Fillable Trine irb application 2015-2016

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Trine irb application 2015-2016

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Human Informed Consent ISE 003 19 N.indd (Trine University)

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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Review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.



InstructionsforCompletingtheIRBApplication



Youmustcompletetheapplicationinitsentirety.Informationandotherrelevantmaterialsmust

besubmittedinthedesignatedarea.Donotinsert“seeattached”inanyoftheapplicationblanks.

Youmayexcerptmaterialfromothersourcesandmayexpandonthespaceprovidedinthe

document,buttheapplicationshouldberelativelyconcise.



ApplicationSubmission



 PleasesubmityourapplicationelectronicallyasaWord™document.Allsubmissions

shouldbesenttotheIRBChair(emailaddresscontactinfohere…)with“AttentionIRBor

similar”inthesubjectline.

 Applicationsthatlackclarityduetoexcessiveerrorsorincompleteinformationmaybe

returnedtotheinvestigator.Thiswilldelaythereviewprocess.Pleasespellandgrammar

checkyourdocumentbeforesubmission.

 Investigatorswillelectronicallysigntheapplicationforreview.



ChecklistforApplicationSubmission



☐IRBApplicationwithanelectronicsignature

☐Informedconsentform

☐Recruitingmaterials(phonescript,fliers,ads,etc.)

☐Survey/questionnaire(s),focusgrouporinterviewquestions(ifapplicable)

☐Conflictofinterest/financialinterestdisclosure(ifapplicable)

☐Letter(s)ofsupport(ifconductingresearchatanotheragency,school,etc.)



TrineUniversity

InstitutionalReviewBoard

InvestigationInvolvingHumanSubjects

ApplicationForm2015‐2016



APPLICATIONDATA

IRBNo.________

(TobeassignedbyTUIRB)

DateofApplication:



Indicatetypeofreview: ☐Exempt ☐Expedited ☐Full



ForExemptReviewspleaseindicatewhichofthefollowingapply:



☐1.NormalEducationalPractices

☐2.EducationalTests

☐3.Surveyand/orInterviewProcedures

☐4.Observation

☐5.SecondaryuseofData



Note:TherearethreelevelsofIRBReview.Youshouldindicatethelevelofreviewyoubelieveis

requiredforyourresearch.TheIRBmaydeterminethatadifferentlevelofreviewisnecessary.



ExemptStatus

ResearchisreviewedforExemptstatusbyanIRBmemberifitinvolvesveryminimalornorisk.In

general,researchwhichdoesnotproposetodisruptormanipulatethenormallifeexperiencesof

subjects,incorporateanyformofintrusiveproceduresorsensitivetopics,orinvolvedeceptionwill

beexemptfromfullIRBreview.Projectsthatinvolvemorethanveryminimalriskandthosethat

includeanydegreeofdeceptiondonotqualifyforExemptstatus.



Pleasenotethatalloftherightsandprotectionaffordedtohumansubjectsinresearcharerequired

inExemptstatuscases.ResearchersengagedinhumansubjectsresearchthatqualifiesforExempt

statusmuststillcompleteafullapplicationformandprepareaninformedconsentstatement.

Researchersmustengageinpracticesthatminimizerisk,maximizebenefitandensureprivacy.In

short,researchwithExemptstatusisexemptonlyfromfullIRBreview.



ExpeditedReview

Expeditedreviewisaprocedurethroughwhichcertainkindsof

researchmaybereviewedand

approvedwithoutconveningameetingoftheentireIRB.Theterm"expedited"canbemisleading:

reviewsofthistypearenot"quicker"orconductedwithlessrigor,butfewerreviewersare

requiredforapproval.Formoreinformationaboutthetypesofresearchlistedintheexpedited

category,visittheIRBwebsiteatwww.stkate.edu/irb.



FullReview

AllresearchnotqualifyingforExemptstatusorExpeditedreviewandresearchinvolvingprotected

classesofsubjectsrequiresFull(LevelIII)review.IngeneralresearchrequiringFullreviewplaces

thesubjectatgreaterthanminimalrisk.Fullreviewmeansthattheresearchprotocolisread,

discussedandvoteduponbythefullIRB.



APPLICANTDATA

Investigatorname(s)andcredentials(eg.Ph.D.,RN,PEetc)(Pleaselistallco‐investigators):



ProjectTitle:



Advisor:

DepartmentandCampus(ifnotTrinemaincampus):

InvestigatorMailingAddress:

InvestigatorEmailAddress:

InvestigatorTelephone:

DatesofProjects:

Allstate,federalandprivatelyfundedexternalgrants,andmostpublishedresearch

isrequired

toundergoIRBreviewifhumansubjectsareinvolved.





Isthisresearchfundedbyagrant?☐Yes  ☐No

IfYES,pleaseprovidethenameofthefundingagency



HasthisresearchbeenreviewedbyanotherIRB? ☐Yes  ☐No

IfYES,pleaseprovideacopyoftheletterof

approval,orindicatethestatusofyouapplication.



WillthisresearchbereviewedbyanotherIRB?  ☐Yes  ☐No

IfYES,pleaseindicateyourplansforreview.





I. RESEARCHSUMMARY:Pleasecompleteeachsectioninclear,easytoreadlanguagethatcanbe

understoodbyapersonwhoisunfamiliarwithyourresearchandfieldofexpertise.



a. PurposeoftheResearch:Provideaclear,concisestatementofpurpose.



b. Background:Provideaconcise

summaryin1to2briefparagraphstoexplainthe

importanceoftheresearchandhowitfitswithpreviousresearch.



c. ResearchMethodsandQuestions:Giveageneraldescriptionofthestudydesign,and

specificmethodsyouwilluseinyourinvestigation.Specifyallofyourresearchoptionsand/or

hypotheses.Reviewerswillconsiderwhethertheinformationyouaregatheringfrom

participantsisnecessarytoansweryourresearchquestion(s),sothisshouldbeclearinyour

application.



d. ExpectationsofParticipants:Giveastepbystepdescriptionofallproceduresthatyouwill

haveparticipantsdo.Attachanysurveys,

tests,instruments,interviewquestions,data,

collectionforms,etc.thatyouwillusewithparticipants.



e. EstimatedTimeCommitmentforParticipants:

Numberofsessionsforeachparticipant:

Timecommitmentpersessionforeachparticipant:

Totaltimecommitmentforeachparticipant:



f. AccesstoExistingData:Ifyouareanalyzingexistingdata,records,specimens,explainthye

source,type,meansofaccess,andpermission(s)tousethem.



II. SUBJECTS:Provideyourbestestimatesbelow.



a. AgeRangeofsubjects:



b. Numberofsubjects:  Male  Female  Total



c. TargetPopulation:Describeyourtargetpopulation(eg.Seniors,childrenages9–12,

healthyadults18orover,etc)



d. SpecificExclusions:Ifwomenand/orminorities

aretobeexcludedfromthestudy,clear

rationaleshouldbeprovidedinsection“f”below.



III. RECRUITMENT:LOCATIONOFSUBJECTS(Checkallthatapply)



☐TrineUniversityStudentsMainCampus



☐TrineUniversityStudentsBranchCampus(specifybranch)



☐SchoolSetting(PreK–12)



☐HospitalorClinic



☐OtherInstitutions(Specify)



☐Noneoftheabove(Describelocationofsubjects)



NOTE:Ifsubjectsarerecruitedorresearchisconductedthroughanagency

orinstitutionotherthan

TrineUniversity,submiteitherwrittenorelectronicdocumentationofapproval.



a. RecruitmentMethod:Describehowyouwillrecruityoursubjects.Bespecificand

attachacopyofanyadvertisement,flyer,letter,orstatementthatyouwillusefor

recruitmentpurposes.



b. Incentives:Willsubjectsbe

offeredinducementsforparticipation?IfYes,explain.



RISKSANDBENEFITSOFPARTICIPATION



a. Doestheresearchinvolve:(checkallthatapply)



☐Useofprivaterecords(medicaloreducational)

☐Possibleinvasionofprivacyofthesubjectsand/orfamily

☐Manipulationofpsychologicalorsocialvariables

☐Probingforpersonalorsensitiveinformationinsurveysorinterviews

☐Useofdeception

☐Presentationofmaterialswhichsubjectsmightconsideroffensive,threatening,

ordegrading

☐Riskofpersonalinjurytosubjects

☐Otherrisks

☐Noneoftheabove



b. Risks:Brieflydescribetherisksofparticipationin yourstudy,ifany.Describethe

precautionstominimizetheserisks.



c. Benefits:Listanyanticipated

directbenefitstoyoursubjects.Ifnone,statethathereand

intheconsentform.



d. Risks/BenefitRatio:Justifythestatementthatthepotentialbenefitsofthisstudy

outweighanyprobablerisks.



e. Deception:Theuseofdeceptioninresearchposesparticularrisksandshouldonlybe

usedifnecessary

toaccomplishtheresearchandwhenrisksareminimized.The

researchershouldnotusedeceptionwhenitwouldaffectthesubject’swillingnessto

participateinthestudy.



Willyoubeusingdeceptioninyourresearch?  ☐Yes  ☐No



Ifyes,justifywhydeceptivetechniquesarenecessaryintermsofthestudy’sscientific,

educational,orappliedvalue.Explain

whatalternativeswereconsideredthatdonotuse

deceptionandwhytheydidnotmeettheresearcher’sobjective.





IV. CONFIDENTIALITYOFDATA



a. Willyourdatabeanonymous?   ☐Yes  ☐No



Willyourdatabeconfidential?  ☐Yes  ☐No



(Anonymousdatameansthattheresearchercannotidentifysubjectsfromtheirdata,

whileconfidentialdatameanstheresearchercanidentifyasubject’sresponse,but

promisesnottodosopublicly.)



b. Howwillyoumaintainanonymity/confidentialityoftheinformationobtainedfrom

yoursubjects.



c. DataStorage:Wherewillthedatabekept,andwhowillhaveaccesstoitduringthat

time?



d. DataDestruction:Howlongwillthedatabekept?Whatisthedatewhentheoriginal

datawillbedestroyed?Allstudiesmustspecifyadate

whenoriginaldatathatcouldbe

linkedbacktoasubject’sidentitywillbedestroyed.



e. AvailabilityofData:Willdataidentifyingsubjects bemadeavailabletoanyoneother

thanyouoryouradvisor?Ifyes,pleaseexplainwhowillreceivethedata,andjustifythe

need.



OfficialRecords:Willthedatabecomepartofthemedicalorschoolrecord?Ifyes,

explain.





V. INFORMEDCONSENT



a. HowwillyouGainConsent?Statewhatyouwillsaytothesubjectstoexplainyour

research.



b. ConsentDocument:Attachtheconsentformortextoforalstatement.



c. TimingofConsentProcess:Whenwillyouobtainconsent?(Thatday,severaldays

before

theproject,aweek/monthbefore,etc)



d. AssuranceofParticipantUnderstanding:Howwillyouassessthatthesubject

understandswhathe/shehasbeenaskedtodo?(Asimpleyes/noanswerfromthesubject

isnotsufficient.Thesubjectshouldbeabletoexplainthepurposeofthestudy,the

procedures,

whathappensiftheyelecttowithdraw,etc.)





VI. ASSURANCESANDSI GNATURES



Thesignaturesbelowcertifythat:



 Theinformationfurnishedconcerningtheprocedurestobetakenfortheprotectionof

humansubjectsiscorrect.

 Theinstructor,tothebestofhis/herknowledge,iscomplyingwithFederalregulations

governinghumansubjectsinresearch.

 TheinstructorwillseekandobtainpriorwrittenapprovalfromtheCommitteeforany

substantivemodificationintheproposal,including,butnotlimitedtochangesin

cooperatinginvestigators,proceduresandsubjectpopulation.

 Theinstructorand/orstudentinvestigatorwillpromptlyreportinwritingtotheCommittee

anyunexpectedorotherwisesignificantadverseeventsthatoccurinthecourseofthe

study.

 TheinstructorwillpromptlyreportinwritingtotheCommitteeandtothesubjectsany

significantfindingswhichdevelopduringthecourseofthestudywhichmayaffecttherisks

andbenefitstothesubjectswhoparticipateinthestudy.

 TheresearchwillnotbeinitiateduntiltheIRBprovideswrittenapproval.

 Thetermofapprovalwillbeforoneyear.Toextendthestudybeyondthatterm,anew

applicationmustbesubmitted.

 Theresearch,onceapproved,issubjecttocontinuingreviewandapprovalbythe

Committee.

 TheinstructorwillcomplywithallrequestsfromtheIRBtoreportonthestatusofthe

studyandwillmaintainrecordsoftheresearchaccordingtoIRBguidelines.

 Iftheseconditionsarenotmet,approvalofthisresearchmaybesuspended.



Note:Applicationsreceivedwithout(applicable)signatureswillbereturned.



Asprimaryinvestigator(s),I/weunderstandandwillfollowtheaboveconditions.



Signatureofinvestigator Date



AsAdvisororSponsor,Iassumeresponsibilityforensuringthattheinvestigatorcomplieswith

UniversityandfederalregulationsregardingtheuseofHumanSubjectsinresearch.



SignatureofAdvisor/Sponsor  Date



AsDepartmentChair,Iacknowledgethatthisresearchisinkeepingwiththestandardssetbyour

departmentandassurethattheinvestigatorhasmetalldepartmentrequirementsforreviewand

approvalofthisresearch.



SignatureofDepartmentChair Date



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Completed 1 November 2019

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