2019

TheElementsofInformedConsentA Toolkit Governance Team | Sage Bionetworks V.2.0 JULY 2019

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Welcome!We’regladyou’rehere.

Wehopethistoolkitwillhelpyoumakeyourconsentandinformingexperiencethebestthatitcanbe.Insideyou’llfind:

WhatWeKnow:Usecasesdescribingourapproachtotheinformedconsentprocess,includingeConsent

RealExamples:WhatdotheseideaslooklikewhentheyareputintopracticeConsentChecklist:Runthroughthesequestionstomakesureyou’vethoughtitthrough

AdditionalResources:Checkoutsomeoftheotherresourcesweconsultwhendoingourwork

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What’sNewinVersion2?

WelcomeBack!Alothashappenedsinceweputoutversion1ofthistoolkitinOctober2018.We’veaddednewinformationtoreflecttheJanuary2019updatestotheCodeofFederalRegulations(theCommonRule).We’vealsoaddedsomenewsections:

KeepingitLegal:TheInternationalEdition PrivacyPoliciesandTermsofService:OrganizingInformation Usingwearabledevicesinyourstudy Translation

NumeracyDataSharingandSecondaryuse

IfyouhavefeedbacktoanyoftheinformationprovidedhereorothertopicsyouwouldlikeustocoverUsethisformtoshareyourfeedbackorsuggestionswithusorTweetus@SageBio.

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TableofContentsHowtoUsethisResource............................................................................................4 GettingStarted............................................................................................................5

//TheElementsofInformedConsent:CodeofFederalRegulations.....................................5 //KeepingitLegal...................................................................................................................6 //KeepingitLegal:TheInternationalEdition.........................................................................7 //Consentinthe21stCentury...............................................................................................8 //PrivacyPoliciesandTermsofService.................................................................................9 //PrivacyPoliciesandTermsofService:Organizinginformation.........................................10 //Usingwearabledevicesinyourstudy..............................................................................11 //Genomics..........................................................................................................................13 //DataSharingandSecondaryUse......................................................................................14

KnowYourAudience.................................................................................................15 //Introduction......................................................................................................................15 //Adaptability:EnsuringYourConsentisNavigable............................................................16 //Readability:UsingLanguageYourParticipantsUnderstand.............................................17 //DoYourOwnReadabilityAnalysis....................................................................................18 //Numeracy.........................................................................................................................19 //ConsideringPersonswithCognitiveDecline....................................................................20 //Translation........................................................................................................................21

WhatisDifferentintheRemoteSetting?..................................................................23 //Pointstoconsider.............................................................................................................23

ShouldIUseAQuiz?..................................................................................................25 //Formativeassessment......................................................................................................25 //SummativeAssessment....................................................................................................26

DesigningandDevelopingyoureConsent..................................................................27 //WhatisApp-MediatedConsent?......................................................................................27 //DefiningtheNarrativeArc................................................................................................28 //InformationPresentation.................................................................................................29 //LayeredInformation.........................................................................................................30

CheckYourConsent...................................................................................................31

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HowtoUsethisResource IfyouareaResearcher…

Thinkaboutwhatinformationyourparticipantsneedtoknowtomakeaninformeddecisionaboutparticipatinginyourstudy.Thinkaboutthewords,images,orvideosyouwillusetoconveythisinformationinawayparticipantswillunderstand.Sectionstoreview:• Consentinthe21stcentury• ShouldIuseaquiz?• Keepingitlegal

Ifyouareadesigner…

Thinkabouttheaudienceandhowyourdesignmayfacilitateparticipantlearning.Sectionstoreview:• Knowyouraudience• Personsofcognitivedecline• DesigninganddevelopingyoureConsent

Ifyouarecurious…

Thinkabouthowprovidinginformationinwaythatisengagingandunderstandablemaybuildtrustandfacilitateautonomy. Sectionstoreview:• Doyourownreadabilityanalysis• Definingthenarrativearc• Whatisapp-mediatedconsent?

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GettingStarted//TheElementsofInformedConsent:CodeofFederalRegulations Weusetheseelementsasastartingpointinourapproachtoinformedconsentforresearch.Weencourageyoutofocusontransparencyandclarityinallaspectsofinformedconsent. TheCodeofFederalRegulationsfortheprotectionrequiresthatinvestigatorsobtainlegallyeffectiveinformedconsentpriortoenrollinghumansubjectsinresearch(45CFR46).TheCFRmandatesthefollowingelementsbeincludedinanyinformedconsentforhumansubjectresearch:

1. Description:Tellyourparticipantsthisisresearch.Explainthepurposeofthestudy,howlongitwilllast,andtheprocedures.

2. Risksordiscomforts3. Benefits4. Alternativestoproceduresorparticipation5. Compensation6. Whotocontactwithquestions7. Participationisvoluntaryandprocedureforwithdrawal

TheCodeofFederalRegulationswasrevisedeffectiveJanuary2019.Withthisrevision,informedconsentnowmustalsoinclude:Applicabletoallstudies:

• Beginwithaconciseandfocusedoverviewofinformation• Addressfutureuse(secondaryresearchuse)ofidentifiableinformation

Whenapplicable:

• Addresswhetherornotthereisthepotentialforcommercialprofitbasedontheresearch

• Addresswhetherclinicallyrelevantinformationwillbereturnedtoparticipants• Addresswhethertheresearchwillormightincludewholegenomesequencing

AdditionalResourcesTherevisedCommonRule:https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTMLStanfordUniversityexplainstherevisionstotheCommonRule:https://researchcompliance.stanford.edu/panels/hs/common-rule#informed1

Anexampleinformedconsentthatincludesgenomics,secondaryresearchuse,andiscompliantwiththerevisedCommonRule:consenttojointheNationalKidneyPrecisionMedicineProject:https://kpmp.org/wp-content/uploads/2019/06/KPMP_AKI_Consent_v9_2019-05-14.pdf

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//KeepingitLegal Importantdisclaimer:wearenotlawyers.Thatsaid,herearesomeresourcesthatwehavedevelopedfornavigatingregulatorycomplianceintheU.S..SomeofthetermscommonlyusedinU.S.state/territory-specificregulations:

• Accesstorecords:arequiredstatementwithintheinformedconsentindicatingthatparticipantshavetherighttoaccessspecificrecordsaboutthemselves

• Ageofmajority:ageatwhichapersoncanconsentthemselvestoparticipationinresearch

IntheU.S.,theageofmajoritywithrespecttoresearchparticipationis18withtwoexceptions.InPuertoRicotheageofmajorityis21.InAlabama,theageofmajoritywithrespecttoresearchparticipationis19,withthenotableexceptionofIRB-approvedresearchconductedbyafederally-accreditedcollegeoruniversity.

• Billofrights:formaldeclarationoftherightsoftheresearchparticipant(e.g.,CaliforniaExperimentalResearchSubject’sBillofRights)

• eSignature:anessentialfacilitatorofentirelyremoteconsentinteractions• Sensitivedataconfirmation:personsmustspecificallyacknowledgethereleaseof

sensitivedatatypescontainedwithintheirrecords(e.g.,sexualhealth)• Witnesssignature:somestatesrequireparticipantstohaveapersonwhocanattest

totheiridentitywitnesstheparticipant’ssignatureontheinformedconsent.• Expiry:Somestatesrequireadateortermofexpirybestatedwithintheinformed

consentform.Adateofexpiryisanactualdate(e.g.,December31,2099).Atermofexpirydescribesatimeperiodorevent(e.g.,12monthsfromsignature).

SageBionetworkscompletedareviewofstate/territory-regulationsacrosstheU.S.forseveraldomainsofhumansubjectresearchfortheAllofUsResearchProgram(AoU).AoUisalongitudinalnationalcohortprogramfundedbytheU.S.NationalInstitutesofHealth(NIH),withinvestigators,studyinfrastructure,datamanagementsystems,andgovernanceschemadistributedacrosstheU.S.Youcanreadourpaperusingthelinktotheright.

AdditionalResources

Ourreviewof50statesandUSterritoriesregulationsrelatedtoconsentforresearch:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6417826/

InsuranceRiskClassificationinanEraofGenomics:IsaRationaleDiscriminationPolicyRational?Prince,Anya2018https://digitalcommons.unl.edu/nlr/vol96/iss3/4/TheWebofLegalProtectionsforParticipantsinGenomicResearchWolf,Leslieetal.2019https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3328892

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//KeepingitLegal:TheInternationalEdition Again,wearenotlawyers.HerearesomepointstoconsiderforyourinformedconsentandPP/ToSifyouaretakingyourstudyoverseas:

• Evenifyoualreadyhaveapprovalfromanethicsboardinyourhomecountry,westronglyencourageyouhaveyourstudyreviewedbytheresearchethicsauthorityineachofthecountriesintowhichyouwishtoexpand.Thisisalegalrequirementofmanycountries,itisarequirementofmanyinstitutionsandfunders,anditisgoodresearchethicspractice

• Havingalocalsponsor(localPI)ineachcountryintowhichyouareexpandingyourstudyisalegalrequirementofmanycountriesandisalsogoodresearchethicspractice

• Withinyourinformedconsentandotheruseragreements(e.g.,privacypolicy,terms

ofservice),ensurethatyouareexplicitwhendescribingwherethedataisbeingtransferredtoandstoredandforanyadditionaltransfersforsecondaryusewithspecialattentiontocross-bordertransfer

o Thisisalegalrequirementinmanyjurisdictionso Somecountriesrequireanexplicitoptinfromparticipantsfordatatransfer

acrossborders

• Researchandprivacylawsareevolvingrapidlyworldwide;considerengaginglocallegalcounseland/orafirmexperiencedwithinternationalresearchregulationtoensureyourparticipant-facingresearchagreementsarecompliantwithanyapplicablelaws

AdditionalResources

TheEuropeanCommission’sofficialwebsitedescribingtheGeneralDataProtectionRegulation:https://ec.europa.eu/commission/priorities/justice-and-fundamental-rights/data-protection/2018-reform-eu-data-protection-rules_en

AcompendiumofinternationalhumanresearchstandardsfromtheUSDepartmentofHealthandHumanServices:https://www.hhs.gov/ohrp/sites/default/files/2018-International-Compilation-of-Human-Research-Standards.pdf

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//Consentinthe21stCentury Ifyourstudyincludeselectronicdatacaptureofanytype,itisessentialthatyourstudy’sinformedconsentprocessaddressdatasecurityandtransferability.Additionally,ifyouemployamobileappand/orwearablesensorforyourstudy,youmayneedtoincludeinformationfromoneormoreprivacypolicesand/ortermsofservice.

Ifyourstudyincludesdatacapturefromamobilephone(directlyorthroughanapp),considerdescribingwithintheinformedconsent:• Iftherewillbepassivedatacollectionofanykind,suchasfromGPS• Ifyourstudywillpulldatafromotherapps,suchasHealthKitorFitbit• Ifyouwantpermissiontoaccessphonefeatures,suchaspushnotificationsIfyourstudyusesamobileappforresearch,suchasthosedevelopedusingResearchKit(iOS)orResearchStack(Android),considerdescribing:• Whoisdevelopingtheapp?• Willthedatabeencryptedbothatrestandintransmission?• Whowillreceive/store/usethedata:theresearchteam,athirdparty,orboth?

Describetoparticipantswhoelsewillhaveaccesstotheirdatabesidestheresearchteam:• Arethereanydatadisclosuresrequiredbylaw?• Addresssellingor“renting”participantdatatothirdparties• Willtherebedatasharingforfutureusebeyondtheoriginalresearchteam?

Ifyouareusingamobileappforresearch,someorallofthisinformationmaybefoundintheprivacypolicyortermsofserviceforyourapp.Readmoreaboutthishereandhere.

AdditionalResources Forperspectiveontheconsentlandscapeinapp-mediatedresearch,seeourpaper:ConsentProcessesforMobileAppMediatedResearch:SystematicReview:https://mhealth.jmir.org/2017/8/e126/Ifyourstudyincludesanapp,takealookattheFTC’smobilehealthappchecklist:https://www.ftc.gov/tips-advice/business-center/guidance/mobile-health-apps-interactive-tool

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//PrivacyPoliciesandTermsofService

Privacypolicies(PP)andtermsofservice(ToS)aretraditionallyusedbyapps,websites,andwearabledevices(likefitnessmonitors)todescribetheiracceptableuseandthedatatheycollect.Specifically,privacypoliciesfocusonthecollectionanduseoftheapp/websiteuser’spersonalinformation.PPareoftenrequiredtolistyourstudyappinanappstore.ToScovertherulesandrequirementsof

websiteand/orappuse,forexample,copyright,alloweduses,anddefinitionofabuse.PP/ToShavenottraditionallybeenconsideredpartoftheinformedconsentprocess.However,theycanhaveatremendousimpactonprivacyandconfidentialityofresearchdataandthereforeareincreasinglybeingrequestedandreviewedbyethicsreviewboards.ReadmoreabouthowPP/ToScanundermineyourconsenthere.Issuestolookoutfor:

• PP/ToSareoftendifficultforregularpeopletounderstandbecausethey’relong,complicated,andcontainlotsoflegaljargonwithsectionsinALLCAPS

• PP/ToSareoftenwrittenwiththeprotectionofthedeveloperinmindratherthantheparticipant(contrarytotheethicalfoundationsofhumansubjectresearch)

• MakeyourPPeasytofind.Despitetheirimportance,PP/ToSarefrequentlynotintegratedwithintheinformedconsentprocess.TheremaynotbeanyrequirementfortheparticipanttosignalthattheyhavereviewedandagreetothePP/ToS.

Consider:

• Reviewprivacypolicyandtermsofserviceasyouwouldaconsentdocumento Reducereadinglevelo AvoidjargonandwritinginALLCAPSo EnsureharmonizationbetweentheinformedconsentandPP/ToSo IntegratePP/ToSwithintheinformedconsentprocessforyourstudy

• Don’tforgetthatyouhavetofollowthetermsofyourpostedPP/ToS!

AdditionalResourcesForanexampleofagoodToS,seetheAllofUsResearchProgram’s:https://www.joinallofus.org/en/terms-of-service

Moreonelectronicconsent,includingPPandToSfroma2017presentationatGlobalBiobankWeek:http://sagebionetworks.org/wp-content/uploads/2018/11/GBW2-DOERR-13Sept17-converted.pdf

Forperspectiveontheconsentlandscapeinapp-mediatedresearch,includingPPandToS,seeourpaper:ConsentProcessesforMobileAppMediatedResearch:SystematicReview:https://mhealth.jmir.org/2017/8/e126/

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//PrivacyPoliciesandTermsofService:Organizinginformation Organizinginformationhelpsusdigestitmoreeasily.Forexample,whenwetakenotes,weoftenuseanoutlineformattohelpusorganizeourthoughts.Whenwriting,weuseheadingsandsubheadingstocreatealogicalflowofinformationandtosignaltoreadershowtheinformationwearepresentingisinter-related.Unlikeinformedconsentwhichhasanorganizationalframework

imposedbyfederalregulation,privacypolicies(PP)andtermsofservice(ToS)donothaveanimposedstructure.ThisfreedommeansthatthosedraftingPP/ToSneedthinkcriticallyaboutthestructuretheinformationtheyarepresenting.Consider:

• CreatingatableofcontentsforyourPP/ToS–thiswillencourageyoutogroupsimilarinformationtogether.

• Layeringinformationsopeoplecanchoosehowdeeptheygo• ThinkingthroughyourPP/ToSlogically.Whathappensfirst,second,andthird?For

example:o Whatinformationdoyoucollect?Why?o Wheredoestheinformationyoucollectgo?Howisitstored?o Doyousharetheinformationyoucollectwithanyone?Ifso,why?

• Fortheloveofallthatisholy,donotuseanonlinePP/ToSgeneratorwithoutcarefulreviewandeditingoftheoutput

AdditionalResources

Acoupleofexamplesofwell-organizedPP:- TheDigitalMedicineSociety

(onewehelpededit):https://www.dimesociety.org/index.php/privacy-policy

- TheFederalTradeCommission:https://www.ftc.gov/site-information/privacy-policy

TakealookatTermsofService;Didn’tRead:https://tosdr.org/TheInstagramPrivacyPolicywasre-writtensothatkidscanunderstandit:GrowingupDigitalForlayoutdesignandapproachability,Google'sPPisusefulresource:https://policies.google.com/privacy?hl=en.

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//UsingwearabledevicesinyourstudyTheincreasingubiquityofwearabledevicesisapotentialboonforresearchers.TheuseofwearabledevicesinhumansubjectresearchisanareaofexponentialgrowthandhasdrawntheattentionofregulatorsandIRBs.Therearetwoapproachestointegratingwearabledevicesinmobilehealthstudies,andeachwithitsownrisksandbenefits.BYOD:BringyourowndeviceBYODallowsparticipantstosyncdatatoyourstudyfromadevicetheyalreadyownanduse.Checkitoutintheexamplebelow.Pros:ParticipantshavealreadyagreedtothePP/ToSforthatdeviceCons:TheremaybeequityconcernsraisedduringethicsreviewGivingyourparticipantsadevicetouseYourstudywillbegatheringdatausingaknowndeviceyougivetoparticipants.Pros:Thereisnobarriertoequalparticipation,whichmakeseveryonehappyCons:ReviewPP/ToSforthedevicecarefullytoensureitdoesnotundermineyourstudy’sinformedconsentorPP/ToS.Beonthelookoutforexculpatorylanguage.Formoreinformationonexculpatorylanguage,seethejointguidancefromOHRPandFDA.

AdditionalResources

GuidancefromtheFDAondigitaldevicesincludingwearables.https://www.fda.gov/medical-devices/digital-healthIfyourstudyincludesanapptogoalongwithawearable,takealookattheFTC’smobilehealthappchecklist:https://www.ftc.gov/tips-advice/business-center/guidance/mobile-health-apps-interactive-tool

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Wearables-checkitout:ParticipantsintheAllofUsResearchProgram(AoU)havetheopportunitytolinktheirFitbitdatatotheotherdatatheycontributetothestudy.TheimagesaboveshowhowaparticipantnavigatesfromthisoptionwithintheAoUparticipantportal(Image1and2).ThentheparticipantleavestheportaltotheFitBitoAuthscreen,wheretheparticipantchooseswhattypesofFitBitdatatheywillsharewiththestudy(image3).Image1 Image2

Image3

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//Genomics

Increasingly,researchstudiesareintegratingdiverseapproachestogenomicanalysisand/orbiobankingtotheirprotocols.Whendescribingtheseresearchactivitiesinaninformedconsentprocess,itisimportanttorememberthattherearefederalandstatelawsthatapplytoresearchthatincludesgenomicinformation.TherevisedCommonRulerequiresthatinvestigatorstellparticipantswhetherornottheresearchactivitieswillormightincludewholegenomesequencing.

TherevisedCommonRulealsorequires• Astatementofwhetherbiospecimensmaybeusedforcommercialprofitand

whethersubjectswillshareintheprofit.• Astatementaboutwhetherresultswillbedisclosedtoparticipants.

Herearesomeadditionaltopicsyoushouldconsideraddressinginyourinformedconsent:

• Willparticipantshaveaccesstotheirrawgenomicfiles?• Ifyouwillreturnresultstoparticipants,cantheyoptoutofreceivingthis

information?• Willyoubecreatingcelllines?Considerexplicitpermissionandclearstatementsof

whatwilloccurtothesecelllinesattheconclusionoftheresearchstudy.• Secondaryresearchuseofgenomicdata

Explainingconceptsaboutgenomicsinawaythateveryonecanunderstandcanbechallenging.TheKPMPconsentincludessomegreatlanguageaboutcelllinesandthereturnofgeneticinformationyoucouldconsideradaptingforyourstudy.

AdditionalResources

NIH’sRevisionstotheCommonRule,seesubheading,“MajorRevisionsRelevanttoGenomics”https://www.genome.gov/about-genomics/policy-issues/Human-Subjects-Research-in-Genomics/Highlights-of-Revisions-to-the-Common-Rule

WereviewstatelawsregardinggeneticsinresearchfortheAllofUsResearchProgramhere:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6417826/

TheWebofLegalProtectionsforParticipantsinGenomicResearchWolf,Leslieetal.2019https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3328892

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//DataSharingandSecondaryUse

TherevisedCommonRuleincludesaprovisiontoallowforbroadconsentforsecondaryuseofidentifiableinformationandidentifiablebiospecimens.TherevisedCommonRulealsorequiresthatallstudiesincludeastatementaboutwhetherornotthedatacollectedfromparticipantswillbestrippedofidentifiers*andusedforfutureresearch.Asyoudraftyourinformedconsent,givecarefulthoughttohowthe

datayoucollectwillbeused.Willyousharethedata?Areyourequiredbyyourfundertoshareorreleasethedatayoucollectinwholeorinpart?Whowillhaveaccesstothesedata?InthemPowerstudyforParkinsonDisease,wetellparticipantsaboutdatasharingforfutureresearchintheinformedconsent:

• Sharingyourcodedstudydatabroadly(withoutinformationsuchasyourname)maybenefitthisandfutureresearch.

• Yougettodecideifyouwanttoshareyourcodedstudydatabroadlywithqualifiedresearchers.

• Oncewehavesharedyourdatawithotherresearcherswecannotwithdrawit.

Participantschoosehowtheywanttheirdataused:

ForastudyliketheAllofUsResearchProgram,participantsconsenttodatadonationandusebyawiderangeofresearchers.YoucanwatchtheAllofUsconsentvideofordatasharinghere.

AdditionalResources

*Whatisconsideredtobeanidentifiermayvarybasedonthecontextofthestudyandwhatotherinformationyoucollectaboutyourparticipants.Herearesomeresourcestohelpyounavigatethesometimesmurkyworldofidentifiers.

HIPAAidentifiers:https://www.hipaajournal.com/considered-phi-hipaa/

Methodsforde-identification:https://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-identification/index.html

CodedPrivateInformationorSpecimensUseinResearch(OHRPGuidance2008):https://www.hhs.gov/ohrp/regulations-and-policy/guidance/research-involving-coded-private-information/index.html

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KnowYourAudience//Introduction Thegoalofinformedconsentistoexplaintointerestedparticipantswhatyourstudyentails.Youneedtoclearlydefinetheintendedaudienceandtothinkcarefullyabouthowbesttocommunicatewiththem.Thislistisfarfromexhaustive,buthereareafewmajordomainstoconsider:

• Adaptationsforphysicalimpairment:canpeoplewithvisual,auditory,orphysicalimpairmentunderstandandnavigateyourinformedconsent?

• Readability:canpeopleofdifferentreadingabilitiesunderstandyourconsent?

• Adaptationsforpeoplewithmildcognitiveimpairment:howdoyouengageandinformpeoplewhoarecompetenttoconsentbutmaybestrugglingwithmemorydeclineorothercognitiveimpairment?

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//Adaptability:EnsuringYourConsentisNavigableNomatterifyouarecreatingapaperconsenttobeusedinpersonoraself-navigatedelectronicconsent,ensurethatyourstudy’sconsentisaccessibletopeoplewhoareblind,deaf,and/orhavemobilityimpairment.Forcontentthatiselectronic,therearestandardsthatguideadaptationstoensureaccessibility.IntheU.S.,Section508oftheRehabilitationActof1973requiresfederalagenciestomakeelectronicassetsofallkindsaccessibletopeoplewhowilluseadaptivetechnology.TheUSDepartmentofHealthandHumanServices(HHS)hascreatedexcellentguidestoapplyingthesestandards.AstheHHSguidesoutline,therearestraightforwardadaptationsyoucanimplementtoensurethatthatelectroniccontentadherestoformattingstandardsthatallowautomatedaccessibilitytoolstoparsethecontentwithouttheuseofamouseorakeyboard.ThisinvolvestaskslikestructuringHTML,wordprocessing,andPDFfilessuchthattheyareeasilydigestedbytheseaccessibilitytools.Forexample,usingheadingsproperly,alttextonfigures,andusingXMLformattingstructure.Ifyouareworkingwithatechnologyorimplementationvendor,besuretodiscussadaptivetechnology.Doublecheckthatwhenyourstudydocumentsareuploadedandmadeavailablethatadaptivefeaturesarenotlost.

AdditionalResourcesFromtheUSDepartmentofHealthandHumanServices,moreonSection508:https://www.hhs.gov/web/section-508/index.htmlGuidesformakingelectroniccontentaccessible:https://www.hhs.gov/web/section-508/making-files-accessible/index.htmlThePDF508Compliancechecklist:https://www.hhs.gov/web/section-508/making-files-accessible/checklist/pdf/index.html

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//Readability:UsingLanguageYourParticipantsUnderstandReadabilityistheeasewithwhichapersoncanunderstandwrittentext.TwoofthemostcommonmeasuresofreadabilityaretheFlesch-KincaidgradelevelandtheFleschreadingease.Readabilityanalysisiswhenyouapplyreadabilitytoolstoyourcopy.Readabilityanalysisisanessentialstepindevelopingtheinformedconsentprocessforyourstudy.

Checkitout:

Hereisanexampleofthesameinformedconsentcontentpresentedtwodifferentways.About10%ofAmericanswillbeabletoreadthetextontheleft,whileabout80%willbeabletoreadthetextontheright.

AdditionalResourcesHereisanamazingmapofU.S.healthliteracylevelsbyU.S.Censustrack:http://healthliteracymap.unc.edu/HereisaprimeronreadabilitythatwewroteandusehereatSageBionetworks:http://sagebionetworks.org/wp-content/uploads/2018/11/Primer-on-readability-25April17-1.pdfAtooltohelpyouwriteyourcontentinplainlanguage:http://www.hemingwayapp.com/

LearnmoreaboutusingeverydaywordsinhealthcommunicationsontheCDC’shealthliteracyresourcewebsite:https://www.cdc.gov/healthliteracy/

Gradelevel:12.1Readingease:46.3 Gradelevel:5.4Readingease:80.1

Ifyoudecidetojointhestudyyouwillneedtodownloadthefreestudyapplicationonyourmobiledeviceandregistertothestudy.Then,periodicallywewillaskyoutoanswersurveyquestionsand/orperformactivitiesonorwhileholdingyourmobilephone.Inaddition,ifyouareabletosustainmoderateactivity,wemaysendyoumotivationalpromptstoremainactive.Yourstudydatawillincludeyourresponsestosurveysandthemeasurementsfromthephoneitselfwhenyouperformanactivity.

Ifyoudecidetojointhestudy,youwillneedtodownloadthemPowerstudyappontoyourphone.Theappisfreefromyourphone’sappstore.Thenyouwillneedtoregisterforthestudy.Aspartofthestudy,wewillaskyoutoanswerquestionsontheapp.Also,wewillaskyoutodoactivitieswhileholdingyourphone.Wemightsendyounotificationsthroughtheapptellingyoutokeepupthegoodwork.Youranswerstothequestionsandthemeasurementsfromyouractivitiesareyourstudydata.

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//DoYourOwnReadabilityAnalysis OneoftheeasiestwaystodoreadabilityanalysisonyourcopyisbyusingthereadabilitytoolsinMicrosoftWord.Highlightthetextyouwishtocheck,clickTools>SpellingandGrammar>CheckDocument.Attheendofyourcheckyouwillseeaboxthatlookslikethis:

FleschReadingEase:scoredoutof100.Youwantthisnumbertobehigh,ideallyabove75.

Flesch-KincaidGradelevel:scoredoutof16.Youwantthisnumbertobelow,ideally8orbelow.

Reviewourfullprimeronreadabilityanalysishere.

Consider:

• Useplainlanguage

• Useactivevoice

• Keepyoursentencesshort;avoidmultipleclauses

• Consistencyingradelevel/readingeaseismoreimportantthanaveragegradelevel/readingease

AdditionalResources

The2003NationalAssessmentofAdultLiteracygivesmoredetailsabouthealthliteracyintheU.S.https://nces.ed.gov/pubs2006/2006483.pdf

SimplyPut,CDC’sguidetocreatingeasy-to-understandmaterialsisanotherexcellentresource:https://www.cdc.gov/healthliteracy/pdf/simply_put.pdf

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//Numeracy

ThemajorityofAmericansstruggletointerpretnumberswhenusedinahealthcontext.Hereareafewoftheguidelinesweuseformakingthenumbersweusemoreaccessible:

• Usewordsratherthannumbers• Usecomparison

o Comparetosomeotherthing§ Makesurethatyourcomparisoneventisrelativelyequivalenttothe

thingthatmighthappen–forexample,donotcomparetheriskofdyingfromkidneybiopsy(bad)totheriskofwinningthelottery(good)eventhoughbotharerare

o Comparetoitself§ Doesithappenmorethan/thesameas/lessthanusual?More

than/thesameas/lessthanintheaverageperson?• Avoidthe“XinY”phrasing.Ifyoufindyoudoneedtousethisformat,ensurethat

thedenominatorstaysthesameacrossallthenumbersyoupresent.

HereisanexamplefromtheKidneyPrecisionMedicineProject’sinformedconsent:

• Peopleoftenhavebleedingafterakidneybiopsy.Thiscanbemild,moderate,orsevere.

o Ifthebleedingismild,yoururinemaylookpinkorredfor1to2days.Youusuallyhavenootherproblems.Thisiscommon.Ithappenstoabout100in1000people.

o Ifthebleedingismoderate,youmayneedabloodtransfusion.Yoururinemayberedforupto7to10days.Thisislesscommon.Ithappenstoabout10in1000people.

o Inrarecases,thebleedingissevere.Youmayneedadditionalmedicalprocedurestostopit.Thishappenstoabout1in1000people.

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//ConsideringPersonswithCognitiveDecline Peoplewithmemoryissuesorotherformsofcognitivedeclinemaystillbecompetenttoconsentforresearchparticipation.IncollaborationwithEmoryUniversityandtheUniversityofWisconsinMadison,SageBionetworksinvestigatedtheinformedconsentneedsofpeoplewithcognitivedeclineaspartoftheAlzheimer’sDiseaseResearchCenter(ADRC)study.Theconsentdesignusesatiledesignaswellasummativeevaluationquestionstotestmasteryofkeyconcepts(formoreinformationabouttiledesign,seeDefiningtheNarrativeArc).Studycoordinatorsareinformedofparticipants’answerstoquizquestions,allowingthemtofocustheireffortsonclarifyingandremediatingspecifictopicsratherthanreviewingtheentireconsentwithparticipants.

Consider:

• Useiconsmeaningfullyandconsistentlytoaidmemoryandretention

• Presentconceptsinsmallincrements

• Interspersequizquestionswithintheconsentprocess

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//TranslationInordertorecruit,enroll,andretainadiverseparticipantpool,youmayneedtotranslateyourconsentdocumentsandotherparticipant-facingstudymaterials.Giventheintricaciesoflanguageandculture,specialconsiderationisneededtoensurethateverypotentialparticipantisprovidedaccurateandmeaningfulinformationaboutthestudy.Tomakesureyourstudyisaccessibleandequitable,high-qualitytranslationisessentialforyourinformedconsentandotherparticipant-facingmaterials(includingPP/ToS).Weadvocatefortranslationasaniterativecyclewithtwomainstepstoensureaccuracyandconsistencyofreview.Thetwostepsare:

1. PrimaryTranslation:TranslatetothetargetlanguageTheprimarytranslatorisresponsibleforprofessionaltranslationoftheoriginalEnglishmaterialsintothetargetlanguage.Theprimarytranslatorwillensurethattranslationisdoneinaconsistentandstandardizedwayusingindustrybestpractices.Youcanoftenhireanoutsidegrouptodothisstep.

2. SecondaryTranslation:ReviewforculturalmeaningThesecondarytranslatorisresponsibleforexpertreviewandrevisionofprimarytranslatedmaterials.Ideallytheyareamemberofyourstudyteamorareveryfamiliarwithyourstudy.Thesecondarytranslatorwillensurethatthetranslationsareaccurate,culturallyappropriate,accessible,andcomprehensibletothetargetaudience.ThesecondarytranslationproviderwillverifythatthereadingleveloftheoriginalEnglish(forexample,middleschool-levelorcollege-level)ismaintainedinthetranslation.

Translationshouldbeaniterativecycletoensurethatthereisbothaccuracyinmeaningandculturalrelevance.

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Expertreviewerqualificationsinclude:• Bilingual(Englishandyourtargetlanguage);stronglyprefernativespeakers• Expertiseincommunicatingclinicalresearch;prefercliniciansandclinicalresearch

coordinatorswithfirst-handexperienceenrollingnon-Englishspeakingvolunteersinresearchstudies

• AbilitytounderstandthestudyprotocolandmaterialsinEnglishCheckitout:

English SpanishText Ifyouhaveafitnesstracker

(likeonetocountthestepsyoutakeinaday),youmightbeabletosharedatafromitwithAllofUs.Ifyoudon’thaveafitnesstracker,wemayaskyoutouseonethatwegiveyou.YoucansaynoandstilltakepartinAllofUs.

Sitieneunmonitor(sensor)deactividadfísica(como,porejemplo,unoquecuentelospasosqueusteddaenundía),podríacompartiresosdatosconAllofUs.Sinotieneunmonitor(sensor)deactividadfísica,podríamospedirlequeuseunoquenosotrosledaremos.Puedenegarsey,aunasí,continuarsiendopartedeAllofUs.

Video WatchonYouTube WatchonYouTube

Itisimportanttonotethatmanylanguages(suchasSpanish)havedifferentdialectsorwordsthatareusedforcertaintermsdependingonthecountryorcommunityoforigin.Havingatranslationteamthatisrepresentativeoftheseethno-regionaldifferencesenrichesandimprovestranslationfidelity.Forexample,considerincludingtranslatorsfromavarietyofSpanish-speakingnationsonyourtranslationteam,suchasSpain,Honduras,Venezuela,PuertoRico,Ecuador,Guatemala,Colombia,and/orMexico.

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WhatisDifferentintheRemoteSetting?//PointstoconsiderRemoteelectronicconsentisapowerfultoolformanyreasons:Itisscalable.Itmayreducetimepressureonparticipants,researchers,andclinicians.Itallowsfordiverse,integratedinformationpresentationmethods,includingvideo,audio,andotherinteractiveapproaches.Beforeyoujumpin,herearesomeimportantpointstoconsiderbeforeusingremoteelectronicconsentforyourstudy:1. Ensureparticipantsmeettheeligibilitycriteriaforthestudy.

SageBionetworkshasreliedonparticipants’self-reportofeligibilityforremotestudiesorhaveconfirmedeligibilitycriteriaataninpersonvisitaspartofthestudy.Thinkcarefullyaboutwhatinformationyoucollectaboutparticipantsbeforeensuringtheymeettheeligibilitycriteria.Eligibilitycriteriashouldcomebeforeaccountcreation.

AdditionalResources

CheckouthowProjectBaselinepresentseligibilitycriteria.Click“AmIeligible?”https://www.projectbaseline.com/

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2. Identityconfirmation.Forexample,ofpeopleprovidingpermissionforchildrentoparticipateinresearch.TheFeverPrintsapp-mediatedresearchstudyasksadultstohandtheirphonetothechild,andaskthechildtocompletestepsonthephone,usingphysicalproximityasaproxyforguardianship.(leftimage)

3. eSignature.Intheremoteelectronicsetting,signingconsentforms(includingHIPPA

authorizations)hasbecomestandard.Participantsusetheirfingeroramousetosign,ortypetheirnametoindicatetheirconsent.Thesignatureisappendedtoacopyoftheconsentformandemailedtotheparticipantfortheirrecords.(rightimage)

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ShouldIUseAQuiz?Therearetwomainapproachestoincludingawrittenassessmentinyourinformedconsent:formativeandsummativeassessment.Eachhasitsownfeatures.Readmorebelow. //Formativeassessment Formativeassessmentisamethodofteachback.Itcanbeusedeveninentirelyremotestudiestoencouragepeopleconsideringparticipationtoreflectontheirinformednesspriortojoining.SageBionetworkshasimplementedformativeassessmentsinmanymobilehealthstudies,includingforthemorethan200,000participantsoftheAllofUsResearchProgram.Eitherthroughoutorattheendoftheconsentprocess,theresearchteamposesquestionsaboutkeyaspectsofthestudy.Afteranswering,participantsarepresentedwiththecorrectanswer,reinforcingunderstanding.Prospectiveparticipantscanbeofferedtheopportunitytogobackandreviewspecificcontentareasortalkwithamemberofthestudyteambeforejoining.

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//SummativeAssessmentBycontrasttoformativeassessments,asummativeassessmentcanbeusedasagateforresearchparticipation.Asummativeassessmentisatraditional“test”–therearerightandwronganswersandthereisa“passingscore”tomoveontothenexttask.Summativeassessmentsmeasureaperson’smasteryofcontentandmaybeappropriateineConsentforstudiestargetingvulnerablepopulations,suchasthosewithcognitiveimpairment.SageBionetworksusesasummativeapproachtocontentmasteryassessmentintheParkinsonmPowerStudyandADRC.

AdditionalResources Thinkabouthowtoincorporatetheteachbackmethodinyourconsentexperiencetofacilitatelearning:https://www.ahrq.gov/professionals/quality-patient-safety/quality-resources/tools/literacy-toolkit/healthlittoolkit2-tool5.html

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DesigningandDevelopingyoureConsent //WhatisApp-MediatedConsent? Therearethreecomponentsofelectronicinformedconsent:theeConsent,longformconsent(LFC),andprivacypolicyand/ortermsofservice(PP/ToS).

• eConsentisaseriesofscreensthatpresentinformationtraditionallyhighlightedbythestudycoordinatorduringtheinformedconsentprocess

• LFCsarethetraditional“informedconsentdocuments”andarecommonlyinterpretedtoberequiredbyU.S.regulation.ParticipantsarepresentedwithanLFCforreviewandelectronicsignaturefollowingeConsent.

• PP/ToSaretraditionallyusedwithinappsandbywebsitestoalertuserstotheapp/website’sdatagathering,use,management,storageanddisclosurebytheorganizationhostingtheapporwebsite.Forthisreason,PP/ToSarecriticaltoelectronicinformedconsentprocesses.

AdditionalResources: JohnWilbanksandMegDoerrgiveanoverviewofapp-mediatedconsentatOHRP(theirpresentationstartsat2h57minmarkofthisvideofile)https://videocast.nih.gov/summary.asp?live=28334&bhcp=1HereisaSageBionetworkswhitepapergivingmoredetailaboutelectronicconsentscreendesign:https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2769129

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//DefiningtheNarrativeArc Therearedifferentwaystopresentthenarrativearcofyourconsentexperience.Linear:Alinearpresentationofinformationleadsparticipantsfromonetopictothenext.Participantscanonlynavigateforwardorbackward,notbetweencontentareas.Thisdesignallowsresearcherstopresenttheinformedconsentlikeastory,witheachscreenbuildingontheonebefore.Non-linear:Presentinginformedconsenttopicsinagridor“tiles”allowsparticipantstonavigatetopicsintheorderoftheirchoosing.Participantsclickthroughfromthemaingridtolearnmoreabouteachofthetopicspresented.Thisdesignallowsparticipantstoseethebreadthofinformationyouwillcoverintheinformedconsentprocessinoneglance.Italsofacilitatesparticipant-driveninformationseeking,butmayrequireyoutorepeatinformationsothateach“tile”standsonitsown.Exampleoflinearpresentation Exampleofnon-linearpresentation

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//InformationPresentation WestronglysuggestthatyouthinkcarefullyaboutlayoutoftheinformationyoupresentoneacheConsentscreen.Keepwordcounttoaminimumandusevideosoriconstohelpanchortheconceptsyoupresent. AtSageBionetworks,wehavetwostandardtemplatesforeConsentscreens.Thevideoscreentemplateisontheleft.Theiconscreentemplateisontheright.MainconceptTextinformationareaVideo(withclosedcaptioning)LinktovideotranscriptContactinformation

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//LayeredInformation Usingalayeredapproachtoinformationallowstheparticipanttochooseiftheywishtolearnmoreaboutaparticulartopicwithintheconsentexperience.Intheexample(left),theparticipantispresentedwiththescreenontheleftwhichopensthescreentotheright.

ImagesfromMyHeartCounts(StanfordUniversity)

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CheckYourConsent Readthroughthechecklisttoidentifyquestionsmostrelevanttoyourspecificprojectorconsentexperience.Afteryouhavedeterminedquestionsapplicabletoyourproject,gobacktoreviewspecificsectionsofthisdocument.Assesswhetheryouneedtomakeadjustmentstoyourconsentexperience.

Elementsofinformedconsent:HaveyouincludedallrequiredelementsofinformedconsentundertherevisedCodeofFederalRegulations?

KeepingitLegal:Haveyoureviewedanyrelevantstateor

federallawsthatapplytoyourproject?Considerthejurisdictioninwhichyouoperateandreviewanyapplicablelawsorregulations,includingcollectingandtransferringdataacrossinternationalborders.

ReadabilityandNumeracy:Didyouusewordsthatyour

participantscanunderstand?Didyoucheckyourreadabilityscore?Haveyouusednumbersorrealworldcomparisontoexplainrisk?

Consideryourparticipantaudience:Haveyouconsideredaccessibility

readability?Willyourecruitpeoplewithcognitivedecline?

Translation:Giventhepopulationyouaretryingtorecruit,doyouneedtotranslateyourconsenttoanotherlanguage?Haveyouusedaniterativetranslationprocesstoensureforaccuracyandculturalrelevancy?

Remotesetting:Ifapplicable,haveyouaccommodatedforconsentina

remotesetting?Haveyoupromptedyourparticipantaudiencewitheligibilitycriteria?

Consentinthe21stcentury:Willyourstudyincludeelectronicdatacapture?Ifso,haveyouharmonizedPP/ToSwiththestudy’sconsent?HaveyouhighlightedPP/ToStoparticipants?

PP/ToS:Doyouneedtoincludeaprivacypolicy

ortermsofserviceinyourconsentexperience?Howhaveyouorganizedtheinformation?HaveyoucheckedthePP/ToS’sreadabilityscore?

Didyouconsiderusingaquiztoserveasateach

backmethodortoassessparticipantunderstanding?

Didyoupresentyourconsentexperienceinan

engagingwayforyourparticipantaudience?Didyouconsiderusingicons,text,videos,oraudio?

Howwillyourparticipantaudiencenavigate

throughyourconsentexperience?Willtheydeterminetheorderorhaveyourpredefinedthenarrativearc?

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AbouttheSageBionetworksGovernanceConsentToolkitSageBionetworks’TheElementsofInformedConsenttoolkitwillhelpresearchersthinkthroughwhatinformationparticipantsshouldreceiveaspartoftheconsentingprocessinordertomakeaninformeddecisionaboutwhetherornottojoinastudy.Webelievethatinformedparticipantsmakethebestparticipants;theyunderstandthestudy,itsrisksandbenefits,andhowtheirdatawillbetreated.Thistoolkitcanhelpinformyourconsentdesign,especiallyifyouareconsideringusingtechnology.Thegoalisalwaystopresentpertinentinformationtoyourpotentialparticipantsinawaytheycanunderstandandcomprehend.ThisisV.2.0ofthistoolkit,uploadedonJuly17,2019.Wewillcontinuetoupdatethistoolkitovertime.We’llletyouknowwhenwedorighthere.CopyrightinformationAllthematerialsinthistoolkitnototherwisecopyrightedarecopyrightedbySageBionetworks,andlicensedtothepublicundertheCreativeCommonsAttribution4.0license.Youarewelcometouse,share,andadaptanyoftheseresourcesinwholeorinpartunderthislicense.Weaskthatyougiveappropriatecreditasyoudoso.LimitstousingthisresourceTheElementsofInformedConsenttoolkitisnotlegaladvice.ItisacompendiumofthepracticesandprinciplesweatSageBionetworksusetoguideourworkininformedconsent.Wewillupdatethisdocumentovertimeaswegrowourbodyofworkandlearnmoreaboutbestpracticesininformedconsent.

ContactusFeedback?DidyouuseorconsultourConsentToolkit?Usethisformtoshareyourfeedbackorsuggestionswithus.

Email:Ifyouwouldliketocontactourteamaboutworkingonaconsent-relatedprojectortoaskaquestion,pleaseemailmegan.doerr@sagebionetworks.org

Tweetus!@SageBio

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AboutSageBionetworksSageBionetworksisanonprofitthatdevelopsandimplementscollaborativepracticesandtechnologytosupporttheintegrationofdatascienceintobiomedicalresearch.Sagesitsatauniquenexusofthefieldsofdatascience,open-accesstechnologyplatformdevelopment,anddatagovernance.WearelocatedinSeattleandwearesupportedthroughaportfolioofphilanthropicdonations,competitiveresearchgrants,andcommercialpartnerships.LearnmoreaboutSageBionetworksatsagebionetworks.orgAcknowledgementsSpecialthankstoMeganDoerr,SarahMoore,ChristineSuverandJohnWilbanks.TheSageBionetworksGovernanceTeam,ToriAllen,VanessaBarroneAllieSerroussi,andAmyTroungTheSageBionetworksDesignTeam,especiallyWoodyMacDuffieandStockardSimon.TheSageBionetworksMarketingandOperationsTeam,especiallyHsiao-ChingChouandErinScanlan.OurcolleaguesattheAllofUsResearchProgram,especiallyMichaelStokesandToralContractor.