The Petitioner, a clinical trials specialist seeking to include more ethnic minorities in the U.S. drug development process, requests classification under the employment-based, second-preference (EB-2) immigrant visa category and a waiver of the category's job-offer requirement. See Immigration and Nationality Act (the Act) section 203(b )(2)(B)(i), 8 U.S.C. § 1153(b )(2)(B)(i). U.S. Citizenship and Immigration Services (USCIS) has discretion to excuse job offers in this category - and thus the need for certifications from the U.S. Department of Labor (DOL)- if petitioners demonstrate that waivers of the U.S.-worker protections would be "in the national interest." Id.; see also Brasil v. Secy, Dep 't ofHomeland Sec., 28 F .4th 1189, 1193 (11th Cir. 2022) (holding that national interest waivers are discretionary benefits).
Service Center Operations (SCOPS) denied the petition. SCOPS found the Petitioner qualified for the EB-2 category and that his proposed U.S. endeavor has "substantial merit." But SCOPS concluded that he did not demonstrate that a waiver would serve the national interest. On appeal, the Petitioner contends that SCOPS overlooked evidence that: his endeavor has "national importance;" he is "well positioned" to advance it; and, on balance, a waiver would benefit the United States.
The Petitioner bears the burden of demonstrating eligibility for the requested benefit by a preponderance of the evidence. Matter of Chawathe, 25 I&N Dec. 369, 375-76 (AAO 2010).
Exercising de novo appellate review, see Matter of Christo 's, Inc., 26 I&N Dec. 537, 537 n.2 (AAO 2015), we conclude that he did not establish the claimed national importance ofhis proposed endeavor. We will therefore dismiss the appeal.
Law
To demonstrate eligibility for national interest waivers, petit10ners must first establish their qualifications for the EB-2 category, either as members ofthe professions holding "advanced degrees," or as aliens of "exceptional ability" in the sciences, arts, or business. See section 203(b )(2)(A) of the Act. To protect jobs for U.S. workers, this immigrant visa category generally requires prospective U.S. employers to offer aliens work and to obtain DOL certifications to permanently employ them in the country. See section 212(a)(5)(D) of the Act, 8 U.S.C. § 1182(a)(5)(D). Petitioners may avoid the p. 2 job-offer and labor-certification requirements by demonstrating that waivers of the U.S.-worker protections would be "in the national interest." Section 203(b )(2)(B)(i) of the Act.
Neither the Act nor regulations define the term "national interest." So, to adjudicate these waiver requests, we have established a framework. If otherwise qualified as advanced degree professionals or aliens of exceptional ability, petitioners may warrant waivers ofthe job-offer and labor-certification requirements by demonstrating that:
- Their proposed U.S. work has "substantial merit" and "national importance;"
- They are "well positioned" to advance their intended endeavors; and
- On balance, waivers of the job-offer and labor certification requirements would benefit the United States.
Matter ofDhanasar, 26 I&N Dec. 884, 889-91 (AAO 2016); see generally 6 USCIS Policy Manual F.(5)(D)(l), www.uscis.gov/policy-manual.
Analysis
A. The Petitioner and His Proposed Endeavor
The record shows that the Petitioner earned a bachelor of science degree in herbal medicine in Ghana and a master of science degree in international health in the United Kingdom (UK). At the time of the petition's filing, he was pursuing a UK doctoral degree in health studies. In Ghana, he worked as a health policy analyst for the country's government and founded a digital start-up that developed an application to detect counterfeit medication in the country. Since 2021, he has worked for the National Health Service in the UK, as a clinical research fellow, research facilitator, and senior clinical trials practitioner.
In the United States, the Petitioner proposes to develop and implement a digital platform using artificial intelligence (AI) to recruit underrepresented ethnic minorities to participate in U.S. clinical drug trials and related research. His written plan indicates that he would establish a business to develop his proposed AI-driven clinical research platform. He stated that the business would match eligible minority participants to clinical drug trials and work with sponsors and contract research organizations to design "linguistically and culturally appropriate recruitment, informed consent, and engagement strategies." According to the plan, the platform would allow the business's clients to monitor clinical trial diversity in real time. He stated that his business's initial customers would include contract research organizations, academic health systems, biopharmaceutical companies, and public health agencies. The business would initially operate in a large northeastern U.S. city and eventually expand its services to underserved communities nationwide. He would serve as the business's founder/chief executive officer. The company would also employ six others, including: a chief technology officer; clinical research lead; community engagement specialist; regulatory affairs consultant; software engineer; and data analyst.
The Petitioner states that his proposed endeavor would "mitigate disparities in patient outcomes caused by gaps in real-world evidence, enhance the safety and efficacy of medical treatments for all Americans, and contribute to a more equitable and effective U.S. healthcare system."
The record supports SCOPS' finding that the Petitioner qualifies for EB-2 classification as an advanced degree professional and that his proposed endeavor has substantial merit. We will next review SCOPS' finding regarding his endeavor's claimed national importance.
B. National Importance
When determining whether a proposed endeavor has national importance, users must focus on the particular venture, specifically on its "potential prospective impact." Matter ofDhanasar, 26 I&N Dec. at 889. "An undertaking may have national importance, for example, because it has national or even global implications within a particular field, such as those resulting from certain improved manufacturing processes or medical advances." Id. Also, "[ a ]n endeavor that has significant potential to employ U.S. workers or has other substantial positive economic effects, particularly in an economically depressed area, for instance, may well be understood to have national importance." Id. at 890.
Ultimately, if the evidence ofrecord demonstrates that the person's proposed endeavor has the significant potential to broadly enhance societal welfare or cultural or artistic enrichment, or to contribute to the advancement of a valuable technology or field of study, it may rise to the level of national importance.
Benefits to a specific employer alone, even an employer with a national footprint, are not sufficiently relevant to the question of whether a person's endeavor has national importance. At issue is whether the petitioner can demonstrate that the person's own individual endeavor stands to have broader implications, such as for a field, a region, or the public at large.
6 USCJS Policy Manual F.5(D)(3).
The Petitioner argues that, by discounting articles about U.S. healthcare disparities because the materials "do not discuss any details relating to [his] specific endeavor," SCOPS erred. He states: The adjudicating officer's assertion that the evidence must explicitly reference the specific endeavor is misplaced, as the focus ofthe analysis is on whether the endeavor's objectives and anticipated outcomes further matters ofrecognized national importance, not on whether the endeavor is explicitly cited in the supporting evidence.
We agree with the Petitioner that probative evidence of national importance need not necessarily reference a specific proposed endeavor. But, to the extent he argues that an endeavor need only further a nationally important matter, we disagree. An endeavor's furtherance ofa nationally important matter or support for national initiatives, alone, may be insufficient to demonstrate the venture's national importance. Rather, a petitioner must show that their specific endeavor has broad implications. See 6 USCJS Policy Manual F.5(D)(3) ("The analysis considers whether the petition contains substance that explains and substantiates how working in the proposed endeavor meets the national importance standard.") In the Petitioner's case, recruiting minorities to participate in clinical drug trials would further a national goal of eliminating healthcare disparities. But - unless the recruitment tool itself represents an advancement in the field - such recruitment for a limited number of clinical trials would not likely have national implications.
As previously indicated, a proposed endeavor may have national importance if"it has national or even global implications within a particular field, such as those resulting from certain improved manufacturing processes or medical advances." Matter ofDhanasar, 26 T&N Dec. at 889. In response to SCOPS' request for more evidence, the Petitioner asserted that his proposed platform "addresses a known market and public health gap not adequately solved by existing commercial recruitment tools." He also contended: "The AT platform model that I propose offers a data-informed, equity-driven alternative to the fragmented and often exclusionary recruitment systems used in the U.S. today." But counsel made these statements, and thus they are not evidence.Claims not backed by documents See, e.g., Matter ofS-M-, 22 T&N Dec. 49, 51 (BIA 1998) ("statements in a brief: motion, or Notice of Appeal are not evidence and thus are not entitled to any evidentiary weight"). The record lacks independent documentary evidence substantiating counsel's assertions that the Petitioner's proposed clinical trial recruitment tool would advance his field. See 6 USCIS Policy Manual F.5(D)(3) ("[P]etitioners should submit ... supporting documentary evidence to establish that the endeavor is of national importance.") The Petitioner contests SCOPS' finding that his "[r]eliance on background information and statistics concerning various topics is generally not probative" of his proposed endeavor's claimed national importance. He states:
The evidence is not presented in isolation but is thoroughly analyzed and tied directly to the specific objectives and anticipated outcomes of the endeavor. The Petitioner has gone beyond merely citing general statistics or background information by explaining how the endeavor addresses specific, well-documented issues of significant national concern, such as improving clinical trial recruitment, enhancing the generalizability of real-world data, and increasing the inclusivity of underrepresented populations in medical research.Proposed endeavor too vague
We acknowledge the Petitioner's use of background information and statistics to illustrate problems that his proposed endeavor seeks to solve. Indeed, we affirm SCOPS' finding that his proposed endeavor has substantial merit. But, as previously discussed, he has not demonstrated that his endeavor would combat these problems in a nationally important way. The record does not demonstrate that his proposed business would recruit enough minorities into clinical trials to substantially affect the U.S. healthcare field or the national economy. Also, he has not established that his proposed clinical research platform represents an advancement over current clinical trial recruitment tools in the field. 1
The Petitioner contends that recommendation letters on his behalf demonstrate that his proposed endeavor would broadly affect the U.S. healthcare field. For example, an assistant professor of medicinal chemistry at a U.S. university predicted that the Petitioner's AI clinical trial platform "will make a significant impact in the U.S." The professor stated: "I believe this innovative approach not only has the potential to decentralize clinical research but also to significantly enhance the involvement of minorities in it."
The Petitioner's recommendation letters, however, do not discuss his proposed platform or its claimed significance in detail. The letters do not explain how his proposed system would represent an advancement over existing clinical trial recruitment tools. Under USCIS policy:
The Petitioner notes that, in Dhanasar, when finding that a researcher's proposed endeavor had national importance, we cited articles he submitted about his field. See Matter ofDhanasar, 26 I&N Dec. at 892 ("He also provided media articles and other evidence documenting the interest of the House Committee on Armed Services in the development of hypersonic technologies and discussing the potential significance of U.S. advances in this area ofresearch and development.") The Petitioner claims that, in his case, SCOPS failed to similarly credit articles about his field.
Dhanasar, however, is factually distinguishable from the Petitioner's case. Dhanasar's proposed endeavor involved publishing research in scientific journals available to others in the researcher's field. The researcher's field-wide sharing of his work established his endeavor's broad implications. In contrast, the record does not indicate the Petitioner's intent to share his proposed clinical trial recruitment tool with his field (other than with co-workers and customers). Thus, to show that his specific endeavor has national importance, he must demonstrate broader implications.
For the foregoing reasons, the Petitioner has not sufficiently demonstrated that his proposed endeavor has national importance. We will therefore affirm the petition's denial.
C. The Remaining Dhanasar Requirements
To obtain a national interest waiver, a petitioner must satisfy all three prongs ofour Dhanasar analysis. Matter ofDhanasar, 26 I&N Dec. at 889. Because the Petitioner did not demonstrate the claimed national importance of his proposed endeavor under Dhanasar's first prong, we need not determine whether he met the remaining two prongs. We therefore need not reach and hereby reserve review of whether he established that he is well positioned to advance his proposed endeavor and that, all things considered, a waiver would benefit the United States. See INS v. Bagamasbad, 429 U.S. 24, 25 ( 1976) (per curiam) (holding that agencies need not make "purely advisory findings" on issues unnecessary to their ultimate decisions).
Conclusion
The Petitioner did not demonstrate the claimed national importance of his proposed endeavor. We will therefore affirm the petition's denial.
ORDER: The appeal is dismissed.
NOTICE: This is the final decision in this matter. A motion's filing would not postpone the decision's effect. 8 C.F.R. § I 03.S(a)(l )(iv). Aliens who are unlawfully present, or who are otherwise inadmissible or deportable, may receive Forms I-862, Notices to Appear, placing them in removal proceedings. See section 240 of the Act, 8 U.S.C. § 1229a. Removal proceedings may result in an alien's removal from the United States and ineligibility for future U.S. visas or other immigration benefits.