Last revised 4/15/15

INTRODUCTION AND STATEMENT OF POLICY

TheNationalInstitute on Aging (NIA) hasestablishedthe NIA Genetics of Alzheimer’s Disease Data Storage Site (NIAGADS) as a resource to serve as a repository for many types of data generated by NIA supported grants and cooperative agreements and/or NIA funded biological samples. NIAGADS operates under theNIH Genomics Data Sharing Policy (GDS) and the NIA Genomics of Alzheimer’s Disease Data Sharing Policy . Becausethehumangenomic and phenotypicdatacontained inNIAGADS is,insome instances, potentiallysensitive information, e.g.,datarelatedto thepresenceorriskof developingAlzheimer’s Disease and related neurodegenerative disorders,andinformationregardingfamilyrelationships orancestry,datamustbe sharedin amannerconsistentwiththeresearchparticipants’informedconsent,andtheconfidentialityof thedataand the privacyof participantsmustbe protected.

Accessto humangenomic data willbeprovided toresearchinvestigators who,alongwiththeirinstitutions,havecertifiedtheiragreementwiththe expectationsandterms ofaccessdetailedbelow. Itistheintentof NIHand theNational Institute on Aging (NIA)thatapprovedusers ofdatasetsobtainedthroughthis NIAGADS DataAccessRequest (DAR) recognize anyrestrictionsondatauseestablishedbythe submittinginstitutionthrough theInstitutionalCertificationandstated onthe NIAGADS website

Definitions ofterminology usedin thisdocumentarefound intheAppendix.

Thepartiestothisagreementinclude: thePrincipalInvestigator (PI)requestingaccesstothegenomicstudydataset(an“ApprovedUser”), the PI’shomeinstitution asrepresented bytheInstitutionalSigningOfficial(the“Requester”),andNIAGADS. Theeffective date ofthisagreementshallbethe ProjectApprovalDate, asspecified ontheNIAGADS approvalnotification.

TERMS OF ACCESS

  1. Research Use

TheRequesteragreesthatifaccessisapproved,(1)thePInamed in the DataAccessRequest(DAR)and

(2)thosenamed inthe“Senior/KeyPersonProfile”sectionofthe DAR,includingthe InformationTechnologyDirectorandanytrainee,employee, or contractor1workingon the proposedresearchprojectunderthedirectoversightoftheseindividuals,shallbecomeApproved Usersoftherequesteddataset(s).Researchusewilloccursolelyin connectionwiththeapprovedresearchprojectdescribedinthe DAR,

1 Ifcontractorservicesaretobeutilized,theprincipalinvestigator(PI)requestingthedatamustprovideabriefdescriptionoftheservicesthatthecontractor willperformforthePI(e.g.,datacleaningservices)intheresearchusestatementoftheDAR.Additionally,theKeyPersonnelsectionoftheDARmustincludethenameofthecontractor’semployee(s)whowillconductthework.Theserequirementsapplywhetherthecontractorcarriesoutthe workatthePI’sfacilityoratthecontractor’sfacility.Inaddition,thePIisexpectedtoincludeinanycontractagreementrequirementstoensurethatanyofthecontractor’semployeeswho haveaccesstothedataadheretothe GDSPolicy,thisDataUseCertificationAgreement,andtheNIHSecurityBestPracticesforControlled-Access DataSubjecttotheGDSPolicy.Notethatanyscientificcollaborators,includingcontractors,whoarenotatthesameinstitutionasthePI mustsubmittheirownDAR.

whichincludes a 1-2paragraphdescriptionoftheresearchobjectives and design.Investigatorsinterestedin usingcloudcomputing2fordatastorage and analysismustindicate intheirDataAccessRequest(DAR)thattheyarerequestingpermission tousecloudcomputingand identifythecloud serviceprovider(CSP)3 or providers and/orPrivateCloudSystem(PCS)thattheyproposeto use.Theymustalsosubmit a CloudComputingUseStatementaspartoftheDAR thatdescribesthetypeofserviceand howitwill be used tocarryoutthe proposedresearchdescribed inthe ResearchUseStatementofthe DAR.Ifinvestigatorsplantocollaboratewithinvestigators outsidetheirowninstitution,theinvestigatorsateachexternalsitemustsubmitanindependentDAR usingthesameprojecttitleand Research Use Statement, and ifusingthecloud,CloudComputingUseStatement. Newusesofthesedataoutsidethosedescribed intheDAR willrequiresubmission ofa newDAR;modificationsto theresearchprojectwillrequiresubmissionof anamendmenttothisapplication(e.g.,addingor deletingcollaboratorsfromthe sameinstitution,addingdatasetsto anapprovedproject).Access totherequesteddataset(s)is grantedforaperiodof 1 yearasdefinedbelow.

  1. Requester andApproved User Responsibilities

TheRequesteragrees through the submissionoftheDARthatthe PInamed has reviewed andunderstandsthe principlesforresponsibleresearchuseand datamanagementof thegenomicdatasets asdefinedin theNIH SecurityBestPracticesforControlled-Access Data SubjecttotheGDSPolicy. TheRequester and ApprovedUsersfurtheracknowledgethattheyareresponsibleforensuringthatallusesof thedataareconsistentwithnational,tribal,andstatelaws andregulations, as appropriate,aswellasrelevantinstitutionalpolicies andproceduresfor managingsensitivegenomic andphenotypicdata.TheRequester certifiesthatthePIis in goodstanding(i.e.,no knownsanctions)withtheinstitution,relevantfundingagencies,andregulatoryagenciesand iseligible to conductindependentresearch (i.e., isnotapostdoctoralfellow,student, or trainee).TheRequester andallApprovedUsersmayuse thedataset(s)onlyin accordancewiththeparametersdescribed onthe NIAGADS websitefortheappropriateresearchuse,as wellas anylimitationson such use,ofthedataset(s)and asdescribedinthe DARand asrequired bylaw.

Throughsubmission ofthe DAR, the PIagrees to submiteithera projectrenewal or close-outrequestpriortotheexpirationdateof the1-year data accessperiod.The PIalso agreestosubmitan annualprogressupdateor afinalprogressreportpriortothe 1-yearanniversaryofthe DAR, as describedunderResearch UseReportingbelow.Failureto submita renewalortocompletetheclose-outprocess, includingconfirmationof datadestruction bytheInstitutionalSigningOfficial,may resultinterminationof allcurrentdataaccessand/orsuspensionofthe PIand allassociatedpersonnelandcollaboratorsfromsubmittingnew DARs foraperiodto be determinedbyNIH. Repeated violationsor unresponsiveness toNIH requestsmay resultin furthercompliancemeasuresaffectingtheRequester.

2TheNationalInstituteforStandardsandTechnologydefinescloudcomputingasamodelforenablingubiquitous,convenient,on-demandnetworkaccesstoasharedpoolofconfigurablecomputingresources(e.g.,networks,servers,storage,applications,andservices)thatcanberapidlyprovisionedandreleasedwithminimalmanagementeffortorserviceproviderinteraction.Formoreinformationsee:

3TheNationalInstituteforStandardsandTechnologydefines acloudserviceproviderasacompanythatoffers

somecomponentofcloudcomputingtootherbusinessesorindividual,typicallyInfrastructureasaService(IaaS),SoftwareasaService(SaaS)orPlatformasaService(PaaS),asdefinedbytheNationalInstituteofStandardsandTechnology.Formoreinformationsee:

ApprovedUsers who haveaccessto personalidentifyinginformationforresearchparticipantsintheoriginalstudyattheirinstitution orthroughtheircollaboratorsmay be requiredtohaveIRB approval.Byapprovingand submittingthe attachedDAR,theInstitutional SigningOfficialprovidesassurancethatrelevantinstitutional policies and national,tribal,and statelaws andregulations, asapplicable,havebeenfollowed,includingIRB approvalifrequired.The Institutional SigningOfficialalsoassuresthroughtheapprovalofthe DARthatotherinstitutionaldepartmentswithrelevantauthorities(e.g.,thoseoverseeinghumansubjectsresearch,informationtechnology, or technology transfer)havereviewedtherelevantsections ofthe NIHGDSPolicyand theassociatedproceduresandareinagreementwiththeprinciplesdefined.

Insome cases, NIH anticipatesthatcontrolled-accessdatasetssubjecttothe GDSPolicy willbeupdatedwithadditionalinformation. Unlessotherwiseindicated,allstatementshereinarepresumed tobetrueandapplicabletotheaccess anduse ofallversionsofthesedatasets.

  1. Public Posting of Approved Users’ Research Use Statement

PIsagreethatifthey becomeApproved Users, informationaboutthemselvesandtheirapprovedresearchusewillbepostedpubliclyonthe NIAGADS website.TheinformationincludestheApproved User’sname andinstitution,projectname,researchusestatement,and a non-technicalsummaryof theresearchusestatement. Inaddition, andifapplicable,thisinformationmay include the CloudComputingUseStatementand name ofthe CSPorPCS. Citationsofpublicationsresultingfromthe useofdatasetsobtainedthroughthisDARmayalso be posted on theNIAGADS website.

  1. Non-Identification

ApprovedUsersagreenotto usetherequesteddatasets,either aloneorinconcertwithanyotherinformation,toidentifyor contactindividualparticipantsfromwhomdata and/or DNA sampleswerecollected.Thisprovisiondoesnotapplyto researchinvestigatorsoperatingwithspecificIRB approval,pursuantto 45CFR46, tocontactindividualswithindatasetsorto obtain anduseidentifyinginformationunder an IRB approvedresearchprotocol.Allinvestigatorsconducting“humansubjectsresearch”withinthescopeof 45 CFR46 mustcomplywiththerequirementscontainedtherein.

  1. Non-Transferability

TheRequesterandApprovedUsersagreetoretaincontrolofthedataandfurtheragreenottodistributedataobtainedthroughtheDARto anyentityorindividualnotidentifiedinthesubmittedDAR. IfApprovedUsersareprovidedaccessto controlled-accessdatasetssubjecttothe GDSPolicyforinter-institutionalcollaborativeresearchdescribedin theresearch usestatementofthe DAR, and allmembersof thecollaborationarealsoApprovedUsersthroughtheirhomeinstitution(s),dataobtainedthroughthisDARmay be securelytransmittedwithinthecollaborativegroup.ApprovedUsersareexpected tofollowalldatasecuritypracticesandotherterms ofusedefined inthisagreement, the

NIH SecurityBest Practicesfor Controlled-AccessDataSubjecttothe GDSPolicyandthe Requester’sITsecurityrequirementsand policies.

TheRequesterandApprovedUsersacknowledgeresponsibilityforensuringthereview and agreementtothetermswithinthisDataUseCertificationAgreementandtheappropriateresearchuseofcontrolled- accessdataobtainedthroughthisDAR by researchstaffassociatedwith anyapproved project,subjecttoapplicablelawsandregulations. Controlled-accessdatasetsobtainedthroughthis DAR, in wholeorinpart,may notbe sold toanyindividualatanypointintime for anypurpose.

PIsagreethatiftheychangeinstitutionsduringtheaccessperiodtheywillcompletetheDAR close-outprocessbeforemovingto theirnew institution.AnewDARand Data UseCertification,inwhichthe newRequester agreestotheGDSPolicy,mustbe approved bythe NIAGAD Data Use Committee beforecontrolled-accessdataobtainedthroughthisDARmay be re-accessed. Aspartoftheclose-outprocess, anyversionsof thedatastoredatthe institutionand/orCSP mustbedestroyed anddestructionconfirmed bythe SigningOfficial,asdescribedbelow.

  1. Data Security and DataRelease Reporting

TheRequesterandApprovedUsers,includingtheinstitutionalITDirector,acknowledgeNIH’sexpectationthattheyhavereviewed andagreetomanage the requesteddataset(s)accordingtothecurrent NIH SecurityBestPracticesforControlled-AccessDataSubjectto theGDSPolicy and theinstitutionalITsecurityrequirementsandpolicies,andthattheinstitution’sITsecurityrequirements and policiesaresufficienttoprotecttheconfidentialityand integrityofthe NIH controlled-accessdataentrustedto theRequester.

Ifapproved byNIH tousecloudcomputingfortheproposedresearchproject, asoutlined inthe Researchand CloudComputingUseStatements of theDataAccessRequest,theRequester acknowledgesthattheITDirectorhasreviewedandunderstandsthecloudcomputingguidelines in theNIH SecurityBest Practicesfor Controlled-AccessDataSubjecttothe GDS Policy.

Requesters andPIsagree tonotifytheNIAGADS Data Use Committee of anyunauthorizeddatasharing,breachesofdatasecurity, orinadvertentdatareleasesthatmay compromisedataconfidentialitywithin 24hours ofwhentheincidentisidentified. As permitted bylaw, notificationsshouldincludeanyknowninformationregardingtheincidentand a generaldescription oftheactivities orprocessin placetodefineand remediatethesituationfully. Within3 businessdays oftheNIAGADS Data Use Committee notification,theRequester,throughthe PIand the Institutional SigningOfficial,agreetosubmittotheNIAGADS Data Use Committee a detailedwrittenreportincludingthe dateand natureoftheevent,actionstakenorto betakento remediatetheissue(s),andplansor processesdevelopedtopreventfurtherproblems,includingspecificinformation ontimelinesanticipatedforaction.

Allnotifications andwrittenreports ofdatasecurityincidentsshouldbesentto:

NIAGADS Data Access Administrator

NIA,NIH, or another entitydesignated by NIHmay, as permitted bylaw, alsoinvestigate anydatasecurityincident. Approved Usersandtheirassociatesagree tosupportsuchinvestigationsand

provideinformation,withinthelimitsofapplicablelocal,state,and federallawsandregulations.Inaddition,Requesters andApprovedUsersagreetoworkwiththeNIAGADS Data Use CommitteeandNIHto assurethatplansandproceduresthat aredevelopedtoaddressidentifiedproblems are mutuallyacceptableandconsistentwithapplicablelaw.

  1. IntellectualProperty

Byrequestingaccessto genomicdataset(s),theRequesterand ApprovedUsersacknowledgetheintentof

theNIHthatanyoneauthorizedforresearchaccessthrough the attached DAR follow theintellectualproperty(IP)principles intheNIHGDSPolicyas summarizedbelow:

Achievingmaximumpublic benefitistheultimategoalof datadistributionthrough the NIH-designateddatarepositories. TheNIHencouragesbroaduseofNIH-supportedgenotype-phenotypedatathatisconsistentwitharesponsibleapproachtomanagementofintellectualproperty derivedfromdownstreamdiscoveries,asoutlinedintheNIHBestPracticesforthe LicensingofGenomicInventionsanditsResearchToolsPolicy.

The NIHconsidersthesedataaspre-competitive and urgesApprovedUsers toavoidmaking IPclaimsderiveddirectlyfromthegenomicdataset(s).Itisexpectedthat theseNIH-provideddata,and conclusionsderivedtherefrom,willremainfreelyavailable,withoutrequirementforlicensing. However, the NIHalsorecognizes theimportanceofthesubsequentdevelopmentof IPon downstreamdiscoveries,especiallyintherapeutics,whichwillbe necessarytosupportfullinvestmentinproductstobenefitthepublic.

  1. Research Dissemination and Acknowledgement ofControlled-AccessDatasetsSubjectto theGDS Policy

Itis NIH’sintentto promote thedisseminationofresearchfindingsfromcontrolled-accessdataset(s)subjecttothe GDSPolicy as widelyas possiblethroughscientificpublicationorother appropriatepublicdisseminationmechanisms. ApprovedUsersare stronglyencouraged to publishtheirresultsinpeer-reviewedjournals andto presentresearchfindings atscientificmeetings.

ApprovedUsersagreetoacknowledge the Contributing Investigator(s)whosubmitteddatafromtheoriginalstudyto NIAGADS, theprimaryfundingorganizationthatsupportedtheContributingInvestigators, andthe NIAGADS in alloralandwrittenpresentations,disclosures,and publicationsresultingfromanyanalyses ofcontrolled-accessdataobtainedthrough this DAR.ApprovedUsersfurtheragreethattheacknowledgmentshallincludethereference to NIAGADS- specificversionof the dataset(s)analyzed. A sampleacknowledgmentstatementfortheADSP dataset(s)follows:

Acknowledgment statement for NIAGADS

Approved users agree that the acknowledgment shall include the NIAGADS-specific version of the dataset(s) analyzed. A sample statement for the acknowledgment of the ADSP dataset(s) follows:

Data for this study were prepared, archived, and distributed by the National Institute on Aging Alzheimer’s Disease Data Storage Site (NIAGADS) at the University of Pennsylvania (U24-AG041689-01), funded by the National Institute on Aging.

  1. Research Use Reporting

ToassureadherencetoNIH policies andproceduresforgenomicdata,PIsagreetoprovideannualprogressupdatesas partofthe annualprojectrenewalor projectclose-outprocesses,prior totheexpirationofthe 1-yeardataaccessperiod. PIs who areseekingrenewalor close-outof a projectagreetocompletethe appropriateonlineforms and providespecificinformationsuchashowthe datahave beenused,includingpublications orpresentationsthatresultedfromthe useoftherequesteddataset(s), asummaryof anyplans forfutureresearchuse (iftherequesterisseekingrenewal),anyviolationsoftheterms ofaccessdescribedwithinthis Data UseCertificationAgreementandtheimplementedremediation,and information onanydownstreamintellectual propertygeneratedfromthe data.PIs also may includegeneralcommentsregardingtopicssuchastheeffectivenessofthe dataaccessprocess(e.g.,easeofaccessanduse),appropriatenessof dataformat,challenges in followingthepolicies, andsuggestionsforimprovingdata accessortheprogramin general. Informationprovided intheprogressupdateshelpsNIHevaluateprogramactivitiesand may be consideredbythe NIHGDSgovernancecommitteesaspartofNIH’seffortto provideongoingoversightandmanagementofdatasharingactivities subjecttothe GDSPolicy.

Notethatanyinadvertentorinappropriatedatareleaseincidentsshouldbereportedto the NIAGADS Data Use Committee accordingto theagreementsandinstructionsunderTerm 6.

  1. Non-Endorsement,Indemnification

TheRequesterandApprovedUsersacknowledgethatalthoughallreasonableeffortshave beentaken toensuretheaccuracyandreliabilityof controlled-accessdata obtainedthroughthisDAR,theNIH, theNIAGADS Data Use Committee, and ContributingInvestigators donotandcannotwarranttheresultsthatmay be obtainedbyusinganydataincludedtherein. NIH, theNIAGADS Data Use Committee, and allcontributorstothesedatasetsdisclaimallwarranties asto performanceorfitnessofthedatafor anyparticularpurpose.

Noindemnificationfor anyloss,claim,damage, orliabilityisintended orprovidedbyanypartyunderthisagreement. Eachpartyshallbeliableforany loss,claim,damage, orliabilitythatsaidpartyincursasa resultofitsactivitiesunderthisagreement,exceptthatNIH, as an agencyof theUnitedStates,may beliableonlytotheextent providedundertheFederalTortClaims Act, 28 USC2671etseq.

  1. Terminationand Violations

Uponprojectclose-out, allApprovedUsersagreeto destroyallcopiesoftherequesteddataset(s),onbothlocalserversand hardware,andifcloudcomputingwas used,deletethedataand cloudimages from cloudcomputingproviderstorage,virtualandphysicalmachines,databases,andrandomaccessarchives,exceptasrequired bypublicationpracticesorlaw toretainthem.

TheRequesterand PIacknowledgethatthe NIHor theNIAGADS Data Use Committeemay terminatethisagreementandimmediatelyrevoke accessto allcontrolled-accessdatasets subjectto theGDSPolicy atany time ifthe Requester isfound tobe no longerinagreementwiththepolicies,principlesandproceduresoftheNIH and the NIA Data Use Committee.

By signing below, the signee acknowledges that the information in this document has been read and agrees to the terms and conditions prescribed herein.

Signature of the Principal InvestigatorDate

Printed name of the Principal Investigator

Signature of Institutional OfficialDate

Printed name of the Institutional Official

Appendix follows…

APPENDIX

DEFINITIONS

ApprovedUser:A userapproved bythe relevantDataAccessCommittee(s) toaccessone ormoredatasetsfor aspecifiedperiod oftime and onlyforthepurposesoutlined inthePrincipalInvestigator(PI)’sapprovedResearchUseStatement.The Information Technology(IT)Directorindicated ontheDataAccessRequest,as wellas anystaff membersandtraineesunderthedirectsupervisionofthe PIarealso ApprovedUsersand mustabide bythetermslaidoutintheData Use CertificateAgreement.

Collaborator:Anindividualwhois notunderthedirectsupervisionof the PI(e.g., notamemberofthePI’slaboratory)whoassistswiththe PI’sresearchproject involvingcontrolled-accessdatasubjectto theGDSPolicy. InternalcollaboratorsareemployeesoftheRequesterandworkatthesamelocation/campusas thePI.ExternalcollaboratorsarenotemployeesoftheRequesterand/or donotworkatthesamelocation asthePI, and consequentlymustbe independentlyapproved toaccesscontrolled-accessdatasubjecttothe GDSPolicy.

ContributingInvestigator:Aninvestigatorwhosubmitted a genomicdatasettoan NIH-designateddatarepository(e.g.,NIAGADS).

Cloud Computing:A modelforenablingubiquitous,convenient,on-demandnetworkaccess toa sharedpoolofconfigurablecomputingresources(e.g.,networks,servers,storage,applications,andservices)thatcan berapidlyprovisionedand releasedwithminimalmanagementeffortorserviceproviderinteraction.

Cloud ServiceProvider(CSP):A companythatofferssomecomponentofcloudcomputingto otherbusinessesorindividual,typicallyInfrastructureas a Service(IaaS),SoftwareasaService(SaaS)orPlatformas aService(PaaS).

DataAccessRequest (DAR):A requestsubmittedtoa Data AccessCommitteefor a specific“consentgroup”specifyingthe datatowhichaccessissought,theplannedresearchuse,andthe names ofcollaboratorsandtheITDirector.TheDAR is signedbythePIrequestingthedata and her/hisInstitutionalSigningOfficial.Collaboratorsandprojectteammembers on a requestmustbefromthesameinstitutionororganization.

DataDerivative:anydataincludingindividual-leveldataoraggregategenomic datathatstems fromtheoriginaldatasetdeposited(e.g.imputed orannotateddata) in NIH-designateddatarepositories(e.g.,NIAGADS). Summaryinformationthatis expectedto besharedthroughcommunitypublicationpracticesinnotincludedinthisterm.

DataUseCertificationAgreement(DUC):AnagreementbetweentheApprovedUsers,theRequester,and NIH regardingthe termsassociatedwithaccess ofcontrolled-accessdatasetssubjectto theGDSPolicyand theexpectationsfor useofthesedatasets.

ApprovedUserCodeofConduct: Keyprinciplesandpracticesagreedto byallresearchinvestigatorsrequestingaccesstocontrolled-accessdatasubjecttotheGDSPolicy. Theelementswithinthe CodeofConductreflectthe terms ofaccessinthe DataUseCertification agreement. Failuretoabide bytheCode ofConductmay resultinrevocation ofan investigator’saccesstoanyand allapproveddatasets.

(See

InformationTechnology(IT)Director:Generally, aseniorITofficialwiththe necessaryexpertiseand authoritytoaffirmthe ITcapacitiesatanacademicinstitution,company, or otherresearchentity.

The ITDirectorisexpected to havetheauthorityand capacitytoensurethattheNIH SecurityBest Practicesfor Controlled-AccessDataSubjecttothe NIH GDSPolicyandtheinstitution’sITsecurityrequirementsand policiesarefollowed bytheApprovedUsers.

InstitutionalCertification:Certificationbythe Institutionthatdelineates,among otheritems, theappropriateresearchusesofthedataandtheusesthatare specificallyexcludedbythe relevantinformedconsentdocuments.(See

InstitutionalSigningOfficial:TheSigningOfficialhasinstitutionalauthoritytolegallybindtheinstitutionin grantsadministrationmatters.Thelabel,"SigningOfficial,"is usedin conjunction withthe NIHeRACommons.Theindividualfulfillingthisrolemayhave anynumberof titles inthegranteeorganization,butistypicallylocated initsOffice of SponsoredResearchorequivalent.The SigningOfficialreviewsDataAccessRequestapplicationssubmitted byPrincipalInvestigatorsand on behalfoftheinstitution,agreesto adheretothe termsdescribedin theData Use CertificationAgreementiftheapplicationissubmittedtoNIH.

PrivateCloud System(PCS): A cloudinfrastructureprovisionedforexclusiveuse bya singleorganizationcomprisingmultipleconsumers(e.g.,businessunits). Itmaybe owned, managed, andoperatedbythe organization, a thirdparty, orsomecombinationof them, and itmayexiston or offpremises.

ProgressUpdate:InformationincludedwiththeannualDataAccessRequest(DAR)renewalor close-outsummarizingthe analysisofcontrolled-accessdatasetsobtainedthroughtheDARand anypublicationsandpresentationsderivedfromthe work.

ProjectClose-out:Terminationofa researchprojectthatusedcontrolled-accessdatafroman NIH-designateddatarepository(e.g.,NIAGADS) andconfirmation of datadestructionwhen theresearchiscompletedand/ordiscontinued.Theprojectclose-outprocessis completedby NIAGADS.

ProjectRenewal:Renewalof aPI’saccesstocontrolled-accessdatasetsfor aprior-approvedproject.

Requester: The homeinstitutionororganization ofthePIthatappliesto NIAGADS foraccess to controlled-accessdatasubjecttotheGDSPolicy.

Senior/KeyPersons:Collaboratorsatthehomeinstitutionofthe datasubmitterorRequester,such astheInformationTechnologyDirector.