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MTAAgreementontransfer ofbiologicalmaterial(sv. Avtalom överföringav biologisktmaterial), Version 1.0, 2016-11-18
DocumentID:
AGREEMENTonthetransferofhumanbiologicalmaterials
Thisagreement is not negotiable.
The purposeof thisagreement istoregulate eachparty’sresponsibilitieswhen human biological materialsanditsassociatedcoded personaldataisto betransferredfromaSwedish biobank toa recipient,whowillusethe human biologicalmaterialsforaresearchproject that hasbeen approved byan ethicscommitteeinSweden.
The agreementisboth an agreement totransferof human biologicalmaterials anda personaldata processingcontract. Moreover,itregulateshowhuman biologicalmaterialsandcoded personal datashould be handledonexpiryof theagreement sothat human biologicalmaterialandthe coded personaldata nolongercan be used forresearchoranyotherpurposebytherecipient.
1.PARTIES
This agreementfor thetransfer ofhuman biologicalmaterials("Agreement") issigned between the Swedish Biobankresponsibleforsamples inSweden[Karolinska InstitutetBiobank, Box 281, 17177 StockholmSweden] (the“Biobank”), andtherecipientof samples[](the“Recipient”),eacha “Party”andcollectively hereafterreferredto, asthe “Parties”.
2.BACKGROUND
TheBiobankis inpossessionof acertainhuman biological materials(the “Materials”)andassociated PersonalData(as defined below),which needs tobeanalyzed withintheframeworkof aresearch project(enter informationaboutthestudy inTable1 below)(the“Project”).TheBiobank collaborateswiththeResponsibleresearcher1for theProject.
ThePartieswishtheRecipienttobeabletoanalyzetheMaterial fortheProjectandtheBiobank agrees tomaketheMaterial and associatedcoded PersonalData available totheRecipientforthe purposesof theProject.
For thepurposes ofthis Agreement, “PersonalData”meansanyinformationthatidentifiesorthat can beusedto identifya natural personwhois alive.
Table1. Studyinformation
Studyname:Sample collectionworkingtitle (ifapplicable): / Study-ID (ifapplicable):
Registrationno.ofthe ethicalreview board’sdecision:
Responsible researcher1
1Theresearcherthat isresponsiblefortheresearchprojectinSweden. ForexamplePrincipalinvestigator,National investigator,ClinicalTrialInvestigatororSamplecollectionsresponsible person
Name: / Phone: / E-mail:Work address: / Postcode: / City: / Country:
3.TRANSFEROFBIOLOGICALMATERIALSANDPERSONALDATA
TheBiobankundertakestoassisttheRecipientwiththeMaterialspecified inattachment1,for specific analysesand associatedPersonalData specified inattachment1.TheMaterial and associatedPersonalDatafor analysis is provided inapseudo-anonymised form, i.e. codedsamples andcodedPersonalDatasothatthe individual donor(whetherlivingor deceased)fromwhomthe Materials wereobtained(the“Donor”) canonly beidentified withthekeyfor thecode(asdescribed below)2.
Theprincipalof the Biobankshall keep thekeyforthecode tothe Personal Datafor the identificationoftheMaterialsandthecodedPersonalData duringthetermofthis Agreement.The Recipientacknowledges thatBiobankwill notprovide anyinformationtotheRecipientaboutthe Materialsor Personal Datathatcan directly identify orbeusedtoidentifythe Donor. TheRecipient acknowledgesthatsinceakeyexists,thePersonalData and anyinformationderived byRecipient thatusessuchPersonalData fromtheMaterialaredeemedtobePersonalDatafor whichthe Biobankisresponsible. All rights to and inthetransferred Material andassociatedcodedPersonal Data remains withtheBiobank.
4.PERMITTEDUSEetc.
TheBiobankdeclaresthatthecollectionof biologicalmaterials and personal data fortheresearch projecthas been approvedbyanethics committeeinSweden. TheBiobankmakes no representationsthattheusedoes notinfringeanyrights ofthird parties.
TheRecipientagreesto usetheMaterials and/orcodedPersonalData as described intheresearch plan inattachment2(the “Purpose”).TheRecipientalsoagreestousetheMaterials and related codedPersonalDatain accordancewiththisPurposeand notfor anyother purpose and in accordancewith applicablelaws, regulations, policies,guidelines, andethicalrequirements, together with anyconstraints setforth byethical reviewboards, applicabletotheresearchunder theProject andthehandling and protectionoftheMaterialand/or PersonalData.
TheRecipientacknowledges thattheMaterialismadeavailableforexperimentaluse onlyandshould notbeused in humans.
Intheeventofa withdrawal of donorConsent,theBiobankshall promptlyinformtheResponsible researcherof suchchanges.
5.ACCESSTOTHEBIOLOGICALMATERIALSANDDATA
TheRecipientagreestoensurethatonlythosepersons involved intheProject, shall haveaccess to andtheuseoftheMaterials and/or codedPersonal Data providedbytheBiobank.
TheRecipientagreesthat onlyauthorizedlaboratorypersonnelintheRecipient’s business/organization performs analysisof theMaterials and processesthecodedPersonalData. Unless expressed permission is documentedto providetostudysponsoror third partyprovider.
2Notethatevenencodedorencrypted dataispersonal dataaslongascodeorencryptionkey isleft,(personaldata"),forwhichtheBiobankisresponsible
6.SUBCONTRACTORS
TheRecipientshallensurethatthis Agreementis forwardedto andcompletedby anysubcontractor or third partyprovider prior to anytransferoftheMaterials and/orcodedPersonal Data.The Recipientshall alsoensurethatanysubcontractoror third partyprovidershall handletheMaterial and/or codedPersonalData in accordancewiththisAgreement.
RecipientagreesthatBiobankshall retaintitle totheMaterialandthe PersonalData, inRecipient’s or anysubcontractor’s possession.
7.SECURITYFORBIOLOGICALMATERIALANDPERSONALDATA
TheBiobankprincipal isthecontrollerof the PersonalData.TheBiobankagreesthattheMaterials and anycodedPersonalData will besuppliedtotheRecipientwithoutanyinformationor datathat could resultinthe Donorbeing personallyidentifiablebyRecipient, underapplicabledata protection/privacylaws.
TheRecipientagreesto protecttheintegrityandsecurityof theMaterialsandassociatedcoded PersonalData fromunauthorized access,useor theftin accordancewith applicabledata protection or humanbiologicalmaterial legislation.
TheRecipientagreestomeettherequirements and instructionsonITsecurity fromtheBiobankin attachment3or theprovisionsof theCOMMISSIONIMPLEMENTINGDECISION(EU) 2016/1250 (Privacy Shield). RecipientswhopleadPrivacyShield shall, viaenclosurean appendix[insertappendix number] tothis MTA, demonstratethattheyareregistered intheU.S.Department of Commercelist of companies affiliatedtothe PrivacyShield, sothattheserulescanbeusedtomeetthe requirements for ITsecurityinthetransferofpersonal data totheUnitedStates.
TheRecipientacknowledges thatitshall notin anycircumstancetrytousethecoded PersonalData toidentifytheDonoror tomakecontactwiththe Donor. If theRecipientbecomes awareofany unauthorized useor disclosure oftheuseof thecodedPersonalData,theRecipientundertakes to promptlycontacttheBiobank.
8.RESULTSANDPUBLICATIONS
Results and publicationofdata processedin accordancewiththis Agreementmaybesubjectto separateagreements between theResponsibleresearcher andtheRecipient.
9.INDEMNITY
TheRecipientagreesto indemnify and holdtheBiobankand/orits employeesharmlessfrom any third partyclaim,including reasonablelegal fees,duetoor arisingoutof anywrongful use, lossor damageas a resultof theuse, handling, storage,transportorotheractivitiesrelatingtotheMaterials and/orcodedPersonalData under this Agreement.
TheRecipientshall notberesponsibleforanythird partyclaimsas a resultofthetransportofthe materials carriedoutbya subcontractor.
HowevertheRecipientagrees toonlycontractsubcontractors for transportwith appropriate insurancewhichcan usedtoindemnifytheBiobankand/or hold its employees harmless from any third partyclaim arisingout ofanywrongful use, lossordamagetotheMaterialsand/orcoded PersonalData duringtransport.
10.TERMANDTERMINATIONOFTHISAGREEMENT
This Agreementshall comeintoforceon [insertdate]andshall remain in force[for five(orX)years or] until research underthe Projecthasbeencompleted, whichever occurs first.
This Agreement maybeterminatedbyeitherPartyforanyreason,bygivingthe other Partythirty
(30)day´s writtennotice.
TheBiobankhastheright toterminatethisAgreementwithimmediateeffectif theRecipientis in material breachofitsobligations underthis Agreement or becomes bankrupt,liquidatedor otherwisebecomes insolvent.
11.TERMINATIONOFTREATMENTOFBIOLOGICALMATERIALSANDDATA
TheRecipientagrees,onexpiry ofthis Agreement,tostoptheuseoftheMaterials andcoded PersonalData.
TheRecipientagreesto returnor destroyanyresidualMaterial andcopiesoftheassociated coded PersonalData,whentheProjectiscompleteorwithinthirty(30) days after terminationor expiration of this Agreement,whichever occurs first.
Statethe estimated end date forusingthe biologicalmaterialsaccordingtothisagreement Statewhenthe analysisisplannedto be finished(year,month):
Sampleswillbe:
Completelyconsumed duringanalysis.
Destroyed afteranalysis.Estimate date fordestructionof samples(year,month): Returned afteranalysis.Estimate date forreturnofsamples(year,month):
Other:
TheRecipientisresponsible forthe destructionorreturnof the MaterialsandPersonalData.
TheRecipientshall havetherighttoretainsuchcopies as arerequiredtocomplywithanyapplicable laws, rulesand regulations.
12.OTHER
Noprovisionofthis Agreementmaybeamendedormodified, exceptbywritten instrumentduly executed by an authorizedrepresentativeof eachParty.
All communicationsconcerningthis Agreementshall beinwritingandshall bedeliveredtothe address indicatedbelow, unless aPartyhas specificallybeennotified bytheother Partyof another address forthis purpose.
Messageis delivered in person, bymail, e-mailor fax.A receiptshall alwaysbeprovidedforeach receivedmessage.
13.APPLICABLELAWANDDISPUTES
Note;If cooperation/funding agreements alsoexist-checkthattheyharmonizewiththetermsof this agreements.
This Agreementis governed bySwedishlawand anydisputes arising underor inconnectionwiththis Agreementshall beprimarilyresolvedthrough negotiations amongthepartiesormediation under therulesoftheStockholm Chamberof CommerceMediation Institute(SCC).
If thedisputecannotberesolved bymediation,itshallbesettled bymeansof arbitration administered bytheStockholm Chamberof CommerceArbitration Institute(SCC).
This Agreementis issued(2) original,wherebothParties havetakenone(1)copyeach.
CONTACT
Sampleprincipal”Biobank” (nameof principal):KarolinskaInstitutet
Nameof Biobank:
KIBiobank / Biobankno. (IVO):
222
Authorizedrepresentativefor Biobankin Sweden
Name:
Mark Divers
Address:
Box281
Postcode:
171 77 / City:
Stockholm
Country:
Sweden
E-mail:
Phone work:
+46852482301
SIGNATURES
Authorized representativefor recipient(for the laboratory/analysisunit orcompanywithinoroutside Sweden) / Date andcity:Nameincapitals:
Authorized representativefor Biobankin Sweden / Date andcity:
Nameincapitals::
ATTACHMENT1:BIOLOGICALMATERIAL
Describe the Biological Material and Personal Data to be transferred:
TheMaterialandassociatedPersonalDataforanalysisisprovidedinpseudo-anonymisedform3.
A detailed list of the samples to be transferred will be attached by the responsibleresearcher with each sample shipment.
SIGNATUREbytheresponsibleresearcher
Date andcity:Signature:
Nameincapitals:
Responsibleresearcher=theresearcherresponsiblefortheresearchprojectinSweden.ForexamplePrincipalinvestigator,Nationalinvestigator,ClinicalTrialInvestigatororSamplecollectionsresponsibleperson
3Notethatevenencodedorencrypted dataispersonal dataaslongascodeorencryptionkeyisleft,(personaldata"),forwhichBiobankprincipal isresponsible.
ATTACHMENT2:RESEARCHTOBECONDUCTEDONCURRENTSAMPLES
Attached byresponsibleresearcher
DetailedspecificationofthepurposesforwhichbiologicalmaterialandPersonalDatamaybeused.Specifysothatonlysuchusethatareincludedintheethicalboarddecisionmaybeconductedandsothatthereisnoroomleft forotheruse.
Descriptionof theresearchproject:
SIGNATUREbytheresponsibleresearcher
Date andcity:Signature:
Nameincapitals:
Responsibleresearcher=theresearcherresponsiblefortheresearchprojectinSweden.Forexample, Principalinvestigator,Nationalinvestigator,ClinicalTrialInvestigatororSamplecollectionsresponsibleperson
ATTACHMENT3:ITSECURITYREGULATION
Accessprotection:
Whencomputer equipmentand removablestorage media arenotundersupervision, theequipment andthemedia aretobelocked awaytoprotectthemfrom unauthorized use, tampering andtheft. Otherwise, allPersonalData mustbeencrypted. Personal Dataon laptopcomputers andtheir removablestorage mediamustalways beencrypted.
Back-ups:
PersonalDatamustberegularlybacked up. Thesecopies areto bekeptseparateandwell protected sothattheinformationcanberecoveredaftera crash.
Authorization:
If thecomputer isusedbymorethanoneperson, access toPersonalDatamustbecontrolledwitha technical authorizationsystem. Authorization is tobeconfinedtotheperson(s)whoneedthe information intheirwork.Usernames and passwordsarepersonal andnon-transferrable.Procedures mustbein placeforthegrantingof authorization.
Log:
If thecomputer isusedbymorethanoneperson, anautomatic logor similarmustbeinstalledto makeit possible tomonitor who has had accesstoPersonalData ata futuredate. This log is tolist theuser,thedateandtimeof access, andthenames of theperson(s) whosedatawas retrieved. This informationis tobechecked as necessary.
Datacommunication:
External data communication links aretobeprotectedwithacallbackorother technical function for checking authorization.PersonalDatatransferredviadata linktoacomputer locatedoutsidethe jurisdictionof theorganizationmustbeencrypted.
Destruction:
Whenstationaryor removablestoragemediacontainingPersonalData arenolonger to beusedfor their intended purpose,allstoragemediamustbedestroyed. Alternatively,the PersonalDatamust beerased inawaythatisimpossibletoretrieve.
Repairandservice:
Whencomputer equipmentis repairedorserviced bya third party,a securityagreementmustbe signedwiththeservicecompanyin question.
Whencomputer equipmentis beingserviced, allstoragemedia containingPersonal Datamustbe removed;ifthis isnotpossible, theservicemustbecarriedoutunder thesupervisionofthe organization.
Serviceviadata linkmayonlyproceed aftertheperson performing it hasbeensecurelyidentified. Servicepersonnel aretobegivenaccess tothesystem forthedurationof theserviceonly.
If a separatecommunicationchannel is in placefor service,itmustbekeptclosedwhenserviceis not beingcarriedout.