuments),andpartsthatare

typicallyofhigherquality(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 ____________________ ______________________