TheSleepHeartHealthStudy (SHHS) Data Distribution Agreement
Thepurpose of thisDataDistributionAgreement(DDA) istogivetheRecipientaccesstodata fromtheSleepHeartHealthStudytouse for healthresearchrelatedanalyses.In addition,this documentismeanttoensuretheprivacyof studyparticipantsandtheconfidentialityof the informationtheyhaveprovided.ThedocumentalsorequirestheRecipienttoappropriately acknowledgethesourceof thedataandthecontributionof theStudyInvestigatorsincollecting andmanagingthedatatocreatethisdistributeddataset.TheRecipientmustagreetotheuse or disclosureof thehealthinformationcontainedintheSHHS analyticdatasetonlyas permittedin thisDataDistributionAgreement(DDA). TheDDA mustbesignedandapprovedpriortothe distributionof SHHS data.
RESEARCH PROJECT
1. Nameande-mailaddress of Recipient;nameof Recipient’saffiliateinstitution:
2. TheDataaretobeused solelyinconnectionwiththefollowingresearchprojectnamed below:
3. In additiontothenameor briefdescriptionrecordedabove,asynopsis of theproposalistobe includedas anattachment.
Therequestedsynopsis isattached.
4. Bysigningthisagreement,you agreetohaveyour name,titleor descriptionof your research project,andthesynopsis you haveattachedtothisdocumentpostedtothepublicallyaccessible areaof theSHHS websiteinatablewhichlistsallproposalsandmanuscriptsinprogress.
5. TheResearchProject(circleone):[does][does not]involveSHHS Investigator(s)as co- investigator(s).If theProjectdoes involveSHHS Investigator(s),listthename(s)below:
DATA DISTRIBUTION DOCUMENT
1. One projectperagreement- ThisDistributionAgreementcoversonlytheabove-described ResearchProject.RecipientwillsubmitacompletedDistributionAgreement(thisdocument)for eachresearchprojectfor whichdataarerequested.
2. Non-transferability- ThisDistributionAgreementisnottransferable.Recipientagreesthat substantivechangesmadetotheResearchProjectdescribedabove,and/orappointmentby Recipientof anotherPrincipalInvestigatortocompletetheResearchProject,requireexecution of anew DistributionAgreementinwhichthenew PrincipalInvestigatorand/ornew Research Projectaredesignated.
PUBLICATION AND MANUSCRIPT REVIEW
1. Publication- Promptpublicationor anypublicdisclosureof theresultsof theResearch Project isencouraged.TheRecipientagreestoprovidetheSHHS ResearchGroup acopyof any manuscriptor otherdisclosuredocumentthirty(30) days inadvanceof submissionfor publicationinordertoensurecompliancewiththeconfidentialityandacknowledgment requirementssetforthinthisAgreement.
2. ManuscriptReview,Acknowledgments,andDisclaimers
2a.CollaborationswithSHHS Investigators
•If theResearchProjectinvolvescollaborationwithaSHHS Investigator,the RecipientwillacknowledgeSHHS Investigatorsas co-authors,as appropriate,on anypublication
•Resultingmanuscriptswillbereviewedby theSHHS ResearchGroup according tostandardSHHS policiespertainingtopublicationandpresentationas specified initsmanualof operationsandon thewebsite,
•If theRecipientuses SHHS datafromtheStrongHeartStudycohort,thestandard
IndianHealthServicedisclaimerbelowMUST beincludedinthemanuscript:
"Theopinionsexpressedinthispaper are thoseoftheauthor(s) and do notnecessarily reflecttheviewsoftheIndianHealthService."
In addition,ifusingdatafromtheStrongHeartcohort,alayabstractmustbesubmitted for tribalapproval.Tribalapprovalalsoisrequiredfor anyanalyses/publicationswhichincludes datafromtheStrongHeartStudy.Itistheresponsibilityof therequestinginvestigatortoobtain andsubmitdocumentationof tribalapproval.Toobtainsuch approval,thefollowingtribal representativeshouldbecontacted:
ElisaLeeof theUniversityof Oklahoma.E-mailaddress:
•Manuscriptsshallincludeacknowledgmentof theSHHS ResearchGroup as printedbelow:
“The SleepHeart HealthStudywas supported byNationalHeart, Lung and Blood InstitutecooperativeagreementsU01HL53940 (UniversityofWashington), U01HL53941 (BostonUniversity),U01HL53938 (UniversityofArizona), U01HL53916
(UniversityofCalifornia,Davis), U01HL53934 (UniversityofMinnesota),U01HL53931 (NewYork University),U01HL53937 and U01HL64360 (Johns Hopkins University), U01HL63463 (Case WesternReserveUniversity),and U01HL63429 (Missouri Breaks Research).AlistofSHHS investigators,staffand theirparticipatinginstitutionsis availableon theSHHS website,
The AtherosclerosisRiskinCommunitiesStudy(ARIC),theCardiovascularHealthStudy (CHS), theFramingham Heart Study(FHS), theCornell/Mt.SinaiWorksiteand HypertensionStudies,theStrongHeart Study(SHS), theTucson EpidemiologicStudyof AirwaysObstructiveDiseases (TES), and theTucson Healthand EnvironmentStudy (H&E)allowedtheircohortmembers tobepartoftheSHHS and permitteddata
acquiredbythemtobeused inthestudy.”
2b. Requestsfrominvestigatorsoutsideof SHHS
•Creditistobegiventotheinvestigatorsof TheSleepHeartHealthStudyinthe
Methods sectionof thepaperbutisnottobeincludedaspartof thetitle.
•Namesof SHHS sitesandtheirgrantnumbersarenottobeincluded
•Non-study Investigators who request any data fromStrong HeartStudy (SHS) cohorts MUST collaboratewithSHHSInvestigator(s). (Seeitem2a,3rdbullet,above)
•For allproposals notreviewedby theSHHS PublicationsandPresentations
Committee,thefollowingdisclaimeristobeadded:
“This paper represents thework oftheauthors and nottheSHHS.”
•If theRecipientuses SHHS datafromtheStrongHeartStudycohort,thestandard
IndianHealthServicedisclaimerbelowMUST beincludedinthemanuscript:
"Theopinionsexpressedinthispaper are thoseoftheauthor(s) and do notnecessarily reflecttheviewsoftheIndianHealthService."
In addition,ifusingdatafromtheStrongHeartcohort,alayabstractmustbesubmitted
fortribalapproval.Tribalapprovalalsoisrequiredforanyanalyses/publicationswhichincludes datafromtheStrongHeartStudy.Itistheresponsibilityoftherequestinginvestigatortoobtain andsubmitdocumentationoftribalapproval.Toobtainsuchapproval,thefollowingtribal representativeshouldbecontacted:
ElisaLeeoftheUniversityofOklahoma.E-mailaddress:
ADDITIONALREQUIREMENTS -TheRecipientagreestothefollowing:
1.Datasetswillnotbefurtherusedordisclosedotherthanaspermittedbythisagreement orotherwiserequiredbylaw
2.Appropriatesafeguardswillbeusedtopreventtheuseordisclosureofthedatasetsother thanasoutlinedbythisagreement
3.Anyuseordisclosureofthedatasetbeyondthatprovidedforinthisagreementwillbe immediatelyreportedtotheCoordinatingCenter
4.Anyagents,includingsubcontractors,towhomtheRecipientprovidestheSHHSdatasetwillagreetothesamerestrictionsandconditionsthatapplytotheRecipient
5.Therewillbenoattempttoidentifythepersonsfromwhomthedatasetsoriginatedorto contactsuchindividuals
6.IRBapprovalmustbeobtainedfromtheRecipient'sinstitution.Documentationof
IRBapprovalMUSTbesubmittedalongwiththissignedagreement.
Bysigningthisform,theRecipientiscertifyingthathe/shewillusetheanalyticdatasetunder theconditionsdescribedinthisdocument.
RECIPIENT-signatureanddate:
______
SHHS-Authorizedrepresentative signatureanddate: