The Implementation Checklist (with default vs. flexible implementation)

The Implementation Checklist highlights the flexible provisions of the SMART IRB Agreement and allows the institutions engaged in the reliance arrangement to document which options they will implement as part of the Ceded Review.

The Implementation Checklist should be completed jointly between the Reviewing IRB Point of Contact (POC) and the Relying Institution POC to ensure mutual agreement of the terms to be implemented on study. 

The use of the Implementation Checklist is optional but encouraged, to ensure that all parties under the sIRB review are aware of any flexible arrangements that are operational for a given study or studies.

Default vs. Flexible Implementation

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: 
 

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).
 

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.
 

Validation, Signatures, etc

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.