Assessing Risks and Benefits - UCI Office of Research Archive

Risk/Benefit Assessment. The IRB is responsible for evaluating the potential risks and weighing the probability of the risk occurring and the magnitude of harm ... News&Announcements|ContactUs|Applications&Forms Menu ElectronicResearchAdministration(ERA)Facilities&Services--ULARandTMFUCIrvineOfficeofResearch ElectronicResearchAdministration(ERA)Facilities&Services--ULARandTMF   Menu ElectronicResearchAdministration(ERA)Facilities&Services--ULARandTMF AssessingRisksandBenefits Background Definitions Overviewofrisksandbenefits Risk/benefitassessment  Typesofrisktoresearchsubjects Waystominimizerisk Background PerDHHSandFDAregulations(45CFR46.111and21CFR56.111)twooftherequiredcriteriaforgrantingIRBapprovaloftheresearchare: Riskstosubjectsareminimizedbyusingprocedureswhichareconsistentwithsoundresearchdesignandwhichdonotunnecessarilyexposesubjectstorisk,andwheneverappropriate,byusingproceduresalreadybeingperformedonthesubjectsfordiagnosticortreatmentpurposes. Riskstosubjectsarereasonableinrelationtoanticipatedbenefits,ifany,tosubjects,andtheimportanceoftheknowledgethatmayreasonablybeexpectedtoresult.Inevaluatingrisksandbenefits,theIRBCommitteewillconsideronlythoserisksandbenefitsthatmayresultfromtheresearch,asdistinguishedfromrisksandbenefitsoftherapiessubjectswouldreceiveevenifnotparticipatingintheresearch. Definitions BenefitAvaluedordesiredoutcome;anadvantage.  RiskTheprobabilityofharmorinjury(physical,psychological,social,oreconomic)occurringasaresultofparticipationinaresearchstudy.Boththeprobabilityandmagnitudeofpossibleharmmayvaryfromminimaltosignificant.Federalregulationsdefineonly"minimalrisk." MinimalRiskAriskisminimalwheretheprobabilityandmagnitudeofharmordiscomfortanticipatedintheproposedresearcharenotgreater,inandofthemselves,thanthoseordinarilyencounteredindailylivesofthegeneralpopulationorduringtheperformanceofroutinephysicalorpsychologicalexaminationsortests.  MinimalRiskforResearchinvolvingPrisonersThedefinitionofminimalriskforresearchinvolvingprisonersdifferssomewhatfromthatgivenfornon-institutionalizedadults.Minimalriskisinthiscaseisdefinedas,"theprobabilityandmagnitudeofphysicalorpsychologicalharmthatisnormallyencounteredinthedailylives,orintheroutinemedical,dentalorpsychologicalexaminationsofhealthypersons." OverviewofRisksandBenefits Therearetwosourcesofconfusionintheassessmentofrisksandbenefits.Onearisesfromthelanguageemployedinthediscussion: "Risk"isawordexpressingprobabilities; "Benefits"isawordexpressingafactorstateofaffairs. Itismoreaccuratetospeakasifbothwereintherealmofprobability:i.e.,risksandexpectedoranticipatedbenefits.Confusionalsomayarisebecause"risks"canrefertotwoquitedifferentthings: thosechancesthatspecificindividualsarewillingtoundertakeforsomedesiredgoal;or theconditionsthatmakeasituationharmfultoasubject. ResearchersshouldprovidedetailedinformationintheIRBapplicationaboutpotentialrisksandbenefitsassociatedwiththeresearch,andprovideinformationabouttheprobability,magnitudeandpotentialharmsassociatedwitheachrisk. Risk/BenefitAssessment TheIRBisresponsibleforevaluatingthepotentialrisksandweighingtheprobabilityoftheriskoccurringandthemagnitudeofharmthatmayresult.Itmustthenjudgewhethertheanticipatedbenefit,eitherofnewknowledgeorofimprovedhealthfortheresearchsubjects,justifiesinvitinganypersontoundertaketherisks.TheIRBcannotapproveresearchinwhichtherisksarejudgedunreasonableinrelationtotheanticipatedbenefits.TheIRBmust: Identifytherisksassociatedwiththeresearch,asdistinguishedfromtherisksoftherapiesthesubjectswouldreceiveevenifnotparticipatinginresearch; Asapplicable,evaluatetheavailableclinicalandnonclinicalinformationonaninvestigationalproducttodetermineifthedataisadequatetosupporttheproposedclinicaltrial; Determinethattheriskswillbeminimizedtotheextentpossible[seebelow]; Identifytheprobablebenefitstobederivedfromtheresearch; Determinethattherisksarereasonableinrelationtobebenefitstosubjects,ifany,andtheimportanceoftheknowledgetobegained;and Assurethatpotentialsubjectswillbeprovidedwithanaccurateandfairdescription(duringconsent)oftherisksordiscomfortsandtheanticipatedbenefits. TypesofRisktoResearchSubjects Theriskstowhichresearchsubjectsmaybeexposedhavebeenclassifiedasphysical,psychological,social,andeconomic. PhysicalHarmsMedicalresearchofteninvolvesexposuretominorpain,discomfort,orinjuryfrominvasivemedicalprocedures,orharmfrompossiblesideeffectsofdrugs.Alloftheseshouldbeconsidered"risks"forpurposesofIRBreview.Someoftheadverseeffectsthatresultfrommedicalproceduresordrugscanbepermanent,butmostaretransient.Procedurescommonlyusedinmedicalresearchusuallyresultinnomorethanminordiscomfort(e.g.,temporarydizziness,thepainassociatedwithvenipuncture).Somemedicalresearchisdesignedonlytomeasuremorecarefullytheeffectsoftherapeuticordiagnosticproceduresappliedinthecourseofcaringforanillness.Suchresearchmaynotentailanysignificantrisksbeyondthosepresentedbymedicallyindicatedinterventions.Ontheotherhand,researchdesignedtoevaluatenewdrugsorproceduresmaypresentmorethanminimalrisk,and,onoccasion,cancauseseriousordisablinginjuries. PsychologicalHarmsParticipationinresearchmayresultinundesiredchangesinthoughtprocessesandemotion(e.g.,episodesofdepression,confusion,orhallucinationresultingfromdrugs,feelingsofstress,guilt,andlossofself-esteem).Thesechangesmaybetransitory,recurrent,orpermanent.Mostpsychologicalrisksareminimalortransitory,butsomeresearchhasthepotentialforcausingseriouspsychologicalharm.Stressandfeelingsofguiltorembarrassmentmayarisesimplyfromthinkingortalkingaboutone'sownbehaviororattitudesonsensitivetopicssuchasdruguse,sexualpreferences,selfishness,andviolence.Thesefeelingsmaybearousedwhenthesubjectisbeinginterviewedorfillingoutaquestionnaire.Stressmayalsobeinducedwhentheresearchersmanipulatethesubjects'environment-aswhen"emergencies"orfake"assaults"arestagedtoobservehowpassersbyrespond.Morefrequently,however,isthepossibilityofpsychologicalharmwhenbehavioralresearchinvolvesanelementofdeception. Invasionofprivacyisariskofasomewhatdifferentcharacter.Intheresearchcontext,itusuallyinvolveseithercovertobservationor"participant"observationofbehaviorthatthesubjectsconsiderprivate.TheIRBmustmaketwodeterminations: Istheinvasionofprivacyinvolvedacceptableinlightofthesubjects'reasonableexpectationsofprivacyinthesituationunderstudy; Istheresearchquestionofsufficientimportancetojustifytheintrusion? TheIRBmustalsoconsiderwhethertheresearchdesigncouldbemodifiedsothatthestudycanbeconductedwithoutinvadingtheprivacyofthesubjects.Breachofconfidentialityissometimesconfusedwithinvasionofprivacy,butitisreallyadifferentrisk.Invasionofprivacyconcernsaccesstoaperson'sbodyorbehaviorwithoutconsent;confidentialityofdataconcernssafeguardinginformationthathasbeengivenvoluntarilybyonepersontoanother.Someresearchrequirestheuseofasubject'shospital,school,oremploymentrecords.Accesstosuchrecordsforlegitimateresearchpurposesisgenerallyacceptable,aslongastheresearcherprotectstheconfidentialityofthatinformation.However,itisimportanttorecognizethatabreachofconfidentialitymayresultinpsychologicalharmtoindividuals(intheformofembarrassment,guilt,stress,andsoforth)orinsocialharm(seebelow). SocialandEconomicHarmsSomeinvasionsofprivacyandbreachesofconfidentialitymayresultinembarrassmentwithinone'sbusinessorsocialgroup,lossofemployment,orcriminalprosecution.Areasofparticularsensitivityareinformationregardingalcoholordrugabuse,mentalillness,illegalactivities,andsexualbehavior.Somesocialandbehavioralresearchmayyieldinformationaboutindividualsthatcould"label"or"stigmatize"thesubjects.(e.g.,asactualorpotentialdelinquentsorschizophrenics).Confidentialitysafeguardsmustbestrongintheseinstances.Participationinresearchmayresultinadditionalactualcoststoindividuals.Anyanticipatedcoststoresearchparticipantsshouldbedescribedtoprospectivesubjectsduringtheconsentprocess. WaystoMinimizeRisk Providecompleteinformationintheprotocolregardingtheexperimentaldesignandthescientificrationaleunderlyingtheproposedresearch,includingtheresultsofpreviousanimalandhumanstudies. Assemblearesearchteamwithsufficientexpertiseandexperiencetoconducttheresearch. Ensurethattheprojectedsamplesizeissufficienttoyieldusefulresults. Collectdatafromstandard-of-careprocedurestoavoidunnecessaryrisk,particularlyforinvasiveorriskyprocedures(e.g.,spinaltaps,cardiaccatheterization). Incorporateadequatesafeguardsintotheresearchdesignsuchasanappropriatedatasafetymonitoringplan,thepresenceoftrainedpersonnelwhocanrespondtoemergencies,andprocedurestoprotecttheconfidentialityofthedata(e.g.,encryption,codes,andpasswords). Regulations: OHRP:45CFR46.111 FDA:21CFR56.111 ResearchProtectionsHumanResearchProtectionsAboutHRPandtheIRBResearchersIRBMembersParticipantsSingleIRB(sIRB)/ReliancesOtherUCICommitteesAnimalCare&UseHumanStemCellResearchInstitutionalBiosafety VisitDirectionsEmailWebSupportContactUs:ORStaffDirectory ReadNewsWatchYouTube UniversityofCalifornia,IrvineOfficeofResearch160AldrichHallIrvine,CA92697 Login:StaffIntranetLogin:ResearchAdminWikiPrivacy&LegalNotice ©2021TheRegentsoftheUniversityofCalifornia ReadNews WatchYouTube  VisitDirections EmailWebSupport ContactUs:ORStaffDirectory Login:ORStaffIntranet Login:ResearchAdminWiki UniversityofCalifornia,IrvineOfficeofResearch160AldrichHallIrvine,CA92697 ©2021TheRegentsoftheUniversityofCalifornia    Privacy&LegalNotice          ReadNews WatchYoutube VisitDirections   EmailWebSupport ContactUs:ORStaffDirectory Login:ORStaffIntranet Login:ResearchAdminWiki UniversityofCalifornia,IrvineOfficeofResearch160AldrichHallIrvine,CA92697 ©2021TheRegentsoftheUniversityofCalifornia    Privacy&LegalNotice