Download - Institutional Review Board (IRB) Form 1 Initial ......question mark icon, throughout the application as well as at the top of your screen. Be sure to select UTK IRB Application!! If

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

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

[email protected]

CollegeofArchitecture&DesignHaslamCollegeofBusiness

CollegeofEducation,Health&HumanSciencesUniversity-WideUnits

Sara Mulville IRB Assistant Compliance Officer

[email protected]

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

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

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.



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).



(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.



(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.

Exempt Application 8


(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.



(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.



(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.

Expedited & Full Board Application 11


(701)Define"Expedited"andMinimalRiskIfyouselected"Expedited"in(485)above,youwillreceivethisscreen.Pleaserespondtothesecondquestioncarefully:ifconfidentialitywerebreached,wouldyourparticipantsbeatrisk?IfyourresponsestothefirsttwoquestionsindicateyoumaybeeligibleforExpeditedreview,youwillbeaskedtoindicatethecategoriesthatapplytoyourstudy;pleasereadcarefullyandselectallcategoriesthatapply.

(780)NotExpeditedIfyourresponsesaboveindicatethatyourstudyisnoteligibleforExpeditedreview,youwillbedirectedtosubmitusingtheFullBoardapplication.


(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.


(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.


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.


(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.


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.


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.


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.


(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!


(3329)f.InformedConsentThiswindowandthosethatfollowareveryimportanttoIRBreview,astheinformedconsentprocessishowwedemonstratetheBelmontReportprincipleofRespectforPersons.In(3329),selectallstatementsthataretrueforyourstudy.• Ifyoudonotindicatethatyouarerequestinga

waiverand/oralterationofconsent,youwillbranchdirectlyto(3393)ConsentSummary.

• Ifyoudoindicatethatyouarerequestingawaiverand/oranalterationofconsent,youwillreceivescreen(3352)todescribethegroup(s)forwhichthesearebeingrequested.


(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).

Closing Screens (all applications) 21



(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)



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.



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.

Appendix: HIPAA Screens Specific to Studies Using PHI 24


(3455)ff.HIPAAThisscreen,andthosethatfollow,willbeshownonlytoinvestigatorswhohaverequestedin(3450)toaccesstheProtectedHealthInformation(PHI)ofparticipantswithoutsecuringtheparticipants'explicitinformedconsenttodoso.

Download - Institutional Review Board (IRB) Form 1 Initial ......question mark icon, throughout the application as well as at the top of your screen. Be sure to select UTK IRB Application!! If

Top Related