Every successful EB-2 National Interest Waiver petition is built around a single document: the NIW endeavor statement. This is where the applicant explains, in their own words, what they propose to do in the United States, why the work matters beyond their own career, and how they plan to carry it out. It is not a résumé in paragraph form; it is a legal argument, and the logic it must follow is the three-prong test established in the 2016 Matter of Dhanasar NIW framework and now anchored in the USCIS Policy Manual. In plain terms, the petitioner must show that the proposed endeavor has substantial merit and national importance, that they are well positioned to advance it, and that, on balance, waiving the job offer and labor certification requirements benefits the United States.
The sample below is a complete NIW endeavor statement example written for a bioethics and public health specialist whose endeavor is to strengthen ethical governance in the U.S. clinical research system. Rather than listing credentials, it defines the endeavor with precision, grounds every claim in evidence, and moves through the USCIS EB-2 NIW Dhanasar framework three prongs in order—merit and national importance first, the petitioner’s positioning second, and the balancing analysis last. That structure is deliberate. The Dhanasar framework prongs for EB-2 NIW applicants are cumulative, not optional, and a statement that answers them one by one is far easier for an officer to approve than one that leaves the analysis for the reader to assemble. Supporting documents such as an EB2 NIW business plan or an EB-2 NIW Professional Plan add operational depth, but the endeavor statement is what frames the entire petition.
This sample is fictionalized: the petitioner’s name, institutions, contact details, dates, and identifying information have been changed, and any similarity to actual individuals or organizations is purely coincidental. It is provided for reference only and does not constitute legal advice. As you read, pay attention to two things—how the statement keeps the proposed endeavor, rather than the applicant’s biography, at the center of every section, and how the Dhanasar analytical framework shapes the order of the arguments. Together, they show what it takes to meet the USCIS EB-2 NIW Dhanasar framework criteria in practice.
Immigrant Petition for Alien Worker
for the Alien with Exceptional Ability in Science (EB2-NIW)
TABLE OF CONTENTS
- Form I-140, Immigrant Petition for Alien Workers
- Form I-140 Filing Fee Payment
- Asylum Program Fee Payment for Form I-140
- Form I-907, Request for Premium Processing Service, with Premium Processing Fee
- Form G-1450, Authorization for Credit Card Transactions
- Supporting Identity and Immigration Documents
- My Endeavor Statement in Support of My EB-2 National Interest Waiver Petition
- Exhibits A-I
Dr. Jane A. Doe
123 Main Street, Apt. 2
Anytown, AA 12345
Tel. (123) 456-7890
April 28, 2026
U.S. Citizenship and Immigration Services
Attn: I-140
P.O. Box 660128
Dallas, TX 75266
RE: EB-2 IMMIGRANT PETITION FOR PERMANENT RESIDENCY WITH REQUEST FOR A NATIONAL INTEREST WAIVER
Section 203(b)(2)(B) INA [8 U.S.C. § 1153]
Dear USCIS Officer:
I, Dr. Jane A. Doe, respectfully submit this petition under the EB-2 National Interest Waiver (NIW) classification. I am a bioethics and public health specialist with advanced academic training across Africa, the United States, and Europe, supported by over 13 years of professional experience in research ethics, clinical research governance, and public health research. I hold a Doctor of Philosophy (PhD) in Bioethics, a Master of Public Health in Bioethics, and a Master of Philosophy in Gender and Health. My academic training reflects a structured progression from ethical theory and social systems to applied bioethics, with a focus on participant protection, inclusion in research, and ethical oversight in biomedical and public health research.
My professional record reflects sustained contributions to the field through academic, institutional, and international research engagements, as well as a strong body of peer-reviewed scholarship. I have authored and co-authored peer-reviewed publications across recognized journals, with research addressing clinical trial ethics, participant inclusion, antimicrobial resistance, and post-trial obligations. I have also received formal recognition through selective appointments to editorial and advisory roles in international bioethics and research ethics initiatives. In addition, I have participated in internationally funded research initiatives and competitive fellowship programs, reflecting recognition of my expertise and continued contributions to advancing ethical governance in clinical research.
My proposed endeavor is to strengthen ethical governance in the United States clinical research system through the development and implementation of standardized ethical frameworks, policy guidance, decision-support tools, and training programs. I will focus on improving the inclusion of underrepresented populations, particularly pregnant and lactating individuals, in clinical research. I will also address inconsistencies in protocol design and ethical review processes by promoting harmonized practices and strengthening the application of ethical standards.
Through this endeavor, I will collaborate with research institutions, clinical research teams, and ethics review bodies to support protocol development, risk-benefit assessment, and informed consent processes, while also developing practical tools to enhance protocol readiness and alignment among reviewers. I will implement targeted training and mentorship activities for both researchers and ethics review bodies to strengthen capacity, improve consistency in ethical decision-making, and support more efficient and reliable clinical research processes.
I am filing this petition under the EB-2 classification as an individual holding an advanced degree and, in the alternative, as an individual of exceptional ability pursuant to section 203(b)(2) of the Immigration and Nationality Act. Based on the nature of my qualifications and the work I propose to undertake in the United States, I respectfully request a National Interest Waiver of the labor certification requirement. This petition demonstrates the following:
- I meet the eligibility requirements as an individual holding an advanced degree and as an individual of exceptional ability in the field of bioethics, clinical research governance, and public health research.
- My proposed endeavor has substantial merit and national importance, as it will address systemic gaps in the United States clinical research system related to participant inclusion, protocol design, ethics review processes, and workforce capacity, while aligning with federal priorities on human subjects protection, scientific integrity, and the generation of representative and reliable clinical evidence.
- I am well-positioned to advance my proposed endeavor based on my academic training, professional experience, record of contributions in research ethics, clinical research oversight, and multi-country public health research initiatives, as well as letters of support from established professionals in the field who can attest to my expertise and the significance of my work.
- On balance, it would be beneficial to the United States to waive the labor certification requirement, as my proposed endeavor will contribute to strengthening the quality, inclusivity, and ethical integrity of clinical research systems and their application to public health and patient care.
The outline below presents the structure of this petition and the organization of the arguments in support of my request for classification under the EB-2 National Interest Waiver.
I. SECTION 1 – ELIGIBILITY AS AN INDIVIDUAL WITH AN ADVANCED DEGREE AND EXCEPTIONAL ABILITY
A. Eligibility as an Advanced Degree Professional
B. Eligibility as an Individual with Exceptional Ability
B1. Evidence of Official Academic Record Relating to the Area of Expertise
B2. Evidence of More Than 13 Years of Full-Time Professional Experience
B3. Evidence of Recognition for Achievements and Significant Contributions to the Field of Bioethics and Clinical Research Governance
B4. Evidence of Comparable Contributions Demonstrating Exceptional Ability
II. SECTION 2 – MY PROPOSED ENDEAVOR HAS BOTH SUBSTANTIAL MERIT AND NATIONAL IMPORTANCE
A. The Substantial Merit of My Proposed Endeavor
A1. Overview of My Proposed Endeavor
A2. Key U.S. Challenges Addressed by My Proposed Endeavor
A3. Demonstration of the Substantial Merit of My Proposed Endeavor
B. The National Importance of My Proposed Endeavor
B1. Description of My Proposed Endeavor
B2. Prospective National Impact of My Proposed Endeavor
B3. Alignment of My Proposed Endeavor With National Priorities
B4. Conclusion: The National Importance of My Proposed Endeavor
III. SECTION 3 – I AM WELL POSITIONED TO ADVANCE MY PROPOSED ENDEAVOR
- Education, Skills, Knowledge, and Record of Success in Related Efforts
- Development of a Detailed Plan for My Proposed Endeavor
- Implementation Strategy and Progress Toward Pursuing My Proposed Endeavor
- Support from Industry and Academic Experts
IV. SECTION 4 – ON BALANCE, A WAIVER OF THE JOB OFFER AND LABOR CERTIFICATION REQUIREMENT BENEFITS THE UNITED STATES
- Impracticality of the Labor Certification Process
- National Benefit Independent of the Availability of Other U.S. Workers
- Urgency of the National Interest Served by My Proposed Endeavor
- Balancing of Interests Under the Matter of Dhanasar
The Exhibits Index below identifies and organizes the supporting documentation submitted with this petition. Each exhibit is labeled and corresponds to the claims presented in the following sections. The documentation includes my academic credentials, professional experience, research contributions, evidence of recognition, and letters of support, all of which establish my qualifications and support the national importance of my proposed endeavor.
| Exhibit A | Educational Credentials and Professional Background |
| A1 | Curriculum Vitae |
| A2 | Doctor of Philosophy (PhD) in Biomedical Sciences (Bioethics), East Africa Medical University (EAMU) |
| A3 | Master of Public Health (MPH), Bioethics Track, U.S. Research University, United States |
| A4 | Master of Philosophy (MPhil) in Gender and Health, European Public Health University, Norway |
| A5 | Bachelor of Arts (BA) in Philosophy and Sociology, African Public University, Kenya |
| A6 | ICH Good Clinical Practice (GCP) Certification, Global Health Training Centre |
| Exhibit B | EB-2 NIW Professional Plan |
| Exhibit C | Professional Experience and Employment History |
| C1 | Appointment Letter as Head of Department, Behavioral and Social Sciences, EAMU, Tanzania |
| C2 | Institutional Review Board (IRB) Appointment and Membership Documentation, EAMU |
| C3 | Employment Contract and Appointment as Assistant Lecturer, EAMU, Tanzania |
| C4 | Service Agreement and Appointment as Alumnae and Career Counseling Officer, EAMU – U.S. Partner University MEPI Project |
| C5 | PharmAccess Foundation Program Coordination Documentation, KNCU Health Plan |
| Exhibit D | Recognition for Achievements and Contributions |
| D1 | Appointment Letter, Editorial Board Member, African Journal of Bioethics |
| D2 | African Journal of Bioethics Journal Overview, Governance, and Institutional Partnerships |
| D3 | Editorial Board Engagement Contract, African Journal of Bioethics |
| D4 | Advisory Board Participation Letters, GREEN Program, Nigeria |
| Exhibit E | Scholarly Publications and Citations |
| E1 | “Patient and Provider Perspectives on Pediatric Care in Public Hospitals in East Africa” (Publication and Citations) |
| E2 | “Informed Consent and Enrollment Decision-Making in Pediatric Clinical Trials in Rural Settings” (Publication and Citations) |
| E3 | “Primary Healthcare Workers’ Perspectives on Antibiotic Use and Resistance in Childhood Infections” (Publication and Citations) |
| E4 | “Caregiver Experiences With Antibiotic Use Among Children Under Five in Low-Resource Communities” (Publication and Citations) |
| E5 | ‘“Participant Perspectives on Clinical Trial Endpoints and Post-Trial Care in Infectious Disease Research” (Publication) |
| E6 | “Post-Trial Transition, Participant Care, and Ethical Responsibilities in Clinical Research” (Publication and Citations) |
| E7 | “Expanding Access to Bioethics Education and Practice in Regional Health Research Systems” (Book Chapter) |
| E8 | “Post-Trial Responsibilities in Clinical Research: Perspectives From Ethics Committees and Investigators” (Publication) |
| E9 | “Healthcare Workers’ Perspectives on Antibiotic Use in Young Children in Central African Health Settings” (Publication) |
| Exhibit F | Competitive Research Roles and Fellowships |
| F1 | Certificate of Scholarship in International Research Ethics (NIH Fogarty International Center, U.S. Research University) |
| F2 | NIH-Funded GFBR Fellowship Contract (SARETI, Southern African Research University) |
| F3 | Postdoctoral Letter of Agreement (Canadian Research University, Department of Epidemiology, Biostatistics and Occupational Health) |
| F4 | Institutional Support Letter from Dr. Eleanor Grant (Canadian Research University, PregTrial Project) |
| Exhibit G | Training Delivery, Curriculum Development, and Capacity-Building Activities in Research Ethics and Clinical Research Governance |
| G1 | Regional Clinical Trials Review Training Program Clinical Research Review Introductory Module |
| G2 | Regional Clinical Trials Review Training Program Training for Ethics Review of Clinical Research: Facilitator Schedule and Agenda |
| G3 | GCP Training Programs and Facilitator Materials, EAMU and KCRI |
| G4 | Independent Consultant Contract and Contribution to UNESCO O3PLUS End-of-Phase Assessment Report |
| G5 | Research Ethics Consultancy and Co-Authorship, CONSORT Study (U.S. Research University and U.S. Partner University) |
| G6 | Research Ethics Book Contribution Documentation (U.S. Research University-Affiliated Project) |
| Exhibit H | Letters of Support from Industry and Academic Experts |
| H1 | Letter of Support from Prof. Daniel Okoro (Assistant Director, Office of Research Excellence, U.S. Academic Institution) |
| H2 | Letter of Support from Dr. Samuel Adeyemi (Pharmacist, Healthcare Company A) |
| H3 | Letter of Support from Mr. Michael Kamau (Tech-for-Impact Strategist & Insurance and Health Systems Innovator, Social Impact Organization A) |
| H4 | Letter of Support from Dr. Thomas Santos (Urologist Surgeon, Outspan Hospital, Nyeri, Kenya) |
| H5 | Letter of Support from Dr. Isaac Mwenda (Research Scientist, National Institute for Medical Research, Tanzania) |
| Exhibit I | Reference Materials and Source Documents Cited in this Endeavor Statement |
| I1-I25 | Peer-Reviewed Journal Articles, Federal Policy Documents, Federal Agency Reports and Datasets, Institutional Webpages, and Industry and Economic Reports Supporting the Proposed Endeavor |
Based on the evidence presented, I request favorable consideration of this petition.
Respectfully,
J.A.Doe
Dr. Jane A. Doe
Petitioner
I. SECTION 1 – ELIGIBILITY AS AN INDIVIDUAL WITH AN ADVANCED DEGREE AND EXCEPTIONAL ABILITY
A. Eligibility as an Advanced Degree Professional
I respectfully submit that I qualify as an advanced degree professional under the EB-2 classification pursuant to section 203(b)(2) of the Immigration and Nationality Act and 8 C.F.R. § 204.5(k)(2). My academic background reflects formal, graduate-level education in bioethics, public health, and interdisciplinary health research, with specialized training directly aligned with my work in research ethics, clinical research governance, and inclusive biomedical research.
Evidence of Advanced Academic Degrees
I have earned the following academic qualifications:
- Doctor of Philosophy (PhD) in Bioethics, East Africa Medical University (EAMU), Tanzania, conferred in 2025, with research focused on ethical issues in biomedical and public health research
- Master of Public Health (MPH) in Bioethics, U.S. Research University A, United States, conferred in 2015, with a focus on special problems in human medicine and philosophical issues in biomedicine
- Master of Philosophy (MPhil) in Gender and Health, European Public Health University, Norway, conferred in 2004, with a focus on gender-related health disparities and population-level health analysis
- Bachelor of Arts (BA) in Philosophy and Sociology, African Public University, Kenya, conferred in 1992, providing foundational training in ethical theory and social systems
Official academic records, including diplomas and transcripts for the above degrees, are provided as supporting evidence (see Exhibits A2-A5).
My PhD in Bioethics represents the highest level of academic specialization in my field and required advanced, independent research addressing ethical challenges in biomedical and public health research. The program involved rigorous training in ethical theory, research governance, regulatory standards, and applied research methodologies. My doctoral work focused on issues such as participant protection, inclusion in research, and ethical oversight mechanisms, all of which are directly aligned with my proposed endeavor to improve ethical governance and inclusivity in clinical research.
Completion of this degree required the design and execution of original research contributing to the field of bioethics, demonstrating my capacity to address complex ethical and regulatory challenges in real-world research settings.
My Master of Public Health in Bioethics at U.S. Research University included graduate-level coursework within a United States academic setting. My transcript reflects completion of courses such as Philosophical Issues in Biomedical Ethics, Independent Study, and Special Problems in Human Medicine, which provided training in ethical analysis, biomedical ethics, and research-related inquiry (see Exhibit A3). These courses required critical engagement with ethical issues in healthcare and research, including evaluation of ethical principles, research questions, and applied problem-solving. This academic experience contributed to my understanding of ethical considerations relevant to clinical and public health research and supports my ability to engage in ethical analysis within research settings in the United States.
My Master of Philosophy in Gender and Health from the European Public Health University provided advanced training in analyzing structural and population-level factors affecting health outcomes and participation in research. The program focused on health inequities, gender-based disparities, and barriers to healthcare access. This training is directly relevant to my proposed endeavor, which addresses the underrepresentation of specific populations, including pregnant and lactating individuals, in clinical research. The program required interdisciplinary analysis combining public health, social science, and policy perspectives, strengthening my ability to evaluate how research design affects different population groups.
My Bachelor of Arts in Philosophy and Sociology from the African Public University provided foundational training in ethical reasoning, social systems, and critical analysis. This academic background established the theoretical basis for my subsequent specialization in bioethics and public health. Training in philosophy strengthened my ability to engage with ethical principles and frameworks, while sociology provided an understanding of how social structures influence health systems and research participation.
Thus, my academic qualifications demonstrate a clear progression from foundational training in ethics and social systems to advanced specialization in bioethics and public health research. Each degree contributes directly to my ability to evaluate, design, and improve ethical frameworks in biomedical and public health research. My education spans institutions in Africa, the United States, and Europe, reflecting both depth of specialization and exposure to diverse research systems and regulatory environments.
Accordingly, I meet the regulatory requirement for classification as an individual holding an advanced degree under 8 C.F.R. § 204.5(k)(2).
B. Eligibility as an Individual with Exceptional Ability
In addition to qualifying as an advanced degree professional, I also meet the criteria as an individual of exceptional ability based on a sustained record of professional work and recognition in my field. Beyond my academic training, I have accumulated more than 13 years of full-time experience in research ethics, clinical research governance, and public health research. I have contributed to peer-reviewed publications, received recognition for my scholarly and professional contributions through selective appointments, and have been selected for research roles and funded projects through competitive processes, including my current postdoctoral appointment. Presenting this basis of eligibility reflects the full scope of my qualifications, which include both formal education and a demonstrated record of continued professional contribution and recognition.
B1. Evidence of Official Academic Record Relating to the Area of Expertise
As outlined in Section I-A on pages 7 and 8 of this document, I hold multiple graduate-level degrees directly related to my areas of expertise in bioethics, clinical research governance, and public health research, supported by official academic records, including diplomas and transcripts (see Exhibits A2-A5). My academic training includes formal education in research ethics, human subjects protection, public health systems, and the analysis of structural and population-level factors affecting participation in research, all of which are directly relevant to my work.
The progression of my academic qualifications demonstrates sustained and specialized development in this field, from foundational training in ethical theory and social systems to advanced graduate education in bioethics and public health. My doctoral-level training further reflects the ability to conduct independent research and address complex ethical and regulatory issues in biomedical and public health research, supporting my qualification under this criterion.
B2. Evidence of More Than 13 Years of Full-Time Professional Experience
My professional record reflects over 13 years of full-time experience in research ethics, clinical research governance, and public health research across academic institutions, research programs, and multi-country collaborations. My work has involved leadership in academic departments, participation in institutional review processes, delivery of ethics training, and contribution to research implementation and health systems initiatives.
The roles outlined on the following pages demonstrate sustained and progressive involvement in my field and are supported by official documentation from current and former institutions, including appointment letters, service agreements, and employment records documenting my roles and duration of full-time experience over a period exceeding 13 years (see Exhibits C1-C5).
- Head, Behavioral and Social Sciences Department – Institute of Public Health, East Africa Medical University (EAMU), Tanzania
From June 2015 to December 2024, I served as Head of the Behavioral and Social Sciences Department at EAMU, with responsibilities including curriculum development, teaching coordination, and faculty mentorship. I taught courses in bioethics and public health ethics and supervised undergraduate and postgraduate research projects. I also led curriculum revisions that impacted over 100 students annually and strengthened departmental research output through mentorship and proposal support. In 2019, I was also appointed as a member of the College Counseling Team (see Exhibit C1).
- Deputy Chairperson, Institutional Review Board (IRB) and Member, Research Ethics and Review Committee – EAMU, Tanzania
I previously served as Vice Chairperson of the Institutional Review Board at East Africa Medical University, as reflected in the 2023 IRB membership records (see Exhibit C2). In this leadership role, I participated in the ethical review and oversight of human subjects research, including the coordination of protocol evaluations, committee deliberations, and regulatory interpretation. I contributed to the review of over 100 research protocols annually, supporting ethical clearance decisions and adherence to established research standards.
Currently, I serve as a Member of the EAMU Research Ethics and Review Committee (KURERC), following my formal appointment in August 2025 (see Exhibit C2). In this capacity, I continue to engage in protocol review, ethical evaluation, and monitoring of approved studies, supporting compliance with ethical and regulatory requirements in clinical and public health research.
- Assistant Lecturer and Bioethics Instructor – EAMU, Tanzania
From September 2016 to September 2018, I served as an Assistant Lecturer at EAMU on a contract basis, as confirmed by my employment agreement. In this role, I contributed to teaching and academic activities, including instruction in research ethics, clinical trial ethics, and Good Clinical Practice, and supported the training of medical students and early-career researchers. My work in this capacity formed part of my broader, ongoing involvement in bioethics education and institutional capacity development (see Exhibit C3).
- Alumnae and Career Counseling Officer – EAMU – U.S. Partner University MEPI Project, Tanzania
From September 2015 to August 2016, I served as an Alumnae and Career Counseling Officer under the EAMU – U.S. Partner University Medical Education Partnership Initiative (MEPI) Project.
In this role, I supported academic mentorship and career development activities for students and early-career professionals, including guidance on academic progression and engagement in global health training programs. My work contributed to strengthening institutional capacity through structured mentorship and professional development support within the academic environment (see Exhibit C4).
- Program Coordinator – PharmAccess International, Tanzania
From March 2010 to December 2012, I served as a Program Coordinator with PharmAccess Foundation, where I was involved in the implementation of the KNCU Health Plan and related health financing initiatives. In this role, I coordinated stakeholder engagements, supported program planning and reporting, and facilitated collaboration among implementing partners, healthcare providers, and program stakeholders, as reflected in project communications and documentation (see Exhibit C5). My work supported the enrollment of over 1,000 coffee farmers into the KNCU Health Plan, improving access to primary healthcare services for rural households and farming communities.
In addition to these roles, I have also taken on responsibilities in advisory and professional board roles, training and capacity-building initiatives, and research projects and consultancies. These additional contributions further demonstrate the breadth of my professional experience and are discussed in greater detail in Section III, where I present my qualifications to advance my proposed endeavor.
B3. Evidence of Recognition for Achievements and Significant Contributions to the Field
My work in bioethics, research ethics, and clinical research governance has been formally recognized by professional and academic organizations through selective appointments to editorial and advisory roles. These roles are not based on general membership but are extended to individuals based on demonstrated expertise, scholarly contributions, and professional standing in the field. Such appointments involve defined responsibilities in research oversight, peer review, policy input, and mentorship, and therefore reflect recognition by peers and institutions of my ability to advance ethical standards and research practices.
- Member, Editorial Board of the African Journal of Bioethics (AJB)
On September 8, 2025, I was appointed as a Member of the Editorial Board of the African Journal of Bioethics (see Exhibit D1). AJB is a peer-reviewed, open-access academic journal launched in October 2022 under the Africa Bioethics Network.
AJB is dedicated to advancing ethically grounded scholarship in health, science, and society across Africa and globally. The journal provides a platform for scholars, practitioners, and policymakers to engage in bioethical discourse, supports peer review capacity development, and operates in collaboration with international research networks, including The Global Health Network, a WHO Collaborating Center for Research Equity (see Exhibit D2).
As stated in the appointment letter, my appointment recognizes my “expertise, scholarly contributions and commitment to advancing bioethics across Africa and beyond.” The letter further confirms that my role is “integral in supporting the journal’s mission of fostering high-quality, ethical, and impactful scholarship.” As an Editorial Board Member, my duties and responsibilities include the following (see Exhibit D1):
- “Advising the Editor-in-Chief on journal policies, scope, and strategic directions for future development of the journal.”
- “Acting as an ambassador for AJB by promoting the journal through professional networks, institutions, and conferences.”
- “Encouraging and inviting high-quality manuscript submissions from colleagues and relevant scholars.”
- “Safeguarding the accuracy and reliability of published research and upholding the journal’s integrity.”
- “Supporting a fair, unbiased, and rigorous peer review process.”
- “Providing constructive feedback to authors to improve their work and contribute to effective scientific communication.”
My appointment is further formalized through an Editorial Board Engagement Contract that outlines the structure, expectations, and responsibilities of the role. The contract establishes a two-year term of appointment, subject to renewal based on performance, and confirms that my contributions are evaluated annually. It requires active participation in editorial leadership, including supporting policy development, strategic planning, and thematic initiatives, as well as direct involvement in the peer-review process by reviewing multiple manuscripts each year with timely, substantive feedback.
The contract further specifies ongoing responsibilities in mentorship and capacity building, promotion of the journal through professional networks, and contribution to advancing African-centered ethical frameworks while maintaining international publishing standards (see Exhibit D3).
- Advisory Board Member of the GREEN Program (Nigeria)
In addition, I served as an Advisory Board Member for the Growing Research Ethics Environment in Nigeria (GREEN) program, a collaborative initiative between the West African Partner University and U.S. Research University, supported by the U.S. National Institutes of Health Fogarty International Center. This role is documented through letters dated May 12, 2020 and April 20, 2022, confirming my participation in the Advisory Board and continued involvement in supporting the development of graduate-level research ethics training programs aligned with the Nigerian context (see Exhibit D4).
As part of this role, my responsibilities included:
- Participating in Advisory Board meetings held twice per year, either by phone, video call, or in person.
- Providing expertise in bioethics education, particularly in teaching postgraduate students and supporting the development of locally contextualized bioethics curricula.
- Sharing Institutional Review Board (IRB) experience, including ethical review processes and challenges encountered in African medical institutions.
- Contributing perspectives on research ethics in low-resource settings, including the application of ethical standards in culturally diverse environments.
- Supporting the development of research ethics training programs, including Master’s and PhD-level initiatives under the GREEN project.
My contributions drew on my experience in bioethics instruction, IRB leadership, and international clinical research, including work on informed consent processes and ethical considerations in vulnerable populations. This role involved active participation in a multi-institutional initiative to strengthen research ethics capacity and advance ethical standards in global health research.
B4. Evidence of Comparable Contributions Demonstrating Exceptional Ability
In addition to satisfying at least three of the regulatory criteria for classification as an individual of exceptional ability, I further provide comparable evidence demonstrating a sustained record of professional contribution and recognition in my field. This evidence is presented through two distinct but related areas: (1) scholarly research output and (2) selection for competitive research roles, including research projects, consultancies, and postdoctoral appointments.
Scholarly Research Output
My scholarly research output demonstrates a sustained record of peer-reviewed publications over more than 17 years, with work published between 2008 and 2025 across multiple international journals and academic platforms. I have contributed to nine peer-reviewed publications and scholarly outputs, including articles in Transactions of the Royal Society of Tropical Medicine and Hygiene, IRB: Ethics & Human Research, Antimicrobial Resistance & Infection Control, Global Bioethics, and the African Journal of Bioethics, as well as an academic book chapter published by Brill. My roles include lead author, co-author, and contributing researcher. These publications address specific and high-impact areas such as therapeutic misconception in pediatric malaria trials (2017), antibiotic use and antimicrobial resistance in children (2021, 2022, 2025), HIV clinical trial participation and endpoints (2023), post-trial responsibilities and ethical obligations (2024, 2025), and access to bioethics education in Africa (2024). Several of these works have been highlighted as top publications in their respective journals, reflecting their relevance and contributions to ongoing discourse in research ethics.
My published research is summarized in the table below, which presents my research output chronologically, including year of publication, authorship, publication title, journal or publisher, role, and documented impact. Supporting evidence includes copies of these peer-reviewed publications (see Exhibits E1-E9), as well as citation data demonstrating the extent to which selected works have been referenced within the academic community. Earlier publications, including my 2008 study on pediatric care in Tanzania, my 2017 study on therapeutic misconception in malaria trials, and my 2021 study on antibiotic use and resistance, have received the highest citation counts, reflecting continued engagement and use by other researchers.
| Year | Authors | Title | Journal / Publisher | Role | Impact |
| 2008 | Doe, J.; et al. | Patient and Provider Perspectives on Pediatric Care in Public Hospitals in East Africa | Transactions of the Royal Society of Tropical Medicine and Hygiene | Lead & Co-author | Provides insights into patient care practices in East Africa |
| 2017 | Doe, J.; et al. | Informed Consent and Enrollment Decision-Making in Pediatric Clinical Trials in Rural Settings | IRB: Ethics & Human Research | Lead & Co-author | Informs consent processes; supports development of consent toolkits in Canada and the U.S. |
| 2021 | Emgård, M.; Doe, J.; et al. | Primary Healthcare Workers’ Perspectives on Antibiotic Use and Resistance in Childhood Infections | Antimicrobial Resistance & Infection Control, 10, 94 | Co-author | Supports antimicrobial resistance (AMR) policy and stewardship efforts |
| 2022 | Emgård, M.; Doe, J.; et al. | Caregiver Experiences With Antibiotic Use Among Children Under Five in Low-Resource Communities | Antimicrobial Resistance & Infection Control, 11, 130 | Co-author | Provides caregiver-centered insights; informs interventions and policy |
| 2023 | Doe, J.; et al. | Please Do Not Leave Us: HIV-Infected Participants’ Perspectives on Clinical Trial Endpoints in Tanzania | African Journal of Bioethics | Lead & Co-author | Informs ethical trial design and participant protection |
| 2024 | Doe, J.; et al. | Post-Trial Transition, Participant Care, and Ethical Responsibilities in Clinical Research | African Journal of Bioethics | Lead & Co-author | Shapes post-trial ethical standards; supports standardized consent tools |
| 2024 | Doe, J.; et al. | Expanding Access to Bioethics Education and Practice in Regional Health Research Systems | An African Research Ethics Reader: From the Ground Up, Brill | Author | Influences ethics education and curriculum development |
| 2025 | Doe, J.; et al. | Post-Trial Responsibilities in Clinical Research: Perspectives From Ethics Committees and Investigators | Global Bioethics | Lead & Co-author | Influences clinical trial governance and ethics frameworks |
| 2025 | Doe, J.; et al. | Healthcare Workers’ Perspectives on Antibiotic Use in Young Children in Central African Health Settings | Antimicrobial Resistance & Infection Control | Lead & Co-author | Strengthens antibiotic stewardship and contributes to global AMR policy |
Competitive Research Roles
My professional record includes selection for competitive, externally funded research roles and fellowship programs, which reflect recognition of my expertise and ability to contribute to high-impact research initiatives in bioethics and clinical research governance. These roles are awarded through structured selection processes and are supported by leading academic institutions and international funding bodies, including the U.S. National Institutes of Health (NIH) and major research universities.
- Research Ethics Fellow – NIH Fogarty International Center Training Program, U.S. Research University, United States
In May 2015, I completed the NIH Fogarty International Center-funded Training for Scholarship in Research Ethics Fellowship at U.S. Research University, conducted in collaboration with the African Partner University. This program focuses on building capacity in international research ethics and is awarded to individuals who demonstrate strong potential in research ethics and public health. Completion of this fellowship reflects early recognition of my capabilities and my commitment to advancing ethical research practices (see Exhibit F1).
- GFBR Fellow – South African Research Ethics Training Initiative (SARETI), Southern African Research University, South Africa
On June 30, 2023, I was awarded a Global Forum for Bioethics Research (GFBR) Fellowship under the South African Research Ethics Training Initiative (SARETI) at the Southern African Research University, funded by the NIH Fogarty International Center. This fellowship provided support for participation in a competitive international research program and required compliance with NIH research standards and reporting requirements. The award reflects formal selection by a steering committee and confirms that my work aligns with internationally recognized priorities in bioethics and research ethics capacity building. The fellowship contract explicitly states that the program is funded through the NIH Fogarty International Center and administered through an academic training initiative, demonstrating both the competitive and institutional nature of this role (see Exhibit F2).
- Postdoctoral Fellow – Department of Epidemiology, Canadian Research University
I was appointed as a Postdoctoral Fellow within the Department of Epidemiology, Biostatistics, and Occupational Health at Canadian Research University, with a defined research period from November 9, 2025 to March 31, 2027 (see Exhibit F3). This appointment reflects continued recognition at the international level and involves structured academic and research engagement under the supervision of a Principal Investigator.
My appointment is supported through external funding and includes an annual stipend of $50,000, reflecting a formal, funded research role within a leading research institution. The associated research project, PregTrial, is a Canadian Institutes of Health Research (CIHR)-funded implementation science initiative focused on improving the inclusion of pregnant and lactating individuals in clinical trials, directly aligning with my proposed endeavor (see Exhibit F3).
In addition, a Letter of Support from Dr. Eleanor Grant, Principal Investigator of the PregTrial Project, confirms that my expertise is essential to advancing the project’s objectives:
“Dr. Doe is a highly qualified bioethicist with extensive experience reviewing World Health Organization (WHO) guidelines, facilitating Good Clinical Practice (GCP) courses, and mentoring ethics teams for internationally funded clinical trials. Her expertise is especially important to research involving pregnant and lactating women, a population that has historically been underrepresented in clinical trial design and participation. Through her guidance, our research can apply rigorous ethical standards while supporting more responsible, inclusive, and evidence-based approaches to maternal health research.”
Canada is currently reviewing International Council of Harmonisation guidelines to improve protections for this group, including the development of consent templates and ethical guidance. Dr. Doe is contributing directly to this process. Her perspective from the Global South adds critical value to this work, given her longstanding involvement with WHO and similar organizations.” (See Exhibit F4)
Further demonstrating the active and ongoing nature of my contributions in this postdoctoral role, I am currently developing peer-reviewed research outputs and applied studies directly aligned with the objectives of the PregTrial project. These include an ongoing manuscript titled Ethical Inclusion of Pregnant and Lactating Individuals in Clinical Trials: Closing the Implementation Gap, as well as a mixed-methods study titled Evaluating the Acceptability, Appropriateness, and Readiness of an Informed Consent Toolkit to Support the Inclusion of Pregnant and Lactating Individuals in Clinical Trials: A Mixed-Methods Study of Canadian Clinical Research Stakeholders.
These research activities focus on addressing barriers to inclusion, strengthening informed consent processes, and developing practical tools to improve ethical and regulatory practices in clinical trials, thereby demonstrating continued research productivity and direct contribution to advancing ethical governance in clinical research.
II. SECTION 2 – MY PROPOSED ENDEAVOR HAS BOTH SUBSTANTIAL MERIT AND NATIONAL IMPORTANCE
A. The Substantial Merit of My Proposed Endeavor
A1. Overview of My Proposed Endeavor
My proposed endeavor will strengthen ethical governance in the United States clinical research system through the development and implementation of standardized ethical frameworks, policy guidance, decision-support tools, and structured training programs. It will focus on improving the inclusion of underrepresented populations, particularly pregnant and lactating individuals, and will support the generation of more complete and applicable clinical evidence. In addition, my activities will address inconsistencies in protocol design and ethical review by promoting harmonized practices, strengthening the application of ethical and regulatory standards, and supporting consistent implementation across research institutions through targeted training.
Through these efforts, my proposed endeavor will address three interconnected challenges in the U.S. clinical research system: gaps in the inclusion of key patient populations, inefficiencies and fragmentation in clinical trial review processes, and limitations in ethics-related capacity and training. Each challenge affects how clinical studies are designed, reviewed, and implemented, and collectively influences the quality, reliability, and applicability of clinical research outcomes. As discussed in the following section, addressing these challenges demonstrates the substantial merit of my proposed endeavor.
A2. Key U.S. Challenges Addressed by My Proposed Endeavor
Problem 1: The United States clinical research system produces incomplete and non-representative medical evidence due to the exclusion of key patient populations, particularly pregnant and lactating individuals, leaving critical gaps in safety, efficacy, and dosing data.
The United States clinical research system continues to generate incomplete and non-representative medical evidence due to the exclusion of pregnant and lactating individuals from clinical trials, despite their significant need for medical treatment. Each year, more than 3.5 million births occur in the United States, and a substantial proportion of pregnancies involve acute or chronic conditions requiring therapeutic intervention, including infections, hypertension, diabetes, and obesity. Medication use during pregnancy is widespread, with studies indicating that over 90% of pregnant women take at least one medication, and approximately 30% take five or more. Despite this, the evidence base guiding treatment decisions for this population remains very limited (see Exhibit I1).
The scale of exclusion is severe. An analysis of randomized controlled drug trials registered in ClinicalTrials.gov between 2008 and 2023 found that only 0.8% of 44,160 trials included pregnant participants, while approximately 75% explicitly excluded them, and 24% did not address their inclusion (see Exhibit I1). As a result, critical gaps persist in safety, efficacy, and dosing data. Physiological changes during pregnancy, including a 50%-60% increase in plasma volume and alterations in drug metabolism, significantly affect pharmacokinetics and pharmacodynamics, yet only a small fraction of studies are designed to assess these changes (see Exhibit I2). Moreover, historical data show that 97.7% of FDA-approved medications lack sufficient evidence on teratogenic risk, 73.3% provide no data supporting use in pregnancy, and only 5% of newly approved therapeutics include human pregnancy data, with nearly half lacking breastfeeding data (see Exhibit I3). Medical treatment decisions for pregnant patients, therefore, often proceed without rigorous evidence on the appropriate dose, expected benefit, or actual risk profile in pregnancy.
The consequences of this exclusion are not theoretical but systemic. Risk is not eliminated by excluding pregnant individuals from clinical trials; it is shifted into routine clinical practice, where medications are used without adequate evidence. This creates ongoing uncertainty in treatment decisions, limits the ability to conduct informed risk-benefit analyses, and exposes both patients and fetuses to avoidable harm. At the same time, available data indicate that a notable proportion of pregnant individuals are willing to participate in clinical research, with 35% expressing willingness to participate in medication trials and 25% in vaccine trials; however, participation is contingent on perceived benefit and concerns about fetal safety (see Exhibit I1). These conditions collectively demonstrate a persistent, well-documented gap in the U.S. clinical research system, underscoring a clear and significant need for improved ethical frameworks and inclusive research practices.
Addressing Incomplete and Non-representative Clinical Research Through My Endeavor
To address this structural gap in clinical research, I will develop and apply ethical frameworks and decision-support tools to enable the safe and systematic inclusion of pregnant and lactating individuals in clinical research. I will also work with research institutions and ethics review bodies to strengthen protocol design, risk-benefit assessment, and informed consent processes to support more inclusive and evidence-based clinical trials. A more detailed description of my proposed endeavor and the specific activities I will undertake is provided in the section, The National Importance of My Proposed Endeavor.
Problem 2: Structural inefficiencies and fragmentation in the U.S. clinical trial start-up and review processes delay study activation and limit system-wide efficiency.
Ethics-related inconsistencies in protocol design and review remain a significant source of delay in the United States clinical trial system, particularly during study start-up and approval. A 2025 analysis of cancer studies reported that the National Cancer Institute’s Operational Efficiency Working Group sets an aspirational target of 90 days for full study start-up, yet an Association of American Cancer Institutes survey of 61 North American centers found a median interval of 167 days. These delays are driven in part by serial and overlapping review processes, including scientific review, Institutional Review Board (IRB) review, and additional institutional approvals, each applying distinct scientific, ethical, operational, and regulatory criteria. As a result, clinical trial activation timelines are extended, delaying patient access to new treatments and reducing the overall efficiency of the U.S. clinical research system (see Exhibit I4).
The persistence of these delays reflects ongoing variability in how IRB policies, processes, and regulatory requirements are implemented across institutions. A 2023 study on the implementation of the single IRB requirement found continued duplication of review processes, lack of harmonization, and significant variation in institutional practices across participating sites (see Exhibit I5). Federal oversight further indicates that the United States lacks standardized measures to assess the effectiveness of IRB review processes, limiting the ability of regulatory agencies to evaluate consistency and identify system-wide inefficiencies (see Exhibit I6).
Addressing Clinical Trial and Review Process Inefficiencies Through My Endeavor
Given that clinical trials already require several years to progress through development, inefficiencies at the ethics review stage further delay the availability of new treatments. To address these inefficiencies, I will develop standardized ethical guidance and implementation tools to ensure consistency in protocol design and ethics review across institutions. My work will focus on aligning ethical and regulatory expectations early in the study design process, reducing the need for repeated revisions during review. I will also collaborate with research institutions and ethics review bodies to identify duplication and variation in current review workflows and to introduce structured approaches that promote harmonization, improve coordination among review entities, and support more efficient study activation timelines.
Problem 3: Limited capacity and inconsistent training in clinical research ethics in the United States constrain the ability of the clinical research system to effectively design, review, and oversee complex studies.
A 2023 competency framework study identified that health research ethics (HRE) practice requires proficiency across 7 competency domains and 27 subdomains, including regulatory interpretation, ethical issue analysis, stakeholder engagement, and system-level coordination. Despite the expansion of formal training programs, the same study found that no clearly articulated shared framework for educational outcomes exists, and that variation in training content persists across programs, limiting the ability to evaluate workforce readiness and effectiveness (see Exhibit I7). The absence of standardized competencies directly affects the consistency and quality of ethical oversight, as individuals performing ethics review and governance roles may possess uneven skill sets across critical domains such as risk-benefit analysis, protocol evaluation, and regulatory compliance. Given the increasing complexity of clinical research, including multisite trials and advanced biomedical interventions, these gaps undermine the system’s ability to consistently and efficiently apply ethical standards at scale.
Operational evidence further demonstrates that gaps in ethics-related expertise and support capacity contribute to inefficiencies in clinical trial oversight. A 2023 national analysis of single Institutional Review Board (sIRB) implementation reported that many research teams are neither adequately trained nor resourced to manage IRB coordination responsibilities, resulting in delayed submissions, poor-quality applications, and repeated cycles of revision (see Exhibit I5). Complementing these findings, a national survey of research ethics consultation services found that nearly half of services are staffed by only 1-2 consultants, and almost two-thirds handle fewer than 10 consultations annually (see Exhibit I8). These patterns suggest that research ethics consultation services remain limited in scale and may be underutilized or insufficiently integrated within research workflows.
Addressing Limited Capacity and Inconsistent Training Through My Endeavor
In response to these gaps, I will strengthen capacity in clinical research ethics by developing and implementing targeted training programs for both researchers and ethics review bodies. For researchers, I will provide training on ethical protocol design, risk-benefit evaluation, and informed consent processes. For ethics review bodies, including IRB members and regulatory personnel, I will deliver specialized training to support consistent application of ethical and regulatory standards and improve the efficiency and reliability of review processes.
A3. Demonstration of the Substantial Merit of My Proposed Endeavor
My proposed endeavor has substantial merit as it will address critical and well-documented challenges in the United States clinical research system that directly affect patient care, research quality, and the efficient development of medical treatments. The gaps identified in participant inclusion, ethics review processes, and workforce capacity are not isolated issues but systemic constraints that influence how clinical evidence is generated, evaluated, and applied in practice. Addressing these issues is essential to improving the reliability, safety, and applicability of medical research outcomes.
Improving the inclusion of underrepresented populations, such as pregnant and lactating individuals, in clinical research has direct implications for patient safety and treatment effectiveness. When clinical evidence does not reflect the populations receiving care, healthcare providers are required to make decisions without adequate data, thereby increasing uncertainty in treatment planning and limiting the ability to optimize therapeutic outcomes. Strengthening ethical frameworks and research practices to support inclusive study design contributes to more accurate and generalizable evidence, which is essential for informing clinical decision-making and improving patient outcomes across diverse populations.
Enhancing the consistency and efficiency of clinical trial start-up and review processes also carries significant practical value. Delays in study activation affect the timely development and evaluation of new treatments, slowing the translation of research into clinical use. By improving coordination and reducing variability in ethics review processes, my proposed endeavor will support more efficient research operations and facilitate faster patient access to new therapies. This will contribute to strengthening the overall performance of the U.S. clinical research system and improving its responsiveness to evolving healthcare needs.
Strengthening capacity in clinical research ethics and governance further supports the integrity and sustainability of the research system. Well-trained professionals and standardized approaches to ethical oversight are essential for maintaining consistency in protocol evaluation, regulatory compliance, and participant protection. By developing training programs and strengthening institutional capacity, my proposed endeavor will improve the quality of ethical review and reduce variability across research settings.
Thus, my proposed endeavor will advance the development of a more inclusive, efficient, and ethically consistent clinical research system. These improvements will have direct implications for public health, healthcare delivery, and the advancement of medical knowledge, demonstrating the substantial merit of my proposed endeavor in the United States.
B. The National Importance of My Proposed Endeavor
In addition to establishing substantial merit, my proposed endeavor has national importance as it will address system-level challenges that extend beyond individual institutions and have implications for the broader U.S. clinical research system. My proposed endeavor will be directed not only at improving ethical inclusion, protocol design, and review processes but also at strengthening training and institutional capacity in clinical research ethics, thereby supporting the broader adoption of consistent practices across research settings. Through its combined focus on governance, implementation, and workforce development, my proposed endeavor will influence how ethically complex studies are designed and overseen at a scale that reaches beyond a single organization or position.
The following sections provide a detailed description of my proposed endeavor and explain its national-level impact. They also present my implementation approach, my target institutions and geographic areas of focus, and alignment with federal priorities on human subjects protection, scientific integrity, and maternal health.
B1. Description of My Proposed Endeavor
Scope and Focus of My Proposed Endeavor
The scope and focus of my proposed endeavor consist of three core areas of work that define the services and activities I will carry out within the United States clinical research system. My proposed endeavor will be implemented through a professional route within established roles in clinical research, including protocol development, ethics review, and training activities.
1. Ethical Inclusion and Protocol Design for Underrepresented Populations
Work in this area will focus on integrating ethical inclusion considerations into protocol development and ethics review stages of clinical research, particularly for pregnant and lactating individuals. Activities will be applied at points where study design, participant selection, safety evaluation, and informed consent are defined and refined, allowing inclusion decisions to be evaluated within the context of clinical use and available evidence.
| Category | Details |
|---|---|
| Service Overview | Structured frameworks will be developed and applied to guide investigators in defining inclusion and exclusion criteria during protocol development. These frameworks will be based on established ethical principles, including risk-benefit assessment, and will be used to evaluate whether participation is supported by sufficient safety data and clinical justification. Application of these frameworks will support consistent evaluation of inclusion decisions across protocol development and ethics review stages. |
| Key Activities | Activities under this component will be implemented across protocol development, ethics review, and revision stages and will include the following:
|
| Implementation Approach | Implementation will follow the staged workflow, beginning with protocol development, continuing through ethics review, and extending into revision and alignment. During protocol development, draft protocols will be reviewed to assess inclusion and exclusion criteria, participant selection, safety data, and risk-benefit considerations. This stage will involve identifying exclusion practices that lack sufficient scientific or safety justification and developing protocol-level recommendations for eligibility criteria, safety monitoring procedures, and informed consent content.
During ethics review, engagement will involve direct collaboration with investigators, study teams, and Institutional Review Boards to support evaluation of ethical and regulatory requirements and interpretation of reviewer feedback. During revision and alignment, protocol documentation will be refined in response to IRB comments, including incorporation of recommended changes and alignment of supporting materials with review expectations. |
| Expected Outputs And Results | This work will result in the development of standardized ethical inclusion frameworks, protocol design guidance documents, and structured tools for risk-benefit assessment and participant selection. Protocols developed or reviewed under this approach will include clear, documented justification for inclusion or exclusion decisions and a more consistent evaluation of underrepresented populations.
Over time, research teams and ethics review bodies will shift from default exclusion practices to structured evaluation of inclusion, resulting in study populations that better reflect clinical use. Clinical trials will generate evidence more applicable to real-world patients, particularly for populations currently underrepresented in research. |
2. Review Process Alignment And Early-Stage Protocol Coordination
A contributing factor to delays in clinical trial approval is the lack of alignment between submitted protocols and institutional and regulatory expectations at the time of ethics review. This misalignment arises from differences in how review bodies interpret similar requirements, as well as fragmented and overlapping review processes, which often lead to repeated revisions and extended activation timelines. My work in this area will focus on improving how protocols are prepared and coordinated prior to and during ethics review by introducing structured approaches that align expectations, reduce duplication, and improve coordination among review entities.
| Category | Details |
|---|---|
| Key Activities | The activities under this area will include the following:
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| Implementation Approach | Implementation will take place through direct involvement in protocol preparation and institutional review processes within research settings. At the pre-submission stage, I will work with research teams to align protocol documentation with expected ethical and regulatory requirements, reducing gaps that commonly lead to revision during review.
During ethics review, my role will focus on improving coordination between investigators and review bodies by supporting clearer interpretation and integration of reviewer feedback, particularly where multiple review entities are involved. I will also engage with institutions to examine how review workflows are currently structured, including areas where duplication or sequencing issues contribute to delays. Based on this, I will introduce structured approaches that improve coordination across review stages without altering institutional authority, allowing scientific review, ethics review, and administrative processes to function more cohesively. |
| Expected Outputs And Results | Outputs will include standardized ethical review guidance, pre-submission alignment tools, and structured workflow approaches that can be integrated into existing institutional processes. Protocols prepared under these conditions will enter review with clearer documentation and stronger alignment to expected requirements. The goals of this work include the following:
|
3. Training, Mentorship, and Institutional Capacity Development
Gaps in training and workforce capacity continue to limit the consistency and effectiveness of clinical research ethics in the United States, particularly as study designs become more complex and involve multiple sites and regulatory requirements. My work in this area will focus on strengthening practical competencies among both researchers and ethics review bodies, with the objective of improving the quality of protocol development, the consistency of ethical review, and the overall efficiency of research oversight. The tables below summarize the key components of my training, mentorship, and capacity development activities, while a more detailed description of the specific activities and implementation plan is provided in a separate exhibit (see Exhibit B, EB-2 NIW Professional Plan).
a. Training and Mentorship for Researchers
| Category | Details |
|---|---|
| Training Overview | This training will focus on strengthening the ability of researchers to prepare ethically sound and review-ready clinical research protocols. Emphasis will be placed on improving how ethical and regulatory requirements are applied during protocol development to reduce delays during ethics review. |
| Participant Selection | Participants will include principal investigators, clinical researchers, study coordinators, and research staff involved in protocol development and IRB submissions, particularly those engaged in clinical trials involving complex populations or multi-site studies. |
| Mode of Delivery | Training will be delivered through a combination of in-person (face-to-face) sessions and live virtual sessions, depending on institutional setting and participant availability. Structured workshops will be conducted in small-group formats, either onsite within research institutions or through video conferencing platforms for remote participation.
Project-based mentorship will be provided through scheduled one-on-one or small-group consultations, conducted both in-person and virtually, aligned with active protocol development and IRB submission timelines. Training materials and supporting resources will be distributed through digital platforms to support continued reference during protocol preparation and revision. |
| Topics Covered | Topics will include ethical protocol design, risk-benefit evaluation, informed consent development, regulatory requirements, preparation of IRB submissions, and common deficiencies that lead to protocol revisions. Additional focus will be placed on improving clarity, completeness, and alignment of protocol documentation with review expectations. |
| Duration | Training will be delivered over a 4-6 week cycle, consisting of 1-2 sessions per week with each session lasting approximately 2-3 hours. Additional mentorship support will be provided throughout protocol development and ethics review, typically involving 1-2 hours per week as needed. |
b. Training and Institutional Capacity Development for Ethics Review Bodies
| Category | Details |
|---|---|
| Training Overview | Strengthening institutional review capacity requires more than general training; it involves improving how review bodies interpret requirements, conduct evaluations, and manage internal processes. The focus of this training is to enhance the consistency and reliability of ethics review by addressing variation in reviewer judgment, gaps in applied knowledge, and inefficiencies in how review responsibilities are carried out across committees.
Approach and content will vary depending on the institutional context. Factors such as IRB size, volume of protocols reviewed, level of reviewer experience, and existing workflow structure will determine whether emphasis is placed on foundational reviewer calibration, advanced review of complex protocols, or process-level improvements in coordination and review management. |
| Participant Selection | The training will be directed toward IRB members, ethics committee chairs, regulatory reviewers, compliance personnel, and administrative staff responsible for coordinating protocol review and institutional oversight processes. |
| Mode of Delivery | Delivery will take place through a combination of onsite institutional sessions and live virtual engagements, selected based on operational requirements and institutional preference. Sessions will include facilitated group discussions, technical workshops, and structured review exercises based on real or simulated protocol materials.
Institution-focused working sessions will be incorporated to examine existing review workflows, with targeted discussions on process gaps and areas requiring refinement. Follow-up engagement will be conducted through scheduled advisory sessions, either in-person or virtual, aligned with active review cycles and institutional needs. |
| Topics Covered | Content will address both reviewer-level competencies and institutional review processes, including the following:
|
| Duration | Training will be structured as a series of focused sessions delivered over approximately 3-4 weeks, with each session lasting 2-3 hours. The schedule will remain flexible to accommodate institutional review cycles, with additional targeted sessions conducted as needed to address complex protocols or workflow-specific challenges. |
Target Geographic Areas and Institutions
The primary implementation of my proposed endeavor will take place in major U.S. biomedical and regulatory hubs where clinical research, ethics oversight, and policy development are concentrated. These locations are selected based on their role in shaping national standards for human subjects research, clinical trial conduct, and regulatory compliance. Positioning my proposed endeavor within these areas will allow direct engagement with institutions responsible for advancing clinical research quality, inclusion, and ethical governance across the United States.
- Washington, D.C. – Maryland – Virginia (DMV Region)
The Washington, D.C.–Maryland region serves as the central hub of U.S. clinical research oversight, driven by the presence of the National Institutes of Health (NIH) in Bethesda, Maryland, which employed 18,478 people in 2021 (see Exhibit I9) and secured a 2025 budget of $48 billion (see Exhibit I10). The NIH Clinical Center alone supports approximately 1,500 active research studies and has served over half a million research participants (see Exhibit I11), reflecting the scale and complexity of federally coordinated clinical research. This concentration of federal funding, large-scale clinical trial activity, and regulatory oversight creates an environment where ethical frameworks, inclusion strategies, and review process improvements can be implemented within high-impact, policy-aligned research systems.
- Boston, Massachusetts
Boston is one of the most concentrated biomedical research ecosystems in the United States, with sustained growth in life sciences employment and continued investment in advanced clinical research areas such as gene therapy and biologics. The broader U.S. life sciences sector expanded by nearly 20% between 2019 and 2023, with Boston as one of the hubs for pharmaceutical and clinical trial innovation and workforce expansion (see Exhibit I12). Boston also houses the Multi-Regional Clinical Trials Center, which develops ethical, actionable, and practical solutions to address challenges in clinical trial conduct and oversight (see Exhibit I13). The scale of research activity and institutional capacity in this region creates a setting in which ethical governance, protocol standardization, and review coordination are essential for managing complex, multi-site studies.
- Research Triangle Park (RTP), North Carolina (Durham–Chapel Hill–Raleigh area)
Research Triangle Park and the surrounding Durham–Chapel Hill–Raleigh area provide a practical setting for implementing work that intersects clinical trials, ethics review, and institutional oversight. RTP’s official site states that the park’s 7,000 acres house more than 385 companies with 55,000 employees and that it sits at the center of three Tier-1 research universities, creating a dense environment of academic, governmental, nonprofit, and industry research activity (see Exhibits I14 and I15). The regional fit is strengthened by Duke’s research infrastructure, including the Duke Health Institutional Review Board, whose mission is to protect human research subjects through scientific and ethical review while also providing leadership and education for the research community (see Exhibit I16). These conditions make the area a credible location for work focused on review efficiency, ethics training, and institutional coordination in clinical research.
While the long-term objective of my proposed endeavor is to achieve nationwide impact across the United States clinical research system, initial implementation will be concentrated in the identified geographic areas. These regions host a high concentration of federal agencies, academic medical centers, clinical trial sponsors, and research networks that play a central role in shaping clinical trial standards, ethics review practices, and regulatory frameworks. Focusing early efforts within these established hubs will enable the practical implementation, validation, and refinement of ethical frameworks, decision-support tools, and training programs in settings where they can be applied at scale and aligned with national priorities.
Within these target areas, my engagement will focus on institutions and stakeholders directly involved in clinical research design, funding, ethics review, and regulatory oversight. These include NIH-funded researchers, Institutional Review Boards, clinical trial sponsors, hospital-based research units, and university-based bioethics and public health programs, where my work can be applied to improve inclusion practices, strengthen ethical decision-making, and enhance the consistency and efficiency of clinical trial review processes.
| Institution/Type | Relevance and Application to My Proposed Endeavor |
|---|---|
| National Institutes of Health (NIH) and NIH-Funded Research Networks | The NIH is the primary federal agency that funds and coordinates biomedical research in the United States. NIH-funded researchers and clinical trial networks will serve as primary users of the ethical frameworks, inclusion toolkits, and protocol development guidance, applying these tools during study design to align with federal priorities on diversity, inclusion, and human subjects protections. |
| Food and Drug Administration (FDA) and Regulatory-Facing Research Settings | The FDA establishes regulatory standards governing clinical trials and human subjects protection. While not the primary operational users, FDA regulators and associated stakeholders will engage with the resulting policy guidance and harmonized ethical standards, supporting improved interpretation and application of regulatory requirements. |
| Academic Medical Centers and University-Affiliated Hospitals | These institutions conduct a high volume of clinical trials and maintain IRBs responsible for protocol evaluation. They serve as primary implementation sites where researchers, IRBs, and clinical teams can apply ethical frameworks, inclusion tools, and review process improvements in active studies. |
| Institutional Review Boards (IRBs) and Ethics Committees | IRBs are central users of the decision-support tools and standardized review frameworks developed through this endeavor. These tools will be integrated into IRB review processes to improve consistency in ethical evaluation, strengthen risk-benefit assessment, and reduce variability across reviewers and institutions. |
| Clinical Trial Sponsors (Pharmaceutical, CROs, and Academic Sponsors) | Clinical trial sponsors will apply inclusion and consent-related tools during protocol development to improve regulatory readiness and reduce downstream revisions. Early integration of ethical guidance will support more efficient trial design, recruitment, and regulatory approval processes. |
| Hospital Systems and Clinical Research Units | Hospital-based research units and academic health systems manage active clinical trials and patient recruitment. These settings provide practical environments for applying ethical frameworks, informed consent models, and inclusion strategies during real-time trial implementation and oversight. |
| University-Based Bioethics, Public Health, and Global Health Programs | These programs support research, training, and policy development in clinical research ethics and health equity. Collaboration will enable the dissemination of frameworks, the development of training programs, and the integration of ethical guidance into academic and research training environments. |
| Research Ethics and Clinical Trial Centers (e.g., Clinical Trials Policy Center and similar entities) | These centers develop practical tools and policy guidance for improving clinical trial ethics and operations. Engagement will support the development, validation, and scaling of structured approaches to inclusion, ethics review consistency, and regulatory alignment across research systems. |
B2. Prospective National Impact of My Proposed Endeavor
By addressing the structural and ethical challenges identified in Section A2. Key U.S. Challenges Addressed by My Proposed Endeavor, my endeavor will strengthen the operational performance of the United States clinical research system at a national level. The U.S. clinical research system operates across a distributed network of academic medical centers, hospitals, universities, sponsors, and regulatory bodies. Improvements in ethical frameworks, protocol design, and review processes will therefore extend across multiple institutions and research settings.
1. Impact on Patient Populations and Clinical Decision-Making
With more than 3.5 million births occurring annually in the United States, pregnancy-related treatment decisions affect a large patient population (see Exhibit I1). The clinical significance of these decisions is reflected in the prevalence of pregnancy-related conditions that commonly require treatment and monitoring. The Centers for Disease Control and Prevention (CDC) reports that gestational diabetes affects 5% to 9% of U.S. pregnancies each year (see Exhibit I17). CDC-supported analyses further show that hypertensive disorders of pregnancy have become increasingly common in the United States, with estimates ranging from 10.1% to 15.9% of births in 2019 (see Exhibit I18). These figures demonstrate that pregnancy-related care frequently involves conditions requiring timely and well-informed treatment decisions.
The national significance of this issue is also reflected in the scale of healthcare utilization associated with pregnancy and childbirth. Recent data indicate that the average total cost of pregnancy, childbirth, and postpartum care exceeds $20,000 per patient, with out-of-pocket costs averaging approximately $2,700 even among insured populations (see Exhibit I19). Therefore, pregnancy-related care represents a significant component of healthcare utilization and spending. Clinical management during pregnancy often involves ongoing monitoring, diagnostic testing, and treatment of conditions that require timely medical intervention. Variability in clinical decision-making, which is driven in part by limitations in population-specific evidence, contributes to differences in care approaches, additional testing, and extended care pathways, all of which increase healthcare utilization and costs. Strengthening ethical inclusion and improving clinical trial design and review processes will support the generation of more complete, population-specific evidence for use in pregnancy. Improved evidence availability will enable more precise treatment selection, reduce unnecessary variation in care, and support more efficient use of healthcare resources.
2. Impact on Clinical Trial Efficiency and Research System Performance
A second area of national impact of my proposed endeavor is the improvement of efficiency across the United States clinical trial system. Alignment between protocol design and ethics review processes at the outset of study development supports more streamlined transitions from study conception to activation. This reduces avoidable delays in patient enrollment and the evaluation of new treatments.
The national significance of this impact is reflected in the measurable economic consequences of delays in clinical research. A 2024 white paper from the Tufts Center for the Study of Drug Development estimates that a single day of delay in drug development is associated with approximately $800,000 in unrealized or lost prescription drug revenue and approximately $40,000 in direct daily trial costs (see Exhibit I20). Delays at the protocol design and ethics review stages, therefore, extend beyond administrative inefficiency and directly affect the pace of therapeutic development and access to care. Improving protocol readiness and introducing more standardized review approaches will reduce avoidable inefficiencies in study initiation. These improvements will accelerate the generation of clinical evidence, support more timely evaluation of new therapies, and enhance the efficiency of research operations across institutions.
3. Impact on Public Trust and Participation in Clinical Research
A further national impact of my proposed endeavor is strengthening workforce capacity and institutional capability in clinical research ethics and governance across the United States. The scale of the U.S. biomedical research enterprise demonstrates the need for a highly trained and consistently prepared workforce. According to the 2026 update on the economic impact of the National Institutes of Health (NIH), NIH-funded research supported 390,863 jobs nationwide in Fiscal Year 2025 and generated $94.15 billion in economic activity across all 50 states and the District of Columbia, reflecting the extensive human and institutional infrastructure involved in clinical research.
The national reach of this workforce is further demonstrated by the distribution of research activity across the country. In Fiscal Year 2025, 39 states supported at least 1,000 NIH-related jobs, 22 states supported more than 5,000 jobs, and 13 states supported more than 10,000 jobs, while 47 states generated at least $100 million in research-related economic activity, and 24 states exceeded $1 billion (see Exhibit I21). These figures establish that clinical research operates as a nationwide system with broad geographic and economic impact, requiring consistent standards of training, ethical oversight, and protocol development.
Despite this scale, workforce readiness and consistency remain critical challenges. Clinical research depends on coordinated efforts among investigators, Institutional Review Boards (IRBs), and research personnel, all of whom must apply ethical and regulatory standards in a consistent and practical manner. Variability in training and interpretation contributes to differences in protocol quality, inconsistencies in review outcomes, and inefficiencies in study implementation across institutions.
My proposed endeavor will address these challenges by developing structured, scalable training programs and practical ethics frameworks for both researchers and IRBs. These efforts will improve competency in ethical decision-making, strengthen the quality of protocol design, and enhance the consistency of ethical review across institutions.
B3. Alignment of My Proposed Endeavor With National Priorities
In addition to the national impacts described in the prior section, my proposed endeavor aligns with current federal priorities governing clinical research in the United States. These priorities focus on improving the representativeness of study populations and strengthening the reliability of evidence used in clinical and public health decision-making.
Federal agencies, including the National Institutes of Health (NIH) and the Department of Health and Human Services (HHS), have introduced policies and guidance to improve inclusion, standardize research practices, and enhance oversight mechanisms. Addressing gaps in protocol design and ethics review processes supports the consistent implementation of these requirements across institutions and research settings.
1. NIH Statutory Requirements on Inclusion and Generalizability
Federal law establishes clear requirements for inclusion in clinical research. Under the Public Health Service Act (Section 492B, 42 U.S.C. § 289a-2), the NIH is mandated to ensure the inclusion of women and members of racial and ethnic minority groups in all NIH-funded clinical research, in a manner appropriate to the scientific question under study. The statute further emphasizes that research must be designed to determine whether outcomes differ across these populations (see Exhibit I22). These requirements reflect a national directive to produce generalizable and population-relevant clinical evidence.
Strengthening ethical inclusion and improving protocol design and review processes directly supports the implementation of this mandate by enabling research teams and review bodies to operationalize inclusion requirements more effectively and consistently across studies.
2. Federal Priorities on Scientific Integrity, Transparency, and Research Quality
Federal priorities also emphasize improving the rigor, transparency, and trustworthiness of federally funded science. Executive Order 14303, Restoring Gold Standard Science, issued on May 23, 2025, states that federally funded research should be transparent, rigorous, reproducible, communicative of uncertainty, subject to unbiased peer review, and free from conflicts of interest. The Order further directed the Office of Science and Technology Policy (OSTP) to issue implementation guidance for agencies, and on June 23, 2025, OSTP issued that guidance, requiring agencies to incorporate Gold Standard Science principles into their scientific activities (see Exhibit I23). These directives are directly relevant to my proposed endeavor as ethical governance in clinical research depends on the same operational values identified in the Order: transparency in evidence generation, clear communication of uncertainty, rigorous review, and consistent application of standards across institutions. By strengthening protocol design, ethics review processes, and training in clinical research ethics, my proposed endeavor will support priorities aimed at improving the quality, reliability, and trustworthiness of scientific research used to inform policy and clinical decision-making.
3. HHS Priorities on Human Subjects Protection and Maternal Health Research
Protection of human subjects in the United States is governed by the Common Rule (45 CFR 46), which establishes a comprehensive framework for ethical review, participant protection, and Institutional Review Board oversight across multiple federal agencies (see Exhibit I24). The regulation includes specific safeguards for vulnerable populations, including pregnant women, and requires consistent application of ethical standards in protocol design, risk-benefit assessment, and informed consent. These requirements govern how clinical research is conducted and directly influence the quality and reliability of evidence used in healthcare decision-making.
National priorities on maternal health, as outlined in the Department of Health and Human Services Maternal Health Action Plan, emphasize improving outcomes, reducing maternal mortality and morbidity, and strengthening data systems for pregnant and postpartum populations (see Exhibit I25). Achieving these objectives depends on the availability of high-quality clinical research evidence that is both ethically generated and applicable to these populations. My proposed endeavor will support these national priorities by improving the design, evaluation, and implementation of clinical research involving pregnant and lactating individuals, thereby strengthening the evidence base that informs maternal healthcare across the United States.
B4. Conclusion: The National Importance of My Proposed Endeavor
My proposed endeavor satisfies the national importance requirement under Matter of Dhanasar, as reflected in the EB-2 NIW Dhanasar framework USCIS Policy Manual guidance, by addressing conditions that affect the conduct of clinical research nationwide. Initial implementation will occur in major biomedical and regulatory regions, including the Washington, D.C.–Maryland–Virginia corridor, Boston, and the Research Triangle area, where federal agencies, academic medical centers, and clinical trial networks shape research standards used across the country. Work carried out in these locations is positioned to influence research practices beyond the immediate host institutions. The information presented in Sections B1 through B3 shows that my proposed endeavor will address conditions that affect how clinical studies are designed, how quickly they are approved, and how consistently ethical standards are applied across institutions.
The national scope of my proposed endeavor is reinforced by the structure of the United States clinical research system itself. Study design, ethics review, and implementation occur across academic medical centers, hospital-based research units, universities, sponsors, contract research organizations, and Institutional Review Boards (IRBs). The same inclusion barriers, protocol deficiencies, and review inconsistencies arise across that decentralized system, not in a single isolated setting. For that reason, the problems my proposed endeavor addresses will affect how clinical research operates across multiple institutions and at various stages of review.
Scalability and replicability follow from the way my proposed endeavor is structured. The frameworks, tools, and training components described in Section B1 are designed for use within existing protocol development and ethics review processes already used across U.S. research settings. A protocol review approach introduced at one academic medical center can be applied at another institution serving a different patient population or therapeutic area, while retaining the same function of improving ethical clarity, protocol readiness, and regulatory alignment. My training activities will also support repeated application by allowing researchers, IRBs, and institutional personnel to continue using the same methods across future protocols and review cycles. Thus, expansion across institutions stems from the adoption of common methods within shared research processes, not from dependence on a single employer or project.
Federal priorities further confirm the national importance of my proposed endeavor. The evidence shows alignment with national directives on participant inclusion, scientific integrity, human subjects protection, and maternal health, each of which depends on stronger protocol design, more consistent review practices, and more reliable evidence generation. My proposed endeavor will advance those objectives through implementation at the points where studies are planned, evaluated, and approved. The resulting effects will be system-level in character, capable of replication across institutions, and relevant to the broader performance of the U.S. clinical research system. On that basis, my proposed endeavor meets the national importance standard.
III. SECTION 3 – I AM WELL POSITIONED TO ADVANCE MY PROPOSED ENDEAVOR
A. Education, Skills, Knowledge, and Record of Success in Related Efforts
Academic Training and Technical Expertise in Research Ethics and Clinical Research
To demonstrate that I am well-positioned to advance my proposed endeavor, I present my academic training, professional experience, and record of contributions in research ethics, clinical research governance, and public health, which directly support the specific activities required to improve protocol design, ethical review processes, and participant inclusion in clinical research.
My academic background (see Exhibit A: Educational Credentials and Professional Background) provides the technical foundation required to address complex ethical and regulatory challenges in clinical research. My training in bioethics, public health, and interdisciplinary research equips me to evaluate risk-benefit considerations, informed consent processes, and inclusion frameworks, particularly for underrepresented populations, such as pregnant and lactating individuals. Formal training within the U.S. context further supports my ability to operate within Institutional Review Board systems and apply federal human subjects protection requirements.
My professional experience (see Exhibit C: Professional Experience and Employment History) reflects over 13 years of direct involvement in research ethics, clinical research oversight, and multi-country research implementation. This experience is essential to my proposed endeavor, as it provides practical insight into how protocols are developed, reviewed, and implemented across different institutional and regulatory environments. Through these roles, I have developed the ability to identify gaps in protocol design, address inconsistencies in ethical review, and support the application of ethical and regulatory standards in real-world research settings.
My record of peer-reviewed scholarship (see Exhibit E: Scholarly Publications and Citations), recognition through editorial and advisory roles (see Exhibit D: Recognition for Achievements and Contributions), and selection for competitive research fellowships and appointments (see Exhibit F: Competitive Research Roles and Fellowships) further demonstrate my ability to contribute to advancing ethical governance in clinical research. These contributions are directly relevant to my proposed endeavor, as they address key issues such as participant inclusion, informed consent, antimicrobial resistance, and post-trial obligations, and reflect sustained engagement in improving research practices and ethical standards.
Together, these qualifications demonstrate not only subject matter expertise but also the applied skills and experience necessary to develop and implement ethical frameworks, improve protocol design, and strengthen the consistency and effectiveness of clinical research systems.
Applied Experience in Training, Capacity Building, and Implementation of Ethical Governance in Clinical Research
In addition to my academic training, professional experience, and record of contributions presented in the preceding section, my applied work in training, capacity building, and research implementation further demonstrates my ability to advance my proposed endeavor. The following sections highlight my direct experience in strengthening ethical review processes, supporting protocol development, and improving the consistent application of ethical and regulatory standards across research institutions.
1. Training and Capacity Building in Research Ethics and Clinical Research Governance
a. Bioethics Trainer – AVAREF–MRCT Clinical Research Review Training for Ethics Committees
In 2021, I served as a Bioethics Trainer under the Regional Clinical Trials Review Training Program initiative, a collaborative program between the African Vaccine Regulatory Forum (AVAREF) and the Multi-Regional Clinical Trials Center (see Exhibit G1). The initiative is designed to strengthen the capacity of Research Ethics Committees and regulatory bodies to review clinical trials through structured training aligned with Good Clinical Practice and international ethical standards.
In this role, I delivered structured bioethics and clinical research ethics training focused on protocol assessment, risk-benefit evaluation, informed consent, and participant protection. Training was conducted through a formal, module-based curriculum supported by interactive sessions, case-based discussions, and applied ethics exercises to strengthen practical decision-making in ethics review. I trained over 100 participants from 36 countries and contributed to strengthening ethical review capacity for multicenter clinical trials and to improving consistency in the application of ethical standards across diverse regulatory environments.
b. Co-Facilitator – AVAREF–MRCT Bioethics Capacity Building Initiative
Building on my prior role as a trainer, I subsequently served as a Co-Facilitator for the AVAREF–Clinical Trials Policy Center’s Training for Ethics Review of Clinical Research, a multi-session program conducted from March 22 to April 14, 2022 (see Exhibit G2). The training consisted of eight structured sessions covering core areas of research ethics, including informed consent, risk–benefit assessment, study design, adverse events, post-trial responsibilities, and ethical review processes. In this role, I contributed to case study discussions, supported breakout group facilitation, and provided input based on my experience in Institutional Review Boards and bioethics education, helping participants apply ethical principles in practical research review settings.
c. Good Clinical Practice (GCP) Trainer – EAMU and Institutional Review Boards
In addition to my roles under the Regional Clinical Trials Review Training Program initiative, I served as a GCP Trainer at EAMU and the Regional Clinical Research Institute, with documented training delivery in June 2021 and December 2024, in collaboration with Institutional Review Boards and clinical research teams (see Exhibit G3). These training sessions were conducted through structured, multi-session programs focused on clinical research and ethical standards.
In these programs, I facilitated key sessions including Introduction to Research Involving Human Participants, GCP Principles and ICH-GCP Guidelines, Audits and Inspections in Clinical Trials, and Roles and Responsibilities in GCP. The training also covered protocol development, informed consent processes, adverse event reporting, and regulatory requirements, helping participants apply ethical and regulatory standards in clinical trial settings.
My training activities have included delivering more than 10 GCP and research ethics training sessions across institutional and regional platforms, as well as ongoing instruction within formal academic programs. I have also provided approximately 40 hours of bioethics training annually to over 150 postgraduate medical trainees, supporting the consistent application of ethical and regulatory standards in clinical research.
2. Development and Implementation of Ethical Frameworks and Research Programs
My experience in developing and implementing ethical frameworks and research programs includes engagement in large-scale, multi-country evaluation initiatives. As an Independent Consultant for the UNESCO O3PLUS End-of-Phase Assessment with the International Public Health Institute, I contributed to a mixed-methods evaluation of sexual and reproductive health and rights programs across multiple higher education institutions in Tanzania and other participating countries from January 2024 to July 2024 (see Exhibit G4). My work involved qualitative data collection, analysis, and reporting, contributing to an evaluation that integrated surveys, focus group discussions, and stakeholder interviews across 2,614 participants. This work supported evidence generation used to assess program effectiveness, inform policies, and guide implementation strategies within the O3PLUS framework.
In the same year, I also served as a Consultant on the incentive preferences of voluntary health mobilizers, in collaboration with International Public Health Institute (Amsterdam, Netherlands) and Global Health NGO (London, UK), contributing to the study design, analysis, and stakeholder engagement.
My work also includes leading and contributing to clinical and implementation research addressing complex public health challenges. In 2024, I served as Lead Researcher on a study focused on point-of-care HIV monitoring for adolescents, where I designed and implemented research protocols to assess feasibility and effectiveness, coordinated multidisciplinary teams, and generated evidence to improve adolescent care and retention in treatment programs. During the same period, I worked as a Researcher and Trainer on a multi-country initiative to develop digital adherence tools for pediatric HIV in Tanzania and Rwanda, contributing to protocol development, delivering training to healthcare providers, and supporting the implementation of digital health interventions across multiple settings. I also contributed as a Researcher to a USAID-supported initiative on respectful maternity care, supporting research on patient-centered care and maternal health systems.
In 2023, I served as Principal Investigator for a research program on antibiotic stewardship in pediatric care, where I designed and led study protocols, coordinated multi-institutional collaboration, and supervised multidisciplinary teams. This work produced findings that supported improved prescribing practices and strengthened institutional capacity in antimicrobial resistance research. In the same year, I also served as Lead Researcher for a UNICEF-supported study on COVID-19 vaccine acceptability, leading study design, data collection, and analysis, and producing findings that informed immunization strategies and public health communication efforts.
In addition, I serve as a Research Ethics Consultant on the Confidential Social Network Referrals for HIV Testing (CONSORT) project in collaboration with the U.S. Research University and U.S. Partner University. As confirmed in my letter dated June 10, 2025, I will contribute to the final two years of the project by advising on human subjects’ research ethics and by supporting the development of manuscripts and dissemination materials. My involvement in this initiative also includes co-authorship of a multi-institutional study submitted to the AIDS 2024 Conference, reflecting my participation in research activities related to the CONSORT project and its implementation in Tanzania (see Exhibit G5).
3. Measurable Impact and Institutional Reach
My work has produced sustained and measurable impact in research ethics training, clinical research governance, and Good Clinical Practice implementation across multiple professional groups and institutional settings, primarily at East Africa Medical University (EAMU) and its affiliated research and clinical training institutions, as well as through regional and international research collaborations. Each year, I directly support over 150 individuals through structured teaching, training, and mentorship. This includes delivery of approximately 40 hours of formal bioethics instruction to Master of Medicine postgraduate trainees at EAMU.
I also facilitate approximately 10 Good Clinical Practice training workshops each year for clinical researchers, study teams, and research staff within EAMU and affiliated research programs, supporting compliance with international ethical and regulatory standards, including participant safety, protocol adherence, and data integrity. In addition, I provide ongoing training and onboarding support for Research Ethics Committee members within the EAMU Institutional Review Board and related institutional review structures.
Beyond training, I contribute to the ethical development and review of clinical research protocols conducted within EAMU and collaborative global health research programs, particularly in pediatric and public health research. These contributions support improvements in protocol quality, regulatory compliance, and participant protection. Across these combined activities, my work spans training, protocol development, and ethics review in active clinical research environments and contributes to strengthening institutional research governance systems at both institutional and collaborative levels.
B. Development of a Detailed Plan for the Proposed Endeavor
As outlined in Section B1, my proposed endeavor is organized into core areas of activity, including ethical inclusion and protocol design, review process alignment, and training and capacity development for researchers and ethics review bodies. These components collectively define how I will address gaps in participant inclusion, protocol design, and ethics review processes within the United States clinical research system.
To provide a comprehensive and structured presentation of these activities, I have prepared a separate document, Exhibit B: EB-2 NIW Professional Plan, which outlines the detailed implementation of my proposed endeavor. This document was intentionally developed as a standalone exhibit to clearly present the operational components of my work, including specific activities, implementation approaches, training structures, and expected outputs. It provides a more detailed description of how my proposed endeavor will be carried out across institutional settings and supports the practical feasibility and scalability of my work in the United States.
C. Implementation Strategy and Progress Toward Pursuing My Proposed Endeavor
Implementation Strategy
I will carry out my proposed endeavor through direct collaboration with research institutions, clinical research teams, and ethics review bodies, including through research appointments, advisory roles, and project-based engagements supporting protocol development and review. My implementation approach will focus on embedding ethical frameworks, decision-support tools, and training programs within existing clinical research systems, allowing for direct application during protocol design, ethics review, and study implementation.
Engagement will take place across academic medical centers, university-affiliated research programs, Institutional Review Boards, and clinical trial networks, where I will help improve participant inclusion, protocol quality, and consistency in ethical review processes. Activities will include providing input during study design, supporting alignment between investigators and review bodies, and delivering training and mentorship for researchers and ethics committees.
Progress Toward Pursuing My Proposed Endeavor in the United States
I have already demonstrated the ability to carry out the core components of my proposed endeavor through my extensive experience in international research collaborations. My prior roles included implementing ethics training programs, participating in IRB processes, developing research protocols, and leading multi-country research initiatives. I have also previously been granted a J-1 visa under which I engaged in formal research and training activities in the United States. These experiences directly align with the activities described in my proposed endeavor and demonstrate that the work is not prospective in nature but has already been implemented in practice across multiple settings.
I am currently a Postdoctoral Researcher at Canadian Research University in Montréal, Québec, Canada, with an appointment through March 2027 (see Exhibit F3). My work under the PregTrial project focuses on improving the ethical inclusion of pregnant and lactating individuals in clinical trials. This work directly aligns with my proposed endeavor and involves developing ethical tools, consent frameworks, and implementation strategies also applicable to the United States clinical research system. My current role does not restrict my ability to engage in advisory, collaborative, or project-based work with other institutions. Academic research roles inherently involve multi-institutional engagement, which is consistent with how I will carry out my proposed endeavor in the U.S.
In addition, I have established ongoing professional relationships with institutions and initiatives relevant to the U.S. clinical research system. My prior and current collaborations include engagement with the Multi-Regional Clinical Trials Center through the Regional Clinical Trials Review Training Program initiative (see Exhibits G1 and G2), collaboration with the U.S. Research University f and U.S. Partner University through my role as a research ethics consultant on the CONSORT project, including advisory contributions on human subjects research and manuscript development (see Exhibit G5), and academic engagement through my contribution as an author to a research ethics book project coordinated by U.S. Research University-affiliated editors, currently under peer review and consideration for publication (see Exhibit G6). To conclude, these activities demonstrate that the key components of my proposed endeavor, including ethical framework development, protocol design support, ethics review engagement, and structured training, are already being implemented. My existing experience and established institutional collaborations position me to expand these activities into the U.S. clinical research system and to carry out my proposed endeavor at a national level.
D. Support from Industry and Academic Experts
To further demonstrate that I am well-positioned to advance my proposed endeavor, I provide Letters of Support from professionals and collaborators who have directly worked with me in research ethics, clinical research governance, and public health research settings. These letters reflect informed, experience-based assessments of my expertise, contributions, and the relevance of my work to strengthening ethical oversight and participant inclusion in clinical research.
- Prof. Jonathan Baldwin, Assistant Director of the Office of Research Excellence at U.S. Academic Institution, confirms that my work addresses “persistent gaps within the U.S. clinical research environment, particularly in relation to the inclusion of populations such as pregnant and lactating individuals, where evidence remains limited and uneven.” He further explains that my “approach involves developing practical ethical frameworks, policy guidance, and decision-support tools that can be used by researchers, institutional review boards, and public health institutions,” and concludes that I “possess the capacity to influence how ethical standards are applied in practice and to contribute to strengthening the integrity and inclusivity of clinical research systems in the United States.” (see Exhibit H1)
- Dr. Samuel Adeyemi, a pharmacist with over 20 years of experience in healthcare systems and pharmaceutical operations, highlights the applied impact of my work, stating that my “contributions have helped improve the timeliness and consistency of protocol review, allowing studies involving human participants to proceed with clearer ethical guidance and fewer delays.” He further notes that my “work has led to tangible improvements in how research is conducted and applied within healthcare settings,” and emphasizes that I “combine ethical knowledge, research leadership, and an understanding of healthcare systems,” enabling contributions that improve the quality, relevance, and impact of research (see Exhibit H2).
- Mr. Michael Kamau, a health systems innovator and technology strategist, describes my approach to ethical governance as integrated and implementation-focused, noting that I do “not treat ethical review as a final checkpoint, but instead incorporate ethical considerations at the earliest stages of study development,” and that my work “reflects a clear understanding of both the technical and operational dimensions of research.” He concludes that my experience positions me to develop solutions that are both relevant and implementable within clinical research systems (see Exhibit H3).
- Dr. Thomas Santos, a medical doctor and urology specialist with over 30 years of clinical experience, provides a clinically grounded perspective on the importance of my work. He explains that “certain populations, including pregnant and lactating individuals, are often underrepresented or excluded from clinical studies, resulting in limited or uncertain evidence to support safe and effective care for these groups,” and notes that this results in clinicians being “required to make critical care decisions without robust clinical data.” He further emphasizes that my work “can support research institutions and review boards in improving participant inclusion, strengthening ethical oversight, and promoting responsible decision-making,” highlighting its relevance to improving clinical research systems in the United States (see Exhibit H4).
- Dr. Isaac Mwenda, a Principal Research Officer and social anthropologist with over 20 years of experience in interdisciplinary health research, highlights the structural and systems-level relevance of my work. He explains that “there remains a persistent challenge in ensuring that clinical research systems are inclusive, ethically consistent, and responsive to diverse populations,” and that “variability in ethical review practices undermines both the quality of evidence generated and public trust in research systems.” He further notes that my work will address these issues “by improving how ethical standards are applied across U.S. institutions, thereby strengthening both research integrity and public health outcomes,” reinforcing the national relevance of my proposed endeavor (see Exhibit H5).
IV. SECTION 4 – ON BALANCE, A WAIVER OF THE JOB OFFER AND LABOR CERTIFICATION REQUIREMENT BENEFITS THE UNITED STATES
A. Impracticality of the Labor Certification Process in the Context of My Proposed Endeavor
The labor certification process is not well-suited to the nature of my proposed endeavor, which will not be confined to a single employer, position, or fixed set of job duties. My proposed endeavor will involve developing and applying ethical frameworks, training programs, and protocol-level guidance across multiple institutions, including research organizations, Institutional Review Boards, clinical trial teams, and academic centers. These activities will be carried out through a combination of research appointments, advisory roles, and project-based engagements, rather than a traditional, employer-sponsored role.
The PERM labor certification process is designed to assess the availability of U.S. workers for a specific, permanent position with defined duties under a single employer. My proposed endeavor does not fit within this structure, as it will require flexibility to engage across institutions and to address system-level challenges in clinical research design, ethics review, and workforce capacity. Limiting my work to a single employer would restrict the scope of implementation and reduce the broader impact of the frameworks, tools, and training activities that are central to my proposed endeavor.
In addition, my proposed endeavor will involve functions that are not captured by standard occupational classifications, including protocol-level ethical integration, alignment of cross-institutional reviews, and applied training for both researchers and ethics review bodies. These responsibilities extend beyond conventional job roles and require a level of independence and cross-functional engagement that the labor certification process is not designed to accommodate.
B. National Benefit Independent of the Availability of Other U.S. Workers
The benefit of my proposed endeavor is not dependent on whether other qualified U.S. workers are available, as its value lies in the broader improvements it will produce across the United States clinical research system. My proposed endeavor will strengthen ethical governance, improve participant inclusion, support more consistent protocol design, and reduce inefficiencies in ethics review processes. These contributions wKill improve how clinical studies are structured, reviewed, and implemented, producing benefits that extend beyond any single employer, position, or institution.
My proposed endeavor will also produce practical benefits for healthcare delivery, research efficiency, and the generation of clinically relevant evidence. By improving the inclusion of underrepresented populations, particularly pregnant and lactating individuals, my proposed endeavor will support the development of evidence that is more applicable to patient populations. More complete and population-relevant evidence will support better-informed treatment decisions, reduce uncertainty in clinical care, and improve the reliability of research findings used in public health and medical practice.
In addition, my proposed endeavor will support more efficient research operations by improving protocol readiness and strengthening consistency in ethics review. Delays in study activation and repeated protocol revisions increase the cost of clinical research and slow the evaluation of new therapies. My proposed endeavor will address these inefficiencies through ethical frameworks, decision-support tools, and structured training that will improve alignment between investigators and review bodies.
Lastly, my proposed endeavor will also have the potential to generate broader economic and institutional benefits. A stronger, more efficient clinical research system will support the timely development of new treatments, improve the performance of research institutions, and enhance the quality of evidence used in healthcare decision-making. More reliable and inclusive clinical research will also support public trust, better patient participation, and stronger institutional research capacity. These benefits are national in scope and will remain valuable regardless of whether other U.S. workers are available, as they arise from the implementation and impact of my proposed endeavor itself. Supporting documentation and detailed evidence for these impacts have been provided in the preceding sections under Section B, The National Importance of My Proposed Endeavor.
C. Urgency of the National Interest Served by My Proposed Endeavor
The national interest served by my proposed endeavor is urgent due to persistent gaps in clinical research that directly affect patient care, research efficiency, and the reliability of evidence used in healthcare decision-making. Underrepresentation of key populations, including pregnant and lactating individuals, continues to limit the applicability of clinical trial findings, while inconsistencies in protocol design and ethics review processes contribute to delays in study initiation and completion. These conditions affect the United States’ clinical research system’s ability to generate timely, population-relevant evidence. Delays in protocol approval slow the evaluation of new therapies, and gaps in inclusion reduce the usefulness of research outcomes in real-world clinical settings. Variability in training and interpretation of ethical and regulatory standards further contributes to inconsistencies across institutions.
My proposed endeavor will address these challenges at the points where they occur, including protocol development, ethics review, and workforce training. By improving inclusion practices, strengthening protocol quality, and supporting more consistent review processes, my proposed endeavor will contribute to more efficient research operations and more reliable clinical evidence. Given the scale and impact of clinical research in the United States, addressing these issues carries clear and immediate national importance.
D. Balancing of Interests Under the Matter of Dhanasar
On balance, and consistent with the Matter of Dhanasar framework for EB-2 NIW adjudications, it would be beneficial to the United States to waive the requirement of labor certification. The structure and implementation of my proposed endeavor are not compatible with the constraints of the labor certification process, and requiring such certification would limit the scope and effectiveness of my work.
My proposed endeavor will depend on cross-institutional engagement, flexible implementation, and the ability to operate across research, advisory, and training functions. Restricting these activities to a single employer would reduce the ability to address system-level challenges and limit the broader impact on clinical research practices.
Granting a waiver will allow my proposed endeavor to be carried out across multiple institutions and research settings, supporting improvements in ethical governance, protocol design, and workforce capacity. These contributions will strengthen the performance, consistency, and inclusivity of the United States clinical research system.
The record of my qualifications, experience, and prior contributions demonstrates that I am well-positioned to advance my proposed endeavor, and the resulting benefits extend beyond any single employer or position. For these reasons, waiving the labor certification requirement is warranted under the Matter of Dhanasar.
Frequently Asked Questions (FAQs)
What is the Dhanasar framework?
The Dhanasar framework is the three-part legal test USCIS applies to every EB-2 National Interest Waiver petition. It takes its name from Matter of Dhanasar, 26 I&N Dec. 884 (AAO 2016), the precedent decision that replaced the older NYSDOT standard. To satisfy the framework, a petitioner must demonstrate that (1) the proposed endeavor has both substantial merit and national importance, (2) the petitioner is well positioned to advance the proposed endeavor, and (3) on balance, it would be beneficial to the United States to waive the job offer and labor certification requirements.
Where does USCIS explain how the framework is applied?
The controlling guidance is the USCIS NIW Dhanasar framework policy manual chapter—Volume 6, Part F, Chapter 5 of the USCIS Policy Manual. It describes the kinds of evidence relevant to each prong and is the same reference the Matter of Dhanasar framework USCIS NIW adjudicators consult when they review a petition, which is why reading it before drafting is one of the most useful preparation steps a petitioner can take.
How should an endeavor statement address the three prongs?
A strong endeavor statement answers each prong in sequence, exactly as this sample does. It defines the proposed endeavor and documents its substantial merit and national importance with independent sources, presents the petitioner’s education, experience, record of success, plan, and progress to show they are well positioned, and closes by explaining why requiring a job offer and labor certification would hold the endeavor back. Because the Dhanasar framework EB-2 NIW USCIS officers use is cumulative, weakness in one prong cannot be offset by strength in another—every claim should point to a specific exhibit, citation, or letter of support.
Is the endeavor statement the same as an EB-2 NIW business plan?
No—they play different roles. The endeavor statement is the petitioner’s narrative argument addressed directly to USCIS, while a business plan or professional plan is a supporting exhibit that shows how the endeavor will operate, grow, and generate measurable impact. The two must tell one consistent story: the statement makes the legal case, and the plan supplies the operational proof behind it.
Do entrepreneurs, researchers, and employees all face the same test?
Yes. Whether the endeavor is a company, a research agenda, or a professional practice, every petition is judged under the same Matter of Dhanasar EB-2 NIW framework. What changes is the evidence: an entrepreneur leans on a business plan and market data, while a researcher—like the petitioner in this sample—leans on publications, citations, fellowships, and expert letters. In every case, an endeavor statement organized around the three prongs gives the filing its clearest path through adjudication.