PRACTICAL GUIDE | 2026
US-Funded Research Abroad in 2026: What ‘America First’ Scrutiny Means for LATAM Trials
Most LATAM FIH sponsors can skip this article. If your trial money comes from the US federal government, read it twice.
By Julio G. Martinez-Clark
CEO, bioaccess®
Last verified: September 2026 | General information only—not legal or regulatory advice. Rules change frequently; confirm the strategy with qualified regulatory counsel.
Publishing package
Key entities, defined plainly. NIH is the US National Institutes of Health — the largest public funder of biomedical research in the world. FIH means first-in-human. LATAM is Latin America. The Uniform Guidance (2 CFR Part 200) is the federal rulebook for grants: it sets the rules for who can receive federal money and under what conditions. A subrecipient carries out part of the funded project and is subject to the award’s compliance terms; a contractor (vendor) simply provides goods or services. A foreign component is project work performed outside the United States that requires NIH prior approval — approval obtained before the work starts. A subaward is funding passed from the prime awardee to a subrecipient. The False Claims Act is the federal law that penalizes false claims for federal money — including mischaracterized grant relationships. A grants counsel is a lawyer who specializes in federal grant compliance.
Who does this post apply to?
A minority of sponsors: those whose LATAM trial work is funded by US federal grants, such as NIH awards. If your FIH program is funded by venture capital, a corporate balance sheet, or any other commercial source, stop here — none of what follows applies to your trial. This distinction matters because most commentary on ‘America First’ research policy gets shared as if it affects everyone. It does not.
What did NIH change in 2025?
Two things sponsors should know at a high level:
- Foreign subaward restrictions. Since 2025, NIH has restricted foreign subawards — funding passed through a US prime awardee to a foreign subrecipient. The policy direction is toward less money flowing abroad through subaward structures.
- Heightened data-access requirements. Foreign subrecipients face heightened requirements around US access to research data — what data must be accessible, where it is stored, and who can review it.
The details are moving. Do not rely on summaries — verify the current position against the live NIH Grants Policy pages before making any decision. This post deliberately cites no notice numbers, because notice numbers go stale and stale citations are worse than none.
What are the operative legal distinctions?
Under the Uniform Guidance (2 CFR Part 200), the questions that determine your obligations are:
| Distinction | Why it matters |
|---|---|
| Subrecipient vs. contractor — | A subrecipient performing part of the project inherits the award’s compliance terms, including audit and reporting obligations. A contractor providing goods or services does not. Misclassifying the relationship creates audit exposure. |
| Foreign component vs. domestic work — | Work performed outside the US under the award may be a ‘foreign component’ requiring NIH prior approval. The characterization turns on where and how the work is performed — not on how the money moves. |
That last point is the one sponsors get wrong most often — which is the subject of the next section.
What is the wrong takeaway?
US-Funded Research Abroad in 2026: What ‘America First’ Scrutiny Means for LATAM Trials narrows to this: the legal line runs through the nature of the relationship and the location of the work — never through the payment plumbing. Any structure built on the opposite assumption is built on sand.
What should a grant-funded sponsor do next?
Three steps — and a hard boundary:
- Classify the relationship honestly. Is the LATAM party a subrecipient or a contractor under 2 CFR Part 200? Get the classification right before the budget is built.
- Determine foreign-component status. Does the LATAM work require NIH prior approval? Answer this before the work starts — prior means prior.
- Verify against live policy. Check the current NIH Grants Policy pages. 2025-era restrictions are the starting point, not necessarily the current position.
Frequently asked questions
Does any of this apply to my commercially funded FIH trial?
No. These rules govern US federally funded research. Commercially funded trials — the vast majority of FIH programs — are unaffected.
Can I avoid the foreign-component characterization by routing payment through a US CRO?
No. The characterization turns on the substance of who performs the work and where, not on how many entities sit in the payment chain. Adding a US middleman does not eliminate it.
What is a ‘foreign component’?
Project work performed outside the United States under a federal award. It generally requires NIH prior approval — approval obtained before the work begins.
Why does subrecipient vs. contractor matter?
A subrecipient inherits the award’s compliance, audit, and reporting obligations under 2 CFR Part 200; a contractor does not. Misclassification creates audit exposure.
Where do I verify the current NIH position?
The live NIH Grants Policy pages. This area is moving — treat 2025 restrictions as the starting point and verify before acting.
Can bioaccess® help with grant-funded LATAM work?
Operationally, yes — sites, investigators, regulatory filings, and study execution. But structural and legal questions about the award belong to qualified grants counsel.
For the minority of sponsors working with federal money, US-Funded Research Abroad in 2026: What ‘America First’ Scrutiny Means for LATAM Trials is a map of where the real questions live: the relationship classification, the foreign-component determination, and live NIH policy. Everything else — especially payment-chain engineering — is a distraction from those three.
References
- NIH Grants Policy Statement and NIH Grants Policy pages (verify current foreign-subaward and data-access provisions).
- Uniform Guidance, 2 CFR Part 200 (subrecipient vs. contractor; foreign component; prior approval).
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