Letter of Indemnification - SMART IRB Indemnification (Section 4.11) - Johns Hopkins University and LAC+USC Medical Center

Sep 15, 2026

Indemnification letter pursuant to Section 4.11 sets out the terms under the SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement between Johns Hopkins University School of Medicine and LAC+USC Medical Center. It applies to covered research where Johns Hopkins may serve as IRB of record for reliance. The scope specifies responsibilities for federal human-subject protection requirements and HIPAA within the Agreement’s framework, including allocation of liability for third-party claims, with duties to defend, indemnify, and cooperate. The letter differentiates responsibilities for non-state versus state institutions and limits obligations where sovereign immunity or applicable law constrains agreement.

LanguageEnglish

CategoryLetters

FormatPDF

Pages2

Reading Time1 min

AccessFree to download

Effective Date

Scope of Reliance

Claims

Non-state Institutions

State Institutions

Letter of Indemnification pursuant to section 4.11“Indemnification”of the SMART IRB MasterCommon Reciprocal Institutional Review Board Authorization AgreementBetween Johns Hopkins University School of Medicine (Reviewing IRB Institution) and LAC+USC Medical Center ___________(Relying Institution) This Letter of Indemnification("LOI")is entered this 02 day of October __,2019,("Effective Date")by ReviewingIRB Institution,which operates the Johns Hopkins University School of Medicine 's Institutional Review Board(IRB)("ReviewingIRB”);and LAC+USC Medical Center (“Relying Institution”);each a party to the SMART IRBMaster Common Reciprocal Institutional Review Board Authorization Agreement (the"Agreement").This LOI is in furtheranceof section 4.11 “Indemnification”.All defined terms herein are consistent with Exhibit A of the Agreement. The Agreement permits Participating Institutions to make aditional arrangements among themselves regarding allocation ofliability in connection with the Ceded Review of any Research.In accordance with the terms of the Agreement,the undersignedParticipating Institutions wish to apply the terms set forth herein to the Ceded Review(s)among them of the Research identifiedbelow:Any study where the SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement will serve as the basis for IRB reliance on the above-named Reviewing IRB. ("Covered Research").ThisLOI is applicable to and shall be enforceable as to the undersigned Participating Institutions only. I. Effective Date.Reviewing IRB may become the IRB of Record for Relying Institution for Covered Research as of the datethat this LOI is fully executed. II. Scope of Reliance.Reviewing IRB will only assess compliance with federal humansubjects protection requirements andwith HIPAA to the extent provided in Section 5.6 of the Agreement.As contemplated in the Agreement,RelyingInstitution is solely responsible for determining whether research reviewed by Reviewing IRB (including but notlimited to any consent process or documentation),meets all other applicable federal,state,and local legal and policyrequirements.Although,all information about "local considerations"as defined in Section 6.4 of the“Agreement”willbe considered by the Reviewing IRB for purposes of assessing federal human subjects protection requirements,theReviewing IRB and Reviewing IRB Institution make no representation about the compliance or compatibility ofits reviewwith a Relying Institution's obligations under other applicable federal and state law and local policy requirements. # I. Claims. a.Non-state Institutions:Except to the extent the Participating Institution is a state institution subject to sovereignimmunity laws(such institutions shall be governed by Subsection(b)below),each Participating Institution hereunderwill be responsible("Responsible Institution")for any third-party claim,cause of action,liability,damage,cost orexpense(including,without limitation,reasonable attorney's fees and court costs related thereto)("Claims”),andshall defend,indemnify,and hold harmless,the other Participating Institution hereunder(“Other Institution”),andtheir trustees,officers,faculty,IRB members,students,volunteers,and employees("Other InstitutionalRepresentatives”),to the extent such Claims arise out of:(i)any breach of the Agreement by the ResponsibleInstitution,or(ii)the negligent acts and omissions made by the Responsible Institution,Responsible Institution'sIRB,as applicable,or any trustees,directors,officers,representatives,employees,or other agents of the ResponsibleInstitution in their performance of the Agreement,including without limitation,negligent use or disclosure of anyinformation,except to the extent that such Claims result from the negligence or willful misconduct of the OtherInstitution and/or its Other Institutional Representatives.The Other Institution se

FAQs

When does this letter become effective and what triggers IRB of record status?

The letter is entered with an Effective Date of the date it is fully executed. Reviewing IRB may become the IRB of Record for the Relying Institution for Covered Research as of that fully executed date.

What does the Reviewing IRB assess under the scope of reliance?

The Reviewing IRB assesses compliance with federal human-subjects protection requirements and HIPAA to the extent provided in Section 5.6 of the Agreement. The Relying Institution remains responsible for determining whether other applicable legal requirements are met.

How are third-party claims handled under indemnification?

Each Responsible Institution is responsible for third-party claims that arise from its breach or negligent acts and omissions, including negligent use or disclosure of information. The Responsible Institution must defend, indemnify, and hold harmless the other participating institution and its representatives, with duties to cooperate during investigation and defense.

Sep 15, 2026

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