institutional review board (irb) form 1 initial ......question mark icon, throughout the application...
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Institutional Review Board (IRB)Form 1 Initial Application Step-by-Step Instructions
updatedJune 2018
Institutional Review Board(865) 974-7697, [email protected]
irb.utk.edu
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Institutional Review Board (IRB) Human Research Protection Program (HRPP)
TheUniversityofTennessee,KnoxvilleOfficeofResearchandEngagement1534WhiteAvenue(BlountHall)
KnoxvilleTN37996-1529
(865) 974-7697 [email protected]
Kristine Hershberger, CIP,
HRPP Director and IRB Compliance Officer [email protected]
CollegeofEngineeringCollegeofLaw
CollegeofNursingCOHPAudiologyandSpeechPathology
Jennifer Engle IRB Assistant Compliance Officer
CollegeofArchitecture&DesignHaslamCollegeofBusiness
CollegeofEducation,Health&HumanSciencesUniversity-WideUnits
Sara Mulville IRB Assistant Compliance Officer
CollegeofAgriculturalSciences&NatResourcesCollegeofArts&Sciences
CollegeofCommunication&InformationCollegeofSocialWork
CollegeofVeterinaryMedicine
Tammy Loy, Compliance Coordinator [email protected]
Colleen P. Gilrane, IRB [email protected] Marlys Staudt, IRB Vice [email protected]
Tami Wyatt, IRB Vice [email protected]
June 2018
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3
Form 1 Initial Submission Instructions ApplyingforInstitutionalReviewBoard(IRB)Approval
UsingtheUT,KnoxvilleApplicationRevised6/1/2018
Thisguideincludesscreen-by-screeninstructionsforcompletingtheapplicationforinitialapprovalofanewprojectbytheUT,KnoxvilleIRB.Youwillnotseeallofthescreensshownhere;thesoftwarewillbranchyoutothoseappropriatetoyourapplication,basedonyourresponses.
PleasecontacttheIRBatutkirb@utk.eduor974-7697ifyouneedfurtherassistance.
Table of Contents Initial Screens (all applications) 4 - 7
NewApplicationKeyStudyPersonnelReviewBoardRoutingFundingStudy/ProjectInformation
Exempt Application 8 - 10 Expedited Screening Questions 11 Expedited & Full Board Application 12 - 20 Closing Screens (all applications) 21 - 23
ConflictofInterestHIPAAFERPAReferencesRoutingFormAttachments
Appendix: HIPAA Screens Specific to Studies using PHI 24 - 26
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Initial Screens (all applications) 4
Application Screen Completion Instructions
BeginbyloggingintotheiMedRISonlinesubmissionsystemathttps://ris01.uthsc.eduusingyourUTKnetIDandpassword.IfthisisyourfirsttimeiniMedRIS,itmaytake24hoursafteryourinitialloginforthesystemtosetupyouraccount,andforyoutohavetheStudyAssistantmenu(nextscreen)available.(StudyAssistantisneededtosubmitanapplication.)ContacttheIRBifyouhavequestionsorencounterdifficultiesloggingin.
InyourStudyAssistantmenu,selectAddaNewProject.Whenyoucomebacktoworkontheprojectonceit'sbeencreated,youwillfinditasa"Draft"inMyProjects.
Pleasenotethathelpisavailablewheneverthereisaquestionmarkicon,throughouttheapplicationaswellasatthetopofyourscreen.
BesuretoselectUTKIRBApplication!!IfyousendyourapplicationtotheHealthSciencesCenterinMemphis,ortotheGraduateSchoolofMedicine,ortoaBiosafetyCommittee,theUTIRBcannotseeit,reviewit,orapproveit.
1.0GeneralInformationEnterthecompletetitleofyourstudy(sameasanyfundingproposals,ifapplicable)inthefirsttextbox."WorkingTitle"isanabbreviatedversion(andiswhatyouwillseeinyour"MyProjects"listing).
2.0AddDepartment(s)Yourdefaultdepartment(fromtheUTLDAPdirectory)isalreadylistedandselected.Please"add"otherdepartmentsasappropriate,bothforyourselfandforothersaffiliatedwithyourproject,andthenindicatewhichisthePrimaryDepartmenti.e.,theonethatwillreviewandapprove,andwillhaveoversightresponsibility.
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Initial Screens (all applications) 5
Application Screen Completion Instructions
3.0Assignkeystudypersonnel3.1ThePrincipalInvestigatormustbethesameaslistedonanyfundingproposals(ifapplicable).GraduateorundergraduatestudentsservingasPIsmustselect"Student"andnameanAdvisorin3.4.3.2ResearchStaff(NB:CollaboratorsfromoutsideUTKshouldnotbelistedhere,butin(650)or(925)below.)Therearetwocategoriesofresearchstaff:• AdditionalInvestigatorsincludeCo-PIs,Co-
InvestigatorsandSub-InvestigatorsatUTK.TheymustcompleteCITItrainingandmustsignoffontheinitialapplication.
• ResearchSupportStaffincludeResearchAssistants,ResearchAssociates,StudyCoordinator,DataAnalyst,ResearchStaff,andotherindividuals(seedropdownmenu).TheseindividualsmustcompleteCITItrainingbutarenotrequiredtosignoffontheapplication.
3.3ProjectContact:ThePIwillautomaticallybeaprojectcontact,andyoushouldaddanyoneelsewhomyouwishtoreceiveallautomatednotificationsfromiMedRIS.StudentsmustaddtheirAdvisorsasProjectContacts.3.4StudentsmustaddtheirFacultyAdvisor3.5DepartmentalApprovals:YoumustaddaDepartmentReviewChair(DRC)andaDepartmentHead(calledDepartmentChair)iniMedRIS.NB:IfyouareamemberofthestudystaffandtheDRCorDeptHead,youmustdesignatesomeoneelsetoserveasreviewerforyouonthisstudy.ApprovingyourownprojectwouldpresentaConflictofInterest.3.6ResearchAdministrativeSpecialist(s):Iftherearestaffmemberswhoseworkwillbeonlyadministrative—theywillnotenrollorconsentparticipants,orcollectoranalyzedata,oraccessstudyrecords—theymaybelistedhereanddonotneedCITItraining.
Please check with your Department/College for specific instructions regarding how Departmental Approvals are handled—some units have specific arrangements with the IRB that you need to know before you complete screen 3 and route for signatures (at the end of the application below).
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Initial Screens (all applications) 6
Application Screen Completion Instructions
(300)UTKIRBSubmissionClassification:IndicateifyourstudyisaResearchProject,aDissertation,aThesis,oranUndergraduateHonorsThesis.Mostprojectsfallintooneofthesecategories;ifyoubelieveyoursdoesnot,select"other"andspecifythecategoryinthetextbox.Submissionstatus:Leavethedefault,"Iamrequestinginitialapprovalforresearch,"unlessyouhavebeeninconversationwiththeIRBandhavebeenexplicitlytoldtoselecttheotheroption.
(415)UTKKeyProjectStudyContactInformation(417)UTKKeyStudyPersonnel(KSP)CredentialsPleaseincludeinthesesectionstherequestedinformationforthefollowingcategoriesofpersonnelwhoareaffiliatedwiththeUniversityofTennessee,Knoxville(aslistedinsection3.0above):
• 3.1PrincipalInvestigator• 3.2ResearchStaff• 3.3ProjectContact• 3.4FacultyAdvisor
Youwilllistcollaboratorsatotherinstitutionsinyourstudydesign/proceduresbelowin(925)Study/ProjectSynopsis.
(420)ReviewBoardRoutingQuestionsPleaseanswerthesequestionscarefullyastheIRBusesthisinformationtodeterminewhetherornotcoordinationwithothercomplianceofficesoncampusisneededforyourproject.
(468)FundingSourceIfyourespond,"No,"inscreen468,youwillnotseetherestofthefundingscreens.(470)FundingSourceIfyourespond,"Yes,"inscreen468,youwillbeaskedtonameyourfundingsourcehere.
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Initial Screens (all applications) 7
Application Screen Completion Instructions
(475)ContractInformationIfyouresponded"Yes"to(468),pleaseselectfromthedrop-downmenutheofficeorinstitutionthatisprocessingyourgrantorcontract(orspecify"other).Pleaseindicatewhereyouareinthesubmission/fundingprocess.(TheIRBpreferstoreviewyourworkbeforeyouhaveyourfunding,topreventdeadlinecriseslater.)ProposaltitlesthatarethesamehelptheIRBcoordinatewiththeOfficeofSponsoredProjects,whichfacilitatessettingupyouraccounts.(SomesponsorsrequiretheIRBapplicationtitletomatchthegrantproposaltitle.)TheseAwardnumbers,whenknown,arethemostefficientwayfortheIRBtocommunicatewiththeOfficeofSponsoredProgramsaboutyourproject.
(485)Study/ProjectInformationPleaseindicatethelevelofreviewyoubelieveisrequiredforyourstudy,aswellaswhetherornotyouareadministeringandevaluatingadrug,device,and/orbiologicaspartofyourproject.Yourresponsesherewillbranchyoutothenextappropriatescreens.
(490)Drug,Biologics,andDeviceInformationandAdministrationYouwillreceivethisscreenonlyifyouselected"Yes"abovethatyourstudyinvolvesadrug,biologicordevice.Pleasenameanddescribetherelevantitemsandthetrainingandexperienceofthepersonswhowillbeauthorizedtoadministertheminyourstudy.
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Exempt Application 8
Application Screen Completion Instructions
(591)ExemptCategoriesYouwillreceivethisscreenifyouselected"Exempt"in(485).Pleasereadthedescriptionsofeachcategorycarefully;andindicatefortheIRBifyourprojectfitsCategory2,Category4,orboth.
(653)StudiesInvolvingExistingDataYouwillreceivethisscreenifyouselectedCategory4above.Ifyourstudyinvolvesthereviewofexistingdata,thissectioniswhereyougivethereviewertheinformationaboutthedatasetthatisneededtodetermineifitqualifiesforExemptCategory4.Itisimportantthatyouruseofthedatainyourstudyisnotinviolationofwhateverconsenttheparticipantsgavewhenthedatawerefirstcollected,andthatwhoeverownsthedatahasgivenyoupermissiontouseitforresearchpurposes.Pleasenotethatifyourdatasetislistedathttp://irb.utk.edu/public-use-data-sets/andifyourstudycomplieswiththeconditionslistedthere,youdonotneedtoapplyforExemptreviewandmaybegin.
(658)SurveyorInterviewYouwillreceivethisscreenifyouselectedCategory2above.Ifyourstudyinvolvestheadministrationoftests,surveys,etc.,thisisthesectionwhereyougivethereviewertheinformationneededtodetermineifitqualifiesforExemptCategory2or3.Thereviewwillattendparticularlytotherelationshipbetweenyourparticipantpopulationandthesensitivityofthequestionsyouareasking.PleasenotethatCategory2doesnotapplytoresearchwithchildren.Pleaseattachattheendoftheapplicationacopyofyourinstrument,uploadingitasanOtherStudyDocumentinthe"Surveys/Questionnaires/DataCollectionInstruments"category.DonotincludetheConsentStatementpageinthesurvey,attachitseparately—see(660)below.
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Exempt Application 9
Application Screen Completion Instructions
(660)InformedConsentInformedConsentproceduresarealwaysrequiredbeforeyoumaycollectdatafromlivingindividuals,evenwhenyoudonotcollectsignedforms.Mostinvestigatorswillselectoption#2forExemptCategory2studies,anduseanInformationSheet/ConsentElementsasthefirstpage/screenoftheirsurvey.Pleaseseehttp://irb.utk.edu/forms/forsampleformsincludingtherequiredelementsofInformedConsent.Pleaseattachattheendoftheapplicationacleancopyofyourconsentformtobereviewed,anddatedandstampedifIRBapproved,uploadingitasanInformedConsentDocument,andselectingthe"ConsentStatement/Elements"category.
(925)Study/ProjectSynopsisUsethetextbox(byclickingonthetexteditor)todescribeyourresearchplansusingthefoursubheadingsprovided.(Manyinvestigatorsprefertowritethissectioninawordprocessordocument,andthencopyandpastethetextintoiMedRIS.)Item#3iswhereyoushouldnameanynon-UTKnoxvillecollaboratorsandtheirinstitutions,anddescribetheirrolesinyourstudy.(1075)Background&CurrentStatusofWorkintheFieldPleaseprovideasummarydescriptionofworkinyourfieldthatshouldprovide—toalayaudience—ascientificrationaleforyourstudy.
(1200)SiteInformationPleaselistinthetextboxalllocationswhereyourstudywilltakeplace,andinformationaboutwhichprocedureswilltakeplaceatwhichsites,ifmorethanone.TheIRBmusthavedocumentationthatyouhavepermissiontoconductresearchatothersites.Theseletters• mustbeonofficialletterheadofthe
school/business/organization(notofUT)and• mustexplicitlybepermissionforresearch.Pleaseattachthemattheendoftheapplicationas"OtherStudyDocuments"intheLetterofSupportcategory.
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Exempt Application 10
Application Screen Completion Instructions
(1400)ParticipantPopulationItisveryimportantfortheIRBtoknowwhoyourparticipantswillbe,andhowmanyofthemtherewillbe.Youmaynotenrollmoreparticipantsthanareapproved,sodecidecarefullywhatnumbertoenterhere.Theagerangeiscriticalasresearchinvolvingminors(anyoneunder18yearsofage)requiresspecialprotections,includingparentpermission.Inaddition,dependingonthetypeofstudyactivities,otheragegroupsmightbeatincreasedrisk.Ifyouplantoexcludeanyracialorethnicgroup,youmustprovidearationalefordoingso.
(1488)VulnerableParticipantsPleasereadandcompletethissectionverycarefully;manyapplicationsarereturnedforcorrectioninthisarea.Donotassumeyourparticipantsarenotvulnerablebeforereadingthelistofcategories.Dependingonthecategoryofvulnerableparticipant,andthedesignofthestudy,itmaynotbethecasethatanyspecialprotectionsareneeded;ifso,justexplainthatinthetextbox.Ifspecialprotectionsarewarranted,youwillexplaintheminyourselectionandrecruitmentprocedures,andinyourinclusion/exclusioncriteria.
(1490)(1492)FERPAInthefirstscreen,pleaseselect"Yes"or"No"toindicatewhetherornotyouareseekingtouseinformationprotectedundertheFamilyEducationalRights&PrivacyAct(FERPA)withoutparticipants'consent.Pleaseseehttp://ferpa.utk.edu/formoreinformationaboutFERPAontheUTcampus.Ifyouselect"Yes"youwillbebranchedtothesecondscreen,inwhichyouneedto• describeinthetextboxtheFERPA-protected
materialyouwishtouse,and• attachattheendoftheapplicationdocumentation
ofyourpermissionfromtheUniversity'sFERPAofficertodoso.
(3300)ConflictofInterestPleasereadverycarefullyandindicatewhetheryouoranyofyourkeystudypersonnel(ortheirfamilies)haveaconflictofinterestwithrespecttoanysponsorofyourresearchoranyentitybeingstudiedinyourresearch.Ifyouselect"Yes"foranyofthesequestions,youwillneedtohaveaConflictofInterestManagementPlaninplacethatincludesdisclosuretoparticipantsintheInformedConsentform.
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Expedited & Full Board Application 11
Application Screen Completion Instructions
(701)Define"Expedited"andMinimalRiskIfyouselected"Expedited"in(485)above,youwillreceivethisscreen.Pleaserespondtothesecondquestioncarefully:ifconfidentialitywerebreached,wouldyourparticipantsbeatrisk?IfyourresponsestothefirsttwoquestionsindicateyoumaybeeligibleforExpeditedreview,youwillbeaskedtoindicatethecategoriesthatapplytoyourstudy;pleasereadcarefullyandselectallcategoriesthatapply.
(780)NotExpeditedIfyourresponsesaboveindicatethatyourstudyisnoteligibleforExpeditedreview,youwillbedirectedtosubmitusingtheFullBoardapplication.
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Expedited & Full Board Application 12
(925)Study/ProjectSynopsisUsethetextbox(byclickingonthetexteditor)todescribeyourresearchplansusingthefoursubheadingsprovided.PleaseprovideenoughdetailthattheIRBunderstandsclearlywhatyouproposetodo,withwhom,andwhy.(Manyinvestigatorsprefertowritethissectioninawordprocessordocument,andthencopyandpastethetextintoiMedRIS.)Item#3iswhereyoushouldnameanynon-UTKnoxvillecollaboratorsandtheirinstitutions,anddescribetheirrolesinyourstudy.(1075)Background&CurrentStatusofWorkintheFieldPleaseprovideasummarydescriptionofworkinyourfieldthatshouldprovide—toalayaudience—ascientificrationaleforyourstudy.
(1200)SiteInformationPleaselistinthetextboxalllocationswhereyourstudywilltakeplace,andinformationaboutwhichprocedureswilltakeplaceatwhichsites,ifmorethanone.TheIRBmusthavedocumentationthatyouhavepermissiontoconductresearchatothersites.Theseletters• mustbeonofficialletterheadofthe
school/business/organization(notofUT)and• mustexplicitlybepermissionforresearch.Pleaseattachthemattheendoftheapplicationas"OtherStudyDocuments"intheLetterofSupportcategory.
(1400)ParticipantPopulationItisveryimportantfortheIRBtoknowwhoyourparticipantswillbe,andhowmanyofthemtherewillbe.Youmaynotenrollmoreparticipantsthanareapproved,sodecidecarefullywhatnumbertoenterhere.Theagerangeiscriticalasresearchinvolvingminors(anyoneunder18yearsofage)requiresspecialprotections,includingparentpermission.Inaddition,dependingonthetypeofstudyactivities,otheragegroupsmightbeatincreasedrisk.Ifyouplantoexcludeanyracialorethnicgroup,youmustprovidearationalefordoingso.
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Expedited & Full Board Application 13
(1488)VulnerableParticipantsPleasereadandcompletethissectionverycarefully;manyapplicationsarereturnedforcorrectioninthisarea.Donotassumeyourparticipantsarenotvulnerablebeforereadingthelistofcategories.Dependingonthecategoryofvulnerableparticipant,andthedesignofthestudy,itmaynotbethecasethatanyspecialprotectionsareneeded.Ifspecialprotectionsarewarranted,youwillexplaintheminyourselectionandrecruitmentprocedures,andinyourinclusion/exclusioncriteria.
(1490)(1492)FERPAInthefirstscreen,pleaseselect"Yes"or"No"toindicatewhetherornotyouareseekingtouseinformationprotectedundertheFamilyEducationalRights&PrivacyAct(FERPA)withoutparticipants'consent.Pleaseseehttp://ferpa.utk.edu/formoreinformationaboutFERPAontheUTcampus.Ifyouselect"Yes"youwillbebranchedtothesecondscreen,inwhichyouneedto• describeinthetextboxtheFERPA-protected
materialyouwishtouse,and• attachattheendoftheapplicationdocumentation
ofyourpermissionfromtheUniversity'sFERPAofficertodoso.
(1494)Study/ProjectDurationPleasedescribeinthetextboxhowlongyouexpectanyindividualparticipanttobeinvolvedinstudyactivities.Besurethatwhatyouwriteherematcheswhatyoutellparticipantsabouttimeestimatesinyourconsentform.Usethecalendartoindicatehowlongyouexpecttheentireprojecttolast,includingdataanalysis.Thisisanestimate,andmaybechangedatanytime.
(1600)ParticipantRecruitmentPleaseindicateifyourresearchislimitedsolelytothesecondaryuseofde-identifieddata;inthiscase,youwillskiptherestoftherecruitmentsection.
Ifyouarerecruitingparticipants,youwillbeaskedfirsttoindicatehowyouwillidentifypotentialparticipantsforstudy.
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Expedited & Full Board Application 14
Inthetextbox,describehowtheidentificationwillbecarriedout,includingsuchdetailsashowyouhaveobtainedaccesstoanylistsorrecords,orhowindividualsmightbereferredtoyourstudy.Then,checkalldirectand/orindirectmethodsthatyouwillusetocontactpotentialparticipantsforyourproject.
Describeinthetextboxtheproceduresyouwillfollowtocarryouttherecruitmentmethodsyouhavecheckedinthelist(s)above.
Ifyouplantocontactpotentialparticipantsmorethanoncetoinvitethemtoparticipate,select"Yes"andyouwillreceivethetextboxtodescribethetimingofthesecontacts.
Ifyourprojectwillinvolveeligibilityscreening,select"Yes"andthenprovidedetailsinthetextbox,addressingthebulletpointslisted.RecruitmentMaterials:TheIRBmustreviewallrecruitmentmaterials,suchasflyers,emails,invitationletters,verbalscripts,orsocialmediaposts.Pleaseattachtheseattheendoftheapplication,as"OtherStudyDocuments"intheRecruitment/AdvertisingMaterialscategory.
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(2000)Risks&BenefitsAssessingtherisk/benefitratioofastudyisoneoftheIRB'smostimportanttasks,andthisiswhereyougivetheinformationnecessaryforthatassessment.Inthefirsttextbox,listany/allpotentialrisks,including(butnotlimitedto)
• violationofprivacy• breachofconfidentiality• distress• physicalharm
Inthesecondtextbox,describetheproceduresthatyouhavebuiltintoyourstudytominimizetherisks.Benefitreferstothegoodthatmayresultfromyourresearch,andtheremustbeapossiblesocietalorscientificbenefit,evenifthereisnotanydirectbenefittoyourindividualparticipantsortotheclassofparticipants.Whenyoudescribethepotentialbenefit(s)ofyourstudyinthetextbox,rememberthatincentivesorcompensationthatyouoffertoparticipantsarenotconsideredbenefits,andshouldbedescribedin(3045)and(3050)belowratherthanhere.
(2800)Privacyofparticipantsandconfidentialityofinformationand/orbiospecimensInthetextbox,describetheproceduresyouwillusetoprotecttheprivacyofindividualsduringidentification,recruitment,anddatacollection.Possibleproceduresincludethefollowing:•Researchprocedureswillbeconductedinaprivatesettingoraccordingtotheparticipant'swishes
•Onlyauthorizedresearchstudypersonnelwillbepresentduringresearch-relatedactivities
•Thecollectionofinformationaboutparticipantsislimitedtotheamountnecessarytoachievetheaimsoftheresearch
•Datawillbecapturedandreviewedinaprivatesetting•Participantswillnotbeapproachedinasettingorlocationthatmayconstituteaninvasionofprivacyorcreateunwantedattention(sensitivetopics,etc.)
Then,checkthebox(es)thatindicatetheformat(s)youwillusefordatacollection.Theseresponseswilldeterminewhichadditionalscreensyouwillsee.
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Ifyouarecollectingorobtainingelectronicdata,checkthebox(es)thatindicatetheproceduresyouwilluse,anddescribethoseindetailinthetextbox.Examplesofsuchproceduresincludethefollowing:• Web-basedsurveyexamples:QuestionPro,Qualtrics,SurveyMonkey,etc.Seehttps://oit.utk.edu/research/websurveys/
• ComputerApplication(notinternet-based)examples:softwareuser-testing,virtualreality,augmentedreality,somemobiledeviceapplications,somewearabletechnology,etc.
• ComputerApplication(internet-based)examples:onlinetools,mobiledeviceapplications,somewearabletechnologyapplications,etc.
• SocialMediaPlatformsexamples:socialnetworkingsites(Facebook,GooglePlus);micro-bloggingsites(Twitter,Tumblr);photosharing(Instagram);crowd-sourcing(AmazonMechanicalTurk);collaborationtools(WikiTravel);videosharing(YouTube,Vimeo)
• Survey/Researchserviceexamples:callcenters,socialresearchinstitutes,etc
• Mobile/Wirelesstechnologyexamples:tablets,smartphones,activitytrackers,etc.
Selectanddescribeinthisscreenhowelectronicdatawillbestoredandsecured.Examplesofsecureelectronicstorageoptionsincludethefollowing:• SecuritySoftware:firewall,anti-virus,anti-intrusion/malwear,etc.
• SecuredDatabaseexample:REDcap• SecuredFileHostingSiteexamples:UT’sOneDrive,UT’sGoogleDrive
Selectanddescribeinthisscreenhowidentifiabledatawillbetransmitted,shipped,ormovedinanywayfromonelocationtoanother.Thisincludesemailingdatatoyourselforothers.DescriptionsofsomeelectronictransmissionmethodsareavailablebyclickingtheHelpbutton.
Ifnoidentifiabledatawillbetransmittedorshipped,select"Noneoftheabove"andentern/ainthetextbox.
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Inthisscreen,describeyourplansforsecurestorageofpaper/analog/hardcopyresearchmaterials.Examplesofappropriatesafeguardsincludethefollowing:•Allresearchinformationbeingcollectedorobtainedwillbecompletelyanonymous
•Restrictedaccesstoauthorizedresearchpersonnel•Lockedcabinetorfilestorage•Lockedoffice/lab•Lockedrefrigerator•Accessrightsareterminatedwhenauthorizedresearchpersonnelleavethestudy
•Other:specify
Ifyouplananyadditionalprotections,describethosehere.Someotherpossiblesafeguardsincludethefollowing:•Destructionofsourcedataimmediatelyafterdatacollection(topreserveanonymityofparticipants)
•Recordings(audio/video)willbetranscribedandthenwillbedestroyedpriortoanalysis
•recordings(audio/video)willbemodifiedsothatparticipantscannotbeidentified(blurring,facedblocked,etc)
•Photos/imageswillbemodifiedsothatparticipantscannotbeidentified(blurring,facedblocked,etc)
•Other:specifyEntern/ainthetextboxifthisisnotapplicabletoyourstudy.
Selectanddescribetheprotectionsyouplantoimplementbeforeyoubeginanalysisofyourdata.
Select"Yes"or"No"todescribewhetherornotidentifiableinformationwillbeincludedinpublicationsorpresentationsabouttheproject.Thisincludesthepossibilitythatindividualidentitiesmightbeinferredfrominformationyoupresent—evenifdirectidentifiersarenotused.Ifyouselect"Yes,"usethetextboxtodescribeyourplansforconsentand/orprotections.
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Expedited & Full Board Application 18
Describehowyourdatawillbehandledoncethestudyisterminated(after you have completed all research activity including analysis and have submitted a study termination application to the IRB). Examplesofdispositionincludethefollowing:•Directidentifiersand/orthekeytothecodeswillbedestroyeduponcompletionoftheresearch(alldata/specimenswillbestrippedofidentifyinginformationand/orthekeytocodesdestroyed).
•Paperdocumentsshredded,electronicfilespurged,electronicmediasecurelyerased).
•Directidentifiersand/orthekeytothecodeswillberetained
•Thesedata/biospecimensand/orresearchresultswillbesharedwiththesource/provider.
•Thesedata/biospecimensand/orresearchresultswillbesharedwithholderofthecodekey.
•Thesedata/biospecimensand/orresearchresultswillbesharedwithcollaboratorsexternaltoUTK.
•Retainedbytheinvestigatorforfutureresearchuse.•RetainedbytheinvestigatorforfutureusesUNRELATEDtoresearch
•Willbesubmittedtoanexistingrepositoryorinvestigatorwillcreatearepository).
•Sharedaccordingtoadatasharingagreement•Restrictedusedatawillbedestroyedorreturnedtothesource.
•Ifapplicable,ProtectedHealthInformation(PHI)willbedestroyedorreturnedtothesourceandresearchrecordsretainedfor6yearsafterclosureofthestudy
•Nodirectorindirectidentifiersarebeingcollected.Theanonymousdataand/orspecimenswillberetained.
•Thisresearchwillberetainedinaccordancewiththesponsor’srequirements
•Other(specify)
NOTE:ThisquestionisNOTaskingaboutresearchrecordssuchasconsentdocumentationandpaymentlogsthatinvestigatorsareresponsibleforretainingaftercompletionoftheresearch.
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Expedited & Full Board Application 19
(3045)Payment(3050)DescribePaymentIfyouareofferingparticipantsanysortofcompensationfortheirparticipationinyourstudy,youmustselect"Yes"in(3045)andthedescribethepaymentin(3050).TheIRB—andtheparticipants(viayourConsentForm)—mustunderstand• theamountofcompensation,• howitwillbeprorated(forexample,will
participantsreceivepartialpaymentiftheybeginbutdonotcompletethestudy?),
• towhomitwillbegiven,and• inwhatform.Whendecidingonanappropriateamountofcompensationitisimportantthatyounotoffersuchalargepaymentthatitcouldexertundueinfluenceandcausepersonstovolunteertoparticipateinyourstudywhenthatmightnotbeintheirbestinterest;i.e.,theamountofpaymentshouldnotbecoercive.Pleasenotethatcoursecreditisconsideredpayment!
(3300)ConflictofInterestPleasereadverycarefullyandindicatewhetheryouoranyofyourkeystudypersonnel(ortheirfamilies)haveaconflictofinterestwithrespecttoanysponsorofyourresearchoranyentitybeingstudiedinyourresearch.Ifyouselect"Yes"foranyofthesequestions,youwillneedtohaveaConflictofInterestManagementPlaninplacethatincludesdisclosuretoparticipantsintheInformedConsentform.
(3329)f.InformedConsentThiswindowandthosethatfollowareveryimportanttoIRBreview,astheinformedconsentprocessishowwedemonstratetheBelmontReportprincipleofRespectforPersons.In(3329),selectallstatementsthataretrueforyourstudy.• Ifyoudonotindicatethatyouarerequestinga
waiverand/oralterationofconsent,youwillbranchdirectlyto(3393)ConsentSummary.
• Ifyoudoindicatethatyouarerequestingawaiverand/oranalterationofconsent,youwillreceivescreen(3352)todescribethegroup(s)forwhichthesearebeingrequested.
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Expedited & Full Board Application 20
(3360)and(3365)AlterationofConsentIfappropriate,youwillreceivethesescreenstodescribehowyouwishtoaltertheprocess,andtoshareyourrationalefortherequest.Alterationsofconsentcaninclude,butarenotlimitedto,• notcollectingsignedinformedconsentformsand• notdisclosingalloftheelementsofinformed
consentbeforeparticipation(useofdeception).TheIRBcannotapprovealterationswithoutsufficientrationaleandprotectionsinplace;pleaseincludeasmuchdetailaspossibleifyouarerequestinganalterationofconsent.
(3370)ff.WaiverofConsentIfyouindicatedin(3329)thatyouarerequestingawaiverofconsentforsomeorallofyourparticipants,youwillreceivethesescreenstodescribeyourrationaleforthisrequest,andtoprovidetheIRBwiththeinformationrequiredtodetermineifyourstudymeetsthecriteriaforbeinggrantedawaiverofconsent.TheIRBcannotapprovewaiverswithoutsufficientrationaleandprotectionsinplace;pleaseincludeasmuchdetailaspossibleifyouarerequestingawaiverofconsent.
(3440)ConsentProcessIfyouareobtainingconsent(evenwithalteration)fromanyofyourparticipants,youwillexplaininthistextboxwhenandhowconsentwillbeobtained,andbywhom.TheIRBwillbeconcernedthattheprocessincludessufficienttimeforparticipantstomakeathoughtful,voluntarydecisionthatisnotundulyinfluencedbyanyrelationshipstheymighthavewiththeindividualsaskingfortheirconsent.Theformsthataretobeusedshouldbeattachedattheendoftheapplication,as"InformedConsent"itemsintheappropriatecategories(e.g.,MainConsentForm,ConsentStatement/Elements).
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Closing Screens (all applications) 21
Application Screen Completion Instructions
(3300)ConflictofInterestPleasereadverycarefullyandindicatewhetheryouoranyofyourkeystudypersonnel(ortheirfamilies)haveaconflictofinterestwithrespecttoanysponsorofyourresearchoranyentitybeingstudiedinyourresearch.Ifyouselect"Yes"foranyofthesequestions,youwillneedtohaveaConflictofInterestManagementPlaninplacethatincludesdisclosuretoparticipantsintheInformedConsentform.
(3450)HIPAAInthisscreen,pleaseselect"Yes"or"No"toindicatewhetherornotyouareseekingtouseProtectedHealthInformation(PHI)withoutparticipants'consent,eithertoconductthestudy,ortoidentify/recruitparticipants.Ifyouselect"Yes"youwillbranchtofollow-upscreenstoprovideinformationthatwillhelptheIRBdetermineifyouqualifyforaHIPAAwaiver.(seeappendix)Fortheseconditem,indicatewhetherornotyouplantocollectPHIyourself.IfyouarenotusingPHIatall,simplyselect"No"forbothitems.
(10000)RoutingforSignaturesandAttachingDocumentsIntheeventthatthereismoreyouwishtotelltheIRBaboutyoursubmission,thisistheplacetodoit.Clickon"Saveandcontinue"toadvancetothescreensforaddingattachments,androutingfornecessaryreviewandapproval.
1.0RoutingFormOnceyouhavecompletedtheapplication,iMedRISwilltakeyoutotheroutingformforyoursubmission,whereyouwillbepromptedtoattachanydocumentsthattheIRBneedstoreviewaspartofyourapplication.Theapplicationyouhavebeenworkingonisalreadyattached."SaveandContinue"unlessyouwishtoattachadifferentversionoftheapplication.
2.0(555)ConsentForm(s)Pleaseuploadyourconsentdocumentshere,andnotas"otherstudydocuments."Usethedropdownmenu(inthedialogwindowinwhichyouupload)toselecttheappropriatecategoryofconsentform:• MainConsentForm
• ConsentStatement/Elements(thisisthecover
sheetusedforsurveys)
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Closing Screens (all applications) 22
Application Screen Completion Instructions
3.0(575)AdditionalStudy/ProjectDocuments• Recruitment/AdvertisingMaterials(asdescribed
in(1600)above• Surveys/Questionnaires/DataCollection
Instruments(attachanyinstrumentsherethatyouwilluse,includingthoselistedaswellasobservationchecklists,interviewprotocols,etc.)
• LetterofSupport1. requiredforanyexternalsitesdescribedin
(1200)above2. requiredforuseofanyexistingdatasetsyou
wishtoanalyzethatyoudonotown(orattachdocumentationoftheirhavingbeenmadepubliclyavailableforresearchpurposes)
3. thiscategoryiswhereyoucanuploadtheIRBapprovalforyourCo-PIsatotherinstitutionsthatyouhavelistedinItem#3ofyourSynopsis(650)or(925)above
• OtherMiscellaneousDocuments(usethiscategoryfordocumentsyouwishtoattachthatdonotfitintooneofthespecificcategoriesinthedropdownmenu)
4.0(800)UTKFormCompletionWhenyouaresureyouhavecompletedyourapplicationandallofitsattachments,youwillclick"signandsubmit."Youarenotfinishedyet!!Donotstophere.
Itfacilitatesreviewifyouuploadthesedocumentsinthecorrectcategories,sothatreviewerscanfindthem.Usethedropdownmenu(inthedialogwindowinwhichyouupload)toselecttheappropriatecategories,aslistedtotheright.
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Closing Screens (all applications) 23
Application Screen Completion Instructions
RoutingiMedRISwillpromptyoutoindicatethosetowhomyourstudymustberoutedforreview,approval,andsignoffonitswaytotheIRB.Select"Yes"thefirsttimeyousubmitanewproject,asallofthefollowingpersonsmustsignoffbeforetheIRBcanbeginitsreview:
• PI• any/allCo-PIs(orCo-Investigators,orSub-
Investigators)• Advisor(ifastudentstudy)• DRC(DepartmentReviewChair)• DepartmentHead(calledDepartmentChairin
iMedRIS)PleasecheckwithyourDepartment/Collegeforspecificinstructionsregardinghowthisishandled—someunitshavespecificarrangementswiththeIRBthatyouneedtoknowbeforeyoucompletescreen3(above)androuteforsignatures.Pleaseviewthis10-minutevideoforspecificinstructionsonrouting.http://utkdms.utk.edu/Mediasite7/Play/a05002db21df4a5883d842f84f24cfa81d
ThevideoisalsoavailableintheiMedRIS"Help"menu(upperrighthandcornerofyourscreen).Onceyourroutinglistiscomplete,youwill"approve"thesubmissionandsignoffusingyourUTKnetIDandpassword.Yourapplicationwillthenbesenttoeachpersononyourroutinglist,inorder.YourapplicationwillnotbereceivedbytheIRBuntilallhavesignedoff.Ifyouhavenotroutedtoeveryonelistedabove,yourapplicationwillbereturnedtoyouforcorrectrouting.
SubmissionRoutingSignoffSheetOnceyouhaveindicatedeveryonewhoneedstosignoff,allofthoseindividuals(includingyou)willhavetodoso.Inthisscreen,scrolltothebottomand1. ReviewtheUTKPIResponsibilities(youare
agreeingtothesewhenyousign),andthen2. ApproveusingyournetIDandPassword,and
finally,3. SaveSignoff
Be sure to change the radio button to "YES" when submitting a new project for the first time. The default on this page is "NO" because for most of the life of your study—whenever you modify it or renew it—you will not need to route to additional persons. Only for the initial review must it be signed by all investigators and department approvers as listed to the right.
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Appendix: HIPAA Screens Specific to Studies Using PHI 24
Application Screen Completion Instructions
(3455)ff.HIPAAThisscreen,andthosethatfollow,willbeshownonlytoinvestigatorswhohaverequestedin(3450)toaccesstheProtectedHealthInformation(PHI)ofparticipantswithoutsecuringtheparticipants'explicitinformedconsenttodoso.
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Appendix: HIPAA Screens Specific to Studies Using PHI 25
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Appendix: HIPAA Screens Specific to Studies Using PHI 26