Your Roadmap to Single IRB Review Getting Started with SMART IRB & the Online Reliance System

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Your Roadmap to Single IRB Review Getting Started with SMART IRB & the Online Reliance System

Now that your institution has joined SMART IRB, what s next? Start using the Agreement right away for IRB reliance arrangements. The SMART IRB Agreement is responsive to the NIH Single IRB Policy and proposed revisions to the Common Rule.

Using SMART IRB to streamline IRB review for multi-site research As an IRB or INSTITUTION Use the SMART IRB Agreement to facilitate single IRB review The Reviewing IRB takes on all IRB oversight responsibilities As a PRINCIPAL INVESTIGATOR Work with your institution s SMART IRB Points of Contacts (POCs) to determine an appropriate reliance arrangement and discuss your responsibilities related to single IRB review Relying Institutions provide Reviewing IRB with local context regarding state law, study team member training / qualifications, and any applicable conflicts of interest

Access SMART IRB Resources at Expertise and Guidance 1) Connect with an ambassador in your region who is knowledgeable in the practicalities of IRB reliance, or 2) Request guidance through our consultation service Support for Single IRB Review Access our growing collection of resources, including SMART IRB s FAQs and SOPs, as well as a Single IRB Review Start-up Package Online Reliance System Use our web-based system to track, facilitate, and document reliance arrangements on a study-by-study basis

SMART IRB Online Reliance System Provides a single point of entry to standardize reliance processes Serves as communication portal to eliminate tracking requests via email or other methods Guides investigators and institutions through the workflow, making clear when action is required The system works for institutions: 1 2 3 With and without significant reliance experience Familiar or unfamiliar with one another With limited or substantial infrastructure to support single IRB review This system allows all SMART IRB Participating Institutions to work together to establish reliance decisions

Flexibility for Institutions 1) Customize the displayed contact information for your institution, in case someone needs to reach you about a request 2) Add a cc email to be included on all system notifications (e.g. an office or group email) 3) Add one or more backup(s); can perform same actions in the system as the POC, with regard to processing requests Various configurations are available to meet your needs contact help@ to learn more

Centralized Tracking of Reliance Requests/Arrangements NEW! Filtered listview allows you to see all your requests and easily sort those requiring your action

Central access to arrangement details for each study Each request package provides: Overall details of study/arrangement Clear picture of request status Contact info for key personnel Comments from Reviewing IRB Request history

Adding a site to a reliance arrangement This amendment feature is ideal for sites that join a study at a later date, or for those that were not yet ready to rely when the original arrangement was documented. The process is simple: 1 2 3 An investigator or study team member completes and submits a brief site amendment form. The POC at the new site indicates whether they are willing to rely on the Reviewing IRB. The Reviewing IRB POC confirms whether they will review for the new site and issues the determination. About the amendment process Only the submitter of the original request can submit an amendment. One site added per amendment; one amendment may be under consideration at a time. Requests that are under review cannot be amended until a reliance determination is issued.

The Reliance System Is For Investigators (or their designees) A centralized mechanism to request single IRB review for their studies and track the status of those requests For Institutions A platform to review reliance requests and determine and record appropriate reliance arrangements for each study The Reliance System Is NOT A mechanism to submit an application for IRB review and approval A document storage system

Benefits for INVESTIGATORS Clarity and Guidance The system guides you through the request process, collecting the information institutions need to determine an appropriate arrangement for your study Automatic Notifications Email notifications ensure you are informed at key points in the decision-making process Reliance Tracking The system gives you a window into the decisionmaking process and provides a single place to track reliance arrangements for your studies

Benefits for INSTITUTIONS Provides a centralized place to record and track reliance arrangements on a study-by-study basis Connects you with the appropriate POC for each site, eliminating the need to track down their information Guides you through the decision-making process, making clear when your action is required Provides a central, transparent platform to communicate local context issues

SMART IRB Online Reliance System DEMO With the short video that follows we highlight key features of the SMART IRB Online Reliance System

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