COI when a federal agency is a Relying Institution

Federal agencies — including the NIH Intramural Research Program, which joined under Version 2.0 — are bound by federal conflict-of-interest laws and generally cannot disclose their employees' financial information to an outside IRB. The Agreement therefore treats federal Relying Institutions differently from non-federal ones.

The assurance model (§§5.7 and 6.8). When a federal agency is a Relying Institution, it provides the Reviewing IRB with an assurance that the agency has completed its COI analysis and that its Personnel's participation in the research is permissible and consistent with federal law. The Reviewing IRB relies on that assurance in place of the institution-level disclosures it would receive from a non-federal site.

No stricter requirements. A Reviewing IRB may not impose additional or more stringent COI prohibitions or management plans on a federal agency's Personnel. It remains free to take actions that are not COI-specific — limiting the number of participants any site may enroll, for example.

If the Reviewing IRB cannot accept the assurance. Some IRBs' policies require specific financial information or management of interests below federal thresholds. A Reviewing IRB that has agreed to review for a federal agency but concludes it cannot rely on the assurance informs the agency, and the study is withdrawn from ceded review with respect to that agency, without an approval or disapproval. (Nothing in the Agreement obliges any IRB to agree to serve as Reviewing IRB for a federal agency in the first place.)

What happens to the rest of the study. The Reviewing IRB can continue as Reviewing IRB for the other Relying Institutions. For NIH-funded research, the NIH Intramural Research Program can work with the applicant institution to seek an exception from the NIH single IRB policy and from the Common Rule's cooperative research provision (which involves OHRP), or can withdraw from the study so as not to delay approval for the other sites.

NIH's own FAQ on its intramural COI policies and what it can and cannot share with a Reviewing IRB: FAQ on the Conflict of Interest Policies of the NIH Intramural Research Program for SMART IRB.

See also - COI for non-federal Relying Institutions - Selecting the Reviewing IRB