Conflicts of Interest: Is the language in Sections 5.8 and 6.6 of SMART IRB Agreement v2.0 relating to assurance to the Reviewing IRB of satisfaction of investigator conflict of interest policies from the NIH compliant with AAHRPP standards?

Some organizations have voiced concerns that the language in Sections 5.8 and 6.6 of SMART IRB Agreement v2.0 relating to assurance to the Reviewing IRB of satisfaction of investigator conflict of interest policies from the NIH (such as from the NIH Intramural Research Program) is not compliant with AAHRPP standards regarding conflict of interest. Is this aspect of SMART IRB Agreement v2.0 compliant with AAHRPP standards?

Yes. AAHRPP has affirmed that since investigators at the NIH, including the NIH Intramural Research Program, are legally bound to comply with policies that in effect prohibit the existence of a conflict (as defined in NIH policies), the NIH assurance that these policies are met is acceptable under AAHRPP’s standards.