clinical research management
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 Beneficiary's endeavor has substantial positive economic effects and potential to employ U.S. workers.
Evidence type: none specified
U.S. Citizenship and Immigration Services (USCIS) finding: INSUFFICIENT
“the Petitioner did not show how the Beneficiary's position has significant potential to employ U.S. workers or otherwise offer substantial positive economic effects for our nation.”
Decision PDF, p. 4Open source PDF
Petitioner argued: The Beneficiary's work in managing clinical trials for cancer therapeutics has national importance due to its alignment with national health initiatives and potential to improve public health.
Evidence type: letters of recommendation, industry reports, expert opinion letters
USCIS finding: INSUFFICIENT
“the Petitioner did not sufficiently establish it has national importance.”
Decision PDF, p. 2Open source PDF
Petitioner argued: The Beneficiary's role has broader implications beyond the employer, contributing to FDA approvals and benefiting thousands of patients.
Evidence type: letters of recommendation, expert opinion letters
USCIS finding: INSUFFICIENT
“the record did not establish the national importance of the endeavor as it did not show that the endeavor would have broader implications beyond the impact on the Beneficiary's current employer.”
Decision PDF, p. 2Open source PDF
Petitioner argued: The Beneficiary's specific role as a study management associate II has a direct impact on the development of new therapies.
Evidence type: supervisor letter
USCIS finding: INSUFFICIENT
“the evidence does not sufficiently demonstrate how the Beneficiary as a single employee would affect the industry more broadly.”
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
- Prong 1 (substantial merit & national importance) was not established here — specifically, that the Beneficiary's endeavor has substantial positive economic effects and potential to employ U.S. workers.. What does my case need to show on this element?
- 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?