Fillable Irb application renewal form 2015-2016

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Irb application renewal form 2015-2016

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TrineUniversityiscommittedtosafeguardingandrespectingtherightsandwelfareofhuman
subjectsinvolvedinresearch.TheTrineInstitutionalResearchBoard(IRB)isresponsiblefor
conductinginitialandcontinuingreviewofresearchinvolvinghumansubjects.Researchinvolving:
physicalorpsychologicalstress,ariskofharm,invasionsofprivacy,documentationofprivate
informationinwhichsubjectsmightbeidentified,concealmentofdeception,oranyundesirable
consequencesforthesubject,areallsubjecttoIRBreview.Investigatorscannotbeginresearch
withhumansubjectsuntilacompletedapplicationhasbeensubmitted,reviewedandapprovedby
theTrineIRB.
Thepurposeofthisapplicationistoensurethathumanresearchsubjectsareprotected.Itisthe
taskoftheresearchertominimizethenegativeconsequencesofanyresearch,justifyanynegative
consequencesthatcannotbeeliminated,andtoprovideadequateinformationforsubjectstomake
informeddecisions.IRBapprovalnotonlyprotectsthehumansubjects,butalsoprotectsthe
researcher,theadvisor,andTrineUniversity.
RenewalApplication
AnnualIRBreviewisrequiredforongoinghumansubjectsresearch.Researcherscontinuingwith
recruitmentofhumansubjectsand/ordataanalysismustapplyforrenewalusingthisapplication.
Researcherswithongoinghumansubjectsprojectswillreceiveemailnotificationtwomonthsprior
totherenewaldeadline.
Note:Ifaresearcherdoesnotfileforrenewalbytheproject’soneyeardeadline,he/shewillbe
requiredtoresubmithis/herprojectthroughtheentireIRBapplicationprocessasanewproject.
InstructionsforCompletingtheIRBRenewalApplication
Completethefollowingapplicationinitsentirety.Donotinsert"seeattached"inanyofthe
applicationblanks.Youmayexcerptmaterialfromyourthesisorgrantproposal,butyour
applicationshouldberelativelyconcise.
Note:Ifyouhavemadechangestoanyofsupporting documentssuchasyourinformedconsent,
childassentform(ifapplicable),recruitingmaterials,orsurvey/interviewquestions,submit
copiesofthenewdocumentswithyourrenewalapplication.
TrineUniversity
InstitutionalReviewBoard
RenewalApplicationForm
2015‐2016
Checklistforapplicationsubmission:
☐SignedIRBRenewalApplication(Typednameinsignaturesectionwillconstituteanelectronic
signature)
Ifanychangeshavebeenmade,alsosubmit:
☐Informedconsentform
☐Childassentform(ifapplicable)
☐Recruitingmaterials(phonescript,fliers,ads,etc)
☐Survey/questionnaire,focusgrouporinterviewquestions(ifapplicable)
☐Conflictofinterest/financialinterestdisclosure(ifapplicable)
☐Lettersofsupport(ifyouareconductingresearchatanotheragency,school,etc).
RenewalApplicationSubmission:
SubmityourRenewalApplicationviaemailtoAlisonWitte(wittea@trine.edu).
TrineUniversity
InstitutionalReviewBoard
RenewalApplicationForm
2015‐2016
IRBNumber(asassignedbyIRB):
RENEWALDATA
DateofLastApproval:
Indicatetypeofreview:
☐Exempt ☐Expedited ☐Full
APPLICANTDATA
Investigatorname(s):
ProjectTitle:
Department:
InvestigatorMailingAddress:
InvestigatorE‐mailAddress:
InvestigatorTelephone:
1.Whatisthestatusofthisstudy:

☐Recruitingsubjects
☐Recruitmentcomplete;followingsubjects
☐Datacollectioncomplete;Dataanalysisonly
☐Studynotbegun
☐Other(pleaseexplain):
2.Whatisthetotalnumberofsubjectsapprovedforthisstudy(ifthisisamulti‐sitestudy,pleaseindicate)
Male Female Total
3.Currently,howmanysubjectshavebeenenrolled?
Male FemaleTotal
4.Isthisprojectfunded? ☐Yes ☐No
a.Ifyesto#4,whatisthefundingagencyandgrantnumber(notallgrantshavegrant
numbers;ifyouhavereceivedaninternalgrantoracorporate/foundationgrant,please
indicatethesourceoffunding)?
b.Ifyesto#4,arethereanyconflictsofinterestbetweentheinvestigator(s)andthefunder?
5.Describeanysubjectcomplaints,earlywithdrawals,adverseevents,injuriesorproblemswith
theresearchstudy:(Ifnone,simplywrite“none.”)
6.Havetherebeenchangesinprincipalinvestigator,co‐investigators,orresearchstaff?
(Ifyes,pleaseexplain)
☐Yes ☐None
7.Givenanypreliminaryresults,havetherebeenanychangesthatwouldaffectasubject’sdecision
onwhethertoparticipateinthisstudy?
(Ifyes,pleaseexplain)
☐Yes ☐None
8.Hastherisk/benefitrelationshipforsubjectschangedsincetheinitiationofthestudy?
(Ifyes,explainhow)
☐Yes ☐None
9.ListpreviouschangesinthestudyanddatesapprovedbytheIRB.(Iftherewerechangeslist
thembelow)
☐Yes,changes ☐None
10.Havetherebeenanychangestotheconsent/assentformssincethelastIRBapproval?

☐Yes ☐None
Ifyes,pleaseattachallcur r entconsent/assentforms.Highlightanychangesfromtheoriginally
approvedversion.Explainanychangeshere.
ASSURANCESANDSIGNATURES
Asprincipalinvestigator(s),I(we)assurethattheinformationcontainedonthisformis
accurate.
SignatureofPrincipalInvestigator(s) Date
SignatureofAdvisor/Supervisor Date
SignatureofDepartmentChair Date
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Irb application renewal form 2015-2016

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Completed 6 January 2020

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