A Researcher’s Legal Liability : Ethical and Legal Considerations
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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