The SMART IRB Letter of Acknowledgment (or 'LOA') is one of the primary ways to execute SMART IRB reliance arrangements, particularly when not using the SMART IRB Reliance System or the IREx IRB Exchange. The SMART IRB offers three official options for using the LOA, including:
Letter of Acknowledgment (Basic)
The 'basic' version of the Letter of Acknowledgment outlines in a 1 page summary the reliance request. This version of the LOA is most similar to the original version of this document that SMART IRB produced in 2017.
Letter of Acknowledgment (Default Implementation)
The 'default implementation' version of the Letter of Acknowledgment outlines the standard implementation terms of the SMART IRB Reliance Agreement.
Letter of Acknowledgment (Flexible Implementation)
The 'flexible implementation' version of the Letter of Acknowledgment allows institutions to mutually outline when flexible provisions of the SMART IRB Reliance Agreement are being exercised.
LOA Customization
The LOA may be customized by institutions to meet their needs. Institutions frequently add signature blocks, local institutional logos, eIRB submission numbers, local contact numbers, or grant numbers on the LOA. Institutions are free to customize the LOA provided no customization contradicts the terms of the SMART IRB Agreement.
LOA Storage
SMART IRB Points of Contact should work with their institutional leadership to ensure that Letters of Acknowledgment (LOAs) are stored in a manner consistent with institutional policy. As the LOA may be requested by a federal regulatory agency during audit, it is recommended that the materials be stored in a location that is easily accessible by IRB/HRPP personnel, in addition to within the institution's local eIRB system or equivalent.
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