Aspects of vulnerable patients and informed consent in clinical trials
作者： Ferdinand Hundt , Maria Kuthning
DOI: 10.3205/000171
关键词:
摘要: Abstract Scope:TodiscusstherationalebehindinformedconsentinclinicaltrialsfocusingonvulnerablepatientsfromaEuropeanandGermanviewpoint. MariaKuthning 1 FerdinandHundt Methods:ScientificliteraturesearchviaPubMed,Medline,Google.Results:Voluntary informed consent is the cornerstone of policiesregulatingclinicaltrials.Toenrollapatientintoaclinicaltrialwithout 1UniversityDuisburg-Essen, havingobtainedwrittenandsignedconsentistobeconsideredasa Germany seriousissueintheconductofaclinicaltrial.DevelopmentofethicalguidanceforphysiciansstartedbeforeChristErawiththeHippocraticOath.Mainfunctionofconsent,asarticulatedinallguidelinesdevelopedforclinicalresearch,istofacilitateanindividual’sfreedomofchoice,respectautonomy,andthustoensurewelfareoftheparticipantsinclinicaltrials.Minorsareunabletoprovidelegallybindinginformedconsent,thisissueisaddressedthroughacombinationofparentalpermissionandminor’sassent.Illiteracyisacriticalproblemthataffectsallcornersofourearth;ithasnoboundariesandexistsamongeveryraceandethnicity,agegroup,andeconomicclass.Newstrategiestoimprovecommunicationwithpatientsincludingtheuseofvideotapesoranimatedcartoonillustrationscouldbetaught.Finallythetimewiththepotentialparticipantseemstobethebestwaytoimproveunder-standing.Conclusion:Discoveryoflifesavingandlifeenhancingnewtreatmentsrequirespartnershipthatisbasedongoodcommunicationandtrustbetweenpatientsandresearchers,sponsors,ethicscommittees,au-thorities,lawyersandpoliticianssothatvulnerablepatientscanbenefitfromtheresultsofwellcontrolledclinicaltrials.Keywords:informedconsent,vulnerablepatients,minors,illiteracy
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