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NIH Applications rejected for failing Foreign Risk Assessment

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Recently we have had numerous NIH SBIR/STTR proposals rejected because they have failed the foreign risk assessment. These are well scored proposals that would have likely been funded and moved to the Just-In-Time (JIT) paperwork stage. This is an unfortunate outcome of what would otherwise be excellent projects with potentially good outcomes.

The foreign risk assessment is not entirely new, but has taken on more importance in recent months. It is an added layer of review that the NIH program managers have little to no control over. My understanding, is that the prospective proposals are sent to reviewers who assess the project for foreign influence, control, and even visibility. The foreign countries of most concern are China, North Korea, Russia, and Iran. I believe the rejections we are aware of are specifically because of indirect connections to China.

We are gathering more information, but the reasonings are not completely understood. When a proposal is rejected, there is no requirement to be told specifically which part or personnel is of concern, so our clients are at a loss on how to address or fix the problem for future proposals. Once rejected, there is not an appeal process or opportunity for the proposal to be repaired or altered. The sparse advise from NIH that our clients have been given is to resubmit a modified proposal or submit a completely new one at the next deadline with the foreign influence addressed. This might be difficult if there is no guidance as to which part of the proposal raised the red flag for rejection.

My cursory, albeit uninformed and nascent, view is that any direct or indirect connect to these countries of concern could trigger the rejection. Clearly, key personnel who are foreign nationals to the countries would be an issue; but it might also be that previous or current funding from one of the countries, or even a publication that lists an author from a country of concern could cause rejection.

There are some resources that the NIH provides that might help address or at least provide information on how to avoid such rejections.

Reach out to us for assistance in resubmission if you are one of these companies!