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©MRCTCenter|November2017

ReturnofIndividualResultstoParticipants:Principles

TheaimsoftheMulti-RegionalClinicalTrialsCenterofBrighamandWomen’sHospitalandHarvard(MRCTCenter)ReturnofIndividualResultsworkgroupwereto(1)developamethodologyandprinciplesbestsuitedforreturnofindividualresearchresults;(2)definemethodstofacilitatedisclosureandcommunicationofresultstoindividuals;(3)identifybestpracticestomanagedisclosuretoandfollow-upwithindividuals;and(4)developaframeworktomanagereturnofresultsintheglobalcontextofclinicalresearchtrials.Thefoundationoftherecommendationsdocumentandtoolkitare9principlesdirectlyrelevanttothereturnofindividualresearchresults.Theprinciples,developedbytheMRCTCenterReturnofIndividualResultsWorkgroup,addressthereturnofindividualresultscollectedduringaclinicaltrialtoresearchparticipantsortheirdesignees.Theseprinciplescomplementpreviousrecommendationsforthereturnofaggregateresearchresults(seehttp://mrctcenter.org/projects/return-of-results-to-participants/). Individual resultsaregenerated indifferentcontextsandatdifferenttimesduringatrial.Wheneveravalidated result isurgentlymedicallyactionable, there isanethical responsibility to return the relevant resulteitherdirectlytothephysician(s)withprimaryresponsibilityforcaretotheindividualortotheparticipant,documentingthecommunicationandtransferofresponsibility.1. Providingindividualresearchresultsrespondstotheexpressedinterestsandexpectationsofmanyclinical

trialparticipantsthattheirresultsbecommunicatedtothem.2. Considerationspertainingtothereturnofindividualresearchresultstoclinicaltrialparticipantsshouldbe

integratedintotheclinicaltrialandproactivelyplanned.3. Theinformedconsentprocessshouldincludeinformationaboutthesponsor’sintentionregardingthe

returnofresearchresultsandallowfordiscussionofparticipants’preferencestoreceivetheseresults.

4. Theplanforthereturnofindividualresearchresultsshouldbereviewedbyanindependentethicsbody

overseeingtheresearchtoensuretherightsandwelfareofresearchparticipantsareprotected.5. Ifresultsareoffered,participantsshouldbeabletochoosewhetherornottoreceivetheirindividual

researchresults.

6. Sponsorsandinvestigatorshaveanobligationtoactresponsiblywhenreturningindividualresults,taking

intoaccountmedicalsignificance,analyticalvalidityandpersonalutility.7. Individualresearchresultsshouldbereturnedinwaysandattimesthatmaintaintheintegrityofthe

research,insofarasthesafetyandwelfareoftheresearchparticipantsarenotatrisk.8. Thepurposeofresearchisnotclinicalcare,andreturnofindividualresearchresultscannotsubstitutefor

appropriateclinicalcareandadvice.9. Returnofindividualresearchresultsshouldbeplannedandexecutedincompliancewithinstitutional

policiesandlocal,regional,andnationallawsandregulations.

FormoreinformationabouttheMRCTCenter’sworkonthereturnofindividualresults,visit:

http://mrctcenter.org/projects/return-of-individual-results/


Principle1:Providingindividualresearchresultsrespondstotheexpressedinterestsandexpectationsofmanyclinicaltrialparticipantsthattheirresultsbecommunicatedtothem.Theclinicalresearchenterpriseincreasinglyrecognizesthatparticipantscanandshouldbeengagedaspartnerswhoareactivelyinvolvedinresearchandthegenerationofnewscientificknowledge.Providingclinicaltrialparticipantswithinformationaboutthemgeneratedthroughtheirparticipationinthetrialisimportantasamatterofrespectforindividuals’autonomy. Principle2:Considerationspertainingtothereturnofindividualresearchresultstoclinicaltrialparticipantsshouldbeintegratedintotheclinicaltrialandproactivelyplanned.Intheplanningstage,considerationshouldbegivenastowhetherandhowmuchdatatoreturn,whichresultstoreturn,andwhen,bywhom,andhowresultswillbeprovided.Resourcesforthereturnofindividualresultsprocessshouldbeallocatedaccordingly.Theoperationalchallenges,feasibilityandburdensplaceduponinvestigators,sitesandsponsorsshouldbeconsideredatthistime.

Principle3:Theinformedconsentprocessshouldincludeinformationaboutthesponsor’sintentionregardingthereturnofresearchresultsandallowfordiscussionofparticipants’preferencestoreceivetheseresults.Theinformedconsentprocessshouldbeexplicitastowhetherindividualresearchresultswillbereturnedtoparticipantsandwhatandwheninformationwillbereturned.Participantsshouldbeinformedthattheyalsohavetherighttochangetheirdecisionatthetimeinformationismadeavailable.Ifresultswillnotbereturned,thisshouldbestatedclearly,preferablywithanexplanationoftherationaleforthedecisionnottoreturn.Principle4:Theplanforthereturnofindividualresearchresultsshouldbereviewedbyanindependentethicsbodyoverseeingtheresearchtoensuretherightsandwelfareofresearchparticipantsareprotected.Theoverallplanforreturnofindividualresearchresults(whether,how,whenandbywhomresultswillbedisseminated)shouldbereviewedandapprovedbyanindependentbody,generallyaresearchethicscommittee(REC)orinstitutionalreviewboard(IRB)thatischargedwiththeresponsibilityofprotectingtheparticipants’rightsandwelfare.TheREC/IRBshouldalsoreviewdisclosuresthatwerenotplannedbutaredeemednecessaryforcompellingclinicalorethicalreasons(e.g.,unexpectedgeneticfindingswithpotentialimpactonaparticipantortheirfamily).




Principle5:Ifresultsareoffered,participantsshouldbeabletochoosewhetherornottoreceivetheirindividualresearchresults.Formostcategoriesofresults,individualsshouldhavetheopportunitytodecidewhetherornottheywishtoreceivethem.Resultsofcriticalandimmediateclinicalimportancemayrepresentexceptionstothispresumption;thattheseresultswillbecommunicated—andwhy—shouldbeexplainedtotheparticipantsduringtheinformedconsentprocess.Principle6:Sponsorsandinvestigatorshaveanobligationtoactresponsiblywhenreturningindividualresults,takingintoaccountmedicalsignificance,analyticalvalidityandpersonalutility.Participantsshouldbeprovidedaccesstoasmuchoftheirdataaspossible;however,considerationshouldbegiventothevalidityofthetestaswellastothemedical,social,and/orpersonalusefulnessoftheresultstoparticipants.Additionally,communicationshoulduseplainlanguageandfollowhealthliteracyprinciples.

Principle7:Individualresearchresultsshouldbereturnedinwaysandattimesthatmaintaintheintegrityoftheresearch,insofarasthesafetyandwelfareoftheresearchparticipantsarenotatrisk.Theplanforreturningresearchresultsshouldsafeguardtheintegrityofthestudyandtheabilitytoattainthestudy’sresearchaims,insofarasthesafetyandwelfareofresearchparticipantsarenotcompromised.Timelyreturnofresultswillhelptoensurethatanydirectorindirectbenefitsoftheresultstotheparticipantswillberealized.Studydesign,thespecifictypeofdataandthemedicalimportanceofthefindingmayinfluencethetimingofreturn.Principle8:Thepurposeofresearchisnotclinicalcare,andreturnofindividualresearchresultscannotsubstituteforappropriateclinicalcareandadvice.Thepurposeofresearchistoproducegeneralizableknowledgeforthebenefitofsociety.Thisdiffersfrommedicalcarethatisintendedtobenefitindividualpatients.Therefore,itisimportanttodefineintheinformedconsentformthelimitsoftheclinicaltrialandtheroleandmissionoftheresearchersinthattrial.Principle9:Returnofindividualresearchresultsshouldbeplannedandexecutedincompliancewithinstitutionalpoliciesandlocal,regional,andnationallawsandregulations.Anyplansforreturnofindividualresearchresultsshouldcomplywithinstitutionalpoliciesofthesponsorandinvestigatorandthesovereignlawsandregulationsofthejurisdictioninwhichtheparticipantresidesandinwhichthesponsor,investigatorand/orinstitutionoperates.




ReturnofIndividualResultsWorkgroupCo-Chairs:DebraMathews,SandyPrucka,andDavidPulford

CarmenAldinger,MRCTCenterMaryEllenAllen,Genentech/RocheMarkBarnes,MRCTCenter,Ropes&GrayLLPKarinaBienfait,Merck&Co.,Inc.BarbaraBierer,MRCTCenter,Brighamand

Women’sHospital,HarvardMedicalSchool

JuanCarmona,MRCTCenterPoorviChablani,Biogen-IdecKarlaChilders,Johnson&JohnsonCathrynClary,NovartisLindaColeman,QuorumReviewIRBDeborahCollyar,PatientAdvocatesinResearch

(PAIR)KellyCoulbourne,AstraZenecaPatrickCullinan,TakedaPharmaceuticals

International,Inc.RobertaDriscoll,Dana-FarberCancerInstituteRicardoEccarddaSilva,ANVISA,BrazilAriannaFranca,JohnsHopkinsUniversityElizabethFrank,Dana-FarberCancerInstituteand

Dana-Farber/HarvardCancerCenterZacharyHallinan,ClinicalTrialsTransformation

InitiativeLeaHarty,Pfizer,Inc.NicoleHinton,Biogen-IdecTab(Tabassum)Hoda,AmgenInc.JaimeHoude,EMDSeronoCherylJernigan,SusanG.KomenMichaelJohnson,MRCTCenterScottKennedy,NovartisYoungshinKim,BeijingUnitedFamilyHospital

andClinics,ChinaBarbaraKress,Merck&Co.,Inc.

SarahLarson,Biogen-IdecDavidLeventhal,Pfizer,Inc.RebeccaLi,MRCTCenterDylanMarashi,MRCTCenterGloriaMason,HarvardMedicalSchoolDebraMathews,JohnsHopkins

BermanInstituteofBioethicsMeganMcBride,Janssen/Johnson&JohnsonJulesMitchel,TargetHealth,Inc.ThomasMorgan,NovartisDanaLeffNiedzielska,AugustResearchP.PearlO'Rourke,PartnersHealthCareJanePerlmutter,GeminiGroupUsharaniPingali,Nizam’sInstituteofMedical Sciences,IndiaWasanaPrasitsuebsai,GlaxoSmithKline;

formerly:HIV-NAT,theThaiRedCrossAIDSResearchCentre,Thailand

SandyPrucka,EliLillyandCompanyDavidPulford,GlaxoSmithKline,

UnitedKingdomLizRoberts,UCBStephenRosenfeld,QuorumReviewIRBJessicaScott,GlaxoSmithKlineJinaShah,Genentech/RocheLanaSkirboll,SanofiLynnSleeper,BostonChildren’sHospital/ HarvardMedicalSchoolAdrianThorogood,GlobalAllianceforGenomics

andHealthCarolWeil,NIHCrispinWoolston,SanofiSheilaYoung,GlaxoSmithKline