Background: How will SMART IRB Agreement v2.0 allow NIH to collaborate with extramural organizations?

Federal agencies, including the research arm of NIH—the NIH Intramural Research Program—must follow laws that apply specifically to federal agencies. SMART IRB Agreement v1.0 was not written to reflect these requirements. The specific requirements relate to liability coverage and conflict of interest disclosure.

SMART IRB Agreement v2.0 changes select provisions in SMART IRB Agreement v1.0 to be compliant with requirements that apply to federal agencies and will allow the NIH Intramural Research Program to take advantage of the efficiencies provided by the SMART IRB platform. It will also allow other sites and institutions to utilize the SMART IRB platform if the NIH is serving as the Reviewing IRB.