aahrpp site visit tips for irb members and staff...
TRANSCRIPT
UniversityofMichiganHumanResearchProtectionProgram [email protected],2016
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AAHRPPSiteVisit2016:InterviewGuideforIRBMembersandStaff
AccreditationAAHRPP,ortheAssociationfortheAccreditationofHumanResearchProtectionPrograms,willconductareaccreditationsitevisitatU-MfromMarch30,2016–April1,2016.AAHRPPisaninternational,independentnonprofitorganizationthatreviewsandaccreditsaninstitution’shumanresearchprotectionsprogram(HRPP).U-MhasbeenaccreditedbyAAHRPPsince2008.AAHRPPhasbeenprovidedwithawrittendescriptionofU-M’sHRPPpolicies,procedures,andresources,aswellaswithalistofallactiveIRBprotocols.Duringthesitevisit,representativesfromAAHRPPwillconductinterviewsandreviewrecordstoensurethatthosepoliciesandprocedureshavebeenimplementedeffectivelyandarebeingadheredtothroughouttheuniversity.AsanIRBmemberorstaffperson,youareanintegralpartoftheU-MHRPP.Duringthesitevisit,AAHRPPwillselectnearly100individualstobeinterviewed.Anyonewhohasaroleinhumansubjectsresearchmaybeselectedforaninterview.AnumberofIRBmembersandstaffwillbeinterviewed.AAHRPPwillprovidealistofindividualsselectedforinterviewsapproximatelythreeweekspriortothevisit.IfselectedforaninterviewbyAAHRPP,youwillbenotifiedclosertothevisitdateandprovidedwithadditionalinformation.Weanticipateeachsessionwilltakebetween20-40minutes.Sessionswillbeintheformofindividualorgroupinterviews.Weexpectquestionstobefocusedonregulatoryissuesrelatedtoresearchwithhumansubjects,butquestionsmayalsorelatetoyourimpressionsoftheHRPPandIRBsatU-M.Werecommendthatyouresponddirectlytothequestionasked.Ifaquestionseemsunrelatedtothetypeofworkyoudo,pleaselettheinterviewer(s)know.PreparingfortheSiteVisitEarlypreparationiskeyandthisdocumentisintendedtohelpyouprepare.Youmaybefamiliarwiththeinformationincludedhowever,itisimportantthatyourefreshyourunderstanding.Eachsectionofthisdocumentisfollowedbyalistofquestionsthatyoumaybeasked.Thisdocumentincludessectionsonthefollowingtopics:
§ Section1:GeneralTips
§ Section2:HRPPPoliciesandProcedures
§ Section3:EthicalConductofResearchandFederalRegulations
§ Section4:IRBReview
§ Section5:MinimizingRiskstoSubjectsandProtectingSubjects’RightsandWelfare
§ Section6:CompliancewithIRBandOtherReviewUnitRequirements
§ Section7:ObtainingandDocumentingInformedConsent
§ Section8:ConflictofInterestDisclosure
§ Section9:AccountabilityandAdditionalAdministrativeRequirements
§ Section10:Education
§ Section11:AdditionalResources
UniversityofMichiganHumanResearchProtectionProgram [email protected],2016
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Section1:GeneralTipsU-M’sHRPPre-accreditationlargelydependsontheseinterviews.Youwillbeexpectedto:
§ UnderstandtheU-MHRPPstructure§ ClearlydescribeyourroleintheU-MHRPP§ KnowtheU-MHRPPpolicies§ UnderstandtheAAHRPPaccreditationprocess§ Understandanddescribetheethicalaspects,thepurpose,andthevalueofyourwork§ Knowwheretoobtainanswerstoethical/regulatoryquestions§ KnowtheprocessfornoncompliancereportingatU-M§ KnowhumansubjectstrainingrequirementsandresourcesatU-M§ Describethetrainingyou’vehadasanIRBreviewer§ Understandwhatconstitutesconflictofinterestatalllevels(i.e.staff,IRB,institution)§ UnderstandhowaconflictofinterestismanagedatU-M§ Knowtheethicsofrecruitmentandinclusion/exclusioncriteria
PossibleGeneralQuestionsRoleoftheIRB§ WhatdoestheIRBdo?WhatareyourresponsibilitiesasanIRBmember?§ WhatistheIRB’sreputationoncampus?§ IstheIRBworkloadfair?§ WhydoesU-MvalueAAHRPPaccreditation?Whatdoyouthinkofit?
Section2:HRPPPoliciesandProceduresThefollowingsectionsummarizeskeyelementsofU-Mpoliciesandproceduresthatyoushouldbefamiliarwithforyourinterview.ThesourceofthisinformationistheHRPPOperationsManual.InparticularPart3:HRPPPolicythatarticulatesminimumrequirementsforIRBSOPs.JackHu,theVicePresidentforResearch(VPR),servesastheInstitutionalOfficial(IO)fortheU-MHRPPandheisresponsiblefortheconductofresearchattheUniversityofMichigan.TheVPRestablishedtheHRPPatU-M.TheHRPPissupportedby:
§ TheU-MOfficeofResearch(UMOR)anditscentraloperatingunits,includingUMOR’sHRPPstaff,theOfficeofResearchandSponsoredProjects(ORSP),theOfficeofHumanResearchComplianceReview(OHRCR),andcoordinatingcommittees,suchastheIRBCouncil;
§ Academicunits,includingschools,colleges,andotheracademicunitstowhichfaculty,staff,andtraineesengagedinhumanresearchareappointed;
§ TheIRBs(i.e.,IRBMED,IRB-HSBS,IRB-Dearborn,andIRB-Flint);
§ Otherresearchreviewandsupportunitsandcommittees,suchastheMichiganInstituteforClinical&HealthResearch(MICHR),theconflictofinterestcommittees(UMORCOIandMEDCOI);and
§ Keyexecutiveandadministrativeoffices,includingtheProvost'sOffice,theExecutiveVicePresidentforMedicalAffairs,theChancellorsatFlintandDearborn,andtheGeneralCounsel.
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ThepurposeoftheHRPPistoprotecttherightsandwelfareofhumansubjectsparticipatinginbiomedicalandbehavioralresearchconductedatU-MorelsewherebyUniversityfaculty,staffandtrainees;promotecompliancewithrelevantlegalrequirementsandethicalstandardsatalllevels;andsupportinvestigatorsintheirresearchactivities. Generally,theHealthSciencesandBehavioralSciencesIRB(IRB-HSBS)hasoversightforhumansubjectresearchconductedbytheschools,colleges,andunitsoftheUniversitythatcomprisetheAnnArborcampus,butthatarenotpartoftheMedicalSchool.IRBMED,ontheotherhand,overseesresearchconductedattheMedicalSchoolandtheU-MHealthSystem,whileIRB-DearbornandIRB-Flintoverseeresearchattheirrespectivecampuses.PossibleQuestionsAboutHRPPPoliciesandProcedures
§ WhoistheinstitutionalofficialresponsibleforresearchatU-M?§ WhatistheU-MHRPP?§ WhatisyourroleintheU-MHRPP?Section3:EthicalConductofResearchandFederalRegulationsU-Mfostersaresearchenvironmentthatpromotesrespectfortherightsandwelfareofindividualsrecruitedfor,orparticipatingin,researchconductedbyorundertheauspicesofU-M.AllmembersoftheU-McommunityinvolvedinhumansubjectresearchareexpectedtocomplywiththehigheststandardsofethicalandprofessionalconductinaccordancewithfederalandstateregulationsandinstitutionalandIRBpoliciesgoverningresearchinvolvinghumansubjects.ThereviewandconductofresearchatU-MisguidedbyprinciplessetforthintheBelmontReportandperformedinaccordancewithDepartmentofHealthandHumanServices(DHHS)regulations(45CFR46orthe“CommonRule”),andFoodandDrugAdministration(FDA)regulations(21CFR50,21CFR56),aswellasallotherapplicablefederal,state,andlocallawsandregulations.
§ TheBelmontReportidentifiesandsummarizesthreemainethicalprinciplesthatshouldgovernresearchwithhumansubjects:
o Respectforpersons(autonomy/voluntaryparticipation/adequateinformation)o Beneficence(risksofresearcharereasonableinrelationtothebenefitstheresearchmay
providetosubjectsorscience)o Justice(selectionofsubjectsisequitableandisrepresentative)
§ TheCommonRule(45CFR46)isthefederalregulatoryframeworkthatgovernsfederallyfundedresearchwithhumansubjectsandcodifiestheethicalprinciplesoftheBelmontReport.UndertheCommonRule,researchwithhumansubjectsisdefinedasfollows:
o Research–Asystematicinvestigation,includingresearchdevelopment,testingandevaluation,designedtodeveloporcontributetogeneralizableknowledge.
o Humansubject–Alivingindividualaboutwhomaninvestigator(whetherprofessionalorstudent)conductingresearchobtains:(1)datathroughinteractionorintervention,or(2)identifiableprivateinformation.
§ 21CFR50and21CFR56serveastheregulatoryframeworkforresearchregulatedbytheFDA(i.e.,researchinvolvingdrugs,devices,biologics).ThissetofregulationsisderivedfromtheCommonRule,buttherearesomenotabledifferencesintheircontent.
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§ Otherfederalandstatelawsandregulationsthatapplytoresearch(i.e.DoD,DOE,ED,EPA).
§ Institutionalpoliciesandprocedures. PossibleQuestionsAbouttheEthicalConductofResearchandFederalRegulations
§ WhatarethethreefundamentalethicalprinciplesoftheBelmontReport?§ WhenwasthefirsttimeyouheardoftheBelmontReport?§ WhatistheCommonRule(45CFR46)?§ WhatistheOfficeforHumanResearchProtections(OHRP)?§ WhattypesofresearchareregulatedbytheFDA?§ WhatisHIPAAandwhatisitsrelevancetohumansubjectsresearch?§ ArethereadditionalrequirementsforDoD-sponsoredstudies?DOE-sponsoredresearch?Section4:IRBReviewIRBsmustobtainsufficientinformationpriortoreviewofapplicationsforinitialorcontinuingreviewsothatitcanapplyandsatisfytherequirementsforapprovalofresearch(seeOMPart3.III.C4.bforthelistofrequiredinformation).TheIRBconsidersthefollowingwithrespecttoeachapplicationforinitial,amendment,orcontinuingreview:
1. DoestheactivitydescribedintheIRBeResearchapplicationmeetthedefinitionofresearchwithhumansubjectsasdefinedintheCommonRule?
2. IstheactivityhumanresearchasdefinedinFDAregulations?3. IstheUniversityofMichiganengaged?IstheresearchexemptfromIRBoversight?
ThesedeterminationsaremadeconsistentwiththeguidanceprovidedattheUSDepartmentofHealthandHumanServicesHumanSubjectRegulationsDecisionChartsandinconsultationwithIRBadministratorsorchairs,asappropriate.Iftheresearch:|
• InvolvesactivitiesordatasubjecttootherrulesorregulationssuchastheHealthInsurancePortabilityandAccountabilityAct(HIPAA)PrivacyRule,theHealthInformationTechnologyforEconomicandClinicalHealthAct(HITECH)SecurityRule,theFamilyEducationalRightsandPrivacyAct(FERPA)orrulesofotherfederalagencies,thereviewensurescompliancewiththeseotherregulationsorrules.
• Isnotregulated,adesignatedIRBstaffmembermayissuea“notregulated”determinationthrougheResearchorthePrincipalInvestigatormaymakeaself-determinationandreceivedocumentationthroughabriefeResearchaffirmationprocess.ThereisnoregulatoryrequirementforIRBreviewofresearchthatisnot-regulatedundertheCommonRule.
• Isexempt,anIRBstaffmemberensuresthattheapplicationindicatestherequestforanexemptdeterminationordirectsthePItorevisetheapplicationtodoso.
IRBsensureresearchisapprovedonlywhenalloftherequirementsin45CFR46.111or21CFR56.111(forFDA-regulatedresearch)aremet.ThecriteriaforIRBapprovalincludes:(a)scientificmeritandfeasibility;(b)minimizingrisk;(c)risk-benefitanalysis;(d)equitablesubjectselection;(e)informedconsentandparentalpermission;(f)datamonitoring;(g)privacyandconfidentiality;(h)vulnerablesubjects;(i)testarticleaccountabilityprocedures;and(j)resources.
UniversityofMichiganHumanResearchProtectionProgram [email protected],2016
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BecauseIRBMDreviewsFDA-regulatedclinicaltrials,theyhaveadditionalrequirementsincluding:determiningwhetheranINDorIDEisrequired;fordevicestudies,makingsignificant/non-significantriskdeterminations;emergencyusenotificationandreportingprocedures;proceduresforreviewingprotocolsforanticipatedadditionaluseinemergencysituations;waiverofinformedconsentforcertainemergencyresearch,ifpermittedbytheIRB;adverseeventreportingguidelinesandprocedures;communications,ifany,withsponsorsandINDandIDEholders;andtestarticleaccountabilityprocedures.PossibleQuestionsAbouttheIRBReview
§ Whatisyourprocessforreviewingastudy?Doyouutilizeguidanceorwrittenchecklists?§ WhatistheprocessforscientificreviewofresearchatU-M?§ Doyouconsiderthescientificvalidityofstudiesthatyoureview?§ Whataretheexpeditedandexemptedcategories?Whenaretheyused?§ Whatisthedifferencebetweenexempthumansubjectsresearchandnot-human-subjects
research?§ Whatiscontinuingreview?§ DoyouknowwhatisnotpartofIRBreview?Canyougiveexamples?§ AreIRBcommunitymembersrecognizedascontributingboardmembers?
Section5:MinimizingRiskstoSubjectsandProtectingSubjects’RightsandWelfareMinimizingriskstosubjectsandensuringsubjects’rightsandwelfarearekeycomponentsofhumansubjectsprotections.Belowaresomestrategiesthroughwhichthesegoalscanbeaccomplished.
§ Designandimplementprotocolsthatcomplywithapplicableregulatoryandinstitutionalpolicies,aswellastheprinciplesoftheBelmontReport.
§ Verifyproceduresareconsistentwithsoundresearchdesignbyensuringthattheresearchisreasonablyexpectedtoanswertheproposedquestionandthattheresultingknowledgeisexpectedtobesufficientlyimportanttojustifytheresearch.
§ Ensurethatrecruitmentproceduresfostertheequitableselectionofsubjects.
§ Utilizeproceduresalreadybeingperformedfordiagnosticortreatmentpurposes,whenpossible.
§ Ensurethatappropriateresourcesareavailabletoconducttheresearch
§ Establishadequateprovisionsformonitoringsubjectstoidentifyadverseeventsandtoreviewdatacollectedtoensuresubjectsafety,whenappropriate.
§ Developplansforprotectingsubjectprivacyandtheconfidentialityofdata.Inhumansubjectsresearch,thesetermsaredefinedasfollows:
o Subjectprivacy–Relatestoanindividual’shavingcontrolovertheextent,timing,andcircumstancesregardingthesharingofinformationaboutthemselveswithothers.
o Confidentiality–Relatestotheprotectionofsubjectdatathathasbeensharedwiththeresearcherwiththeexpectationthatitwillbeprotectedandnotdisclosed.
§ Putinplaceadditionalprotectionsforsubjectsvulnerabletocoercionorundueinfluence(e.g.,children,prisoners,pregnantwomen,mentallydisabledpersons,etc.).
Forfurtherguidanceonstudyrisklevels,refertotheGuidelinesforUsingMagnitudeofHarminCategorizingRiskLevel.
UniversityofMichiganHumanResearchProtectionProgram [email protected],2016
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PossibleQuestionsAboutMinimizingRisksandProtectingSubjects’RightsandWelfare
§ Whatisthedifferencebetweenprivacyandconfidentiality?§ Whatadditionalmechanismscanbeputinplacetoprotectresearchsubjects?§ Whatarethedifferentpossiblelevelsofriskassociatedwithastudy?Howisrisklevelassigned?§ Cansensitiveinformationaffecttherisklevel?§ Whatareyourprimaryconcernswhenreviewingaprotocol?
Section6:CompliancewithIRBandOtherReviewUnitRequirementsResearchatU-MmustbeconductedincompliancewithIRB,aswellasotherinstitutionalandregulatoryrequirements.Belowaresomerequirementsthatyoushouldbeawareofrelatedtothisresponsibility.
§ AllresearchwithhumansubjectsmustobtainIRBreviewandapprovaloradeterminationofexemptionbeforeworkcanbegin.
§ IRBdisapprovaldecisionsmaybeappealedtotheIRB,butcannotbeoverruledbyanyotherinstitutionalofficialororganization.
§ TherequirementsoftheIRB(i.e.,initialreview,continuingreview,amendments,andreportingofadverseeventsandunanticipatedproblems)mustbemetandresearchmustbeconductedasspecifiedintheIRB-approvedprotocol.
§ Allproposedchangestotheresearch,nomatterhowminor,mustbeapprovedbytheIRBpriortoimplementationunlessnecessarytoeliminateimmediatehazardtosubjects.
§ MaterialsmustbesubmittedtotheIRBinatimelyfashion(e.g.,requestsforchanges,contingencies,continuingreviewapplications,etc.).
§ Unanticipatedproblemsinvolvingriskstosubjectsorothers(UaPsorsometimescalledUPIRSOs)andadverseevents(AEs)mustbereportedtotheIRBinatimelymanner.Thesetermsaredefinedasfollows:
o UnanticipatedProblem(UaP)–Aneventthatisnotexpectedintermsofitsnature,severity,orfrequencyandforwhichthereisareasonablepossibilitythattheeventmayhavebeencausedbyorlinkedtotheresearch.Theeventsuggeststhattheresearchplacessubjectsorothersatgreaterriskofharmthanpreviouslyknownorrecognized.
o AdverseEvent-Eventsthatinvolvephysiological,social,economic,orpsychologicalharmtosubjects.Thiscanalsoindicaterisksofharmtoothers.AEsincludeexpectedandunexpectedharmfuleffects,andunexpectedharmsofaninteractionorintervention.
§ Potentialnoncompliancewithlaws,regulations,orIRBrequirementsbytheresearchteamorothersmustbereported,evenifthisnoncompliancewasunintentionalordiscoveredduringthecourseofqualityassuranceactivities.Subjectsbeingexposedtounnecessaryriskmayalsobereportedaspotentialnoncompliance.
§ Protocoldeviations,subjectcomplaints,orlossofresearchdatamustbereportedtotheIRBviaanOtherReportableInformationorOccurrence(ORIO)report.
UniversityofMichiganHumanResearchProtectionProgram [email protected],2016
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PossibleQuestionsAboutCompliancewithIRBandOtherReviewUnitRequirements
§ Whatistheprocessforcontinuingreview?§ WhatisthedifferencebetweenanAEandaUaP/UPIRSO?§ Whatisnoncompliance?Whenisitconsideredseriousand/orcontinuing?§ Whatisthedifferencebetweennoncomplianceandanadverseevent?Section7:ObtainingandDocumentingInformedConsentInformedconsentisthevoluntarychoiceofanindividualtoparticipateinresearchbasedonacompleteandaccurateunderstandingofthestudy.Informedconsentisnotasingleeventordocumentbutratheranongoingprocessinvolvingtheinvestigator(ordesignees)andtheresearchparticipant.Informedconsentrequiresfulldisclosureofthenatureoftheresearchandtheparticipant’sroleinthatresearch,understandingofthatrolebythepotentialparticipant,andtheparticipant’svoluntarychoicetojointhestudy.
§ InvestigatorsareresponsibleforobtaininganddocumentinginformedconsentbeforetheresearchbeginsunlesstheIRBwaivesthisrequirement.
§ Informedconsentmustbeconveyedinlanguagethatisunderstandabletoparticipantsortheirlegallyauthorizedrepresentative.
§ Consentmustbesoughtundercircumstancesthatminimizepotentialforcoercionorundueinfluence.
§ Timeforquestioningbetweentheinitialrequestforparticipationandthefinaldecisionasrecordedintheconsentdocumentshouldbeallowed.
§ Itmustbemadecleartosubjectsthattheirparticipationisvoluntaryandthattheymaywithdrawatanytimewithnopenalty.
§ ConsentisdocumentedbyuseofaconsentformapprovedbytheIRBunlessawaiverofinformedconsentorawaiverofdocumentationofinformedconsentisgranted.
§ TheCommonRule(45CFR46.116(a))outlinestherequiredelementsofinformedconsent:
o Astatementthatthestudyinvolvesresearch;o Informationonthepurposeoftheresearch;o Theexpecteddurationofsubjectparticipation;o Adescriptionoftheprocedures(identificationofexperimentalprocedures);o Adescriptionofreasonablyforeseeablerisksorharms;o Adescriptionofanybenefitstosubjectsorothers;o Disclosureofappropriatealternativetreatments/procedures,iftheresearchinvolvesclinical
treatment;o Adescriptionofhowtheconfidentialityofrecordswillbemaintained;o Adescriptionofproceduresrelatedtocompensationforinjury,iftheresearchismorethan
minimalrisk;o ContactinformationforthePIandIRB;ando Astatementthatparticipationisvoluntaryandthatthesubjectmaywithdrawatanytime
withnopenaltyorlossofbenefits.
§ Theparticipant(ortheirlegallyauthorizedrepresentative)mustbeprovidedwithacopyoftheconsentdocumentatthetimeofconsentunlessthisrequirementiswaivedbytheIRB.
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§ Investigatorsareresponsibleforretainingsignedconsentdocumentsforatleastthreeyearsaftercompletionoftheresearch(sevenyearsifprotectedhealthinformationwillbeusedordisclosedinconnectionwiththestudy)orlongerifrequiredbytheinstitutionorresearchsponsor.
Insomecases,anIRBmaywaivetherequirementtoobtainconsentformorwaivetherequirementfordocumentationofinformedconsent.Toreviewinformedconsentwaivers,alterations,exceptions,andsubstitutionsrefertothesectiononwaiversinPart3oftheOM.PossibleQuestionsAboutInformedConsent§ Whataretherequiredelementsofinformedconsent?§ HowcanasubjectobtaininformationabouthumansubjectsprotectionsatU-M?§ Whenreviewingaconsentform,whatdoyoulookfor?§ Whatdoestheconsentprocessentail?§ Whatisthedifferencebetweenawaiverofconsentandawaiverofdocumentationofconsent?Section8:ConflictofInterestDisclosureApotentialconflictofinterest(COI)existswheneverpersonal,professional,commercial,orfinancialinterestsoractivitiesoutsideoftheuniversityhavethepossibility(eitherinactualityorinappearance)of(1)compromisingafacultyorstaffmember’sjudgment;(2)biasingthenatureordirectionofscholarlyresearch;(3)influencingafacultyorstaffmember’sdecisionorbehaviorwithrespecttoteachingandstudentaffairs,appointmentsandpromotions,usesofUniversityresources,interactionswithhumansubjects,orothermattersofinteresttotheUniversity;or(4)resultinginapersonalorfamilymember’sgainoradvancementattheexpenseoftheUniversity.Familymembersincludespouse,domesticpartnersanddependents.Withrespecttoresearch,COIsmustbemanagedtoensuretheydonotimproperlyaffect,orgivetheappearanceofaffecting,theconductoftheresearch.PotentialfinancialCOIsareidentifiedthroughannualdisclosurerequirementsandquestionsintheeResearchIRBandproposalmanagementsystems,andarereviewedbytheUMORCOIorMedicalSchoolCOI(MEDCOI)Committees. TheStandardPracticeGuide(SPG)201.65-1representstheoverarchinguniversitypolicyonconflictsofinterestandconflictofcommitment.Inaddition,theUniversityestablishedoperationalpoliciestoguideemployeesindisclosingandmanagingoutsideconflictsofinterestandcommitmentandtoensurethatclinicaltrialsconductedatU-MareconductedwithoutuntowardinfluenceresultingfromtheUniversity’sequityholdingsinanystart-upcompanysupportingtheclinicaltrials.Pleasetakesometimetoreviewthefullpolicies,usingthelinksbelow(orfindthemontheCOIwebsite):
§ PolicyforIdentificationandManagementofFinancialConflictsofInterest§ PolicyonInstitutionalConflictofInterestinClinicalTrialsofDrugs,Devices,orBiologics
SupportedbyUniversityStart-upCompanies
PossibleQuestionsAboutConflictofInterestDisclosure
§ Whatisaconflictofinterest?§ HowdoesU-Massessandmanageconflictsofinterest?§ Whatshouldbedisclosedtosubjectsregardingafinancialconflictofinterest?§ DoestheIRBviewandapproveCOImanagementplansforhumanresearch?§ Whatdoyoudoifyouhaveaconflictofinterestrelatedtoaprotocolyouarereviewing?
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Section9:AccountabilityandAdditionalAdministrativeRequirementsPrincipalinvestigatorsmustperformordelegatetoqualifiedresearchstaffallnecessarytaskstocarryoutresearch,includingspecifically,obtainingIRBapprovalbeforeresearchbegins;securinginformedconsentofparticipantspriortostudyenrollment;conductingcontinuingreviewinatimelymanner;informingtheIRBofanydisapprovals,suspensionsorterminationsbyotherreviewunits;andthecreationandmaintenanceofaccuraterecords.ThePIisultimatelyresponsibleforproperconductofthestudyandfulfillmentofrelatedobligations.
ResearchersmaycontacttheInstitutionalOfficial(JackHu,VPR),theDeputyInstitutionalOfficial(JamesAshton-Miller,AssociateVPR),theHRPPDirector(LoisBrako,AssistantVPR)orOfficeofGeneralCounseltoobtainanswerstoquestions,expressconcerns,orsharesuggestionsregardingtheHRPP.Ananonymouscompliancehotlineisalsoavailableforreportingconcernsat:compliancehotline@umich.edu.PossibleQuestionsAboutAccountabilityandAdditionalAdministrativeRequirements§ Doyouthinkyouhaveaccesstoadequateresourcestoperformyourdutiesrelatedtohumanresearchsubjects?
§ WhatsortofsupportdoyoureceivefromU-M’sadministration?§ Towhomdoyougoforhelponissues,betheyregulatoryorethical?§ HowiscommunicationfacilitatedthroughouttheHRPP?Isthisaneffectivesystem?§ IstheIRBworkloadreasonable?§ Describeyourannualevaluationprocess.Section10:EducationTheProgramfortheEducationandEvaluationinResponsibleResearchandScholarship(PEERRS)isaweb-basedcurriculumthatservesastheminimumlevelofhumansubjectsprotectioneducationrequiredforallinvestigatorsandkeypersonnelinvolvedinconductingresearchwithhumansubjectsatU-M.PleasetakeamomenttovisitthePEERRSwebsiteandverifyyourcertificationstatusfortherequiredPEERRScoursesforyourrole.IRBchairs,members,andstaffaretrainedthroughadetailedorientationproceduretoprovidethemwiththeknowledgeandskillstoeffectivelydischargetheirdutiesandupholdthefederalandlocallaws,Universitypolicies,andethicalstandardsrelatedtohumansubjectsresearch.ContinuingeducationfornewandexistingIRBstaffandmembersisalsorequiredandisprovidedintheformofworkshops,presentations,nationalwebinars,andprintedandelectronicmaterialsthataresharedonanongoingbasis.IRBmembersandstaffarealsokeptinformedofopportunitiesforcontinuingeducationandencouragedtoattend.Detailsoftheinitialorientationprocedure,continuingeducationrequirements,andevaluationsofIRBChairs,members,andstaffaredescribedintheIRBSOPs.IRB-HSBSandIRBMEDalsoofferin-personeducationalseminarsandconsultationsforresearchers,students,andstaff,hostcourses,anddistributenewslettersandeducationalmaterialsinordertokeeptheresearchcommunityapprisedofdevelopmentsrelatedtohumansubjectsresearchregulation.OnlineeducationalresourcesareavailableontheHRPPandIRBwebsites.
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PossibleQuestionsAboutEducation
§ Describethetrainingyou’vehadtobequalifiedtoreviewhumansubjectsprojects.§ Whatsortofcontinuingeducationdoyoureceiverelatedtoresearchethicsandhumansubjectsresearch?
§ Whatongoingprofessionalmeetings/trainingsareofferedorhaveyouattended?§ Howdouniversityofficialskeepyouinformedofnewdevelopmentsinhumansubjectsregulations?
Remember!Protectingresearchparticipantsisasharedresponsibility.HRPPstaffareavailabletoansweryourquestionsandtohelpyouhaveasuccessfulinterview.
Ifyouhaveanyquestions,don’thesitatetocontactusat:[email protected].
Section11:AdditionalResources§ U-MAAHRPPRe-AccreditationWebpage
http://research-compliance.umich.edu/human-subjects/aahrpp-re-accreditation
§ U-MHRPPWebpage(includeslinkstoIRBwebsites)http://research-compliance.umich.edu/human-subjects
§ U-MHRPPOperationsManualhttp://research-compliance.umich.edu/operations-manual-contents-page
§ PEERRShttp://my.research.umich.edu/peerrs
§ AAHRPPhttp://www.aahrpp.org/
§ OfficeofHumanResearchProtectionshttp://www.hhs.gov/ohrp/