Section 4.3 �Using Studies Wisely

Sec$on4.3Objec$ves

•  Describethescopeofinferencethatisappropriateinasta$s$calstudy

•  Evaluatewhetherasta$s$calstudyhasbeencarriedoutinanethicalmanner

ScopeofInference

ChallengesofEstablishingCausa$on

•  Lackofrealismincertainstudiesthatcanonlybedoneinalab(laboratoryvstherealworldmaygiveslightlydifferentoutcomes)

•  Unethicaltodojustanytypeofexperiment(thinkaboutaparachuteexperimenttoestablishwhetherparachutessavelives)

•  Establishingcausa$onwithoutanexperimentisdifficult.Itcansome$mesbeestablishedifwehavemanystudiesyieldingthesameresultsover$me(seelungcancerproblem).

NextaresomeexamplesofNever-Been-Done-BeforeExperimentsThatWouldBeDismissedbyTheIRBDuetoBeing“Unethical”

ViewerDiscre-onAdvised

RealExperimentsFromOurPastThatAren’tConsideredEthicalaccordingtotoday’sstandards

In1961,StanleyMilgram,apsychologistatYaleUniversity,beganaseriesofsocialpsychologyexperimentsthatmeasuredthewillingnessoftestsubjectstoobeyanauthorityfigure.ConductedonlythreemonthsaQerthestartofthetrialofGermanNaziwarcriminalAdolfEichmann,Milgram’sexperimentsoughttoanswertheques$on,“CoulditbethatEichmannandhismillionaccomplicesintheHolocaustwerejustfollowingorders?”Intheexperiment,twopar$cipants(onesecretlyanactorandoneanunwi\ngtestsubject)wereseparatedintotworoomswheretheycouldhear,butnotsee,eachother.Thetestsubjectwouldthenreadaseriesofques$onstotheactor,punishingeachwronganswerwithanelectricshock.Thoughmanypeoplewouldindicatetheirdesiretostoptheexperiment,almostallsubjectscon$nuedwhentheyweretoldtheywouldnotbeheldresponsible,orthattherewouldnotbeanypermanentdamage.

In1956and1957,theUnitedStatesArmyconductedanumberofbiologicalwarfareexperimentsontheci$esofSavannah,GeorgiaandAvonPark,Florida.Inonesuchexperiment,millionsofinfectedmosquitoswerereleasedintothetwoci$es,inordertoseeiftheinsectscouldspreadyellowfeveranddenguefever.Notsurprisingly,hundredsofresearcherscontractedillnessesthatincludedfevers,respiratoryproblems,s$llbirths,encephali$s,andtyphoid.Inordertophotographtheresultsoftheirexperiments,Armyresearcherspretendedtobepublichealthworkers.Severalpeoplediedasaresultoftheresearch.

Ini$allyestablishedinthe1950sasasub-projectofaCIA-sponsored,mind-controlresearchprogram,Opera$onMidnightClimaxsoughttostudytheeffectsofLSDonindividuals.InSanFranciscoandNewYork,unconsen$ngsubjectswereluredtosafehousesbypros$tutesontheCIApayroll,unknowinglygivenLSDandothermind-alteringsubstances,andmonitoredfrombehindone-wayglass.Thoughthesafehouseswereshutdownin1965,whenitwasdiscoveredthattheCIAwasadministeringLSDtohumansubjects,Opera$onMidnightClimaxwasatheaterforextensiveresearchonsexualblackmail,surveillancetechnology,andtheuseofmind-alteringdrugsonfieldopera$ons.

ShortlyaQerWorldWarII,withtheimpendingColdWarforefrontonthemindsofAmericans,manymedicalresearcherswerepreoccupiedwiththeideaofradioac$vityandchemicalwarfare.InanexperimentatVanderbiltUniversity,829pregnantwomenweregiven“vitamindrinks”theyweretoldwouldimprovethehealthoftheirunbornbabies.Instead,thedrinkscontainedradioac$veironandtheresearcherswerestudyinghowquicklytheradioisotopecrossedintotheplacenta.Atleastsevenofthebabieslaterdiedfromcancersandleukemia,andthewomenthemselvesexperiencedrashes,bruises,anemia,lossofhairandtooth,andcancer.

In1932,theU.S.PublicHealthServicebeganworkingwiththeTuskegeeIns$tutetotrackthenaturalprogressionofuntreatedsyphilis.Sixhundredpoor,illiterate,malesharecropperswerefoundandhiredinMaconCounty,Alabama.Ofthe600men,only399hadpreviouslycontractedsyphilis,andnoneweretoldtheyhadalifethreateningdisease.Instead,theyweretoldtheywerereceivingfreehealthcare,meals,andburialinsuranceinexchangeforpar$cipa$ng.EvenaQerPenicillinwasprovenaneffec$vecureforsyphilisin1947,thestudycon$nuedun$l1972.Inaddi$ontotheoriginalsubjects,vic$msofthestudyincludedwiveswhocontractedthedisease,andchildrenbornwithcongenitalsyphilis.In1997,PresidentBillClintonformallyapologizedtothoseaffectedbywhatisoQencalledthe“mostinfamousbiomedicalexperimentinU.S.history.”

DataEthicsBigIdeas

•  Ins$tu$onalReviewBoardmustapproveallexperiments(IRBestablishedin1974)

•  InformedConsentFormsmustbegiventosubjectsinformingthemoftheirrights

•  Confiden$alityofSubject’sInforma$onmustberespectedandensured