April9,2010 BoardofRegents UniversityofMinnesota 600McNamaraAlumniCenter 200OakStS.E. MinneapolisMN554552020 ClydeAllen,Chair LindaCohen,ViceChair Members: DeanJohnsonStevenHunter AnthonyBaragaDavidLarson RichardBeesonMaureenRamirez DallasBohnsackPatriciaSimmons VenoraHungJohnFrobenius Re:ComplaintofAcademicMisconductagainstStephenCOlson,M.D.

M.D. AssociateProfessor,DepartmentofPsychiatry,MedicalSchool, UniversityofMinnesota. ThisletterintroducesastatementofcomplaintallegingacademicmisconductagainstDr.StephenC. Olson,AssociateProfessor,PrincipalInvestigator,DepartmentofPsychiatry,UniversityofMinnesota.Dr. OlsonspatternofbehaviorasaAssociateProfessorandclinicaltrialprincipalinvestigatorissoegregious innaturethatIamconfidentyouwillagreeafterreviewingtheattachedmaterials,thisaccusationof misconductisclearlyconspicuousandflagrant.Dr.Olsonhasbeenallowedtoengageinunethical professionalbehaviorandmisrepresentationinordertoachieveacademicandpersonalgain.Itappears thatDr.Olsonhasbeenallowedtoflyundertheradarbecauseaninsulatedshieldisinplacewithinthe DepartmentofPsychiatryanditschairDr.CharlesSchulz. PrincipalInvestigatorshaveprimaryresponsibilityfortheexecutionandmanagementofresearchprojects theydirect,andmustbevigilantinseeingthatthestandardsofprofessionalandethicalconductare maintainedinallphasesoftheirprojects.Inordertoprotectboththeintegrityandtheautonomyofthe University,itiscrucialthatresearchersachievethesehighstandardsandoffernothinglessthantotal compliance.Astheattachedcomplaintwillexposeindetail,Dr.Olsonhasshownacompletedisregard fortheseresponsibilitiesbyhisrepeatednegligenceandcallousnesstowardsfulfillinghisacademicduties. Noeventismoredamagingtothereputationofclinicalresearchperformedonhumansubjectsatthe UniversityofMinnesotathanthediscoveryoffalseorfraudulentlyobtaineddata.Moreover,the exposingofprotectedhealthinformationerodestherelationshipsrequiredfortheconductofclinical trials,violatesfederalstatutes,andviolatesthetrustbetweenthepatientandthehealthcareteam.Such behaviorpoisonsthepublicsperceptionofallclinicalinvestigationsperformedattheUniversity. Researchmisconductinanyformthreatenstheintegrityofthescience,theresearchinvestigatorand especiallytheUniversity.ResearchmisconductandviolationsoftheBoardofRegentspoliciestherefore cannotbetolerated.MisconductisdefinedbytheUniversityspoliciesasfabrication,falsification,or plagiarisminproposing,conducting,reportingorreviewingsponsoredorunsponsoredresearch.Dr. Olsonhasfailedtocomplywithmaterialandrelevantaspectsofvalidstatutoryorregulatory

requirementsgoverningpsychiatricresearchsuchasengaginginunauthorizedaccesstopatient informationorusingauthorizedaccesstosuchinformationinanunauthorizedmannerinviolationof stateand/orfederalprivacylaws. Dr.Olsonsactionscannotbeexcusedasasimpleinstanceofanerrorinjudgment,amisinterpretationof therules,afailureindeductivereasoning,oranerrorincarryingoutexperiments.Hisrecklessactions displayaroguepsychiatristactinginsuchamannerthatheconsciouslyandunjustifiablydeviatesfrom thestandardofconductthatareasonableindividualwouldobserveandtheUniversitydemandsofits professors.ItappearsthatDr.Olsonisallowedtogobyhisownsetofrulesonhowtoconductresearch, onebeingtellalieenoughtimesanditbecomesfact. TheBoardofRegentspoliciesdemandthatallscientificresearchconductedatthatinstitutionmustrest onafoundationofmutualtrust.EachemployeeoftheUniversityofMinnesotaisexpectedtoadhereto thisstandardwheneverheorsheactsonbehalfoftheUniversity.Toaverylargedegree,thattrustis thoroughlyjustified.Dr.Olson,however,hasbeenallowedtoexploithispositionasatreating psychiatrist,associateprofessor,andclinicalresearcherandengageinscientificmisconductthathas underminedthattrustandcredibility.TheUniversityscredibilityisonlyasgoodastheintegritylevelat whichclinicalstudiesthereareconducted.Thisistheproblem.IftheUniversityallowsDr.Olsonto continuehistotaldisregardforpoliciesandregulations,hismanipulationofflaweddataandmeasures,it willbeasdevastatingasputtinginthewrongcoordinatesbeforeamoonshot.Hemustbedealtwith quicklyandforcefullyinordertosustaintheatmosphereoftrustnecessaryforscienceandthecredibility oftheMedicalSchoolattheUniversityofMinnesota. ScientistsatourUniversityneedtorealizethattheyarenotaccordedasmuchtrustastheyoncewere. OursocietyissignificantlymorecynicalandlesstrustingthanitwasbeforetheVietnamWarand Watergate,andespeciallynowregardingToyota.TheUniversityofMinnesotashouldbelikeeveryother sectorofsociety,moreheavilyregulatedthaninthepast;manyoftheseregulationshavingbeenadapted afterscandalsbroke.TheUniversityofMinnesotaiscertainlynotimmunetothistopic.Similarly,the Universitymustunderstandthatfindingthetruthaboutchargesofmisconductisaparamountobligation, andthatchargesmustbeinvestigatedaccordingtoestablishedproceduresthatarefairtoallinvolved. Probesmustrelyuponthefacts,notpersonalitiesorreputations,asthebasisfordecisions. Whenanybehaviorposesasignificantpublichealthrisk,mostinstitutionspunishsuchbehavior vigorously.Forinstance,mostauthoritiesheavilypenalizepeoplewhodriveanautomobilewhile intoxicated;thegoalistoprotectthepublicbydeterringthebehavior.Similarly,itishardtoenvisiona Regentspolicythatprotectsthepublicortheinstitutionfromacademicmisconductwithoutpunishing thebehavior.Dr.Olsonhasbeenallowedtoengageinbehaviorthatisunethical,unprofessional, dishonest,andattimescriminal. Itismysincerehopethatyouwillinvestigatetheseveryseriousviolationsofpoliciesandtakeappropriate swiftactiontorestorethetrustandintegrityintheMedicalSchoolattheUniversityofMinnesota. GeorgeOrwelloncewrotethat...intimesofuniversaldeceit,truthbecomesarevolutionaryact.Itis veryapparentthattheDepartmentofPsychiatryregardsauthorityastruth,ratherthantruthasauthority. Pleasenotifymeinwritingoftheresultsofyourinvestigation.Youmaycontactmeat Respectfully, MikeHoward cc:Dr.R.ChristopherBardenJeremyOlson Dr.CarlElliottPaulTosto

StatementofComplaintagainstDr.StephenCOlson ClinicalInvestigator,DepartmentofPsychiatry UniversityofMinnesota

ThisStatementofComplaintisregisteredagainstDr.StephenCOlson,Departmentof Psychiatry,UniversityofMinnesota.Dr.Olsonhasrepeatedly,throughignoranceoroutright intention,violatednumerousCodeofConductpoliciesinstitutedbytheBoardofRegentsatthe UniversityofMinnesota. UNIVERSITYOFMINNESOTABOARDOFREGENTSPOLICY ACADEMICMISCONDUCT Subd.1.Definition.Academicmisconduct,forthepurposeofthispolicy,shallmeanthe fabricationorfalsificationofdata,researchprocedures,ordataanalysis;destructionofdatafor fraudulentpurposes;plagiarism;abuseofconfidentially;orotherfraudulentactionsin proposing,performing,reviewing,orreportingtheresultsofresearchorotherscholarlyactivity. Subd.3.Expectations.TheUniversityexpectsacademicintegrityfromitsemployeesatalltimes andinallcircumstances.Universityemployeesmaynotengageinactionsthatconstitute academicmisconductinresearchorotherscholarlyactivity. PROTECTIONOFINDIVIDUALHEALTHINFORMATION Subd.1.PolicyStatement.ItisthepolicyandpracticeoftheUniversityofMinnesota (University)thatindividuallyidentifiablehealthinformationgathered: (a) inthecourseofresearchconductedattheUniversity;or (b) throughtheprovisionofhealthcarebytheUniversity;or (c) inthecourseofhealthplanadministrationattheUniversity shallbeprotectedinaccordancewithapplicablestateandfederallaw,including,butnotlimited to,theHealthInsurancePortabilityandAccountabilityActof1996,anditsimplementing regulations. Subd.3.Application.Theadministrativepoliciesandproceduresimplementingthispolicyshall applytoallUniversityfacultymembers,employees,trainees,students,andvolunteers,who handle,transmit,receive,orhaveaccesstoprotectedhealthinformationinthecourseof researchconductedattheUniversity,throughprovisionsofhealthcareattheUniversity,andin thecourseofhealthplanadministrationattheUniversity.

ENCLOSURE1.Dr.Olsonaccessedandsharedprivate,protected,personalhealthinformation withmembersofhisresearchteamtoactivelyrecruitamentallyillpatientintoaclinicaltrial forwhichDr.Olsonwasprincipalinvestigator.Dr.OlsonneverobtainedasignedHIPAA releasefromthepatient/enrolleenorhadthepatientsignedageneralreleaseofinformation untilthreeweeksintothestudy.InstatementsmadebyDr.Olsoninacivilmalpractice lawsuitinvolvinghimselfandtheUniversityofMinnesota,Dr.Olsonacknowledgesnothaving obtainedsignedHIPAAreleasesregardingenrolledsubjectsaswellasnotevenunderstanding whenorhowtheHIPAAregulationswererequiredforresearchattheUniversityof Minnesota.HisowntestimonycontradictspublishedfederalregulationsontheUniversitys ownwebsitedeclaringhowaclinicalstudyistobeconducted. CODEOFCONDUCT Subd.2.CommitmenttoEthicalConduct.Communitymembersmustbecommittedtothe highestethicalstandardsofconductandintegrity.ThestandardsofconductinthisCode, supportedthroughpolicies,procedures,andworkplacerules,provideguidanceformaking decisionsandmemorializetheinstitutionscommitmenttoresponsiblebehavior. STANDARDSOFCONDUCT Subd.3.ManageResponsibility.TheUniversityentrustscommunitymemberswhosuperviseor instructemployeesorstudentswithsignificantresponsibility.Managers,supervisors, instructors,andadvisorsareexpectedto: ensureaccesstoanddeliveryofpropertrainingandguidanceonapplicableworkplace andeducationalrules,policies,andprocedures,includingthisCode; ensurecompliancewithapplicablelaws,policies,andworkplacerules; Subd.7.EthicallyConductTeachingandResearch.Universityresearchershaveanethical obligationtotheUniversityandtothelargerglobalcommunityastheyseekknowledgeand understanding.Communitymembersareexpectedto: propose,conduct,andreportresearchwithintegrityandhonesty; protectpeople,andhumanelytreatanimalsinvolvedinresearchorteaching; learn,follow,anddemonstrateaccountabilityformeetingtherequirementsof sponsors,regulatorybodies,andotherapplicableentities; ENCLOSURE2.Onnumerousoccasionswhileconductingaclinicaltrialforantipsychotic drugs,Dr.Olsonexhibitedtotaldisregardforregulationsrequiredbystateandfederallaws fortheconductofclinicaltrials.Heblatantlyfalsifiedalettertoastateagencythatwas investigatingthedeathofoneofhistrialenrollees.Onnumerousoccasionsinacivil depositionheacknowledgeshavingnoknowledgeofcertainregulatorystatutesrequiredfor theconductingofclinicaltrialsandtheprotectionofhumansubjects.Dr.Olsondelegatedthe dispensingofverypowerfulantipsychoticdrugstoastudycoordinatornotlicensedto dispensedrugs,whohadreceivednopriortrainingnoreducationregardinghowthesedrugs aretaken,theseveresideeffectsthatanenrolleemightexperience,consequencesfor stoppingthedrugunexpectedlyandtheexperiencetomonitorwhetherthestudydrugsare appropriateforthesymptomsbeingtreatedandarehavingthedesiredeffect.This

fundamentalfailureshowsareckless,ifnotwillful,disregardoftheenrolleeswelfare,and exposestheenrolleetounnecessaryrisksofharm. Subd.8.AvoidConflictsofInterestandCommitment.Communitymembershaveanobligation tobeobjectiveandimpartialinmakingdecisionsonbehalfoftheUniversity. Toensurethisobjectivity,communitymembersareexpectedto: avoidactualindividualorinstitutionalconflictsofinterest; disclosepotentialconflictsofinterestandadheretoanymanagementplanscreatedto eliminateanyconflictsofinterest. ENCLOSURE3.Dr.OlsoncompletelydisregardedtheUniversitysownwebsitepublished recommendationofavoidingresearcher/treatingphysicianpatientrelationshipsregarding enrollinghisownpatientsintoclinicalstudies.Dr.Olsonacknowledgedhavingrecruited numerousmentallyillpatientsfromapsychiatricunitattheUniversityintohisownstudies. Subd.9.CarefullyManagePublic,Private,andConfidentialInformation. Communitymembersarethecreatorsandcustodiansofmanytypesofinformation.Thepublic righttoaccessandtheindividualrightstoprivacyarebothgovernedbylawsandUniversity policies.Tomeettheseresponsibilities,communitymembersareexpectedto: learnandfollowlawsandUniversitypoliciesandagreementsregardingaccess,use, protection,disclosure,retention,anddisposalofpublic,private,andconfidential information; followdocumentpreservationandretentionguidelines. ProfessorsandAssociateProfessorsattheUniversityofMinnesotashouldbeguidedbyadeep convictionoftheworthanddignityoftheadvancementofknowledge,andrecognizethespecial responsibilitiesplaceduponthem.Theirprimaryresponsibilitytotheirprofessionistoseekand statethetruth,notjustastheyseeit,butwhatourlawsandsocietydemand.Theymustaccept theobligationtoexercisecriticalselfdisciplineandjudgmentandaboveallpracticeanddisplay totalhonesty.Sometruthsarejusttoobigforpeopletoface.(GeorgeOrwell) TherecanbenootherconclusionbutthatDr.Olsonengagedinbehaviorunbecominga PhysicianandAssociateProfessorattheUniversityofMinnesota.Thereismorethanenough evidencetoindicatethatthereisabsolutelynowayDr.Olsonshouldeverbeinvolvedinclinical researchagain,andmustbeheldaccountableforhisflagrantmisconduct.Weallmake mistakes,buttherearesomemoreegregiousthanothers.Thisisespeciallytruewhenthey happenrepeatedlysuchaswithDr.Olson,thatshoulddisqualifyhimfromteachinguniversity students,conductingresearchonthelatestdrugs,andespeciallycaringforvulnerablepatients.

Never doubt that a small group of thoughtful committed citizens can change the world; indeed, its the only thing that ever has. (Margaret Mead)