October 17, 2016 SMART IRB Agreement Final (Version 1.2) https://smartirb.org ANY ATTEMPTED REVISION(S)/MODIFICATION(S) TO THIS AGREEMENT BY A PARTICIPATING INSTITUTION WILL BE NULL AND VOID, AND UNENFORCEABLE. Page 1 of 23 Master Common Reciprocal Institutional Review Board Authorization Agreement Introduction The purpose of this SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement (“Agreement”) is to support Institutional Review Board (“IRB”) reliance in facilitation of multi- site human subjects research. The Agreement allows Participating Institutions (defined below) to cede IRB review (“Relying Institution”) to the IRB (“Reviewing IRB”) of another Participating Institution (“Reviewing IRB Institution”). Developed under an award from the National Center for Advancing Translational Sciences (“NCATS”), the National Institutes of Health (NIH), the Agreement sets forth the respective authorities, roles, and responsibilities of the parties when a Ceded Review (defined in Exhibit A) is determined to be acceptable by Participating Institutions in accordance with the process set forth herein. This Agreement is open to participation by any institution that (i) meets the eligibility requirements outlined herein and (ii) agrees to accept the terms and conditions of the Agreement through the execution of a Joinder Agreement, as further set forth in Section 1 below (“Participating Institution”). This Agreement is also open to participation on the same conditions by any independent IRB organization that provides IRB review services (“IRB Organization”). The terms “Participating Institution” and “Reviewing IRB” as used herein, and all rights and obligations of Participating Institutions and Reviewing IRBs hereunder, shall include and apply to IRB Organizations unless otherwise noted herein. A glossary of all acronyms and capitalized terms used in this Agreement, whether or not they are defined within the body of the Agreement, is provided at Exhibit A, which is attached hereto and incorporated by reference herein. This Agreement meets federal requirements for designation of another Participating Institution’s IRB as the Reviewing IRB. This Agreement shall be kept on file at each Participating Institution and shall be provided to the Office for Human Research Protections (“OHRP”) or other federal agencies upon request. 1. Eligibility and Process To Participate in the Agreement An Institution is eligible to participate in this Agreement if it meets the following requirements: 1.1 FWA; Oversight of All Research. Unless it is an IRB Organization, the institution must maintain an OHRP-approved Federalwide Assurance (“FWA”), regardless of whether it engages in federally funded human subjects research that is subject to the Federal Policy for the Protection of Human Subjects (“Federal Policy”). In addition, the institution, by policy or otherwise, must require IRB review and provide institutional oversight of its human subjects research regardless of funding source or the scope of its FWA. In the case of human subjects research that would be exempt from IRB review under Federal Policy, the institution must still provide institutional oversight of such research. Such policy need not require, and this Agreement does not require, reporting unanticipated problems, serious or continuing noncompliance, or suspension/termination of such research to OHRP or other agencies when such reporting is not required by the institution’s FWA or policies or otherwise by regulation. However, nothing in the institution’s policies may preclude, and this Agreement shall not preclude, the institution from reporting such events to OHRP or other agencies in such circumstances. The institution must inform all Participating
The purpose of this SMART IRB Master Common Reciprocal Institutional Review Board AuthorizationAgreement(“Agreement”)istosupportInstitutionalReviewBoard(“IRB”)relianceinfacilitationofmulti-sitehumansubjectsresearch.TheAgreementallowsParticipatingInstitutions(definedbelow)tocedeIRBreview(“RelyingInstitution”)totheIRB(“ReviewingIRB”)ofanotherParticipatingInstitution(“ReviewingIRBInstitution”).DevelopedunderanawardfromtheNationalCenterforAdvancingTranslationalSciences(“NCATS”),theNational Institutes of Health (NIH), the Agreement sets forth the respective authorities, roles, andresponsibilitiesofthepartieswhenaCededReview(definedinExhibitA)isdeterminedtobeacceptablebyParticipatingInstitutionsinaccordancewiththeprocesssetforthherein. This Agreement is open to participation by any institution that (i) meets the eligibility requirementsoutlined herein and (ii) agrees to accept the terms and conditions of the Agreement through theexecutionofaJoinderAgreement,asfurthersetforthinSection1below(“ParticipatingInstitution”).ThisAgreementisalsoopentoparticipationonthesameconditionsbyanyindependentIRBorganizationthat provides IRB review services (“IRB Organization”). The terms “Participating Institution” and“ReviewingIRB”asusedherein,andallrightsandobligationsofParticipatingInstitutionsandReviewingIRBshereunder,shallincludeandapplytoIRBOrganizationsunlessotherwisenotedherein.AglossaryofallacronymsandcapitalizedtermsusedinthisAgreement,whetherornottheyaredefinedwithinthebodyoftheAgreement,isprovidedatExhibitA,whichisattachedheretoandincorporatedbyreferenceherein.ThisAgreementmeets federal requirements fordesignationofanotherParticipating Institution’s IRBasthe Reviewing IRB. This Agreement shall be kept on file at each Participating Institution and shall beprovidedtotheOfficeforHumanResearchProtections(“OHRP”)orotherfederalagenciesuponrequest.1. EligibilityandProcessToParticipateintheAgreementAnInstitutioniseligibletoparticipateinthisAgreementifitmeetsthefollowingrequirements:1.1 FWA; Oversight of All Research. Unless it is an IRB Organization, the institutionmustmaintain anOHRP-approvedFederalwideAssurance (“FWA”), regardless of whether it engages in federally fundedhuman subjects research that is subject to the Federal Policy for the Protection of Human Subjects(“FederalPolicy”).Inaddition,theinstitution,bypolicyorotherwise,mustrequireIRBreviewandprovideinstitutionaloversightofitshumansubjectsresearchregardlessoffundingsourceorthescopeofitsFWA.InthecaseofhumansubjectsresearchthatwouldbeexemptfromIRBreviewunderFederalPolicy,theinstitutionmust still provide institutional oversightof such research. Suchpolicyneednot require, andthisAgreementdoesnotrequire,reportingunanticipatedproblems,seriousorcontinuingnoncompliance,or suspension/termination of such research to OHRP or other agencies when such reporting is notrequired by the institution’s FWA or policies or otherwise by regulation. However, nothing in theinstitution’spoliciesmaypreclude,andthisAgreementshallnotpreclude,theinstitutionfromreportingsucheventstoOHRPorotheragenciesinsuchcircumstances.TheinstitutionmustinformallParticipating
Institutions involved inResearch(definedbelow)oftheapplicabilityof itsFWAtotheResearchpriortosuch institution’s participation in any determination of the acceptability of a Ceded Review for theResearchpursuanttoSection3hereof.
For clarity, it is not a requirement for participation as a Relying Institution in this Agreement for aninstitutiontohaveanIRB.
1.2HRPPQuality.IfithasanIRBorisanIRBOrganization,theinstitutionmusthaveundergoneorhaveinitiated an assessment of the quality of its human research protection program (“HRPP”). Suchassessment must have occurred or have been initiated within the past five (5) years prior to theinstitution joining the Agreement. The assessment may be accomplished by accreditation through anexternalorganization,orthroughOHRP’sQualityAssessmentProgram,orotherequivalentapproach.
1.3PointsofContact(“POCs”).Theinstitutionmustidentifyandestablishatleastoneindividualwhowillserveas the contactperson responsible for communicatingonbehalfof the institutionwith respect tomattersconcerningtheinitialandongoingimplementationofthisAgreement.1.4ExecutionofaJoinderAgreement.
1.4.1 The institutionmustexecutea JoinderAgreement in substantially the same formasattachedheretoatExhibitB.TheJoinderAgreementdocuments:(i)thejoininginstitution’srepresentationandwarranty that it meets all eligibility requirements specified in Sections 1.1 through 1.3 forparticipationintheAgreement;(ii)thejoininginstitution’sagreementthatitmayacceptandrelyonthe reviewof any of the IRBs of the Participating Institutions and that any Participating Institutionmay rely on its IRB (if applicable) for Research when so elected by such Participating InstitutionsundertheAgreement;and(iii)thejoininginstitution’sagreementthatitwillbeboundbyandsubjectto the terms and conditions of the Agreement. With respect to IRB Organizations, the JoinderAgreement documents (i) the IRB Organization’s representation and warranty that it meets theeligibilityrequirementsspecifiedinSections1.2and1.3forparticipationintheAgreement;(ii)theIRBOrganization’sagreementthatanyParticipatingInstitutionmayrelyonitsIRBforResearchwhensoelectedbysuchIRBOrganizationandParticipatingInstitutionundertheAgreement;and(iii)theIRBOrganization’s agreement that itwill be bound by and subject to the terms and conditions of thisAgreement.TheEffectiveDateof theAgreementwith respect toanyParticipating Institution is theEffective Date of its Joinder Agreement, as identified in the Joinder Agreement; however, theParticipatingInstitution’sactualparticipationinanyactivitiesundertheAgreementmaybesubjecttoactivationorotherprocesses.
1.4.2 Each Participating Institution acknowledges and agrees that, if an institution meets theapplicableeligibilityrequirementsasspecifiedaboveandexecutesaJoinderAgreement, itwillbeapartytothisAgreement.
1.4.3 Forclarity, thisAgreement ismadebyandamongonly theParticipating Institutionsanddoesnot include any other separate FWA-holding entities or separate legal corporations with which aParticipating Institution or its IRB(s) may be affiliated or have an IRB reliance relationship. EachaffiliateorotherentitythathasitsownseparateFWAorisaseparatelegalcorporationwillneedtoexecuteitsownJoinderAgreementinordertoparticipateintheAgreement.
1.5StandardOperatingProcedures;OtherPoliciesandProcedures.ParticipatingInstitutionsarestronglyencouraged to use and follow the SMART IRB StandardOperating Procedures (SOPs) with respect toResearch covered under this Agreement. However, Participating Institutionsmay opt to use their ownpolicies and procedures for the reliance relationship if doing so would not render the ParticipatingInstitutionsinviolationofanytermoftheAgreement.Insuchcases,ParticipatingInstitutionsagreethatifaprovisionoftheirownpoliciesorproceduresconflictswithatermoftheAgreement,theAgreementwillgovern as to that term. Participating Institutionsmay, with respect to certain Research, be subject tospecific external policies and procedures governing the IRB reliance relationship (e.g., when theyparticipateinaclinicaltrialnetworkorwhenthereisanIRBconsortiumorprogramthatmustbeusedtooverseetheResearch),andinsuchcases,notwithstandinganythingelseinthisSection1.5,suchpoliciesand procedures will apply and will override any requirements of this Agreement with which theyconflict.In all cases, all Participating Institutions involved in Research under the Agreement mustcommunicatewith one another regardingwhether the SMART IRB SOPs or another set of policies andprocedureswillapplytosuchResearch,andmustrequiretheirResearchPersonnel(definedinExhibitA)toreviewandfollowtheapplicablepoliciesandprocedures. TheSMARTIRBSOPswillbepubliclypostedandmadeavailabletoallParticipatingInstitutions.TheSMARTIRBSOPswillbereviewedperiodicallyandmaychangefromtimetotime.Materialchangeswillbeopenforwrittencommentsontheappropriatescopeofthechange(s)and/oronspecifictopics. 2.AgreementScope2.1Scope.ThisAgreementappliesto:(i)anyhumansubjectresearchwithinthemeaningoftheFederalPolicyorwithinthemeaningofanyotherfederalhumansubjectsresearchregulationsorpolicies;(ii)anyclinicalinvestigationwithinthemeaningoftheFoodandDrugAdministration(“FDA”)IRBregulations;and(iii) any other research for which any Participating Institution(s) seek or are required to rely upon aReviewing IRB (“Research”). As used in this Agreement, Research may reference a specific study orprotocolinwhichtherewillbeaReviewingIRBandRelyingInstitutionoperatingpursuanttothetermsofthisAgreement,orcollectivelythestudiesreviewedundertheAgreement.TheParticipatingInstitutionsmayalsorelyononeanotherunderthisAgreementfordeterminationsanddocumentationofexemptionfrom IRB review pursuant to the Federal Policy; in such cases, the following specific terms of thisAgreement shall apply: Sections 1, 2.1-2.3, 3, 4, 5.1-5.3, 5.5, 5.9, 5.12, 5.14, 6.1, 6.3, 6.13, 6.14 (lastsentence),7,8,ExhibitA,andExhibitB.
2.2 Elective Use. Each Participating Institution shall have the right to elect, on a case-by-case basis,whethertocedeorprovideIRBreviewofanyResearchunderthisAgreement.
2.3Non-Exclusivity.ThisAgreementdoesnotprecludeanyParticipating Institutionfromparticipating inany other IRB authorization or reliance agreements that itmay have or enter intowith other entities,includingotherParticipatingInstitutions,orfrommakingseparatefinancialagreementstosupportreviewofResearch,whether suchResearch is cededunder thisAgreementornot. Such financial agreementsmayinclude,withoutlimitation,coverageofreviewcostsandindemnificationarrangements(asprovidedinSection4.11).
2.4DurationandNatureofCededReview.WhenreviewofResearchiscededunderthisAgreement,theResearchwillremainundertheoversightauthorityoftheReviewingIRBdetermined/selectedpursuanttoSection 3 hereof for as long as IRB review is required for the particular Research (presuming thatparticipationoftheReviewingIRBandRelyingInstitutionintheAgreementhasnotterminatedpursuant
toSection7),exceptinthecircumstancewhereaRelyingInstitutiondeterminesinitssolediscretionthatitmustwithdrawtheResearchfromCededReview(inwhichcaseitmaydosoimmediately).TheRelyingInstitutionacknowledgesandagreesthatitswithdrawalofResearchfromCededReviewmaybesubjecttootherrequirementsormayaffectitscontinuedinvolvementintheResearchpursuanttoorasaresultof other laws, regulations, funding policies, or agreements, or other external sources apart from thisAgreement,andthatinnoeventshallaReviewingIRBorReviewingIRBInstitutionberesponsibleforsuchrequirementsorconsequences.IncaseswheretheRelyingInstitutionwillcontinuewiththeResearch,theReviewing IRB and Relying Institution will work together to facilitate the transfer of IRB oversight toanother IRBwith the goals of ensuring the continuedprotectionofhuman subjects andof limiting thepotentialdisruptiontotheResearch.
3.CollaborativeProcessforConsiderationofCededReviewRequestsandDeterminationofReviewingIRB3.1RequestProcess.TheOverallPI(definedinExhibitA)(ordesignee)maymaketherequestforCededReviewofparticularResearchtotheIRBoftheParticipatingInstitutionwheretheOverallPI isprimarilyemployed or affiliated. Such Participating Institution will make an initial determination about theappropriatenessof CededReview for theResearch that is the subject of the request. TheParticipatingInstitution of the Overall PI may also on its own initiative determine that particular Researchmay beappropriate for Ceded Review. If the Overall PI and the Overall PI’s Participating Institution are notseekingbutdonotobjecttoCededReview,otherParticipatingInstitutionsmaystillparticipateinaCededReview;inthatcase,aSiteInvestigator(definedinExhibitA)maymakearequestforCededReviewoftheResearch to the IRBof theParticipating Institutionwhere theSite Investigator isprimarilyemployedoraffiliated.3.2 Review of Requests. If the Participating Institution of the Overall PI (or of the requesting SiteInvestigatorasprovidedabove)determinesthattheResearchmaybeappropriateforCededReview,thatParticipating Institutionshall consult,asneeded,with relevantParticipating Institutions (ordesignee(s))involved in the particular Research to determine whether each agrees that the requested Research isappropriateforCededReview.IfanyParticipatingInstitutiondisagreesthattheResearchisappropriateforCededReviewanddeclinestoparticipateintheCededReview,theResearchshallremaineligibleforCededReviewwithrespecttotheotherParticipatingInstitutionsthathaveagreed,ifany.NoParticipatingInstitution shall be obligated to participate as a Reviewing IRB Institution or a Relying InstitutionwithregardtoanyparticularResearch.ShouldaParticipatingInstitutiondecidetoparticipateasaReviewingIRB Institution or a Relying Institution with regard to any particular Research, no additional individualauthorizationorrelianceagreementsneedtobecompletedtoeffectuatetheCededReview.
3.3 Determination of Appropriate Reviewing IRB(s). Following a determination to apply Ceded ReviewpursuanttoSection3.2,theParticipatingInstitutionoftheOverallPIwillhavetheopportunitytodecidewhetheritwillserveastheReviewingIRBInstitutionfortheResearch(iftheParticipatingInstitutionhasanIRB),unlessanotherReviewingIRBisrequiredordesignatedpursuanttoapplicableregulation,fundingpolicy,orotherexternalrequirements.IfnosuchrequirementsapplyandiftheParticipatingInstitutionof the Overall PI does not wish to serve as Reviewing IRB, then the determination of the appropriateReviewingIRB(s)willbemadebyandamongtheParticipatingInstitutionsinvolvedintheCededReview.Ifany Participating Institution disagrees with the selection of the Reviewing IRB(s) and declines to cedereview to that Reviewing IRB(s), such decision does not affect the selection for those ParticipatingInstitutions that have agreed, if any. For clarity, there may be Research for which more than oneReviewingIRBmaybeselected.
3.4NotificationofAcceptanceorDeclinationofCededReview.Unlessotherwiseagreed,theReviewingIRB(s)(ordesignee(s))shallgenerallybetheone(s)tonotifytheOverallPIandtheSiteInvestigator(s)andthe applicable Participating Institutions (i) whether the request for Ceded Review of the Research hasbeenacceptedordeclinedunderthisAgreement;and(ii)ifaccepted,whichIRB(s)shallbetheReviewingIRB(s).3.5Exceptions. Participating Institutions acknowledge and agree thatwith respect to certain Research(forexampleResearchconductedbycertainclinical trialnetworksthathavedesignatedcentral IRBs,orindustry-sponsored Research where the sponsor is utilizing the services of an independent IRB, orResearch subject to certain federal requirements), specific mandates or alternative requirements forceding IRBreviewandprocesses fordeterminationof theReviewing IRBmayapply.WhenParticipatingInstitutionselect touse thisAgreement toprovide forCededReviewof suchResearch, theyagree thatany such specific or alternative mandates, requirements, or processes shall govern instead of theprocessessetforthinSections3.1through3.4herein.4.ResponsibilitiesoftheParticipatingInstitution(s)With respect to any Research for which review is ceded under this Agreement, each ParticipatingInstitutionthatisengagedinorconductingtheResearchagrees:4.1Education/Training/Qualifications. To ensure that its Research Personnel have adequate education,training, and qualifications to perform the Research and safeguard the rights and welfare of researchsubjects.This includes,but isnot limitedto,havingany locally institutionally requiredprofessionalstaffappointments,credentialing,insuranceorotherliabilitycoverage,traininginhumansubjectsprotections,andbackground checks for their assigned role in theResearch.AParticipating Institution’s selectionofappropriateeducation/trainingrequirementsandotherqualifications for itsResearchPersonnel isat itsdiscretion.AParticipating Institutionshallprovide informationordocumentationregarding itsResearchPersonnel’seducation,training,andqualificationsinconnectionwithaCededReviewasrequestedbytheReviewingIRB.4.2Compliance.TorequirethatitsResearchPersonnelcomplywiththedeterminationsandrequirementsof theReviewing IRB(s), applicable federal regulations, andall applicable state and local lawsand localinstitutionalrequirementsrelatingtotheResearch.4.3NotificationofandCompliancewithObligations.ToensurethatitsResearchPersonnelareinformedof and required to comply with all of the Participating Institution’s obligations under this Agreementpertainingtorequiredcoordination,communication,compliance,andreporting.4.4 Monitoring; Quality Assurance/Quality Improvement (“QA/QI”) Function/Program. To maintain,implement, or have access to a human subjects researchQA/QI process, function, program, or servicethat can conduct and report to the Participating Institution the results of for-cause and not-for-causeauditsoftheinstitution’sanditsResearchPersonnel’scompliancewithhumansubjectsprotectionsandother relevant requirements. Participating Institutions that do not have access to a QA/QI process orfunctionmusthaveanalternatemeansofmonitoringtheconductofResearchasappropriatetoensurecompliance.However,anyParticipatingInstitutionsagreeingtoparticipateinaCededReviewmayagreebetweenor among themselves towaive the requirement to have access to aQA/QI process, function,
programorserviceoralternatemeansofmonitoringwithrespecttotheResearchthat isthesubjectoftheCededReview.4.5 HIPAA. Except with respect to certain HIPAA (defined in Exhibit A) determinations as set forth inSection5.6,toberesponsible,iftheParticipatingInstitutionisaHIPAACoveredEntity(definedinExhibitA), for its own HIPAA compliance and obligations in connection with the Research (certain HIPAAdeterminationsareaddressedseparatelyinSection5.6).Inaddition,eachParticipatingInstitutionagrees:
4.6 NotificationofLegalRequirements,RequestsandClaims;Cooperation.If it isrequiredorreceivesarequesttoprovideinformationpursuantto laworto legalprocess(e.g.,asubpoenaorapublicrecordsrequest) inconnectionwiththecededResearch,or if itbecomesawareofathreatenedoractualclaim,suit,oractionarisingfromthecededResearch,tonotify(i)theReviewingIRBand(ii)otherParticipatingInstitutions that are engaged in or conducting the Research and that are affected by the requirement,request or claim (for example, that are named in or hold information responsive to the requirement,requestorclaim,orwhoseactivitiesmaybeaffectedbytherequirement,requestorclaim).EachinvolvedParticipating Institution shall reasonably assist the other(s) in investigating and responding to suchrequirements, requests or claims as mutually determined appropriate to the matter at hand. If therequirement, request or claim seeks Confidential Information (defined in Exhibit A), the affectedParticipating Institutions shall cooperate, to the extent possible, in asserting applicable exceptions todisclosure of the information. Notwithstanding the foregoing, in no event shall any ParticipatingInstitutionberequiredtocontraveneitslegalresponsibilities.Ifcommunications,analyses,orotherinformationpertainingtolegalrequirements,requestsorclaimsaresubject to the attorney-client privilege or other privilege or rule of confidentiality (e.g., peer review,patientsafetyworkproduct),thenParticipatingInstitutionsarenotrequiredtoprovideoneanotherwithanything subject to such protections, but may request development of an appropriate confidentialityagreement,otherassuranceofconfidentiality,orjointdefenseagreementtopermitsuchsharing,whichrequestshallbeconsideredbylegalcounselfortherespectiveinstitutions,asapplicable. 4.7 Notification of Changes in FWA, IRB Registration, or HRPP Status. To notify those ParticipatingInstitutionsforwhichitisthenservingastheReviewingIRB,orwithrespecttowhichitisthenaRelyingInstitution,promptlyinwritingof,asapplicable:anysuspension,restriction,termination,orexpirationofitsFWA;anyfailuretomaintainregistrationofitsIRB(s);oranylossoforchangetoitsHRPPaccreditationstatusorotherassessmentstandardperSection1.2above.4.8 Confidential Information. To treat Confidential Information provided to it by other ParticipatingInstitutionspertainingtoResearchorthereviewofResearchcededunderthisAgreement,includingbutnotlimitedtoConfidentialInformationregardingResearchPersonnelconflictsofinterestandassociateddeterminations,prohibitions,andmanagementplanssharedpursuanttoSection6.6ofthisAgreement,inaccordancewiththesamestandardsandprotectionsforconfidentialityandsecurityasitwouldapplytoits own such information, including but not limited to restricting accesswithin the institution to thosewith a need-to-know. Nothing in this Section 4.8 prevents a Participating Institution from disclosingConfidential Information to theextent suchdisclosure is requiredby law;however, the institutionshallcomplywiththetermsofSection4.6asapplicabletothedisclosure.
4.9UseofName.That itshallnotusethenameor logonoranyadaptationoracronymthereof,ofanyotherParticipatingInstitutionoritsaffiliatesinanyadvertising,promotional,orsalesliteratureorinanypublicity without the prior written approval obtained from a representative of the other ParticipatingInstitutionauthorizedbysuchParticipatingInstitutiontoprovidesuchapproval.4.10Insurance.Thatitshallmaintaininsurancecoverageofsufficienttype(s)andinreasonableamount(s)to cover its respective activities under the Agreement, including as applicable coverage of its IRB/IRBmemberswhen theParticipating Institution is acting as aReviewing IRBhereunder. Before agreeing toparticipate in a Ceded Review as either a Relying Institution or a Reviewing IRB Institution, anyParticipating Institutionmay requestfrom any other Participating Institution a certificate or equivalentdocumentationof its relevant coverage (including any sponsor-provided coverage), andmaydecline toparticipate in the Ceded Review if the requesting Participating Institution does not agree that theinsurancecoverageheldbyanyof theotherParticipating Institutions thatwill participate in theCededReviewisadequate.ForanyParticipatingInstitutionthatisastateagencyoraninstrumentalityofastateor federal government, documentation that such Participating Institution has self-funded liabilitycoverageorreliesontheapplicablelawofitsstateorfederaljurisdictiontoprotectandlimititsliabilityasan instrumentality of such state or federal government constitutes documentation of coveragehereunder. Alternatively, any Participating Institutions agreeing to participate in a Ceded ReviewmayagreewithrespecttothemselvestowaivetherequirementofthissectiontomaintaininsurancecoveragewithrespecttotheResearchthatisthesubjectoftheCededReview.4.11Indemnification.ThatanyParticipatingInstitutionmayrequestanyotherParticipatingInstitution(s)to enter a separate agreement providing for indemnification obligations or other arrangements forallocationofliabilitywithrespecttoanyResearchcededunderthisAgreementinwhichsuchinstitutionsare involved.Whethersuchagreementsorarrangementsarenegotiatedoradoptedshallbeentirely inthediscretionoftheinstitution(s)makingandreceivingtherequest.5.ResponsibilitiesoftheReviewingIRB(s)andReviewingIRBInstitution(s)WithrespecttoanyResearchforwhichreviewiscededtoitunderthisAgreement,aReviewingIRB,withsupportasapplicablefromtheReviewingIRBInstitution,will:5.1 IRBRegistration.Maintaincurrent IRB registrationwithOHRP incompliancewith theFederalPolicyandapplicableFDAregulations.5.2IRBMembership.MaintainIRBmembershipthatsatisfiestherequirementsoftheFederalPolicyandotherapplicablefederalhumansubjectsresearchregulationsorpolicies.5.3 Policies and Procedures. Make available to the Relying Institution(s), when applicable and uponrequest,theReviewingIRB’spoliciesandprocedures,includingpoliciesandproceduresoftheReviewingIRB/ReviewingIRBInstitutionregardingexemptiondeterminations.5.4 IRBReviewandOversight.Perform initialandcontinuingreviewsofsubmittedResearch; reviewsofamendments;reviewsofunanticipatedproblemsthatmayinvolveriskstosubjectsorothers;reviewsofpotentialnoncompliancewithapplicablehumansubjectsprotectionregulationsorwiththerequirementsordeterminationsoftheReviewingIRB;andreviewsofotherdocuments,requests,orinformationrelatedtotheapprovalandcontinuingoversightoftheResearch,asapplicable.ThereviewandoversightoftheResearch by the Reviewing IRB will be performed in accordance with the human subjects protection
requirements of the Relying Institution’s(s’) FWA(s), any applicable federal human subjects researchregulations and ethical principles referenced therein and any other applicable federal human subjectsresearchregulationsorpolicies.TheReviewingIRBwillconsideranylocalrequirementscommunicatedtotheReviewingIRBpursuanttoSections6.4,6.5,6.6,and6.10hereof.
5.5 Recordkeeping. Maintain records of its membership, its review activities and determinations, andother records as required by applicable federal regulations and the policies of the Reviewing IRB, andmakesuchrecordsaccessibletodesignatedofficialsattheRelyingInstitution(s),uponreasonablerequest,including,totheextentnotrestrictedunderapplicablelaw,portionsofmeetingminutesoftheReviewingIRBrelevanttotheResearchandtherequestingRelyingInstitution. 5.6HIPAA.OnbehalfofanyRelyingInstitution(s)thatareHIPAACoveredEntities,makedeterminationsas required by and in compliance with the HIPAA Privacy Rule (defined in Exhibit A) for the use anddisclosureofProtectedHealth Information (“PHI”) for theResearch, such that, to theextent theHIPAAPrivacyRuleapplies,PHIwillnotbesousedordisclosedunlessoneofthefollowingoptionsismet:
5.6.1.1Whenanauthorization is required, theauthorization languagewillbeprovidedbytheReviewingIRBandmaybeincorporatedintotheinformedconsentdocumentsfortheResearch,unless the Relying Institution obtains agreement from the Reviewing IRB to use a separateauthorization form (inwhichcase theRelying Institutionshallbe responsible forensuring theseparateformcomplieswithapplicablerequirementsintheHIPAAPrivacyRule).
5.6.1.2TheReviewingIRB,inthecaseofacombinedconsentandauthorizationform,andtheRelying Institution(s), in the case of a separate authorization form, will ensure that theauthorizationpermitsPHItobeusedbyanddisclosedtotheReviewingIRBandtheReviewingIRBInstitutionandallRelyingInstitutions(whetherlistedindividuallyordescribedasagroup)asnecessary forconducting, reviewing,andoverseeingtheResearch (including investigationandevaluationofevents)ascontemplatedbytheResearchandthisAgreement.
5.6.2AspermittedbytheHIPAAPrivacyRule,awaiveroralterationofauthorizationwillbegrantedby the Reviewing IRB. Participating Institutions agree that the Reviewing IRB Institution/IRBOrganizationneednotbeaHIPAACoveredEntityforpurposesoftheReviewingIRBmakingawaiveroralterationofauthorizationdeterminationsolongastheReviewingIRBmeetsthecompositionandqualificationrequirementsofapplicableregulation.TheReviewingIRBandReviewingIRBInstitutionmake no representation about the compatibility of a waiver or alteration of authorization with aRelyingInstitution’sprivacypractices,implementationofHIPAAorobligationsunderstatelaw.Asanalternative,aRelyingInstitution,withtheagreementoftheReviewingIRB,mayretainresponsibilityforreviewingandapprovingwaiversoforalterationsofauthorizationforResearchcededunderthisAgreementinaccordancewiththeHIPAAPrivacyRule.5.6.3Whenapplicable,thePHIislimitedtoaLimitedDataSet(definedinExhibitA)andtheLimitedDataSetwillbeusedanddisclosedpursuanttoaDataUseAgreement(definedinExhibitA).
willmakesuchdeterminationsfortheResearchsoastoensurethatPHIwillnotbeusedordisclosedforthe Research unless one of the options in Sections 5.6.1, 5.6.2, or 5.6.3 is met. Without limiting theforegoing,ifinsuchcaseaRelyingInstitutiondeterminesthatauthorizationforuseanddisclosureofPHIisrequired,itwilluseaseparate(freestanding)authorizationformasdescribedinandincompliancewiththeapplicablerequirementsofSections5.6.1.1and5.6.1.2.
5.7ConsentForms.ProvidetoeachRelyingInstitutionandSiteInvestigator(s)informedconsentformstouse for theResearchwhere theReviewing IRBhasdetermined that sucha consent form(s) is required.TheReviewing IRBwill permit aRelying Institution/Site Investigator(s) to customize limited site-specificsections of the form, generally the sections on the availability of treatment and compensation forresearch-related injury; payment or reimbursement of research costs incurred by subjects; and localcontacts.AnysuchmodificationswillbesubjecttoapprovalbytheReviewingIRB,whichwillthenprovideafinalapprovedconsentform(s)totheRelyingInstitution(s)/SiteInvestigator(s)foruse.5.8 Conflicts of Interest. Consider any applicable conflict of interest determinations and associatedmanagementplansprovidedbyaRelying Institutionpursuant toSection6.6hereofwith respect to theOverall PI, Site Investigator(s), and other Research Personnel in connection with the Research. TheReviewingIRBwillensurethatanymanagementplanisincorporatedintoitsinitialorcontinuingrevieworother deliberations, as applicable, and without limiting the foregoing, that any disclosures to subjectsrequiredbytheplanandthatareapprovablebytheReviewingIRBareincludedintheapprovedinformedconsent form(s) for the relevant Relying Institution. TheReviewing IRB retains the authority to imposeadditionalprohibitionsorconflictmanagementrequirementsmorestringentorrestrictivethanproposedbyaRelyingInstitutionifnecessarytoapprovetheResearch,provided,however,theReviewingIRBwillnotmodifyorchangeanymanagementplanormandateddisclosuretosubjectswithoutdiscussionwithandacceptancebytheRelyingInstitution.In the extraordinary circumstance that the Reviewing IRB is unable to implement/approve a RelyingInstitution’sprohibitionsormanagementplans,theReviewingIRBwillsoinformsuchRelyingInstitutionor, if the Relying Institution fails to accept any additional prohibitions or requirements, the RelyingInstitutionwillsoinformtheReviewingIRB.Iftheinstitutionsarenotabletoidentifyamutuallyagreeableapproach, theResearchwillbewithdrawnfromCededReview(withoutan IRBapprovalordisapproval)withrespecttothatRelyingInstitution.5.9 Notification of IRB Decisions, Changes, Lapses in Approval. Promptly notify the Overall PI, SiteInvestigator(s), and theRelying Institution(s)of itsdeterminations (e.g.,exemption)or reviewdecisionsregarding theResearch (e.g.,approval,disapproval, requiredmodifications);ofchanges in theResearchreviewedandapprovedbytheReviewingIRBafterinitialapproval;andoflapsesinIRBapprovalandanyapplicablecorrectiveactionplans.SuchnotificationmaybemadethroughtheReviewingIRB’sdesignee,asdeterminedbytheParticipatingInstitutionsinconnectionwiththespecificResearch.
5.10 Notification of Unanticipated Problems, Injuries, Complaints. Promptly notify the Overall PI, SiteInvestigator(s), and Relying Institution(s) of applicable review decisions as well as of any findings andactions(includinganysuspensionorterminationofIRBapprovaloftheResearchandrequiredcorrectiveactions), with respect to: (i) any unanticipated problems involving risks to human subjects or others,subjectinjuriesrelatedtoResearchparticipation,orsignificantsubjectcomplaints(e.g.,thosethatcouldaffecttheconductoftheResearch)thatoccurredattheRelyingInstitution,and(ii)sucheventsoractionsthat occurred at any institution if such events or actions relate to or may affect the conduct of the
Researchor thesafety, rightsorwelfareofhumansubjectsparticipating in theResearchat theRelyingInstitution(s).SuchnotificationmaybemadethroughtheReviewingIRB’sdesignee,asdeterminedbytheParticipatingInstitutionsinconnectionwiththespecificResearch.
5.11 Notification of Serious and/or Continuing Noncompliance. Promptly notify the Overall PI, SiteInvestigator(s),andRelyingInstitution(s)ofanyfindingsofseriousand/orcontinuingnoncompliancewithapplicable human subjects protection regulations or with the requirements or determinations of theReviewing IRB, or of apparent serious and/or continuing noncompliance with such regulations orrequirements,pertainingtotheRelyingInstitutionoritsResearchPersonnelaswellasanyactionstaken(includinganysuspensionorterminationofIRBapprovaloftheResearch)andthestepstheReviewingIRBdeemsnecessaryforremediationofthenoncomplianceattheRelyingInstitution.TheReviewingIRBwillalsonotifytheOverallPI,SiteInvestigator(s),andRelyingInstitution(s)ofanysuspensionorterminationof IRB approval and any remediation actions pertaining to findings of serious and/or continuingnoncomplianceatanyotherinstitutionifsuchfindingoractionsrelatetoormayaffecttheconductoftheResearchorthesafety,rights,orwelfareofhumansubjectsparticipating intheResearchattheRelyingInstitution(s).IftheReviewingIRBdeterminesthatthefactsofanoncompliancematteroranyothermatterunderthisSection5.11orunderSections5.9or5.10hereofraiseissuesapartfromorinadditiontononcompliancewithhumansubjectsprotectionrequirements(suchasapotentialallegationofresearchmisconduct),theReviewing IRB shall notify and refer those issues to the Relying Institution for review. Any of thenotificationsrequiredinthissectionmaybemadethroughtheReviewingIRB’sdesignee,asdeterminedbytheParticipatingInstitutionsinconnectionwiththespecificResearch.
5.12Audits,Investigations;CorrectiveActions.PromptlynotifyaRelyingInstitutionwithrespecttowhichit is conducting an audit or investigation of an allegation ormatter relating to the Ceded Review, andreport its findings of fact to such Relying Institution within a reasonable timeframe. Alternately, theReviewing IRBmay request theRelying Institution to conduct itsownaudit/investigationand report itsfindings of fact back to the Reviewing IRB, or the Reviewing IRB and Relying Institution may workcooperatively to conduct an audit/investigation. In any of these circumstances, the Reviewing IRBwillreasonably cooperatewith theaudit/investigationby theRelying Institutionasnecessary, includingbutnotlimitedto,providingResearchreviewrecordsandrelatedinformation,meetingwithrepresentativesfromtheRelyingInstitution,andhelpingtoimplementcorrectiveactions,asapplicable.Fortheclarity,noParticipating Institution is obligated to provide to another its communications, analyses, or otherinformation subject to attorney-client privilege or other privilege or rule of confidentiality (e.g., peerreview, patient safety work product), but a Participating Institution may elect to do so under anappropriateconfidentialityorotheragreementorotherassuranceofconfidentiality.The Reviewing IRB shall inform the Relying Institution of any corrective actions in connectionwith theaudit,investigation,orresolutionofanymatterunderSections5.9through5.12hereofthatarerequiredbytheReviewingIRBbutshallnotpreventtheRelyingInstitutionfromadopting itsownmorestringentadditionalcorrectiveactions.5.13 Reporting. Notify a Relying Institution in advance if the Reviewing IRB determines that underapplicable regulations or under the terms of the Relying Institution’s FWA a report is required to aregulatory agency (e.g., OHRP, FDA), sponsor, funding agency, and/or other oversight authority of any
unanticipated problems involving risks to human subjects or others, serious and/or continuingnoncompliance with applicable human subjects protection regulations or with the requirements ordeterminationsoftheReviewingIRB,and/oranysuspensionsorterminationsofIRBapproval.
5.13.1Unlessanalternate reportingarrangement isagreedupon, theReviewing IRB/Reviewing IRBInstitutionwilldraftthereportandwillprovidetheinvolvedRelyingInstitution(s)theopportunity(nofewer than five (5) business days,whenever possible) to review and comment on the draft reportbefore theReviewing IRB/Reviewing IRB Institution sends the report to theexternal recipients.TheRelying Institution(s) will promptly provide any comments on the draft report to the ReviewingIRB/Reviewing IRB Institution.TheReviewing IRB/Reviewing IRB Institution isundernoobligationtoadoptcommentsofaRelyingInstitution.However,nothinginthisAgreementshallpreventaRelyingInstitution from making its own report in addition to any report prepared by the ReviewingIRB/ReviewingIRBInstitution;ifaRelyingInstitutionsoelects,itwillprovideacopyofsuchreporttotheReviewingIRB/ReviewingIRBInstitution.
5.13.2Alternatively,theReviewingIRB/ReviewingIRBInstitutionandRelyingInstitution(s)mayagreeto make a joint report, or, depending on the circumstances the Reviewing IRB/Reviewing IRBInstitutionmayrequesttheRelyingInstitution(s)tomakethereport.
5.13.3 If theReviewingIRB/ReviewingIRBInstitutionrequeststheRelying Institution(s)tomakethereport,theRelyingInstitution(s)willpromptlypreparethedraftreportandwillprovidetheReviewingIRB/Reviewing IRB Institutionwith theopportunity (no fewer than five (5)businessdays,wheneverpossible)toreviewandcommentonthedraftreportbeforetheRelyingInstitution(s)sendsthereportto external recipients. The Reviewing IRB/Reviewing IRB Institution will promptly provide anycommentsonthedraftreporttotheRelyingInstitution(s).ARelyingInstitutionisundernoobligationto adopt comments of the Reviewing IRB/Reviewing IRB Institution. However, nothing in thisAgreementshallpreventaReviewingIRB/ReviewingIRBInstitutionfrommakingitsownreport.
5.14NotificationofCommunicationswithRegulatoryAgencies.PromptlynotifytheRelyingInstitution(s)of any communications regarding unanticipated problems, suspension or termination of IRB approval,serious and/or continuing noncompliance, or other regulatory compliance concerns regarding theResearchreceivedfromtheFDA,OHRP,and/orotherregulatoryagencies.5.15CongruenceofFederalGrantApplications/ContractProposals.Unlessotherarrangementsaremadein advance, to review the congruence of any federal grant application or contract proposal for humansubjectsresearchwiththeResearchsubmittedforIRBreviewandapproval,whensuchreviewisrequiredbyfederalregulationsoroversightagencies.
6. ResponsibilitiesoftheRelyingInstitution(s)In itsconductofanyResearchforwhichreviewiscededunderthisAgreement,eachRelying Institutionretains responsibility for the protection of human subjects, for compliance with applicable laws,regulationsandethicalstandards,andforcompliancewiththetermsofitsFWA.EachRelyingInstitutionwill:6.1 Acceptance of IRB Decisions and Requirements. Accept the decisions and requirements of theReviewingIRB.ARelyingInstitutionoritsResearchPersonnelmaynotinitiateanyResearchorchangeto
theResearch,exceptwherenecessarytoeliminateapparentimmediatehazardstosubjects,withoutfirstreceivingpriorapprovalfromtheReviewingIRB.6.2ContinuingReview.Require itsResearchPersonneltoprovideany informationaboutconductoftheResearchattheRelyingInstitutionthattheReviewingIRBrequiresforcontinuingreview.6.3Recordkeeping.Require itsResearchPersonnel tomaintainallResearchrecords, including informedconsent documents and HIPAA authorizations, in accordance with applicable federal, state, and localregulations.6.4LocalConsiderations.CommunicatetotheReviewingIRBtherequirementsofanyapplicablestateorlocal laws, regulations, institutional policies, standards, or other local factors, including local ancillaryreviews, relevant to theResearch (“LocalConsiderations”) thatwouldaffect theconductorapprovaloftheResearchat theRelying Institution.SuchcommunicationmaybemadethroughtheReviewing IRB’sdesignee,asdeterminedbytheParticipatingInstitutionsinconnectionwiththespecificResearch.6.5ConsentForms.Provide theReviewing IRBwith thesite-specific informationrequested/identified inthecustomizablesectionsoftheReviewingIRB’sconsentform,forreviewandapprovalbytheReviewingIRB,whenwritteninformedconsentisrequired.OncetheconsentformisapprovedforusebytheRelyingInstitution/SiteInvestigator(s),theRelyingInstitutionwillnot,andwillrequirethatitsSiteInvestigator(s)not,makeanychange to the formwithoutobtainingpriorapprovalof thatchange fromtheReviewingIRB.
6.6 Conflicts of Interest. Maintain policies regarding the disclosure and management of ResearchPersonnelconflictsofinterestrelatedtoResearchandtosharethosepolicieswiththeReviewingIRB,asrequested. Unless the Reviewing IRB and the Relying Institution agree to an alternate approach inadvance, the Relying Institution will perform its own conflict of interest analysis under its relevantpolicies. Relying Institution(s) will provide to the Reviewing IRB any resulting conflict of interestdeterminations, prohibitions, and management plans as well as any updates to such prohibitions,determinations,orplans,thattheRelyingInstitutionhasdeterminedtobenecessaryfortheconductandapprovaloftheResearchattheRelyingInstitutionundersuchpolicies.TheRelyingInstitutionwillabideby and will require its Research Personnel to abide by its institutionally required prohibitions ormanagementplansrelatedtotheResearch,aswellasanyadditionalprohibitionsorconflictmanagementrequirementsrequiredbytheReviewingIRB.AsprovidedinSection5.8,intheextraordinarycircumstancethat the Reviewing IRB is unable to implement/approve the Relying Institution’s prohibitions ormanagementplans, theReviewing IRBwill so informtheRelying Institution,or if theRelying Institutionfails toacceptanyadditionalprohibitionsor requirementsof theReviewing IRB, theRelying InstitutionwillsoinformtheReviewingIRB.Iftheinstitutionsarenotabletoidentifyamutuallyagreeableapproach,theResearchwillbewithdrawnfromCededReview(withoutanIRBapprovalordisapproval)withrespecttothatRelyingInstitution.6.7 InjuryCoverage.Ensurethattheprovisionsofanyapplicablegrantorcontractthataddressfinancialcoverageforresearch-related injuries inconnectionwithResearchfunded inwholeor inpartbyanon-federal entity (e.g., corporation, foundation) are consistent with the approved Research protocol andconsent form or that the approved Research protocol and consent form, ifmore protective of humansubjects,willcontrol.
6.8 Complaints. Ensure that an institutionalmechanismexists bywhich complaints about theResearchcanbemadebylocalResearchparticipantsorotherstoalocalcontact.6.9HIPAA.WorkwiththeReviewingIRBtoestablishwhetheraseparateHIPAAauthorizationformwillbeusedforResearchorwhetherHIPAAauthorizationlanguagewillbeincorporatedintotheconsentform.
6.9.1 If a separateHIPAAauthorization formwillbeused forResearchpursuant toSections5.6.1.1and5.6.1.2hereof,theRelyingInstitutionwillensuretheaccuracyoftheinformationwithintheform,thecomplianceoftheformwiththeHIPAAPrivacyRule,and,asstatedinsuchsections,thattheformpermitsPHItobeusedbyanddisclosedtotheReviewingIRB,theReviewingIRBInstitution,andallRelyingInstitutions(whetherlistedindividuallyordescribedasagroup)asnecessaryforconducting,reviewingandoverseeingtheResearch(includinginvestigationandevaluationofevents). 6.9.2IftheHIPAAauthorizationlanguagewillbeincorporatedintotheconsentdocument,theRelyingInstitutionwillworkwith the Reviewing IRB to provide, as requested, any language specific to theRelyingInstitution.
In the event that, pursuant to Section 5.6, the Reviewing IRB has communicated to the RelyingInstitution(s) that it does not, as a matter of policy or otherwise, make research-related HIPAAdeterminations,theRelyingInstitution(s)willmakesuchdeterminationsfortheResearchsoastoensurethatPHIwillnotbeusedordisclosedfortheResearchunlessoneoftheoptionsinSections5.6.1,5.6.2,or5.6.3 is met. Without limiting the foregoing, if in such case a Relying Institution determines thatauthorizationforuseanddisclosureofPHIisrequired,itwilluseaseparate(freestanding)authorizationformasdescribedinandincompliancewiththeapplicablerequirementsofSections5.6.1.1and5.6.1.2.
6.10 Notification of Local Restrictions. Promptly notify the Reviewing IRB of any specific localrequirements and restrictions on use and disclosure of PHI that could prevent the Reviewing IRB fromapprovingarequestforwaiverofHIPAAauthorizationwithrespecttotheRelyingInstitution.6.11 Notification of Unanticipated Problems, Injuries, Complaints. Require the Site Investigator(s) topromptly notify the Reviewing IRB of any unanticipated problems that may involve risks to humansubjects or others, or any subject injuries related to Research participation, or any significant subjectcomplaintsthatoccurredattheRelyingInstitution.6.12NotificationofNoncompliance;Restriction/SuspensionofAuthority.Promptlynotify theReviewingIRB of any potential noncompliancewith applicable human subjects protection regulations orwith therequirements or determinations of the Reviewing IRB in connection with the Research at the RelyingInstitution,andofanysuspensionorrestrictionbytheRelyingInstitutionoranythirdpartiesofanyofitsResearchPersonnel’sauthoritytoconducttheResearch.6.13 Audits, Investigations; Corrective Actions. Cooperate, and require its Research Personnel tocooperate,withanyauditor investigationbytheReviewingIRB/ReviewingIRBInstitutionofanymatterunderthisAgreement.Suchcooperationwillinclude,butisnotlimitedto,providingResearchrecordsandrelatedinformation,meetingwithrepresentativesfromtheReviewingIRB/ReviewingIRBInstitutionandhelpingtocarryoutcorrectiveaction(s),asapplicable.IftheRelyingInstitutionisaskedbytheReviewingIRB/Reviewing IRB Institution to conduct its ownaudit/investigation, or towork cooperativelywith theReviewing IRB/Reviewing IRB Institution to conduct an audit/investigation, then the Relying Institution
will do so and will report its findings of fact to the Reviewing IRB/Reviewing IRB Institution within areasonabletimeframe.AsstatedinSection5.12hereof,forclarity,noParticipatingInstitutionisobligatedto provide to another its communications, analyses, or other information subject to attorney-clientprivilegeorotherprivilegeorruleofconfidentiality(e.g.,peerreview,patientsafetyworkproduct),butitmay elect to do so under an appropriate confidentiality or other agreement or other assurance ofconfidentiality. The Relying Institution shall comply with and shall require its Research Personnel tocomplywith all corrective actions requiredby the Reviewing IRB/Reviewing IRB Institution but nothingherein shall prevent the Relying Institution from adopting its ownmore stringent additional correctiveactions.
6.14 Reporting; Notification of Communications with Regulatory Agencies. Promptly provide anycommentsonanydraftreporttoexternalpartiesthatwillbemadebytheReviewingIRB/ReviewingIRBInstitution pursuant to Section 5.13.1 through 5.13.3 hereof. If the Reviewing IRB/Reviewing IRBInstitution requests that the Relying Institution make the report, the Relying Institution will promptlyprepare thedraft report andprovide theReviewing IRB/Reviewing IRB Institutionwith theopportunity(no fewer than five (5) businessdays,wheneverpossible) to reviewand commenton thedraft report,after which time the Relying Institutionmay finalize and send the report to external recipients. If theRelying Institutionelects tomake itsownadditional report, itwillprovideacopyof such report to theReviewing IRB/Reviewing IRB Institution.TheRelying Institutionwill alsopromptlynotify theReviewingIRB/Reviewing IRB Institution of communications received by the Relying Institution or between theRelyingInstitutionandFDA,OHRP,and/orotherregulatoryagencies,regardingunanticipatedproblems,noncompliance,orothercomplianceconcernsregardingtheResearch,andwillrequiretheOverallPIandSite Investigator(s) todothesamewithrespect tosuchcommunicationsbetweentheOverallPIorSiteInvestigator(s)andsuchagencies.
7.Term;Termination7.1.Term.ThisAgreementwillbecomeeffectivewithrespecttoeachParticipatingInstitutionassetforthin Section1.4.1hereofandwill remain ineffectwith respect to thatParticipating Institutionuntil suchtime that the Participating Institution provideswritten notice of termination of its participation to theotherParticipatingInstitutionsinvolvedinanyongoingResearchassetforthinSection7.2.2,oruntil itsparticipationautomaticallyterminatesassetforthinSection7.2.3,oruntilsuchtimeastheAgreementisterminatedinitsentiretyassetforthinSection7.2.1.7.2.Termination:
7.2.1ThisAgreementmaybeterminatedinitsentiretyonlyuponthemutualagreementofallthen-Participating Institutions. For clarity, termination of a Participating Institution’s participation in thisAgreementwillnotterminatetheAgreementwithrespecttotheremainingParticipatingInstitutions.In the event of termination of the Agreement, the Participating Institutions will work together todetermine theeffect of such terminationon anyResearch andassociatedResearch activities beingconductedunderthisAgreementatthetimeoftermination.7.2.2 A Participating Institution (referred to in this Section 7.2 as a Terminating Institution) mayterminateitsparticipationunderthisAgreementatanytimewithoutcauseuponthirty(30)businessdays’ prior written notice to the other Participating Institutions involved in any ongoing ResearchundertheAgreement.
7.2.3 A Participating Institution’s (also referred to in this Section 7.2 as a Terminating Institution)participationinthisAgreementwillterminateimmediatelyintheeventofandasoftheeffectivedateofanysuspension,restriction,termination,orexpirationofitsFWA;or,ifservingasaReviewingIRB,intheeventandasoftheeffectivedateofanyfailureof itsIRBtoremainregisteredwithOHRP. Ifthe Participating Institution’s FWA is subsequently reinstated or its IRB is subsequently registeredwithOHRP,theParticipatingInstitutionwillbeeligibletore-jointheAgreementatthattimeprovidedthatallotherrequirementsforparticipationaresatisfied.
7.2.4 Participating Institutions acknowledge and agree that with respect to certain Research (e.g.,Research conducted by certain clinical trial networks that have designated central IRBs), additionalspecific bases for termination of a Participating Institution’s participation in such IRB reliancearrangementsmayapply.WhenParticipatingInstitutionselecttousethisAgreementtoprovideforCeded Review of such Research, they agree that any such specific bases for termination of aParticipating Institution’s participation in that arrangement shall govern with respect to thatarrangement,butthattheParticipatingInstitutionmaystillparticipateintheAgreementwithrespecttootherResearch.
7.2.5IntheeventofanyterminationofaParticipatingInstitutionpursuanttoSections7.2.2or7.2.3above,theTerminatingInstitutionandtheotherinvolvedParticipatingInstitutionswillworktogethertodeterminetheeffectofsuchterminationonanyResearchandassociatedResearchactivitiesbeingconductedunderthisAgreementatthetimeoftermination.Withoutlimitingtheforegoing,whethertheTerminatingInstitutionisaRelyingInstitutionortheReviewingIRBInstitution,theReviewingIRBwill,whenpossibleandappropriate,providecontinuedoversight forsuchongoingResearch for thereasonable time necessary to appropriately transfer oversight of the Research to another IRB. Forclarity, termination of participation in this Agreement by the Terminating Institution will notterminatethisAgreementwithrespecttotheremainingParticipatingInstitutions.
8.Miscellaneous8.1 Execution of Joinder Agreements. The Joinder Agreements through which institutions will becomeparties to thisAgreementmaybeexecutedbyeachParticipating Institutiononaseparatecounterpart,eachofwhichJoinderAgreementswhensoexecutedandsubmittedshallbedeemedanoriginal,andanyandallofwhich togetherwithoneanotherandwith theAgreementshall constituteoneand thesameinstrument, binding as between any and all of the Participating Institutions. Signatures on JoinderAgreementsdeliveredbyfacsimile,PDF,orotherelectronicmeansshallbedeemedtheequivalentofwetinkoriginals.8.2Survival.ThefollowingrequirementsandobligationsofeachParticipatingInstitutionwillsurviveanyexpiration or termination of this Agreement, either in its entirety orwith respect to that ParticipatingInstitution:Sections2.4,4.3,4.6,4.8-4.11,5.5,5.10-5.14,6.3,6.11-6.14,7.2.1,7.2.5,8.1-8.3,8.5-8.9,andExhibitA.8.3NoInferences,ResponsibilityforOthers’Acts/OmissionsBasedonParticipation.Noinferencesaboutany Participating Institution or its HRPP shall be drawn simply on the basis of its participation in thisAgreement, and no Participating Institution shall be responsible for the acts or omissions of otherParticipatingInstitutionssimplybyvirtueofthefactthatallarepartiestotheAgreement.Withrespectto
anyparticularResearchundertheAgreement,theAgreementshallbeconsideredanagreementamongtheParticipating Institutions involved intheconductorreviewofthatResearch,andotherParticipatingInstitutionsshallbeunaffectedthereby.8.4Amendment.TheAgreementwillbereviewedperiodicallyandmaybeamendedfromtimetotime.Anymaterialchangesinconsiderationwillbeopenforwrittencommentsontheappropriatescopeofthechange(s)and/oronspecifictopics.Everypartyisentitledtoparticipateintheamendment’snegotiationsandtocontinueparticipationintheamendedAgreementwithoutfurtheraction(unlesstheamendmentisdeterminedtobesosignificantastorequirere-executionofJoinderAgreements).8.5Enforceability.IfanyprovisionofthisAgreementshallbeheldtobeinvalid,illegal,orunenforceable,thevalidity,legality,andenforceabilityoftheremainingprovisionsofthisAgreementshallnotbeaffectedthereby.8.6NoWaiver.ThefailureofaParticipatingInstitutiontoinsistupontheperformanceofanyofthetermsof thisAgreement shallnotbe construed tobeawaiveror relinquishmentby suchpartyofanyof thetermsoftheAgreementorofthewholeAgreement.8.7 Headings. All the titles and headings contained in the Agreement are inserted only as amatter ofconvenienceandreferenceanddonotdefine, limit,extend,ordescribethescopeofthisAgreementortheintentofanyofitsprovisions.8.8RelationshipoftheParties.NothinginthisAgreementwillbeconstruedtoplacethepartiesheretoinan agency, employment, franchise, joint venture, or partnership relationship. No party will have theauthoritytoobligateorbindanyotherpartyinanymanner,andnothinghereincontainedwillgiveriseoris intended to give rise to any rights of any kind to any third parties. No party will represent to thecontrary,eitherexpressly,implicitly,orotherwise.8.9Assignment.ThisAgreementisnotassignableinwholeorinpart,andanyattempttodososhallbevoid.
Ceded Review: An instance of IRB review in which one or more Participating Institutions invoke thisAgreementtotransferIRBreviewandoversightauthorityforaninstanceofResearchandrelyonanotherParticipatingInstitution’sIRBthatacceptsresponsibilityforIRBreviewandoversightofsuchResearch.
Confidential Information:Anynon-public,confidentialand/orproprietary information, includingbutnotlimitedtothescientificcontentofResearchproposalsandinformationprovidedbytheOverallPIorSiteInvestigator(s)orotherResearchPersonnelnotgenerally knownoravailable to thepublic. InformationwillnotbedeemedConfidentialInformationhereunderifsuchinformation:(a)isknowntothereceivingpartypriortoreceiptfromthedisclosingpartydirectlyorindirectlyfromasourceotherthanonehavinganobligationofconfidentialitytothedisclosingparty;(b)becomesknown(independentlyofdisclosurebythedisclosingparty)tothereceivingpartydirectlyor indirectlyfromasourceotherthanonehavinganobligationofconfidentialitytothedisclosingparty;(c)becomespubliclyknownorotherwiseceasestobesecret or confidential, except through a breach of this Agreement by the receiving party; or (d) isindependentlydevelopedbythereceivingparty.
DataUseAgreement:Awrittenagreementmeetingtherequirementsof45CFR164.514(e)(4),pursuanttowhichaHIPAACoveredEntitymayuseordiscloseaLimitedDataSetforresearchpurposes.DHHS:U.S.DepartmentofHealthandHumanServices.EffectiveDate:WithrespecttoanyParticipatingInstitution,theEffectiveDateof itsJoinderAgreement,asidentifiedintheJoinderAgreement.Exemption Determinations: Determinations that Research is exempt from IRB review pursuant to theFederalPolicy.FDA:TheUnitedStatesFoodandDrugAdministration.FederalPolicy:TheFederalPolicyfortheProtectionofHumanSubjectssetforthintheDHHSregulationsat45CFRPart46,SubpartAandcorresponding regulationsofother federaldepartmentsandagenciesadoptingsuchPolicy.
HIPAA: Collectively, the Health Insurance Portability and Accountability Act of 1996, the HealthInformationTechnologyforEconomicandClinicalHealthActof2009,andtheirimplementingregulations.
HIPAA Privacy Rule: The implementing regulations of HIPAA that address the privacy and rights ofindividualswithrespecttoPHI,foundat45CFRPart160andSubpartsAandEofPart164.
HRPP:HumanResearchProtectionProgram.
InstitutionalOfficial or Signatory: Thepersonwhohas the authority onbehalf of an institution tobindsuchinstitutiontothetermsandconditionsofthisAgreement.
IRB(s):InstitutionalReviewBoard(s).
IRBOrganization:An independent IRBorganization thatprovides IRB reviewservicesandhasagreed tobecome the Reviewing IRB for another Participating Institution for an instance of Research under thisAgreement.Joinder Agreement: Such agreement in substantially the same form set forth at Exhibit B bywhich aninstitution represents and warrants that it meets all eligibility requirements for participation in theAgreementandagreestobeboundbythetermsandconditionsofthisAgreement.LimitedDataSet (LDS):Asdefined in45CFR164.514(e)(2),ProtectedHealth Information thatexcludesthefollowingdirectidentifiersoftheindividualorofrelatives,employers,orhouseholdmembersoftheindividual: name; postal address information, other than town or city, state, and zip code; telephonenumbers; fax numbers; electronic mail addresses; social security numbers; medical record numbers;health plan beneficiary numbers; account numbers; certificate/license numbers; vehicle identifiers andserialnumbers;device identifiersandserialnumbers;webUniversalResourceLocators (URLs); internetProtocol (IP) address numbers; biometric identifiers, including finger and voice prints; and full facephotographicimagesandanycomparableimages.AnLDSmaycontain,forexample:datesofbirthdatesofdeath;datesofservice;townorcity;state;orzipcodeoracombinationofonlythoseelements.LocalConsiderations:Requirementsofanyapplicablestateorlocallaws,regulations,institutionalpolicies,standardsorotherlocalfactors,includinglocalancillaryreviews,relevanttoaninstanceofResearch.
Overall PI: The lead multi-site principal investigator with ultimate responsibility for the conduct andintegrity of Research (generally, the initiating principal investigator or funding principal investigator, asapplicable).
Participating Institution: An institution (including an IRB Organization) that meets the eligibilityrequirementssetforthintheAgreementandagreestoacceptthetermsandconditionsoftheAgreementthroughtheexecutionofaJoinderAgreement,therebybecomingasignatorypartytothisAgreement.
POC: Points of contact. At least one individual who will serve as the contact person responsible forcommunicating on behalf of the institutionwith respect tomatters concerning the initial and ongoingimplementation of this Agreement. For example, the POC would be the person designated at each
Participating Institution to make determinations regarding requests for his/her site to serve as theReviewingIRBforResearchorcedeIRBreviewandarelikelytobeindividualswithinanIRBofficeorothercomponentofthehumanresearchprotectionprogram.
Research:HumansubjectresearchwithinthemeaningoftheFederalPolicyorwithinthemeaningofanyotherfederalhumansubjectsresearchregulationsorpolicies;clinicalinvestigationswithinthemeaningofthe FDA IRB regulations; and any other research, for which any Participating Institution(s) seek or arerequiredtorelyonaReviewingIRB.AsusedinthisAgreement,Researchmayreferenceaspecificstudyorprotocol in which there will be a reviewing and relying party operating pursuant to the terms of thisAgreement,orcollectivelythestudiessubjecttoCededReviewundertheAgreement.
ResearchPersonnel:Membersoftheresearchteam(includingtheOverallPIandSiteInvestigator(s))engagedorinvolvedinaninstanceofResearch.Theseindividualsmayinclude,asapplicable,physicians,researchnurses,coordinators,datamanagers,labtechnicians,postdoctoralfellows,students,volunteersand/orotherpersonnel. ReviewingIRB:The“IRBofrecord”(includinganIRBOrganization)towhichauthorityforIRBreviewandoversight has been ceded by another Participating Institution for an instance of Research under thisAgreement.
Reviewing IRB Institution: The Participating Institution whose IRB has become the Reviewing IRB foranotherParticipatingInstitutionforaninstanceofResearchunderthisAgreement.SiteInvestigator(s):Aninvestigator(s)responsiblefortheconductoftheResearchathis/herParticipatingInstitution.
SMART IRB SOPs: Standard Operating Procedures developed in support of the SMART IRB MasterCommonReciprocalInstitutionalReviewBoardAuthorizationAgreement.TerminatingInstitution:AParticipatingInstitutionwhoseparticipationinthisAgreementisterminating.
ThisJoinderAgreementismadepursuanttotheSMARTIRBMasterCommonReciprocalInstitutionalReviewBoard Authorization Agreement (“Agreement”) and establishes that the below-identified, undersignedinstitutionisapartytoandParticipatingInstitutionintheAgreement,withalloftheassociatedrightsandobligationsthereunder.ByexecutionofthisJoinderAgreement,theundersignedinstitutionhereby:(i)representsandwarrantsthatitmeetsalleligibilityrequirementsforparticipationintheAgreementand(ii)joinsin,accepts,andagreestobeboundbyallof thetermsandconditionsof theAgreementand,without limiting the foregoing,agreesthat itmayacceptand relyon the reviewofanyof the IRBsof theParticipating Institutionsand thatanyParticipatingInstitutionmayrelyonitsIRB(ifapplicable)forResearchwhensoelectedbysuchParticipatingInstitutions under the Agreement; provided that, if it is an IRB Organization, the undersigned institutionhereby instead: (i) represents and warrants that it meets all applicable eligibility requirements forparticipation in the Agreement and (ii) joins in, accepts, and agrees to be bound by all of the terms andconditions of the Agreement and,without limiting the foregoing, agrees that any Participating InstitutionmayrelyonitsIRBforResearchwhensoelectedbysuchIRBOrganizationandParticipatingInstitutionundertheAgreement.This JoinderAgreementcoversthebelow-identifiedParticipating Institutiononlyanddoesnot includeanyotherseparateFWA-holdingentitiesorseparate legalcorporationswithwhichtheParticipating InstitutionoranyofitsIRBsisaffiliatedorhasanIRBreliancerelationship.EachaffiliateorotherentitythathasitsownseparateFWAorisaseparatelegalcorporationwillneedtoexecuteitsownJoinderAgreementinordertoparticipateintheAgreement.AnycapitalizedtermsusedinthisJoinderAgreementandnotdefinedhereinshallhavethesamemeaningsgiventothemintheAgreement.TheEffectiveDateofthisJoinderAgreementisthedateonwhichtheParticipatingInstitutionexecutestheJoinder Agreement as indicated by its Authorized Institutional Official/Signatory below; however, theParticipating Institution’s actual participation in any activities under the Agreement may be subject toactivationorotherprocesses.The Participating Institutionmust keep this Joinder Agreement and a copy of the Agreement on file andprovideittoOHRPorotherfederalagenciesuponrequest.ParticipatingInstitutionLegalName:ParticipatingInstitutionLegalAddressStreet:City,State,ZipCode:☐ Check here if Participating Institution is an IRB Organization (as defined in the Agreement). If an IRBOrganization,providethefollowing:
Isyourinstitution’sFWAapplicabilityrestrictedtofederally-fundedresearch(i.e.,hasyourinstitution“uncheckedthebox”onitsFWA)?☐ Yes☐No,institutionappliessubpartsA,B,C,andDregardlessofsourceofsupport.☐No,institutionappliessubpartAonly,regardlessofsourceofsupport.IfyourinstitutionhasanIRBorisanIRBOrganization,theinstitutionmusthaveundergoneorhaveinitiatedanassessmentofthequalityofitshumanresearchprotectionprogram(HRPP).Suchassessmentmusthaveoccurredorhavebeeninitiatedwithinthepast5yearspriortotheinstitutionjoiningtheAgreement.Theassessment may be accomplished by accreditation through an external organization, through OHRP’sQuality Assessment Program, or other equivalent approach. What method does your institution use toassurethequalityofitsHRPP?Checkallthatapply.
Iunderstand and affirm that ParticipatingInstitutions are strongly encouraged to use and follow theSMART IRB Standard Operating Procedures (“SMART IRB SOPs”) for research covered under theAgreement,andthatifinstitutionsdonotusetheSMARTIRBSOPs,theymustcommunicatetoeachotherandtheResearchPersonnelthepoliciesandproceduresthatwillapplytothecededResearch.
