1Background

Summarizethepurposeandobjectivesofthetissuebankinthissection.

2EligibilitytoParticipateintheResearchTissueBank

ThissectionshouldspecifywhoiseligIBLetoparticipateintheTissueBank.Ifthereareplanstocollectresidualtissue,(forexampleleftoverbloodsamplesfromablooddrawortissuebiopsyfordiagnosisormedicalevaluationunrelatedtocollectionforthetissuebank),whichwouldnotinvolvetissuedonorinformedconsent,thatshouldbenotedhereaswell.Inthatinstance,itwillbenecessarytoobtainIRBapprovalforsuchactions,andtocollectandstorethesamplesasde-identifiedtissuesamples(consistentwithHIPAAregulatoryproceduresforde-identification)–andthatrequirementshouldbenotedhere.

Fortissuesamplescollectedspecificallyforresearch,writteninformedconsentshouldbeobtainedfromeachtissuedonorinaccordancewithHHSregulationsnotedin45CFR46.116.Includedamongthebasicelementsofinformedconsentshouldbeacleardescriptionofthe:

• operationofthecellrepository
• lengthoftimethespecimenwillbestored
• specifictypesofresearchtobeconducted(ifthetissuebankissetupfortoserviceawidevarietyofresearchinterests,thatcanbesostatedratherthannotingaspecificresearchtype)
• conditionsunderwhichdataandspecimenswillbereleasedtorecipient-investigators
• proceduresforprotectingtheprivacyofsubjectsandmaintainingtheconfidentialityofdata

Thissectionshoulddescribetheprocedureforobtainingdonorinformedconsent,i.e.whomaysigntheconsent,locationoftheoriginalinformedconsentform,etc.TheTissueBankinformedconsentformshouldbereferencedhereandaddedtothisTissueBankProtocolasanattachment.

3SampleCollection

Thissectionshouldspecifyhowcollectionproceduresaretobeaccomplished.Iftherearetissue-typespecificcollectionrequirements,thatshouldbecapturedasasubsection.Thesubsectionsbelowarelistedastypicalexamples.Add,modifyordeletetheexamplesubsectionsasappropriate.

TypicallytissuemustbetransportedtotheTissueBankwithinaspecifiedperiodoftimeaftercollectionfromthedonorinordertoremainviable.Suchrequirementsandanytissuetransportrequirements(e.g.whetherornotthetissuemustbetransportedondryice,etc.)shouldbeincludedinthissectionortheassociatedsubsections.

NOTE:allpersonnelinvolvedinthehandlingandtransportationofhumantissuearerequiredtosuccessfullycompletetheapplicabletrainingofferedbytheOfficeofEnvironmentalHealthandRADIationsSafety(EHRS).Forfurtherinformationaboutthistrainingrequirementandcourseofferings,pleasecontacttheERHSat:215.898.4453orehrs@ehrs.upenn.edu.

4TissueSampleProcessingandStorage

Thissectionshouldoverviewtherequirementsfortissueprocessingandlengthofstorageasnotedinthefollowingsubsections.

Notethelengthoftimesampleswillbestoredinthissection.Thereisnoregulatoryorlegalrequirementforalimitonthedurationofstorage,thoughifthereclearplansforalimitonthelengthofstorageinyourtissuebank,thatshouldbenotedhere.Forexample,someTissueBankshaveplanstostorecertaintypesoftissue,suchasbloodserum,indefinitely,whilelimitingtheplannedstoragetimeofothertypesoftissue,suchassofttissueorbone.

ThissectionshoulddiscusstheprocessforlabelingofTissueBanksamplesincludingtheinformationtobeincludedonthelabel.

Thesectionshouldoverviewthetissue/cellseparationandstorageprocedures.Thefollowinggivessomeexamplesubsectionsandassociatedlanguage:

4.3.1BloodSamples

Asanexampleoflanguagethatmightbeusedinthissection:

Whenadonorbloodsampleisreceived,anattemptismadetoisolate,collectandstoreperipheralbloodmononuclearcells(PBMC),granulocytesandserum.Thesessamplesarestoredinliquidnitrogenand/or–80°Cfreezeraccordingtothetissuebankstandardoperatingprocedures.

[Addfurtherdescriptionofprocessingasappropriate.]

4.3.2SoftTissueSamples

4.3.3BoneTissueSamples

4.3.4etc.

5TissueDonorPrivacyandConfidentiality

ThissectionshoulddescribehowtheidentityofthetissuedonorisprotectedandshouldincludeastatementtotheeffectthatonlypersonnelauthorizedbythePrincipleInvestigator(owner)ofTissueBankwillhavedirectaccesstothetissuestoragefacilitiesandsamples.

AccordingtotheabovesectiondescribingeligibilityforstorageintheTissueBank,insomecasestissuesampleswillarrivewithoutdonoridentifiers,inothercasestherewillbespecificdonoridentifiers.Thissectionmustdescribetheprocessforhandlingandmanagingtissuesamples,withadetaileddescriptionoftheprocedurestobefollowedwhenreceivingsamplesthatarrivewithtissuedonoridentifiers.

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