A Researcher’s Legal Liability : Ethical and Legal Considerations

2001-01-01

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ARESEARCHER’SLEGALLIABILITY:ETHICALANDLEGALCONSIDERATIONS

CatherineBergeron*
LEGERROBICRICHARD
,L.L.P.
Lawyers,PatentandTrademarkAgents
CentreCDPCapital
1001Square-Victoria–BlocE–8thFloor
Montreal,Quebec,CanadaH2Z2B7
Tel.(514)9876242–Fax(514)8457874
www.robic.ca–info@robic.com

Medicallaw,morespecificallytheareaofdoctors’liability,isafieldwhichhas
knownmanydevelopmentsduringthelastfewyearsinQuebec.Butwhat
aboutresearchers’liability,thatistosaytheliabilityofthosespecialists
devotedtomedicalresearchonhumanbeings?Thisarticlewillprovidea
briefoverviewofdifferentaspectsofaresearcher’sliabilityfromalegal
standpointandalsofromanethicalpointofview.
1.LegalAspects:MainDutiesoftheResearcher
Thedutiesimposedonmedicalresearcherstowardstheirsubjectsarelargely
inspiredbyadoctor©sdutiestowardshispatients.Sincethereareveryfew
differencesbetweenthedutiesofadoctorandthoseofaresearcher,we
cansaythatthesedutiesoriginatefromacommonsource:anindividual©s
rightstotheinviolabilityandintegrityofhisorherperson.Moreover,itis
importanttonotethatdutiesimposedonresearchersareatleastequalifnot
superiortothoseimposedondoctorsandsurgeonstowardstheirpatients
(Halushkav.UniversityofSaskatchewan(1965),53D.L.R.(2d)436(Sask.C.A.,
J.Hall)).
Firstly,theresearcherhasadutytoinformhissubject.Inordertofulfilthisduty,
theresearcherhastomeetfourmainrequirements:hehastoclearlysetout
tothesubjectthepurposeofhisexperimentandmakesurethatthesubject
understandsthemeaningandtheimpactofthispurpose;hemustsetoutto
thesubjectwhatthebenefitsoftheexperimentareforhimorherandfor
society;hemustinformthesubjectoftherisksrelatedtotheexperiment
keepinginmindthat”thedutytoinforminmattersrelatingtopurelyscientific
experimentationisthemostexactingpossible.Thisdutyincludesthe
revelationofallrisks,includingthosewhicharerareorremoteandespecially

CIPS,2001.*OfLEGERROBICRICHARD,L.L.P.,amultidisciplinaryfirmoflawyers,andpatentand
trademarkagents.PublishedintheFall2001issue(Vol.5,No.4)issueofourNewsletter.
Publication068.042E.

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thoseriskswhichmayentailseriousconsequences.”(Weissc.Solomon,[1989]
R.J.Q.731(S.C.Que.,J.DeBloisatp.743),andfinally,inthecaseof
therapeuticresearch,theresearcherhastoinformhissubjectaboutall
possibleresearchalternatives.
Secondly,theresearcherhastoobtainawritten,freeandclearconsentfrom
hissubject.Thissecondobligationisunquestionablythecorollaryofthefirst
oneasthesubjecttoanexperimentmusthavereceivedalltherelevant
informationinordertogiveaclearconsent.
Thirdly,owingadutyofcaretohissubject,theresearcherhastorespecta
certain“codeofconduct”.Throughoutthecourseoftheexperiment,the
researcher’sbehaviourmustbeobjectiveandtheresearchmustbecarried
outwithreasonablecare.Anyfailuretorespectthesepre-setstandards
couldleadtotheresearcher©sliability,whetherprofessionalliability,orcivilor
contractualresponsibility.
Finally,theresearcherhasanobligationofconfidentialitytowardshissubject.
Thisobligation,whichisdirectlyrelatedtoprofessionalsecrecy,findsitssource
inthetrustwhichmustbefoundbetweentheresearcherandthesubjectand
alsointherighttoprivacyanddignity,tworightsprovidedforinsections4
and5oftheQuebecCharterofHumanRightsandFreedoms.
2.Ethicalaspects
2.1Historyofthedevelopmentofethicalconsiderationsregarding
experiments
TheNurembergCode(1948)andtheDeclarationofHelsinki(1964),whichare
stilltodayconsideredasguidelinesintendedfordoctorsandothermedical
researchersinteractingwithhumanbeings,haveinspiredrecentethical
developmentsconcerningexperimentswithhumansubjects.Thelegal
considerationsmentionedaboveputaside,thesemedicalresearchesmust
alsomeetethicalcriteria.
2.2Ethicalapprovalcriteriaofresearchprotocols
Inordertoevaluatethe“ethicalcontent”ofresearchprotocols,themain
objectiveofwhichistogiveadetaileddescriptionoftheresearchestobe
carriedout,ethicalcommitteeshaveestablishedethicalapprovalcriteria.
Eventhoughthenatureandthenumberofthesecriteriacanvaryfromone
researchtoanother,somecriteriaareessentialinevaluatingaresearch
protocol.

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Sinceexperimentalresearchonhumanbeingsisonlyethicalifitis
acceptableonascientificbasis,thefirstcriterionconcernsthedetermination
ofthescientificvalueoftheresearchprotocol.Itisuptotheresearcherto
justifytheperformanceofresearchonhissubjectbydemonstratingthatsuch
researchisnecessaryfortheadvancementofscientificknowledgeandthe
enhancementofthequalityofhumanlife.Secondly,anethicalcommittee
hastobalancetherisksandbenefitsoftheexperimentalresearchandsuch
researchwillonlybeethicalifthebenefitsoutweightherisksforthesubjector
forsocietyatlarge.Thirdly,inordertobeethicallyacceptable,aresearch
protocolhastoensuretheconfidentialityofthefactscollectedforthe
purposeoftheexperiment.Amongotherthings,theresearcherhasto
establishmeasureswhichwillguaranteethatthesubject©sanonymitywillbe
protectedanddetermineinadvance,aspreciselyaspossible,theinstances
wheretheresearcherwillbeexemptedfromthedutyofconfidentiality
towardshissubject.Finally,theresearcherwillalsohavetomakesurethat
thesubjectgivesafreeandclearconsentbyaskinghimorhertosigna
consentformwhichheorshefullyunderstandsandtowhichheorshe
liberallyadheresto.

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