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IRBPolicyNovember1,2015 REGISUNIVERSITY POLICIESANDPROCEDURESFORTHE REVIEWOFRESEARCHINVOLVINGHUMANSUBJECTS 1 TABLEOFCONTENTS I. A. GeneralDistributionofResponsibility………………………………………………………….…... B. AbbreviationsandDefinitionsusedinPolicyandProcedures………………………….. C. DefinitionsUsedbytheDepartmentofHealthandHumanServices………………… D.DefinitionsusedbyRegisUniversity…………………………………………………………….….. E. GeneralInformationonSubmittingMaterialstotheIRB…………………………….……. II. III. 14 14 14 IV. ResponsibilitiesandActionsoftheHumanProtectionsAdministratorandThe ComplianceCoordinator…………………………………………………………………………………………....15 V. Responsibilitiesandrightsoftheprincipalinvestigator………………………………………………16 A. Responsibilities………………………………………………………………………………………..……….. B. Rights………………………………………………………………………………………………………..………. C. ResponsibilitiesofthePIuponLeavingRU……………………………………………………..... VI. 11 11-13 13 13 13 13 13-14 ResponsibilitiesandActionsoftheAuthorizedInstitutionalOfficial………………………….14 A. AdministrativeResponsibilitiesoftheAIO…………………………………………………….….. B. ActionsoftheAIOuponReceiptofNoticeoftheIRBActionfromtheChair….… C. RevisionsofthePoliciesandProcedures…………………………………………………….……. 5 5 6 6-10 10 ResponsibilitiesandActionsoftheInstitutionalReviewBoard……………………………………10 A. CompositionoftheIRBandAppointmentofMembers……………………………………. B. ChairpersonandViceChair(s)……………………………………………………………….………….. C. MeetingsandQuorums……………………………………………………………………………......... D.FunctionsandOperationsoftheIRB……………………………………………………….……….. E. ReviewofResearch………………………………………………………………………………………….. F. ApprovalofResearch…………………………………………………………………………….…………. G.ActionsandAuthorityoftheIRB…………………………………………………………………….… Introduction………………………………………………………………………………………....................... 5 ProcessfortheIRBReviewandApprovalofResearch………………………………………………..17 A. LevelsofReview……………………………………………………………………………………….………. B. LengthofIRBApproval………………………………………………………………………………….….. C. VerificationofSourcesOtherthanthePI……………………………………………………....... VII. 16 16 16 17-21 21 21 ProblemsInvolvingRisk,AdverseEffectsandNoncompliance……………………………........21 A. GuidelinesforDefiningProblemstobereported…………………………………………….. B. GuidelinesfordefiningNoncompliance…………………………………………………………… C. ReportingofProblemsorNoncompliancebythePI…………………………………………. D.InvestigationsofProblemsandNoncompliance………………………………………………. E. SuspensionorTerminationofApprovalofResearchActivities………………………… F. ReportingbyRUofProblemsorNoncompliance……………………………………………… 2 21-22 22 22 22 23 23 VIII. ConflictingInterests…………………………………………………………………………………………………….24 A. FinancialConflict………………………………………………………………………………………..……… 24 B. IntellectualProperty…………………………………………………………………………………….…… 24 C. ConflictsofCommitment……………………………………………………………………………..…… 24 D.DualRelationships………………………………………………………………………………………..…… 24 IX. CooperativeResearch………………………………………………………………………………………………… 24 X. InformedConsent………………………………………………………………………………………………….…..25 A. InformedConsentRequirements…………………………………………………………………..…… B. AlterationstotheInformedConsentProcedure…………………………………………..……. C. AlterationsintheDocumentationoftheInformedConsent………………………..……. D.ResearchInvolvingChildren……………………………………………………………………………..... XI. ProtectionofConfidentialInformation…………………………………………………………………..…….26 A. StorageandRetentionofConfidentialRecords………………………………………………….. B. CertificateofConfidentiality………………………………………………………………………………. C. AccesstoConfidentialRecords…………………………………………………………………………… D.OtherRegulationsRelatedtoPrivacy,Confidentiality,andConsent…………………… 26 26 27 27 XII. InternetResearch……………………………………………………………………………………………………….27 XIII. HumanSubjectProtectioninFieldResearch…………………………………………………………….28 XIV. OtherStudiesInvolvingHumanSubjects………………………………………………………………… 28 25 25 25 26 A. StudentProjects…………………………………………………………………………………………………..28 XV. Training……………………………………………………………………………………………………………………29 A. CITI:TheCollaborativeIRBTrainingInitiative…………………………………………………….29 XVI. StudentsasResearchSubjects………………………………………………………………………………….30 A. RecruitmentofStudentsforResearchStudies……………………………………………………30-31 XVII. ProtectedHealthInformation(PHI)………………………………………………………………………..…31 XVIII. Appendices…………………….………………………………………………………………………………………….32 Appendix1–InstructionsforSubmissionsandForms……………………….. 33-59 Appendix2–ReviewerChecklist……………………………………………………..…60-63 Appendix3–InformedConsentInformation…..……………………………….. 64-67 Appendix4–ReferenceMaterials……...……………………………………………. 68-77 3 I. INTRODUCTION RegisUniversity,aJesuitCatholicinstitutionofhighereducation,hasadutytoensuretheprotectionofthe rightsandwelfareofhumansubjectsparticipatinginresearch.Inkeepingwithitsmission,theUniversitywill followtheguidelinesandpoliciessetforthbytheU.S.DepartmentofHealth&HumanServicesOfficefor HumanResearchProtections. RegisUniversityfaculty,students,andemployeeswhointendtoconducthumansubjectsresearchmust,prior tocommencinganyeffort,satisfyDepartmentofHealth&HumanServicesregulations[45CFRPart46] (accessibleathttp://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html)andFDAregulations[21CFR Part50and56](accessibleat http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm155713.htm)regardingthe protectionofhumansubjectsresearch. Todeterminewhetheranactivitymeetsthedefinitionofhumansubjectsresearchpertheaforementioned regulations,onemustconsidertwofederaldefinitions:researchandhumansubject. I. Research,forthepurposeofunderstandingprojectsforwhichIRBreviewandapprovalmayberequired,is asystematicinvestigationspecifictoafieldordiscipline,whichincludesresearchdevelopment,testingand evaluation,andisdesignedtodeveloporcontributetogeneralizableknowledge.A"systematicinvestigation" isanactivitythatinvolvesaproposedendeavorthatincorporatesdatacollection,eitherquantitativeor qualitative,anddataanalysistoansweraquestion.Examplesofsystematicinvestigationsinclude: • surveysandquestionnaires • interviewsandfocusgroups • analysesofexistingdataorbiologicalspecimens • epidemiologicalstudies • evaluationsofsocialoreducationalprograms • individualperformancedata • cognitiveandperceptualexperiments • medicalchartreviewstudies Researchbydefinitionisdesignedtodevelopnewknowledgeorcontributetoexistingknowledge,isintended toinformgeneralconclusionsorpublicpolicy,ordesignedtogeneralizefindingsbeyondasingleindividualor aninternalprogram(e.g.,publicationsorpresentations).Publicationand/orpresentationofresearchresults donotdeterminewhetheranexperimentordatagatheringeffortis“research”.Rather,simplyintentto contributeto"generalizable(scholarly)knowledge"makesanexperimentordatacollection“research”. Humanparticipantsinresearchstudieshavelegalrightspertainingtoprivacyandprotectionregardlessof whetherfindingsarepublished. II. Ahumansubjectisalivingpersonaboutwhomaresearcherobtains(1)datathroughinterventionor interactionwiththeindividual;or(2)identifiableprivateinformation. • Interventionincludesbothphysicalproceduresbywhichdataaregathered(e.g.,venipuncture)and manipulationsofthesubjectorthesubject'senvironmentthatareperformedforresearchpurposes. • Interactionincludescommunicationorinterpersonalcontactbetweeninvestigatorandsubject. • Privateinformationincludesinformationaboutbehaviorthatoccursinacontextinwhichanindividualcan reasonablyexpectthatnoobservationorrecordingistakingplace,andinformationwhichhasbeenprovided forspecificpurposesbyanindividualandwhichtheindividualcanreasonablyexpectwillnotbemadepublic (forexample,amedicalrecord).Privateinformationmustbeindividuallyidentifiable(i.e.,theidentityofthe subjectisormayreadilybeascertainedbytheinvestigatororassociatedwiththeinformation)inorderfor obtainingtheinformationtoconstituteresearchinvolvinghumansubjects. 4 Note:Thesisordissertationprojectsinvolvinghumansubjectsconductedtomeettherequirementofa graduatedegreeareoftenconsideredgeneralizable,andthereforeDOrequireIRBreviewandapproval. PursuanttotheNationalResearchAct(P.L.93-348§212a)and45CFR46.103,RegisUniversitymaintainsan InstitutionalReviewBoard(IRB)andhascreatedthewrittenpolicyofthisdocumenttogovernitsactions.AtRegis University,theIRBischargedwithassuringtheprotectionoftherightsandwelfareofhumansubjectsparticipating inresearch.RegisUniversityIRBwillfollowfederaldefinitionofhumansubjectsresearchandwillonlydealwillthoseissuesas statedinthefederalguidelines.Therefore,theIRBisrequiredtoreviewallresearchinvolvinghumansubjectspriorto theconductingofanyresearch.AnyquestionsmaybeaddressedtotheChairoftheIRBatirb@regis.edu.Helpful guidelinesanddocumentsmaybefoundathttp://www.regis.edu/Academics/Academic-Grants.aspx.Appendices containforms,instructions,andotherguidelinestoassisttheresearcher,thevariousacademicdepartments andotherunitsofRU,andtheIRBincarryingoutthereviewprocess. Datacollectedorstudiesconductedforpurposesofprovidinginformationtotheuniversity,anyunitwithinthe university,oranyotherorganization(e.g.,accreditingagency),withthepurposeofaddressingissuesdeemed importanttouniversityoperationsisconsideredtobeinstitutionalresearch.Studiesofthisnaturedonotrequire IRBreview.Ifinformationcollectedisintendedforfurtherdissemination,publication(includingInternet),or involvesmorethanminimalrisk,IRBreviewisrequired. WhenIRBreviewisnotrequired,institutionalresearchprojectsorotheractivitiesmuststillcommunicate applicableelementsofinformedconsent(e.g.,purpose,risk,benefit,voluntaryparticipation,permissionto withdraw)andincludeappropriateanonymityandconfidentialityprotections. Projectssuchasprogramevaluation,policyanalysis,orqualityassurancestudiesconductedforthepurposeof providinginformationonlytotheorganizationstudieddonotrequireIRBreview,providedtheymeetthe followingconditions: (1)Theyarenotintendedtoproduceknowledgethatcontributestothegeneralbaseof humanknowledgeorpublishable;(2)TheyinvolvenomorethanminimalriskasdefinedinFederalregulations andRUpolicy;(3)Theydonotinvolvevulnerablepopulations. A.GeneralDistributionofResponsibility ItistheresponsibilityofeachinvestigatortoseekreviewbytheIRBforanystudyinvolvinghumansubjectsprior tobeginningtheproject.RegisUniversity’sIRBisresponsibleforthereviewofhumansubjectresearchasdefined byfederalguidelines.TherespectiveauthoritiesanddutiesoftheIRBaredescribedinthispolicymanual. Consistentwithfederalregulations,theauthorizedinstitutionalofficial(AIO)appointsmemberstotheIRB. At Regis,theAIOistheProvost. TheHumanProtectionsAdministrator(HPA)willassistthechairoftheIRBoperationallytoachievethe administrationofalloftheabove,theIRBprocessandpolicyandassistwithassuranceofcompliancewithfederal regulations.AtRegis,theHPAistheDirectorofAcademicGrants.TheComplianceCoordinatorisresponsiblefor managingadministrationoftheapplicationreviewprocess,recordkeepingandreporting,managingIRBdirected humansubjectsresearchtraining. B. AbbreviationsandDefinitionsUsedinPolicyandProcedures Federalregulationsanduniversitypolicyusethefollowing abbreviations: 5 CFR CodeofFederalRegulations FDA FoodandDrugAdministration DHHS DepartmentofHealthandHumanServices OHRP OfficeforHumanResearchProtection IRB InstitutionalReviewBoard AIO AuthorizedInstitutionalOfficial(Provost) PI PrincipalInvestigator OAG OfficeofAcademicGrants EAP Executive,Administrative,andProfessionalstaff HPA HumanProtectionsAdministrator(DirectorofAcademicGrants) CC ComplianceCoordinator Federalregulationsanduniversitypolicydefinevarioustermsinregardtoprotectionofhumanresearchsubjects. 45CFR46isthebodyofregulationspromulgatedbyDHHS. 45CFR46includesthefollowingdefinitions: C. DefinitionsUsedbytheDepartmentofHealthandHumanServicesandRegisUniversity (1)SecretarymeanstheSecretaryofHealthandHumanServicesandanyotherofficeroremployeeoftheDHHSto whomauthorityhasbeendelegated. (2)DepartmentorAgencymeanstheheadofanyfederaldepartmentoragencyandanyotherofficeroremployeeof anydepartmentoragencytowhomauthorityhasbeendelegated. (3)Humansubjectmeansalivingindividualaboutwhomaninvestigator(whetherprofessionalorstudent) conductingresearchobtains(a)datathroughinterventionorinteractionwiththeindividual,or(b)identifiable privateinformation. • Interventionincludesbothphysicalproceduresbywhichdataaregathered(e.g.,venipuncture)and manipulationsofthesubjectorthesubject’senvironmentthatareperformedforresearchpurposes (e.g.,cognitiveexperiment). • Interactionincludescommunicationorinterpersonalcontactbetweeninvestigatorandhumansubject (e.g.,atelephoneinterview). • Privateinformationincludesinformationaboutbehaviorthatoccursinacontextinwhichanindividualcan reasonablyexpectthatnoobservationorrecordingistakingplace,andinformationwhichhasbeenprovided forspecificpurposesbyanindividualandwhichheorshecanreasonablyexpectwillnotbemadepublic (e.g.,amedicalrecord). (4)MinimalRiskmeanstheprobabilityandmagnitudeofharmordiscomfortanticipatedintheresearcharenot greaterinandofthemselvesthanthoseordinarilyencounteredintheparticipant'sdailylifeorduringtheperformance ofroutinephysicalorpsychologicalexaminationsortests.[45CFR§46.102(i)]Inresearchinvolvingprisoners,minimal riskisalsodefinedastheprobabilityandmagnitudeofphysicalorpsychologicalharmthatisnormallyencounteredin thedailylives,orintheroutinemedical,dental,orpsychologicalexaminationofhealthypersons.[45CFR§46.303(d)] (5)Vulnerablepopulationmeanschildren,prisoners,pregnantwomen,mentallydisabledpersons,economicallyor educationallydisadvantagedpersons,individualswhoareunabletogiveinformedconsentduetoaphysicalormental condition,orindividualswhosecircumstancesmaymakethemespeciallyvulnerabletocoercion(e.g.,probationers). (6)Prisonermeansanyindividualinvoluntarilyconfinedordetainedinapenalinstitution.Thetermisintendedto encompassindividualssentencedtosuchaninstitutionunderacriminalorcivilstatute,individualsdetainedinother facilitiesbyvirtueofstatutesorcommitmentproceduresthatprovidealternativestocriminalprosecutionor incarcerationinapenalinstitution,andindividualsdetainedpendingarraignment,trial,orsentencing.Prisoners 6 receiveadditionalprotectionsunder45CFR46,SubpartC. (7)Childmeansapersonwhohasnotyetattainedtheageofconsenttotreatmentsorproceduresinvolvedinthe research,undertheapplicablelawsofthejurisdictioninwhichtheresearchwillbeconducted. Childrenreceive additionalprotectionsunder45CFR46,SubpartD. (8)Parentmeansachild’sbiologicaloradoptiveparent. (9)Guardianmeansanindividualwhoisauthorizedunderapplicablestateorlocallawtoconsentonbehalfofachild togeneralmedicalcare. (10)Assentmeansachild’saffirmativeagreementtoparticipateinresearch. Merefailuretoobjectshouldnot, absentaffirmativeagreement,beconstruedasassent. (11)Permissionmeanstheagreementofparent(s)orguardiantotheparticipationoftheirchildorwardin research. (12)Adverseeffectmeansanundesirableandunintended,althoughnotnecessarilyunexpected,resultoftherapyor otherintervention(e.g.,subjectbecomesupsetfollowingcompletionofadepressionquestionnaire,subject experiencesintestinalbleedingassociatedwithaspirintherapy)thatisdirectlyorindirectlyduetoparticipationina researchstudy. (13)ProtectedhealthinformationorPHIisindividuallyidentifiablehealthinformationtransmittedbyelectronicmedia, maintainedinelectronicmedia,ortransmittedormaintainedinanyotherformormedium.PHIexcludeseducation recordscoveredbytheFamilyEducationalRightsandPrivacyAct,asamended,20U.S.C.1232g,recordsdescribedat20 U.S.C.1232g(a)(4)(B)(iv),andemploymentrecordsheldbyentityinitsroleasemployer. (14)IndividuallyIdentifiableHealthInformationisinformationthatisasubsetofhealthinformation,including demographicinformationcollectedfromanindividual,and(1)createdorreceivedbyahealthcareprovider,health plan,employer,orhealthcareclearinghouse;and(2)relatestothepast,present,orfuturephysicalormentalhealth orconditionofanindividual;theprovisionofhealthcaretoanindividual;orthepast,present,orfuturepaymentfor theprovisionofhealthcaretoanindividual;and(a)thatidentifiestheindividual;or(b)withrespecttowhichthereis areasonablebasistobelievetheinformationcanbeusedtoidentifytheindividual. SomestudiesmayfallundertheregulationspromulgatedbytheFDA(21CFR50). Thesewillgenerallybestudiesthat involvethetestingofaninvestigationalmedicationoramedicaldevice.Referto21CFR50forspecificdefinitions regardingthesestudies.SomeFDAdefinitionsdifferfromtheaboveDHHSdefinitions. D.DefinitionsUsedbyRegisUniversity Inadditiontodefinitionspromulgatedbyfederalagencies,RegisUniversitypolicyusesthefollowingdefinitions: (1)PrincipalInvestigator(PI)meanstheindividualwithsignatorypoweronalldocumentsrelatedtotheresearch project.Thispersonhasfinalauthorityovertheproject,isaccountablefortheoverallconductofaparticular researchprotocol,andisaccountablefortheoverallconductofastudy.ThePIacceptsresponsibilityfortrainingall personnelassociatedwiththestudyincompliancewiththehumansubjectsregulationsof45C.F.R.46."Co- principalInvestigator"isthatindividualwhoco-signsondocumentsrelatedtotheprojectorwhomaybe designatedasaco-principalinvestigatoringrant-relateddocuments.Thispersonhasdecisionmakingpowerwith regardtotheconductoftheresearch.Theco-principalinvestigatorreportstotheprincipalinvestigatorwhois ultimatelyresponsiblefortheconductoftheresearch. 7 Otherswithdecision-makingpowermayincludesuchpersonsasprojectmanagers,directors,andtrainers.These designationsarenotall-inclusive.Operationally,theseindividualshavesomeoversightresponsibilityforoneor moreportionsoftheproject.Individualsinthiscategoryaredetermineduniquelyforeachprojectbytheprincipal investigator. (2)KeyPersonnelincludethePI,thefacultysponsorofastudentconductingresearch,andanystudentconducting researchthatisnotconsidereda“studentproject”asdefinedinItem4below. (3)UndergraduateStudentprojectmeansastudyinwhichanundergraduatestudentinvestigator(individuallyor aspartofagroup)gathersoranalyzesinformationinasystematicmanner,primarilyforpedagogicalpurposes.It isnotintendedtocontributetothegeneralbaseofhumanknowledgeandisnottobepublished(including publicationontheInternet),presented,orarchived.Researchconductedforamaster’sthesis,doctoral dissertation,orundergraduatestudentresearchdoesnotfallunderthisdefinition. (4)InstitutionalresearchisastudyconductedbyRUstaffthatisdesignedtoobtaininformationtoassistinthe administrationoftheuniversity.Institutionalresearchprovidesinformationforadministrativeplanning,policy making,decisionmaking,andincludesexaminationsofinstitutionaleffectiveness.Itisnotintendedtocontribute tothegeneralbaseofhumanknowledge. (5)TrainingreferstoaprocessapprovedbyRU,andrequiredbyfederalregulations,toinstructinvestigatorsin theconductofresearchinvolvinghumansubjects. (6)Researchmeansasystematicinvestigation—includingresearch,development,testing,andevaluation— designedtodeveloporcontributetothegeneralbaseofhumanknowledge. Disseminationoffindingstoa scientificaudienceisasufficient(butnotnecessary)criterionforidentifyingresearchthatcontributestothe generalbaseofhumanknowledge.Disseminationincludes,butisnotlimitedtopresentationatascientificmeeting orconference;submissiontoorpublicationinascientificjournal(paperorelectronic);andInternetpostings. Activitiesthatmeetthisdefinitionconstituteresearchforpurposesoftheseregulations,whetherornottheyare supportedorfundedunderaprogramwhichisconsideredresearchforotherpurposes. InadditiontodefinitionsusedbyRUthefollowingdefinitionsareusedbytheIRBandmaybehelpful: (1)Abstain-WhenanIRBmemberdoesnotvoteuponaprotocolunderreview. (2)Agent-Arepresentativewhoactsonbehalfofotherpersonsororganizations. (3)Assurance-Anagreementbetweenanorganizationandafederalagencythatstipulatesthattheorganization willcomplywiththeagency'sregulatoryrequirements.[45CFR§46.103] (4)ConflictofInterest-APIorco-PIissaidtohaveaconflictofinterestwheneverthatPIorIRBmember,hisorher spouse,ordependentchildfallsunderanyofthefollowingconditions: 1.Isaninvestigatororsub-investigatorontheprotocol(IRBmembersonly,notapplicabletoPIs); 2.IftheIRBmember,themember'sspouse,ordependentchildrenareinvolvedintheconductof research; 3.Hasenteredintoafinancialarrangementwiththesponsororagentofthesponsor,wherebythe outcomeofthestudycouldinfluencethevalueoftheeconomicinterest; 4.Actsasanofficer,director,oragentofthesponsor;or 5.Hasidentifiedhimorherselfforanyotherreasonashavingaconflictinginterest. (5)Consent-Theagreementofaparticipantortheparent(s)orguardian(s)totheparticipationoftheirchildor wardintheresearch/clinicalinvestigation 8 (6)Continuingreview-TheperiodicreviewofaresearchstudybyanIRBtoevaluatewhetherthestudycontinuesto meetorganizationalandregulatoryrequirements.Federalregulationsstipulatethatcontinuingreviewshouldbe conductedatintervalsappropriatetothelevelofriskinvolvedinthestudy,andnotlessthanonceperyear.[45 CFR§46.109(e)] (7)DataandSafeMonitoringPlan(DSMP)–Aprocessthatreviewstheintegrity,safetyandprogressofaresearch protocolwiththepurposeofprotectingparticipantsduringthecourseofstudyandmakesdecisionsregarding continuance,modification,orstoppingofthestudyforreasonsofefficacyorsafety.ADSMPmaytakeavarietyof forms,suchasaninvestigatorreviewinghisorherowndata,areviewbyanotherfacultymembernototherwise involvedintheconductoftheresearch,acommitteeofinvestigators,anindependentcommittee,oran independentdataandsafetymonitoringboard.Thetypeofsafetymonitoringthatisadequatedependsonthe specificsoftheresearch. (8)Decisionmakingcapacity-Theabilitytounderstandthechoicespresented,toappreciatetheimplicationsof choosingonealternativeratherthananother,andtomake,andcommunicate,achoice. (9)EngagedinResearch-Aninstitutionitsemployeesoragents(allindividualsperforminginstitutionally designatedactivitiesorexercisinginstitutionallydelegatedauthorityorresponsibility)(i)interveneorinteract withlivingindividualsforresearchpurposes;or(ii)obtainindividuallyidentifiableprivateinformationforresearch purposes[45CFR46.102(d),(f)].Solicitationofconsentbyperformancesitestaffwouldbeconsideredengagement. (10)FederalWideAssurance(FWA)-Adocumentthatfulfillstherequirementsof45C.F.R. Part46andisapprovedbytheSecretaryofHealthandHumanservices.RegisUniversityhasanapprovedFWA numberasfollows: FWA00010784. (11)HumanSubjectsResearch-Theregulatorydefinitionofresearchisasystematicinvestigation,includingresearch development,testing,andevaluation,designedtodeveloporcontributetothegeneralbaseofhumanknowledge. Contributingtothegeneralbaseofhumanknowledgeisagoalofmostbasicresearch.Evenresearchaboutthe mostnarrowlydefinedtopic,suchasanindividualcasestudyorthestudyofanisolatedcommunity,maybe intendedtocontributetoabodyofknowledge(45C.F.R.46.102(d)). (12)InformedConsent-Theagreementtoparticipateinresearchthatismadevoluntarilybyanindividualwithlegal andmentalcompetenceandtherequisitedecision-makingcapacity,afterdisclosureofallmaterialinformation abouttheresearch.Informedconsentmeanstheknowingconsentofanindividualorhisorherlegallyauthorized representative,sosituatedastobeabletoexercisefreepowerofchoicewithoutundueinducementoranyelement offorce,fraud,deceit,duress,orotherformofconstraintorcoercion.Informationconveyedintheinformed consentproceduremustincludeallessentialelementsoftheappropriateconsentformlistedinAppendix3ofthis manual. (13)Institution-AnypartofRegisUniversity. (14)InstitutionalReviewBoard-Anindependentcommitteecomprisedofscientific,non-scientific,andnon- affiliatedmembersestablishedaccordingtotherequirementsoffederalregulations.Anyboard,committee,or othergroupformallydesignatedbyanorganizationtoreviewresearchinvolvinghumansasparticipants,to approvetheinitiationofandconductperiodicreviewofsuchresearch.[45CFR§46.402(g)] (15)Legallyauthorizedrepresentative-Anindividualorjudicialorotherbodyauthorizedunderapplicablelawto consentonbehalfofaprospectiveparticipanttothatsubject'sparticipationintheproceduresinvolvedinthe research.[45CFR§46.402(c)] 9 (16)Monitoring-Thismayrefertodatamonitoringormonitoringtheconductofresearch.Datamonitoringmeans thesystematictrackingofdatafromaresearchstudywiththeintenttoevaluatetheharmsandbenefitsthat accruetoparticipants.Monitoringtheconductofresearchmeanthesystematictrackingoftheimplementationof aresearchstudywiththeintenttomaintaincompliancewiththeprotocolandregulations,andmaintainthe integrityofthedata. (17)OfficeforHumanResearchProtections-Theofficethatisresponsibleforregulatoryoversightofhuman subjectresearch. (18)Protocol-Aformalplanthatincludes,atminimum,theobjectives,rationale,design,populationofinterest, methods,risksandbenefits,andotherconditionsfortheconductofaresearchstudy. (19)ReportingRequirements-ColoradoStateLawrequiresthatifyouhavereasonablecausetoknoworsuspect thatachildhasbeensubjectedtoabuseorneglectorwhohasobservedthechildbeingsubjectedto circumstancesorconditionswhichwouldreasonablyresultinabuseorneglectshallimmediatelyuponreceiving suchinformationreportorcauseareporttobemadeofsuchfacttothecountydepartmentorlocallaw enforcementagency.[Section19-3-307andsections25-1-122(4)(d)and25-4-1401(1z0(d),C.R.S.] (20)ResearchStaff-IndividualswhoaredelegatedresponsibilitybythePIforspecificresearchtasks. (21)SeriousUnanticipatedproblem-Anyeventthatresultsindeath,alife-threateningsituation,hospitalizationor prolongedhospitalization,persistentorsignificantdisability/incapacityoracongenitalanomaly/birthdefector requiresmedicalinterventiontopreventoneoftheoutcomeslistedabove.Seriousunanticipatedproblemsrequire promptreportingtotheIRB. (22)Site-Asitewhosestaff,facilitiesorprivaterecordsofidentifiableindividualsareengagedintheconductof research;or,asitethatreceivesHHSfunds.Theperformancesiteistheactualplacewheretheresearchactivity takesplace(e.g.,clinic,hospital,orclassroom).Theperformancesite’slocationmaybedifferentfromthelocation wheretheIRBreviewtakesplace. (23)UndergraduateStudent-AnyindividualwhoisenrolledatRegisUniversityasanundergraduate. E. GeneralInformationonSubmittingMaterialstotheIRB Allapplicationswillbesubmittedelectronicallythroughtheonlineapplicationprocess(IRBNet™)ontheOAGwebsite. PIsshouldsubmittheirapplicationselectronicallythroughtheonlineapplicationprocessontheOAGwebsiteforreview bytheIRB. AnewapplicationconsistsofeitheraRequestforExemptRevieworRequestforExpedited/FullBoard Reviewandtheresearchgrantproposal,ifthePIisseekingfundingorhasreceivedfunding. Similarly,anysubmissions afterIRBinitialapproval,includingprotocolmodificationrequestsandprotocolcontinuationreviews,shouldbe submittedelectronicallythroughtheonlineapplicationprocess(IRBNet™). TheIRBchairtogetherwiththeCompliance Coordinatorwilldeterminethelevelofreviewrequired. ThesubmittingPIwillreceiveemailconfirmationofthe submission. Allcorrespondencerelatedtorequiredmodificationsorrevisionsaswellasprotocolapprovalwillbe conductedthroughIRBNet™.CommunicationwiththeIRBmaybeinitiatedbyusingtheemailaddressirb@regis.edu. Reportsofadverseeventsmustbemadeimmediatelyviaphoneore-mailirb@regis.edutotheIRBchair.Awritten reportoftheadverseevent,mustthenbesubmittedtotheIRB,within5workingdaysafterfirstawarenessofthe situation. RefertoSectionGformoreinformation. II. RESPONSIBILITIESANDACTIONSOFTHEINSTITUTIONALREVIEW 10 BOARD A.CompositionoftheIRBandAppointmentofMembers FederalregulationsrequirethattheIRBmustbecomposedofatleastfivemembers(45CFR46.107).AtRU,theIRB shallbecomposedof21votingmembers. RepresentationwillincludetheIRBChair,ViceChair(s),(4)fourfacultymembersfromeachfromAcademic CollegesoftheUniversity,(1)onememberfromthelibrary,(1)atleastonememberwhoisacommunitymember andnotaffiliatedwiththeUniversity,(1)atleastonenon-sciencememberfromtheUniversityatlarge community.AnynewcollegesatRegisUniversitywillhavea1yeargraceperiodandthenwillprovide4facultyto serveontheIRB.Allwillserveasvotingmembers.TheChairandViceChairwillvoteonduetotheruleofnecessity tokeepquorum Inaddition,themembershipshallincludemenandwomen,aswellasrepresentationofracialandethnic minoritygroupstothefullestextentpossible. InmeetingtheIRBcompositionrequirementssetforthinthepreviousparagraph,RegisUniversityusesthe followingmethods:TheChairandViceChairsareappointedbytheAIO. IRBmembersandalternatesare appointedbytheAIOafterconsultationwithdeansorothers.Thenomineesmustbeconfirmedbyappointment bytheAIO. AllIRBmembersandanylibraryalternateshallservethree-yearterms,whicharestaggered. Theymaybe reappointedforconsecutiveterms(Note:Thereisnolimitonnumberoftermsmembersmayserve).Acceptance LettersofAppointmentwillbekeptonfile.Additionally,thecurrentmembershiplistiskeptonfilebytheHPA,and isopentoinspectionbyanyemployeeorstudentoftheUniversity.Additionally,acurrentmembershiplistis postedontheIRBwebsite. IftheIRBchairpersontakesasabbaticalorotherleaveofabsence,orleavestheUniversity,theVice-Chairwill assumethechairoftheIRB.Ifthereismorethan1Vice-Chair,theAIOwillappointoneoftheVice-Chairstobea replacementfortheperiodofleaveorfortheremainderofthechair’sterm,orappointanewchair. AllmembersoftheIRBarerequiredtocompleteappropriateCITItrainingandwillworkdiligentlyand conscientiouslytakinganytrainingofferedandwillattendmeetingsasnecessarytounderstandtheprocessin ordertoparticipateinameaningfulmanner. B. ChairpersonandViceChair(s) TheAIOshallappointtheIRBChairandViceChair(s). IRBChairsandVice-Chair(s)willbeappointedtooperate withinthemembershipoftheIRBCommitteeforthree-yeartermsandareeligibleforreappointmentatthree-year intervals.Duringtheappointmentperiod,anIRBChairorVice-ChairmayberemovedatthediscretionoftheAIO. InadditiontotheirauthoritiesandresponsibilitiesasIRBChairandVice-Chair(s),suchindividualsserveasmembers oftheIRBandserveasvotingmembersbyruleofnecessity forthepurposeofmaintainingquorum.Theyshall havevotingprivilegesandotherauthoritiesandresponsibilitiesofmembersincludingtheresponsibilitytoreview, makemotions, participateindiscussionsandvoteonapproval/disapprovalofstudies.TheIRBChairservesasthefinaldecision makerforwhetherornotastudyisreferredtofull-boardreview. ResponsibilitiesoftheIRBChairincludebutarenotlimitedtothosedefinedinthefollowingthreesections.In theabsenceoftheIRBChair,aVice-ChairshallassumetheresponsibilitiesoftheIRBChair.TheVice-Chairwill 11 supportandassisttheChairinalltheresponsibilitiesoftheChair. 1. OngoingIRBChairResponsibilities: • ConveneanddirectIRBmeetings.Thisincludesschedulingreviews,certifyingIRBactions,andcertifyingapproval anddisapprovalofprotocols. • serveasreviewerandthesupporttheCCinroutingprotocolsthatdonotrequireFullBoardreview • reviewandapprove,whenappropriate,expeditedsubmissionsinaccordancewithregulatoryrequirements • determineexemptsubmissionsinaccordancewithregulatoryrequirements • review(ordefertotheprimaryreviewerorotherIRB-designeetoreview)allon-siteseriousadverseevent reports(SAEs)andunexpectedproblemsaffectingthesafetyofsubjectsand,asnecessary,determineifoneor moreofthefollowingisnecessary: (a)immediateactiontoaddressthesafetyofsubjectsor (b)callanemergencymeetingoftheIRB (c)scheduleforcauseauditsasneeded • appointqualifiedIRBmembersasIRB-designeeswithauthorityforexpeditedreviewsandotheractionsas definedinthesePoliciesandProcedures • maintainathoroughunderstandingoffederalregulationspertainingtohumansubjectprotections,theRegis UniversityIRBWrittenPoliciesandProcedures,andotherapplicablestate,andlocalregulations.Assurethat regulationsandpoliciesareappliedinallIRBmatterswithacommitmenttofosterethicallyandscientifically soundhumansubjectresearch • respectthediversebackgrounds,perspectivesandsourcesofexpertiseofallIRBmembersandfostersuch respectamongtheIRBmembers • upholdIRBjudgmentsnomatterhowthesearereceivedorperceivedbyPrincipalInvestigators • makesurethatallIRBprocedureisappropriatelydocumented.Thisincludes,butisnotlimitedto,reporting ofIRBactionstotheProvost,liaisonwiththestaffsupport,andliaisonwithfacultyingeneral • befamiliarwith(45CFR46)especiallyCommonRule(45CFR46.101through46.409) • overseethedevelopmentandexecutionoftheeducationaleffortsoftheIRBoncampus 2. IRBChairResponsibilitiesPriortoEachConvenedMeeting: togetherwiththeComplianceCoordinatorandViceChair(s),establishtheIRBmeetingscheduleandagenda. ensurecoveragebytheVice-ChairwhennotabletoserveasChairpersonforthemeetingandnotifytheOfficeof AcademicGrantswhennotabletoserve • provideguidancetotheCContheassignmentofreviewerstostudiesrequiringconvenedIRBreview • assisttheIRBreviewersandotherIRBmemberswithanyconcernsinpreparingforthemeeting,asnecessary recommendedconsultswhenappropriatetoassistinIRBreviews 3. IRBChairResponsibilitiesDuringIRBMeetings: • presideoverIRBmeetingsandensurethatmeetingsareconductedinanefficient,orderlyandfairmannerwith respectgiventotheopinionsofallmembers.Robert'sRulesofOrdershouldbeusedasaguidebookfor conductingthemeeting. • ensureaquorumforeachstudyreviewandensurethatthisquorumisproperlydocumented. • ensurethatallregulatory-requiredelementsofreviewareaddressedduringthemeetingandthatthereis meaningfulandsubstantivediscussionofrelevantmattersand/orquestions. • ensurethatassignedreviewerspresentaclearandconcisereviewofstudymaterialsincludingconsent documentsandrecruitmentitemsandprocess. • ensurethatallIRB-requiredchangestoconsentandotherdocumentsaredocumented. 12 • • • • • • • ensurethattheIRBdiscussesspecificfindings,asrequiredbyregulations,wheneverthereistheinvolvementof vulnerablepopulations,e.g.children,prisoners,pregnantwomenandfetuses. acceptappropriatemotionsfromvotingmembersoftheIRB. asnecessary,ensurethatthespecificelementspertainingtothemotionareclearlyunderstoodbytheIRB andaccuratelyrecordedinthemeetingminutes. ensurethatIRBdecisionsaremadeinaccordancewithfederal,stateandlocalregulationsandwiththe IRB WrittenPoliciesandProcedures. ensurethatminutesofIRBmeetingsandvotesoftheIRBmembersaccuratelyreflectdiscussionsandactions. C. MeetingsandQuorums AquorumisrequiredtoconveneaformalmeetingoftheIRB.Aquorumconsistsofatleastamajorityof themembersbeingpresentatthemeeting,eitherinpersonorviaaconferencecall,(onlywhennecessary).At leastonememberwhoisanonscientistmustbepresentatthemeeting.Whenmembersareassociatedwitha projectbeingreviewed,theyareineligibletovoteontheproject.Memberswillexcusethemselvesfromthe meetingduringthereview.ConflictsofinterestshouldbenotedintheIRBmeetingminutes.Shouldthequorum failduringameeting(e.g.,lossofamajoritythroughrecusalofmemberswithconflictinginterests,early departures,absenceofanonscientistmemberoralternate),theIRBmaynottakefurtheractionsorvotesuntil thequorumisrestored.TheChairand/orViceChair(s)mayvotebytheruleofnecessitytomaintainquorum. D.FunctionsandOperationsoftheIRB • • • • • • Conductinitialandcontinuingreviewofresearchwithhumansubjectsandreportthefindingsandactionstothe PIinwriting. Determinewhichprojectsrequiremorethananannualreviewandwhichprojectsrequireverification (fromsourcesotherthantheinvestigators)thatnomaterialchangeshaveoccurredsincethepreviousIRB review.Considerationsusedtomakethesedeterminationsincludetheabsoluterisktothesubject, whethertherisksoutweighthebenefits,andpriorconductoftheinvestigator(s)regardingtheprotection ofhumanresearchsubjects. Reviewproposedchangesinresearchactivitiestoinsurethattheprotectionofhumanresearchsubjects ismaintained. Investigateanyreportedadverseeventsorincidentsofon compliance. Observeprojectactivitiesatanypointtoascertainwhetherhumansubjectprotectionsareimplementedsoas toreducethelikelihoodofanadverseeventornoncompliance. WorkwiththeIRBChairtodetermineanyneedforHumanSubjects Training. E. ReviewofResearch Inconductingthereviewofresearch,theIRBshallfollowtheregulationsstatedin45CFR46.109. F.ApprovalofResearch RequirementstobemetforapprovalarelistedinAppendix2. Requirementsaredescribedin45CFR46.111.Inorder toapproveresearchcoveredbystatedregulations,theIRBshalldeterminetheserequirementshavebeenmet. G.ActionsandAuthorityoftheIRB Actiononanyoftheoptionslistedbelowrequiresamajorityvoteofthequorum. Actiontorequirerevisionofan applicationincludestheoptionofempoweringthechairperson,ordesignatedIRBmembertoacceptrevisionson 13 behalfoftheIRBortorequirereconsiderationoftheapplicationasrevisedatasubsequentmeeting. 1. ActionsRegardingApprovalofApplications TheIRBmayreachanyofthefollowingdeterminationswithrespecttoanyproposedproject: • • • • • • Approveapplicationsassubmitted. Approvependingchanges.TheIRBdeterminesthechangesthatarerequiredforapprovalandtheseare communicatedinwritingtothePI.ThePIsubmitsthechangestotheIRBchairperson.Thechair,or designatedIRBmember,mayapprovetheapplicationonbehalfoftheIRBifthechangesmeetthe requirementsdescribedinthewrittencommunicationwiththePI. RequiremodificationsandresubmissiontotheIRB. Requestconsultantreview. Atanypoint,theIRBchairperson,ortheIRBmaydeterminethatsomeonenot ontheIRBwithrelevantexpertiseneedstobeconsultedtoaddressresearchissues,astheyrelatetothe protectionofhumanresearchsubjects. Theconsultantshallnotbeinvolvedintheproposedproject. In somecases,theidentityoftheconsultantmayneedtoremainconfidentialifthereisanyquestionthat therecouldbeproblemsshouldthePIknowtheidentityoftheconsultant. Disapprovetheapplicationassubmitted:Whenaprojectisdisapproved,thePImayrevisetheproposalin accordancewithIRBrecommendations;discusstheprojectwiththeIRBchairpersonorrespondin writing;orwithdrawtheproposalapplication. 2. AdditionalActionsandAuthorityoftheIRB • • Consult with the HPA concerning matters of development and implementation of policies and procedures regarding the protection of human subjects and the training of RU employees and studentsregardingtheconductofresearchinvolvinghumansubjects Suspendorterminateapprovalofresearchthatisnotbeingconductedinaccordancewiththe requirementsorthathasbeenassociatedwithunexpectedseriousharmtosubjects.Anysuspensionor terminationofapprovalshallincludeawrittenstatementofthereasonsfortheIRB’sactionandshallbe reportedpromptlytotheHPAandthefundingagency(ifapplicable). III. RESPONSIBILITIESANDACTIONSOFTHEAUTHORIZEDINSTITUTIONALOFFICIAL A.AdministrativeResponsibilitiesoftheAIO • • • AppointmemberstotheIRB. AppointtheIRBChairandwillalsoappointViceChairpositionsasnecessary. ReviewresearchapprovedbytheIRBinaccordancewith45CFR46.112. B. ActionsoftheAuthorizedInstitutionalOfficialUponReceiptofNoticeofIRBActionfromtheChairperson • TheAIOmayreview,approve,ordisapproveresearchthathasbeenreviewedandapprovedbytheIRB.TheAIO maynotapproveresearchcoveredbytheseregulationsthathasnotbeenapprovedbytheIRB(45CFR 46.112). • IftheAIOdoesnotalsoapproveprojectsapprovedbytheIRB,heorshewillnotifytheIRBandthePIinwriting ofhisorheractionandofnecessarysubsequentactionbythePI. • RecordsoftheseactionswillbecomepartoftheprojectfilemaintainedbytheIRB. C. RevisionsofPoliciesandProcedures 14 TheAIO,inconsultationwiththeIRBchairand/ortheIRB,mayinstituteanychangesofpolicyandprocedurefor thereviewofresearchinvolvinghumansubjectsasmaybeconsistentwithcurrentlyapplicableregulations, institutionalrequirements,andIRBexperience. Aschangesoccurin45CFR46andapplicableportionsof21CFR 50,theywillbeincludedinRegisUniversitypolicyandproceduresbyreference,withoutrequiringseparateaction bytheAIO. TheHPAwillmaintainacurrentmastercopyofRUpolicy,willprovideacopyofanychangesinRegis UniversitypolicytoallIRBmembersandalternates.Additionally,theAIOshalldeterminetheappropriatemethod ofdisseminationofpolicyandproceduralchangestotheuniversitycommunity. IV.RESPONSIBILITIESANDACTIONSOFTHEHUMANPROTECTIONSADMINISTRATORANDTHECOMPLIANCE COORDINATOR TheHPAwillbedesignatedbytheAIO. ThefollowingactionsaretheresponsibilityoftheHPA: • • • • • • • • RetainRegisUniversity’sfederalwideassurance,copiesofpertinentfederalregulations,policiesand guidelinesrelatedtotheinvolvementofhumansubjects,aswellasRegisUniversity’spoliciesand procedures. Coordinatewithgrantandcontractservicesregardingcomplianceonnew,continuing,andcompeting proposalswithhumansubjectsregulationsandpolicy. ArrangeandoverseethetrainingprogramforIRBmembers,IRBalternates,PIs,faculty,staff,andstudents ontheethicalconductofresearchinvolvinghumansubjects. EducatemembersoftheuniversityresearchcommunityabouttheRegisUniversityHumanSubjects PolicyandchangestotheIRBpolicyandprocedures. EnsureallcooperatingresearchsitesinfederallysupportedresearchhaveappropriateOHRP-assurancesand provide certificationofIRBapprovalofproposedresearchtotheappropriatefederaldepartmentoragency. ReporttotheIRB,AIO,andappropriateinstitutionalofficialsanyunanticipatedinjuriesorproblemsinvolving riskstosubjectsorothers,anyseriousorcontinuingnoncompliancewiththeregulationsorrequirementsofthe IRB,andanysuspensionorterminationofIRBapprovalofresearch. Delegateresponsibilitiestoanadministrativeassistant,asappropriate. TheCCwillbedesignatedbytheAIO.ThefollowingactionsaretheresponsibilityoftheCC: § § § § § § § § § Overseespre-awardUniversitycompliancewithhumansubjectsresearch WorkswithappropriateUniversitypersonneltoensureaccurateinterpretationoffederalregulationsand guidelinespertainingtohumansubjectsandresearchintegrity. Communicatesaccurateinterpretationstorequestingpartiesinordertoassurecomplianceandlimitrisk. MonitorsUniversityprocesses,policies,andprocedurestoensureacompliantatmosphereandshared understandingswithintheinstitutionregardingpre-awardcompliance. Providesinputasrequestedornecessaryregardinggoalsandobjectivespertainingtoresearchactivities. Intheeventofallegedorrealhumansubjects’violations,theComplianceCoordinatorisrequiredto immediatelynotifythechairoftheinstitutionalIRB. AttendsallIRBmeetingsasanex-officio,non-votingmember,andprovidesinputasrequestedorasappropriate regardinghumansubjectscomplianceissues,statusofsubmissions,andutilizationofIRBNet™. MaintainsadatabaseofCollaborativeInstitutionalTrainingInitiative(CITI)educationcompletiondataregarding Regisresearchers,andprovidesupdatedinformationinthisregardasrequested.Preparescomplianceviolation reportsasneeded. ServesasliaisonbetweenIRBNet™users(students,researchers,andIRBmembers)andtechnicalsupport professionalswithspecificregardtotheIRBNet™platform. 15 § § § SchedulesregularplanningmeetingswithIRBleadership(Chair,Vice-Chair[s])tofacilitatetimelyreviewand approvalofsubmittedresearchproposals. UpdatetheOAGwebsitetoassureIRBcontentiscurrent. EnsurethatIRBrecordsarebeingmaintainedappropriatelyandthatrecordsareaccessibleuponrequest,to authorizedfederalofficials. V. RESPONSIBILITIESANDRIGHTSOFTHEPRINCIPAL INVESTIGATOR A.Responsibilities ThePIhasprimaryresponsibilityforallaspectsoftheprotectionofhumansubjectsonagivenproject,including: • • • • • • • • • ConsultwiththeIRBChairorComplianceCoordinatorifunsurewhetherastudymeetsthedefinitionofresearch withhumansubjects. Submitapplicationsforreviewandapprovalpriortoinitiatingresearch,andinaccordancewithSectionFof RegisUniversitypolicy. Whenafullreviewisrequired,provideadditionalinformationand/ordocumentationto theIRBpriortoany meeting atwhichtheapplicationisreviewed.Conductthestudyinaccordancewiththeethicalstandards describedintheBelmontReport,federalregulations,RegisUniversitypolicy,andtheprotocolasapprovedby theIRB. BeginresearchactivitiesonlyafterwrittenapprovalbytheIRB. Ifchangesareneededinanapprovedprotocol,submittheproperapplicationtomodifytheprotocolandwait toreceivewrittenapprovalbeforeimplementinganychanges. SubmitrequestsforcontinuingreviewinaccordancewiththetimeframeestablishedbytheIRBatthetimeof approvaloftheprotocol. Reportanyunanticipatedrisks,physicalorpsychologicalharm,orotherproblemstotheIRBChairorViceChair immediatelyuponbecomingawareofthem. SectionGofthispolicyprovidesdefinitionsandexamplesof problemsthatshouldbereported. Retainsignedinformedconsentformsandresearchmaterialsforatleastthreeyearsafterthecompletionof theresearchproject.Somefundingagenciesmayhavedifferentretentionrequirements,andthePIis responsibleforunderstandingandcomplyingwiththosepolicies. Makeaccessibleallrecordsforinspection,copying,andreviewbytheIRBChairorthedepartmentor agencysupportingtheresearch. B. Rights • • • • ApplicationsshallbereviewedbytheIRBinaccordancewiththeethicalprinciplesdescribedintheBelmont Report,federalregulations,andRegisUniversitypolicy. Whenprotocolsaresubmitted,theIRBshallreviewtheapplicationwithin10-28workingdays,barringany unforeseenandinsurmountableproblems. AlldecisionsoftheIRBshallbeconveyedtothePIinwriting. ThePImayconsultwiththeIRBchairpersonifheorsheisunclearabouttherationaleforitsdecisionsorifany questionsariseatanytime. C. ResponsibilitiesofthePIuponLeavingRegisUniversity WhenaPIplanstoleaveRegisUniversityandcontinuetheresearchactivitiesatanotherinstitution,heorshemust notifytheIRBinwriting. ThiswillallowtheIRBtoclosetheactiveresearchfile. ThePIisresponsibleforobtaining 16 IRBapprovalatthenewinstitution. IftheresearchprojectwillcontinueatRegisUniversityunderanother investigator,thePImustsubmitarequestformodificationformandtheIRBwillfollowthereviewguidelinesset forthinthispolicy. VI. PROCESSFORIRBREVIEWANDAPPROVALOFRESEARCH A.LevelsofReview ThissectiondescribesthethreepossiblelevelsofIRBreviewforstudiesthatinvolvehumanresearchsubjects. 1. ExemptionCertificationReview (a)NewApplication Researchactivitiesinwhichtheinvolvementofhumansubjectsconstitutesnomorethanminimalrisk andfallswithinoneormoreoftheexemptioncategoriesdescribedin45CFR46.101maybeeligiblefor exemptionreviewandapproval. ThePImayrequestthattheresearchapplicationreceiveexemption certificationbysubmittingtheappropriateapplicationformonIRBNet™. OnlytheIRBmaycertifythat theproposedresearchmeetstheexemptioncriteria. ExemptreviewisconductedbytheIRBchair,or designatedIRBmembers,whowillverifylevelofreviewthroughthecategorieslistedintheExempt application. IftheIRBChairisinvolvedwiththestudyorhasaconflictofinterestwiththeprotocolunderreview,the IRBchairwilldesignateanotherIRBmember,whoisnotinvolvedwiththeproject,toreviewthestudy forexemptioncertification. • • • • TheIRBChair,ordesignatedIRBmember,maytakeoneofthefollowingactions: CertifytheresearchprojectasexemptandrequiringnofurtherIRBreview,unlessmodificationsare proposedwhichareoutsidetheexemptioncategories. ThePIissentanexemptioncertificationletter. Requireadditionalinformationormodification(s). TheIRBChairordesignatedIRBmemberwillcontact thePItorequesttherequiredadditionalinformationormodification(s). IftheIRBChair,ordesignated IRBmember,issatisfiedthattheprotocolmeetstheexemptioncriteria,theresearchprojectiscertifiedas exemptandanexemptioncertificationletterissenttothePI. Denyexemptioncertification. Iftheprotocoldoesnotfallwithinoneormoreoftheexemptioncategories, asdeemedbytheIRBChair,ordesignatedIRBmember,thePIiscontactedinwritingorviae-mailandthe applicationisconsideredforexpeditedorfullreview. (b)ModificationRequest Ifastudyiscertifiedasexempt,thePImustrequestapprovalforanyproposedmodificationstothe researchproject’sprotocolorparticipantinformationsheetsthatdonotfallwithintheexemption categories. ThemodificationsmustbeapprovedbytheIRBpriortoimplementation. (c)ContinuationRequest Onceastudyiscertifiedasexempt,continuationreviewsarenotrequired. 2. ExpeditedReview (a) Newapplication Researchactivitiesinwhichtheinvolvementofhumansubjectsinvolvesnomorethanminimalriskandfall withinoneormoreoftheexpeditedreviewcategoriesmaybeeligibleforexpeditedreview. ThePImay requestthattheresearchapplicationreceiveexpeditedreviewbysubmittingapplicationandjustifyingthe criteriaforexpeditedstudyapproval. OnlytheIRBmaydecidewhethertheproposedresearchmeetsthe expeditedreviewcriteriarequirements. ExpeditedreviewisconductedbytheIRBChair(orViceChairin 17 theabsenceoftheChair)andadesignatedIRBmemberortwo(2)designatedIRBmemberswhowillverify levelofreviewthroughthecategorieslistedintheapplicationandevaluateforconsistencywiththeissues delineatedinthereviewerchecklist(Appendix2),theinformedconsentinformation(Appendix3),and localcontextissues. Ifthereisaconflictofinterestforthechair,theViceChairandadesignatedIRB memberwillconductthereview. PriortosendingtheapplicationforreviewtheIRBChair,ordesignated IRBmember(s),mayaskthePItomakerevisionstotheprotocolorinformedconsentprocedures. • • • Undertheexpeditedreviewprocess,thereviewersmaytakeoneofthefollowingactions: Approvetheresearchapplicationanddecideonthelengthoftimethestudyisapproved(oneyearor less). Requireadditionalinformationormodifications. TheIRBChairoradesignatedIRBmemberwillcontact thePItorequesttherequiredadditionalinformationormodifications. Thereviewer(s)maydecide additionalinformationormodificationsareneeded. Ifthereviewer(s)aresatisfiedthattheprotocol meetstheIRBreviewcriteria,theresearchprojectisapprovedforoneyearorlessandaletterofapprovalis senttothePI. Requireafullreviewoftheapplication. Iftheprotocoldoesnotfallwithinoneormoreoftheexpedited reviewcategories,thereviewershaveconcernsabouttherightsandwelfareofthesubjects,the reviewer(s)willforwardtheapplicationforafullreview. ThePIwillbenotifiedviae-mailthatafullreview isrequiredandwillbeinformedofthereasonsforthisdecision. Additionally,thePImaybeaskedtorevise theapplicationpriortodistributionoftheapplicationtothefullIRBcommittee. (b)ModificationRequest ThePImustrequestapprovalforanyproposedmodificationstotheresearchproject’sprotocolorinformedconsent orassentforms. ThemodificationsmustbeapprovedbytheIRBpriortoimplementation. Modificationrequeststotheprotocolorinformedconsentorassentformsforresearchprojectsthatwerepreviously approvedthroughtheexpeditedreviewprocessmaybereviewedundertheexpeditedreviewprocess. ThePIwill submittheappropriateformviaIRBNet™forreview.Forminormodificationsthatdonotchangethesubstanceofthe project,thelevelofrisktothesubjects,orthelevelofreviewrequired,theIRBchair,oradesignatedIRBmembermay conductthereview. Formorethanminormodifications,thereviewprocessisthesameasforanewapplication. The reviewersmaytakeoneofthefollowingactions: • Approvetherequestedmodifications. ThePIissentaletterofapprovaloftherequestedmodifications. • Requireadditionalinformationormodifications. TheIRBchairpersonordesignatedIRBmemberwill contactthePItorequesttherequiredadditionalinformationormodification(s). Ifthereviewer(s)are satisfiedthattherequestedmodificationsmeettheIRBreviewcriteria,themodificationsareapproved andaletterofapprovalissenttothePI. • Requireafullreviewofthemodificationrequest. Ifthemodificationschangethestudyprotocolsuchthat thestudynolongerfallswithinoneormoreoftheexpeditedreviewcategories,thereviewershave concernsabouttherightsandwelfareofthesubjects,ortheadditionalinformationormodificationsare extensive,thereviewerswillforwardthemodificationrequestforafullreview. ThePIwillbenotifiedin writingthatafullreviewbytheIRBisrequiredandwillbeinformedofthereasonsforthisdecision. Additionally,thePImaybeaskedtorevisethemodificationrequestpriortodistributionofthemodification requesttothefullIRB. (c) ContinuationRequest Researchprojectswhichareapprovedundertheexpeditedreviewprocesswillrequirecontinuationreviewata specifiedinterval,whichwillnotexceedoneyear. Acontinuationrequestforaresearchprojectthatwasapprovedunderexpeditedreviewproceduresmaybe reviewedundertheexpeditedreviewprocess. ThePIwillsubmittheappropriateformviaIRBNet™. TheIRB 18 chairpersonoradesignatedIRBmemberwillverifytheappropriatelevelofreviewforthecontinuationrequest,and willinformthePIinwritingorviae-mailifafullreviewisneeded. Theexpeditedreviewprocess,andreviewactions arethesameasforanewapplication. IfthePIfailstorequestacontinuationorsubmitrequestedinformation,IRBapprovalwillbeterminatedonthe approvalexpirationdate. Allresearchactivitiesmustcease,unlesstheIRBfindsitisinthebestinterestofthe individualsubjectstocontinueparticipatingintheresearchinterventionsorinteractions. Anotificationletterwillbe sentbytheIRBChairtothePIand,ifappropriate,theIRBChairwillinformtheHPA.TheHPAwillcontactthefunding agency. (d)InformingIRBmembersofExpeditedReviews AteachregularIRBmeeting,theIRBChairwillprovidetheIRBwithalistofnewresearchapplications, modificationrequests,andcontinuationrequeststhathavebeensubmittedorapprovedthroughtheexpedited reviewprocess. 3. FullReview (a) Newapplication Research activities in which the involvement of human subjects involves more than minimal risk does not fall within one or more of the exemption categories or expedited review categories, or involves vulnerable populations(e.g.,prisoners,pregnantwomen,children)mustundergoafullIRBreview. Priortodistribution totheIRBmembers,theIRBChair,oradesignatedIRBmemberwillreviewtheapplicationandmayaskthePIto makerevisionstotheprotocolorinformedconsentprocedures. Oncerevisions,ifneeded,arereceived,afull reviewwillbescheduledforthenextregularIRBmeetingoraspecialmeetingmaybecalled. Theapplication materialswillbedistributedtotheIRBmembersatleastsevenworkingdaysbeforethemeeting.Theapplication materialsmustbesubmittedtoIRBNet™atleast14workingdayspriortothemeeting. ThePIisresponsibleforsubmittingtherequiredmaterialstotheIRBChairbythedeadline,14workingdaysprior toa scheduledmeeting.Themeetingscheduleis postedontheOAGwebsite. Submissionofmaterials bythe deadlinedoesnotguaranteethefullreviewwillbeconductedatthenextmeeting.Reasonsfor delayingreviewuntilthenextmeetingmayincludeanincompleteprotocol,studentprotocolmissingadvisor’s approval,alreadyfullagendaortheprotocolrequiresrevisionspriortoreview.Therefore,theIRBrecommends thatthePIsubmitthematerialsasearlyaspossible.Ifafullboardreviewofanapplicationisapprovedorrequires changesthePIwillbenotifiedwithin5workingdaysoftheIRBmeeting.TheIRBmayvotetoconditionallyapprove anapplicationdependentuponrequiredchangesbeingmade.Inthiscasean applicationwouldnothavetowaitamonthforthenextmeetingforanotherfullboardreviewandrequired revisionscouldbereviewedbytheIRBChair,ViceChairoradesignatedBoardmember. Underthefullreviewprocess,theIRBwilldiscussissuesdelineatedinthereviewerchecklistandtheinformed consentforminformation,aswellasissuesrelatedtothelocalcontext. TheIRBmaytakeoneofthefollowing threeactions: • Approvetheresearchapplicationanddecideonthelengthoftimethestudyisapproved(oneyearorless fromthedateoftheconvenedmeetingatwhichtheIRBreviewedandapprovedtheproposal). • Requireadditionalinformationormodifications. DuringtheIRBmeeting,theBoardmayrequestadditional informationnotavailableintheapplication.ThePIwillforwardthisinformation,inwriting,totheIRB chairperson,assoonaspossible. Additionally,theIRBmayrequirethatmodificationsbemade. Atthe conclusionofthereview,theIRBwilldecidewhether: o TheIRBChair,ordesignatedmembermayreviewtheadditionalinformationormodificationstoensure thattheymeettheIRBrequirementsandapprovetheapplication,ifappropriate. Iftheadditional informationormodificationsarenotsufficient,theIRBChair,ordesignatedIRBmembermaycontinueto workindividuallywiththePIuntiltheIRBrequirementsaremetorrequestthattheIRBcontinueits 19 reviewatthenextmeeting,or TheIRBmayrequirethattheadditionalinformationormodificationsbereviewedatthenextIRB meeting. Disapprovetheresearchapplication. ThePIissentaletterdescribingthereasonstheresearchapplication wasnotapproved. ThePImayrevisetheresearchapplicationinaccordancewithIRBrecommendations; discussthereasonsfordisapprovalwiththeIRBChairoradesignatedIRBmember;orwithdrawtheresearch application. o • (b)ModificationRequest ThePImustrequestapprovalforanyproposedmodificationstotheresearchproject’sprotocolorinformedconsent orassentforms. ThemodificationsmustbeapprovedbytheIRBpriortoimplementation. Modificationrequeststotheprotocolorinformedconsentorassentformsforresearchprojectsthatwerepreviously approvedthroughthefullreviewprocessmaybereviewedundertheexpeditedreviewprocessiftherequested modificationsareminor(seeModificationRequestunderthediscussionofExpeditedReviews,above);otherwise,afull reviewprocesswillbeused.ThePIwillsubmittherequiredapplicationformviaIRBNet™andtheIRBchairperson,ora designatedIRBmemberwilldecidetheappropriatelevelofreviewforthemodificationrequest. ThePIwillbe informedofthelevelofreviewrequired. Formodificationrequests,whichcanbereviewedundertheexpeditedreview process,seethemodificationrequestsection(SectionF.1.2.1)underexpeditedreviewprocess(SectionF.1.2). For modificationrequeststhatrequireafullreview,priortodistributiontotheIRBmembers,theIRBchairpersonora designatedIRBmemberwillreviewtheapplicationandmayaskthePItomakerevisionstotheprotocolorinformed consentprocedures. Oncerevisions,ifneeded,arereceived,afullreviewwillbescheduledforthenextregularIRB meetingoraspecialmeetingmaybecalled. ThemodificationrequestwillbedistributedtotheIRBmembersatleast5 workingdaysbeforethemeeting. TheIRBmaytakeoneofthefollowingactions: • Approvetherequestedmodifications. ThePIissentaletterofapprovaloftherequestmodifications. • Requireadditionalinformationormodifications. DuringtheIRBmeeting,theIRBmembersmayrequest additionalinformationnotavailableintheapplication.ThismustbesubmittedtotheIRBbeforefinal approvalcanoccur. Additionally,theIRBmayrequirethatmodificationsbemade. Attheconclusionofthe review,theIRBwilldecidewhether: o TheIRBChair,ordesignatedIRBmembermayreviewtheadditionalinformationormodificationsto ensuretheymeettheIRBrequirementsandapprovetheapplication,ifappropriate. Ifthe additionalinformationormodificationsarenotsufficient,theIRBchair,ordesignatedIRBmember maycontinuetoworkindividuallywiththePIuntiltheIRBrequirementsaremetorrequestthatthe IRBcontinueitsreviewatthenextmeeting,or o TheIRBshouldrequirethattheadditionalinformationormodificationsbereviewedatthenextIRB meeting. • Disapprovethemodificationrequest. ThePIissentaletterdescribingthereasonsthemodification requestwasnotapproved. ThePImayrevisethemodificationrequestinaccordancewithIRB recommendations;discussthereasonsfordisapprovalwiththeIRBchairperson,IRBvicechairperson,or designatedIRBmember;orwithdrawthemodificationrequest. (c) ContinuationRequest ResearchprojectsthatareapprovedbytheIRBwillrequirecontinuationreviewataspecifiedinterval,which willnotexceedoneyearifthePIwouldliketocontinuetheresearch. Acontinuationrequestforaresearchprojectthatwasapprovedunderthefullreviewproceduresmaybereviewed undertheexpeditedreviewprocessiftheresearchprojectmeetstherequirementslistedintheapplication.APImay submitbothmodificationsandacontinuationrequestsimultaneouslyusingoneform. ThePIwillsubmitthe 20 appropriateapplicationformviaIRBNet™andtheIRBchairperson,oradesignatedIRBmemberwilldecidethe appropriatelevelofreviewforthecontinuationrequest. ThePIwillbeinformedofthelevelofreviewrequired. For expeditedreviews,seeContinuationReviewinSectionF.1.2.2underExpeditedReview(SectionF.1.2). Forfullreviews, thereviewprocessandreviewactionsarethesameasforanewapplication. If the PI fails to request a continuationor submit requestedinformation,IRB approvalwill be terminatedon the approvalexpirationdate. Allresearchactivitiesinvolvinghumanparticipantsmustcease.Anotificationletterwillbe senttothePIand,ifappropriate,thefundingagency. B. LengthofIRBApproval Typically,theIRBapprovesaresearchstudyorcontinuationrequestforoneyear. However,approvalmaybe grantedforlessthanoneyearinsomecircumstances,whichmayinclude,butarenotlimitedto,high-risk protocols,projectsinvolvingunusualtypesofrisktosubjects,projectsinvolvingvulnerablesubjects(e.g., prisoners),andprojectsconductedbyaPIwhohaspreviouslyfailedtocomplywithIRBrequirements. C. VerificationofSourcesotherthanthePI SomeprojectsmayrequireverificationfromsourcesotherthanthePIsthatnomaterialchangeshaveoccurred sincepreviousIRBreview. Thecriteriafordeterminingwhichstudiesmayneedoutsideverificationinclude,but arenotlimitedtocomplexprojectsinvolvingunusuallevelsortypesofrisktosubjects;projectsconductedbyPIs whopreviouslyfailedtocomplywith45CFR46ortherequirementsordeterminationsoftheIRB;andprojects whereconcernaboutpossiblematerialchangesoccurringwithoutIRBapprovalhavebeenraisedbasedon informationprovidedincontinuingreviewreportsorfromothersources. VII. PROBLEMSINVOLVINGRISK,ADVERSEEFFECTS,AND NONCOMPLIANCE A.GuidelinesforDefiningProblemstobeReported UnanticipatedproblemsinvolvingriskstosubjectsorothersandadverseeffectsneedtobereportedtotheIRB. Adverseeffectsmaybedirectlyorindirectlyrelatedtotheresearchandmaybeexpectedorunexpected. Thefollowingexamplesillustratewhatneedstobereported: Unanticipatedprobleminvolvingrisktosubjects: Thelaptopcomputerwhichhasidentifyinginformationabout researchsubjectsisstolen. Unanticipatedprobleminvolvingrisktoothers: Theresearchassistantinvolvedintheprojectis inadvertentlyexposedtoalowlevelofradiation. Expectedadverseeffect:SubjectAbecomesupsetwhenaskedaboutfeelingsregardingpriorsexualabuse. Thesubjectisreferredforcounseling. Unexpectedadverseeffect:SubjectBbecomesagitatedandangrywhenaskedgeneralnon-invasive questionsabouttheappropriatenessofcorporalpunishmentofchildren.Thesubjectisreferredfor counseling. Thelasttwoscenariosareexamplesofdirecteffects.AnexampleofanindirecteffectisifSubjectAorBmissesclass orworkduetothepsychologicalconditionsdescribed. 21 Ingeneral,thePImustreportthefollowingadverseeventstotheIRBchairperson: • • • • • • • • Situationsrelatedtotheprotectionofstudydata,suchthatthereisaninadvertentbreachofconfidentiality Negativeoutcomesfromunintentionalorintentionaldeviationsfromresearchprotocolorinformed consentprocess(e.g.,lossofprivacy,lossofrights,damagetoreputation,legalproblems,academic failure) Unforeseeableeventsthatoccurduringorafteraresearchintervention,evenifitisunclearwhetherthey wereactuallycausedbytheintervention Knownsideeffectsofanintervention Allergicreactions(orotheradversereactionstomedications,devices,orprocedures) Complicationsfromprocedures(e.g.,infection,abnormalEEG,psychologicalchange) Complicationsfromresearch-relatedtests(medicalandpsychological) Increaseinseriousnessofaprimaryconditionorsituation B. GuidelinesforDefiningSeriousNoncompliance Noncomplianceincludes,butisnotlimitedto: • Breakingconfidentiality,unlessrequiredbylaw(e.g.,childabuse) • Unapprovedsubjectrecruitmentactivities • Failuretosecureconfidentialrecordsintherequiredmanner • Failuretoreportproblemsinvolvingphysicalorpsychologicalinjurytosubjectsorothers • Failuretoreportriskstosubjectsorothersthatexceedtheprotocolasapproved • ReportfromasubjectofabusebythePIorresearchstaff Eventhoughthesetypesofeventsmustbereported,thePIisencouragedtocontacttheIRBchairpersonifanything occursthatcausesconcernregardingtheprotectionofhumansubjects. C. ReportingofProblemsorNoncompliancebythePI ThePImustcontacttheIRBchairpersonviaphoneore-mailimmediatelyfollowinganincidentofinjury,increasein risk,unanticipatedrisk,otheradverseeffectsexperiencedbysubjectsorothersinvolvedinresearch,orincident(s)of seriousnoncompliance. Additionally,thePImustsubmittheappropriateadverseeventformviaIRBNet™assoonas possiblethereafter,afterfirstawarenessoftheproblem. ThereportwillbereviewedbytheIRBchairperson, designatedIRBmember(s),orthefullIRB. Iftheincidentissevereorincreasestherisktosubjectsorothers,thePImay beaskedtosuspendresearchactivitiespendingfurtherreviewbytheIRBorAIOforapplicationoftheRegisNonCompliancePolicy.Incasesofnon-compliancenotconsideredseriousandnotendangeringparticipantstheIRBChair mayrequesttheybehandledby theRegisNon-CompliancePolicy. D.InvestigationsofProblemsandNoncompliance IfanymemberoftheIRBreceivesinformationaboutinjuriestosubjects,unanticipatedproblemsinvolvingriskto subjectsorothers,orseriousnoncompliance,throughasourceotherthanthePIorco-PI,heorshewillimmediately informtheIRBChair.TheIRBChairmaytemporarilysuspendIRBapprovalforastudy,pendinganinvestigation,after learningoftheproblem,adverseeffect,orseriousnoncompliance. Incasesofnon-compliancenotconsideredserious andnotendangeringparticipantsmaybehandledbytheRegisNon-CompliancePolicy. IftheIRBChairdeterminesitnecessary,duetofederalregulation,asubcommitteeoftheIRBconsistingoftheIRB Chair,andtwoIRBmembers,(notinthePI’sdepartmentordivision)willinvestigatetheallegationofaprobleminvolving risktosubjectsorothers,anadverseeffect,ornoncompliance. TheIRBChairwillrequestaninterviewwiththe 22 individual(s)allegingtheproblem,adverseeffect,ornoncompliance,unlesstheallegationwasreceivedinwriting. The IRBChairwillsharetheresultsofthisintervieworwrittencorrespondencewiththeothermembersoftheadhoc committee,andtheywilldecidehowtoproceed. TheIRBChairwillnotifythePIinwritingwithinfiveworkingdays thatanallegationofproblem,adverseeffect,ornoncompliancewasreceived. Followingtheintervieworuponreceipt ofawrittenallegation,theIRBChairwillrequestaninterviewwiththePIandanyotherresearchersinvolved,inorder toassessthesituation,requirechangesintheprotocol,ifnecessary,andresolvetheissueswithoutfurtherofficial action.TheadhoccommitteememberswilldecideifbothneedtobepresentattheinterviewwiththePIandother researchersinvolved.Iftheadhoccommitteemembersarenotsatisfiedwiththeresultsoftheinitialinterviewwith thePI,theymayexpandtheinvestigation.Theadhoccommitteemembersmayinterviewtheresearchstaffandany otherpersonswhohaverelevantinformation,includingresearchsubjects.Theadhoccommitteewillproducewritten summariestotheinterviewedpartiesforcomments,andwrittencommentsreceivedwillbeincludedintherecordof theinvestigation. Theadhoccommitteewillprepareareportwhichincludesadescriptionoftheinvestigativeactivities,howandfrom whominformationwasobtainedabouttheproblem(s),alistofthoseinterviewed,a summaryofrecordsobtained,finding,basisoffindings,andactionstaken. BeforethereportissharedwiththeIRB,CC, andAIO,identifyinginformationwhichmayputtheindividualmakingtheallegationatriskwillberemoved. Thefinal report,whichcontainsallidentifyinginformation,willbefiledwithconfidentialprojectrecords. Appropriateinstitutionalofficials,OHRPandfundingagencyofficials(ifapplicable)willbenotifiedifproblemsare confirmedbytheadhoccommittee. E. SuspensionorTerminationofApprovalofResearchActivities Atanypoint,theIRBmayvotetosuspendastudyundereitheroftwoconditions: (1)TheIRBfindsthatunacceptable anduncorrectablelevelsofriskorharmtothesubjectsorothersexist;or(2)seriousdisregardonthepartofthe researchertothepoliciesanddirectivesoftheIRBhasoccurred. TheIRBChairwillpromptlynotifythePI(s),aswellas theHPAandAIO,CCinwritingofthisdecisionandthereason(s)forsuspensionofapproval. TheAIOwill,if appropriate,notifyOHRPandfundingagency(ifapplicable)ofthesuspensionorterminationofapproval. F. ReportingbyRUofProblemsorNoncompliance TheIRBChairorHPAwillmakethereportsbyPIsorothersofunanticipatedproblemsinvolvingrisktosubjectsor others,adverseeffects,seriousorcontinuingnoncompliance,andsuspensionorterminationofIRBapprovalavailable totheAIO. TheAIOoranappropriateAIOdelegatedindividualwillnotifyappropriateinstitutionalofficials,OHRP(if appropriate),andtheDepartmentorAgencyheadofthefundingagency(ifthestudyisfunded)ofunanticipated problemsinvolvingrisktosubjectsorothers,unanticipatedadverseeffects,seriousadverseeffectsthatmayhavebeen expected,seriousorcontinuingnoncompliance,andtheIRBsuspensionorterminationofapprovalforresearch activities.Incasesofnon-compliancenotconsideredseriousandnotendangeringparticipantsmaybehandledbythe RegisNon-CompliancePolicy. VIII. ConflictingInterests Severaltypesofconflictinginterestsmayariseinconductingresearch.Projectpersonnelmustreportallsuchrealor potentialconflictstothePI.ThePIisresponsibleformakingcertainthatnoprojectpersonnelperformresearchtasks ifthereislikelytobeaconflictinginterest. Conflictinginterestsapplytobothfundedandnon-fundedresearch.45CFR46doesnotdirectlyaddressconflictsof interest,buttheIRBisrequiredtodeterminethatinformationprovidedtopotentialandactualsubjectsregardingthe researchisobjectiveregardingtherisksandbenefits.Itisalsorequiredtodeterminewhetherrisksoftheresearch havebeenproperlyaddressedintheprotocol.Ifconflictinginterestsexist,thensuchobjectivityandhandlingofrisks canbecompromised. 23 Suchpotentialconflictinginterestsinclude,butarenotnecessarilylimitedtothosediscussedbelow. A.FinancialConflictofInterest Disclosureofanysuchconflictsmustbemadeinwriting.FederalpolicycoversFinancialConflictsofInterestin ResearchthatisfundedbyDHHS,FDA,andNSF,amongothers. TheAIOhasfinalresponsibilitytoassurecompliancewithuniversitypolicyandstateandfederallaw regardingfinancialconflictsofinterest. B. IntellectualProperty AllinvestigatorsmustadheretoRU’spolicyregardingintellectualpropertyclaims. C. ConflictsofCommitment Conflictsofcommitmentarisewhenaninvestigator’stimeorothercommitmentstoaprojectcannotbehonored becauseofexistingcommitmentstotheUniversity.Allinvestigatorsmustavoidsuchconflictsthatmayarisedue totheconductofaresearchproject. D.DualRelationships Dualrelationshipsexistwheneveroneroleoftheinvestigatorcallsintoquestionhisorherabilitytobeobjective aboutfulfillmentofanotherrole.Whilesuchdualrelationshipsmayinvolvefinancialconflictsofinterest,manydo not.AtRU,themostcommonsituationsarelikelytobethoseinwhichfacultyrecruitstudentsforresearch projects.Facultymustnotrecruitstudentsfromtheirclasses,unlesstheIRBgrantsapprovalfordoingso.See SectionPofthispolicyforadetaileddiscussionofstudentsasresearchsubjects. IX. COOPERATIVERESEARCH Cooperativeresearchprojectsarethoseprojectswhichinvolvemorethanoneinstitution.Theofficialrelationship betweenthetwoinstitutionsisnotrelevant. Eachinstitutionisresponsibleforsafeguardingtherightsandwelfare ofhumansubjectsandforcomplyingwithfederalandinstitutionalpolicies. See45CFR46.114formore information. RegisUniversityfaculty,staff,andstudentswhoareconductingresearchatanotherinstitutionarerequiredtoabide byuniversityrequirements,aswellastherequirementsoftheotherinstitution. IftheotherinstitutionhasanIRB,the PImayberequiredtoseekitsapprovalaswell,orfilearequesttodesignateoneoftheinstitutions’IRBtoreviewthe research(e.g.,IRBauthorizationagreement). ForstudiesfundedbyDHHSthePIisresponsibleforensuringalldata collectionsiteswithinthecooperativeresearchprotocolhaveanapprovedDHHSassurance(e.g.,federalwide assurance),andeachwillreviewtheresearchseparatelyordesignateoneoftheinstitutions’IRBstoreviewthe research(e.g.,IRBauthorizationagreement). WhenRegisUniversityisconsideredtobe“engagedinresearch”(seeOHRPguidancedocument“Engagementof InstitutionsinResearch,”January26,1999)butthePIisnotassociatedwithRegisUniversity,thePIgenerallymust submitthefollowingforreviewbytheIRB: anapplicationviaIRBNet™ TheIRBmayopttousetheformatofthe cooperatinginstitutionfortheirreview.TheIRBwillthencompletetheappropriatereviewprocess,basedonthe natureoftheresearchproject. RUmaychoosetorelyonthereviewofthePI’sIRB,inwhichcasebothinstitutions wouldneedtocompletetheIRBauthorizationagreement. WhenRUisnot“engagedintheresearch,”theunaffiliated PIneedstoobtainIRBapprovalathisorherinstitutionandsecurepermissionfromtheRegisUniversityIRBtoconduct 24 thestudyatRegisUniversity X. INFORMEDCONSENT A.InformedConsentRequirements Informedconsentisanongoingprocess,notjustaformthatissigned. Informedconsentassuresthatpotential subjectsunderstandthenatureoftheresearchprojectandtheirparticipationandcanmakeaninformed, voluntarydecisionaboutparticipatingornotparticipatinginaresearchstudy. Thelanguageusedtopresentthe informationneedstobeappropriateforthetargetedsubjectpopulation. Researchersshouldkeepinmindthat individualshavetherighttoparticipateornotparticipateinastudyandthosewhodecidetoparticipatemay withdrawtheirconsentfromthestudyatanytimeforanyreason,withoutincurringnegativeconsequences. Theprocessofobtaininginformedconsentmustcomplywiththerequirementsof45CFR46.116.Documentation ofinformedconsentmustcomplywith45CFR46.117. Unlesschangestotheinformedconsentprocessare approvedbytheIRB,thePIisresponsibleforensuringthatinformedconsentisobtainedinwritingfromthe subjectorthesubject’slegallyauthorizedrepresentative(e.g.,parent),isunderstandabletothesubject(or representative),isobtainedincircumstancesthatarenotcoerciveandthatofferthesubject(orrepresentative) sufficientopportunitytodecidewhetherheorshewillparticipate.Ifanysubjectsaremembersofcertain vulnerablepopulations,45CFR46SubpartB,SubpartC,andSubpartDdescribeadditionalinformedconsent requirements. Theinformedconsentformdelineatesthebasicelementsthatmustbeincludedinaninformedconsentform. The checklistalsoprovidesadditionalelementsthatmayneedtobeincludedintheinformedconsentform,depending onthenatureoftheresearchstudy. Informedconsentformsshouldbewritteninsecondperson(e.g.,“Youare invitedtoparticipate…”),withtheexceptionofthesignaturesection,whichmaybewritteninfirstperson. Use offirstpersoninthebodyoftheinformedconsentmaybeinterpretedassuggestiveorcoercive.Theinformed consentformmaynotincludeexculpatorylanguageinwhichthesubjectorrepresentativeismadetowaiveor appeartowaiveanyofthesubject’slegalrights,orreleasesorappearstoreleasethePI,sponsor,orinstitution(or itsagents)fromliabilityfornegligence. Thepersonwhosignstheinformedconsentformshouldbegivenacopyas areference. InformedconsentproceduresmustbedelineatedintheresearchdescriptionportionoftheapplicationtotheIRB. Anywaiverstotheprocedureordocumentationmustberequired,aswell.Forstudiesinwhichthedocumentation ofinformedconsentiswaived,aletterofinvitationtoparticipate,whichincludestheelementsofinformedconsent maybeappropriate.Additionally,informedconsentformsandassentforms,ifapplicable,mustbesubmittedtothe IRBforreview.Consentformswithoriginalsignaturesbyparticipants,personalrepresentatives(e.g.parents),and thePImustbekeptonfileforaminimumofthreeyears. B. AlterationstotheInformedConsentProcedure Federalregulationsoninformedconsentdoallowformodificationsintheconsentproceduresand,under certaincircumstances,informedconsentmaybewaivedentirelyiftheresearchmeetscertainconditions[see 45CFR46.116(c)(d)].NotethatsuchmodificationsandwaiversarenotallowedunderFDAregulations. See 45CFR46.116(c)(d)andAppendix3formoreinformation. C. AlterationsintheDocumentationofInformedConsent Typically,informedconsentmustbedocumentedthroughtheuseofawritteninformedconsentformthathas beenapprovedbytheIRBandsignedbythesubjectorthesubject’slegallyauthorizedrepresentative. Acopy 25 shouldbegiventotheindividualsigningtheform. However,documentationofinformedconsentmaybewaived insomecircumstances. See45CFR46.117(c)andAppendix3formoreinformation. D.ResearchInvolvingChildren Researchprojectsinvolvingchildrenassubjectstypicallyrequirethewrittenpermissionofoneorbothparents[see 45CFR46.408(b)]orguardianinaccordancewiththeinformedconsentproceduresdelineatedintheinformed consentrequirements(SectionJ.1).Inadditiontoparentalorguardianpermissionforachildtoparticipateina researchstudy,theassentofthechildmaybesolicited,assumingthechildiscapableofprovidingassent. To makethisjudgment,theIRBwillconsidertheage,maturity,andpsychologicalstateofthetargetedchild population. Evenifthechildrenarecapableofprovidingassent,theIRBmaywaivetheassentrequirement whenconsentrequirementsarewaived(seeCFR46.116). Typically,parentalorguardianpermissionmustbedocumented. However,aPImayrequestawaiverofthe documentationofinformedconsentbasedon45CFR46.117(c)(seeAppendix3forinformation).Additionally,the IRBmaydeterminethatparentalorguardianpermissionisnotareasonablerequirementtoprotectsubjects(e.g., neglectedorabusedchildren)anditmaywaivetheconsentrequirements,providedthatanappropriate mechanismforprotectingthechildrenwhoparticipateassubjectsintheresearchissubstitutedandthewaiveris notinconsistentwithfederal,state,orlocallaw[45CFR46.408(c)]. XI. PROTECTIONOFCONFIDENTIALINFORMATION ThePIisresponsibleforensuringtheprivacyandconfidentialityofallpersonallyidentifiableinformationfrom researchsubjects,exceptasrequiredbylaw(e.g.,childabuse)orallowedwithwrittenpermissionoftheresearch subject. Thisinformationmaybecontainedineitherelectronicorhardcopyformats.Whenappropriate,the informedconsentdocumentshouldoutlinethoseconditionsunderwhichdataarenotconsideredconfidential(e.g., childabuse). Datacollectionandstorage,andsafeguardstoensureconfidentialitymustbedelineatedbythePIin theresearchdescriptionportionoftheapplicationtotheIRB. A.StorageandRetentionofConfidentialRecords ThePImuststoreconfidentialhardcopyinformationgatheredfromoraboutanyresearchsubjectinasecure (locked)facilitytowhichonlythePIandauthorizedprojectstaffhaveaccess.Electronicdatashallbepasswordprotectedattheworkstationorfilelevel.Ifthislevelofprotectionisnotfeasible,electronicdatashouldbestored onremovablemediawhichcanbelockedandprotected. Records(e.g.,signedinformedconsentforms,data) relatingtothe researchprojectmustberetainedforatleastthreeyearsaftercompletionoftheresearch(fiveyearsforFDA studies).Allrecordsmustbeaccessibleforinspectionandcopyingbyauthorizedrepresentativesofthedepartment oragencysupportingorconductingtheresearchatreasonabletimesandinareasonablemanner[45CFR 46.115(b)]. B. CertificateofConfidentiality Forstudies,whetherfundedornotfunded,inwhichdataarebeingcollectedaboutsensitiveissues,thePImayobtain fromtheappropriateFederalagencyanadvancegrantofconfidentiality,knownasaCertificateofConfidentialitythat willprovideprotectionofresearchdataagainstsubpoena. Sensitiveissuesinclude,butarenotlimitedto,the collectionofinformationfallingintooneormoreofthefollowingcategories: • informationrelatingtosexualattitudes,preferences,orpractices; • informationrelatingtotheuseofalcohol,drugs,orotheraddictiveproducts; • informationpertainingtoillegalconduct; 26 • • • • informationthatifreleasedcouldreasonablybedamagingtoanindividual’sfinancialstanding,employability, orreputationwithinthecommunity; informationthatwouldnormallyberecordedinapatient’smedicalrecord,andthedisclosureofwhich couldreasonablyleadtosocialstigmatizationordiscrimination; informationpertainingtoanindividual’swell-beingormentalhealth; otherinformationthatisnotlistedheremayalsobeconsideredsensitive,givenspecificculturalorotherfactors. Sensitiveinformationmayexistinanumberofforms,including,butnotlimitedto,surveyresponses,medicalor otherrecords,resultsofmedicalorpsychologicaltests,orresponsestoexperiments. StudentresearchorsurveysinvolvingthesensitiveinformationabovewillonlybeapprovedbytheIRBunderspecial circumstances. ForinformationonhowtoapplyforaCertificateofConfidentiality,contacttheIRBChair. C. AccesstoConfidentialRecords TheUniversityhastherightofaccesstothesupportingrecordsforallresearchattheUniversityorsupportedby University-sponsoredfunds,providedsuchaccesstotherecordsshallbeforreasonablecause,atreasonabletimes, andafterreasonablenotice.Theuniversity'srightofaccesstothedatashallcontinueregardlessofthelocationofthe responsibleinvestigator.ExtramuralsponsorsprovidingsupportforresearchatRUmayalsohavetherighttoreview thedataandrecordsresultingfromthatextramuralsupport.Co-investigatorsandtraineeswhoareanintegralpartof aresearchprojecthavetherighttoreviewallrecordsanddatawhicharepartofthatproject. D.OtherRegulationsRelatedtoPrivacy,Confidentiality,andConsent Inadditionto45CFR46andFDAregulations(21CFR50),otherfederalregulationsmayapplytoresearchinvolving humansubjects. (1)PrivacyRuleundertheHealthInsurancePortabilityandAccountabilityActof1996(HIPAA)PublicLaw104- 191,104thCongress ThePrivacyRule,aFederalregulationundertheHealthInsurancePortabilityandAccountabilityAct(HIPAA)of 1996,regulatesthewaycoveredentitieshandleindividuallyidentifiablehealthinformationknownasprotected healthinformation(PHI). ThePrivacyRuleitselfappliesonlytocoveredentities,nottoresearchitself;however, thePrivacyRulemayaffectresearchersbecauseitestablishestheconditionsunderwhichcoveredentitiescanuse ordisclosePHIforresearch. WhenthePrivacyRuleisormaybeinvolvedinaresearchprojectthePIshouldconsultboth(1) Universitypolicy regardingHIPPAand(2)theChairoftheIRBpriortopreparinganIRBapplication. XII. INTERNETRESEARCH ResearchusingtheInternethasuniquecharacteristicsthatarenotdirectlyaddressedbytheFederalregulations. Currently,theInternetisusedprimarilyfortworesearchactivities–recruitmentofsubjectsandsurveyadministration. MosthumansubjectsprotectionissuesthatariseinconductingresearchactivitiesontheInternetconcernprivacyand consent.Forathoroughdiscussionofthepertinentissues,referto“EthicalandLegalAspectsofHumanSubjects ResearchontheInternet,”preparedforDHHSbyTheAmericanAssociationfortheAdvancementofScience (http://www.aaas.org/spp/dspp/sfrl/projects/intres/main.htm) TheabilitytoconsentisdifficulttoascertainovertheInternet.Generally,thisabilityisrelatedtoage,butmaybe 27 relevanttoothervulnerablepopulations(e.g.,decisionallyimpaired,incarcerated).Also,email-basedactivitiesarefar lesssecurethanwebsite-basedactivities.Softwareexiststoenhancetheprivacyofbothtypesofactivities.RUstrongly recommendsthatresearchersworkwithavendorthatspecializesinInternet-basedresearchtominimizerisksinthese areas. Internet-basedstudiesmaynotincludeminorsassubjectsunlesstheIRBwaiveswrittenparentalpermission andinformedconsent. Generally,Internet-basedsurveysdonotrequirewrittendocumentationofconsent,buttheIRBstronglyencourages theuseofacoverstatementorletterofconsent/assent. InallInternet-basedsurveys,individualsmustbeabletoeasilyprintareadablecopyofinformationaboutthestudy andtheinformedconsentdocumentation(ifrequired)fortheirownrecords. XIII HUMANSUBJECTSPROTECTIONINFIELDRESEARCH Fieldresearchtypicallyinvolvesobservationofandinteractionwithindividualsandgroupsintheirownenvironment, oftenoverlongperiodsoftime. Italsoincludesothertypesofgenerallyqualitativeactivitiesthatfallunderthe definitionofresearch,suchasinterviewsconductedforhistoricalorbiographicalresearchandarchivalresearchon identifiablelivingindividuals. Interviewsbyjournalistsconductedsolelyforthepurposeofwritinganarticleina newspaper,magazine,orothermediaoutletarenotconsideredresearchanddonotrequireIRBreview. Itmaynotbepossibletospecifyinaninformedconsentstatementthedetaileddescriptionoftheresearchprotocol,as theresearchitselfmayinvolveinteractionsbetweentheresearcherandsubjectsthatevolveovertime. Likewise, differencesinlanguage,culture,orthenatureofthesubjectsortopicmayprecludetheuseofawritteninformed consentdocument. Ifappropriatejustificationisgiven,theIRBmaywaivetherequirementforsomeorallofthe informedconsentrequirementsortherequirementtoobtainsignedinformedconsentincertainsituations;45CFR 46.116(c)and(d)describesthecircumstancesinwhichwaiverispossible(alsoseeAppendix3ofthispolicyformore information). Theinvestigatorshouldrequestsuchawaiverifheorshedeterminesthatitisappropriate. TheIRBwill makethefinaldetermination. Inaddition,thesensitivenatureofsomefieldresearchmaymakeitadvisableforthe investigatortoconsiderobtainingaCertificateofConfidentiality(seeSectionK.2ofthispolicyformoreinformation). Investigatorsconductingfieldresearchshouldconsiderguidelinesdevelopedbyarelevantprofessionalassociation. XIV. OTHERSTUDIESINVOLVINGHUMANSUBJECTS Thissectionsetsoutpolicyforconductingothertypesofstudiesthatincludehumansubjects,butdonotmeetthe Federaldefinitionofresearch. UndergraduateStudentProjects UndergraduateStudentProjectsinvolvinghumansubjectsareconsiderednon-conventionalresearch.Regis UniversityhasguidelinescreatedbytheHumanSubjectsIRBoutliningappropriatesubjectsforstudentresearch withhumansubjects.StudentswillbeguidedbytheadviceoftheirRegisUniversityfacultysponsor,faculty advisor,orclassinstructorwhendesigningresearchprojectswithhumansubjects. Facultyapprovalwillbe necessaryfortheHumanSubjectIRBtoapprovetheresearchtobeconducted.Allstudentresearchinvolving humansubjectswillonlybedoneunderthesupervisionofaRegisUniversityFacultyMember. (1)DistinguishingStudentProjectsfromConventionalResearch 28 Generallyundergraduatestudentresearchinvolvinghumansubjectsiseitherintheformofclassprojects or independentdirectedresearchprojects.The typeof reviewrequiredis determinedby whetherthe researchprojectsareintendedtocontributetogeneralbaseofhumanknowledge. Disseminationoffindingstoascientificaudienceisasufficient(butnotnecessary)criterionforidentifying whenastudycontributestothegeneralbaseofhumanknowledge.Disseminationincludes(butisnotlimited to)presentationatascientificmeetingorconference;submissiontoorpublicationinascientificjournal(paper orelectronic);andInternetpostings. Iftheprojectfallsunderthisdefinitionofresearch,reviewandapproval ofahumanparticipantsresearchprotocolbytheIRBisalwaysrequired. Instructorsareadvisedtodiscussprotectionofhumansubjectswithstudentsbeforetheinstructional assignmentorprojectbeginssothatinformeddecisionscanbemadeaboutwhetherIRBreviewisneeded. If eventheslimmestlikelihoodexiststhataninstructionalassignmentorprojectmayfallunderthedefinitionof researchoutlinedinthisdocument,instructorsareadvisedtosubmittheappropriatehumanparticipants researchprotocoltotheIRBforreviewandapproval. PleaserememberthatIRBapprovalofaresearch protocolcannotbegrantedretroactivelyunderanycircumstances. (2)SponsorResponsibilitiesinStudentProjects All student projects must have a Regis University faculty sponsor. For class projects, this is usually the instructor.Thesponsor/instructorwillberesponsibleforthesupervisionofthestudentresearchersufficiently to assure the protection of human research subjects in accordance with ethical standards of the relevant discipline. XV.TRAINING Trainingiscriticaltothesuccessfuloperationofaninstitution’shumansubjects’protectionprogram. Thefollowing describeshowfaculty,staffandstudentsattheUniversitymaybecomeinvolvedwiththeoneofthebesttraining systemsavailable. ForspecificinformationregardingtheseprogramsindividualsshouldcontacttheOfficeofAcademic Grants. A.CITI:TheCollaborativeIRBTrainingInitiative TheInstitutionalReviewBoard(IRB)atRegisUniversityrecognizesthevalueofthemultiplemethodological approachestaughtandemployedatRegisUniversity.Centraltoallthesemethodsistherightsandprotectionof humansubjectswhoparticipateinourresearchandlearning. BasedonFederalguidelinesand,moreover,the basicgroundingprincipleofRegisUniversity,“Howoughtwetolive?”theIRBCommitteeatRegisUniversity outlinesthefollowingasmandatory: (1)AllRegisUniversityFacultyteachingresearchmethodclasses,capstoneclasses,andalliedcourseworkthat involvesdatagatheringfromprimaryresearchwithhumansubjectsbeCITIcertified.* (2)AllfacultyandstudentsatRegisUniversityparticipatinginresearchmethodclasses,capstoneclasses, andalliedcourseworkthatinvolvesdatagatheringfromprimarysources orengaginginprimary independentresearchthatinvolveshumansubjectparticipationotherthanexemptprotocolsmustbe CITIcertified.*CITIcertificationmustrenewedeverythreeyears. Oncecompleted,thefacultyorstudentwillprintcopiesofthecertificatesfortheirrecords.ThefollowingCITI moduleswillberequired: (1)Introduction(noquiz) (2)HistoryandEthicalPrinciples-SBR 29 (3)TheRegulationsandTheSocialandBehavioralSciences- SBR (4)AssessingRiskinSocialandBehavioralSciences-SBR (5)InformedConsent-SBR (6)Privacyandconfidentiality-SBR *Thesemodulesarenecessarybutnotnecessarilysufficient. TrainingotherthantheSocialBehavioralResearch modulesmayberequired(e.g.,Biomedicalmodules). Additionally,otherSocialBehavioralResearchmodulesmaybe requireddependingonthetypeofresearchbeingconducted. Forexample(butnotlimitedto),apersonworkingwith childrenwouldberequiredtocompletetheResearchwithChildrenmodule;apersonworkingwiththeprison populationwouldberequiredtocompletetheResearchwithPrisonersmodule;aspersonworkinginthepublicschool systemwouldberequiredtocompletetheResearchinPublicElementaryandSecondarySchoolsmodule;aperson doinginternationalresearchwouldberequiredtocompletetheInternationalResearchmodule. XVI.STUDENTSASRESEARCHSUBJECTS Studentsareoftenusedassubjectsinresearchstudies,bothbyRUstudent,faculty,andstaffresearchersaswellas researchersfromotheruniversitiesandorganizations.Becauseoftheiruniqueposition,RUpolicyaddressesseveral issuespertainingtotheuseofstudentsinresearchprojects. A.RecruitmentofStudentsforResearchStudies Facultyshouldthinkverycarefullyabouttheimplicationsofusingstudentsasparticipantsinresearch.Although studentsoftenprovideareadysourceofpotentialparticipants,theyarenotalwaysasrepresentativeor appropriatetotheresearchasothersubjectpools,andmanyresearchproposalsandmanuscriptshavebeen rejectedforfundingorpublications,respectively,onthosegrounds.Ifstudentsaredeterminedtobeappropriate participants,thenseveralkeyissuesneedtobeconsidered. (1)Coercion:IftheinstructorofthecourseisalsothePIontheproject,recruitmentofstudentsintothe projectbytheinstructorcouldbeviewedascoercive.Studentsmayfearthattheirgradeswouldbe jeopardizedbytheirnon-participationintheresearch,especiallysincetheinstructorcouldidentifywhohas participatedandwhohasnot.Therefore,itisimportantthatmeasuresarebuiltintotheresearchtoensure studentsthattheirparticipationisstrictlyvoluntaryandthattheymaywithdrawtheirparticipationatanytime withoutpenalty. (2)Consent:EventhoughpotentialparticipantsareenrolledinthePI'sclass,informedconsentisstill required.ThePImustexplaintheprocedures;disclosealltherisksandbenefits,andanyotherinformation, whichmayinfluencethepotentialparticipant'sdecisiontowillinglyparticipate.Signedinformedconsentis required,exceptunderthefollowingconditions: a. Anonymous(nomeansofidentifyingparticipants)mailedquestionnairesortelephoneinterviews;and b. Theonlyrecordlinkingthesubjectandtheresearchwouldbethesignedconsentdocumentand theprincipalriskwouldbepotentialharmresultingfromabreachofconfidentiality. Pleasenote:Althoughsignedinformedconsentmaybewaived(asinthecaseofExempt-qualified studies),participantsmuststillreceivethestandardconsentinformationintheformofaparticipant informationsheet. Ifcreditisofferedinexchangeforparticipation,analternatemeansofearningequivalentcreditforanequivalent commitmentoftimeandeffortshouldbemadeavailabletotheentirestudentpool. 30 XVII.ProtectedHealthInformation(PHI) RegisUniversityresearchersmayengageinhumansubjectsresearchinwhichPHI,patientcarerecords,ordata protectedbytheHealthInformationPortabilityandAccountabilityActof1996(HIPPA)oftheresearchsubjectsis ultimatelydisclosedwithpermissionpatientifpossible andprovidedthat: • • • • AllRegisUniversityguidelinesandregulationsinvolvingPHIarefollowed. PHIisde-identifiedbyresearchersfullysothatnolinksmaybemadebetweencollecteddataandhuman subjects. ResearchershaveobtainedvalidapprovaloftheresearchprojectfromtheRegisIRB. ResearchershaveobtainedauthorizationfromtheresearchsubjectstousethePHIandthatauthorizations havebeenapprovedbytheRegisIRB. RegisUniversityresearchersmayalsoengageinhumansubjectsresearchinwhichPHI,patientcarerecords,or dataprotectedbytheHealthInformationProtectionActofsubjectsisultimatelydisclosedprovidedthatthe RegisIRBhasreviewedtheresearchand,inaccordwithrelevantfederalregulation,haswaivedthesubject’s authorizationfortheuseoftheirPHI. 31 Appendices Appendix1—Instructionsforsubmissionsandforms AdverseEventForm ResearchContinuationand/orProposedModificationtoProtocolForm ApplicationforExemptApprovalofResearchInvolvingHumanParticipants ApplicationforExpedited/FullBoardResearchInvolvingHumanParticipants Appendix2—ReviewerChecklist Appendix3—InformedConsentInformation InformedConsentFormChecklist Conditionsforwaiverofsomeorallinformedconsentrequirements Conditionsforwaiverofrequirementtoobtainsignedinformedconsent Appendix4—ReferenceMaterial TheBelmontReport TheNuremburgCode TheDeclarationsofHelsinki 32 Appendix1 AdverseEventForm Project Title Clickheretoentertext. Principal Investigators Clickheretoentertext. Contact Address Clickheretoentertext. Telephone Clickheretoentertext. Email (Regis Email) Clickheretoentertext. Research Advisor (student projects) Clickheretoentertext. Research Advisor CITI Training expiration date Clickheretoentertext. Student Researcher CITI Training expiration date Clickheretoentertext. 1. Pleasedescribetheunexpectedevent(s).Includealldetailssuchasthenumberofevents,thedatesof occurrences,numberofparticipantsinvolved,knownorpotentialimpactonparticipants,andanyother relevantinformation. 2. Pleasedescribetheknownorpossiblecause(s)fortheevent(s). 33 3. Pleasedescribetheactions,ifany,thatyou,membersofyourresearchteam,and/orotherstookinresponseto theevent.Includethedatesofthoseactionsaswellaswhotookthem. 4. HaveyousubmittedordoyouplantosubmitforIRBreview,anamendmentasaresultoftheexpected event?Ifyes,pleasedescribetheamendmentbriefly.Ifno,pleaseexplainwhyyoubelievethatan amendmentisnotrequired. 34 5. Willyouinformtheparticipantswhoarealreadyenrolledinyourstudyaboutthisunexpectedeventorany safetyorprocedurerelatedinformationasaresultofthisunexpectedevent?Ifyes,describewhatwillbe communicated,andwhenandhowitwillbecommunicated.Ifthecommunicationwillbeinwriting,please providethetextofthecommunicationtotheIRB. Ifno,pleaseexplain. 35 ReviewofResearchInvolvingHumanParticipants– ResearchContinuationRequestand/orProposedModificationstoProtocol ProjectTitle Clickheretoentertext. PrincipalInvestigators Clickheretoentertext. ContactAddress Clickheretoentertext. Telephone Clickheretoentertext. Email(RegisEmail) Clickheretoentertext. ResearchAdvisor (studentprojects) Clickheretoentertext. ProjectStartDate Clickheretoenteradate. EstimatedProjectEnd Date Clickheretoenteradate. Pleasechecktheboxcorrespondingtotheappropriateportionoftheformtobeused. ☐PartA:ResearchContinuationRequest CompletePartAifyouneedtorequestthatyourpreviouslyapprovedresearchbecontinuedpasttheinitial approvaldate. ☐PartB:ResearchwithProposedModifications CompletePartBifyouneedtomodifyyourpreviouslyapprovedresearch,butdonotneedtoextendthe expirationdateoftheproject. ☐PartC:ResearchContinuationRequestandResearchwithProposedModifications 36 CompletebothPartsA&Btocontinueyourpreviouslyapprovedresearchandmodifyit. PartA:ResearchContinuationRequest Federalguidelines(45CFR46.109e)requirethatInstitutionalReviewBoards(IRB)“conductcontinuingreviewofresearch coveredbythispolicyatintervalsappropriatetothedegreeofrisk,butnotlessthanonceperyear.”Inconductingthe continuationreview,theIRBwillreview,ataminimum,aprotocolsummaryandinformedconsent/assentforms,aswell asastatusreportontheprogressoftheresearch. CompletePartAifyouneedtorequestthatyourresearchbecontinuedpasttheinitialapprovaldate. 1. Approximatetotalnumberofparticipantswhowillbeenrolled: Clickheretoentertext. Numberofparticipantsactuallyenrolledasofthisdate: Clickheretoentertext. Numberofparticipantswhohavedroppedout: Clickheretoentertext. Numberofparticipantswhohavebeenlosttofollow-up: Numberofparticipantswhohaveformallywithdrawn: Clickheretoentertext. Pleasesummarizereason(s)forwithdrawal. Clickheretoentertext. 37 Clickheretoentertext. 2.SincethelastIRBreview,haveanyunanticipatedproblemsinvolvingriskstoparticipantsorothersoccurred?Yes ☐No☐Ifyes,pleasedescribe: Clickheretoentertext. 3. SincethelastIRBreview,haveanyinjuriesoradverseeventsoccurred?Ifyes,pleasedescribe: Clickheretoentertext. 4.SincethelastIRBreview,haveanycomplaintsabouttheresearchbeenreceived?Yes☐No☐Ifyes,please describe: Clickheretoentertext. 5.Arethereanychangesintheprotocolrequested?Yes☐No☐Ifyes,pleasedescribeproposedchangestothe protocolandattachaprotocolsummary.Includeamendmentsormodificationstotheresearchsincethelast review. Clickheretoentertext. 6.Arethereanychangestotheinformedconsent/assentform(s)?Yes☐No☐Ifyes,pleasedescribechangesand attachnewconsent/assentform(s)withchangeshighlightedasaWorddocument. Clickheretoentertext. 7.Arethereanyadditionsand/orchangesinsiteswheredataarebeingcollected?Yes☐No☐Ifyes,listadditional sitesorchanges. Clickheretoentertext. 8.Aretherechangesinkeypersonnelassistingintheresearchproject?Yes☐No☐Ifyes,listthechanges(i.e.,who isbeingadded,whohasleftproject).Includefornewpersonnel,name,rank/degree,affiliation,andresponsibilityin project. Clickheretoentertext. 9.Summarizeanyrelevantrecentliteratureandinterimfindings. 38 Clickheretoentertext. 10.Ifthisisamulti-centertrial,summarizeanyrelevanttrialreports. Clickheretoentertext. InvestigatorAssurance Icertifythattheinformationprovidedforthisprojectiscorrectandthatnootherprocedureswillbeusedinthis protocol.Iagreetoconductthisresearchasdescribedintheattachedsupportingdocuments.Iwillrequestapproval fromtheIRBforchangestothestudy’sprotocoland/orconsentformsandwillnotimplementthechangesuntilI receiveIRBapprovalforthesechanges.IwillcomplywiththeIRBpolicyfortheconductofethicalresearch.Iwill promptlyreportsignificantoradverseeffectstotheIRBinwritingwithin5daysofoccurrence.Iwillberesponsible forensuringthattheworkofothersinvolvedwiththisprojectcomplieswiththisprotocol.Iwillcomplete,on requestbytheIRB,theContinuationRequestorCompletionofResearchActivitiesForms. ___________________________________________________________________Clickheretoenteradate. PrincipalInvestigator’sSignature Date FacultyorPSSAssurance(requiredwhenastudentorpersonexternaltoRegisUniversityisthePI) ThisistocertifythatIhavereviewedthisproposedcontinuationrequestandthatIattesttothescientificmerit ofthisstudyandthecompetencyoftheinvestigator(s)toconducttheproject.Iassurethattheinvestigator(s)is knowledgeableabouttheregulationsandpoliciesgoverningresearchwithhumansubjects.Iagreetomeetwith theinvestigatoronaregularbasistomonitorstudyprogressandcompliancewithIRBpolicyfortheconductof 39 ethicalresearch. ______________________________________________________________Clickheretoenteradate. FacultyorSponsor’sSignature Date PartB:ResearchwithProposedModifications CompletePartBifyouneedtomodifyyourpreviouslyapprovedresearch,butdonotneedtoextendtheexpirationdate 40 oftheproject. 1. Describeproposedchangestotheprotocolandsubmitprotocolwithrevisionsincorporated. Clickheretoentertext. 2. Describe(ifany)proposedchangestotheinformedconsent/assentform(s)withchangeshighlighted. Clickheretoentertext. 3.Arethereanyadditionsand/orchangesinsiteswheredataarebeingcollected?Yes☐No☐Ifyes,listadditional sitesorchanges. Clickheretoentertext. 4.Aretherechangesinkeypersonnelassistingintheresearchproject?Yes☐No☐Ifyes,listthechanges(i.e.,who isbeingadded,whohasleftproject).Includefornewpersonnel,name,rank/degree,affiliation,andresponsibilityin project. Clickheretoentertext. 5. Describeanyproposedchanges,notlistedabove. Clickheretoentertext. 41 Application for Exempt Approval of Research Involving Human Participants Project Title Clickheretoentertext. Principal Investigators Clickheretoentertext. Contact Address Clickheretoentertext. Telephone Clickheretoentertext. Email (Regis Email) Clickheretoentertext. Research Advisor (student projects) Clickheretoentertext. Research Advisor CITI Training expiration date Clickheretoentertext. Notes: • This form must be saved and uploaded into IRBNet as a word document. • For students, please have your faculty research advisor certify your proposed research topic as acceptable before starting the IRB research proposal submission process. • Research must be resubmitted for approval using the Research Continuation Request and/or Proposed Modifications to Protocol Form if changes are made in the research plan that significantly alters the involvement of human participants from that which is described in the application. • Research must be resubmitted for approval using the Research Continuation Request and/or Proposed Modifications to Protocol Form if the project will extend beyond 365 days from your IRB project approval. • Even if a study is determined to be in the exempt category of review from formal IRB review application, letters of approval (for external site or if particpants are military, Federal, or State records/data, employees, or beneficiaries) must be submitted with this application if the study intends to target military, Federal, or State records/data, employees, or beneficiaries. Letters of approval must also be submitted if no formal research agreement exists between Regis University and the host site for the study (exempt only). 42 Table of Contents Section 1: Basis for Exempt Category of Review Section 2: Projected Timeline Section 3: Research Design/Problem § Purpose § Background, Rationale, Research Questions, and Citations/References § Methodology • Target population • Intervention and Materials/Instruments • Method/Procedure Section 4: Outside Approval Section 5: Institutional Considerations Section 6: Risks and Benefits Section 7: Privacy Protection 43 Section 1: Basis for Exempt Category of Review I understand that exempt studies will not involve members of vulnerable populations; data collection related to Federal Departments, their employees, nor eligible beneficiaries; nor international studies. I request that my study be exempt from the Regis University IRB human subjects protection board review process based on one of the following exempt study categories from 45CFR46.101.b. Please check the appropriate box. ☐(1) My research will be conducted in established or commonly accepted educational settings, involving normal educational practices, such as: (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. Personal identifiers will not be collected linking individuals to the collected data. ☐(2) My research will involve the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior. The information obtained will not be recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and no disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. ☐(3) My research will involve the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of 45CFR46.101 but the human subjects are elected or appointed public officials or candidates for public office; or federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. ☐ (4) My research will involve the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens. The sources for data collection are publicly available or the information will be recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. ☐(5) My research or demonstration project will be conducted by or subject to the approval of Federal department or agency heads, and are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs. ☐(6) My research involves taste and food quality evaluation and consumer acceptance studies where: (i) wholesome foods without additives will be consumed; or, 44 (ii) food to be consumed contains a food ingredient at or below the level and use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture. Section 2: Projected Timeline Depending on time of year, applicants should allow a minimum of 14 business days for processing. Projected start date: Clickheretoentertext. Projected finish date: (Studies longer than one year require continuation review on an annual basis): Clickheretoentertext. Section 3: Research Design/Problem Please provide a succinct and thorough overall description of the research project. Include enough information about the background and rationale for the study; the purpose, hypothesis, research question, and objectives; and the research methodology to justify its approval as an exempt study. Each section should stand on its own merit. Sections A through H must be completed. A. Purpose: Provide a brief statement that gives the goal(s) of the study. Clickheretoentertext. B. Background, Rationale and/or Research Questions 1. Background (no more than four pages): • Describe the facts, events, and thought processes leading to the currently proposed research project. • Summarize pertinent studies supporting this proposed project. Human studies are preferred. Clickheretoentertext. 2. Rationale: • Explain how the background information from the literature leads to the current proposed hypothesis(es). Clickheretoentertext. 3. Explain how the performance will advance our knowledge in this field, and/or improve our understanding of the disease or physiological condition being studied. Clickheretoentertext. 45 4. Hypotheses/Research Questions and Implications: Clickheretoentertext. 5. Citations/References: Clickheretoentertext. C. Methodology: • Target population: 1. Describe the participant criteria for inclusion in the study including the sample size and method of recruitment. 2. Describe the participant criteria for exclusion in the study. 3. Include the specific circumstances in which the participant’s participation will be terminated by the investigator. 4. Justification for inclusion or exclusion of vulnerable/at-risk populations (if targeted by the study) Clickheretoentertext. 5. Potential benefit of participation: a. To the individual participants b. To the population from which the participants are drawn Clickheretoentertext. • Intervention and Materials/Instruments 1. Clearly list and describe the instruments to be used and the potential risk of participation. Clickheretoentertext. 2. Are investigational drugs to be used? Yes☐ No☐ 3. Are medical devices to be used? (Medical devices must be FDA approved.) Yes☐ No☐ 4. Is this a multicenter or collaborative study? Yes☐ No☐ If yes, specify sites: Clickheretoentertext. 5. Do you plan to maintain personal identifiers (names, address, birth dates, phone numbers, etc.) after your project is completed? Yes☐ No☐ 46 6. Will personal identifiers be revealed in your study (i.e., not kept confidential)? Yes☐ No☐ If yes, describe your plans for the destruction of linkages to personal identifiers and the time frame. Clickheretoentertext. 7. Will photographs, audio, or video recordings of participants be made? Yes☐ No☐ 8. Will your study involve the collection of data that might produce a regulatory mandate or duty to inform authorities about potentially harmful or illegal activities? Yes☐ No☐ 9. Will you apply for a Federal exemption to reporting? Yes ☐ • No☐ Procedure 1. Indicate type of study (e.g., cross-sectional vs. longitudinal; multicenter, controlled, cross-over, randomized, etc.). 2. Describe sequentially how the study will be conducted. 3. Describe the analytic and statistical methods to be used. 4. If blinding (masking) is involved, describe the procedures, indicate who has the code to the blind and the circumstances and procedures for breading the code. Clickheretoentertext. D. Provide the complete text of any test, interview, or survey instrument to be used as a data collection tool; recruitment tools; and/or any consent statement or letter of consent to be given participants. Clickheretoentertext. Section 4: Outside Approval • Will you be recruiting participants from an organization outside, or conducting the study at an institution other than, Regis University? Yes ☐ No ☐ If YES, your proposal must also be approved by the appropriate authorit(y/ies) within that organization/institution. Section 5: Institutional Considerations • Regis University teaches the Jesuit vision of a values-centered education. Does the proposed 47 research have any potential conflicts with Roman Catholic teachings (i.e., Ethical and Religious Directives)? Yes ☐ o No ☐ An example of a conflict with Roman Catholic teaching is research testing the effectiveness of condom use for preventing the spread of sexually transmitted disease. o • If YES, what are those potential conflicts and what justification can be given for pursuit of this research? Does the proposed research have potential negative implications for Regis University? Yes ☐ o No ☐ An example of potential negative effect on the university is a study design that violates university policy such as observation of individual responses to intentional sexual harassment of students, staff, or faculty. o If YES, what are those potential negative implications and what justifications can be given for pursuit of this research? Clickheretoentertext. Section 6: Risks and Benefits • Risks and benefits to research participants should address any physical, emotional, psychological, financial, academic, employability, and/or reputation risks and/or benefits. Other areas of potential risk or benefit may be addressed as deemed proper for the study. Clickheretoentertext. • What relationship, if any, exists between the researcher(s) and the study participants/subjects? Click here to enter text. • Describe any potential direct benefits to the participants. Click here to enter text. • Describe the broader benefits of the project to society. Click here to enter text. • Describe any potential risks that the participants could encounter through their participation in this study. o Current risks: Click here to enter text. o Future risks: Click here to enter text. 48 • Describe any efforts to minimize risks to the subjects. Click here to enter text. • Describe any costs (financial) to the participants. Click here to enter text. • Will the participants be offered compensation or incentives for participation in the study? Yes ☐ o No ☐ If YES, please describe the compensation/incentives. Click here to enter text. • Describe any planned follow-ups with study participants. Clickheretoentertext. *Please ensure that specific risks and benefits, if any, for vulnerable populations are identified. Clickheretoentertext. Section 7: Privacy Protection Describe the procedures to be used that will ensure collected study information will be kept secure. All collected data and consent forms for expedited or full board approval, or if consent forms are used for exempt studies, must be securely stored for three years after completion of the study or five years for an approved FDA clinical trial. Clickheretoentertext. 49 Application for Expedited or Full-Board Involving Human Participants Project Title Click here to enter text. Principal Investigators Click here to enter text. Contact Address Click here to enter text. Telephone Click here to enter text. Email (Regis Email) Click here to enter text. Research Advisor (student projects) Click here to enter text. Research Advisor CITI training expiration date Click here to enter text. Student Researcher CITI training expiration date Click here to enter text. Notes: • This form must be saved and uploaded into IRBNet as a word document. • For students, please have your faculty research advisor certify your proposed research topic as acceptable before starting the IRB research proposal submission process. • Research must be resubmitted for approval using the Research Continuation Request and/or Proposed Modifications to Protocol Form if changes are made in the research plan that significantly alters the involvement of human participants from that which is described in the application. • Research must be resubmitted for approval using the Research Continuation Request and/or Proposed Modifications to Protocol Form if the project will extend beyond 365 days from your IRB project approval. • Even if a study is determined to be in the exempt category of review from formal IRB review application, letters of approval (for external site or if particpants are military, Federal, or State records/data, employees, or beneficiaries) must be submitted with this application if the study intends to target military, Federal, or State records/data, employees, or beneficiaries. Letters of approval must also be submitted if no formal research agreement exists between Regis University and the host site for the study (exempt only). 50 Table of Contents Section 1: Categories for Expedited or Full-Board Review Section 2: Projected Timeline Section 3: Research Design/Problem § Purpose § Background, Rationale, Research Questions, and Citations/References § Methodology • Target population • Intervention and Materials/Instruments • Method/Procedure Section 4: Outside Approval Section 5: Institutional Considerations Section 6: Risks and Benefits Section 7: Privacy Protection 51 Section 1: Categories for Expedited Review (Optional) The following are the research categories eligible for expedited review/approval (OHRP Categories of Research & 63 FR 60364-60367). Please check the box next to the research category under which you are requesting expedited review. 1. I am conducting a clinical study of a drug/medical device under condition (a) or (b). a. ☐(a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.) b. ☐ Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling. 2. I am collecting blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: a. ☐(a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or b. ☐ from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week. 52 3. ☐ I am conducting prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization. 4. ☐ I am collecting data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Note: Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject=s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual 5. ☐ My research involves materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.) 6. ☐ I am collecting data from voice, video, digital, or image recordings made for research purposes. 7. ☐ I am conducting research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.) 8. This is a continuing review of research previously approved by the convened IRB as follows: a. ☐where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or b. ☐where no subjects have been enrolled and no additional risks have been identified; or c. ☐where the remaining research activities are limited to data analysis. 9. ☐This is a continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified. 53 If this is an expedited review request, please justify the request (no more than two pages): Click here to enter text. Section 2: Projected Timeline Depending on time of year, applicants should allow a minimum of 4-6 weeks for processing. Projected start date: Click here to enter a date. Projected finish date: Click here to enter a date. (Studies longer than one year require a continuation review on an annual basis.) Section 3: Research Design/Problem Please provide a succinct and thorough overall description of the research project. Each section should stand on its own merit. A. Purpose: Provide a brief statement that gives the goal(s) of the study. Click here to enter text. B. Background, Rationale and/or Research Questions: 1. Background (no more than four pages): • Describe the facts, events, and thought processes leading to the currently proposed research project. • Summarize pertinent studies supporting this proposed project. Human studies are preferred. Click here to enter text. 2. Rationale: • Explain how the background information from the literature leads to the current proposed hypothesis(es). Click here to enter text. 3. Hypotheses/Research Questions and Implications: Click here to enter text. 54 4. Explain how the performance advances our knowledge in this field and/or improve our understanding of the disease or physiological condition being studied. Click here to enter text. 5. Citations/References: Click here to enter text C. Methodology: o Target population (no more than two pages): 6. Describe the participant criteria for inclusion in the study including the sample size and method of recruitment. 7. Describe the participant criteria for exclusion in the study. 8. Include the specific circumstances in which the participant’s participation will be terminated by the investigator. 9. Justification for inclusion or exclusion of vulnerable/at-risk populations (if targeted by the study)(no more than two pages): Click here to enter text. 10. Potential benefit of participation: a. To the individual participants b. To the population from which the participants are drawn Click here to enter text. D. Intervention and Materials/Instruments 1. Clearly list and describe the instruments to be used and the potential risk of participation. Clickheretoentertext. 2. Are investigational drugs to be used? Yes ☐ No ☐ 3. Are medical devices to be used (medical devices must be FDA approved). Yes ☐ No ☐ 4. Is this a multicenter or collaborative study? Yes ☐ No☐ If yes, specify sites: Clickheretoentertext. 5. Do you plan to maintain personal identifiers’ (e.g., names, addresses, birth dates, phone numbers, etc.) after your project is completed? 55 Yes ☐ No☐ 6. Describe your plans for the destruction of linkages to personal identifiers and the time frame. Clickheretoentertext. 7. Will photographs, audio, or video recordings of participants be made? Yes ☐ No☐ If yes, describe whether you will maintain, destroy, or return them to participants. Clickheretoentertext. 8. Will personal identifiers will be revealed in your study (i.e., not kept confidential)? Yes ☐ No☐ If yes, provide justification and describe how the subjects will be informed that this information will be disclosed. Clickheretoentertext. 9. Will your study involve the collection of data that might produce a regulatory mandate or duty to inform authorities about potentially harmful or illegal activities? Yes ☐ No☐ 10. Will you apply for a Federal exemption to reporting? Yes ☐ No ☐ If yes, what is your plan for dealing with this information? Clickheretoentertext. E. Provide the complete text of any test, interview, or survey instrument to be used as a data collection tool; recruitment tools; and/or any consent statement or letter of consent to be given participants. Clickheretoentertext. F. Procedure 5. Indicate type of study (e.g., cross-sectional vs. longitudinal; multicenter, controlled, cross-over, randomized, etc.). 6. Describe how the study will be conducted. 7. Describe the analytic and statistical methods to be used. 8. If blinding (masking) is involved, describe the procedures, indicate who has the code to the blind and the circumstances and procedures for breading the code. Clickheretoentertext. 56 Section 4: Outside Approval • Will you be recruiting participants from an organization outside, or conducting the study at an institution other than, Regis University? o Yes ☐ No ☐ (If YES, after approval by this Committee you must also upload your approval by the appropriate authorit(y/ies) within that organization/institution. • Will you be recruiting participants for an international study? o Yes ☐ No ☐ (If YES, after approval by this Committee your proposal must also be approved by the appropriate authorit(y/ies) of the countries in which the study will be conducted according to the laws/regulations of those countries. Section 5: Institutional Considerations • Regis University teaches the Jesuit vision of a values-centered education. Does the proposed research have any potential conflicts with Roman Catholic teachings (i.e., Ethical and Religious Directives)? Yes ☐ o No ☐ An example of a conflict with Roman Catholic teaching is research testing the effectiveness of condom use for preventing the spread of sexually transmitted disease. o If YES, what are those potential conflicts and what justification can be given for pursuit of this research? Clickheretoentertext. • Does the proposed research have potential negative implications for Regis University? Yes ☐ o No ☐ An example of potential negative effect on the university is a study design that violates university policy such as observation of individual responses to intentional sexual harassment of students, staff, or faculty. o If YES, what are those potential negative implications and what justifications can be given for pursuit of this research? Clickheretoentertext. 57 Section 6: Risks and Benefits Risks and benefits to research participants should address any physical, emotional, psychological, financial, academic, employability, and/or reputation risks and/or benefits. Other areas of potential risk or benefit may be addressed as deemed proper for the study. • What relationship, if any, exists between the researcher(s) and the study participants? Clickheretoentertext. • Describe any potential direct benefits to the participants. Clickheretoentertext. • Describe the broader benefits of the project to society. Clickheretoentertext. • Describe any potential risks that the participants could encounter through their participation in this study. o Current risks: Clickheretoentertext. o Future risks: Clickheretoentertext. • Describe any efforts to minimize risks to the participants. Clickheretoentertext. • Describe any costs (financial) to the participants. Clickheretoentertext. • Will the participants be offered compensation or incentives for participation in the study? Yes ☐ o No ☐ If YES, please describe the compensation/incentives. Clickheretoentertext. • Describe any planned follow-ups with study participants. 58 Clickheretoentertext. *Please ensure that specific risks and benefits, if any, for vulnerable populations are identified. Section 7: Privacy Protection Describe the procedures to be used that will ensure collected study information will be kept secure. All collected data and consent forms for expedited or full board approval, or if consent forms are used for exempt studies, must be securely stored for three years after completion of the study or five years for an approved FDA clinical trial. Clickheretoentertext. 59 Appendix 2 Reviewer Checklist Preliminary Steps ☐ Primary investigator or sponsoring faculty (if investigator is a student) has completed mandatory online CITI training ☐ Date of CITI training expiration ☐Primary investigator has made revisions under supervision of faculty ☐ Sponsoring faculty has reviewed and signed the student’s IRB application and provided contact information Proposal IRB application includes the following information: ☐ Who the participants are ☐ How participants will be recruited ☐ What participants will be asked to do 60 ☐ Instruments, tests, materials and/or devices that will be used ☐ Risks and benefits of the study ☐ Procedures used for maintaining confidentiality or anonymity Informed Consent ☐ Consent Form (or Information Sheet for Exempt study), on Regis University letterhead ☐ Statement that the study involves research ☐ Explanation of the purpose of the study ☐ Description of procedures to be followed ☐ Statement that the study includes procedures which are experimental ☐ Expected duration of participant’s involvement ☐ Description of foreseeable risks or discomforts to the participant 61 ☐ Description of any benefits expected from the research ☐ Statement that confidentiality will be maintained ☐ Explanation of whom to contact for questions about the study ☐ Explanation for whom to contact regarding research participants’ rights ☐ Statement that participation is voluntary and that refusal to participate will involve no loss or penalty ☐ Statement that a participant may discontinue participation at any time Materials ☐ Copies of all data instruments and other materials to be distributed to participants (e.g. questionnaires, surveys, interview questions) are included Supporting Documents (If Applicable) ☐ Original Letter of Agreement from outside institutions or agencies where you are conducting the research ☐ Letter of Agreement includes: written permission on company letterhead, title of 62 study, dates for which permission is granted, title and typewritten name of permission-granting authority, and authority signature ☐ Translation of consent forms and all materials to be distributed to participants ☐ Letter of verification signed by a translation authority is included that verifies accurate translation of materials by an individual who is fluent in all applicable languages Final Steps ☐ Submit completed application to IRBNet 63 Appendix 3—Informed Consent Information Informed Consent Form Checklist Conditions of waiver of some or all informed consent requirements Conditions for waiver of requirement to obtain signed informed consent 64 Regis University Institutional Review Board for Review of Research Involving Human Subjects Informed Consent Form Checklist Informed consent/assent forms should be written in second person (e.g., You are being asked to participate…). Basic elements to include A statement that the study involves research An explanation of the purposes of the research The expected duration of the subject’s participation A description of the procedures to be followed Identification of any procedures which are experimental A description of any reasonably foreseeable risks or discomforts to the subject, an estimate of their likelihood, andofa any description steps will takenwhich to prevent minimizebethem A description benefitsof to what the subject or tobeothers may or reasonably expected from the research. Monetary compensation is not a benefit. If compensation is to be provided to research subjects or healthy volunteers, the amount should be inof thetreatment, consent document A disclosure of appropriate alternative procedures or stated courses if any, that might be advantageous to the subject A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. Include description whom may have access to research For research involving more athan minimalof risk, an explanation as to whether anyrecords compensation, and an explanation as to whether any medical treatments are available, if injury occurs and, if so, what theyexplanation consist of, or information maytobe obtained An of where whom further to contact for answers pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitled Additional elements, as appropriate An explanation as to why subject is eligible to participate The approximate number of subjects involved in the study Anticipated circumstances under which the subject’s participation may be terminated by the investigator without to the subject’s Any additional costs regard to the subject that mayconsent result from participation in the research The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination participation by the subjectand if/how it will be prorated if subject does not complete Payment forof participation—give amount Study A statement that the collection of data will be audio taped or videotaped A statement that significant new findings developed during the course of the research, which may relate the subject’s willingness to continue be provided to or theother subject When to appropriate, a statement concerning an participation, investigator’swill potential financial conflict of interest in theisconduct the study If the subject or mayofbecome pregnant, a statement that the particular treatment may involve risks, which are currently unforeseeable, to the subject or to the embryo or fetus 65 Conditions for Waiver of Some or All Informed Consent Requirements The IRB may approve a waiver of some or all of the informed consent requirements provided that: § the research involves no more than minimal risk to the subjects; § the waiver or alteration will not adversely affect the rights and welfare of the subjects; § the research could not practically be carried out without the waiver or alteration; and § whenever appropriate, the subjects will be provided with additional pertinent information after participation. [see 45 CFR 46.116 (d)] Additionally, for research studies that are designed to evaluate or demonstrate possible changes in (or alternatives to) provision of benefits or services provided under federal, state, or local programs, an IRB may approve alteration or waiver of informed consent requirements providing the research could not be practically carried out without such waiver or alteration. [See 45 CFR 46.116 (c)] 66 Conditions for Waiver of Requirement to Obtain Signed Informed Consent Federal regulations [45 CFR 46.117 (c)] allow the IRB to waive the requirement to obtain a signed informed consent for some or all of the subjects providing that the IRB finds either of the following: § the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality; or § the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. Additionally, the IRB may decide to waive written documentation of informed consent (i.e., signature of subjects) for research that falls within one or more exemption categories. For example, a PI who is using a survey may include the elements of informed consent in a letter of invitation to participate and by completing the survey subjects are consenting to participate in the research study. 67 Appendix4—ReferenceMaterials Referencedocumentsrepresentinghistoricalsignificantsocietalstatementsforchangebringingaboutwhatweknow todaytobeHumanSubjectResearchProtection. TheBelmontReport TheNuremburgCode TheDeclarationofHelsinki 68 NationalCommissionfortheProtectionofHumanSubjectsofBiomedicalandBehavioralResearch TheBelmontReportOfficeoftheSecretaryEthicalPrinciplesandGuidelinesfortheProtectionof HumanSubjectsofResearchTheNationalCommissionfortheProtectionofHumanSubjectsof BiomedicalandBehavioralResearchApril18,1979 AGENCY:DepartmentofHealth,Education,andWelfare. ACTION:NoticeofReportforPublicComment. SUMMARY:OnJuly12,1974,theNationalResearchAct(Pub.L.93-348)wassignedintolaw,there-bycreatingthe NationalCommissionfortheProtectionofHumanSubjectsofBiomedicalandBehavioralResearch.Oneofthecharges totheCommissionwastoidentifythebasicethicalprinciplesthatshouldunderlietheconductofbiomedicaland behavioralresearchinvolvinghumansubjectsandtodevelopguidelineswhichshouldbefollowedtoassurethatsuch researchisconductedinaccordancewiththoseprinciples.Incarryingouttheabove,theCommissionwasdirectedto consider:(i)theboundariesbetweenbiomedicalandbehavioralresearchandtheacceptedandroutinepracticeof medicine,(ii)theroleofassessmentofrisk-benefitcriteriainthedeterminationoftheappropriatenessofresearch involvinghumansubjects,(iii)appropriateguidelinesfortheselectionofhumansubjectsforparticipationinsuch researchand(iv)thenatureanddefinitionofinformedconsentinvariousresearchsettings. TheBelmontReportattemptstosummarizethebasicethicalprinciplesidentifiedbytheCommissioninthecourseof itsdeliberations.Itistheoutgrowthofanintensivefour-dayperiodofdiscussionsthatwereheldinFebruary1976at theSmithsonianInstitution'sBelmontConferenceCentersupplementedbythemonthlydeliberationsofthe Commissionthatwereheldoveraperiodofnearlyfouryears.Itisastatementofbasicethicalprinciplesandguidelines thatshouldassistinresolvingtheethicalproblemsthatsurroundtheconductofresearchwithhumansubjects.By publishingtheReportintheFederalRegister,andprovidingreprintsuponrequest,theSecretaryintendsthatitmaybe madereadilyavailabletoscientists,membersofInstitutionalReviewBoards,andFederalemployees.Thetwo-volume Appendix,containingthelengthyreportsofexperts andspecialistswhoassistedtheCommissioninfulfillingthispartofitscharge,isavailableasDHEWPublicationNo. (OS)78-0013andNo.(OS)78-0014,forsalebytheSuperintendentofDocuments,U.S.GovernmentPrintingOffice, Washington,D.C.20402. UnlikemostotherreportsoftheCommission,theBelmontReportdoesnotmakespecificrecommendationsfor administrativeactionbytheSecretaryofHealth,Education,andWelfare. Rather,theCommissionrecommendedthattheBelmontReportbeadoptedinitsentirety,asastatementofthe Department'spolicy.TheDepartmentrequestspubliccommentonthisrecommendation. NationalCommissionfortheProtectionofHumanSubjectsofBiomedicalandBehavioralResearch MembersoftheCommission KennethJohnRyan,M.D.,Chairman,ChiefofStaff,BostonHospitalforWomen.Joseph V.Brady,Ph.D.,ProfessorofBehavioralBiology,JohnsHopkinsUniversity.RobertE. Cooke,M.D.,President,MedicalCollegeofPennsylvania. DorothyI.Height,President,NationalCouncilofNegroWomen,Inc. 69 AlbertR.Jonsen,Ph.D.,AssociateProfessorofBioethics,UniversityofCaliforniaatSanFrancisco. PatriciaKing,J.D.,AssociateProfessorofLaw,GeorgetownUniversityLawCenter. KarenLebacqz,Ph.D.,AssociateProfessorofChristianEthics,PacificSchoolofReligion. ***DavidW.Louisell,J.D.,ProfessorofLaw,UniversityofCaliforniaatBerkeley. DonaldW.Seldin,M.D.,ProfessorandChairman,DepartmentofInternalMedicine,UniversityofTexasatDallas. ***EliotStellar,Ph.D.,ProvostoftheUniversityandProfessorofPhysiologicalPsychology,Universityof Pennsylvania. ***RobertH.Turtle,LL.B.,Attorney,VomBaur,Coburn,Simmons&Turtle,Washington,D.C. ***Deceased. EthicalPrinciples&GuidelinesforResearchInvolvingHumanSubjects Scientificresearchhasproducedsubstantialsocialbenefits.Ithasalsoposedsometroublingethicalquestions.Public attentionwasdrawntothesequestionsbyreportedabusesofhumansubjectsinbiomedicalexperiments,especially duringtheSecondWorldWar.DuringtheNurembergWarCrimeTrials,theNurembergcodewasdraftedasasetof standardsforjudgingphysiciansandscientistswhohadconductedbiomedical experimentsonconcentrationcampprisoners.Thiscodebecametheprototypeofmanylatercodes(1)intendedto assurethatresearchinvolvinghumansubjectswouldbecarriedoutinanethicalmanner.Thecodesconsistofrules, somegeneral,othersspecificthatguidetheinvestigatorsorthereviewersofresearchintheirwork.Suchrulesoften areinadequatetocovercomplexsituations;attimestheycomeintoconflict,andtheyarefrequentlydifficultto interpretorapply.Broaderethicalprincipleswillprovideabasisonwhichspecificrulesmaybeformulated,criticized andinterpreted. Threeprinciples,orgeneralprescriptivejudgments,thatarerelevanttoresearchinvolvinghumansubjectsare identifiedinthisstatement.Otherprinciplesmayalsoberelevant.Thesethreearecomprehensive,however, andarestatedatalevelofgeneralizationthatshouldassistscientists,subjects,reviewersandinterestedcitizensto understandtheethicalissuesinherentinresearchinvolvinghumansubjects.Theseprinciplescannotalwaysbeapplied soastoresolvebeyonddisputeparticularethicalproblems.Theobjectiveistoprovideananalyticalframeworkthat willguidetheresolutionofethicalproblemsarisingfromresearchinvolvinghumansubjects. Thisstatementconsistsofadistinctionbetweenresearchandpractice,adiscussionofthethreebasicethical principles,andremarksabouttheapplicationoftheseprinciples. PartA:BoundariesBetweenPractice&Research Itisimportanttodistinguishbetweenbiomedicalandbehavioralresearch,ontheonehand,andthepracticeof acceptedtherapyontheother,inordertoknowwhatactivitiesoughttoundergoreviewfortheprotectionofhuman subjectsofresearch.Thedistinctionbetweenresearchandpracticeisblurredpartlybecausebothoftenoccur together(asinresearchdesignedtoevaluateatherapy)andpartlybecausenotabledeparturesfromstandard practiceareoftencalled"experimental"whentheterms"experimental"and"research"arenotcarefullydefined. Forthemostpart,theterm"practice"referstointerventionsthataredesignedsolelytoenhancethewell-beingofan individualpatientorclientandthathaveareasonableexpectationofsuccess.Thepurposeofmedicalorbehavioral practiceistoprovidediagnosis,preventivetreatmentortherapytoparticularindividuals.(2)Bycontrast,theterm "research'designatesanactivitydesignedtotestanhypothesis,permitconclusionstobedrawn,andtherebyto developorcontributetothegeneralbaseofhumanknowledge(expressed,forexample,intheories,principles,and statementsofrelationships).Researchisusuallydescribedinaformalprotocolthatsetsforthanobjectiveandasetof proceduresdesignedtoreachthatobjective. 70 Whenacliniciandepartsinasignificantwayfromstandardoracceptedpractice,theinnovationdoesnot,inandof itself,constituteresearch.Thefactthataprocedureis"experimental,"inthesenseofnew,untestedordifferent,does notautomaticallyplaceitinthecategoryofresearch.Radicallynewproceduresofthis descriptionshould,however,bemadetheobjectofformalresearchatanearlystageinordertodeterminewhether theyaresafeandeffective.Thus,itistheresponsibilityofmedicalpracticecommittees,forexample,toinsistthata majorinnovationbeincorporatedintoaformalresearchproject.(3)Researchandpracticemaybecarriedontogether whenresearchisdesignedtoevaluatethesafetyandefficacyofatherapy.Thisneednotcauseanyconfusion regardingwhetherornottheactivityrequiresreview;thegeneralruleisthatifthereisanyelementofresearchinan activity,thatactivityshouldundergoreviewfortheprotectionofhumansubjects. PartB:BasicEthicalPrinciples Theexpression"basicethicalprinciples"referstothosegeneraljudgmentsthatserveasabasicjustificationforthe manyparticularethicalprescriptionsandevaluationsofhumanactions.Threebasicprinciples,amongthosegenerally acceptedinourculturaltradition,areparticularlyrelevanttotheethicsofresearchinvolvinghumansubjects:the principlesofrespectofpersons,beneficenceandjustice. 1.RespectforPersons.--Respectforpersonsincorporatesatleasttwoethicalconvictions:first,thatindividuals shouldbetreatedasautonomousagents,andsecond,thatpersonswithdiminishedautonomyareentitledto protection.Theprincipleofrespectforpersonsthusdividesintotwoseparatemoralrequirements:therequirementto acknowledgeautonomyandtherequirementtoprotectthosewithdiminishedautonomy. Anautonomouspersonisanindividualcapableofdeliberationaboutpersonalgoalsandofactingunderthedirection ofsuchdeliberation.Torespectautonomyistogiveweighttoautonomouspersons'consideredopinionsandchoices whilerefrainingfromobstructingtheiractionsunlesstheyareclearlydetrimentaltoothers.Toshowlackofrespect foranautonomousagentistorepudiatethatperson'sconsideredjudgments,todenyanindividualthefreedomtoact onthoseconsideredjudgments,ortowithholdinformationnecessarytomakeaconsideredjudgment,whenthereare nocompellingreasonstodoso. However,noteveryhumanbeingiscapableofself-determination.Thecapacityforself-determinationmaturesduring anindividual'slife,andsomeindividualslosethiscapacitywhollyorinpartbecauseofillness,mentaldisability,or circumstancesthatseverelyrestrictliberty.Respectfortheimmatureandtheincapacitatedmayrequireprotecting themastheymatureorwhiletheyareincapacitated. Somepersonsareinneedofextensiveprotection,eventothepointofexcludingthemfromactivitieswhichmayharm them;otherpersonsrequirelittleprotectionbeyondmakingsuretheyundertakeactivitiesfreelyandwithawareness ofpossibleadverseconsequence.Theextentofprotectionaffordedshoulddependupontheriskofharmandthe likelihoodofbenefit.Thejudgmentthatanyindividuallacksautonomyshouldbeperiodicallyreevaluatedandwillvary indifferentsituations. Inmostcasesofresearchinvolvinghumansubjects,respectforpersonsdemandsthatsubjectsenterintothe researchvoluntarilyandwithadequateinformation.Insomesituations,however,applicationoftheprincipleisnot obvious.Theinvolvementofprisonersassubjectsofresearchprovidesaninstructiveexample.Ontheonehand,it wouldseemthattheprincipleofrespectforpersonsrequiresthatprisonersnotbedeprivedoftheopportunityto volunteerforresearch.Ontheotherhand,underprisonconditionstheymaybesubtlycoercedorundulyinfluenced toengageinresearchactivitiesforwhichtheywouldnototherwisevolunteer.Respectforpersonswouldthendictate thatprisonersbeprotected.Whethertoallowprisonersto"volunteer"orto"protect"thempresentsadilemma. Respectingpersons,inmosthardcases,isoftenamatterofbalancingcompetingclaimsurgedbytheprincipleof respectitself. 71 2.Beneficence.--Personsaretreatedinanethicalmannernotonlybyrespectingtheirdecisionsandprotectingthem fromharm,butalsobymakingeffortstosecuretheirwell-being.Suchtreatmentfallsundertheprincipleof beneficence.Theterm"beneficence"isoftenunderstoodtocoveractsofkindnessorcharitythatgobeyondstrict obligation.Inthisdocument,beneficenceisunderstoodinastrongersense,asanobligation.Twogeneralruleshave beenformulatedascomplementaryexpressionsofbeneficentactionsinthissense:(1)donotharmand(2)maximize possiblebenefitsandminimizepossibleharms. TheHippocraticmaxim"donoharm"haslongbeenafundamentalprincipleofmedicalethics.ClaudeBernard extendedittotherealmofresearch,sayingthatoneshouldnotinjureonepersonregardlessofthebenefitsthat mightcometoothers.However,evenavoidingharmrequireslearningwhatisharmful;and,intheprocessof obtainingthisinformation,personsmaybeexposedtoriskofharm.Further,theHippocraticOathrequiresphysicians tobenefittheirpatients"accordingtotheirbestjudgment."Learningwhatwillinfactbenefitmayrequireexposing personstorisk.Theproblemposedbytheseimperativesistodecidewhenitisjustifiabletoseekcertainbenefits despitetherisksinvolved,andwhenthebenefitsshouldbeforegonebecauseoftherisks. Theobligationsofbeneficenceaffectbothindividualinvestigatorsandsocietyatlarge,becausetheyextendbothto particularresearchprojectsandtotheentireenterpriseofresearch.Inthecaseofparticularprojects,investigators andmembersoftheirinstitutionsareobligedtogiveforethoughttothemaximizationofbenefitsandthereduction ofriskthatmightoccurfromtheresearchinvestigation.Inthecaseofscientificresearchingeneral,membersofthe largersocietyareobligedtorecognizethelongertermbenefitsandrisksthatmay resultfromtheimprovementofknowledgeandfromthedevelopmentofnovelmedical,psychotherapeutic,andsocial procedures. Theprincipleofbeneficenceoftenoccupiesawell-definedjustifyingroleinmanyareasofresearchinvolvinghuman subjects.Anexampleisfoundinresearchinvolvingchildren.Effectivewaysoftreatingchildhooddiseasesand fosteringhealthydevelopmentarebenefitsthatservetojustifyresearchinvolvingchildren--even whenindividualresearchsubjectsarenotdirectbeneficiaries.Researchalsomakesitpossibletoavoidtheharm thatmayresultfromtheapplicationofpreviouslyacceptedroutinepracticesthatoncloserinvestigationturnoutto bedangerous.Buttheroleoftheprincipleofbeneficenceisnotalwayssounambiguous.Adifficultethicalproblem remains,forexample,aboutresearchthatpresentsmorethanminimalriskwithoutimmediateprospectofdirect benefittothechildreninvolved.Somehavearguedthatsuchresearchisinadmissible,whileothershavepointedout thatthislimitwouldruleoutmuchresearchpromisinggreatbenefittochildreninthe future.Hereagain,aswithallhardcases,thedifferentclaimscoveredbytheprincipleofbeneficencemaycomeinto conflictandforcedifficultchoices. 3.Justice.--Whooughttoreceivethebenefitsofresearchandbearitsburdens?Thisisaquestionofjustice,inthe senseof"fairnessindistribution"or"whatisdeserved."Aninjusticeoccurswhensomebenefittowhichapersonis entitledisdeniedwithoutgoodreasonorwhensomeburdenisimposedunduly.Anotherwayofconceivingthe principleofjusticeisthatequalsoughttobetreatedequally.However,thisstatementrequiresexplication.Whois equalandwhoisunequal?Whatconsiderationsjustifydeparturefromequaldistribution?Almostallcommentators allowthatdistinctionsbasedonexperience,age,deprivation,competence,meritandpositiondosometimesconstitute criteriajustifyingdifferentialtreatmentforcertainpurposes.Itisnecessary,then,toexplaininwhatrespectspeople shouldbetreatedequally.Thereareseveralwidelyacceptedformulationsofjustwaystodistributeburdensand benefits.Eachformulationmentionssomerelevantpropertyonthebasisofwhichburdensandbenefitsshouldbe distributed.Theseformulationsare(1)toeachpersonanequalshare,(2)toeachpersonaccordingtoindividualneed, (3)toeachpersonaccordingtoindividualeffort,(4)toeachpersonaccordingtosocietalcontribution,and(5)toeach personaccordingtomerit. 72 Questionsofjusticehavelongbeenassociatedwithsocialpracticessuchaspunishment,taxationandpolitical representation.Untilrecentlythesequestionshavenotgenerallybeenassociatedwithscientificresearch.However, theyareforeshadowedevenintheearliestreflectionsontheethicsofresearchinvolvinghumansubjects.Forexample, duringthe19thandearly20thcenturiestheburdensofservingasresearchsubjectsfelllargelyuponpoorward patients,whilethebenefitsofimprovedmedicalcareflowedprimarilytoprivatepatients.Subsequently,the exploitationofunwillingprisonersasresearchsubjectsinNaziconcentrationcampswascondemnedasaparticularly flagrantinjustice.Inthiscountry,inthe1940's,theTuskegeesyphilisstudyuseddisadvantaged,ruralblackmento studytheuntreatedcourseofadiseasethatisbynomeansconfinedtothatpopulation.Thesesubjectsweredeprived ofdemonstrablyeffectivetreatmentinordernottointerrupttheproject,longaftersuchtreatmentbecamegenerally available.Againstthishistoricalbackground,itcanbeseenhowconceptionsofjusticearerelevanttoresearch involvinghumansubjects.Forexample,theselectionofresearchsubjectsneedstobescrutinizedinordertodetermine whethersomeclasses(e.g.,welfarepatients,particularracialandethnicminorities,orpersonsconfinedtoinstitutions) arebeingsystematicallyselectedsimplybecauseoftheireasyavailability,theircompromisedposition,ortheir manipulability,ratherthanforreasonsdirectlyrelatedtotheproblembeingstudied.Finally,wheneverresearch supportedbypublicfundsleadstothedevelopmentoftherapeuticdevicesandprocedures,justicedemandsboththat thesenotprovideadvantagesonlytothosewhocanaffordthemandthatsuchresearchshouldnotundulyinvolve personsfromgroupsunlikelytobeamongthebeneficiariesofsubsequentapplicationsoftheresearch. 73 TheNuremburgCode 1.Thevoluntaryconsentofthehumansubjectisabsolutelyessential.Thismeansthatthepersoninvolvedshouldhave legalcapacitytogiveconsent;shouldbesosituatedastobeabletoexercisefreepowerofchoice,withoutthe interventionofanyelementofforce,fraud,deceit,duress,over-reaching,orotherulteriorformofconstraintor coercion;andshouldhavesufficientknowledgeandcomprehensionoftheelementsofthesubjectmatterinvolvedas toenablehimtomakeanunderstandingandenlighteneddecision.Thislatterelementrequiresthatbeforethe acceptanceofanaffirmativedecisionbytheexperimentalsubjectthereshouldbe madeknowntohimthenature,duration,andpurposeoftheexperiment;themethodandmeansbywhichitis tobeconducted;allinconveniencesandhazardsreasonabletobeexpected;andtheeffectsuponhishealthor personwhichmaypossiblycomefromhisparticipationintheexperiment.Thedutyandresponsibilityfor ascertainingthequalityoftheconsentrestsuponeachindividualwhoinitiates,directsorengagesintheexperiment. Itisapersonaldutyandresponsibilitywhichmaynotbedelegatedtoanotherwithimpunity. 2.Theexperimentshouldbesuchastoyieldfruitfulresultsforthegoodofsociety,unprocurablebyother methodsormeansofstudy,andnotrandomandunnecessaryinnature. 3.Theexperimentshouldbesodesignedandbasedontheresultsofanimalexperimentationandaknowledgeofthe naturalhistoryofthediseaseorotherproblemunderstudythattheanticipatedresultswilljustifytheperformanceof theexperiment. 4.Theexperimentshouldbesoconductedastoavoidallunnecessaryphysicalandmentalsufferingandinjury. 5.Noexperimentshouldbeconductedwherethereisanapriorireasontobelievethatdeathordisablinginjurywill occur;except,perhaps,inthoseexperimentswheretheexperimentalphysiciansalsoserveassubjects. 6.Thedegreeofrisktobetakenshouldneverexceedthatdeterminedbythehumanitarianimportanceofthe problemtobesolvedbytheexperiment. 7.Properpreparationsshouldbemadeandadequatefacilitiesprovidedtoprotecttheexperimentalsubject againstevenremotepossibilitiesofinjury,disability,ordeath. 8.Theexperimentshouldbeconductedonlybyscientificallyqualifiedpersons.Thehighestdegreeofskillandcare shouldberequiredthroughallstagesoftheexperimentofthosewhoconductorengageintheexperiment. 9.Duringthecourseoftheexperimentthehumansubjectshouldbeatlibertytobringtheexperimenttoanendifhe hasreachedthephysicalormentalstatewherecontinuationoftheexperimentseemstohimtobeimpossible. 10.Duringthecourseoftheexperimentthescientistinchargemustbepreparedtoterminatetheexperimentatany stage,ifhehasprobablecausetobelieve,intheexerciseofthegoodfaith,superiorskillandcarefuljudgmentrequired ofhimthatacontinuationoftheexperimentislikelytoresultininjury,disability,ordeath totheexperimentalsubject. ReprintedfromTrialsofWarCriminalsbeforetheNurembergMilitaryTribunalsunderControlCouncilLawNo. 10,Vol.2,pp.181-182..Washington,D.C.:U.S.GovernmentPrintingOffice,1949. 74 TheDeclarationofHelsinki Adoptedbythe18thWorldMedicalAssembly,Helsinki,Finland,June1964,amendedbythe29thWorldMedical Assembly,Tokyo,Japan,October1975,andthe35thWorldMedicalAssembly,Venice,Italy,October1983. Introduction Itisthemissionofthephysiciantosafeguardthehealthofthepeople.Hisorherknowledgeandconscienceare dedicatedtothefulfillmentofthismission. TheDeclarationofGenevaoftheWorldMedicalAssociationbindsthephysicianwiththewords,"Thehealthofmy patientwillbemyfirstconsideration,“andtheInternationalCodeofMedicalEthicsdeclaresthat,"Aphysicianshall actonlyinthepatient'sinterestwhenprovidingmedicalcarewhichmighthavetheeffectofweakeningthephysical andmentalconditionofthepatient." Thepurposeofbiomedicalresearchinvolvinghumansubjectsmustbetoimprovediagnostic,therapeuticand prophylacticproceduresandtheunderstandingoftheaetiologyandpathogenesisofdisease. Incurrentmedicalpracticemostdiagnostic,therapeuticorprophylacticproceduresinvolvehazards.Thisapplies especiallytobiomedicalresearch.Medicalprogressisbasedonresearchwhichultimatelymustrestinparton experimentationinvolvinghumansubjects.Inthefieldofbiomedicalresearchafundamentaldistinctionmustbe recognizedbetweenmedicalresearchinwhichtheaimisessentiallydiagnosticortherapeuticforapatient,and medicalresearchtheessentialobjectofwhichispurelyscientificandwithoutimplyingdirectdiagnosticortherapeutic valuetothepersonsubjectedtotheresearch. Specialcautionmustbeexercisedintheconductofresearchwhichmayaffecttheenvironment,andthewelfareof animalsusedforresearchmustberespected. Becauseitisessentialthattheresultsoflaboratoryexperimentsbeappliedtohumanbeingstofurtherscientific knowledgeandtohelpsufferinghumanity,theWorldMedicalAssociationhaspreparedthefollowing recommendationsasaguidetoeveryphysicianinbiomedicalresearchinvolvinghumansubjects.Theyshouldbe keptunderreviewinthefuture.Itmustbestressedthatthestandardsasdraftedareonlyaguidetophysiciansall overtheworld.Physiciansarenotrelievedfromcriminal,civilandethicalresponsibilitiesunderthelawoftheirown countries. I. BasicPrinciples 1.Biomedicalresearchinvolvinghumansubjectsmustconformtogenerallyacceptedscientificprinciplesand shouldbebasedonadequatelyperformedlaboratoryandanimalexperimentationandonathoroughknowledgeof thescientificliterature. 2. The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol which should be transmitted to a specially appointed independent committeeforconsideration,commentandguidance. 3.Biomedicalresearchinvolvinghumansubjectsshouldbeconductedonlybyscientificallyqualifiedpersonsandunder thesupervisionofaclinicallycompetentmedicalperson.The responsibilityforthehumansubjectmustalwaysrestwithamedicallyqualifiedpersonandneverrestonthe subjectoftheresearch,eventhoughthesubjecthasgivenhisorherconsent. 4.Biomedicalresearchinvolvinghumansubjectscannotlegitimatelybecarriedoutunlesstheimportanceofthe objectiveisinproportiontotheinherentrisktothesubject. 5.Everybiomedicalresearchprojectinvolvinghumansubjectsshouldbeprecededbycarefulassessmentofpredictable risksincomparisonwithforeseeablebenefitstothesubjectortoothers.Concernfortheinterestsofthesubjectmust alwaysprevailovertheinterestsofscienceandsociety. 75 6.Therightoftheresearchsubjecttosafeguardhisorherintegritymustalwaysberespected.Everyprecaution shouldbetakentorespecttheprivacyofthesubjectandtominimizetheimpactofthestudyonthesubject'sphysical andmentalintegrityandonthepersonalityofthesubject. 7.Physiciansshouldabstainfromengaginginresearchprojectsinvolvinghumansubjectsunlesstheyaresatisfied thatthehazardsinvolvedarebelievedtobepredictable.Physiciansshouldceaseanyinvestigationifthehazards arefoundtooutweighthepotentialbenefits. 8.Inpublicationoftheresultsofhisorherresearch,thephysicianisobligedtopreservetheaccuracyoftheresults. ReportsofexperimentationnotinaccordancewiththeprincipleslaiddowninthisDeclarationshouldnotbe acceptedforpublication. 9.Inanyresearchonhumanbeings,eachpotentialsubjectmustbeadequatelyinformedoftheaims,methods, anticipatedbenefitsandpotentialhazardsofthestudyandthediscomfortitmayentail.Heorsheshouldbeinformed thatheorsheisatlibertytoabstainfromparticipationinthestudyandthatheorsheisfreetowithdrawvisorher consenttoparticipationatanytime.Thephysicianshouldthenobtainthesubject'sfreelygiveninformedconsent, preferablyinheriting. 10.Whenobtaininginformedconsentfortheresearchprojectthephysicianshouldbeparticularlycautiousifthe subjectisindependentrelationshiptohimorherormayconsentunderduress.Inthatcasetheinformedconsent shouldbeobtainedbyaphysicianwhoisn'tengagedintheinvestigationandwhoiscompletelyindependentofthis officialrelationship. 11.Incaseoflegalincompetence,informedconsentshouldbeobtainedfromthelegalguardianinaccordancewith nationallegislation.Wherephysicalormentalincapacitymakesitimpossibletoobtaininformedconsent,orwhen thesubjectisaminor,permissionfromtheresponsiblerelativereplacesthatofthesubjectinaccordancewith nationallegislation.Whenevertheminorchildisinfactabletogiveaconsent,theminor'sconsentmustbeobtained inadditiontotheconsentoftheminor'slegalguardian. 12.Theresearchprotocolshouldalwayscontainastatementoftheethicalconsiderationsinvolvedandshould indicatethattheprinciplesenunciatedinthepresentdeclarationarecompliedwith. II. MedicalResearchCombinedwithProfessionalCare(ClinicalResearch) 1.Inthetreatmentofthesickperson,thephysicianmustbefreetouseanewdiagnosticandtherapeutic measure,ifinhisorherjudgmentitoffershopeofsavinglife,re-establishinghealthoralleviatingsuffering. 2.Thepotentialbenefits,hazardsanddiscomfortofanewmethodshouldbeweighedagainsttheadvantagesof thebestcurrentdiagnosticandtherapeuticmethods. 3.Inanymedicalstudy,everypatient-includingthoseofacontrolgroup,ifany-shouldbeassuredofthebest provendiagnosticandtherapeuticmethod. 4.Therefusalofthepatienttoparticipateinastudymustneverinterferewiththephysician-patient relationship. 5.Ifthephysicianconsidersitessentialnottoobtaininformedconsent,thespecificreasonsforthisproposal shouldbestatedintheexperimentalprotocolfortransmissiontotheindependentcommittee(1,2). 6. The physician can combine medical research with professional care, the objective being the acquisition of new medicalknowledge,onlytotheextentthatmedicalresearchisjustifiedbyitspotentialdiagnosticortherapeuticvalue forthepatient. III.Non-TherapeuticBiomedicalResearchInvolvingHumanSubjects(Non-ClinicalBiomedical Research) 1.Inthepurelyscientificapplicationofmedicalresearchcarriedoutonahumanbeing,itisthedutyofthe physiciantoremaintheprotectorofthelifeandhealthofthatpersononwhombiomedicalresearchisbeing carriedout. 76 2.Thesubjectsshouldbevolunteers-eitherhealthypersonsorpatientsforwhomtheexperimentaldesignisnot relatedtothepatient'sillness. 3.Theinvestigatorortheinvestigatingteamshoulddiscontinuetheresearchifinhis/herortheirjudgmentitmay,if continued,beharmfultotheindividual. 4.Inresearchonman,theinterestofscienceandsocietyshouldnevertakeprecedenceoverconsiderationsrelatedto thewell-beingofthesubject. Citeas: WorldMedicalOrganization.DeclarationofHelsinki.BritishMedicalJournal(7December) 1996;313(7070):1448-1449. 77 78
