IRBApplicationGuidelinesandTemplates
A.
B.
C.
D.
MountSaintMary’sUniversity
ApplicationfortheApprovalofHumanSubjectsResearch
GENERALINSTRUCTIONS
Allportionsofthisformmustbecompletedbeforesubmission.Incompleteformsmayresultindelayedreview
and/orapproval.Additionalsheetsmaybeattachedtothisform.Ifyouhaveanyquestions,pleasecontacttheChair
oftheHumanSubjectsCommittee.[Currentcontact:Dr.RobinL.Gordon,Education,213.477.2624or
[email protected]]
APPLICATIONREVIEW
ReviewofapplicationsoccursonarollingbasisandbeginsassoonasthePrincipalInvestigator(PI)hassubmittedall
applicationmaterials.Reviewstypicallycanbecompletedwithin2-3weeks,atwhichtimetheCommitteeChairwill
contactthePIwiththecommittee'sdecision.
EXPEDITEDREVIEW
Anexpeditedreviewissimplyareviewbyasub-committeeoftheHumanSubjectsCommittee.Expeditedreviewis
notafasterreview.Aprotocolmustqualifyasminimalriskinaccordancewiththefederalregulationsthatgovern
humansubjectsresearch(45CFR46)inordertoqualifyforexpeditedreview.
NoteonExemptStatus:ExemptdoesnotmeantheprojectisexemptfromIRBreview.ItmeansthattheIRB
appointeedecidesthatifthereisminimalrisk,theremaynotneedtobeareviewbythefullboardreview;however,
theresearcherdonenotmakethisdecision.
SIGNATURES
ALLSIGNATURESMUSTBEOBTAINEDPRIORTOSUBMISSIONOFTHEAPPLICATION/RESEARCH
PROTOCOLTOTHEIRB.STUDENTPROJECTSMUSTHAVETHEFACULTYADVISOR'SSIGNATURE.
FacultysignatureonthisProtocolApprovalFormindicatesthat:
• Youarefamiliarwiththerequirementsforhumansubjectsresearchasdefinedby45CFR46.
• YouhavereviewedthisProtocolApprovalFormandaccompanyingdocumentation.
• Youapproveofthemannerinwhichhumansubjectswillbeinvolvedinthisstudy.
E.OnlineTutorial
AllPrincipalInvestigatorsmusttaketheonlinetutorialfortheprotectionofhumansubjectsat
http://phrp.nihtraining.com/users/login.php?l=3andincludeacopyofthecertificateofcompletionwiththisapplication.
TheHSCwillnotbeginreviewofapplicationswithoutthiscertification.Thetutorialtakesapproximately1-2hoursto
complete.
SUBMITONEElectroniccopyaswellas(1)ORIGINALCOMPLETEDANDSIGNEDHARDCOPY(including
anysupplementarymaterials)to:
RobinL.Gordon,ChairHumanSubjectCommittee
DohenyCampus,Building20
213-477-2624
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IRBApplicationGuidelinesandTemplates
*MSMU would like to thank the Office of Research at California State University,
Northridge for the permission
to use and revise the forms used by their IRB.
MountSaintMary’sUniversity
CommitteefortheProtectionofHumanSubjects
GuidelinesforHavingYourResearchProjectApproved
Thisdocumentismeanttosupplement(notreplace)theinstructionsprovidedontheHumanSubjectsProtocol
form.IfyouhaveanyquestionsregardingtheHumanSubjectsProtocolForm,contacttheChairofthe
committee.
TheHumanSubjectsCommitteehastheresponsibilityofexaminingresearchproposalstodeterminewhether
theymeetguidelinesfortheprotectionofthewelfareofhumansubjects.Approvalforaprojectconductedbya
facultymember,orbyastudentundertheguidanceofafacultymember,mustbeobtainedpriortoinitiationof
contactwithhumansubjects.Thesuccessfulapplicationmeetsthefollowingcriteriaandyoumaywanttoread
yourfinaldraftandcheckoftheboxesbelow.
□ Inplanningtheresearch,investigatorsshouldthinkcarefullyaboutpotentialavoidableharmtosubjects,
forexamplekeepinginmindtheethicalguidelinesoftheAmericanPsychologicalAssociationand
consideringtheneedforculturalsensitivityinapproachingsubjects.Potentialharmwillbeweighed
againstpotentialgainoneachproposalreviewedbytheCommittee.(SeeAppendixB)
□ Benefitsofparticipationinthestudyshouldbeclearlyindicatedintheconsentform.
□ Whenpersonalinformationorvideotapingorvoicerecordingistobeobtainedduringthecourseofthe
research,planneddispositionofthatinformationshouldbeclearlystatedintheconsentform,i.e.how
willtheparticipant’sidentitybekeptconfidential?
□ Remember-Theprotocolformisyourchancetodescribeyourprojectclearlytothecommittee.Failure
toprovidesufficientdetailregardingyourprojectmayresultintheprotocolbeingreturnedtoyou
withoutactioncausingconsiderabledelayinyourresearch.
□ Pleaseprovideallinformationrequestedinaclearandconcisemannerandattachanynecessary
documentation.Besuretoprovideinformationregardingallproceduresandmethodology,andifa
controlgroupwillbeused.
□ Adetaileddescriptionofthemethodstobeusedmustbeprovided.Additionalsheetsmaybeattached
totheprotocolformifnecessary.
□ Thesource,age(s)andnumberofsubjectstobeusedinthestudymustbeclearlystated,andifthe
subjectswillbeobtainedatanon-MSMUinstitution,aletterofpermissionfromarepresentativeof
thatinstitutionmustbeprovided.
□ Thesignificanceoftheworkshouldbeclearlydescribed.
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IRBApplicationGuidelinesandTemplates
□
Aconsentformthatfollowsthesampleformatdetailedintheapplicationmustbeprovided.However,if
yourprotocolrequiresadditionaldetailsbeyondtheexample,pleaseincludethem.
□
Theriskstosubjectsmustbeclearlydetailedbothintheapplicationandintheconsentform."Norisk"
isneverappropriate.Neitheris“passiveconsent”(usingaconsentformthatimpliesconsentifitisnot
returnedtotheresearcher).Risksmayincludeemotionaldistress,physicalstress,boredom,fatigue,or
riskofbodilyinjury,asappropriate.Thereshouldbeanindicationontheconsentformastowhether
financialsupportformedicalorcounselingtreatmentisavailabletosubjectsincaseofdifficulties
resultingfromparticipationintheresearch.
□
Clearlanguagethatisunderstandablebyaneducatedlaypersonmustbeusedthroughouttheprotocol.
Avoidexcessiveuseoftechnicaljargon.
□
Theconsentformmustbewrittenatthelevelofanindividualwhowouldnothavereceivedany
Universityeducationandhasnomorethanan8thgradereadinglevel.Again,avoidalltechnicaljargon.
Seethefollowingappendicesforguidelinesforinformedconsentaswellassamples.
AppendixB:ResearchActivitiesThatMayBeConsideredtoBeofMinimalRisktoSubject
AppendixC:HowtoProtectHumanSubjectsRequirementsforConsentForm
AppendixD:NationalInstitutesofHealthFederalGuidelinesforInformedConsent
AppendixE:ParentConsentRequirements
AppendixF:SAMPLEInformedConsent
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IRBApplicationGuidelinesandTemplates
Appendices
•
Pleasereadthefollowinginformationpages.
•
Downloadandadapttheformsandtemplatesasneeded.Theninsertthem
intoyourapplication.
•
YoumustincludetheSubjectBillofRightswithyourInformedConsent.
•
Pleasedonotincludethegeneralinfopagesandtemplatesinyourfinal
application.
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IRBApplicationGuidelinesandTemplates
MountSaintMary’sUniversity AppendixA-tobeused
EXPERIMENTALSUBJECTS
BILLOFRIGHTS
forstudiesinvolving
medical/psychological
procedures.
Therightsbelowaretherightsofeverypersonwhoisaskedtobeinaresearchstudy.AsanexperimentalsubjectIhave
thefollowingrights:
1) Tobetoldwhatthestudyistryingtofindout,
2) Tobetoldwhatwillhappentomeandwhetheranyoftheprocedures,drugs,ordevicesisdifferentfromwhatwouldbe
usedinstandardpractice,
3) Tobetoldaboutthefrequentand/orimportantrisks,sideeffectsordiscomfortsofthethingsthatwillhappentomefor
researchpurposes,
4) TobetoldifIcanexpectanybenefitfromparticipating,and,ifso,whatthebenefitmightbe,
5) TobetoldtheotherchoicesIhaveandhowtheymaybebetterorworsethanbeinginthestudy,
6) Tobeallowedtoaskanyquestionsconcerningthestudybothbeforeagreeingtobeinvolvedandduringthecourseofthe
study,
7) Tobetoldwhatsortofmedicaltreatment(ifneeded)isavailableifanycomplicationsarise,
8) Torefusetoparticipateatallortochangemymindaboutparticipationafterthestudyisstarted.Thisdecisionwillnotaffect
myrighttoreceivethecareIwouldreceiveifIwerenotinthestudy.
9) Toreceiveacopyofthesignedanddatedconsentform.
10) TobefreeofpressurewhenconsideringwhetherIwishtoagreetobeinthestudy.
IfIhaveotherquestionsIshouldasktheresearcherortheresearchassistant,orcontactHumanSubjectsCommittee,
MountSaintMary’sUniversity,10ChesterPlace,LosAngeles,CA,90007orphone(213)477-2624.
X
SignatureofSubject Date g
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IRBApplicationGuidelinesandTemplates
MountSaintMary’sUniversity
AppendixA-1
Tobeusedfornonmedicalprocedures.
EXPERIMENTALSUBJECTS
BILLOFRIGHTS
Therightsbelowaretherightsofeverypersonwhoisaskedtobeinaresearchstudy.AsanexperimentalsubjectIhave
thefollowingrights:
1. Tobetoldwhatthestudyistryingtofindout,
2. TobetoldspecificallywhatIwillbeaskedtodo,
3. Tobetoldaboutthefrequentand/orimportantrisks,sideeffectsordiscomfortsofthethingsthatwillhappentome
forresearchpurposes,
4. TobetoldifIcanexpectanybenefitfromparticipating,and,ifso,whatthebenefitmightbe,
5. Tobeallowedtoaskanyquestionsconcerningthestudybothbeforeagreeingtobeinvolvedandduringthecourseof
thestudy
6. Torefusetoparticipateatallortochangemymindaboutparticipationafterthestudyisstarted.
7. Toreceiveacopyofthesignedanddatedconsentform.
8. TobefreeofpressurewhenconsideringwhetherIwishtoagreetobeinthestudy.
IfIhaveotherquestionsIshouldasktheresearcherortheresearchassistant,orcontactHumanSubjectsCommittee,
MountSaintMary’sUniversity,10ChesterPlace,LosAngeles,CA,90007orphone(213)477-2624.
X
SignatureofSubject Date
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IRBApplicationGuidelinesandTemplates
MountSaintMary’sUniversity
SujetosExperimentales
AppendixA
enEspañol
DeclaracióndeDerechos
Losderechosqueacontinuaciónsemencionan,sonlosderechosdecadapersonaqueparticipaenestainvestigación.
Todapersonaalparticiparenestosestudios,tienederecho:
1. Asaberqueesloqueelestudioestatratandodeinvestigar,
2. Aestarinformadodeloquesucederá,losprocedimientos,losmedicamentos,ylosdispositivos,seanóno
diferentesalosutilizadosenunprecedimientonormal,
3. Asaberlafrecuenciay/óelgradoderiesgo,efectossecundarios,óincomodidadesquesucederaneneltranscurso
delainvestigación,
4. Asabersihayalgúnbeneficioalparticiparenelestudio,ycualseríaesebeneficio,
5. Asabersiexistenotrasalternativasquepuedansermejoresópeoresque,participarenestainvestigación,
6. Aqueselepermitahacerpreguntasantesdeparticiparenelestudio,aligualqueeneltranscursodelmismo,
7. Asaberquetipodetratamientomédico(siesnecesario)estádisponibleencasodequeocurrancomplicaciones,
8. Arenunciaralaparticipaciónenelestudio,aúncuandoyahayacomenzado.Cualquiercambiodedecisiónno
afectaráelderechoarecibirlaatenciónqueseproveríaalnoserpartedeestainvestigación,
9. Arecibirunacopiafirmadayfechadadelahojadondeseautorizólaparticipación,
10. Aestarlibredecualquierpresiónaldecidirsiquiereónoparticiparenelestudio.
Encasodetenerpreguntas,puedecomunicarseconelinvestigador,elasistentedeinvestigación,óalaoficinadeHuman
SubjectsCommittee,MountSaintMary’sUniversity,10ChesterPlace,LosAngeles,CA,90007óalteléfono(213)477-
2624.
Firmadelparticipante Fecha
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IRBApplicationGuidelinesandTemplates
MountSaintMary’sUniversity
HumanSubjectsCommittee
1.
2.
3.
4.
5.
6.
7.
8.
9.
AppendixB-thisis
informational.PleaseDO
NOTincludeitwiththe
application.
RESEARCHACTIVITIESTHATMAYBECONSIDEREDTOBEOFMINIMALRISKTOSUBJECT
Voicerecordingmadeforresearchpurposesuchasinvestigationsofspeechdefects.
Moderateexercisebyhealthyvolunteers.
Studyofexistingdata,documents,records,pathologicalspecimens,ordiagnosticspecimens.
Researchonindividualorgroupbehaviororcharacteristicsofindividuals,suchasstudiesofperception,
cognition,gametheory,ortestdevelopment,wheretheinvestigatordoesnotmanipulatesubjects’
behaviorandtheresearchwillnotinvolvestresstothesubject.
Researchconductedinestablishedorcommonlyacceptededucationalsettings,involvingnormal
educationalpractices,suchasresearchorregularandspecialeducationinstructionalstrategies,or
researchontheeffectivenessoforthecomparisonamonginstructionaltechniques,curriculum,or
classroommanagementmethods.
Researchinvolvingtheuseofeducationaltests(cognitive,diagnostic,aptitude,achievement),if
informationtakenfromthesesourcesisrecordedinsuchamannerthatsubjectscannotbe
identified,directlythroughidentifierslinkedtothesubjects.
Researchinvolvingsurveyorinterviewprocedures,exceptwhere:
a. Responsesarerecordedinsuchamannerthatthehumansubjectscanbeidentified,
directlythroughidentifierslinkedtothesubjects,and
b. Thesubject’sresponses,iftheybecameknownoutsidethecriminalorcivilliabilityorbe
damagingtothesubject’sfinancialstandingoremployability;ortheresearchdealswith
sensitiveaspectsofthesubject’sownbehavior,suchasillegalconduct,druguse,sexual
behavior,oruseofalcohol.
Researchinvolvingtheobservation(includingobservationbyparticipants)ofpublicbehavior,except
wheretheconditionslistedunder#7exists.
AnyothercategoryspecificallyaddedtothislistbyHHSpublishedintheFederalRegister.
*ThesecategoriesarebasedupontheFederalCode45CFR.
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IRBApplicationGuidelinesandTemplates
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HumanSubjectsCommittee
HOWTOPROTECTHUMANSUBJECTS
RequirementsforConsentForm
AppendixC-thisis
informational.PleaseDO
NOTincludeitwiththe
application.
Theconsentformisdesignedasanagreementfortheprotectionoftherightsandwelfareofanyindividualwho
participatesasasubjectinresearch.ThefollowingsixelementsofinformedconsentarerequiredbyDHHS
regulationsandshouldbecoveredontheconsentformused.
1.
Astatementoftheprocedureandpurposes.Itmuststatethatthestudyinvolvesresearch,an
explanationofthepurposesoftheresearch,adescriptionoftheprocedurestobefollowed,expected
durationoftheparticipant’sparticipation,andidentificationofanyprocedureswhichareexperimental.
2.
Astatementofanypotentialassociatedriskand/ordiscomfortforthesubject.Itmustincludea
descriptionofanyreasonableforeseeablerisksordiscomfortstothesubjects.
3.
Astatementofanyassociatedbenefitsforthesubject.Itmustincludeadescriptionofanybenefitsto
thesubjectortootherswhichmayreasonablybeexpectedfromtheresearch.
4.
Astatementindicatingthatparticipationisvoluntary,andthatthesubjectmaywithdraw atany
time.Itmustincludeastatementthatthesubjectmayrefusetoparticipate,andmaydiscontinue
participationatanytimewithoutpenalty,orlossofbenefitstowhichhe/sheisotherwiseentitled.
5.
Astatementindicatingthatthesubjectwasgiventheopportunitytoaskquestionsabout
the
procedure,andthattheywereansweredpriortothesubject’sagreementtoparticipate.Itmust
includeanexplanationofwhomtocontactforanswerstopertinentquestionsabouttheresearchand
researchsubjects’fights,andwhomtocontactintheeventofaresearch-relatedproblem.Include
telephonenumber.
6.
Astatementregardingtheconfidentialityofthesubject.Itmustincludeastatementdescribingthe
extenttowhichconfidentialityofrecordsidentifyingthesubjectwillbemaintained.
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IRBApplicationGuidelinesandTemplates
A.
•
•
•
•
•
•
•
•
•
•
•
•
AppendixD-thisis
informational.PleaseDO
NOTincludeitwiththe
application.
NationalInstitutesofHealthFederalGuidelinesforInformedConsent
BasicandAdditionalElements
Astatementthatthestudyinvolvesresearch
Anexplanationofthepurposesoftheresearch
Theexpecteddurationofthesubject'sparticipation
Adescriptionoftheprocedurestobefollowed
Identificationofanyprocedureswhichareexperimental
Adescriptionofanyreasonablyforeseeablerisksordiscomfortstothesubject
Adescriptionofanybenefitstothesubjectortootherswhichmayreasonablybeexpectedfromtheresearch
Adisclosureofappropriatealternativeproceduresorcoursesoftreatment,ifany,thatmightbeadvantageoustothesubject
Astatementdescribingtheextent,ifany,towhichconfidentialityofrecordsidentifyingthesubjectwillbemaintained
Forresearchinvolvingmorethanminimalrisk,anexplanationastowhetheranycompensation,andanexplanationastowhether
anymedicaltreatmentsareavailable,ifinjuryoccursand,ifso,whattheyconsistof,orwherefurtherinformationmaybe
obtained
Anexplanationofwhomtocontactforanswerstopertinentquestionsabouttheresearchandresearchsubjects'rights,andwhom
tocontactintheeventofaresearch-relatedinjurytothesubject
Astatementthatparticipationisvoluntary,refusaltoparticipatewillinvolvenopenaltyorlossofbenefitstowhichthesubjectis
otherwiseentitled,andthesubjectmaydiscontinueparticipationatanytimewithoutpenaltyorlossofbenefits,towhichthe
subjectisotherwiseentitled
B.
Additionalelements,asappropriate
• Astatementthattheparticulartreatmentorproceduremayinvolveriskstothesubject(ortotheembryoorfetus,ifthesubjectis
ormaybecomepregnant),whicharecurrentlyunforeseeable
• Anticipatedcircumstancesunderwhichthesubject'sparticipationmaybeterminatedbytheinvestigatorwithoutregardtothe
subject'sconsent
• Anyadditionalcoststothesubjectthatmayresultfromparticipationintheresearch
• Theconsequencesofasubject'sdecisiontowithdrawfromtheresearchandproceduresfororderlyterminationofparticipationby
thesubject
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IRBApplicationGuidelinesandTemplates
•
Astatementthatsignificantnewfindingsdevelopedduringthecourseoftheresearch,whichmayrelatetothesubject's
willingnesstocontinueparticipation,willbeprovidedtothesubject
• Theapproximatenumberofsubjectsinvolvedinthestudy
C.
DocumentationRequirementsforInformedConsent
InformedconsentshallbedocumentedbytheuseofawrittenconsentformapprovedbytheIRB,andsignedbythesubjectorthe
subject'slegallyauthorizedrepresentative.Acopyshallbegiventothepersonsigningtheform.
NATIONALINSTITUTESOFHEALTHTIPSONINFORMEDCONSENT
Theprocessofobtaininginformedconsentmustcomplywiththerequirementsof45CFR46.116.Thedocumentationofinformed
consentmustcomplywith45CFR46.117.Thefollowingcommentsmayhelpinthedevelopmentofanapproachandproposed
languagebyinvestigatorsforobtainingconsentanditsapprovalbyIRBs:
*Informedconsentisaprocess,notjustaform.Informationmustbepresentedtoenablepersonstovoluntarilydecidewhetheror
nottoparticipateasaresearchsubject.Itisafundamentalmechanismtoensurerespectforpersonsthroughprovisionofthoughtful
consentforavoluntaryact.Theproceduresusedinobtaininginformedconsentshouldbedesignedtoeducatethesubjectpopulation
intermsthattheycanunderstand.Therefore,informedconsentlanguageanditsdocumentation(especiallyexplanationofthestudy's
purpose,duration,experimentalprocedures,alternatives,risks,andbenefits)mustbewrittenin"laylanguage",(i.e.understandableto
thepeoplebeingaskedtoparticipate).Thewrittenpresentationofinformationisusedtodocumentthebasisforconsentandforthe
subjects'futurereference.Theconsentdocumentshouldberevisedwhendeficienciesarenotedorwhenadditionalinformationwill
improvetheconsentprocess.
*Useofthefirstperson(e.g.,"Iunderstandthat...")canbeinterpretedassuggestive,mayberelieduponasasubstituteforsufficient
factualinformation,andcanconstitutecoerciveinfluenceoverasubject.Useofscientificjargonandlegaleseisnotappropriate.Think
ofthedocumentprimarilyasateachingtoolnotasalegalinstrument.
*Describetheoverallexperiencethatwillbeencountered.Explaintheresearchactivity,howitisexperimental(e.g.,anewdrug,extra
tests,separateresearchrecords,ornonstandardmeansofmanagement,suchasflippingacoinforrandomassignmentorotherdesign
issues).Informthehumansubjectsofthereasonablyforeseeableharms,discomforts,inconvenienceandrisksthatareassociatedwith
theresearchactivity.Ifadditionalrisksareidentifiedduringthecourseoftheresearch,theconsentprocessanddocumentationwill
requirerevisionstoinformsubjectsastheyarere-contactedornewlycontacted.
*Describethebenefitsthatsubjectsmayreasonablyexpecttoencounter.Theremaybenoneotherthanasenseofhelpingthepublic
atlarge.Ifpaymentisgiventodefraytheincurredexpenseforparticipation,itmustnotbecoerciveinamountormethodof
distribution.
*Describeanyalternativestoparticipatingintheresearchproject.Forexample,indrugstudiesthemedication(s)maybeavailable
throughtheirfamilydoctororclinicwithouttheneedtovolunteerfortheresearchactivity.
*Theregulationsinsistthatthesubjectsbetoldtheextenttowhichtheirpersonallyidentifiableprivateinformationwillbeheldin
confidence.Forexample,somestudiesrequiredisclosureofinformationtootherparties.Somestudiesinherentlyareinneedofa
CertificateofConfidentialitythatprotectstheinvestigatorfrominvoluntaryrelease(e.g.,subpoena)ofthenamesorotheridentifying
characteristicsofresearchsubjects.TheIRBwilldeterminethelevelofadequaterequirementsforconfidentialityinlightofits
mandatetoensureminimizationofriskanddeterminationthattheresidualriskswarrantinvolvementofsubjects.
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IRBApplicationGuidelinesandTemplates
*Ifresearch-relatedinjury(i.e.physical,psychological,social,financial,orotherwise)ispossibleinresearchthatismorethanminimal
risk(see45CFR46.102[g]),anexplanationmustbegivenofwhatevervoluntarycompensationandtreatmentwillbeprovided.Note
thattheregulationsdonotlimitinjuryto"physicalinjury".Thisisacommonmisinterpretation.
*Theregulationsprohibitwaivingorappearingtowaiveanylegalrightsofsubjects.Therefore,forexample,consentlanguagemustbe
carefullyselectedthatdealswithwhattheinstitutionisvoluntarilywillingtodoundercircumstances,suchasprovidingfor
compensationbeyondtheprovisionofimmediateortherapeuticinterventioninresponsetoaresearch-relatedinjury.Inshort,
subjectsshouldnotbegiventheimpressionthattheyhaveagreedtoandarewithoutrecoursetoseeksatisfactionbeyondthe
institution'svoluntarilychosenlimits.
*Theregulationsprovidefortheidentificationofcontactpersonswhowouldbeknowledgeabletoanswerquestionsofsubjectsabout
theresearch,rightsasaresearchsubject,andresearch-relatedinjuries.Thesethreeareasmustbeexplicitlystatedandaddressedin
theconsentprocessanddocumentation.Furthermore,asinglepersonisnotlikelytobeappropriatetoanswerquestionsinallareas.
Thisisbecauseofpotentialconflictsofinterestortheappearanceofsuch.Questionsabouttheresearcharefrequentlybestanswered
bytheinvestigator(s).However,questionsabouttherightsofresearchsubjectsorresearch-relatedinjuries(whereapplicable)may
bestbereferredtothosenotontheresearchteam.ThesequestionscouldbeaddressedtotheIRB,anombudsman,anethics
committee,orotherinformedadministrativebody.Therefore,eachconsentdocumentcanbeexpectedtohaveatleasttwonames
withlocaltelephonenumbersforcontactstoanswerquestionsinthesespecifiedareas.
*Thestatementregardingvoluntaryparticipationandtherighttowithdrawatanytimecanbetakenalmostverbatimfromthe
regulations(45CFR46.116[a][8]).Itisimportantnottooverlooktheneedtopointoutthatnopenaltyorlossofbenefitswilloccurasa
resultofbothnotparticipatingorwithdrawingatanytime.Itisequallyimportanttoalertpotentialsubjectstoanyforeseeable
consequencestothemshouldtheyunilaterallywithdrawwhiledependentonsomeinterventiontomaintainnormalfunction.
*Don'tforgettoensureprovisionforappropriateadditionalrequirementswhichconcernconsent.Someoftheserequirementscanbe
foundinsections46.116(b),46.205(a)(2),46.207(b),46.208(b),46.209(d),46.305(a)(5-6),46.408(c),and46.409(b).TheIRBmay
imposeadditionalrequirementsthatarenotspecificallylistedintheregulationstoensurethatadequateinformationispresentedin
accordancewithinstitutionalpolicyandlocallaw.
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IRBApplicationGuidelinesandTemplates
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ParentConsentRequirements
AppendixE-thisis
informational.PleaseDO
NOTincludeitwiththe
application.
Mostresearchinvolvingdatacollectedfromchildrenrequiresparentconsent,andwillbereviewedbythe
HumanSubjectsCommitteeonacase-by-casebasis.Parentconsentrequirementsmaybewaivedifallofthe
followingconditionsexist:
§ Alldataarecollectedaspartofthenormalcourseofinstructionorevaluationofthechild(e.g.,scores
fromtestingstudentsafteraparticularscienceunit),AND
§ Anymanipulationofteachingactivitiesortechniquesiswithintherealmofacceptableteachingpractices,
AND
§ Thereisnoperceivedpsychologicalorphysicalrisktothechild.
Eveniftheabovecriteriaaremet,allresearchproposalsmustbesubmittedtotheHumanSubjectsCommittee
andreceiveapprovalorexemptstatusbeforebeginningdatacollection.Thepurposeforthisrequirementisthat
anyresearchinvolvinghumansubjectsbyMSMUfaculty,staff,orstudentsrequiresapprovalbytheHSC,evenif
theresearchisminimal/noriskorexempt.Accordingtofederalguidelines,theHSCmustdeterminewhethera
proposalisno-riskorexemptandprincipalinvestigatorsortheiradvisorsmaynotself-exempt.
!a
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Thesearethe
required
componentsof
theconsentwitha
sampleofhowit
mightlook.
ProjectTitle
Introduction
Description
of
Research
Subject
Information
&Risks
Confidentiality
&Final
Dispositionof
Data
Benefit
of
Participation
Concerns
Voluntary
Participation
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AppendixF:SampleInformedConsent
Thissamplehasmostelementsneededbutpleasemakesureitmatchesyourstudy.Seethe
noteoninternetresearch.
CourtesyofCALIFORNIASTATEUNIVERSITY,NORTHRIDGE
PROJECT
(IndicatePARENTALorIndividual)INFORMEDCONSENTFORM
The(inserttitle)
isbeingconductedby(researchers(s)
aspartoftherequirementsforthe
(D.P.T./M.S./M.A.)degreein_________atMountSaintMary’sUniversity.Itisdesignedto:trainprofessionals
interestedinworkingwithinfantsandtoddlersandtheirparentstoworkeffectivelyonteamsandprovidedirect
servicetothechildrenandtheirfamilies.
Theresearchwilladdtothelimitedliteraturewehaveabout:howchildrendevelopandthevariousservicesthey
willneed.Wearehopefulthatthisinformationwillbeofassistancetophysicians,teachers,psychologists,speech
andlanguagespecialists,childdevelopmentspecialists,nurses,andphysicalandoccupationaltherapists.Itisalso
ourintentiontodevelopamodelfortrainingprofessionalssothattheycanbetterservefutureinfantsandtoddlers
andtheirfamilies.
Eachchildandfamilywillbeinthestudyfortwotothreeyears.Ourstudentswillbeengagedinperiodic
assessmentsandinvolvedinhelpingyourchildlearnanddeveloponanindividualbasisaswellashelpingyour
familywithconcernsrelatingtoyourchildwheneverpossible.Therisksfromparticipatinginthisstudyinclude
(insertapplicableinformation,e.g.,emotionaldistress,musclecramps).Neitheryounoryourchildwillreceive
monetarycompensationforparticipationinthisstudy.
Anyinformationthatiscollectedinthisstudythatcanbeidentifiedspecificallywithyourchildwillremain
confidentialandwillbedisclosedonlywithyourwrittenpermissionorifrequiredbylaw.Thecumulativeresultsof
thisstudywillbepublished,butthenamesoridentityofsubjectswillnotbemadeknown.Alldata/documentation
collectedaspartofthisprojectwillbe(chooseone:destroyed,maintained,keptonfile,etc.)bytheresearcherat
theconclusionofthestudy.
However,theremaybespecificbenefitswhichyourchildcanexpectasaresultofparticipationinthisstudy,
including(listinterventionortreatmentthatparticipantwillreceiveasaresultofparticipation).(Ifparticipantwill
notbenefit,thenindicatethattheydonotbenefit.Alsospecifythebenefitofthestudytosociety.)
Ifyouwishtovoiceaconcernabouttheresearch,youmaydirectyourquestion(s)totheMountSaintMary’s
UniversityHumanSubjectsResearchCommittee,10ChesterPlace,LosAngeles,CA90007,andbyphoneat213477-2624.IfyouhavespecificquestionsaboutthestudyyoumaycontactDr. ,facultyadvisor,_____________
insertadvisorcontactinfo.Mycontactinformationis___________(insertresearcher(s)contactinfo.)
Youshouldunderstandthatapprovalforyourchildtoparticipateinthisstudyiscompletelyvoluntary,andyou
maydeclinetoallowyourchildtoparticipateorwithdrawyourchildfromthestudyatanytimewithoutjeopardy.
Likewise,theresearchermaycancelthisstudyatanytime.
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IRBApplicationGuidelinesandTemplates
Includeonlyifyou
areaudiotaping
Includeonlyifyou
arevideotaping
SubjectSignature
Witness/P.I.
signature
Returnformto:
Duringthecourseoftheprojectparticipantsmaybeaudiotaped.Yourinitialshere_____signifyyourconsentto
allowyourchildtobeaudiotaped.(Specifyreasonforaudiotaping)Alltapescollectedaspartofthisprojectwillbe
(chooseone:destroyed,maintained,keptonfile,etc.)bytheresearcherattheconclusionofthestudy.
Duringthecourseoftheprojectparticipantsmaybevideotaped.Yourinitialshere_____signifyyourconsentto
allowyourchildtobevideotaped.(Specifyreasonforvideotaping.)Alltapescollectedaspartofthisprojectwillbe
(chooseone:destroyed,maintained,keptonfile,etc.)bytheresearcherattheconclusionofthestudy.
Ihavereadtheaboveandunderstandtheconditionsoutlinedforparticipationinthedescribedstudy.Ihavebeen
providedwithacopyofthisconsentformtokeepandIgiveinformedconsentformychild,namedbelow,to
participateinthestudy.
Child'sName_________________________________________________
Last
First
MI
Age:________Years________Months
Parent/LegalGuardianPrintedName
______________________________________________________
Last
First
MI
Signature
Date
Witness/P.I.signature Date
Ifyouhavesignedthisform,pleasereturnonecopyinanenvelopebymailto:
Insertthereturninformationhere.
*Besuretokeeponecopyofthisconsentfromforyourrecords.
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IRBApplicationGuidelinesandTemplates
NOTE: If you are using a third party to hold your data or to collect data such as
Survey Monkey, iCloud, etc. you MUST add this information to your consent! Then
you may also use this statement:
“Although every reasonable effort has been taken, confidentiality during actual Internet
communication procedures cannot be guaranteed.”
OR
“Please note that the online survey is hosted by Company ABC which is a web survey
company located in the USA. All responses to the survey will be stored and accessed in
the USA. This company is subject to U.S. Laws, in particular, to the US Patriot
Act/Domestic Security Enhancement Act that allows authorities access to the records that
your responses to the questions will be stored and accessed in the USA. The security and
private policy for Company ABC can be viewed at http://...”
You can use this in the confidentiality section above.
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IRBApplicationGuidelinesandTemplates
AppendixG:AnotherconsentsamplefromtheUniversityofWisconsin–Milwaukee
ConsenttoParticipateinOnlineResearch
StudyTitle:(TitleaslistedonIRBapplication)
PersonResponsibleforResearch:(PI,mayalsoincludeCo-I,and/orstudystaff)
StudyDescription:Thepurposeofthisresearchstudyisto…(addstudyspecificinformation).
Approximately(numberofsubjects)subjectswillparticipateinthisstudy.Ifyouagreetoparticipate,
youwillbeaskedtocompleteasurveythatwilltakeapproximately(lengthoftime)minutesto
complete.Thequestionswillask…(briefdescriptionofsurveyquestions).
Risks/Benefits:Riskstoparticipantsareconsideredminimal.Therewillbenocostsforparticipating,
norwillyoubenefitfromparticipatingotherthantofurtherresearch.
Confidentiality:Yourresponsesarecompletelyconfidentialandnoindividualparticipantwilleverbe
identifiedwithhis/heranswers.Datafromthisstudywillbesavedonapasswordprotectedcomputer
for(lengthoftimedatawillberetained).Only(PI,studystaff,etc.–listwhowillhaveaccesstothe
data)willhaveaccesstotheinformation.
VoluntaryParticipation:Yourparticipationinthisstudyisvoluntary.Youmaychoosetonotanswer
anyofthequestionsorwithdrawfromthisstudyatanytimewithoutpenalty.Yourdecisionwillnot
changeanypresentorfuturerelationshipwiththeUniversityofWisconsinMilwaukee.
WhodoIcontactforquestionsaboutthestudy:Formoreinformationaboutthestudyorstudy
procedures,contact(name)at(emailand/orphonenumber).
WhodoIcontactforquestionsaboutmyrightsorcomplaintstowardsmytreatmentasaresearch
[email protected]
ResearchSubject’sConsenttoParticipateinResearch:
Bycompletingandsubmittingtheattachedsurvey,youarevoluntarilyagreeingtotakepartinthis
study.Completingthesurveyindicatesthatyouhavereadthisconsentformandhavehadallofyour
questionsanswered,andthatyouare18yearsofageorolder.
Thankyou!
If you use this template, make sure
you add the correct contact
numbers, etc.
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IRBApplicationGuidelinesandTemplates
AppendixH:AdditionalSampleLanguageforConsentDocuments
¢ “Yourconfidentialitywillbekepttothedegreepermittedbythetechnologybeingused.Noguarantees
canbemaderegardingtheinterceptionofdatasentviatheInternetbyanythirdparties.”(PennState)
¢ Addressuncertaintyindatalongevityinmoreopen-endedterms:“Datamayexistonbackupsorserver
logsbeyondthetimeframeofthisresearchproject.”
¢ “Yourconfidentialitywillbekepttothedegreepermittedbythetechnologybeingused.Noguarantees
canbemaderegardingtheinterceptionofdatasentviatheInternetbyanythirdparties.”(PennState)
¢ Addressuncertaintyindatalongevityinmoreopen-endedterms:“Datamayexistonbackupsorserver
logsbeyondthetimeframeofthisresearchproject.”
¢ (withmobiledeviceresearch):“Remotedatadeletionwillbeperformedintheeventofalostorstolen
phone”
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IRBApplicationGuidelinesandTemplates
AppendixI:SAMPLEOFLETTERFROMPARTICIPATINGINSTITUTION
Templateletterfrominstitutionalofficialprovidingpermissiontoconductstudyattheirsite
(onlyforstudieswheresubjectswillberecruitedfromalocationotherthanMSMU).
{Lettermustbeonletterheadwithoriginalsignatureofauthorizedofficial}
Date
MountSaintMary’sUniversity
StandingAdvisoryCommitteefortheProtectionofHumanSubjects
10ChesterPlace
LosAngeles,CA90007
DearCommitteeMembers:
[Insertyourname(s)]haspermissiontoconducttheprojectentitled[inserttitleofprojecthere]
at[insertnameoffacility].Ihavereviewedtheprojectandamawareofalltheactivities
involvedintheprojectincluding[listallthatareapplicable,e.g.,surveys,interviews,reviewing
studentrecords].
Signed,
[Insertnameandtitleofauthorizedofficial]
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IRBApplicationGuidelinesandTemplates
AppendixJ:ParentConsenttobeUsedforEducationCaseStudyProjects(EDU296C/D)
ThefollowingconsenthasbeenapprovedbytheMSMUHumanSubjectsCommitteeforuseby
EducationstudentswhoarecompletingacasestudyprojectinEDU296C/D.
OtherdepartmentsarewelcometorevisetheconsentfortheirneedsforusewiththeIRB
application.
`t
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IRBApplicationGuidelinesandTemplates
ParentalPermissionforChildObservation&CaseStudy
EDU296C/D:CaseStudyInquiry&ReportSeminarI&II
Instructor:RobinL.Gordon,Ph.D.,ProfessorofEducation
InstructorContact:[email protected]
MountSaintMary’sUniversity
10ChesterPlace
LosAngeles,CA90007
Date:
EducationStudent’sName:
EducationStudent’sContactInformation:
DearParentorGuardian:
WearerequestingyourpermissionforaMountSaintMary’sUniversityEducationstudenttocompleteacase
studyinquiryprojectwithyourchild.Thecasestudyisanin-depthlookatastudentandiscarriedoutinorderfor
theteacher-candidatetolearnmoreaboutaspecificstudentinacomprehensiveway.Forexample,withyour
permission,theteacher-candidatemayinterviewyouaboutyourchildand/oryourchildabouttheirschool
experiences.Additionaldatathatmightbecollected,withyourpermission,couldbetestscores,learningstyle
assessments,andsurveysaboutschool.Wehopenewteacherswilllookattheirfuturestudentsascomplexpeople
withdiversebackgroundsandexperiences.
Thecasestudywilltakeplaceduringonesemester.Thetimeinvolvedwilldependupontheassessmentsand/or
interviewsyouandtheEducationstudentagreeuponwhichmaybeusedtolearnaboutyourchild.Thiswilllead
tothepreparationandwritingofacasestudyaboutyourchild.ThecasestudyprocesswillenabletheMSMU
studenttogainabetterunderstandingofthephysical,social,emotionalandcognitive(mental)growthand
developmentofschoolagechildren.Wehopethattheknowledgegainedbydoingthecasestudywillhelpthe
candidatebecomeamoreeffectiveclassroomteacher.
Yourchildwillnotbemadeuncomfortableinanyway.Allinformationconcerningyourchildisconsidered
confidential.Participationiscompletelyvoluntary.Youoryourchildmaydecidetodiscontinueparticipationin
thecasestudyatanytime.
Thereisminimalriskforyourchildtoparticipateinthecasestudy;however,ifatanytimeyourchildfeels
uncomfortableaboutthework,youmaywithdrawfromthestudy.Thebenefitforyourchildmaybeabetter
understandingofhis/herclassroomneedswhichmakesmodificationsbytheteacher,ifneeded,moreeffective.
Ifyouwishtovoiceaconcernabouttheresearch,youmaydirectyourquestion(s)totheMountSaintMary’s
UniversityHumanSubjectsResearchCommittee,10ChesterPlace,LosAngeles,CA90007,andbyphoneat213477-2624.IfyouhavespecificquestionsaboutthestudyyoumaycontactDr.RobinGordon,ChairoftheHuman
SubjectsCommitteeandinstructor)[email protected].
PleasecompletethepermissionformbelowifyouagreethattheMSMUstudentmayworkwithyourchildas
describedabove.Wegreatlyappreciateyourcooperationinthiseducationalexperience.
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IRBApplicationGuidelinesandTemplates
DateofAgreement:_____________________________________
MyChild'sNameis:
Boy Girl
MyChild'sAge: yearsmonths______
I,(insertnameofparent/guardian)givepermissionfor(nameofstudent-researcher)tocollectdataforthe
purposeofwritingacasestudywith(nameofchild)asthefocusforher/hisgraduatecoursesatMountSaint
Mary’sUniversity.ThecoursesareEDU296C/D:CaseStudyInquiry&ReportSeminarI&IIwithinstructorDr.
RobinL.Gordon.Iunderstandthatnorealnameswillbeusedandthattheidentityof(nameofchild)willnotbe
revealedinanyotherway.
Duringthecourseofthiscasestudy,thefollowingprocedureswillbeusedtolearnmoreabout(nameofchild).
{Noteto296C/Dstudent:Listeachitemhere:forexample-samplesofschoolwork,interviewswiththe
subject,interviewswiththeparents/teachers,andobservationsofthepersonininteractionwithpeers
orfamilymembersmaybeused.Interviews,samplesofwork,andobservationsmustbedocumented
withdatesandtimesofdatacollection.}
Iandmychildunderstandthatthecourseinstructorwillbegivencopiesofassessments;however,afictitious
namewillbeusedtoprotecttheconfidentialityofmychild’sname.
Iandmychildunderstandthatparticipationisvoluntary,thatmychildorIcanchoosenottoparticipateinpartor
alloftheproject,andthatmychildorIcanwithdrawatanystageoftheprojectwithoutbeingpenalizedor
disadvantagedinanyway.
Iandmychildunderstandthatanydatathattheteacher-candidateobtainsfrominterviewsorassessmentsforuse
inreportswillnot,underanycircumstances,containnamesoridentifyingcharacteristicsofthechild.Upon
completionofthecasestudyproject,anyinterviews,assessments(excludingstatetestsorIEPs)orotherdata
collectedbytheteacher-candidatewillbeshredded.
IandmychildunderstandthatanyinformationIprovideisconfidentialandthatnoinformationthatcouldleadto
theidentificationofanyindividualwillbedisclosedinanyreportsontheproject,ortoanyotherparty.
NameandAddress:____________________________________________________________________________
____________________________________________________________________________________________
Relationtoparticipant:___________________________Phone:______________________________________
AdditionalRemarks:___________________________________________________________________________
____________________________________________________________________________________________
___________________________________________________________
(Parent'sSignature)(Date)
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IRBApplicationGuidelinesandTemplates
SpecialPermissionSignature:
Ifthestudyisbeingconductedbyateacher-candidatewhoisworkingasastudentteacherintheclassroomof
theircooperatingteacher:
Iandmychildgivepermissionfortheresultsofthecasestudytobesharedwiththeteacherofrecord.
___________________________________________________________
(Parent'sSignature)
(Date)
Bysigningthisform,IdeclarethatIamthelegalparent/guardianoftheminorchildlistedaboveand
authorizedtograntsuchpermission.
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