The SMART IRB Agreement Version 3.0 removes the requirement found in previous versions of the agreement (including versions 2.0 and 1.0) for institutional oversight for exempt research. While we encourage participating institutions to maintain policies and procedures to cover oversight of this research, we recognize that the current Common Rule does not require IRB review or trigger any other regulatory obligations.
For research conducted under SMART IRB Agreement Versions 1.0 or 2.0, this oversight provision applies for some research. The intent of this criterion is not to require IRB review or institutional oversight for human subjects research that is exempt from IRB review and other regulatory requirements under the pre-2018 Common Rule. Regarding the 2018 Revised Common Rule, and "limited IRB review," the expectation under the Agreement Versions 1.0 and 2.0 is that institutions will require institutional oversight, which may include limited IRB review in some cases, as well as to cover any applicable other regulatory requirements attached to them.
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