SMART IRB is intended to allow reliant IRB review of US human subjects research.
The research may be externally or internally funded; the Agreement does not limit the scope of what is covered based on funding source or status. Although it is generally expected that SMART IRB will be used for US human subjects research, it could be used for international research if the parties involved in such research determine that SMART IRB and the SMART IRB agreement meet their needs and any international requirements for such arrangements.
NOTE: The Federal Food, Drug, and Cosmetic Act includes language that suggests that IRB review must be “local” in the case of FDA-regulated device studies [Section 520(g)(3)(A)(i) (21 USC 360j(g)(3)(A)(i))]. The regulations state that “the person applying for the exemption submit a plan for any proposed clinical testing of the device ...to the local institutional review committee which has been established in accordance with regulations of the Secretary to supervise clinical testing of devices in the facilities where the proposed clinical testing is to be conducted...”. As part of 21st Century Cures legislation, the FDA may eliminate the “local” IRB requirement for device studies (see section 2262, http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm127013.pdf). The SMART IRB Agreement is silent and does not preclude single IRB review of FDA-regulated device studies. Institutions may exercise discretion when reviewing and relying.