Routledge Handbook of Medical Law and Ethics Informed Consent

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Routledge Handbook of Medical Law and Ethics

Yann Joly, Bartha Maria Knoppers

Informed consent

Publication details https://www.routledgehandbooks.com/doi/10.4324/9780203796184.ch3 Trudo Lemmens Published online on: 29 Aug 2014

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The publisher does not give any warranty express or implied or make any representation that the contents will be complete or accurate or up to date. The publisher shall not be liable for an loss, actions, claims, proceedings, demand or costs or damages whatsoever or howsoever caused arising directly or indirectly in connection with or arising out of the use of this material. Downloaded By: 10.3.98.104 At: 20:42 27 Sep 2021; For: 9780203796184, chapter3, 10.4324/9780203796184.ch3 who criticallyanalyzedKatz’s claims,historicalmedicalrecords,andotherresearch the secondhalfoftwentieth century(Katz Jay Katzalwaysmaintainedthat therewaslittletraceofmeaningfulconsent-seekingprior to sharing wasalreadyrecognized inprofessionalpracticepriortothetwentiethcentury.The late Scholarsdisagreeabouttheextent towhichseekingconsentbasedonsomelevelofinformation- 3.1.2 consent standardstofacilitatepublicinterestorientedresearch. on twoareasofresearchwherecommentatorsareincreasingly callingformoreflexibleinformed pletes thissection.Finally,somebriefcommentsaremadeabout contemporaryissues,focusing increasingly importantstatutoryandguideline-basedgovernance ofinformedconsentcom- of informedconsent,focusinginparticularonCanadiancommon law.Abriefdiscussionof the chapterthenproceedswithanoverviewoflegalrequirements toremedyviolations After anidentificationofsomethekeyfeaturesinformed consentinlawandbioethics, is followedbyadiscussionofthenormativebasisinformed consentinbioethicsandlaw. and legalmainstayonlyinrecentdecades. underlying value.Itisthereforehardtoimaginethatinformedconsenthasbecomesuchamoral circumstances, howitmayneedtobedelayedorreplacedbysurrogateproceduresthatrespectits generally focusesonhowinformedconsentcanbestbeobtainedandpromotedor,inspeciﬁ tices. Thiscontemporaryliteraturedoesnotquestionthevalueofinformedconsent,butrather challenges toinformedconsentand,increasingly,empiricalstudiesaboutprac- ture aboundwithdiscussionsofitsprecisemeaningandcontent,explorationsthevarious ment inmedicalpracticeandresearch.Thespecializedhealthlaw,bioethics,litera- Obtaining‘informedconsent’isnowﬁrmly establishedasapreeminentlegalandethicalrequire- 3.1.1 Introduction 3.1 Legalandethicaltheory Thischapterfirstsituatesthedevelopmentofconceptinitshistoricalcontext. Historical developmentoftheinformedconsentdoctrine 1984 Informed consent ). RuthR.FadenandTomL. Beauchamp, Trudo Lemmens 3 27 c

Downloaded By: 10.3.98.104 At: 20:42 27 Sep 2021; For: 9780203796184, chapter3, 10.4324/9780203796184.ch3 Trudo Lemmens famously statedthat‘[e]veryhuman beingofadultyearsandsoundmindhasarighttodetermine 28 in thetwentiethcentury 3.1.2.1 1986 : 1233). surgery onapatientwithoutobtainingthepatient’spermission’(BeauchampandFaden matic response’since‘[i]tisatbestphysicallydifficultandinterpersonallyawkwardtoperform suggest, consentinthecontextofsurgery,forexample,wasunderstandablyasomewhat‘prag- more commoninsomeareasofmedicalpracticethanothers.AsBeauchampandFaden for autonomousdecision-making. cious effectonmedicalinstitutions(BeauchampandFaden the ideathatprovidinginformationofferedtherapeuticbenefitsordeceptionhadaperni- 1256). Thosewhosupportedsomelevelofinformation-sharingandconsent-seekingdidsowith views dominatedEnglishandAmericanmedicalethicsuntilthemid-twentiethcentury(2004: directly tookover–oftenverbatimPercival’sethicalstanceoninformedconsentandthatthese to shieldinformationthatcouldbeharmfulpatients. (1803: 166),butsuggestedatthesametimethattruth-tellingyieldstoimportantobligation of the‘delicatesenseveracity,whichformsacharacteristicexcellencevirtuousman’ English physicianThomasPercivalstressedinhisinfluentialbook hiding potentiallytroublinginformationfrompatients.Theinfluentialnineteenth-century condition. Earlytwentieth-centuryversionsoftheHippocraticOathevenexplicitlyprescribed was thatpatientsoughtnottobeneedlesslyupsetwithworrisomenewsabouttheirmedical informed consentasanexpressionofself-determination. a keyprincipleofmedicalethics,ratherthanbythemoremodernandlegalconceptualization 56–60). Theypointoutthatconsent-seekingwasdrivenbyacommitmentto‘fi Katz thatthepracticewasdifferentfromwhatwenowunderstandas‘informedconsent’(1986: on consent,suggestthattherewassomelevelofconsent-seekinginmedicine,butagreewith the UScaseof Thestartofthelegaldoctrine ofinformedconsentinAnglo-Americanlawisassociated with al on themostvulnerableinsociety,suchaspoor,(juvenile)prostitutes,andchildren(Katz century inEuropewhencriticalaccountswerepublishedaboutoutrageousresearchpractices requirement forresearchparticipationwerealsoalreadyplantedattheendofnineteenth of theneedtoobtainconsentfromresearchparticipants.Yet,seedsinformed nation ofthepossiblenegativeconsequencesintervention’ (VollmanandWinnau explicitly requiredconsentpriortoexperimentation,whichhad tobebasedon‘aproperexpla- physician formedicalexperimentswithoutconsentandprobably thefirstregulationofitskind, research. APrussianregulationof1900,enactedinthewake oftheprosecutionaGerman some ofthisresearch,wesawthedevelopmentfirstguidelines andregulationsonmedical already feltmorallytroubledaboutthisresearchpractice.In thewakeofpublicexposure only questionableconsent,butalsothatsomepeoplewithin and outsidethemedicalprofession rhea inRussiaandGermanynotonlyillustratethatresearch oftentookplacewithoutorwith . 1972 Inmedicalresearch,the1947 Providinginformationandobtainingsomelevelofagreementpriortointerveningappeared JayKatzdiscussedhowearlyethicalcodesenactedbytheAmericanMedicalAssociation Thedominantattitudeinthemedicalprofession,evenamongthosesensitivetotruth-telling, : 284–92).Criticalreportsofthedeliberateinfectionpatients withsyphilisandgonor- Development ofthedoctrine ofinformedconsent Schloendorff v. New YorkHospital Nuremberg Code [1914]211NY125,inwhich JusticeCardozo isgenerallyseenasthefirststrongaffirmation 1986 : 1233),andnotoutofrespect Medical Ethics rst, donoharm,’ theimportance 1996 ). et Downloaded By: 10.3.98.104 At: 20:42 27 Sep 2021; For: 9780203796184, chapter3, 10.4324/9780203796184.ch3 the recreationof battlefi of themosthorrifi c experimentsonconcentrationcampprisoners. Experimentsrangedfrom Law No.10 Doctor Trials( humans, setoutinthe1947judgment oftheinternationalcriminalcourtinNuremberg obtain consentfrompatients(BeauchampandFaden examination constitutedbattery.Althoughthereareearliercasesthatacknowledgedadutyto the courtfoundthatremovalofatumorfromwomanwhohadonlyconsentedtoan patient’s consentcommitsanassault,forwhichheisliableindamages’(p.126).In what shallbedonetohisownbody;andasurgeonwhoperformsanoperationwithout much throughthecourts,butguidelinesandregulations. Thefi development towardstheimpositionofdetailedinformedconsent requirements,albeitnotso Intheresearchcontext,post-WorldWarII(WWII)period isalsocharacterizedbyasteady research post-WorldWarII 3.1.2.2 later informedconsentcasesaroundtheworld. twentieth-century legaldevelopments.Cardozo’sformulationbecameoneofthekeyquotesin determination andthecharacterizationofsurgerywithoutconsentasbatterysetstagefor the tion oftheneedforinformedconsentininternationalcontext was,asmentionedbefore, cians hadtoexerciseacertaindegreeof‘discretion’(Katz tional practiceofmedicinebyemphasizingthatinprovidingriskinformationtopatients,physi- term ‘informedconsent,’italsotriedtoreconcilethisdutysomedegreewiththetradi- as JayKatzpointsout,intheveryphrasewhichcourtintroducedforfirsttime emphasized thatconsenthadtobebasedonsufficientinformationmakeit‘intelligent.’But, Leland StanfordJrUniversityBoardofTrusteesetal. time toembraceinformedconsentasastandardpractice. decisionmaking’ (BeauchampandFaden ing ofthesocialinstitutionconsentrulesasamechanism for theprotectionofautonomous only incoiningtheterm‘informedconsent,’butalsoby‘set[ting]othersonroadtoconceiv- for litigation.FadenandBeauchampsuggestthat‘caselawhasbeenextremelyinfluential,’not sional medicaldiscoursewasaffectedbyawarenessoflegalandsocialdevelopmentsconcern decisions wereinfluencedbyagrowingemphasisonindividualandconsumerrightsprofes- interacting culturalandsocialchangeswerealsotakingplaceatthesametime.Inparticular,legal failures ofinformedconsent. the informedconsentstandard.Otherjurisdictionsalsoappliedthistwo-prongedapproachto liability innegligence,whilebatteryshouldbereservedforthemostextremedeparturesfrom explicitly thatmostcasesoffailuretoprovideadequateinformedconsentcouldgiverise assault orbattery.LaterUScases,notably sharing, thecourtalsoindicatedthatfailuretoprovideinformedconsentwasnotnecessarilyan of thelegaldebate.Withitsacceptancesomediscretionarydeparturefrominformation- order tomakemeaningfuldecisionswouldbecomeinthesubsequentyearsanimportantpart The ambiguityaboutwhodetermineswhatlevelofinformationpatientsshouldreceivein traditional stancethatinformation-sharingcouldberestrictedtoavoidharmthepatient. Theterm‘informedconsent’itselfwasintroducedonlymuchlater,inthe1957caseof Caselawmayhaveinfluencedprofessionalthinkingaboutinformedconsent,butavarietyof Nuremberg Code Development ofinformedconsentstandardsin 1949).Asiswellknown,German doctorswereprosecutedinthistrialforsome Trials ofWarCriminalsbeforethe NurembergMilitaryTribunalsunderControlCouncil . The eld conditionstofi Nuremberg Code 1986 consistsoftenkeyethicalprinciples forresearchon Canterbury nd survivaltechniques andtreatmentforGerman : 142),evenifmedicalprofessionalstookalonger [1957]154CalApp2d560,wherethecourt v. 1986 Spence 2004 : 116–23),itsassociationwithself- [1972]464F.2d772,confirmed : 1258).Thisreflectedthemore rst infl Informed consent uential formula- uential Schloendorff , Salgo 29 v.

Downloaded By: 10.3.98.104 At: 20:42 27 Sep 2021; For: 9780203796184, chapter3, 10.4324/9780203796184.ch3 Trudo Lemmens 30 suggests thatthe (Advisory CommitteeonHumanRadiationExperiments 1995 ). the natureoftheserules,Ivyallegedthattheywereacodificationcommonresearchpractices later verbatimintegratedintheNurembergdecision.Whenquestionedbydefenselawyersabout which werequicklyadoptedbytheAmericanMedicalAssociation,andsectionsof ing inNuremberg,Ivydraftedasetofrules,includingexplicitinformedconsentrequirements, informed consentaroundthesametimeoutsideofGermany(Reverby itly howseriouslyproblematicresearchcontinuedtotakeplacewithout,orwithquestionable, Health OrganizationsponsoredsyphilisresearchinGuatemalanowconfirmevenmoreexplic- some characteristicswiththeNaziexperiments.RecentrevelationsofUSandPanAmerican not basedonatroublingracialideologyassomeoftheNaziexperiments,sharedarguably infants sufferingfromspinabifida(Schmidt on HumanRadiationExperiments allied countries,forexamplemalariaresearchinStatevillePrisonIllinois(AdvisoryCommittee that therewerenoexplicitethicalstandardsforresearchintheUS.Somepractices the Nazidoctorsforwidelyacceptedethicalprinciplesinresearch,hewasfacedwithfact President oftheUniversityIllinois,AndrewIvy,wasaskedtotestifyaboutdisregard ethics standardsintheUS,partasaresultoftheirroleexpertwitnesses.WhenthenVice requirements formedicalexperimentation. absence ofanyformconsent.Consentthusbecameemphasizedasonethetenkeyethical experiments wastheblatantdisregardforwellbeingofhumanbeings,butobviouslyalso studies oftwinsaimedatconfi rmingNaziracialideology.Themostcommonelementofthese soldiers, tothetestingofpoisonandothermassmurdertools,biologicalwarfare, place duringthewar,containedmoredetailedstandardsthanthoseof 1932 ‘Richtlinien’(guidelines)fornon-therapeuticresearch,whichincongruouslyremainedin few countries,ifnottheonlycountry,thathadintroducedregulationsformedicalresearch.The healthcare andmedicalresearchsectors.And,somewhatcynically,ithadalsobeenoneofthe figures inthemedicalprofession.Afterall,Germanypre-WWIIhadoneofmostsophisticated evant outsideofGermany(Katz medical researchin1953(Lederer fessional organizationsetupinthewakeofWWII,starteddeliberating onethicalstandardsfor of rulesformedicalexperimentation.TheWorldMedicalAssociation (WMA),amedicalpro- included strongrequirementsforconsent(Lederer 2007 ). Faden control overresearchstandardswithintherealmofprofessional self-regulation(Beauchampand Helsinki approval, made theadoptionofDOHeven moreimportant(Annas (FDA) regulations,whichintroduced newclinicaltrials-basedstandardsfordrugregulatory as ahumanrightsissue,nofurther firminternationallegalrulesforresearchweredeveloped. Covenant onCivilandPoliticalRights Nuremberg’s keyrequirement forinformedconsentfounditswayintothe1966 part aimedatcurtailingmoredrasticanddetailedinternational legalrulesaboutresearch.While dependent ontheAmericanpharmaceuticalindustry(Lederer Lederer documentsindetailhowtheyearspriortoitsadoption, theWMAbecamefinancially TheNurembergtrialitselfdidnotappeartohaveahugeimpactoutsideofGermany.Katz Someofthepeopleinvolvedinprosecutionbecameinstrumentaldevelopingresearch FollowingNuremberg,pressuremountedworldwidetodevelop amorecomprehensiveset GeorgeAnnashasarguedthatthe proposedchangestotheUSFoodandDrugAdministration 1986 (DOH)1964.TheDOHcanbeseenasanattemptbythemedical communitytokeep ). Butindustryinterestsalsoinfluenceditsdevelopmentandapproval process.Susan Nuremberg Code wasseenasacodefor‘barbarians’andthereforenotreallyrel- 1992 2007 (ICCPR),whichreaffirmsthe needforinformedconsent 1995 ). Yetitdidleadtoappropriatereflectionamongleading : 150–60)andelevenyearslateradoptedthe : 272)andBritishresearchfundedbythemilitaryon 2004 : 76–7),whilenotashorrificinnatureand 2007 : 157–70).TheDOHwasin 2012 1991 Nuremberg Code ). Priortotestify- ). Therulesof Declaration of International and Downloaded By: 10.3.98.104 At: 20:42 27 Sep 2021; For: 9780203796184, chapter3, 10.4324/9780203796184.ch3 NewEnglandJournalofMedicine academic researchmoregenerally.In1966,HenryBeecherpublishedaseminalarticleinthe academic literatureofunethicalresearchpracticesalsocreatedpressureforreformwithin for informedconsentinclinicalresearch,includingregulatorystandardsconsent. an entirenewclinicaltrialsindustry,andstimulatedmorewidespreadchangeintheprocedures stantial increaseintheneedforclinicaltrials,evenresultingovertimedevelopmentof albeit underspecificconditions.ChangestotheFDArulesandregulationsresultedinasub- mentation, thusprohibitingresearchonincompetentpeople,theDOHpermittedsuchresearch, ICCPR) formulates‘priorinformedconsent’asanecessaryconditionforanyformofexperi- flexibility withrespecttoinformedconsentstandards.WhereasNuremberg(andlateralsothe the DOHweremorespecificthan public exposureoftheTuskegeestudyin cells inunconsentingterminallyillpatients. study, forwhichresearchersweresubsequentlysanctioned,involvedtheinjectionoflivecancer at onepointpreferentialaccesstotheovercrowdedschool.TheJewishChronicDiseasehospital infection withhepatitisasapossibleprophylactic)andincontextofpressure,sinceitprovided with incompleteinformationaboutthenatureofstudy(whichinvolvedtestingdeliberate ents wereaskedtoconsenttheinclusionoftheirchildreninanexperimentalresearchunit,but State schoolstudyandtheJewishChronicDiseaseHospitalstudy.InWillowbrookstudy,par- remain citedasparadigmcasesofviolationsinformedconsentinresearch:theWillowbrook was obtainedfromresearchsubjects(Beecher view, wereethicallydubious,mostofthemalsofailingtoidentifyclearlythatinformedconsent and HumanServices issuedmorespecificregulations, clarifyinginmuchmore detailthanever for informedconsent.Intheyears followingtheBelmontReport,DepartmentofHealth This reflectedastrongemphasis onautonomyandhumandignityasthebasisofneed respect forpersonsexplicitlywith aneedforthedevelopmentofinformedconsentguidelines. tice (NationalCommissionfor theProtectionofHumanSubjects principles forresearchinvolving humans,specificallyrespectforpersons,beneficence,and jus- seminal report,widelyknownastheBelmontReport,inwhich itformulatedasetofkeyethical Subjects ofBiomedicalandBehavioralResearchwassetup. In 1978,theCommissionissueda dures. Followingthisrecommendation,theNationalCommission fortheProtectionofHuman of anationalboardtolookintothedevelopmentmore appropriate researchethicsproce- ance, includingintheareaofinformedconsent.Itfurther recommendedtheestablishment ad hocpaneltoreviewthestudy.Thisemphasizedneed forstrongerresearchguid- become available. in themedicalliteraturereportedonaspectsofstudy– long aftereffectivetreatmenthad Yet, the‘observationalstudy’continueduntilitspublicexposure in1972andseveralpapers for syphiliswasbothtoxicandnotveryeffective,the diseasewasnotwellunderstood. as treatments.Whenthestudystarted,penicillinhadnotyetbeeninvented,standardtreatment they wereinvolvedinresearchandinvestigatorsevenpresentedinvasiveprocedures group of200uninfectedmen.Nonetheresearchsubjectswereadequatelyinformedthat and mortalityratesof400African-Americanmeninfectedwithsyphilisthoseacontrol The Tuskegeestudyoriginallystartedinthe1930sasanobservationalcomparinghealth systems thathavesincemushroomedallovertheworld(BeauchampandFaden and resultedinfirmerofficialinitiativeswhichlieattheoriginofresearchethicsreview Separatefromthisdevelopmentinthecontextofclinicaldrugtrials,exposure Whiletheseandotherpublications,includingthepopularpress,evokeddebate,itwas Inresponsetopubliccriticism,theDepartmentofHealth and HumanServicessetupan inwhichhediscusseddetail22publishedstudieswhich,his Nuremberg Code New YorkTimes 1966 ). Amongthestudiesdiscussedweretwothat , buttheyclearlyalsointroducedgreater in1972thathadthebiggestimpact 1979 ). Thereportconnected Informed consent 1986 : 157–67). 31 Downloaded By: 10.3.98.104 At: 20:42 27 Sep 2021; For: 9780203796184, chapter3, 10.4324/9780203796184.ch3 Trudo Lemmens 32 tioned, thosewho firstacknowledgedthatphysicians shouldobtainconsent recognizedawide how thebenefitofbeinginformed willbeweighedagainstotherbenefitsorharms.Asmen- that ariseoutofrelationand thathelppromotemeaningfulautonomy. unique natureofthedoctor–patient relationandimpliestheexistenceofuniquemoralduties moves informedconsentbeyond anissueof‘benefi consent (O’Neil guarding trustinthedoctorandhealthcareinstitutionsas an importantelementofinformed benefi to plantheirlivesaccordingly;anditcanstrengthendoctor–patient relations,whichmaybeof tion withcurrenttreatment;itmayhelppatientstobemore realisticabouttheirprognosisand consent benefits thepatientinseveralways:itpromotesbettercompliance andparticipa- forward asanimportantrationaleforinformedconsent.Stephen Weiremphasizeshowinformed it wasthebestwayofensuringgoodhealthcareoutcomes.Moreover, patientbenefi foundations oftheconcept.Asmentioned,first calls for consentwerebasedontheideathat Thehistoricaloverviewofthedevelopmentinformedconsent alreadyhintedatdifferent 3.1.2.3 soft-law requirementsinthedrugregulatoryprocessesofvariouscountries(Hirtle has beenveryinfluentialaroundtheworld.AsDOH,theyhaveoftenintegratedas FDA rulesandregulations,includedetailedinformedconsentrequirements.TheICHGCP Guidelines (ICHGCP)inthe1990s.TheseguidelinesreflectkeyrequirementsofUS countries. OneofitskeyinitiativeshasbeenthedevelopmentICHGoodClinicalPractice Harmonization (ICH),aimedatharmonizingdrugregulatoryrequirementsoftheindustrialized cies oftheUSA,EuropeandJapanestablished,forexample,InternationalConferenceon the yearsfollowingadoptionofDOHalsocontributedtothis.Theregulatoryagen- because oftheinternationalizationclinicalresearch.Internationalregulatoryinitiativesin nationally. Informedconsentbecameakeyrequirementinmedicalresearch,particularlyalso to harm(Mosby 2013 ). about failuresof,orseriousproblemswith,informedconsentandexposureofresearchsubjects munities andaboriginalchildrenresidinginresidentialschools,whichraisestroublingquestions Mosby unearthednutritionalresearchundertakeninthepost-WWIIperiodonaboriginalcom- Committee onHumanRadiationExperiments instances ofresearchwithnoorquestionableinformedconsentfromsubjects(Advisory involving radiationthattookplaceinthecontextofColdWar,andwhichrevealednumerous the US,PresidentClintonsetupin1994anAdvisoryCommitteetoinvestigatepostwarresearch suffering fromcervicalcancer,whichledtoapublicinquiry(CommitteeofInquiry was confrontedwithaTuskegee-likeresearchscandalinvolving‘observationalstudies’ofwomen standards followingtheadoptionofinformedconsentrequirements.NewZealand,forexample, developments. Infact,severalreportshaveemergedofseriousviolationsinformedconsent rules doesnotmeanthatnofurtherseriousviolationsoccurredinthedecadesfollowingthese officially becamerequiredinthecontextofresearch. moved theobtainingofinformedconsentinresearchintoanewera,atleastwithrespecttowhat ent proceduralrequirements,suchastheexchangeofacopyinformedconsentform.It before variouscomponentsofinformedconsent,exceptionstothestrictrules,andalsodiffer- Framinginformedconsentmerely asanissueofbeneficenceleavesmuchuncertaintyabout InthewakeofUSregulatoryinitiativesmentionedearlier,developmentsfollowedinter- Themovetowardsstricterresearchethicsreviewofinformedconsentformsandmoredetailed t infuturesituations(2004:72–6).OnoraO’Neillalsoemphasizestheimportance ofsafe- Normative basisofinformedconsent 2002 ). O’Neil’sidentifi cation of‘trust’ asafoundationofinformedconsent 1995 cence.’ Trustin thiscontextreferstothe ). Morerecently,CanadianhistorianIan et al . 2000 ). t isstillput 1988 ). In Downloaded By: 10.3.98.104 At: 20:42 27 Sep 2021; For: 9780203796184, chapter3, 10.4324/9780203796184.ch3 and towhatextent,accordingthestandardsofmedicalprofession( sharing, leftit,untilveryrecently,entirelyuptophysiciansdecidehowthismustbedone was therapeuticallyrequired.Englishcourts,whilerecognizingtheimportanceofinformation- also stressedthatitwasuptothephysiciandeterminewhethersomelevelofnon-disclosure of sharingrelevantriskinformationwithpatientsforthepurposeself-determination,but In the1972UScaseof embraced theinformedconsentdoctrine,atherapeuticexceptionwasstillquiteprominent. excuse insomeofthehistoricalresearchstudiesdiscussedearlier.Infirstcourtdecisionsthat notion thattoomuchinformationcancauseharmiswhatsomeresearchersalsoinvokedasan range ofexceptionstoavoidtroublingthepatientwithpotentiallyharmfulinformation.This rejected the‘informedconsent’doctrineespousedby Royal HospitalGovernors (Grubb or dignityoftheperson,hencesomeautonomy-relatedargument. research proceduresthusrequiressomeconsiderationoftheimpactdisclosureonintegrity avoided byperfectsecrecy.Arguingthatresearchsubjectsareharmedwhennotinformedabout ple’s interestinparticipatingfutureresearchprojects.But,theory,thistypeofharmcouldbe tion riskscreatingpsychologicalharmtoresearchsubjects,orcouldreducetheirandotherpeo- value informedconsentinthatsituation.Onecouldarguethefailuretoprovideinforma- in thatcase,notherapeuticbenefitfrombeingproperlyinformedabouttheprocess,andyetwe research, whentheresearchreallyaimsatgeneratinggeneralizableknowledge.Thepatienthas, which isnowrejectedinmostjurisdictions,alsoincreasinglyquestionedEngland. left toaphysicianandbasedonweighingofthebenefitsharmsinformation-sharing, judgment. However,theideathatdecisionsaboutsharingofinformationshouldentirelybe whether ornottoundergoaparticularmedicalprocedurewasprimarilymatterofclinical English law,holdinginsteadthatthedegreeofdisclosurerequiredtoassistapatientindeciding implementation ofthatideaisnotstraightforward. Inthehealthcarecontext, weoftendealwith mous choice.Yet,aswillbe discussed inthesectiononinformedconsentlaw,practical requires thatpatientsreceiveall informationtheydeemrelevanttoenableameaningfulautono- doctor–patient relationmorefruitful. Informedconsentgroundedinautonomyrequiresmore: it would onlyneedasmuchinformation asrequiredtomaketreatmentmoreeffectiveor the to beshared.Beneficenceishardly theonlyvalueunderlyinginformedconsent,sincepatients has implicationsforhowinformationtobeprovidedand whatlevelofinformationhas Human Subjects 1979 ; Beauchamp andFaden 1986 ). to thevalueofrespectforpersonsandtheirdignity(National CommissionfortheProtectionof for morallyprincipledlives(O’Neill rational self-governance:patientsareexpectedtobeproperly informedtoenablethemopt person’s sovereigntyoverhisorherownbodyandmind(2003). be consideredunacceptable.Informedconsentinthissensereflects JohnStuartMill’sviewofa care providerstoperformactionsunderconditionsofexplicit agreementthatwouldotherwise physical integrity.Informedconsentconstitutesinthatcontext awaiver,whichallowshealth Cardozo’s famousstatement,itmeansthatpatientshavearighttorefuseanyinvasionoftheir governance isreflectedindifferentwaysthecontextofmedicine.Atamostbasiclevel,as as aconditionforproperself-governance.Thisideaofinformedconsentthebasisself- Autonomyismostfrequentlyidentifiedasthecorevalueunderlyinginformedconsent Benefitfailstoprovideasolidbasisforinformedconsentin,example,non-therapeutic Whetherinformedconsentisconnectedtoautonomyor somenotionofbeneficence Adifferent,Kantianautonomy-basednotionofconsentis that itisanimportanttoolto 1998 : 110;BeauchampandFaden [1985]AC871).Infact,in Canterbury v. 2002 Spence : 73–95).Informedconsentis,inthisview,connected 1986 , forexample,thecourtconfirmedimportance ; Mclean Sidaway Canterbury 2010 , theHouseofLordsevenexplicitly : 86–7).Informedconsentisseen v. Spence asnotinlinewith Sidaway Informed consent v. Bethlem 33 Downloaded By: 10.3.98.104 At: 20:42 27 Sep 2021; For: 9780203796184, chapter3, 10.4324/9780203796184.ch3 Trudo Lemmens 34 procedure orintervention. Caselawandvarious statutesdealingwithhealthcare consenthave information; comprehension;voluntariness; competency;andanagreementwiththeproposed the informationconfi both anagreementtoallowthe useofinformationaswellapledgebytheresearchertokeep mutual signingbytheresearch subjectandresearcherof‘informedconsentforms’canbeseen as Informed consentfortheuseofsensitivehealthinformation for researchpurposesinvolvingthe it referstotheagreementallowconfi dential informationtobeusedforspecifi does notleadtoanyconcreteinterventionorphysicalparticipation inresearch.Inthatcontext, of informedconsentisalsowidelyappliedinthecontext health informationwhereconsent possible alternatives,andtheriskspotentialbenefits ofthevariousoptions.Yetconcept research procedures,andbasedonsuffi cient informationaboutthenatureofprocedures, obtain frompatientsorresearchsubjects,priortohealthcare interventionsorenrollmentin stood today.Onewayistodefi Itisdiffi defi nition anddefi 3.2.1 Currentunderstandingandlegalremedies 3.2 have undoubtedlycontributedtoitsgrowingstatus. Western-dominated internationalresearchethicsstandardssuchasthe the growingnumberofinternationalclinicaltrialsand,relatedtothat,influenceclearly important statusaroundtheworld.Theglobalizationofhealthcarepractices,andinparticular it isseenasaformofculturalimperialismornot,informedconsenthasclearlygainedan tries whichuntilrecentlyalsoembracedmorefamilialandcommunalinvolvement.Whether informed consentclearlyseemstohavestrongappeal,evenin,forexample,Europeancoun- lies andcommunitiesinhealthcaredecision-making.Yetpromotingindividualchoicethrough identified asaWesternphenomenon.Manyculturesplaceemphasisontheneedtoinvolvefami- of autonomybasedonapresumptionwhenkeyconditionsaremet. concepts suchas‘undueinducement’and‘vulnerability,’courtstendtoembraceapracticalmodel literature, andfindtosomedegreetheirwayintoethicscodesguidelines,forexamplein contextual factorsonindividualdecision-making.Whiletheseviewsarewidelydiscussedinthe more complexviewsofautonomywilltendtopaygreaterattentionthepossibleimpact relationships withthosearoundthem(McLeodandSherwin patients areinevitablyconnectedtoothersandconstructreaffirmtheirautonomythrough is notunderminedbypersonalandcontextualvulnerabilityduress.Theyemphasizealsothat sophisticated analysisofwhetherparticulardecisionsarecontributingtoaself-developmentthat consent. Someauthorsargueforasituatedcontextualviewofautonomythatcallsmore autonomy thatunderliesthedominantlyliberallegalandbioethicsliteraturearoundinformed it isworthpointingoutherethattherearichliteraturequestioningtheatomisticnotionof to patients. with respecttowhoshoulddecidewhatlevelandtypeofinformationmustbedisclosed that itcanbemeaningfullyusedbypatients.Legalsystemshaveembraceddifferentapproaches highly technicalandcomplexinformationthathastobetranslatedbyhealthcareprofessionalsso Informedconsentismoreoften describedbyemphasizingitscorecomponents:disclosureof Itisworthalsonotingthattheoveremphasisonautonomyandinformedconsentoften Adetaileddiscussionofthenatureautonomyexceedscontoursthischapter,but Current contentofinformedconsent: culttoprovideanall-encompassinglegaldefi ning features ning dential(Lemmens ne itisasanauthorizationthathealthcareprovidershaveto et al . 2013 ). nitionofinformedconsentasitisunder- 2000 ). Thosewhodefendthese Declaration ofHelsinki , c purposes. c Downloaded By: 10.3.98.104 At: 20:42 27 Sep 2021; For: 9780203796184, chapter3, 10.4324/9780203796184.ch3 particularly influential(HawkinsandEmanuel ticularly inthecontextofresearchethics,whereAlanWertheimer’s analysisofcoercionhasbeen in ordertoobtaincompliance.’Thereisvoluminousliterature oncoercioninhealthcare,par- cion occurswhenanovertthreatofharmisintentionallypresented byonepersontoanother Belmont Report(NationalCommissionfortheProtectionofHumanSubjects1979),‘[c]oer- used forallsituationswherepeoplefeelsomeformofpressuretoconsent.Accordingthe factors whichmostcommonlyaffectvoluntariness.Theterm‘coercion’tendstobetooeasily implicit, andexternalorinternal.Coercion,undueinfluence,fraudmisrepresentationare undermine autonomouschoice.Clearly,notallinfluencesdoso.Influencescanbeexplicitor address allrelevantinformationalneeds. should bekeptinmind(Katz this context,JayKatz’sviewofinformedconsentaspartaprocess‘shareddecision-making’ direct communicationthattheinformationisunderstoodbypatientsorresearchsubjects.In than thesigningofaconsentform.Healthcareprovidersandresearchershavetoensurethrough understanding andisoftengivendisproportionateweight.Realinformedconsentrequiresmore pital legaldepartmentsorbyresearchethicscommitteescan,however,alsoobfuscatemeaningful consent process).Theformalizationofinthesigningformsapprovedbyhos- forms alsoservealegalpurpose(i.e.theyprovidesomelevelofevidenceabouttheinformed 2010 highly technicallanguage,anduselanguageof‘agrade6to8readinglevel’(HealthCanada forms, emphasizingthattheyneedtobeadjustedthetargetpopulation,avoidlegalisticand guidelines abouthowtomakeinformationaccessible.Thesetendfocusonconsent comparative risksandpotentialbenefits.Fundingregulatoryagenciesoftenprovidedetailed ping ruleshavetobeexplained,andwherethereisalsoinherentlymoreuncertaintyaboutthe text ofresearch,wherecomplexproceduressuchasrandomization,placebocontrols,andstop- risks canbehardtotranslateintoaccessiblelanguage.Thisisparticularlychallenginginthecon- always easytofulfill.Technicalinformationabouttheproceduresinvolvedandnatureof stand theconsentformstheysign.Inreality,though,comprehensioncomponentisnot people tomakeautonomousdecisions,theyhavegraspwhatarebeingtoldandunder- Care ConsentAct 1996). cedure andofalternativeoptions,theconsequencesnotundergoingaprocedure( about thenatureofprocedure,possiblealternativeoptions,risksandbenefitspro- identified thekeyelementstobedisclosed.Healthcareprovidershaveprovideinformation or inappropriate reward…inordertoensure compliance’(Departmentof Health andHuman ing totheUSOfficeforHuman ResearchProtections,‘occursthroughanofferofexcessive undue, sinceourdecisionsareinevitably shapedbyvariousinfluences.Undueinfluence,accord- concept hasbeenparticularly used inresearchethics.Clearly,notallformsofinfluence are recipients oftheoffermayfeel thattheyhavenootheroptionbuttoaccept. fair conditions,neveracceptsuchanoffer.Inthosecircumstances ofparticularvulnerability,the is extremelyvulnerableduetodistress,need,orpoverty,andwho would,underthemostbasically ‘coercion’ couldalsobeusedtocharacterizeanofferthatisintentionally madetoapersonwho ticipate inresearchwouldresultwithdrawalofallformsmedical care.However,inmyview, 1987 not presentwhenresistingthethreatwouldleaveperson inthesameposition(Wertheimer exists whentherefusaltocomplywiththreatwouldmake apersonworseoff,andthatis Voluntarinessreferstotheneedensurethatconsentisobtainedwithoutinfluences Theneedforcomprehensionseemsobvious.Ifthegoalofinformation-sharingistoenable Undueinfluenceisseenasimpacting moresubtlyonvoluntarinessthancoerciondoes.The ). Theinformedconsentformscanthuscontributetomeaningfulcomprehension.Consent ). Forexample,aphysicianwouldcoercepatientifheorshe indicatesthatrefusingtopar- 1984 ). Physiciansandresearchershavetoengageindialogue 2005 ). Wertheimersuggeststhatcoerciononly Informed consent Health 35 Downloaded By: 10.3.98.104 At: 20:42 27 Sep 2021; For: 9780203796184, chapter3, 10.4324/9780203796184.ch3 Trudo Lemmens examination ofthefacts’(Grubb is clearlyamoreinsidiousandsubtleprocessthanovertpressure and,therefore,callsforacloser English case likelihood thatthepressuremayhavehadaneffect.AsGrubbputsit,indiscussingleading been identifiedthatrelatetothevulnerabilityofperson,relationdependency,and consent. Undueinfluenceiscommonlyusedintestamentarylaw,whereseveralconditionshave tional useofpsychologicalpressure,physicalforce,orthreat,ismoreclearlydeemedtovitiate not alwaysclearlyseparated( and courtstendtobereluctantrulethatnoconsentoccurred.Inlaw,thetwotermsarealso ruling thattherewasnoconsentareseriousforthepersonwhoperformedamedicalprocedure ence areonlyexceptionallyusedinlegalcasesaboutinformedconsent.Theconsequencesof whether informedconsentwaspresentinthepast.Theconceptsofcoercionandundueinflu- informed consentpracticesthatwillbeusedinthefuture.Courts,contrast,havetoruleon undue influenceshouldmakeresearchersandresearchethicscommitteespausetoreevaluatethe from theiruseinlegalcontexts.Inresearchethics,reflectionsonwhatconstitutescoercionor different conceptsastheyareinterrelated. ‘exploitation’ (HawkinsandEmanuel as undueinducementandcoercioninthiscontext,pointingoutthatraisesconcernsabout asked aboutthepossibilityofmeaningfulconsent.Somearecriticaluseconceptssuch ova (Radin expressed concernabouttheuseoffinancialincentivestopushpeopleselltheirorgansor in thecontextoforgantransplantsandassistedhumanreproduction,wherecommentatorshave context aconcernaboutcommodification.Commodificationconcernsarealsowidelydebated 52), particularlyinthecontextofresearchinvolvingpatients.Undueinfluencereflectsthat participation, orresearchparticipationasa‘humanitarianenterprise’(LemmensandElliott jects canbeseenasunderminingwhatisoftencharacterizedthealtruisticnatureofresearch risk underminingthecoremoralvalueattachedtoanactivity.Largepaymentsresearchsub- Reibl in courtthattheirconsentwas affectedbyfraud.TheSupremeCourtofCanadaindicated in resent information.Incontrast, afterproblemsoccur,patientsorresearchsubjectsmayclaim it seemsclear,fromanethical perspective,thatphysiciansoughtnottofraudulentlymisrep- mittees donotspeculatethat an informedconsentprotocolwillbefraudulentlyapplied, and literature onconsent,butarise frequentlyincourt.Thereasonissimple:researchethicscom- unequal powerrelation. was notvalidasaresultofthepatient’svulnerabilityandher dependencyinthecontextof oids inexchange.TheSupremeCourtheldthedoctorliable for battery,concludingtheconsent addicted patientcouldgenuinelyconsenttosexualactivitywith adoctorwhoprescribedopi- the vulnerablewhentheyareinarelationshipofunequalpower’ todeterminewhetheradrug- based ‘doctrinesofduress,undueinfluence,andunconscionability [that]havearisentoprotect supported bythreeofthesixjudges,CanadianSupreme Courtappliedthecontractlaw- 36 Services participation inresearch(Halpern would normallywanttowithdraw,orwhenitleadsdistortionsoftherisksandbenefits people tocontinuetheirparticipationinaclinicaltrialwhentheyexperiencesideeffectsand act ‘againsttheirbetterjudgment’–forexamplewhenpaymentsaresostructuredthattheypush clear answertothatquestion.Ithasbeensuggestedinfluenceisunduewhenitmakespeople Theuseofthetermscoercionandundueinfluenceinresearchethicsshouldbedistinguished Fraudandmisrepresentation,ontheotherhand,arenotoften discussedinthebioethics v. Hughes 2013 1996 Re T(Adult:RefusalofMedicalTreatment) ). Butwhenisarewardexcessiveorinappropriate?Theregulationsprovideno [1980]2SCR 880 thatonlyfraudormisrepresentation invalidatesconsent. The ; Cohen 2002 Norberg ). Inparticular,insituationsofextremepoverty,questionsare 1998 et al v. : 178).Inthecaseof . 2005 Wynrib 2004 ). Yetitseemsartificialtocompletelyseparatethese ). Rewardsmayalsobeseenas‘undue’whenthey [1992]2SCR226,p.247).Coercion,theinten- [1992]4AllER649‘“[u]ndueinfluence” Norberg v. Wynrib (1992),anopinion 2001 : Downloaded By: 10.3.98.104 At: 20:42 27 Sep 2021; For: 9780203796184, chapter3, 10.4324/9780203796184.ch3 fraud ormisrepresentation( a physician’snon-disclosureofhisownepilepsyinthecontextsurgery,isnotconsidered absent forbothprocedures.Butanallegedmisrepresentationrelatedtocollateralissues,suchas wrong spinalvertebraeandthenmisrepresentedwhyanewoperationwasneeded,consent purpose oftheprocedure(Grubb The keyconcerninEnglishcommonlawiswhetherthepatientunderstoodnatureand consequences offraudormisrepresentationdependonthelevelmisrepresentation. consent ( Yet courtscanstillrulethatnotwithstandingthesignedconsentform,therewasnoinformed complex medicalprocedures,suchasinvasivesurgeries,thatinvolvemoreelevatedlevelsofrisk. form mustbeused,particularlyintheresearchcontext.Writtenconsentformsarealsousedfor that specificinformationhasbeenshared.Regulationsoftenprescribeawrittenconsent consent providesstronger–yetnotconclusiveevidencethathasbeenobtainedand Consent doesnotalwayshavetobeformalizedandcanexpressedindifferentways.Written tent tomakeonedecision,butincompetentdecideinmorecomplexsituations. competency istreatmentspecific,sothatapersonwithborderlinecanbecompe- stand andappreciatetheconsequencesofdoingso.Competencyisconnectedtocomprehension: children andadolescentstoprovideconsentwhentheyaredeemedmatureenoughunder- dren, towhichcommonlawjurisdictionsgenerallyapplythematureminorrule,allows of competencyariseinthecontextmentalhealth,andhealthcareorresearchinvolvingchil- adults (see ing atreatmentoptionorresearchparticipation.Competencyispresumedinlawthecaseof understand therelevantinformationandtoappreciateconsequencesofacceptingorreject- be undertakenbythepatientorresearchparticipant. whether thefraudormisrepresentationvitiatesconsentimpactstypeoflegalactionthatcan found in about whattotell patients.Insomesituations, theinabilityofapatienttocomprehend anddeal concept oftherapeuticprivilege clearlynolongerallowsphysicianstomaketheirownjudgment information, andapatientmay alsoexpressadesirenottoreceivefurtherinformation,but the a failuretodiscloserelevantinformation. Physicianshaveadutyofcareinhowtheytransfer exception isstilloftenmentioned, itisdoubtfulwhenphysicianscouldstillinvoketojustify ally givenmuchdiscretionabout hidinginformationthatcoulddistressthepatient.While the has stronghistoricalroots:therapeuticprivilege.Asmentioned before,physiciansweretradition- information atthatpointmayalsobenecessaryforfollow-up interventions. ‘informed consent’butasaproperdebriefinginlinewiththe standardofcare.Theexchange care intervention.Providinginformationafterthefactshould thennotbeseenasobtaining stances itwillbeimpossibletoobtaineventhemostminimal formofconsentpriortoahealth- Specific situationsmayrequireshorterinformationalexchanges, andinexceptionalcircum- 2011: 158–9 as anemergencyexceptiontoinformedconsent,basedonnecessity, iswidelyaccepted(Peppin text. However,usingtheterm‘consent’forthosesituationsseems questionableandunnecessary, impractical orimpossibletoobtain. written consentasanorm,theywilloftenspecifyexceptionswheremaybe form shouldnotbeequatedwiththeabsenceofconsent.Rather,whenregulationsrequire Theactofconsentingcaninmanycircumstancesbeexplicitorimplicit,verbalwritten. Competencyisanotherkeyconditionforinformedconsent.Itreferstoaperson’sability Afinalnoteiswarrantedhereaboutanotherexception thatisoftenmentionedand Itissometimessuggestedthatconsentcanbe‘presumed,’for exampleinanemergencycon- Tremblay Gerula Chapter 7 onmentalhealthforadetaileddiscussionofcompetencyissues).Questions ).Obviously,informedconsentproceduresshouldbeadjusted tothecircumstances. v. v. Flores McLauchlan, (1995)126DLR(4th)506thatwhenasurgeonfirstoperatedonthe Halkyard 2001BCCA444).Inversely,theabsenceofawrittenconsent 1998 v. Mathew : 154–5).TheOntarioCourtofAppealmorerecently [2001]WWR26).Aswillbediscussedfurther, Informed consent 37 Downloaded By: 10.3.98.104 At: 20:42 27 Sep 2021; For: 9780203796184, chapter3, 10.4324/9780203796184.ch3 Trudo Lemmens 38 provide evidenceofconsent(Peppin of theirbody(Katz1997:165).Batteryalsoofferstheadvantage thatitisuptothedefendant proven astheharmresidesinviolationofdignitaryinterest peoplehaveintheintegrity of bodilyintrusionsuffi ces for aclaimofbattery.Nophysicalorpsychologicalharmhastobe protection oftheconceptself-determinationunderlying informedconsent:themerefact physical interferencewiththeirbody.AsKatzpointsout(1997), batteryoffersamorerobust to self-determinationrequiredmedicalprofessionalsobtain consentfrompatientspriortoany trespass ontheperson,seemedalogicaltoolforcourts,once itbecameacceptedthattheright intentional touchingofapersonwithouthisorherconsent. Theactioninbattery,aformof be used,dependingonthenatureofviolation:batteryor negligence.Batteryinvolvesthe what typeoflegalactionisavailabletothematcommonlaw? Twocommonlawactionscan medical procedureorabouttheresearchprojecttheywereenrolledinandfeelharmed, Whenpatients(orresearchsubjects)feelthattheyhavenotbeenproperlyinformedabouta 3.2.2.1 jurisdictions. law. Thiswillbefollowedbyabriefdiscussionoftheregulationinformedconsentinvarious concepts, questions,andteststhathaveemerged,withparticularattentiontoCanadiancommon vary amongjurisdictions.Thediscussionhereaimsatofferingapictureofsomethekeylegal proper information-sharing;andwhattheconsequencesareofviolatingtheserules.Theserules it istobeprovided(e.g.theuseofinformedconsentforms);whodetermineswhatconstitutes But legalandinstitutionalrulesaimtoclarifywhatlevelofinformationisbeprovided;how decisions, andthatsomelevelofinformation-sharingisneededtoenablethis(McLean generally startfromthepremisethatapersonhasrighttomakehisorherownhealthcare will oftenexplicitlyrefertotheidealsdiscussedearlier.Commonlawandciviljurisdictions sibility, andcertainty.Thelegalrulessurroundingtheinstitutionalpracticeofinformedconsent The legalconceptofinformedconsentisdriveninpartbypragmaticconcernsaboutclarity,fea- tutes thesocialpracticeofinformedconsent’aredifferentbutinterrelatednotions(2001:16–17). making’ and‘thelegalinstitutionalrulesrequirementsthefulfi Berg andcolleagues,theideaofconsentas‘autonomousauthorization’or‘shareddecision- meaningful consent.Thelegalnotionofinformedconsenthasitsownmeaning.ForJessicaW. norm istherealbasisforinformedconsent,orhowvariouschallengestoautonomyimpacton do notengageinadetailedphilosophicaldiscussionofwhattypeautonomyorotherethical informed consentwithreferencestoautonomyandtheimportanceofself-determination,they its variouscomponentsinlaw.Yet,eventhoughcourtsandlegislatorsoftengroundtheneedfor Differentnormativefoundationsofinformedconsentmayresultindifferentinterpretations 3.2.2 sures applybasedonsubstitutedecision-making(see Chapter 7 onmentalhealth). with informationmaybeassociatedcompetencyissues.Inthatcase,otherprotectivemea- WWR 741; consented tooneoperationand surgeonsperformedanother( cases wheretherewasnodisclosure astothenatureofprocedure,notablywherepatients with theconsentgivenfora medical procedure.Consequently,batterybecamerestricted to actions inbattery,fearingthe use oftheactioneverytimethattherewasapotentialproblem Katz locatesthis developmentinthejudicial and societaldeferencetothe medical profession. Legal claimsbasedontheinformedconsentdoctrine Informed consent:negligenceorbattery Marshall v. Curry (1993)3DLR260; 2011 : 162).Nonetheless,courtsbecamehesitanttoallow Murray v. McMurchy Mulloy llment ofwhichconsti- v. [1949]2DLR442). Hop Sang [1935]1 2010 ). Downloaded By: 10.3.98.104 At: 20:42 27 Sep 2021; For: 9780203796184, chapter3, 10.4324/9780203796184.ch3 correct anearliermistake; case of to qualifyasbattery(2010:71). and somefailurestoobtaininformedconsent,suchasthefailurediscussalternatives,arehard healthcare practicesdonotinvolvephysicaltouching,suchastheprescriptionofmedication; For McLean,otherfactorsfavoredtheintroductionofaremedybasedonnegligence:some is stilllargelymeasuredaccordingtotheso-calledprofessional standard(McLean decisions, howthatinformationistobeprovidedandmuch informationshouldbeshared recognized theimportanceofprovidinginformationtoenable patientstomakeself-regarding to fullyembracethedoctrineofinformedconsent.Even though Englishcourtshavelong As pointedoutbefore,Englishcommonlawhasbeenmorereluctantthanotherjurisdictions Courtshavedevelopeddifferentstandardstodeterminewhatconstitutessuffi 3.2.2.3 and theharmsuffered. be determined;thenatureofharmsuffered;andcausalitybetweenfailuretoinform the contentofinformationaldutycare,andparticularlyhowstandardcarewill breach andtheharm.Incontextofinformationalnegligence,therearethreekeyissues: must establishadutyofcare,breachthatduty,harmsuffered,andcausationbetweenthe gence, aplaintiffmustovercomeseveralhurdlesassociatedwithtraditionaltortclaims.Patients common claimincasesoffailuretoprovideadequateinformedconsent.Toestablishnegli- relevant informationbeforemakinghealthcaredecisions.Negligencehasbecomethemore cases offailuretoconsent,negligenceprotectsmorewidelytherightpatientshaveall Whilebatteryprotectstherightofpatientstobefreefromphysicalintrusioninextreme 3.2.2.2 The 1985 vaccinating thechildbelievedparentshadconsented. BCSC 15,involvingthevaccinationofaminorwithoutparentalconsent,eventhoughnurse patient’s colonafterbeingaskedtostop;and Nightingale of apriorexpressedwishnottoreceivesuchtransfusion; provided anemergencybloodtransfusiontoaJehovah’sWitnesseventhoughhewasaware disclosure isseenas‘primarily…amatterofclinicaljudgment’ ( Committee the traditionaltestfornegligenceinmedicalpracticefrom facie righttobe informed’( be abandoned:‘[i]nmodernlaw medicalpaternalismnolongerrulesandapatienthasprima Lord Steynstatedevenmore explicitly thatthetraditionalphysician-centeredapproach is to has beenmoreandwidely recognized’inthetimethatelapsedsince a questionofcausation(seebelow), LordWalkerofGestingthorpeemphasizedthat‘autonomy professional judgment(2010:79–81). In cases, whilenotrejectingoutrightthe done (i.e.disclosed)inthosecircumstances.SheilaMcLean notes, however,thatmorerecent Governors etal OtherCanadiancaseshavebroadenedthescopeofbattery:earliermentionedOntario Gerula [1957]1WLR583alsoappliedincasesaboutinformation-sharing. Thedutyof Content oftheinformationalduties Negligence: standardofdisclosure Sidaway v. v. Kaplovitch .), tobedeterminedonthebasisofwhatareasonablephysician wouldhave Flores caseand whereasurgeonperformedsecondoperationunderfalsepretextto

[1989]OJNo585,wherethedoctorcontinuedanexaminationofa Chester Gold Malette v. v. v. Haringey HealthAuthority Afshar Schulman etal. Bolam Chester 2004,p.16).Without explicitlyabandoning Toews test,moveprudentlyawayfrommererelianceon v. v. Afshar Weisner andSouthFraserHealthRegion (1990)72OR(2d)417,whereadoctor [2004]UKHL41,whichdealt with [1988]QB481bothconﬁ Norberg Bolam Sidaway v. v. Friern HospitalManagement Wynrib v. Bethlem RoyalHospital Sidaway cient information. , discussedabove; Informed consent 2010 (1985:92). rmed that Sidaway , : 73–6). , 2001 39 Downloaded By: 10.3.98.104 At: 20:42 27 Sep 2021; For: 9780203796184, chapter3, 10.4324/9780203796184.ch3 Trudo Lemmens 40 decision’ ( elements that‘thedoctorknowsorshouldknowtheparticularpatientdeemsrelevanttoa risk andanyspecialorunusualrisks’( should notonlyinformpatientsaboutthenatureofprocedure,butalso‘anymaterial same positionwouldwanttoknowinordermakeaproperlyinformeddecision.Physicians emphasized thatthedutyofdisclosurehastobeassessedfromwhatareasonablepatientin cases, the perspectiveofpatient’sinformationalneeds.InCanada,aduo1980SupremeCourt sion shouldbedisclosed,thusrecognizingthatinformation-sharingapproachedfrom US with theconceptofself-determinationunderlyinginformedconsent.Asmentionedearlier, causation test. the EnglishLordspromotedpatientautonomythrougharemarkableinterpretationof that hewasunderstood,consideringthepatient’sdifficultywithEnglishlanguage( ability insurance.Alsonoteworthyisthecourt’semphasisthatsurgeonshouldhavemadesure tive surgeryuntilhislifetimeretirementpensionstartedandhewouldhavebeencoveredbydis- had testifiedthatheknownaboutaparticularriskfactor,wouldhavepostponedtheelec- what particularrisksmeantothepersonbecauseofhisorhercircumstances.MrReibl ognized thatinformation-sharingisnotjustabouttransferringmedicalevidence,butalso or surgeontohispatient’( of researchers‘isatleastasgreatas,ifnotgreaterthan,theduty owedbytheordinaryphysician the contextofresearchisrare,buttwoCanadianprecedentssuggest thatthedisclosureobligation mation, particularlywhentheyparticipateashealthyvolunteers inaresearchproject.Caselaw 2011 detailed riskassessmentappearsmoreimportantthaninmedically necessaryprocedures(Peppin more detailedriskinformationwhenmedicalproceduresare elective, asinplasticsurgery,since reasonable patientstandard.Therearesomeprecedentsindicating thatpatientsreasonablyprefer circumstances ofeachcase,someillustrationsareusefultoshowthepossibleconsequences to thepatient-centeredtest.Eventhoughcourtswillmakedecisionsonbasisofparticular professional standards. Hart order tomakehealthcare-relateddecisions( but alsoinformationthatadoctorkneworshouldhaveknownspecificpatientsneededin not onlythetypeofmaterialinformationpatientsgenerallyneedtomakeinformeddecisions, moved awayfromtheEnglishdoctrineandtowardssamerecognitionofadutytodisclose interaction andnotjusttheunilateraltransferofinformation.Australiandecisionshavealso Hughes But thismoredetailed riskassessmentwould nowalsofitunderthe‘reasonable patientinthe subjects wouldgenerallywant toengageinafullerriskassessmentthosecircumstances. context toindicatehowtheresearch standardwas‘different.’Itseemsindeedlogicalthatresearch on healthysubjects(2011:471–2). Hesuggeststhatitwasmoreimportantforthecourtin that standard, whichseemsindeed even lessappropriateinthecontextofnon-therapeuticresearch sure testin1980,andcanthus besituatedasareactionagainsttheexistingprofessionalpractice out, however,that Weiss 443–4). Canadian,Australian,andUScourtshavesincelongadoptedatestthatappearsmoreinline Numerousdecisionsexplorewhattypeofinformationshouldhavebeenprovidedpursuant Canterbury (1998)156ALR517).Theinformation-sharingitselfshouldbedoneaccordingtoproper : 168).Inthesamevein,researchsubjectscanbeexpectedtoprefer moredetailedriskinfor- v. Hopp , p.927).TheSupremeCourtthusemphasizedthatinformedconsentrequiresattentive

The 1965 Solomon Reibl v. Lepp caseemphasizedin1972thatallinformationismaterialtoapatient’sdeci- v. [1989]AQno.312,decidedunderQuebeccivillaw.Michael Hadskispoints Hughes Halushka [1980]2SCR192and Halushka , p.894).The Halushka casefromSaskatchewanwascitedwithapprovalinthe1989 caseof wasdecidedpriortotheaffirmationofpatient-centered disclo- v. Hopp Reibl University ofSaskatchewan v. Reibl Rogers caseisparticularlyinterestingbecausethecourtrec- Lepp v. v. , p.210).Inaddition,thedutyalsoextendsto Hughes Whitacker , rejectedtheprofessionalstandardand (1992)175CLR479; (1965)53DLR(2d)436,pp. Chappel Reibl v. v. Downloaded By: 10.3.98.104 At: 20:42 27 Sep 2021; For: 9780203796184, chapter3, 10.4324/9780203796184.ch3 parative benefits,shouldbeexplained( expect toreceiveasinformation. other hand,couldmakeitpossibletolookatwhatpeopleinsimilarcircumstanceswouldusually of disclosurewouldbehardifnotimpossibletorespect.Areasonablepersonstandard,onthe of research,particularlyinthecontextbiobankwherehighestpossiblestandard simply anapplicationofthereasonablepersonstandard,isimportantincontextnewforms of whetherthereisahigherstandarddisclosureinthecontextresearch,orthis same circumstances’standard,makingthissimplyanapplicationofthetest.Thequestion tangled incourt. of interactionsbymanydifferent peopleandcomplexchainsofcausationthathavetobedisen- a resultoftheprocedure/healthcare product.Theprovisionofhealthcareinvolvesamultitude care becauseitisoftenunclear whethertheharmwasaresultofconditionbeingtreated or healthcare product(theinjury-causation element),tendstobedifficultinthecontextofhealth- procedure atall. and theprocedureclearlyresultedinharmthatcouldhave beenavoidedbynothavingthe when theprocedureiselective(e.g.plasticsurgery),aserious riskfactorwasnotdisclosed, sion andtheharmwouldthusnothaveoccurred.Thismay seemrelativelystraightforward show that,hadproperinformationbeengiven,heorshewould havemadeadifferentdeci- and ‘decisioncausation’(Tenenbaum informed (Peppin consented toharmedthem,andthattheharmwouldhavebeen avoidedhadtheybeenproperly based claims.Innegligence,patientsstillhavetoshowthat theproceduretheyinadequately incomplete orinadequateinformation,withlessseriousimplications forphysiciansthanbattery- tion oftheperson’sphysicalintegrity. obtained. Inthelattercases,noquestionsofcausationariseasharmisintentionalviola- negligence thanwhencourtsﬁ nd batteryincaseswhereconsentwasabsentorfraudulently requirement toproveharmandcausationmakeitmuchharderobtaincompensationfor consent isthecausallinkbetweenbreachofinformationaldutyandharm.The Anotherimportanthurdletosurmountincommonlawliabilityfornegligenceinformed 3.2.2.4 OAC 336; interest. the patient’sinterest,forexamplebecauseapatientaskedquestionsthathintedathisorher for thepractice,andwhetherphysicianscouldbereasonablyexpectedtohaveknownabout risks andpotentialbenefits? in thecontextofmedicine.Shouldphysiciansdisclosethese‘alternatives’anddiscusstheir alternative practices,suchasacupunctureornaturopathy,havegainedsomelevelofacceptance medicine (see Chapter 23 ontraditional,complementary,andalternativemedicine).Other run countertothestandardsofmedicalprofessionandarefirmlyrejectedbymainstream mentary oralternativemedicine,whichincludesawidegamutofpractices,some ‘mainstream’ medicine.Agrowingnumberofpatientsareinterestedinso-calledcomple- to determiningthedutyofphysiciansprovideinformationaboutalternativesoutside alternative options’?Indirectly,professionalstandardcomponentsemergeagainwhenitcomes Courtshaveemphasizedthatallreasonablealternatives,withtheirspecificrisksandcom- Provingonabalanceofprobabilities thatharmwascausedbyaparticularprocedureor Asdiscussed,thedoctrineofnegligenceprovidedpatientsa remedywhenphysiciansgive

Nature oftheharmandcausality Van Mol(Guardianadlitemof) 2011 ). Thismeansthattwoelementshavetobeproven:‘injury causation’ Itmaydependonthelevelofprofessionalandsocietalsupport Van Dyke 2012 v. ). Ininformationnegligencecases,apatienthasto Ashmore v. Grey BruceRegionalHealthCentre , 1999BCCA6).Butwhatare‘reasonable Informed consent [2005]197 41 Downloaded By: 10.3.98.104 At: 20:42 27 Sep 2021; For: 9780203796184, chapter3, 10.4324/9780203796184.ch3 Trudo Lemmens 42 cally in in thecontextofrelationbetweenmanufacturerhealthcareproductsandpatients,specifi- this approachinordinarymedicalmalpracticecases,hasexplicitlyendorsedsubjectivetest WallsendDistrictHospital to determinedecision-causation( properly informed?Differenttestshavebeenusedbycourts. establish –orbetter,hypotheticallyreconstructwhatpatientswouldhavedonehadtheybeen inclined toseethemselvesasriskaverseoncetheyhavesufferedharm.Howdothecourts of riskinevitablychangesinlightpersonalexperiences,andpeopleareobviouslymuchmore ment hasinherentlysubjectivecomponents(WaringandLemmens informed, particularlywhenwearedealingwithcomplexrisk/benefitanalyses.Riskassess- acknowledged in (Mason andLaurie complete, andup-to-dateinformation. this rulewouldonlyhaveappliedifthecompanyhadfullyinformedphysicianwithclear, detailed informationtopatientswithrespectprescriptiondrugs.TheCourtemphasizedthat chain ofcausation.The‘learnedintermediaryrule’referstotherolephysiciansinproviding the manufacturerhadinvokedlearnedintermediaryrule,whichcouldhaveinterrupted respect totheresourcesandavailableinformation.Oneofconfoundingfactorswasthat TheCourtemphasizedthepowerimbalancebetweenmanufacturers,patients,anddoctorswith explained that: failure toinformpatientsofrisksrupturebreastimplants.TheSupremeCourtCanada respect forpatientautonomy (Tenenbaum standard hasbeencriticizedfor conflictingwiththeunderlyingfoundationofinformedconsent: whether thehypotheticalreasonablepatientwouldnothave consented. Theuseofanobjective an objectivestandard,thequestionisnotwhatparticular patientwouldhavedone,but standard ofcausation(Tenenbaum to facilitatejudicialdecision-makingandlimittheliabilityof physicians. negligence cases.Therejectionofthesubjectivetestinthose casesisasmuchapolicydecision of hindsightissignificant.Itunclearwhythiswouldnotbe possibleinstandardinformation cross-examination andtheusualfactualdeterminationat triallevelcanaddressproblems a properweighingbythetrialjudgeofrelevanttestimony’ (para.46).Thisstatementthat that this‘canbeadequatelyaddressedatthetriallevelthrough cross-examinationandthrough concurrent negligent practice)sinceitiseasyto claimthatthereasonableperson inneedofcare difficult toobtaindamageson thebasisofinformedconsentclaimsalone(i.e.ifthereis no are anessentialcomponentofindividual decision-making.Theobjectivestandardmakesit very standard, thereisnoinquiryinto thevalues,preferences,orpersonalsensitivitiesofpatients that SomeNewZealandandAustraliancourtshaveemployedaso-calledsubjectivestandard Itisalsodifficulttoreconstructwhatpatientswouldhavedonehadtheybeenproperly Thissubjectivestandardhasfrequentlybeendescribedas‘opentotheabuseofhindsight’ NearlyallUSstatestatutesgoverningmalpracticeandmost caselawembraceanobjective dangerous sideeffectstotheseproducts. policy perspectivetoholdthemanufacturerastrictstandardofwarningconsumers be overemphasizedandtheriskunderemphasized.Itis,therefore,highlydesirablefroma Inthecaseofamanufacturer…thereisgreaterlikelihoodthatvalueproductwill Hollis v. Dow CorningCorporation Hollis 2006 , butJusticeLaforestsimplystated(foramajorityoffivejudges) that [1990]2MedLR103).TheCanadianSupremeCourt,whilerejecting : 408;Grubb Smith 2012 1998 v. [1995]4SCR634). : 709–20),arguablyforthesamepolicyreason.Under Auckland HospitalBoard : 176),evenbyCanadiancourts.Thisconcernwas 2012 : 718–19).Indeed,according to anobjective ( Hollis v. Dow CorningCorporation, para.46) Hollis addressedthemanufacturer’s [1964]NZLR191; 2004 ). People’sperception Ellis v. Downloaded By: 10.3.98.104 At: 20:42 27 Sep 2021; For: 9780203796184, chapter3, 10.4324/9780203796184.ch3 standard informationnegligencecasesbecauseitwould‘putapremiumonhindsight’( rejection oftheprofessionaldisclosurestandard. causality standardfacilitatesthetypeofmedicalpaternalismthatwasdiminishedthrough would haveconsentedtoaprocedureofferedbyhealthcareprovider.Inway,theobjective describes asasubjectivetest,followedbyanobjectiveappraisal(1998:175). been usedinafewEnglishcases( have decidedtowaitforthesurgery.Thisappearssomewhatsimilara‘hybridtest’thathas earlier, thecourttookintoconsiderationthathewasclosetoretirementandcouldreasonably ‘reasonableness’ oftheparticularpositionpatient.IncaseMrReibl,aspointedout accepted thetreatment.The‘objective’componentoftestliesinrequirement patient, appropriatelyinformedoftherisksandinthoseparticularcircumstances,wouldhave of-the-road test,ormodifiedobjectivetest.Underthisthecourtaskswhetherparticular para. 15).Yetitrecognizedtheproblemsofa‘reasonableperson’standard.Itintroducedmiddle- from patientsinfluencedbyunreasonablefearsandbeliefs’( Hughes emphasizing the fied objectivetestbut,accordingtoPeppin,‘madethesomewhatmoresubjectivebothin more substantially theriskprofileofoperation. have optedtotheoperation performedbyamoreskilledsurgeon,thuschangingperhaps which sharedsomefeatureswith thiscase,butwheretherationalewasthatpatientwould same adverseeventwouldhave happened.TheyreferredtotheAustraliancaseof reflected inhowtheyfeelaboutabortion(Peppin reotypical presumptionsofhowpeople’sbeliefintraditional medicalproceduresmustalsobe the majorityofcourtwithrespecttosuchanintimatearea ofpersonallife,basedonste- Commentators haverightlycriticizedthesecond-guessingthatisreflectedinreasoningof as MsArndt,withhertypeofbeliefsandexpectations,wouldnothaveoptedforanabortion. the lowercourt,majorityconcludedthatreasonablepersoninsamecircumstances time inCanadaalsostillsubjecttoprocedurallimitations).Basedonthefactorsmentioned concluded fromthesefactorsthatshewouldnothaveoptedforanabortion(whichwasat mainstream medicine,herinterestinhavingamidwife,andrejectionofanultrasound, disabled child.ThetrialjudgemadereferencetoMsArndt’sparticularscepticismtowards the reasonablyremoteriskofseriousimplicationsforfoetus.Shegavebirthtoaseriously chicken poxduringpregnancy,wasnotadequatelyinformedbyherfamilyphysicianabout the causalityquestion.In argued thatthesubjectivetestshouldhavebeenused.Thecaseisaninterestingillustrationof interior andparticularizedone’(2011:182).Aminorityofjustices(threeoutnine)even the timeandplacethatshedid to findthathadshebeenwarned oftherisk,shewouldnothavedecidedtotakesurgery ‘ the particularsurgeon.ThreeofLordsconcludedthatto establish causation,itwassufficient Interestingly, therewasnofindingthatMsAfsharwouldnot haveundergonethesurgerywith decided bytheHouseofLordswasonecausationbetween thefailuretowarnandharm. had failedinhisdutytowarnMsAfsharofthissmall,12 percentrisk.Thequestiontobe gery andsufferedfromarareseriousadverseevent.Thetrial judge foundthattheneurosurgeon this case,theHouseofLordshadtodecideoncaseawoman whounderwentlumbarsur- causation intheearliermentionedcaseof Asmentioned,theCanadianSupremeCourtalsoexplicitlyrejectedsubjectivetestin Inthe1997caseof Afinalnoteinthecausationcontext:Englishlawhastaken amostpeculiarapproachto , p.898),andcouldthreatenthemedicalsystemthroughanonslaughtof‘liabilityclaims Reibl elementsofsubjectivityandinmakingthe“inshoesof”testamore Arndt Arndt ’ ( v. Chester , thecourtdealtwithclaimthatMsArndt,whodeveloped Smith Chatterton v. , asplitCanadianSupremeCourtconfirmedthemodi- Afshar Chester v. , p.8),andthatitwasthusvery unlikelythatthe Gerson v. 2011 Afshar [1981]1AllER257)andwhichGrubb : 179–84;NelsonandCaulfield (MasonandLaurie Arndt v. Smith [1997]2SCR539, 2006 Informed consent Chappel : 409–11).In v. Reibl 1999 ). Hart , v. 43 at Downloaded By: 10.3.98.104 At: 20:42 27 Sep 2021; For: 9780203796184, chapter3, 10.4324/9780203796184.ch3 Trudo Lemmens 44 principles’ (p.10). way, through,asitisstatedin recently resistedthedoctrineofinformedconsent,butisnowcatchingupinitsownparticular have alongerhistoryofrecognizingtheinformedconsentdoctrine.Englandhasuntilvery excessive litigation,withtheimportantvalueunderlyinginformedconsent.Somejurisdictions the importanceofavoidingsignificantcoststohealthcaresystemthatcouldresultfrom judicial decision-makingaswellpolicyconsiderationsabouttheneedforcompensation,and common lawjurisdictionshavestruggledintryingtoreconcilethepracticalrequirementsof example, havecodifi ous statutoryprovisions,regulations,andguidelines.Asmentionedearlier,mostUSstates,for Therighttomakeone’sown,well-informedhealthcaredecisionisfurtherrefl ected invari- 3.2.2.5 risks, thepotential benefits,therighttowithdraw fromthestudy,andmeasures inplaceto nature oftheresearch,identity oftheresearchers,proceduresinvolved,foreseeable ing ofconsentformsandprovide adetailedlistofelementsthathavetobedisclosed,suchas the (Hadskis Research InvolvingHumans have issuedanotherresearchethics document,the issued bythedrugregulatoryagency,HealthCanada.The Canadian federalfundingagencies DeclarationofHelsinki the onehand,andforotherformsofpubliclyfundedresearch ontheother.InCanada,both there areoverlappingyetdistinctresearchguidelinesforclinical trialsaimedatdrugapprovalon codifi regulates informedconsentinaspecifi c patientrightscode,partofanewtrendtowardsthe common lawandciviljurisdictions.NewZealandisanexampleofajurisdictionwhich national guidelinesorregulations(Sprumont ity topatients(KouriandPhilips-Nootens CivilCodeofQuebec Canadian provincesalsohavehealthcareconsentlegislation.Since1994,severalprovisionsinthe the requirementsofinformedconsentandrulesaboutcausation(Tenenbaum Yet the Helsinki the historical for research.Thelegalstatusoftheguidelinesenactedbythese agenciesvaries.Some,suchas have historicallyplayedanimportantroleinpromotingbetter informedconsentprocedures could thusbeavailableinsomejurisdictions. rights, suchastherighttoliberty.Otherprivacylawremediesbasedonconstitutionalrights the conceptofprivacyisofteninterpretedasacomponentotherconstitutionallyprotected 2009 information, oftenwithspecificrulesabouthealthinformationresearch(LemmensandAustin information, whichcontainrulesaboutinformedconsentwithrespecttotheuseofpersonal to obtaintheir‘informedconsent’(basicprovisionright7(1)). Rights Onecanconcludefromthisdiscussionofthelegalcomponentsnegligencethatmost Asmentionedearlier,drugregulatoryagencies,medicalorganizations, andfundingagencies Inaddition,manyjurisdictionsalsohaveprivacystatutes,somefocusingspecificallyonhealth ). Itisworthnotinghere,evenifadetaileddiscussionexceedsthescopeofthischapter,that cation ofsuchrights.TheNewZealand 1996explicitlyrequireshealthcareproviderstogivean‘informedchoice’patientsand , arehighlyinfluential,butenactedbyorganizationswith nodirectlegalauthority. Declaration ofHelsinki 2011 Statutory, regulatoryandguideline-basedgovernance Nuremberg Code ). BoththeICHGCPand TCPSrequire–withsomeexceptionsthesign- ed thecommonlawrulesinspecifi 1991sectiononpersonalityrightsgrantspecifi andtheICHGCParementionedinguidancedocumentsfor clinicaltrials (TCPS),whichhastoberespected inallfederallyfundedinstitutions hasbeenintegratedinmanycountriesasareferencedocument in Chester , arepartofinternationallaw.Others,suchasthe , ‘anarrowandmodestdeparturefromtraditionalcausation 2011 et al Code ofHealthandDisabilityServicesConsumers’ ). Thesamedevelopmentisnoticeableinother . Tri-Council PolicyStatement:Ethical Conductfor 2007 ). Inmanycountries,includingCanada, c healthcareconsentstatutes,clarifying c decision-makingauthor- 2012 Declaration of ). Many Downloaded By: 10.3.98.104 At: 20:42 27 Sep 2021; For: 9780203796184, chapter3, 10.4324/9780203796184.ch3 discussion ofalltheseothersoftlaw-basedmechanismsexceedsthescopethischapter. clinical trialsgovernancesystems,andthatemphasizetheimportanceofinformedconsent.A as wellprofessionalethicscodesthatarenotdirectlymentionedinthenationalresearchor informed consent(CampbellandGlass 2001 ). care inthecontextofresearchwhereparticipantstakeresearcherstocourtforfailureobtain also possiblyusetheICHGCPandTCPSassourcestoestablishacommonlawstandardof or suspensionofresearchfundingtotheinvestigatorsinstitutionsinvolved.Courtscould with drugapproval.FundingagenciescanindirectlyenforcetheTCPSthroughwithdrawal practices bythedrugregulatoryagenciesandleadtoaninvestigationsanctionsassociated directly enforceable.ViolationsoftheICHGCPcanbeseenasaviolationgoodclinical impose additionalrequirementsforspecificstudies. tees prospectivelyreviewtheappropriatenessofinformedconsentproceduresandcanthus conflicts ofinterestissues(2011:473).Itisimportanttopointoutthatresearchethicscommit- not theICHGCPguidelines,alsoexplicitlyrequiresdisclosureofcommercializationplansand protect theconfidentialityofinformationprovided.HadskisemphasizesthatTCPS,but 2009 consent requirementsaredifficultifnotimpossibletorespect inthecontextofbiobanks(Kaye authors, includingsomeinthisbook,havepointedoutthattraditional legalandethicalinformed the researcher)arenotknownattimesamplesanddata arecollectedandstored.Many ments ofthedutytoinform(e.g.natureresearch,risks andpotentialbenefits,identityof of biobankresearch,manythespecificitemsthathavetraditionally beenseenasessentialele- associated information,includingclinical,familial,environmental, andsocialdata.Inthecontext projects, whichinvolvethelong-termstorageofbiologicalsamples,andconstantlyaccumulate research. Biobanksareresearchinfrastructures(Kaye its appropriatenessinparticularareasofmedicine,particularlythecontextresearch. subject, thereisnowalsoagrowingchorusofcommentatorsquestioningitsfeasibilityoreven consent andtorefi ne practicestoachievetheidealoffullyinformedpatientandresearch Even ifthereisstillmuchdiscussionabouthowtobestmeettherequirementsofinformed and tofi nally becomingestablishedasacrucialcomponentofmedicalpracticeandresearch. always respected–inthecontextofresearchthroughethicsguidelinesandregulations, law onasomewhatreluctantmedicalprofession,tograduallybeingimplemented–albeitnot Asdiscussedinthischapter,informedconsenthasevolvedfromaconceptimposedbyearlycase 3.3Emerging issues National BioethicsAdvisoryCommission poses, orevenallow generalusewithorwithout anonymizationofsamples. The‘authorization some formsoffutureresearch, determinewhethertheywanttoberecontactedforspecific pur- scale biobankinginmind’(KnoppersandCaulfield Caulfield statethat‘theexistinglawandethicspolicieswere notdevelopedwith…thelarge- which allowsthemtosetparameters surroundingtheuseoftheirsamples(Deschênes authorization. have overlappingelements,includetheuseofanoptionmodel, broad(orblanket)consent,and different informedconsentmodelsforbiobankingresearch. Thesemodels,severalofwhich Courtscouldtheoreticallyalsorefertoagamutofinternationaldeclarationsandstatements, Duetotheirstatusas‘soft’lawinCanada,theICHGCPguidelinesandTCPSarenot Oneareawheretraditionalapproachestoinformedconsentarequestionedisbiobank-based Underthemodelofbroadconsent, biobankparticipantsaregivenasetofcorechoices, ; Deschênes et al . 2001 ; CaulfieldandKnoppers 1999 ; McGuireandGibbs 2009 2010 2010 ) ratherthanone-dimensionalresearch : 4).Manyhavethereforearguedfor ; Allen 2006 et al . ). Theycanthusrefuse 2013 Informed consent ). Knoppersand et al . 2001 ; 45 Downloaded By: 10.3.98.104 At: 20:42 27 Sep 2021; For: 9780203796184, chapter3, 10.4324/9780203796184.ch3 Trudo Lemmens Organization could playaroleindeveloping a propergovernanceframework forinternational able publicinterest-orientedgovernance. InternationalorganizationssuchastheWorldHealth noting inthiscontext,butfurther internationalinitiativesappearneededtoensureaccount- private initiatives,suchasthe Public PopulationProjectinGenomicsandSociety,areworth particularly challengingforresearch thatincreasinglytraversesjurisdictionalboundaries.Some improvement oftheoftenvery weakgovernancestructuressurroundingresearch.Thiswill be cedures willhelpustoadequatelydealwiththis,wesuggest thatthefocusshouldbeon University Greenbergetal. and compensationrequests( of personalbiologicalsamples,hasreceivedmuchattention, and hasalsoresultedinlegalclaims sonal biologicalsamplesandassociatedresearch. peoples, andconcernsaboutthecommercializationofproducts developedonthebasisofper- issues includethefamilialnatureofinformation,impact oncommunitiesandaboriginal that cannotbeappropriatelyaddressedbyindividualconsent(Lemmens andAustin informed consentobfuscatesthefactthatbiobankresearchraises difficultlegalandethicalissues licly accountablegovernancesystem.LisaAustinandIhavearguedelsewherethatfocusingon and biologicalsampletoaspecific‘governancesystem,’whichshouldbesurroundedbypub- of biobanks.Theconsentshouldalsoincludeagreementtosubmitone’spersonalinformation overall areaofresearch,andsomethetypicalissuesconcernsthatcanariseincontext to theconsentstorage,informationcanbeprovidedaboutnatureofbiobank, those forthesubsequentuseofsamplespecificresearch-relatedprocedures.Withrespect consent tostorageofasample(whichonecouldstillappropriatelycall‘consentstorage’)and clarity tohavemoredetailedprovisionsthatareadjustedbiobankresearch. interest. Althoughspeciallegislationmaythereforenotalwaysbeneeded,itcouldindeedprovide whether appropriateprivacyprotectionisinplace,andtheresearchservesapublic work ondynamicconsentsuggeststhattherearewaystopromoteongoingpatientinvolvement), subjects. Theyhavetoevaluatewhetherobtainingconsentisdifficultorimpossible(andKaye’s mining ifappropriateprivacymechanismsandothermeasuresareinplacetoprotectresearch 1996). Researchethicscommitteesaregiventhetaskofevaluatingtheseconditionsanddeter- cumstances (Alberta allows healthinformationtobeusedforresearchpurposeswithoutconsentunderspecificcir- provisions. ManyCanadianprivacystatutes,forexample,containabroadresearchexceptionthat involving storedsamplesandinformationistosomelevelalreadyaddressedthroughlegislative dictions, includingCanada,thedifficultyofobtaininginformedconsentinthistyperesearch (Caulfield consent requirementsandrecommendedthatalegislativeframeworkbeintroducedforbiobanks Some authorshavegoneasfartosuggestthatbiobankresearchmayviolatetraditionallegal the useoftheirdataandsamplesforresearchonacontinuingbasis(Kaye interactive processbetweenpatientsandresearchers.Participantscanexpresspreferencesabout In thismodel,informationtechnologyisusedtotransformconsentintoabidirectional,ongoing, and moredetailedinvolvementofresearchsubjectspatientsinsubsequentpractices. cated foramodelof‘dynamicconsent,’whichinvolvesthecreationcommunicationstructures 46 research participation(Caulfield model’ recognizesthatconsenttotheuseofasampleisnotexactlysameasfor Thecommercializationissue,raisingconcernsaboutexploitation andquestionsofownership Itseemsappropriatetodistinguishinthecontextofbiobanksproceduresfororiginal Areallofthesemodelsinlinewiththelegalandethicalinformedconsentrequirements? v. 2007 Catalona v. ) orthatconsentrequirementsbeoverhauled(Allen Miami Children’sHospitalResearchInstitute Health InformationAct [2007]490F.3d667).Ratherthanpretendingthatinformed consentpro- Moore et al v. . Regents oftheUniversityCalifornia 2003 2000;Ontario ). Morerecently,Kayeandcolleagueshavealsoadvo- Personal HealthInformationProtectionAct [2003]2642d1064; et al . 2013 [1990]51Cal.3d120; et al . 2011 ). ). Yetinmanyjuris- 2009 Washington ). These Downloaded By: 10.3.98.104 At: 20:42 27 Sep 2021; For: 9780203796184, chapter3, 10.4324/9780203796184.ch3 similarly strongsupportletterforOHRPbyotherresearchethicsexperts(Macklin the studyandaccusingOHRPofoverreach(Wilfond of leadingbioethicsandresearchethicsscholarsalsopromptlypublishedaletterinsupport cess andothersmaynotrequirepatientconsentatall’(Faden argue, ‘somerandomizedCERstudiesmayjustifiablyproceed withastreamlinedconsentpro- a maturelearninghealthcaresystemwithethicallyrobustoversight policiesandpractices,’they Faden, Beauchamp,andKasstorethinkourapproachinformed consentforsuchstudies:‘in been fulfilled.Yet thisiscertainlyoverstatedin manyjurisdictions(Lemmens andAustin more flexibleconsentprocedures (i.e.theexistenceofrobustoversightpoliciesandpractices) has administrative burdenimposed byresearchethicsreview(Kim research getsthefocusedattention itdeserves’rejoinsincreasingcriticismontheunnecessary that facilitatingconsentprocedures forminimalriskresearchcouldhelpensurethat‘higher-risk etal flexible informedconsentproceduresforSUPPORT-likecomparative researchstudies(Faden level ofoxygenprovided. which involvedtheuseofmanipulatedoximeterssothatclinicians wouldnotknowtheexact that notallconsentformsexplainedwelltheproceduresinvolved increatingthedoubleblind, to thecritics,adifferenttypeofrisk,whichhadbeexplained toparents.Itwasalsoargued inclusion inasmall,clearlydelineatedgroupofeitherloworhighoxygendidcreate,according the contextofthisresearchstudy.Evenifalloxygenlevelswereusedinstandardcare, ent typesofriskassociatedwithbeingincludedinaclearlydefinedhighorlowoxygengroup 2013 The OHRP,theseresearchethicscommentators,andpatientadvocateSydneyWolfe(Wolfe comparing differentstandardsofcare(Hudson that anelevatedstandardofinformedconsentwasinappropriateandunnecessaryforstudies vided institutionalsupportforthestudy,accusedOfficeofoverzealousness.Theyinsisted Human Services 2013 the researchstudyforviolationsofinformedconsentprocedures(DepartmentHealthand ment ofresearchregulationstheDepartmentHealthandHumanServices,criticized official USagencymandatedwiththeprotectionofhumanresearchsubjectsandenforce- with exposuretohighoxygenlevels.TheOfficeofHumanResearchProtections(OHRP),an reduce theriskofbraindamage,whilestillavoidingblindnessthathasbeenassociated for decadeswithhowmuchadditionaloxygencouldbeprovidedtoprematurenewborns scientific rationaleandtheimportanceofstudysinceneonatologistshavebeenstruggling paring twodifferentlevelsthatwereroutinelyusedinstandardcare.Noonequestionedthe mal oxygensaturationlevelsforprematurenewborns(SUPPORTStudyGroup international, multi-centre,randomizedcontrolledtrial,whichaimedatdeterminingtheopti- the controversysurroundingSUPPORTstudy,alargeNationalInstitutesofHealthfunded subjected onlytorisksassociatedwiththestandardtherapies.Thisissuerecentlycameupin research thataimsatevaluatingdifferentstandardsofcarewhere,arguably,subjectsare provide remediestoindividualsresidinginstatesthatratifiedit. eral detailedprovisionsontheprotectionofhumanrightsincontextbiomedicine,which The research (Gostin Fadenandcolleaguesseemto take forgranted,though,thatoneoftheirkeyconditions Interestingly,aroundthesametime,severalarticlescameoutin theliteraturearguingformore Commentatorsinthemedicalcommunity,someofwhomweredirectlyinvolvedorpro- Anotherrelatedareawheretherehasbeenmuchdiscussionlatelyisinthecontextof . European ConventiononHumanRightsandBiomedicine ) particularlycriticizedthefailuretogivedetailedinformationparentsaboutdiffer- 2013 ; Faden et al et al . . ). 2013 2014 ). Thereareprecedentsofinternationallegalinitiativesinthisarea. ). Particularlynoteworthyaretherepeatedcallsbyconsentexperts et al . 2013 1997,forexample,hasintegratedsev- ; Modi et al et al . et al . 2009 ). 2013 . 2013 2014 ), whichevokedinturna ). Interestingly,agroup : 766).Theirsuggestion Informed consent 2010 et al ) bycom- . 2009 ). 2013 ). 47 Downloaded By: 10.3.98.104 At: 20:42 27 Sep 2021; For: 9780203796184, chapter3, 10.4324/9780203796184.ch3 Trudo Lemmens Caulfi Caulfi Caulfi Campbell 48 Appelbaum AdvisoryCommitteeonHumanRadiationExperiments ( References consent forgranted. not totaketheprogressinprotectionofresearchsubjectsandtrulymeaningfulinformed consent bureaucracyandpromotingresearcheffi cacy areimportant,butitisequallyimportant omous choicesinhealthcareandresearcharealltooeasilytrampledupon.Avoidinginformed out inthefirst parto f thischaptershouldremindushowtherightsofindividualstomakeauton- requirements inordertofacilitateresearch.Researchefficiency isimportant,butthehistorylaid cerned aboutheedingtooquicklycallsfromtheresearchcommunitytoliftinformedconsent sarily increasingresearchsubjectprotection.Atthesametime,thereisalsoreasontobecon- Checking informedconsentformsandimposingritualsisindeednotneces- ignores muchmorediffi cult butkeyquestionsaboutappropriatelevelsofriskinresearch. focuses excessivelyonproceduralrequirements,particularlyrelatedtoinformedconsent,and Thereiscertainlysomethingtobesaidaboutthefactthatresearchethicsreviewnowoften 3.4Conclusion oversight intheUSisalsoseriouslylackingandneedofreform(Lemmens 2014 ). able psychiatricpatientsattheUniversityofMinnesotaaddfueltofirethosearguingthat highly questionableinformedconsentproceduresinthecontextofresearchinvolvingvulner- ing concernsasexpressedinthewakeofSUPPORTStudyandrecentcontroversiesabout Even thoughtheUSAhasoneofmostextensivesystemsforresearchgovernance,ongo- Berg Annas Cohen Allen Beecher , H. K. ( 1966 ) ‘Ethics andclinicalresearch,’ CommitteeofInquiry ( Beauchamp Deschênes DepartmentofHealthandHuman Services,Offi Emanuel medical practiceandresearch,’ tion rationales,’ Practice . Oxford : Oxford UniversityPress . 13 March2014at : http://www.genomecanada.ca/medias/pdf/en/GPS-Policy-Directions-Brief.pdf . countries: Isitaworry?’ paradox?’ Government PrintingOffi involving anauthorizationmodel,’ University Press . 47 – 64 . Contemporary HealthLawandPolicy , 7 : 17 – 45 . Offi and consent:aquestionof“form”?’ University ofAlabamaatBirmingham dated7March2013,viewed132014at : gov/ohrp/detrm_letrs/YR13/mar13a.pdf . , J. W. , eld eld eld , G. J. C. , C. B. ce , , , , T. R. , , . E. J. Currie Joly T. T. , , A. M. , R.

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