clinical trial safety and regulatory…
EB-2 National Interest Waiver — Merits Decision
Underlying petition: DENIED · Service Center Operations (SCOPS)
Legal elements discussed — Matter of Dhanasar
Prong 1 — Substantial Merit & National Importance
FAILPetitioner argued: The proposed endeavor has national importance because it aligns with public health priorities and federal modernization efforts.
Evidence type: business plan and expert opinion letters
U.S. Citizenship and Immigration Services (USCIS) finding: INSUFFICIENT
“the Petitioner has not sufficiently demonstrated the national importance of his proposed endeavor under the first prong of the Dhanasar analytical framework.”
Decision PDF, p. 2Open source PDF
Petitioner argued: The endeavor aligns with government initiatives.
Evidence type: references to government initiatives
USCIS finding: INSUFFICIENT
“alignment with government initiatives alone is insufficient for national importance.”
Decision PDF, p. 3Open source PDF
Petitioner argued: The endeavor will have substantial positive economic effects and job creation.
Evidence type: business plan and claims
USCIS finding: INSUFFICIENT
“without sufficient evidence regarding the projected U.S. economic impact or job creation directly attributable to his future work, the record does not show that the benefits to the regional or national economy resulting from the Petitioner's endeavor would reach the level of 'substantial positive economic effects' contemplated by Dhanasar.”
Decision PDF, p. 3Open source PDF
Petitioner argued: The endeavor will have broader implications in the clinical trials or healthcare field.
Evidence type: declarations and general statements
USCIS finding: INSUFFICIENT
“he has not provided sufficient evidence or detailed information to demonstrate that his proposed endeavor will have broader implications or influence in the clinical trials or healthcare field that will rise to the level of national importance.”
Decision PDF, p. 3Open source PDF
Petitioner argued: Expert letters support the national importance of the endeavor.
Evidence type: expert opinion letters
USCIS finding: INSUFFICIENT
“While these letters are supportive in tone and positive factors, they do not offer sufficient, detailed, and concrete examples of how the Petitioner's endeavor has the potential for broad and measurable implications for the country that would rise to the level of national importance.”
Decision PDF, p. 3Open source PDF
Prong 2 — Well Positioned to Advance the Endeavor
NOT_DISCUSSEDProng 3 — Balancing the Waiver's Benefits
NOT_DISCUSSEDWhat this decision can’t tell you
This decision comes from a case that was denied and then appealed. Every case here is in that position — it cannot be used to estimate an overall approval rate, and it cannot predict the outcome of any individual case, including yours. USCIS officers exercise discretion on facts that are never fully captured in a written decision.
This decision turned on national importance. Describe your own work and see which decisions discussed the same issue.
Describe your situation →Related decisions
Questions this raises for your lawyer
- On Prong 1 (substantial merit & national importance), USCIS found the petitioner's business plan and expert opinion letters insufficient to establish that the proposed endeavor has national importance because it aligns with public health priorities and federal modernization efforts.. What would make comparable evidence in my own case more persuasive?
- What in my own case most resembles the specific facts USCIS focused on in this decision?
- Would additional expert-opinion evidence have changed the outcome here, based on what USCIS said was missing?