Which of the 3 versions of the Letter of Acknowledgment should my institution use?

The SMART IRB recognizes that the enormous success of the Reliance Agreement has been built upon twin pillars of harmonizing sIRB processes while remaining flexible to cover a wide ranging number of institutions across the United States. Indeed, in the years that followed the development of the SMART IRB Agreement, institutions frequently would utilize 'flexible terms addendums' to outline items such as indemnification, insurance, etc. With the launch of Version 3.0 of the SMART IRB Agreement, the SMART IRB team created additional optional resources to allow for institutions to efficiently document these items, as follows:

Letter of Acknowledgment (Basic)
The 'Basic' version of the SMART IRB Letter of acknowledgment most similarly resembles the original Letter of Acknowledgment template.

Letter of Acknowledgment (Default Implementation)

Default implementation refers to the standard approach to the SMART IRB Reliance Agreement. When the 'default' is selected, it is not necessary to document the remaining items, unless the institutions intend to do so to document potential default terms (e.g. whether HIPAA applies).

Letter of Acknowledgment (Flexible Implementation)

Flexible implementation refers to the mutual agreement of institutions engaged in SMART IRB reliance arrangements to exercise a 'flexible' arrangement within the SMART IRB Agreement. For example, institutions may mutually agree to waive the insurance requirement of the agreement, and if so, the institutions are executing a flexible implementation of the SMART IRB Reliance Agreement.

Other changes to the new versions of the Letter of Acknowledgment are as follows:

Institutional Validation:
In both the Implementation Checklist as well as the Letter of Acknowledgment, options for declaring default vs flexible implementation are present, as are options for validating (or signing) among the IRB/HRPP staff. The SMART IRB recognizes that while some institutions require signature for executing reliance arrangements, other institutions do not allow for signature; as a result, our template is flexible and can be modified by institutions to meet their own needs.

Points of Contact
The new versions include hyperlinks to the SMART IRB Participating Institutions page, where you may find the most up-to-date Point of Contact for your institution and the other institution engaged in reliance.