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© MRCT Center | November 2017 Return of Individual Results to Participants: Principles The aims of the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) Return of Individual Results workgroup were to (1) develop a methodology and principles best suited for return of individual research results; (2) define methods to facilitate disclosure and communication of results to individuals; (3) identify best practices to manage disclosure to and follow-up with individuals; and (4) develop a framework to manage return of results in the global context of clinical research trials. The foundation of the recommendations document and toolkit are 9 principles directly relevant to the return of individual research results. The principles, developed by the MRCT Center Return of Individual Results Workgroup, address the return of individual results collected during a clinical trial to research participants or their designees. These principles complement previous recommendations for the return of aggregate research results (see http://mrctcenter.org/projects/return-of-results-to- participants/). Individual results are generated in different contexts and at different times during a trial. Whenever a validated result is urgently medically actionable, there is an ethical responsibility to return the relevant result either directly to the physician(s) with primary responsibility for care to the individual or to the participant, documenting the communication and transfer of responsibility. 1. Providing individual research results responds to the expressed interests and expectations of many clinical trial participants that their results be communicated to them. 2. Considerations pertaining to the return of individual research results to clinical trial participants should be integrated into the clinical trial and proactively planned. 3. The informed consent process should include information about the sponsor’s intention regarding the return of research results and allow for discussion of participants’ preferences to receive these results. 4. The plan for the return of individual research results should be reviewed by an independent ethics body overseeing the research to ensure the rights and welfare of research participants are protected. 5. If results are offered, participants should be able to choose whether or not to receive their individual research results. 6. Sponsors and investigators have an obligation to act responsibly when returning individual results, taking into account medical significance, analytical validity and personal utility. 7. Individual research results should be returned in ways and at times that maintain the integrity of the research, insofar as the safety and welfare of the research participants are not at risk. 8. The purpose of research is not clinical care, and return of individual research results cannot substitute for appropriate clinical care and advice. 9. Return of individual research results should be planned and executed in compliance with institutional policies and local, regional, and national laws and regulations.

Return of Individual Results to Participants: Principles€¦ · 20/11/2017  · 4. The plan for the return of individual research results should be reviewed by an independent ethics

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Page 1: Return of Individual Results to Participants: Principles€¦ · 20/11/2017  · 4. The plan for the return of individual research results should be reviewed by an independent ethics

©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.

Page 2: Return of Individual Results to Participants: Principles€¦ · 20/11/2017  · 4. The plan for the return of individual research results should be reviewed by an independent ethics

FormoreinformationabouttheMRCTCenter’sworkonthereturnofindividualresults,visit:

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

©MRCTCenter|November2017

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).

Page 3: Return of Individual Results to Participants: Principles€¦ · 20/11/2017  · 4. The plan for the return of individual research results should be reviewed by an independent ethics

FormoreinformationabouttheMRCTCenter’sworkonthereturnofindividualresults,visit:

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

©MRCTCenter|November2017

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.

Page 4: Return of Individual Results to Participants: Principles€¦ · 20/11/2017  · 4. The plan for the return of individual research results should be reviewed by an independent ethics

FormoreinformationabouttheMRCTCenter’sworkonthereturnofindividualresults,visit:

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

©MRCTCenter|November2017

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


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