Reliance Agreement Basics Julie Chamberlin, CCRP, CIP IRB Reliance - PowerPoint PPT Presentation

Reliance Agreement Basics Julie Chamberlin, CCRP, CIP IRB Reliance & QA/QI Specialist jchamberlin@hsph.harvard.edu

Meeting Objectives Overview Eligibility Execution & Responsibilities Gain a basic Learn about what Set-up Instructions / understanding of constitutes as eligible Lead site vs. what reliance is for reliance Participaing site responsibilities

01 Reliance Overview

What is reliance and why do I need it?

Why do I need reliance? NIH sIRB Policy Revised Common Rule Reduce Burden January 25, 2018 January 20, 2020 Always been the practice of choice NIH funded multi- “Cooperative site studies involving Research” – more Reduces duplication non-exempt human than one institution of efforts and subjects research administrative Any US site engages burden “ Same protocol ” – in cooperative same research research that is questions, involving subject to the same methodologies Common Rule and outcomes 45 CFR 46.114

02 Reliance Eligibility

Let’s talk about human subjects' research… For reliance to take place we need to ensure we are engaged in non-exempt, human subjects research

Types of IRB Review 2 3 1 Not Human Subjects Not Research Research Exempt Activities do not meet the Activities do not meet the Research activities involving regulatory definition of regulatory definition of human subjects that fall into research involving “human “research” one of the eight categories subjects” Convened IRB Expedited 6 5 Reliance Research involving human subjects Research activities involving human that does not qualify for Exempt or Eligible subjects that involve no more than Expedited review, typically involving minimal risk greater than minimal risk to subjects.

03 Reliance Execution

Three Essential Elements 2. IRB Authorization 1. IRB approval 3. Institutional Agreement or notice Authorization IAA (lead site) (home site ) (typically SMART IRB )

Harvard Serves as Lead IRB (aka Reviewing IRB, IRB of Record) 6. Harvard 1. Harvard 2. Harvard 3. Harvard 4. Reliance 5. Reliance Site Team Site Team Site Team Coordinator Coordinator Site Team • Provide • Identify how • Make sure • Begin either • Finalize IAA • IAA is sites will be ESTR app SMART IRB after all sites attached in notice to involved indicates or IAA have ESTR and psites and reliance process completed reliance is add them in ESTR their portion confirmed

Harvard Serves as Lead IRB ESTR Example (ESTR app) Step 2 Visit a main study workspace (in any state), where it is indicated on the Basic 70 Information page of the SmartForm that BOTH: This is a collaborative or multisite study 2. Harvard 30% AND Site Team Harvard will act as the IRB of record for • Make sure any project ESTR app indicates reliance

Harvard Serves as Lead IRB SMART IRB Example (Begin IAA process) Step 3 If both sites are utilizing the SMART IRB platform then an IAA can be initiated 70 through that process OR 30% 3. Harvard IAA process can occur independently Site Team outside of SMART IRB system and an IAA • Begin either document will be produced separately SMART IRB or IAA process

Harvard Serves as Lead IRB (Reliance Coordinator) Steps 4 & 5 70 Reliance Coordinator finalizes IAA in SMART IRB and in ESTR 30% 4. Reliance 5. Reliance Coordinator Coordinator • Finalize IAA • IAA is after all sites attached in have ESTR and completed reliance is their portion confirmed

Harvard Serves as Lead IRB ESTR Letter Example (Begin IAA process) Step 6 Each participating site needs to be added in to ESTR 70 6. Harvard Site Team 30% • Provide Reliance has not been achieved until notice to psites and receipt that site has been added has been add them in confirmed ESTR

Harvard is a Participating Site (aka Relying Site, pSite)

Harvard is a Participating Site ESTR Example (ESTR app) Step 2 Visit a main study workspace (in any state), where it is indicated on the Basic Information page of the SmartForm that BOTH: 70 This is a collaborative or multisite study AND Harvard will act as the IRB of record for 2. Harvard 30% Site Team any project • Make sure ESTR app It will also be important to fill in the Basic indicates reliance Local Site and External IRB information

Harvard is a Participating Site SMART IRB Example (Begin IAA process) Step 3 If both sites are utilizing the SMART IRB platform then an IAA can be initiated 70 through that process OR 30% 3. Harvard IAA process can occur independently Site Team outside of SMART IRB system and an IAA • Work with document will be produced separately Lead Site to complete IAA

Harvard is a Participating Site (Reliance Coordinator) Step 4 Reliance Coordinator finalizes IAA in SMART IRB or through other methodsd 70 4. Reliance 30% Coordinator • Finalize IAA after all sites have completed their portion

Harvard is a Participating Site ESTR Letter Example (Reliance Coordinator) Step 5 Reliance Coordinator will send a letter from the ESTR system confirming the reliance process. 70 It will note the institution providing oversight 5. Reliance 30% Coordinator • IAA is attached in ESTR and reliance is confirmed

Participating Site Lead Site Responsibilities Responsibilities The lead site is responsible HRPP at participating sites for providing IRB review of will be responsible for the study just as they would meeting all of its current be independent of reliance related responsibilities – but for ALL sites described in the HHS regulations (45 CFR 46) While the lead site is • reviewing conflicts of interest ultimately “in charge”, the • radiation safety participating site is not • ensuring that site investigators obtain without monitoring informed consent from prospective research participants responsibilities • ensuring that site investigators meet local training requirements • overseeing the implementation of the approved protocol • reporting local unanticipated problems involving risks to subjects or others, and study progress to the single IRB.

What are the PI responsibilities? Lead Site PI Relying Site PI ● Appendix D (Investigators Manual) ● Appendix E (Investigators Manual)

References & Resources Implementation of the sIRB policy. (2020). Retrieved August 13, 2020, from https://osp.od.nih.gov/clinical-research/implementation-of-the-sirb- policy/ https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-058.html Hsantiag. (2017, June 27). Single IRB (sIRB) and External IRB: Reliance Arrangements. Retrieved August 19, 2020, from https://research.umn.edu/units/irb/how-submit/single-irb-sirb-and- external-irb-reliance-arrangements

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