2015-16INSTITUTIONALREVIEWBOARDHANDBOOK
GuideforResearchinvolvingHumanSubjects
EffectiveJune2016withtheImplementationofIRBManager
TableofContents
FrequentlyAskedQuestions GuidelinesforResearchInvolvingHumanSubjects
JustinTime(JIT)Review
DataSafetyMonitoringPlans FactorsConsideredwhenReviewingIRBApplications CertificationforProtectionofHumanSubjects
FullBoardReview
ExpeditedReview
ExemptStatus InstitutionalAuthorizationAgreement CourseRelatedResearchbyAPUStudents
InternationalandCrossCulturalResearch
ExternalResearcherReviewProcess InformedConsent
DeceptionandIncompleteDisclosure ConflictofInterest
IntegrityinResearch SuspensionorTerminationofIRBApproval
Researcher’sContinuingResponsibilities
TheInstitutionalReviewBoard
References
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FrequentlyAskedQuestions
(1) DoIneedspecialcertificationtoconductorapproveresearchinvolvinghumansubjectsatAzusa
PacificUniversity?
Yes.Allthosewhoconductresearch,reviewtheapplicationsofresearchers,orteachacoursewitha
requirementforstudentresearchmustcompletetrainingfortheprotectionofhumansubjectsin
research.Pleaseseepage7forinstructionsforcertification.
(2) Ismyproject“research”with“humansubjects”thatmustbereviewedbytheIRB?
Seepage3-4forthedefinitionsof“research”and“humansubjects,andadditionalguidance.
(3)WhatlevelofIRBreviewisappropriateformyresearchproject?
Therearethreecategoriesofreview.Pleasenotethatthecategorylabelsarenotdescriptive.The
differencebetweenthereviewcategoriesisthedegreeofscrutiny,whichdependsonthelevelof
risktohumansubjects.
• FullBoardReviewseepage8
• Expedited–seepages9-10
• ExemptStatus–seepages11-12
(4)WhatdoestheIRBconsiderwhenreviewingaprojectforprotectionofhumansubjects?
Seepage3.
(5)WhendoestheIRBmeet?
TheFullIRBBoardmeetsmonthly,twelvemonthsayear,generallythe3rdWednesdayofeach
month.Thedeadlinetosubmitanapplicationforconsiderationbythefullboardis10workingdays
beforethemeeting.
(6)WhoarethemembersoftheIRB?
TheViceProvostforGraduateProgramsandResearch/ResearchIntegrityOfficerappointsmembers
inaccordancewithfederalguidelines.Amajorityofthemembersarefaculty.Forcurrentmembers
andalternates,contactJoanieStude,IRBCoordinator.
(7)WhatneedstobesubmittedforanIRBapplication?
TheIRBManageronlineapplicationsystemwillguideyouthroughtheprocessincludingrequired
attachmentssuchasInformedConsentform(s),participantrecruitment,andsurveyinstruments.
Youcanaccesstheapplicationandattachmentformsathttps://apu.my.irbmanager.com.
(8)WhatarespecialconsiderationsforpersonsplanningtosurveymembersoftheAPUcommunity?
PersonsplanningtosurveymembersoftheAPUcommunity(whetherelectronicorpapersurveys)
mustcontacttheOfficeofInstitutionalResearch(OIRA)[email protected]
submissiontotheIRBforassistancewiththesurveyandforschedulingtheirdatacollection.
(9)DoesaresearcherfromoutsidetheAPUcommunityneedtoreceiveapprovalfromAPU’s
InstitutionalReviewBoardtoconductresearchusingAPUfaculty,staff,orstudents?
Yes,IRBapprovalatAPUismostoftenrequired,thoughthisisdeterminedonacasebycasebasis.
PleasecontactIRBCoordinatorJoanieStudeatjstude@apu.eduforinformation.
Foranyquestions,contactJoanieStude,[email protected].
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GuidelinesforResearchInvolvingHumanSubjects
Introduction
AzusaPacificUniversity(APU)encouragestheconductofresearchinandamongitsschools,andin
collaborationwithothereducationalinstitutions,agencies,andorganizations.TheUniversity,while
respectingtherightoffacultyandstudentstoacademicfreedominresearch,isfirmlycommittedto
adheringtothebasicChristianethicalprinciplesunderlyingtheacceptableconductofresearchinvolving
humansubjects.
AllresearchersaffiliatedwithAPUwhoareconductingresearchinwhichAPUisengagedmustobtain
APUIRBapprovalfortheirresearchwithhumansubjectsbeforedatacollectionbegins.Engagingin
researchwithhumansubjectswithoutIRBapprovalhasseriousethicalimplicationsandviolates
universityandfederalpolicies.QuestionsregardingwhetherAPU’sIRBapprovalisrequiredmaybe
[email protected].
AdherencetotheCommonRule:OnJune18,1991,seventeenFederalDepartmentsandAgencies
adoptedacommonsetofregulationsknownastheFederalPolicyfortheProtectionofHumanSubjects
or“CommonRule.”Seehttp://www.hhs.gov/ohrp/(Regulations45CFR46).Thesefederalregulations
requirethatanyinstitutionrequestingandreceivingfundsfromafederaldepartmentoragencyfor
researchinvolvinghumansubjectsmustassurethatresearchisreviewedandapprovedbythe
University’sInstitutionalReviewBoard(IRB).Thedesignoftheseregulationsisbasedonestablished,
internationallyrecognizedethicalprinciplesdiscussedintheBelmontReport(1979)asfollows:
Respectforpersonsincorporatesatleasttwoethicalconvictions:“first,thatindividualsshould
betreatedasautonomousagents;andsecond,thatpersonswithdiminishedautonomyare
entitledtoprotection”(thus,theneedtoobtaininformedconsent).
Beneficenceentailstreatingpersons“inanethicalmannernotonlybyrespectingtheir
decisions,butalsobymakingeffortstosecuretheirwell-being...Twogeneralrules:(1)dono
harm;and(2)protectfromharmbymaximizinganticipatedresultsandminimizingpossiblerisks
ofharm.”
Justicerequiresthatthe“benefitsandburdensofresearchbedistributedfairly”
(thus,theprincipleofjusticeisappliedintheselectionofresearchsubjects).
Formoreinformation,pleaserefertoBelmontReport:EthicalPrinciplesandGuidelinesforthe
ProtectionofHumanSubjectsofResearchat:
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
DefinitionofResearchwithHumanSubjects
Research:
Researchisdefinedas“asystematicinvestigation,includingresearchdevelopment,testingand
evaluation,designedtodeveloporcontributetogeneralizableknowledge”(§45CFR.46.102[d]).For
thecurrentCodeofFederalRegulations,pleasesee:
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.
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HumanSubjects:
HumanSubjectsare“livingindividual(s)aboutwhomaninvestigatorconductingresearch
obtains:(1)datathroughinterventionorinteractionwiththeindividual;or(2)identifiable
privateinformation”(§45CFR46.101[f]).
Aprojectorstudyis“research”inthiscontextifit:a)isconductedwiththeintentionofdrawing
conclusionsthathavesomegeneralapplicabilitytopopulationsorsituationsotherthantheonebeing
studied(“generalizableknowledge”),andb)usesacommonlyacceptedqualitativeorquantitative
method.Morespecifically,generalizableknowledgeisinformationbasedonresultsorfindingsthatare
expected1)tobereproducible,and2)toapplybroadlywiththeexpectationofpredictableoutcomes.
Ifyourprojectmeetsthecriteriaofboth“research”andwith“humansubjects”asnotedabove,itmust
havesomelevelofreviewfromtheIRB.Inaddition,theneedforIRBreviewisnotdeterminedby
whethertheresearcherintendstopresentorpublishthestudyoutcomes,sincepublishingtheresultsof
aprojectdoesnotbyitselfclassifythestudyasonethatisgeneralizable.However,insomecases,the
intenttopublishcanbeusedasonecriteriafordeterminingwhethertheprojectmeetstheabove
definitionof“research.”
Opportunitysamples,pilotstudies,andpreliminarystudiesdesignedtohelptheinvestigatorrefinedata
collectionprocedures,instruments,orresearchdesign,requirethesamescrutinyasfull-scaleresearch
projects.TheyarethereforesubjecttoIRBreview.
Researchinvolvingthesecondaryanalysisofexistingdata(e.g.,publicde-identifieddata)doesnot
requirereviewwhenitdoesnotmeetthedefinitionofresearchwithhumansubjectsnotedabove.
However,thesecondaryuseofdatamayqualifyforExemptStatusunderthefederalregulationsifthe
initialdatasetisidentifiableandifitwouldnotbepossiblefortheresearchertoidentifythesubjects.In
somecases,secondaryuseofdatamaywarrantexpeditedorfullboardreview(e.g.,researchinvolving
prisoners,researchusingdatacollectedforapreviousstudywhereadditionalinformedconsentmaybe
warranted).Foradditionaldiscussiononresearchinvolvingthesecondaryuseofexistingdata,please
refertoUniversityofCalifornia,Berkeley’sguidelinesonthistopicwhichcanbefoundat:
http://cphs.berkeley.edu/secondarydata.pdf.
Studiesinitiatedwiththeprimaryintentofimprovinginstitutionalpractice(sometimeslabeledoutcome
studiesorprogramassessment)areconsidered“qualityimprovement”activitiesandaretypicallynot
classifiedasresearch.However,someprogramevaluationprojectsmayfallintothedefinitionof
researchbasedondesignandintenttogeneralizeoutsideofthelocalarea.
Studiesconductedbyfacultywiththeirownstudentswouldnottypicallyleadtogeneralizableoutcomes
andwouldnotnormallyfallunderthecategoryofresearchtobereviewedbytheIRB.Professorsthat
choosetodoresearchwiththeirownuniversitystudentsshouldbeawarethattheywillneedto
mitigatetheinherentpotentialforbiasbuiltintothatmethodology.
Pleasenotethat,ifhumansubjectsareinvolvedinastudywhichdoesnotmeetthedefinitionof
“research,”theymustbeprotectedusingthesamelevelofcareasifIRBreviewhadtakenplace.For
example,theresearchermustalwaysobtainpermissionfromparticipantsanddiscloseanyriskstothem
beforecollectingdata.PleaseconsultwiththeIRBCoordinatorortheIRBChairforadditionalguidance.
SeeDecisionTreeat:http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html,Chart1.
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JustinTimeReview
“Just-in-Time”isaprocedureusedbytheNationalInstitutesofHealthtofacilitatethetimelycollection
ofinformationtosupportproposalsthataredeemedtobeinthefundablerange.Supplemental
informationforproposalswithalikelihoodoffunding(includingIRBapproval)isrequestedjustbefore
NIHcouncilreview,or“just-in-time”fortheawardsdecision.IRBapprovalisthereforenotrequiredat
thetimeofgrantapplication,savingresearchersandIRBpersonnelconsiderableeffortinlightofthelow
fundingoddsforgrantapplications.
Uponnotificationofthe“Just-in-Time”(JIT)request,thePIshouldbegintopreparetheIRBapplication
rightaway.TheOfficeofResearchandGrants(ORG)DirectorofSponsoredResearchwillcoordinatethe
timingoftheprotocolsubmissionwiththePIandtheIRBCoordinator.Thenormaldeadlinetosubmit
theprotocolof10daysbeforeafullboardreviewmaybeshortenedinthesecases.TheIRBapplication
shouldincludeadraftJITresponseletterand/oranexplanationofpotentialdiscrepanciesbetweenthe
grantapplicationandtheIRBapplicationandhowtheywillbereconciled,ifappropriate.Ifatall
possible,afullboardreviewofaJust-in-Timeprotocolshouldbeundertakenduringaregularly
scheduledmonthlyIRBmeeting.Ifthisisnotfeasible,theIRBwillmakeeveryefforttoconveneat
anothertimeinordertofacilitatethetimelyreviewoftheprotocol.
Pleasenotethatfederallysponsoredresearchapplicationsinvolvinghumansubjectsarerequiredbythe
U.S.DepartmentofHealthandHumanServicestobeappropriatelymatchedtoanapprovedIRB
protocol.ThegrantapplicationandthehumansubjectsdocumentsmustbereviewedbyanAPU
representative(typicallyanIRBmember,amemberoftheOfficeofResearchandGrants,orthe
ResearchIntegrityOfficer)anddeterminedtobe“entirelyconsistent”(perOHRPguidanceofMay31,
2000).Thisprocessmaytakeuptotenbusinessdays.Anydiscrepancybetweentheprotocolandthe
grantmustberesolvedoraccountedforbeforethegrantcanbeapproved,andpreferablybeforethe
IRBprotocolisapproved.TheIRBmaythereforerequestthattheIRBapplicationberevisedtoreconcile
discrepancies,bere-submitteddemonstratingitisinalignment,orbesupplementedwithclarification
onthedifferences.Non-federallyfundedgrantsmayalsobesimilarlyreconciled.
DataSafetyMonitoringPlans
IfanexternalfundingagencyrequiresaDataSafetyMonitoringPlan(DSMP),theresearchershould
includethisdocumentintheIRBapplication.ADSMPisadocumentthatdescribeshowtheresearcher
planstooverseethesafetyofhumansubjectsandthesafetyofthedataduringtheconductofthe
study.Itdetailsprotocolcomplianceandthereviewandreportingofunanticipatedevents.Insome
cases,theDSMPwillincludetheexistenceofaDataSafetyMonitoringBoard(DSMB),agroupof
carefullyselectedexpertswhowillmeetperiodicallytooverseethecollectionandprocessingofthe
data.WhereaDSMBisplanned,thedocumentshouldalsoincludeproposedmembershipoftheboard
andtheanticipatedcommunicationoftheDSMBandtheIRB.(e.g.,regardingunanticipatedevents).
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FactorsConsideredwhenReviewingIRBApplications
Benefit-FederalregulationschargetheIRBwithdeterminingthatresearchbenefitsoutweigh
researchrisks.Benefitcanbedefinedasvaluetoanindividualresearchsubject,orsomethingthat
willcontributetotheacquisitionofgeneralizableknowledge.
Risk-Riskcanbedefinedasthemagnitudeofthepotentialharmordiscomfortandtheprobability
oftheharmordiscomfortoccurring.Forpurposesofprotectinghumansubjectsinresearch
projects,riskincludes:
a. Violationofprivacy
b.Violationofconfidentiality
c.Questionsthattheparticipantmayconsidersensitive
d.Possibleemotionaldistressorphysicalinjury
e.Invasiveprocedures
MinimalRisk-Theprobabilityandmagnitudeofharmordiscomfortanticipatedintheresearchare
notgreaterinandofthemselvesthanthoseordinarilyencounteredindailylifeorduringthe
performanceofroutinephysicalorpsychologicalexaminationsortests.
Benefitvs.Risk-TheCommonRuleinstructsInstitutionalReviewBoardstoensurethat“risksto
subjectsareminimized”and“riskstosubjectsarereasonableinrelationtoanticipatedbenefits,if
any,tosubjectsandtheimportanceoftheknowledgethatmaybereasonablyexpectedtoresult”.
Vulnerablepopulations-Vulnerablepopulationsareindividualsorgroupswho,byreasonof
disability,illness,age,orotherstatusexhibitdiminishedpersonalautonomy.NeithertheFederal
regulationsnorethicalcodesproscribeinclusionofvulnerablepersonsasresearchsubjects.
However,theDepartmentofHealthandHumanServicesregulationsmandatespecialjustification
forresearchinvolvingfetuses,pregnantwomen,humaninvitrofertilization,prisoners,andchildren.
Sensitivetopics-Anyresearchprotocolthatinvolvessolicitationofinformationfromhuman
subjectsthatcouldreasonablycauseharmtotheparticipantifthedatawerenotkeptconfidentialis
consideredsensitivetopicresearch.Causingembarrassmentistheminimumthresholdfor
determiningwhetherresearchharmisforeseeableandthussensitive.
Privacy-Privacyisdefinedashavingcontroloverextent,timingandcircumstancesofsharing
oneselfwithothers.Pleasebeattentivetothreatstoparticipants’privacy.Anacceptablepracticeis
todistributeinvitationstoabroadpopulationandaskforpersonstoself-identifyasmeetingmore
narrowcriteria.Anoptionforsomesensitiveinterviewresearchistooffertheparticipantthe
opportunitytoreviewpublicationdraftsforunintendedmarkersofidentity.
Confidentiality-Confidentialitypertainstothetreatmentofinformationanindividualhasdisclosed
inarelationshipoftrustandwiththeexpectationthatitwillnot,withoutpermission,bedivulgedto
othersinwaysthatareinconsistentwiththeunderstandingoftheoriginaldisclosure.Researchers
ordinarilyuseinformationparticipantshavedisclosedorprovidedvoluntarily(i.e.,withtheir
informedconsent)forresearchpurposes.Seepage25forexpandedinformation.
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CertificationforProtectionofHumanSubjects
Certificationfortheprotectionofhumansubjectsinresearchisrequiredofthefollowinggroupspriorto
applicationtotheIRB:
• Faculty,staff,andstudentswhointendtoconductresearchinvolvinghumansubjects.This
includesthosewhoconductInformedConsentorhaveanyothercontactwithparticipants
• Allthosewhoreviewtheapplicationsofresearchers
Inanefforttoprovidethemostcomprehensivetrainingforresearchersofhumansubjects,APU’sIRB
requirestrainingandsuccessfulcompletionoftheCollaborativeInstitutionalTrainingInitiative(CITI)
HumanSubjectsResearchcourse.Thison-linecourseisfreetoAPUfaculty,staff,andstudents,andis
dividedintoanumberofmodules.Thesitecanbeenteredandexitedatanytimeduringthetraining.
ToaccesstheCITIsitegoto:www.citiprogram.org.Thereyouwillloginandchooseapassword.Once
youhavesubmittedyourmemberinformationandhaveaffiliatedwithAPU,youwillbedirectedtothe
APUpage.Fromthereyoucanreviewtheinstructionpage,andthenproceedto“AddaCourseor
UpdateLearnerGroups”.OntheHumanSubjectsResearch(IRB)pageyouwillchoosethelearnergroup
thatismostappropriateforyoufromthefivegroupslistedthere.Youwillnotethatsomemodulesare
requiredandsomeareoptional.Optionalmodulesmayberequiredifyourresearchinvolvesaparticular
topicorpopulation.TheIRBCoordinatorisresponsibletoassignadditionalmodulesbasedonthe
researchtopic.Issuesthatmaypromptadditionalmodulesincludethefollowing:
Vulnerablepopulations
InternationalResearch
InternetResearch
Students
Culturalconsiderations
OncetheCITItrainingiscompleted,theCITICompletionReportisvalidforthreeyears.Youwillreceivea
reminderfromCITIwhenyouareduetotakearefreshercourse.
TheIRBcoordinatorisavailableforanyquestionsyoumighthave.PleasefeelfreetocontactJoanie
[email protected].
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FullBoardReview
CriteriaforaFullBoardReview
Researchthatinvolves(a)vulnerablepopulations,or(b)sensitivetopics,or(c)involvesmorethan
minimalriskrequiresfullboardreview.
A.VulnerablePopulations-Allresearchthatinvolvesfetuses,pregnantwomen,prisoners,orgroups
whomayhavediminishedcapacitytoprovideconsentorwhomaybehighriskmustbeprovidedfull
review.
See§45CFR46.201-207,pregnantwomen;
46.300-306,prisoners;
46.401-409,childrenandminors(exceptasincludedunderexemptandexpeditedcategories)
B.SensitiveTopics-Anyresearchprotocolthatinvolvessolicitationofinformationfromhumansubjects
thatcouldreasonablycauseharmtotheparticipantifthedatawerenotkeptconfidential.Causing
embarrassmentistheminimumthresholdfordeterminingwhetherresearchharmisforeseeableand
thussensitive(Seeinformationboxbelowforexamplesofsomesensitivetopics).
C.MorethanMinimalRisk-Theprobabilityandmagnitudeofharmordiscomfortanticipatedinthe
researcharegreaterinandofthemselvesthanthoseordinarilyencounteredindailylifeorduringthe
performanceofroutinephysicalorpsychologicalexaminationsortests(45CFR46).Invasive
procedures,possibleemotionaldistress,andthepotentialforlackofconfidentiality,forexample,are
consideredgreaterthanminimalrisk.InordertobeapprovedbytheBoard,suchrisksmustbe
addressed.
ExamplesofSensitiveTopicsthatMayRequireFullBoardReview
1.Illegalorpunishableconduct,includinguseofalcohol,drugs,orotheraddictiveproducts
2.Informationthatcoulddamageanindividual’sfinancialstanding,employability,orreputation
3.Information(usuallyinmedicalrecords)thatcouldleadtosocialstigmatizationordiscrimination
4.Psychologicalwell-beingormentalhealth,includingphysicalormentalabuse
5.Sexualorientation,attitudes,preferences,orpractices
6.Incest,rape,daterape,orsexualmolestation
7.Geneticinformation
8.Religiousorientationorviews–Religionisjustoneexampleofasensitivetopic.Aswithallsensitive
topics,thebroaderprincipleiswhetherornotthereisapotentialforharmifthedatawere
revealed.Identifyingreligiousorientationonaresearchprojectwouldnottypicallybeconsidereda
sensitivetopicatAzusaPacificUniversity.However,itshouldbenotedthattherearemany
possiblescenarioswherereligiousresearchcouldbepotentiallyharmfultotheparticipantif
confidentialdatawererevealed.
9.Veteranorwartimeexperiences
10.Topicsthatmaybeperceivedassensitiveorinjuriousbyparticipants
11.Immigrationstatus
Pleasenote:Thesensitivesubjectslistedaboveareexamplesandnotaninclusivelist.
TocompleteanapplicationtotheIRBforFullBoardReviewgotohttps://apu.my.irbmanager.com
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ExpeditedReview
CriteriaforanExpeditedReview
Expeditedreviewproceduresrefertoresearchthatdoesnotinvolvevulnerablepopulations,sensitive
topicsandinvolvesnomorethanminimalrisktohumansubjects.Expeditedresearchproposalsare
reviewedforprotectionofhumansubjectsbytheChairoftheIRBordesignee.
CriteriaforIRBapprovalofexpeditedreviewinclude:
1. Riskstosubjectsareminimized:
• byusingprocedureswhichareconsistentwithsoundresearchdesignandwhichdonot
unnecessarilyexposesubjectstorisk,and
• wheneverappropriate,byusingproceduresalreadybeingperformedonthesubjectsfor
diagnosticortreatmentpurposes.
2. Riskstosubjectsarereasonableinrelationtotheanticipatedbenefitsifanytosubjectsandthe
importanceoftheknowledgethatmaybereasonablyexpectedtoresult.
3. Selectionofthesubjectsisequitable.
4. Informedconsentisreceivedfromeachprospectivesubject.
5. Informedconsentisappropriatelydocumented.
6. Theresearchplanmakesadequateprovisiontoensurethesafetyofsubjects.
7. Adequateprovisionsaremadetoprotecttheprivacyofsubjectsandtomaintainthe
confidentialityofdata.
AlloftheitemsabovemustapplyforanapplicationtobeconsideredforExpeditedReview.
SeeDecisionTreesathttp://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html,Charts8and9.
TocompleteanapplicationtotheIRBforExpeditedReviewgotohttps://apu.my.irbmanager.com
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ResearchCategoriesforanExpeditedReview
Thefollowingcategoriesgenerallyrequireanexpeditedreview.Forfurtherexplanation,see
http://www.hhs.gov/ohrp(seeexpeditedreview).
(1) Clinicalstudiesofdrugsandmedicaldeviceswheneitheraninvestigationalnewdrug
applicationoraninvestigationaldeviceexemptionapplicationisnotrequired.
(2) Collectionofbloodsamplesbyfingerstick,heelstick,earstickorvenipunctureasper
guidelines.
(3) Prospectivecollectionofbiologicalspecimensforresearchpurposesbynoninvasivemeans,
e.g.,hairandnailclippings,excreta,skinswab,etc.
(4) Collectionofdatathroughnoninvasiveprocedures(notinvolvinggeneralanesthesiaor
sedation)routinelyemployedinclinicalpractice,excludingproceduresinvolvingx-raysor
microwaves.
(5) Researchinvolvingmaterials(data,documents,records,orspecimens)thathavebeen
collected,orwillbecollectedsolelyfornon-researchpurposessuchasmedicaltreatmentor
diagnosis.
(6) Collectionofdatafromvoice,video,digital,orimagerecordingsmadeforresearch
purposes.
(7) Researchemployingsurvey,oralhistory,focusgroup,programevaluation,humanfactors
evaluation,orqualityassurancemethodologies.
(8) ContinuingreviewofresearchpreviouslyapprovedbytheconvenedIRB:
(a) where
(i) theresearchispermanentlyclosedtotheenrollmentofnewsubjects;and
(ii) allsubjectshavecompletedallresearch-relatedinterventions;and
(iii) theresearchremainsactiveonlyforlongtermfollow-upofsubjects;
OR
(b) wherenosubjectshavebeenenrolledandnoadditionalriskshavebeenidentified; OR
(c) wheretheremainingresearchactivitiesarelimitedtodataanalysis.
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ExemptStatus
Somestudiesonhumansubjectsmaybeexemptfromtheneedforfullorexpeditedreviewbythe
InstitutionalReviewBoard.ExemptresearchproposalsaresubmittedtotheIRBCoordinatorvia
IRBManagerandthenreviewedforprotectionofhumansubjectsbyamemberoftheInstitutional
ReviewBoard.
WhatcategoriesofresearchmaybeexemptfromrequirementsoftheCodeofFederalRegulations?
Manyeducational,behavioral,andsocialsciencestudiespresentlittleornorisktosubjectsandcanbe
exemptfromIRBreview.SeeCodeofFederalRegulations(45CFR46.101(b)).Studiesofmedicalcharts
arenottypicallyeligibleforexemptreviewunlesssuchrecordsarepubliclyavailable.
Exemption1-NormalEducationalPracticesandSettings
Researchconductedinestablishedorcommonlyacceptededucationalsettings,involvingnormal
educationalpractices,suchas(i)researchonregularandspecialeducationinstructional
strategies,or(ii)researchontheeffectivenessoforthecomparisonamonginstructional
techniques,curricula,orclassroommanagementmethods.
Note:Exemption1islimitedtonormaleducationalpracticesconductedincommonlyaccepted
settings.Anexampleistheevaluationoftheeffectivenessofanexistinginstructionalprogram.
Astudythatinvolvesevaluationofaradicalnewstrategyorrandomassignmentisnotexempt
becausethemethodsemployedarenotnormaleducationalpractices(RefIRBMgmt.and
Function,p94).
Exemption2-AnonymousEducationalTests,Surveys,InterviewsorObservations
Researchinvolvingtheuseofeducationaltests(cognitive,diagnostic,aptitude,achievement),
surveyprocedures,interviewprocedures,orobservationsofpublicbehavior,unless:(i)
informationobtainedisrecordedinsuchamannerthathumansubjectscanbeidentified,
directlyorthroughidentifierslinkedtothesubjects;and(ii)anydisclosureofthehuman
subjects’responsesoutsidetheresearchcouldreasonablyplacethesubjectsatriskofcriminalor
civilliabilityorbedamagingtothesubjects’financialstanding,employability,orreputation.
Note:Thisexemptionreflectsconcernwithprotectingsubjects’privacyandavoidinganyrisks
associatedwithbreachofconfidentiality.Theparticipants’responsestosurveyquestionsmust
beanonymousorde-identifiedbeforedataanalysis.Exemptsurveyresearchdatamustnotbe
linkedtoindividualsubjects.Ifresearchdatacontainpersonallyidentifyinginformationandif
disclosureofdatatounauthorizedpersonscouldharmthesubjectinanyway,theresearchis
notexempt.Surveyresearchthatdealswithsensitiveandprivateaspectsofthesubject’s
behavior,suchassexualpreferencesandsubstanceabuse,isnotexemptifdatacanbelinkedto
individuals.Eveniftheresearchhasnosubjectidentifiers,invasivequestionsthatmaycause
emotionaldistressordiscomfortnegateexemption.
Exemption3
Researchinvolvingtheuseofeducationaltests(cognitive,diagnostic,aptitude,achievement),
surveyprocedures,interviewprocedures,orobservationofpublicbehaviorthatisnotexempt
underExemption2above,if(i)thehumansubjectsareelectedorappointedpublicofficialsor
candidatesforpublicoffice;or(ii)thefederalstatute(s)require(s)withoutexceptionthatthe
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confidentialityofthepersonallyidentifiableinformationwillbemaintainedthroughoutthe
researchandthereafter.
Exemption4-CollectionorStudyofExistingData
Researchinvolvingthecollectionofthestudyofexistingdata,documents,records,pathological
specimens,ordiagnosticspecimens,ifthesesourcesarepubliclyavailableoriftheinformation
isrecordedbytheinvestigatorinsuchamannerthatsubjectscannotbeidentified,directlyor
throughidentifierslinkedtothesubjects.
Note:Thedatamustbe“on-the-shelf”atthetimetheresearchbegins.Theresearchdatamust
berecordedsothatsubjectscannotbeidentified.Inmostcasesthedatacollectionmusthave
beenpreviouslyapprovedbyanIRB.Thisincludesdemographicinformationthatcouldlinkthe
datatothesubject.Theexistenceofakeythatcouldbeusedtoidentifyasubjectdisqualifies
theresearchfromusingthisexemption.
Exemption5
Researchanddemonstrationprojectsthatareconductedbyorsubjecttotheapprovalof
departmentoragencyheads,andwhicharedesignedtostudy,evaluate,orotherwiseexamine:
(i)publicbenefitorserviceprograms;(ii)proceduresforobtainingbenefitsorservicesunder
thoseprograms;(iii)possiblechangesinoralternativestothoseprogramsorprocedures;and
(iv)possiblechangesinmethodsorlevelsofpaymentforbenefitsorservicesunderthose
programs.
Exemption6
Tasteandfoodqualityevaluationandconsumeracceptancestudies,(i)ifwholesomefoods
withoutadditivesareconsumedor(ii)ifafoodisconsumedthatcontainsafoodingredientator
belowthelevelforausefoundtobesafe,oragriculturalchemicalorenvironmental
contaminantatorbelowthelevelfoundtobesafe,bytheFoodandDrugAdministrationor
approvedbytheEnvironmentalProtectionAgencyortheFoodSafetyandInspectionServiceof
theU.S.DepartmentofAgriculture.
Whatresearchcannotqualifyforexemptstatus?
Researchthatcannotqualifyforexemptstatusincludes:
§ Researchinvolvinginteractionwithchildren
§ Researchinvolvingprisoners
§ Researchthatinvolvesdeceptionorwithholdingofinformationfromsubjects
§ Researchthatinvolvesintensephysicalexercise
§ Researchthatmaycauseemotionaldistressordiscomfortgreaterthatwhatwouldbe
expectedindailylife
SeeDecisionTreesathttp://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html,Charts2-7.
TocompleteanapplicationrequestingExemptStatusgotohttps://apu.my.irbmanager.com
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InstitutionalAuthorizationAgreement
Aninstitutionalauthorizationagreement(IAA)isaformal,writtendocumentthatprovidesamechanism
forAPUtoacceptauthoritytoreviewandapproveresearchconductedelsewhere,orforAPUtocede
thatauthoritytoanotherentity.AnIAAisajointreviewarrangementthatfacilitatescollaborationon
humansubjectsresearch,enablingcollaboratinginstitutionstorelyonasingleIRB(an“IRBofRecord”)
forreviewandforsomeorallaspectsofcontinuingoversightoftheresearch,inorderavoida
duplicationofefforts.Inallcases,theInstitutionalOfficial(ViceProvostforGraduateProgramsand
Research)mustapprovethearrangementupontherecommendationoftheIRBChairandtheExecutive
DirectorofResearchandGrants.
SomeinstanceswhenanIAAmaybeappropriateinclude,butarenotlimitedto:
•
•
•
•
Ifanotherinstitutionreceivesagrantandcontractsoutallhumansubjectsresearchto
investigatorsatAPU,thenAPUmayagreetoserveastheIRBofrecord;APUcouldaccept
additionalauthority.
IfAPUresearcherscollaboratewithresearchersfromanotherfederally-assuredinstitutionand
theresearchiscollectedataneutralsite,APUmayagreetoserveastheIRBofrecordincertain
circumstances;APUcouldacceptadditionalauthority.
IfaninvestigatoratAPUcollaboratesonaprojectwithanotherinstitutionandhis/her
involvementislimitedtodataanalysisofresearchcollectedbycollaboratinginvestigatorsatthe
otherinstitution,thentheotherinstitutionmayagreetoserveastheIRBofrecordforthe
project;APUcouldcedeauthority.
IfinvestigatorsatAPUandanotherinstitutionarecollaboratingonaprojectandtheIRBatthe
otherinstitutionisbetter-preparedtoreviewtheresearch,thenthatinstitutionmayagreeto
serveastheIRBofrecordfortheproject;APUcouldcedeauthority.
InvestigatorsmayrequestanIAA,butgenerallytheyareinitiatedbyIRBadministratorsandrequire
approvaloftheInstitutionalOfficialateachinstitution.TheIRBChairandExecutiveDirectorof
ResearchandGrantswillconsiderusinganIAAonacase-by-casebasisincludingfactorssuchas
1)ensuringqualityandthoroughnessofprotocolreview;
2)localcontextissues;
3)institutionalliability;
4)complexityofsharedcontrolandaccountability;
5)costsofdelegatingoracceptingreview;and
6)relationshiptotheoutsideorganization.
Exemptresearchprojectsarenoteligibleforconsideration.Also,APUwillnotnormallyprovideIRB-ofrecordservicesforresearchinwhichtheuniversityisnotengaged,orinwhichitsinvestigatorsarenot
otherwiseinvolved.Itwillalsonotreviewresearchoverwhichtheuniversitycannotappropriately
addressthelocalcontextorotherwiseexerciseadequateoversight.
TheIRBChairandExecutiveDirectorofResearchandGrantswilldetermineeligibilityforanIAAandwill
recommendthetermsofsuchanagreement.ForbecomingtheIRB-of-Record,considerationsinclude,
forexample,thetimeandresourcesrequiredtoacceptthereview,APU’sexpertiseforinitialand
13
continuingreview,andthewillingnessoftheotherinstitutiontomonitorcompliance,reviewadverse
eventsandtohandlecomplaints.Forcedingauthoritytoanotherinstitution,considerationsincludethe
impracticabilityofanAPUIRBreview,theappropriatenessoftheotherIRBtoreviewtheprotocol,and
theproposedarrangementsforthatinstitutiontomonitorandoverseetheresearch.
AspartoftheIAAorinaseparatedocument,thepartiesmustestablishandclearlydocumentrolesand
responsibilities,theIRBofrecordforaprotocol,communicationchannels,etc.Researchmaynot
commenceuntiltheIAAisfullyexecuted.BecauseestablishinganIAArequiresthoroughreview,it
shouldnotbeconsideredasatime-savingeffort;indeed,someagreementstakeseveralweeksto
negotiate,renderingafullboardreviewmoreexpedient.
Insomecases,theFederalwideAssurance(FWA)oftheinstitutionrelyingonanotherinstitution’sIRBor
independentIRBmayneedtobeamendedtolistthereviewinginstitution’sIRBorindependentIRB.
CopiesofthesignedagreementmustbekeptatbothinstitutionsandbemadeavailabletoanyCommon
Ruleagencyuponrequest.
14
CourseRelatedResearchbyAPUStudents
Theinstructorofrecordisresponsibleforsafeguardinghumansubjectsinresearchprojectsundertaken
bygraduateandundergraduatestudentsintheircoursesandprogramsofstudy.Courserelated
researchprojectsmayincluderesearchpracticaandundergraduatethesisprojectsinvolvingresearch
methodologyandcourse-assigneddatacollection.Theseactivitiesgenerallydonotmeetthefederal
definitionofresearchbecausetheirpurposeistoprovidetraininginresearchaspartoftheoverall
educationalmissionofaprogramandarenotdesignedtocontributetonewgeneralizableknowledge.
If,asanexception,aprojectwithhumansubjectsisintendedtocontributetogeneralizableknowledge
ortopossiblyleadtopublication,thefacultyandstudentmustsubmitanapplicationtotheIRBpriorto
thecollectionofdata.
Theinstructorofrecordmusthaveacertificateinprotectionofhumansubjectsandisresponsiblefor
ensuringthatstudentprojectsarelowriskanddonotinvolvechildrenorothervulnerablepopulations.
IngeneralitisadvisablethatallstudentswouldberequiredtocompleteCITItraininginprotectionof
humansubjectsbeforebeginningtheirprojects.Inaddition,theinstructormustdeterminethat
studentsconductingcourse-relatedprojectshavedocumentedinformedconsentfromallparticipants
whenrequired(seep.20orcontacttheIRBCoordinatororIRBChair).Inaddition,theinstructormust
ensurethatstudentresearcherstakeproperstepstomaintainconfidentialityofresearchdata.Itis
essentialtoremoveparticipantnamesfromresearchdata.
Itoccasionallyhappensthatastudentisinvolvedinacourse-relatedactivitydesignedtoteachresearch
methodologies,andtheinstructoralongwiththestudentwishtoconductfurtherinvestigationand
analysesinordertocontributetoscholarlyknowledge.Thissuggeststheneedforfreshdatacollection
conductedwithIRBapproval.APUdoesnothaveaprovisionforretroactiveIRBapproval.
15
InternationalandCrossCulturalResearch
Allhumansubjectresearchconductedinternationallyoracrossculturesmustadequatelyprotectthe
rightsandwelfareoftheresearchsubjects.Researchersmustprovideevidencethatresearchprojects
andtranslateddocumentsaresensitivetoparticipants’localresearchcontext,particularlycultureand
language.Theseprotocolsshouldbecategorized(i.e.,expedited,fullboard)usingthesamerisk/benefit
considerationsappliedtoanyotherresearchproject.InadditiontoobtainingAPUIRBapproval,thePI
mustprovideevidencethatresearchprojectsandtranslateddocumentsaresensitivetoparticipant
context,inclusiveofcultureandlanguage.Thefirstchoicefordocumentingsensitivitytoparticipant
contextisIRBreviewintheparticipants’countryofresidence.Asanalternative,PI’smayseekwritten
documentationofsensitivitytolocalresearchcontextfrompersonswhomeetallthreecriteria,namely
(a)indigenoustotheparticipantculture,(b)aresidentoftheresearchareafortwoofthelasttenyears,
and(c)presentlyservingasanofficialofalocalgovernmentorlocalacademicinstitution.
Internationalandcrossculturalresearchproposalsrequiringtranslateddocumentsshouldinclude
contactinformation/scriptsandinformedconsent.ThePIcandemonstrateaccuracyandsensitivityof
translateddocumentsthroughbacktranslationbypersonsindigenoustotheparticipantcultureand
fluentinparticipantlanguage.ThePIcantranslatedocuments,butcannotserveasbacktranslatorof
documentsemployedinhis/herresearch.LocalconsulatesmayhavepersonnelthatmeetIRBcriteria
thatcanassistwithverifyingthattheplannedresearchisculturallysensitiveand/orwithtranslations.
TheInternationalCompilationofHumanResearchStandardsprovidesaresourceoflaws,regulations,
andguidelinesthatgovernhumansubjectresearchaswellasthestandardsfromanumberof
internationalandregionalorganizations.Thesearelistedbycountryandcanbefoundhere:
http//www.hhs.gov/ohrp/international/index.html.
PIswhoconductresearchinaninternationalsettingmustcompletethesupplementaltrainingmodule
oninternationalresearchintheCITIprogram.
16
ExternalResearchReviewProcess
AllrequestsfromresearchersoutsideofAPUtoinvolveAPUfaculty,staff,andstudentsfortheir
researchwithhumansubjectsshouldbesenttotheIRBCoordinatorwhowillassisttheresearcherin
understandingtheAPUspecificreviewprocessforsuchrequests.TheextenttowhichAPUpersonnel
areinvolvedintheresearchisthefirstreviewcriteria.Iftheproposalisdeemedtobe“non-engaged
research,”theresearchershouldsubmitacopyofhis/herIRBapplicationfromhis/herhomeinstitution,
ifoneexists.Iftheproposalisdeemedtobe“engagedresearch,”theresearchermustsubmita
completedAPUIRBapplication.Thisisanecessarystep,eveniftheresearchwasclassifiedas“exempt”
atanotherinstitution.TheIRBapplicationshould,wheneverpossible,identifyasponsoratAPU--
someoneatthedepartmentchairordirectorlevel.Theexternalresearcher’sproposalandsupporting
materialsareforwardedtoAPU’sViceProvostforGraduateProgramsandResearch.
TheViceProvostwillrequestareviewoftheproposalbyAPU’sExternalResearchReviewCommittee
whichwillconsiderfactorsincludingthetimingoftheprojectrelatedtootherplannedresearch
projects,whethersuchinformationhasrecentlybeencollectedatAPU,andthepurposeandpotential
benefitoftheresearchproject.Baseduponthecommittee’srecommendation,theViceProvostwill
determinewhethertheproposedresearchisapproved.TheViceProvostorIRBCoordinatorwillnotify
theresearcheroftheapprovalordenial,notinganyconditionsinthecaseofapproval,andwilldirect
theexternalresearchertotheOfficeofInstitutionalResearchandAssessmentoranotheridentifiedAPU
contactpersonfornextsteps.Inthecaseof“engaged”researchwithhumansubjects,thenextstepis
IRBreviewandapproval.TheIRBCoordinatorwillthendirecttheresearchertotheon-lineapplication
process.
17
InformedConsent
Noinvestigatormayinvolveahumanbeingasasubjectinresearchcoveredbythesepoliciesunlessthe
investigatorhasobtainedthelegallyeffectiveinformedconsentofthesubjectorthesubject’slegally
authorizedrepresentative.
TheInformedConsentwillcontain:
1. Astatementthatthestudyinvolvesresearch;
2. Anexplanationofthepurposeoftheresearch,aninvitationtoparticipateandexplanationof
whytheparticipantwasselected,andtheexpecteddurationoftheparticipant'sparticipation;
3. Adescriptionofprocedurestobefollowedandidentificationofwhichproceduresare
investigationalandwhichmightbeprovidedasstandardcaretotheparticipantinanother
setting.Useofresearchmethodssuchasrandomizationandplacebocontrolsshouldbe
explained;
4. Astatementofanyfinancialorothermeansofsponsorshipfortheresearch;
5. Adescriptionofanyforeseeablerisksordiscomfortstotheparticipant,anestimateoftheir
likelihood,andadescriptionofwhatstepswillbetakentopreventorminimizethem;aswellas
acknowledgmentofpotentiallyunforeseeablerisks;
6. Adescriptionofanybenefitstotheparticipantortoothersthatmayreasonablybeexpected
fromtheresearch,andanestimateoftheirlikelihood;
7. Adisclosureofanyappropriatealternativeproceduresorcoursesoftreatmentthatmightbe
advantageoustotheparticipant;
8. Astatementdescribingtowhatextentrecordswillbekeptconfidential,includingexamplesof
whomayhaveaccesstoresearchrecordssuchashospitalpersonnel,theFDA,anddrug
sponsors;
9. Anexplanationanddescriptionofanycompensationandanymedicaltreatmentsthatare
availableifparticipantsareinjuredthroughparticipation;wherefurtherinformationcanbe
obtained,andwhomtocontactintheeventofresearch-relatedinjury;
10. Anexplanationofwhomtocontactforanswerstoquestionsabouttheresearchandthe
researchparticipant'srightsincludingthenameandphonenumberofthePrincipalInvestigator
(PI);
11. Astatementinformingthesubjectthatinquiriesregardingthenatureoftheresearch,his/her
rightsasasubject,oranyotheraspectoftheresearchasitrelatestohis/herparticipationasa
subjectcanbedirectedtotheResearchIntegrityOfficeratAzusaPacificUniversity;
18
12. Astatementthatresearchisvoluntaryandthatrefusaltoparticipateoradecisiontowithdraw
atanytimewillinvolvenopenaltyorlossofbenefitstowhichtheparticipantisotherwise
entitled;
13. Astatementthatifaparticipantdeclinestocontinue,anydatagatheredtothatpointmaybe
partofdataanalysis;
14. Astatementindicatingthattheparticipantismakingadecisionwhetherornottoparticipate,
andthathis/hersignatureindicatesthathe/shehasdecidedtoparticipatehavingreadand
discussedtheinformationpresented;
15. Astatementoutliningthenatureofsubjectremuneration(ifany).Remunerationshouldbe
describedasa“tokenofappreciation”forparticipatingsubjects.Careshouldbetakentoensure
thatremunerationisappropriatetothescopeandcontextoftheproject.Excessive
remunerationmaybeviewedaspotentiallycoercive;
16.CaliforniaExperimentalSubject’sBillofRights-ifhumansubjectsareinvolvedinan
experimentalclinicalprocedure;
17.AuthorizationforUseofPrivateHealthInformation-ifpersonalinformationconsidered
“ProtectedHealthInformation”isusedinthestudy;
18.Thesignatureoftheresearcherafterexplainingtheresearchtotheparticipantandwhenthey
aresatisfiedtheparticipantfullyunderstands.Itisnotappropriatefortheresearchertosignin
advanceortouseastampedsignature.
InformedconsentshouldbeonAPUletterhead.
AdditionalElementsofInformedConsent
Whenappropriate,oneormoreofthefollowingelementsofinformationshallalsobeprovidedtoeach
subject:
1. astatementthattheparticulartreatmentorproceduremayinvolveriskstothesubject(orto
theembryoorfetus)ifthesubjectisormaybecomepregnantwhicharecurrently
unforeseeable;
2. anticipatedcircumstancesunderwhichthesubject’sparticipationmaybeterminatedbythe
investigatorwithoutregardtothesubject’sconsent;
3. anyadditionalcoststothesubjectthatmayresultfromparticipationintheresearch;
4. theconsequencesofasubject’sdecisiontowithdrawfromtheresearchandproceduresfor
orderlyterminationofparticipationbythesubject;
5. astatementthatsignificantnewfindingsdevelopedduringthecourseoftheresearchwhich
mayrelatetothesubject’swillingnesstocontinueparticipationwillbeprovidedtothesubject;
6. theapproximatenumberofsubjectsinvolvedinthestudy(§45CFR46.116).
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DocumentationofInformedConsent
1.TheIRBmaywaivetherequirementfortheinvestigatortoobtainasignedconsentformforsome
orallsubjectsifitfindseither:
a. Theonlyrecordlinkingthesubjectandtheresearchwouldbetheconsentdocumentand
theprincipalriskwouldbepotentialharmresultingfromabreachofconfidentiality.Each
subjectwillbeaskedwhetherthesubjectwantsdocumentationlinkingthesubjectwiththe
research,andthesubject’swisheswillgovern;or
b.thattheresearchpresentsnomorethanminimalriskofharmtosubjectsandinvolvesno
proceduresforwhichwrittenconsentisnormallyrequiredoutsideoftheresearchcontext.
SeeDecisionTreesathttp://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html,Charts10
and11.
2.Exceptasprovidedinparagraph1above,informedconsentshallbedocumentedbytheuseofa
writtenconsentformapprovedbytheIRBorbyuseofanelectronicconsentformforelectronic
surveys(seeInformedConsentformtemplatesintheAppendix).Thewrittenconsentforms
mustbesignedbythesubjectorthesubject’slegallyauthorizedrepresentative.Acopyshallbe
giventothepersonsigningtheform.
3.Exceptasprovidedinparagraph1ofthissection,theconsentformmaybeeitherofthe
following:
a. Awrittenconsentdocumentthatembodiestheelementsofinformedconsentrequiredby
§45CFR46.116above.Thisformmaybereadtothesubjectorthesubject’slegally
authorizedrepresentative,butinanyevent,theinvestigatorshallgiveeitherthesubjector
therepresentativeadequateopportunitytoreaditbeforeitissigned;or
b. Ashortwrittenconsentdocumentstatingthattheelementsofinformedconsentrequired
by§45CFR46.116havebeenpresentedorallytothesubjectorthesubject’slegally
authorizedrepresentative.Whenthismethodisused,thereshallbeawitnesstotheoral
presentation.See§45CFR46.117foradditionalrelatedregulations.
InformedConsenttemplatesforface-to-faceandelectronicsurveyresearchcanbefoundalongwith
otherrequiredapplicationformsathttps://apu.my.irbmanager.com.
StudentAssentForm
TheIRBshalldeterminethatadequateprovisionsaremadeforsolicitingtheassentofchildren
participatinginresearchwhen,inthejudgmentoftheIRB,thechildrenarecapableofprovidingassent.
Children12-17yearsofagemustgivetheirwrittenassenttoparticipateinresearch.TheIRBmay
determinethatchildrenyoungerthan12yearsofagemustgivetheirassentforaparticularresearch
project.
TheStudentAssentformforresearchwithminorscanbefoundalongwithotherrequiredapplication
formsathttps://apu.my.irbmanager.com.
20
DeceptionandIncompleteDisclosure
Incertaincircumstances,theuseofdeceptionorincompletedisclosureinresearchareacceptableand
importanttechniques,thoughitplacesspecialresponsibilitiesbothontheresearcherandontheIRB.In
thesecases,theIRBrequestsadditionalinformationfromresearchersandwillreviewthoseproposals
carefully.Whereasdeceptionoccurswhenresearchsubjectsaredeliberatelygivenfalseinformation
aboutsomeaspectoftheresearch,incompletedisclosureresultswhenthetruenatureorpurposeof
theresearchiswithheld.Itisthereforetheprovisionoferroneousinformation(deception)orthe
omissionofinformation(incompletedisclosure)whichcreatesacircumstancewarrantingspecial
considerationfortheprotectionofthosehumansubjects.
Inallcasesofdeceptionorincompletedisclosure,thefollowingguidelinesapply:
• Theresearchmustinvolvenomorethanminimalrisktoparticipants
• Thewaiveroralterationoftheinformedconsentmaynotadverselyaffecttherightsandwelfare
oftheparticipants
• Theresearchcouldnotpracticablybecarriedoutwithoutthealterationorwaiver
• Attheappropriatetime,participantswillbeprovidedwithadditionalpertinentinformation
regardingparticipation
• Participantsmustbegiventherighttowithdrawtheirparticipationoncetheyaremadefully
awareofthestudy’spurpose
IRBapplicationsproposingtousedeceptionorincompletedisclosureshouldincludethefollowing
information:
• Aclearexplanationofwhydeceptionorincompletedisclosureisjustifiedandwhether
alternativemethodscouldachievethesameresearchgoals
• Anindicationofwhetherdeceptionorincompletedisclosuremayaffectaparticipant’s
willingnesstoparticipateinresearch
• IdentifywhatelementsoftheInformedConsenttheresearcherisrequestingtowaive
• Anexplanationoftheprocesstodebriefparticipantsincludingwhowilldebriefthemandat
whatpointinthestudy(includeacopyofthedebriefingstatementandthedebriefingscript).
Theinformedconsentdocumentmustincludethefactthattheinformationprovidedtothe
subjectisincompleteandthattheywillbedebriefedafterresearchproceduresarecompleted.
• Anexplanationofwhetherdeceptionorincompletedisclosureislikelytocausethesubject
discomfortbeforeorafterdebriefingandhowthatriskwillbeminimized
Thedebriefingofparticipantsisrequiredatanappropriatepointintime.Suchadebriefingmustinclude
afullexplanationoftheresearchquestionandhypothesis,theproceduresusedforthestudy,andwhy
deceptionwasnecessary.Innocasecanthedebriefingcausemoreharmthanthedeceptionor
incompletedisclosure.
Initsreview,theIRBmustconsiderfactorsinadditiontothescientificvalueoftheresearchandthe
efficacyofalternativeprocedures.Theywillalsoneedtoconfirmthatthedeceptiondoesnotextendto
influencetheparticipants’willingnesstoparticipate,andthatanyexperimentallyinducedharmmaybe
removedthroughdebriefing.Further,theIRBwillconsiderwhethertheresearcherisequippedto
manageemotionalreactionsthatmayoccurduringdebriefing,andwhethertheproposeddeception
couldfacilitateunwantedandinappropriateinvasionsofprivacy.
21
Deceptionorincompletedisclosurecannotbeapprovedifnon-deceptivealternativesareavailable,if
humansubjectswouldlikelynotparticipateifthetruepurposeofthestudywereknowntothem,andif
itplacesparticipantsatsignificantriskofanytype.
Foradditionalinformation,seeUCLA’sguidanceandprocedureat
http://ora.research.ucla.edu/OHRPP/Documents/Policy/8/Deception.pdfandSwarthmoreCollege’sIRB
policyathttp://www.swarthmore.edu/institutional-review-board/deception-incomplete-disclosuredebriefing.
ConflictofInterest
TheUniversity'sPolicyforConflictsofInterestisconsistentwithfederalrequirementsforresearchand
bestpracticesinacademia.Thefullpolicycanbefoundatwww.apu.edu/grants/policies.Inorderto
preventbiasortheappearanceofbiasinresearch,everyoneengagedinresearch(seedefinitionof
"coveredindividual")mustcompleteaPotentialConflictofInterest(PCOI)disclosureformatthetimeof
applicationforfundedresearchorwhenapplyingforIRBapproval(whichevercomesfirst),andwithin
30daysofchangestoanyresponseontheform.Inthecaseoffederallyfundedresearch,covered
individualsmustverifypotentialconflictsofinterestatleastannually.Potentialconflictsofinterestwill
bereviewedbyaninstitutionalCommitteeforConflictsofInterestandamanagementplanmaybe
establishedinordertomanage,reduce,oreliminateknownorlikelyconflictsofinterestrelatingto
research.BecausefederalregulationschangedonAugust24,2012,IRBapplicantsareurgedtoread
carefullythequestionsonthecurrentformaswellasthedefinitionsofkeytermswhichcanbefound
accompanyingthePCOIformandinthefullpolicy.
TheUniversity,itsfaculty,andothermembersoftheUniversityresearchcommunitycommitthemselves
tothepursuitofresearchattheUniversityinaccordancewiththehigheststandardsofintegrityandin
compliancewithlegal,professional,ethicalandotherrequirementsthatpromoteobjectivityand
protectagainstfinancialconflictsofinterestinresearch.TheUniversitywillidentifypossibleconflictsof
interestinresearch,whetherapparentorreal,andprovidemechanismsfortheirmanagement,
reductionoreliminationincompliancewithfederalandstatelawaswellasanyrelevantpoliciesof
entitiesfundingresearchattheUniversity.
ThesuccessofAzusaPacificUniversity’sresearchprogramdependsupontheintegrityoftheresearch
andtheresearchersaswellasthepublic’sconfidenceinthem.Conflictsofinterestinresearchstrikeat
theheartofaUniversity’sintegrity.Inpursuitofitsmissionasaprivateinstitutionofhighereducation,
theUniversityseeksexcellenceinthequalityofitsresearch,intheteachingandeducationitprovidesto
itsstudents,andintheserviceitprovidestothebroadercommunity.Thisknowledgetransferinevitably
leadstoincreasinglycloserelationshipsbetweenuniversitiesandthosewithfinancialcapitalinthe
privatesector.Thebenefitsthatpotentiallyaccruefromthisproximityareaccompaniedbyrealor
apparentrisksthateconomicinterestsmightcompromiseacademicresearchbyinfluencingan
investigator’sjudgmentaboutthedesign,conduct,reporting,ormanagementofresearch,and,inthe
caseofresearchinvolvinghumansubjects,imperilthesafetyofparticipants.
Facultyassumingtheresponsibilityforthedesign,conductorreportingofresearchhaveaspecial
obligationtoavoidbiasortheappearanceofbiasintheconductofthesestudies.Anypossibleconflict
ofinterestmustbeformallydisclosedtotheinstitution.Questionsaboutthepolicyortheformmaybe
directedtoDr.DianeGuido,ResearchIntegrityOfficer,[email protected]
ThePotentialConflictofInterestDisclosureformwhichisrequiredforapplicationstotheIRBcanbe
foundathttps://apu.my.irbmanager.comalongwiththeotherformsrequiredforapplication.
22
IntegrityinResearch
AzusaPacificUniversityvalueshonestyandintegrityofresearchandisdedicatedtoensuringthe
credibilityandtrustworthinessoftheresearchconductedbyourresearchcommunity,toprotectingthis
communityfromunsubstantiatedallegationsofresearchmisconduct,andtoupholdingtheuniversity’s
highstandardsforresearchactivity.MisconductinresearchrepresentsabreachofthepoliciesofAzusa
PacificUniversity,thestandardsexpectedbyoursponsors,andtheexpectationsofscholarly
communitiesforaccuracy,validity,andintegrityinresearch.ItisthereforethepolicyofAzusaPacific
Universitytoinquireintoand,ifnecessary,investigateandresolvepromptlyandfairlyallinstancesof
allegedresearchmisconduct.Further,itisalsothepolicytocomplyinatimelymannerwithsponsor
requirementsforreportingcasesofpossibleresearchmisconductwhensponsoredprojectfundsare
involved.
Theprimaryresponsibilityformaintainingstandardsofintegrityisheldbyindividualscholarsandthe
departmentsinwhichtheywork.Accordingly,itisincumbentuponallfaculty,principalinvestigators,
andothersinpositionsofresponsibilitytoexerciseactiveleadershipintheirsupervisoryrolestoensure
theintegrityoftheresearchbeingconducted.ThePolicyonIntegrityinResearchsetsforththe
proceduresbywhichAzusaPacificUniversityseekstomaintainandenforceintegrityinresearchthrough
impartialfact-findingandfairadjudicationsofallegationsofresearchmisconduct.Eachallegationof
researchmisconductwillberespondedtoinathorough,competent,objective,andfairmanner.An
AnnualReportonPossibleResearchMisconductisfiledwiththeOfficeofResearchIntegrity(intheU.S.
DepartmentofHealthandHumanServices)bytheResearchIntegrityOfficer(RIO).
Researchmisconductisfabrication,falsification,plagiarism,orotherseriousdeviationfromcommonly
acceptedpracticesintherelevantscientificcommunityforproposing,performing,orreviewing
research,orinreportingresearchresults.Anyobserved,suspected,orapparentresearchmisconduct
mustbereportedtotheRIO.Ifanindividualisunsurewhetherasuspectedincidentfallswithinthe
definitionofresearchmisconduct,heorshemaymeetwiththeRIO(theViceProvostforGraduate
ProgramsandResearch)todiscussthesuspectedresearchmisconductinformally.Ifthecircumstances
describedbytheindividualdonotmeetthedefinitionofresearchmisconduct,theRIOwillreferthe
individualorallegationtootherofficesorofficialswithresponsibilityforresolvingtheproblem.
Foramoredetaileddescriptionofresearchmisconductandtheproceduresforreviewinganallegation,
pleaseseethefullcopyofthePolicyonIntegrityinResearchatwww.apu.edu/grants/policies.
SuspensionorTerminationofIRBApproval
TheIRBhastheauthoritytosuspendorterminateapprovalofresearchthatisnotbeingconductedin
accordancewiththeIRB’srequirementsorthathasbeenassociatedwithunexpectedseriousharmto
participants.Anysuspensionorterminationofapprovalshallincludeastatementofthereasonsforthe
IRB’sactionandshallbereportedwithintwobusinessdaystotheinvestigator,facultysupervisor(ifa
studentisinvolved),DepartmentChairandDean,Provost,andanypertinentgoverninginstitution(such
asafundingagencyortheOfficeofHumanResearchProtection).Asaresponsetocomplaints,pressing
concerns,orevidenceofharmtosubjects,theRIOorIRBChairmaysuspendastudy.Ifnecessary,the
RIOmay,withoneormoreIRBmembers,initiateaninvestigation.Everyinvestigatorwillbegiventhe
opportunitytorespondtotheconcerns.TheconvenedIRBmustvoteonanyactionofsuspensionor
terminationuponcompletionofaninvestigation.
23
Researcher’sContinuingResponsibilities
OnceaprojecthasbeenapprovedbytheIRB,researchersmustadheretotheapprovedprotocoland
followanyadditionalIRBinstructions.Thecontinuingresponsibilitiesinclude:
• enrollingonlythosesubjectsthatmeetIRBapprovedinclusionandexclusioncriteria;
• properlyobtaininganddocumentinginformedconsent;
• obtainingpriorapprovalforanydeviationfromtheapprovedprotocol;
• keepingaccuraterecords;
• promptlyreportingtotheIRBanyunanticipatedproblemsinvolvingriskstosubjectsor
others,includingadverseevents,noncompliance,andprotocoldeviations;
ResearchapprovedbytheIRBmaybemonitoredforcompliance.
PrincipalInvestigator’sResponsibilitiesforReportingUnanticipatedProblemsandProtocolDeviations
PrincipalInvestigatorsarerequiredtoreporttotheIRBallunanticipatedproblemsandadverseevents,
aswellasprotocolchangesanddeviations.ItistheexpectationoftheIRBthatallapprovedprotocol
proceduresarebeingfollowedwithoutalterationunlesstheIRBhasbeeninformedofaprotocolchange
ordeviationeitherbyreportinganunanticipatedproblemoradverseeventbyseekingaprotocol
revision.
Unanticipatedproblemsinvolvingriskstosubjectsorothersreferstoaproblem,event,orinformation
thatisnotexpected,giventhenatureoftheresearchproceduresandthesubjectpopulationbeing
studied,andwhichsuggeststhattheresearchplacessubjectsorothersatagreaterriskofharmor
discomfortrelatedtotheresearchthanwasanticipatedatthetimeIRBapprovalwasconferred.
Specifically,“unanticipatedproblems”arethosethatmeetallthreeofthefollowingcriteria:
1. Unexpected(intermsofnature,specificity,severity,orfrequency)giventheresearch
proceduresdescribedintheprotocol-relateddocumentsandthecharacteristicsofthesubject
populationbeingstudied.
2. Relatedorpossiblyrelatedtoparticipationintheresearch(possiblyrelatedmeansthereisa
reasonablepossibilitythattheincident,experience,oroutcomemayhavebeencausedbythe
proceduresinvolvedintheresearch).
3. Suggeststhattheresearchplacessubjectsorothersatagreaterriskofharm(including
physical,psychological,economic,legal,orsocialharm)thanwasanticipatedatthetimeIRB
approvalwasconferred.
Anadverseeventisdefinedasanuntowardorunfavorableoccurrenceinahumansubjectwhichmay
ormaynotberelatedtothesubject’sparticipationintheresearch.Aseriousadverseeventisone
whichresultsindeath,islife-threatening,requireshospitalization,resultsinasignificant
disability/incapacity,oranyotheradverseeventthat,baseduponappropriatemedicaljudgment,may
jeopardizethesubject’shealthandmayrequiremedicalorsurgicalinterventiontopreventoneofthe
otheroutcomeslisted.
TimeframeforReporting:
1. SeriousadverseeventsmustbereportedtotheIRBortotheRIOwithin24hoursofthe
occurrenceoftheevent.
2. Otherunanticipatedproblemsorprotocolchangesanddeviationsthatmeetthethreecriteria
abovemustbereportedtotheIRBwithin5daysoftheoccurrenceoftheevent.
24
3. Allothereventsoradverseeventsthatdonotmeetthesereportingcriteria,including
unanticipatedprotocolchangesanddeviations,mustbesubmittedwithinoneweekofthe
investigatorbecomingawareoftheproblem.
Ifunanticipatedproblemsoccurduringresearch,thePrincipalInvestigatormustreportthefollowingto
theChairoftheAPUInstitutionalReviewBoard:
• ResearchnumberasassignedbytheIRB,titleofapprovedresearchproject
• Adetaileddescriptionoftheadverseevent,incident,experience,oroutcome
• Anexplanationofthebasisfordeterminingthattheadverseevent,incident,experience,or
outcomerepresentsanunanticipatedproblem,and
• Adescriptionofanyrecommendedchangestotheprotocolorothercorrectiveactionsthathave
beentakenorareproposedinresponsetotheunanticipatedproblem.
ThereportmustbesubmittedinwritingtotheIRBChair,whowillpromptlypresentthereporttothe
IRB.IftheIRBChairisthePrincipalInvestigatormakingthereportunderthispolicy,thereportshallbe
presenteddirectlytotheResearchIntegrityOfficerwhowillpresentthereporttotheIRB.
TheIRB,theChairordesigneewillreviewthereporttoconsiderwhethertheeventimpactsthe
risk/benefitratioandwhetherthatwarrantsareconsiderationoftheapprovalofthestudy,
modificationstothestudy,revisionstothecontinuingreviewtimetable,suspensionofthestudy,or
otheractionrequiredduetosafetyconcerns.TheIRBhastheauthoritytorequire,asaconditionof
continuedapprovalbytheIRB,submissionofmoredetailedinformationbytheinvestigator,the
sponsor,oraDSMBaboutanyadverseeventorunanticipatedproblemoccurringinaresearchprotocol.
TheChairwillbrieftheExecutiveDirectoroftheOfficeofResearchandGrantsaswellastheResearch
IntegrityOfficerconcerningallreports.
Forseriousadverseevents,theChairordesigneehastheauthorityandresponsibilitytomake
immediatechangestothestudy,asnotedabove,andwillrefertheissuetothefullIRBassoonasis
feasibleforadditionalconsideration.OnlyafullIRBcanmakeadeterminationtotakenoactionona
seriousadverseevent.
AzusaPacificUniversity’sResearchIntegrityOfficermustpromptlyreporttotheOfficeforHuman
ResearchProtectionsanyofthefollowingoccurrenceswhenrequiredbylaw:
• Unanticipatedproblemsinvolvingriskstosubjectsandothers
• SeriousorcontinuingnoncompliancewithrequirementsordeterminationsoftheIRB
• SuspensionorterminationofIRBapprovalofnon-exempthumansubjectresearch.
Forfurtherguidance,thePrincipalInvestigatorisencouragedtoreviewtheDepartmentofHealthand
HumanServicesGuidanceonReviewingandReportingUnanticipatedProblemsInvolvingRisktoSubject
orOthersandAdverseEventsathttp://www.hhs.gov/ohrp/policy/advevntguid.html.
PrivacyandConfidentiality
Privacyisdefinedashavingcontroloverextent,timingandcircumstancesofsharingoneselfwith
others.Pleasebeattentivetothreatstoparticipants’privacy.Anacceptablepracticeistodistribute
invitationstoabroadpopulationandaskforpersonstoself-identifyasmeetingmorenarrowcriteria.
Anoptionforsomesensitiveinterviewresearchistooffertheparticipanttheopportunitytoreview
publicationdraftsforunintendedmarkersofidentity.
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Confidentialitypertainstothetreatmentofinformationanindividualhasdisclosedinarelationshipof
trustandwiththeexpectationthatitwillnot,withoutpermission,bedivulgedtoothersinwaysthatare
inconsistentwiththeunderstandingoftheoriginaldisclosure.Researchersordinarilyuseinformation
participantshavedisclosedorprovidedvoluntarily(i.e.,withtheirinformedconsent)forresearch
purposes.Inmostresearch,ensuringconfidentialitycanoccurbyfollowingtheseroutinepractices:
• Substitutingcodesforidentifiersorencryptingidentifiabledata
• Informedconsentdocumentsandde-identifiedresearchdataarestoredinseparatesecure
locations
• Userandomnumberstoidentifyresearchrecords(SocialSecurityandstudentIDnumbersare
notacceptable)
• Removingfacesheets(containingidentifierssuchasnamesandaddresses)fromsurvey
instrumentscontainingdata
• Properlydisposingofcomputersheetsandotherpapers
• Limitingaccesstoidentifiabledata
• Educatingtheresearchstaffontheimportanceofconfidentiality
• Storingpaperrecordsinlockedcabinetsorassigningsecuritycodestocomputerizedrecords
RecordingData
Inrecordingdata,keeptwosimplerulesinmindtoavoidproblemslater,shouldsomeoneaskaboutor
questionyourwork:
• Hard-copyevidenceshouldbeenteredintoanumbered,boundnotebooksothatthereisno
questionlateraboutthedatetheexperimentwasrun,theorderinwhichthedatawere
collected,ortheresultsachieved.Donotuseloose-leafnotebooksorsimplycollectpagesof
evidenceinafile.Donotchangerecordsinaboundnotebookwithoutnotingthedateand
reasonsforthechange.
• Electronicevidenceshouldbevalidatedinsomewaytoassurethatitwasactuallyrecordedona
particulardateandnotchangedatsomelaterdate.Itiseasytochangedatesoncomputersand
therebyalterthedateaparticularfileseemstohavebeencreated.Ifyoucollectyourdata
electronically,youmustbeabletodemonstratethattheyarevalidandhavenotbeenchanged.
Asyourecordyourdata,itmaybehelpfultothinkaboutthemasthelegaltenderofresearch–the
currencyresearcher'scashinwhentheyapplyforgrants,publish,areconsideredforpromotion,and
enterintobusinessventures.Tohaveandholdtheirvalue,researchdatamustbeproperlyrecorded.
(Steneck,2004,pp.92-93)
RetentionandStorageofData
Responsiblehandlingofdatabeginswithproperstorageandprotectionfromaccidentaldamage,lossor
theft:
• Labnotebooksshouldbestoredinasafeplace.
• Computerfilesshouldbebackedupandthebackupdatasavedinasecureplacethatis
physicallyremovedfromtheoriginaldata.
• Samplesshouldbeappropriatelysavedsothattheywillnotdegradeovertime.
Datashouldberetainedforareasonableperiodoftimetoallowotherresearcherstocheckresultsorto
usethedataforotherpurposes.Thereis,however,nocommondefinitionofareasonableperiodof
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time.NIHgenerallyrequiresthatdataberetainedfor3yearsfollowingthesubmissionoftheclosure
report.Somegovernmentprogramsrequireretentionforupto7years.APUrequiresthatdatabekept
for3yearsaftertheclosurereportunlessalongerretentionisrequiredbyaspecificagency.Before
discardingnotebooksorfiles,orerasingyourcomputermemory,giveconsiderationtowhomight
benefitfromorasktoseeyourdatainthefuture.
RequestforRevisionorAdditiontoApprovedResearch
Researcherswhowillinanywaymodifytheirresearchprotocolorpersonnelwhichhasbeenpreviously
submittedtoandapprovedbytheIRBmustsubmitaRequestforRevisionsorAdditionsReviewform.
WhenaRequestforRevisionorAdditiontoanapprovedprotocolisreceivedwheretheonlyaddition
requestedistoaddAPUstudentresearchassistantstotheresearch,thepolicyforapprovalisasfollows:
TheIRBCoordinatorwillverifytherequiredCITIcoursehasbeencompletedandthePotentialConflictof
InterestDisclosureformhasbeenincludedwhennecessary.TheCoordinatorthecanapprovethe
RequestforRevisionsorAdditions.ApprovalmustbereceivedfromtheIRBpriortocommencingwith
therequestedchange.Deviationsfromtheapprovedprotocolmaypromptaninvestigationbythe
ResearchIntegrityOfficerandmayresultinterminationofapprovalbytheIRB.Theformcanbefound
athttps://apu.my.irbmanager.com
RenewalsforContinuingResearch
Aftertheinitialapproval,allstudiesmustundergocontinuingreviewbytheIRBtoensurethattheriskbenefitrelationshipoftheresearchremainsacceptable,theinformedconsentprocessanddocuments
arestillappropriate,andtheenrollmentofsubjectshasbeenequitable.Byfederalregulation,the
maximumperiodbetweentheseIRBreviewsisoneyear.Theinvestigatorisresponsibleforapplyingfor
continuingreviewinatimelymannertoensureIRBapprovaliscontinuous.
Therefore,researchersmustsubmitanannualrenewalrequestfortheircontinuingresearchthree
weekspriortotheanniversarydateoftheoriginalapproval.Youwillreceiveareminderfrom
IRBManagerpriortotheexpirationofyourapproval.Dependingonthedegreeofriskinvolved,more
frequentreportingmayberequestedbytheIRB(§46.109.e).Forresearchthatinitiallyrequiredafull
IRBreview,theRequestforRenewalofContinuingResearchformmaybesubmittedtoandapprovedby
thefullIRB.Iftheinitialapprovalwasanexpeditedreviewprocedure,theIRBChairordesigneereceives
therequestform.Ifastudyisnotre-approvedbeforethestudy’sexpirationdate,theresearchstudyis
automaticallysuspended.
Theformforrequestingarenewalofyourapprovedresearchcanbefoundat
https://apu.my.irbmanager.com
ClosureReportofResearchStudy
TheClosureReportmustbesubmittedafteralldatacollectionandde-identificationiscomplete,and
PRIORtotheone-yearanniversarydateofyourapproval.IRBapplicationsfromresearcherswhoare
delinquentonclosurereportsfrompreviousresearchwillbedelayeduntilclosurereportsarefiled.
TheClosureReportformcanbefoundathttps://apu.my.irbmanager.com
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LeavingAzusaPacificUniversity
ResearchersmustcontacttheIRBassoonastheyareawareofanimpendingdeparturefromAPU.They
musttheneitherfileaclosurereportbeforetheirdepartureormakearrangementstonameanother
appropriatelyqualifiedindividualcurrentlyattheinstitutiontoserveasthePI.
TheAPUIRBwillnolongercoveraninvestigatoronceheorsheleavestheinstitutionevenifthatperson
remainsamemberoftheresearchteam.Inthatsituation,astudyrevisionwouldberequiredindicating
theresearcher’snewroleand,if“engagedinresearch,”theresearchermustobtainIRBapprovalfrom
his/hernewinstitution.
TheInstitutionalReviewBoard(IRB)
Membership
APUfollowstheguidelinesoftheCommonRulethatrequirestheIRBtohaveatleastfivememberswho
areofvaryingbackgroundsandexperience,includingadiversityofraceandgender.TheIRBwillalsobe
comprisedofatleast:
• onescientist,
• onenon-scientist,and
• “onememberwhoisnototherwiseaffiliatedwiththeinstitutionandwhoisnotpartofthe
immediatefamilyofapersonwhoisaffiliatedwiththeinstitution”(45CFR46.107[d]).
Inaddition,atleasttwoalternatefacultymemberswillbeappointedtoassureadequaterepresentation
atscheduledmonthlymeetings.MembersareappointedtooneyeartermsbytheResearchIntegrity
Officerincollaborationwiththedeanofthefaculty’sSchoolorCollege.Allmembersandalternate
membersmusthavecompletedtheCITIinstructionfortheprotectionofhumansubjectsandreceived
theCompletionReportinordertobeappointedtotheIRB.CompletionReportswillbeplacedonfile
withtheInstitutionalReviewBoardCoordinator.
FunctionsandOperationsoftheIRB
TheIRBwillreviewproposedresearchrequiringFullBoardReviewatconvenedmeetings(atleast
monthly)atwhichamajorityofthemembersarepresent,includingatleastonememberwhoseprimary
concernsareinnon-scientificareas.Inorderfortheresearchtobeapproved,itwillreceiveapprovalof
amajorityofthosememberspresentatthemeeting(§45CFR46.108).IRBapplications,meetings,
documents,andminutesareconfidential.
Aboardmemberwhohasaconflictofinterestwithaproposalthatisbeingreviewedmustrecuse
himselforherselffromtheBoard’sdiscussionandthesubsequentvotebytheBoard.Therecusedboard
member,however,mayanswerclarifyingquestionsifrequestedbytheIRB.
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ResponsibilitiesoftheIRB
Inordertoapproveresearch,theIRBmustensurethatthefollowingrequirementsaresatisfied:
•
•
•
•
•
•
•
•
Riskstoparticipantsareminimizedbyusingproceduresconsistentwithsoundresearchdesign
thatdonotunnecessarilyexposeparticipantstorisk.
Riskstoparticipantsarereasonableinrelationtoanticipatedbenefits,ifany,toparticipants,
andtheimportanceoftheknowledgethatmayreasonablybeexpectedtoresult.Inevaluating
risksandbenefits,theIRBshouldconsideronlythosethatmayresultfromtheresearch,as
distinguishedfromthoseparticipantswouldreceiveevenifnotparticipating.
Selectionofparticipantsisequitable.TheIRBshouldconsiderthepurposesoftheresearchand
thesettinginwhichtheresearchwillbeconductedandbeparticularlymindfulofthespecial
problemsofresearchinvolvingvulnerablepopulations.Participantsshouldshareequallyin
foreseeablebenefitsandrisks.
Informedconsentissought,andwillbeobtained,fromeachprospectiveparticipantorthe
participant'slegallyauthorizedrepresentativeinaccordancewith,andtotheextentrequiredby
45CFR46.116.
Informedconsentisappropriatelydocumentedinaccordancewith,andtotheextentrequired
by45CFR46.117.
Whenappropriate,theresearchplanmakesadequateprovisionformonitoringthedata
collectedtoensurethesafetyofparticipants.
Whenappropriate,thereareadequateprovisionstoprotecttheprivacyofparticipantsandto
maintaintheconfidentialityofdata.
Additionally,whensomeoralloftheparticipantsarelikelytobevulnerabletocoercionor
undueinfluence(e.g.,children,prisoners,pregnantwomen,ormentallydisabled,economically
disadvantaged,oreducationallydisadvantagedpersons)additionalsafeguardsareincludedin
thestudytoprotecttherightsandwelfareoftheseparticipants.
TheIRBhastheauthoritytoapprove,requiremodifications(inordertosecureapproval),ornot
approveallresearchactivities.TheIRBwillnotifytheinvestigatorsinwritingthroughIRBManagerofits
decisiontoapproveornotapprovetheproposedresearch,orofmodificationsrequiredtosecureIRB
approval.Iftheproposedresearchisnotapproved,theIRBwillincludeinitswrittennotificationa
statementofthereasonsforitsdecisionandgivetheinvestigatoranopportunitytoreapply.Whenthe
convenedIRBrequestssubstantiveclarificationsormodificationsofprotocolorinformedconsent
documentsfromtheprincipalinvestigator,IRBapprovaloftheproposedresearchmustbedeferred,
pendingsubsequentreviewbytheconvenedIRB.
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References
CollaborativeInstitutionalTrainingInitiative(CITI)protectionofhumansubjectsinresearch.
Programmedinstructionforcertificationwww.citiprogram.org
Steneck,N.H.(2004).Introductiontotheresponsibleconductofresearch.U.S.HealthandHuman
ServicesDepartment.OfficeofResearchIntegrity.
U.S.DepartmentofHealthandHumanServices.OfficeofHumanResearchProtections(OHRP)
CategoriesofresearchthatmaybereviewedbytheInstitutionalReviewBoard(IRB)throughan
expeditedreviewhttp://www.hhs.gov/ohrp/policy/expedited98.html
Continuingreviewpolicy
http://www.hhs.gov/ohrp/policy/continuingreview2010.html
Guidanceoncertificateofconfidentiality
http://www.hhs.gov/ohrp/policy/certconf.html
Humansubjectsregulationdecisioncharts.
http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html
CodeofFederalRegulations
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
Reportingincidences
http://www.hhs.gov/ohrp/policy/incidreport_ohrp.html
HumanSubjects:Guidance
http://www.hhs.gov/ohrp
U.S.DepartmentofHealthandHumanServices.OfficeofResearchIntegrity(ORI)
Policies/Regs/Statuteshttp://ori.hhs.gov
MisconductRegulation,OfficeofResearchIntegrity
http://ori.hhs.gov/policies/ori-policies
U.S.DepartmentofHealthandHumanServices.NationalInstitutesofHealth(NIH)OfficeofHuman
SubjectResearch
BelmontReport:Ethicalprinciplesandguidelinesfortheprotectionofhumansubjects
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
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