Career Program 16: NIH Clinical Research Education and Career Development (CRECD) Program Opportunities

I. Overview of the NIH Clinical Research Education and Career Development (CRECD) Program (Career Program 16)

The National Institutes of Health (NIH), a leading organization in biomedical research, is committed to enhancing the diversity of the scientific workforce. In line with this commitment, the NIH, through its participating Institutes and Centers including the National Institute on Minority Health and Health Disparities (NIMHD), National Institute on Drug Abuse (NIDA), and National Cancer Institute (NCI), is offering the Clinical Research Education and Career Development (CRECD) Program, also known as Career Program 16. This R25 Education Program is designed to support educational activities that foster diversity within the biomedical, behavioral, and clinical research fields.

This funding opportunity, announced under FOA Number PAR-16-350, represents a reissue of PAR-11-325, building on previous initiatives to bolster clinical research education. It is crucial to note that only one application is permitted per institution, emphasizing the focused and competitive nature of this Career Program 16 initiative. The program is categorized under CFDA Numbers 93.307, 93.279, and 93.398, reflecting its broad scope across various health-related research domains.

Funding Opportunity Purpose: Enhancing Diversity through Education

The overarching goal of the NIH Research Education Program (R25), and specifically Career Program 16, is to support research education activities that align with the NIH’s mission areas. For the NIMHD R25 program, the primary objective is to enhance the diversity of the biomedical, behavioral, and clinical research workforce. This is achieved by supporting creative educational activities with a strong emphasis on two core components:

• Courses for Skills Development: Developing robust knowledge and skill sets in clinical research.
• Research Experiences: Providing hands-on research opportunities to promising individuals.

Career Program 16 aims to cultivate a diverse pool of talented scientists capable of addressing the nation’s evolving biomedical, behavioral, and clinical research needs. By focusing on skills development and practical research experience, this program seeks to equip participants from underrepresented backgrounds with the tools necessary to thrive in clinical research careers.

Key Dates and Application Information for Career Program 16

Institutions interested in applying for Career Program 16 funding should be aware of the following key dates:

• Posted Date: June 30, 2016
• Open Date (Earliest Submission Date): August 1, 2016
• Letter of Intent Due Date(s): August 1, 2016 (While not mandatory, a letter of intent is requested)
• Application Due Date(s): September 1, 2016, by 5:00 PM local time of applicant organization.

The scientific merit review is anticipated to take place in December 2016, followed by the Advisory Council Review in January 2017. The earliest start date for funded projects is projected to be April 1, 2017. It is important to note that the expiration date for this particular funding opportunity was September 2, 2016, for the initial announcement. However, as this is a reissue and the content remains relevant for understanding the program’s structure and goals, the information is still valuable for prospective applicants looking for similar future opportunities.

Applicants are strongly advised to adhere to the guidelines provided in the SF424 (R&R) Application Guide, ensuring compliance with all requirements outlined in both the Application Guide and the Funding Opportunity Announcement (FOA). Non-compliant applications risk being excluded from the review process.

II. Full Text of Announcement: Delving Deeper into Career Program 16

Section I. Funding Opportunity Description: The NIH Research Education Program (R25) and Career Program 16

The NIH Research Education Program (R25), under which Career Program 16 falls, is a critical component of NIH’s strategy to bolster the nation’s biomedical research capabilities. This program supports educational activities that complement formal training programs within the NIH Institutes and Centers’ mission areas. The core objectives of the NIH R25 program are multifaceted:

1. Workforce Enhancement: To complement and strengthen the training of a workforce equipped to meet the growing demands of biomedical, behavioral, and clinical research across the nation.
2. Diversity Enhancement: To actively increase the diversity of professionals engaged in biomedical, behavioral, and clinical research, fostering a more inclusive and representative scientific community.
3. Specialty Recruitment: To attract individuals with specific expertise and disciplinary backgrounds to pursue research careers within the biomedical, behavioral, and clinical sciences, addressing specialized needs within these fields.
4. Public Understanding: To cultivate a deeper public understanding of biomedical, behavioral, and clinical research and its wide-ranging implications for health and society.

Career Program 16, specifically managed by NIMHD, NIDA, and NCI, is uniquely focused on the second objective: enhancing diversity. It aims to support educational activities that will significantly increase the representation of individuals from diverse backgrounds within the biomedical, behavioral, and clinical research workforce. To achieve this, Career Program 16 prioritizes creative educational activities centered around:

• Courses for Skills Development: These courses are designed to equip postdoctoral participants with the essential knowledge and skills for clinical research. A key feature of Career Program 16 is its support for programs leading to a Master of Science in Clinical Research, Master of Public Health, or Master in Population Health. This academic rigor ensures participants receive comprehensive training.
• Research Experiences: Career Program 16 provides invaluable research experiences for postdoctorates, clinical and research fellows, and early-stage investigators. These experiences are structured to develop a diverse group of clinical and translational researchers dedicated to clinical and/or population health research. The program places particular emphasis on research related to diseases that disproportionately affect health disparity populations.

Background and Need for Career Program 16: Addressing Disparities and Fostering Innovation

The United States’ scientific research landscape is a complex ecosystem, spanning basic laboratory investigations to clinical and translational applications and policy development. This enterprise demands exceptional intellectual capacity, creativity, and a diverse range of skills and perspectives. The NIH’s ability to maintain the nation’s global leadership in scientific discovery and innovation hinges on a robust pool of highly talented scientists from diverse backgrounds, all contributing to the NIH’s overarching mission.

Extensive research has consistently demonstrated that diverse teams, characterized by a variety of perspectives and innovative ideas, consistently outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring unique viewpoints, creativity, and entrepreneurial spirit to the complex challenges of scientific inquiry. A diverse NIH-supported scientific workforce yields numerous benefits, including:

• Scientific Innovation: Stimulating new ideas and approaches to research questions.
• Global Competitiveness: Strengthening the US’s position in the global scientific arena.
• Robust Learning Environments: Creating richer and more dynamic educational settings.
• Improved Researcher Quality: Enhancing the overall caliber of the scientific workforce.
• Health Equity: Increasing the likelihood that underserved and health disparity populations participate in and benefit from health research, ensuring research outcomes are relevant and accessible to all communities.
• Public Trust: Building greater public confidence in the scientific enterprise through increased representation and inclusivity.

Despite significant progress in scientific research, access to information, education, and research opportunities remains unevenly distributed. Career Program 16 directly addresses this inequity by supporting educational activities designed to enhance diversity in the biomedical, behavioral, and clinical research workforce. The program specifically encourages institutions to diversify their student and faculty populations, thereby increasing the participation of individuals currently underrepresented in biomedical, clinical, behavioral, and social sciences research. It is aligned with the principles outlined in NIH Notice NOT-OD-15-053, which emphasizes the importance of diversity in the scientific workforce. It is important to note that Career Program 16 focuses on postdoctoral and faculty level participants and does not support high school or undergraduate students. Therefore, the disadvantaged background categories (C1 and C2) relevant to those levels are not applicable to this program.

NIMHD’s Specific Interest in Diversity within Career Program 16

The NIMHD’s core mission is to conduct and support research, training, health information dissemination, and other programs specifically focused on minority health and health disparities. Career Program 16, under NIMHD’s guidance, is particularly interested in facilitating the education of participants from diverse backgrounds who are underrepresented in biomedical research. The program encourages pursuit of clinical research, translational research, and/or patient-oriented research, with a specific focus on diseases that disproportionately impact minority and health disparity populations.

By increasing the number of students from underrepresented groups who pursue advanced training in clinical research, NIMHD, through Career Program 16, aims to ensure that the future generation of researchers dedicated to minority health and health disparities is drawn from the broadest possible pool of talented individuals. This approach ensures a rich diversity of aptitudes, perspectives, creativity, and experiences are brought to bear on complex scientific problems related to health equity.

Addressing the Critical Need for Trained Clinical Researchers

There is a widely recognized and critical need for well-trained clinical researchers across numerous health areas, particularly those that disproportionately affect health disparity and underserved populations. Reports from esteemed organizations such as the AAMC, the National Academy of Sciences, the American Federation For Medical Research, and the NSF, among others, provide compelling evidence of the urgent need to replenish and diversify the U.S. research workforce. This need is especially acute within the clinical research community, where insufficient numbers of professionals are available to meet the escalating demands for clinical research expertise. (Refer to NSF data and publications by Ginther et al. and the National Academies for further details on this critical need).

NIMHD and the participating Institutes and Centers recognize this pressing need and understand that Career Program 16 plays a vital role in addressing it. By supporting program development within institutions with a strong historical mission of educating and training individuals from underrepresented groups in the biomedical sciences, Career Program 16 aims to make a significant impact. Specifically, the program’s focus on education and training tailored to the knowledge and skills required for clinical and translational research enhances the potential of these institutions to contribute to vital research advances. These advances are essential for eliminating health and disease disparities experienced by members of diverse underserved communities.

Purpose of Career Program 16: Expanding National Capacity for Health Equity Research

The fundamental purpose of the Clinical Research Education and Career Development (CRECD) Program, Career Program 16, is to significantly expand the national capacity for conducting research aimed at improving health equity. This is achieved by strategically developing the research workforce in clinical and translational sciences. The program provides crucial grant support to institutions that confer doctorate degrees in health professions or health-related sciences. These institutions often have a long-standing history of educating and training professionals from diverse backgrounds who are dedicated to providing healthcare to health disparity populations. They are uniquely positioned to effectively engage these populations in research and to translate research breakthroughs into culturally sensitive, measurable, and sustainable improvements in health outcomes.

Career Program 16’s primary goals are twofold:

1. Skill Development Courses: To support the development and implementation of courses designed to enhance the skills of postdoctoral participants in clinical research. These courses are intended to lead to advanced degrees such as a Master of Science in Clinical Research, Master of Public Health, or Master in Population Health, providing rigorous academic grounding in relevant disciplines.
2. Research Experiences for Clinical Researchers: To provide robust research experiences that cultivate a cadre of clinical researchers equipped with the necessary knowledge and skills to excel in clinical research. These researchers are expected to become integral members of the translational, population health, and/or patient-oriented research workforce, with a particular focus on addressing diseases that disproportionately impact minority and health disparity populations.

The Career Program 16 award provides substantial support for up to five years, structured into two distinct phases: Phase I and Phase II.

• Phase I: Didactic Program and Mentored Research (Skill Development): This phase is focused on enhancing existing courses and establishing a structured didactic program. Participants engage in mentored clinical research projects, culminating in a Master of Science in Clinical Research, Master of Public Health, or Master in Population Health degree. Phase I is designed to build a strong foundation in clinical research methodologies and principles.
• Phase II: Continued Research Experiences (Independent Investigator Development): Phase II provides continued research experiences for graduates of CRECD Phase I for up to three years. This phase is crucial for fostering the transition to independent research careers. Participants further develop their clinical research skills and work towards establishing independent research programs, with the ultimate goal of becoming independent clinical, translational, and population health investigators.

A Program Director/Principal Investigator (PD/PI) leads a multidisciplinary CRECD Advisory Committee (CAC), which plays a crucial role in the design, development, implementation, and evaluation of both Phase I participants and CRECD graduates progressing through Phase II. This committee structure ensures comprehensive oversight and guidance for the program and its participants.

Phase I (Didactic Program Courses for Skill Development in Clinical Research)

Phase I of Career Program 16 is specifically tailored to junior faculty, postdoctoral candidates, clinical or research fellows, and individuals holding health professional doctoral degrees (MD, DDS, DMD, DO, OD, ND, PhD with clinical responsibilities, or PharmD). This phase enables these participants to fulfill the requirements for a Master of Science in Clinical Research, Master of Public Health, or Master in Population Health degree. This includes rigorous coursework and a mentored research project, providing a well-rounded educational experience.

The program’s curriculum must incorporate multidisciplinary, didactic coursework and a collaborative project focused on clinical and translational research. This integrated approach is essential for enhancing participants’ research skills and preparing them for successful careers in clinical research.

Phase II (Mentored Clinical Research Experiences)

The primary objective of Phase II within Career Program 16 is to cultivate researchers who will embark on independent careers as clinical research scientists. It is designed to be a crucial stepping stone toward research independence.

Phase II of the award offers up to three years of support for clinical/translational research experience specifically for graduates of the Career Program 16 program (Phase I). This extended research experience is intended to facilitate participants’ progress in establishing their own independent research programs as clinical research scientists. A key outcome of Phase II is to prepare participants to successfully apply for individual mentored career development (K) awards or research grant (R series) awards, essential for securing independent funding and establishing long-term research careers.

Participants in Phase II are expected to develop and propose a research project aligned with the research interests of the NIH co-funding partners (NIMHD, NIDA, NCI). Each participant is assigned at least one lead mentor who provides guidance and support throughout this phase.

Continued support for Phase II participants is contingent upon a thorough review and positive recommendation from the mentor, the institutional CAC, and the PD/PI. It is anticipated that participants who successfully complete Phase I will seamlessly transition to Phase II without delays. Exceptions for delayed transitions are considered only in specific circumstances, such as personal or family situations involving child or elder care, medical conditions, military service, or disability, recognizing the diverse life circumstances of participants.

For institutions that already have established relevant courses, recent graduates of Phase I programs are eligible to participate in Phase II of Career Program 16. However, support for these scholars in Phase II cannot exceed a total of three years, ensuring focused and time-bound career development.

The participant, their mentor(s), and the PD/PI share responsibility for all aspects of the Phase II program, fostering a collaborative and supportive environment for advanced research training.

Research Scope of Career Program 16: Aligning with NIH Priorities

Applications for Career Program 16 funding are expected to clearly reflect the strategic plans and priorities of the participating NIH Institutes and Centers (NIMHD, NIDA, NCI). Proposals must demonstrate a clear connection between the clinical research education program offered to participants and one or more of the areas of research interest defined by these Institutes.

• National Institute on Minority Health and Health Disparities (NIMHD): NIMHD supports a broad spectrum of research on minority health and health disparities. This includes investigations ranging from genetic, molecular, and biological sciences to clinical, behavioral, and translational research, as well as research focusing on health systems, workforce development, and environmental justice. NIMHD is particularly interested in research addressing the full continuum of factors contributing to health disparities and the complex interplay among these factors.
• National Institute on Drug Abuse (NIDA): NIDA is the leading federal agency supporting scientific research on drug use and its consequences. Its mission is to advance scientific understanding of the causes and consequences of drug use and addiction and to translate this knowledge into improved individual and public health outcomes. NIDA is interested in supporting Career Program 16 participants conducting research in areas such as:
  1. Understanding the complex interactions of factors that influence drug use trajectories across the lifespan.
  2. Accelerating the development of effective treatments for drug abuse and addiction.
  3. Addressing the real-world complexities of drug use and addiction through research.
  4. Advancing bidirectional translation, ensuring research findings are rapidly translated into practice and clinical needs inform research directions.
• National Cancer Institute (NCI): The NCI has a strong interest in supporting participants whose research focus and career development activities are centered on cancer or cancer health disparities research. This includes a wide range of cancer-related research areas, from basic cancer biology to cancer prevention, diagnosis, treatment, and survivorship, with a particular emphasis on addressing cancer disparities in underserved populations.

It is important to note that research education programs supported by Career Program 16 may complement existing research training and education initiatives at the applicant institution. However, the proposed educational experiences must be distinct and demonstrably different from training and education programs already receiving federal funding. While R25 programs like Career Program 16 can augment institutional research training programs (e.g., T32, T90), they are not intended to replace or circumvent Ruth L. Kirschstein National Research Service Award (NRSA) programs, which serve a different and distinct purpose in research training.

III. Award Information for Career Program 16

Funding Instrument: Grant Mechanism

Career Program 16 utilizes a grant mechanism. A grant is a financial support instrument that provides funds, property, or both to an eligible entity to execute an approved project or activity. This mechanism is appropriate for Career Program 16 as it supports educational projects aimed at career development and diversity enhancement in clinical research.

Application Types Allowed: New and Renewal Applications

The NIH welcomes both new applications and renewal applications for Career Program 16.

• New Applications: Institutions that have not previously received CRECD program funding are encouraged to apply for new Career Program 16 grants.
• Renewal Applications: Institutions currently holding a CRECD grant that is approaching the end of its funding cycle are eligible to submit renewal applications to continue their Career Program 16 initiatives.

The OER Glossary and the SF424 (R&R) Application Guide provide comprehensive details on these application types, and applicants should consult these resources for specific requirements and guidelines.

Funds Available and Anticipated Number of Awards for Career Program 16

The number of awards made under Career Program 16 is directly contingent upon NIH appropriations and the quality of applications received. While the NIH aims to support meritorious applications that align with the program’s goals, the final number of awards may vary depending on available funding and the competitive landscape.

Award Budget and Project Period for Career Program 16

• Award Budget: The maximum budget for Career Program 16 is $500,000 in direct costs per year. However, applicants are strongly encouraged to request a budget that accurately reflects the actual needs of their proposed project. Justification for all budget items is essential to demonstrate responsible resource allocation.
• Award Project Period: The maximum project period for Career Program 16 awards is 5 years. This duration provides sufficient time for institutions to implement and evaluate their comprehensive clinical research education and career development programs, encompassing both Phase I and Phase II activities.

Other Award Budget Information: Personnel and Participant Costs in Career Program 16

Personnel Costs

Career Program 16 allows for the inclusion of personnel costs within the budget, recognizing the crucial role of dedicated staff in program success.

• Program Leadership and Faculty: Individuals involved in designing, directing, and implementing the research education program can request salary and fringe benefits commensurate with their level of effort and person months devoted to the program. Requested salaries must align with the institution’s established policies for similar positions and must not exceed the congressionally mandated salary cap. It’s important to note that if mentoring and participant interaction are considered standard academic duties for faculty, these costs are generally not allowable charges to grant funds.
• Program Directors/Principal Investigators (PD/PIs): PD/PIs may request salary support for their leadership, management, coordination, and evaluation responsibilities within Career Program 16. This salary support must be justified by their effort commitment, which should be at least 1.20 person months or ten percent effort (combined for multiple PD/PIs).
• Faculty for Specialized Courses: Faculty members critical to the design, development, implementation, and refinement of specialized courses essential to the didactic component of Career Program 16 may also receive salary support, again proportionate to their proposed level of effort and contribution.
• CRECD Advisory Committee Members: Generally, it is expected that the activities of CRECD Advisory Committee members are considered part of their normal academic faculty responsibilities and are supported by the applicant institution. Therefore, salary compensation for committee members from grant funds is typically not allowable.
• Mentors: While mentors cannot receive direct salary compensation from Career Program 16 grant funds, moderate expenses associated with a mentor’s laboratory or didactic activities that are directly attributable to the program may be charged to the grant. This recognizes the essential contributions of mentors to participant development.
• Administrative and Clerical Staff: Limited administrative and clerical salary costs that are directly linked to Career Program 16 and are not typically covered by the applicant organization may be direct charges to the grant. However, these costs must be specifically identified, thoroughly justified, and demonstrated to be essential for program operation.
• Evaluation Costs: Up to 5% of direct costs may be allocated for the evaluation of the Career Program 16 program itself. Rigorous evaluation is a critical component of ensuring program effectiveness and continuous improvement.

Participant Costs

Career Program 16 recognizes that direct support for participants is often essential for successful research education programs.

• Participant Payments: Participants may be paid if their participation is specifically required for the proposed research education program and is adequately justified in the application. Participant costs must be clearly itemized within the proposed budget.
• Allowable Participant Costs: Allowable participant costs are determined by the educational level and career status of the individuals selected for the program.
• Per Diem: While generally not an allowable cost, per diem for participants may be permissible with strong justification, particularly if such costs are not already included as part of a registration fee.
• Tuition and Education-Related Expenses: Participants may receive funds to partially cover tuition and other education-related expenses directly associated with their involvement in Career Program 16.

Allowable Costs for Phase I Participants

Phase I of Career Program 16 focuses on didactic training and skill development, and allowable participant costs reflect this emphasis.

• Duration of Support: Up to two years of support can be provided for participants pursuing a master’s degree within Phase I.
• Postdoctoral/Faculty Appointees: Postdoctoral fellows and faculty appointees participating in Phase I can be supported up to $95,000 in direct costs per year per participant. These funds can be used for the following types of expenditures:
  • (a) Salaries: Salaries up to $75,000, adjusted based on the actual person months of effort dedicated to the program.
  • (b) Research Expenses: Essential research expenses such as laboratory supplies and technical personnel directly supporting the participant’s research activities.
  • (c) Tuition Remission and Fees: Tuition and fees directly related to courses fulfilling the requirements for the master’s degree program (Master of Science in Clinical Research, Master of Public Health, or Master in Population Health).
  • (d) Travel to Research Meetings: Travel expenses to attend relevant research meetings and conferences for professional development and networking.
  • (e) Statistical Services: Statistical consulting services, including personnel and computer time needed for data analysis and research support.

It is critical that all participant costs are meticulously documented for each individual participant and are directly linked to their research activities within Career Program 16.

Institutions are permitted to supplement the NIH contribution to a participant’s salary, bringing it up to a level consistent with the institution’s established salary scale. However, any institutional salary supplementation must not impose extra duties or responsibilities on the participant that would interfere with the core purpose and goals of the Career Program 16 award, which is focused research training and career development.

Allowable Costs for Phase II Participants

Phase II of Career Program 16 is designed to provide mentored clinical research experiences, and the allowable costs reflect the more advanced research focus of this phase.

• Total Cost Limit: For Phase II awards, the total cost per participant may not exceed $130,000 in total costs per year. This comprehensive amount encompasses salary, fringe benefits, research support allowance, and applicable Facilities & Administrative (F&A) costs.
• Salary Basis and Effort Commitment: The total salary requested for Phase II participants must be based on a full-time, 12-month staff appointment. Phase II participants are required to dedicate a minimum of 75% (i.e., 9.0 person months) of their full-time professional effort to conducting health-related clinical and/or patient-oriented research. The remaining effort can be devoted to activities directly related to advancing their research career or practicing clinical medicine, recognizing the diverse career paths of clinical researchers.
• Career Advancement Encouragement: During Phase II, participants are strongly encouraged to actively prepare and submit applications for individual mentored career development awards (K08, K23) and/or research grant awards (R series). This emphasis on independent funding is a key aspect of transitioning Phase II participants to fully independent research careers.

Travel Funds and Foreign Travel

• Annual Meeting Travel: Travel funds may be requested to enable the PD/PI and Career Program 16 participants to attend an annual meeting in Bethesda, Maryland, facilitating networking and program updates.
• Foreign Travel: Expenses for foreign travel must be exceptionally well justified and directly related to the program’s objectives. Routine foreign travel is generally discouraged unless it is integral to the proposed research education activities.

Individuals with Existing NIH Support

Individuals already supported by other NIH training and career development mechanisms (K, T, or F awards) are eligible and encouraged to participate in educational experiences supported by Career Program 16 as participants. This allows for synergistic training opportunities and broader exposure to clinical research education. However, these individuals may not receive salary or stipend supplementation from Career Program 16 funds, preventing duplication of funding support.

Restrictions on Full-Time Participant Support

Because the R25 mechanism, including Career Program 16, is not intended to serve as a substitute for NRSA institutional training programs (T32), costs to support full-time participants (defined as supported for 40 hours/week for a continuous, 12-month period) are not allowable. Career Program 16 is designed to complement, not replace, existing NRSA programs, and thus focuses on supporting participants in a way that enhances, rather than substitutes for, other training opportunities.

Other Program-Related Expenses for Career Program 16

Career Program 16 recognizes that successful research education programs often require various other program-related expenses beyond personnel and participant costs.

• Allowable Expenses: Consultant costs, equipment (if essential and not readily available), supplies, travel for key program personnel, and other program-related expenses directly necessary for program implementation may be included in the proposed budget.
• Justification Required: All such expenses must be thoroughly justified as specifically required by the proposed program and must not duplicate items that are generally available at the applicant institution. The emphasis is on supporting program-specific needs that are not already met by institutional resources.

Indirect Costs for Career Program 16

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) for Career Program 16 are reimbursed at a fixed rate of 8% of modified total direct costs. This modified total direct cost base excludes tuition and fees and expenditures for equipment, simplifying the indirect cost calculation. This 8% rate is applied in lieu of a negotiated rate agreement, providing a consistent and predictable approach to indirect cost recovery for this specific program.

NIH grants policies, as detailed in the NIH Grants Policy Statement, apply to all applications submitted and awards made in response to the Career Program 16 FOA. Applicants should familiarize themselves with the NIH Grants Policy Statement to ensure full compliance with all applicable regulations and guidelines.

IV. Eligibility Information for Career Program 16

1. Eligible Applicants: Institutions for Career Program 16

Career Program 16 is specifically designed to support higher education institutions committed to fostering diversity in the biomedical research workforce. Eligible applicant organizations are limited to:

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education: State universities and colleges, and other public institutions awarding doctorate degrees in health professions or health-related sciences.
• Private Institutions of Higher Education: Private universities and colleges meeting the same degree-granting criteria.

Encouraged Institutions

The NIH strongly encourages applications from specific types of Higher Education Institutions that have a demonstrated commitment to serving underrepresented populations in higher education:

• Hispanic-Serving Institutions (HSIs)
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

These institutions are recognized for their crucial role in educating students from diverse backgrounds and are particularly well-positioned to contribute to the diversity goals of Career Program 16.

Additional Eligibility Criteria for Applicant Organizations

To be fully eligible for Career Program 16 funding, applicant institutions must meet several specific requirements:

• US-Based, Doctorate-Granting Institutions: Applicant institutions must be located within the United States or its territories. They must award doctorate degrees in health professions or sciences related to health, signifying a strong research and training infrastructure.
• Historical Mission of Diversity Education: A critical criterion is that the institution must have a historical mission of educating and training individuals from groups demonstrably underrepresented in biomedical research, as defined by the National Science Foundation (NSF). This historical commitment to diversity must be evident in the institution’s mission and activities. (Refer to NSF data on underrepresentation in biomedical research for specific group definitions).
• Limited Prior NIH Funding: To ensure Career Program 16 reaches a broad range of institutions, applicant institutions must have received less than an average of $50 million per year in total support from the NIH over the past three fiscal years. This criterion is intended to prioritize institutions that may have fewer existing NIH resources and greater potential to benefit from Career Program 16 support.
• Track Record in Diversity and Research Careers: Eligible institutions must possess a documented track record of successfully recruiting, retaining, training, and graduating underrepresented students, as defined by the NSF. This track record must demonstrate a tangible outcome: an increased contribution to the national pool of graduates from underrepresented backgrounds who actively pursue biomedical research careers. Evidence of this successful track record is a key component of eligibility.
• Accreditation for Master’s Degrees: The applicant institution must be accredited to award a Master’s degree in Clinical Research, Master of Public Health, or Master in Population Health. This accreditation ensures the institution has the capacity to offer the required degree programs within Career Program 16‘s Phase I.
• Prior CRECD Grant Status: Institutions currently holding a CRECD grant and in their final year of funding are eligible to apply for renewal under this FOA. Furthermore, institutions that have never received CRECD awards are also fully eligible to apply, broadening program access.

Institutional Commitment

The sponsoring institution must provide assurance of its strong commitment to the proposed Career Program 16 program. Appropriate institutional commitment includes, but is not limited to, the provision of adequate staff, facilities, and educational resources that are essential for the planned program’s success. This commitment must be demonstrated in the application, often through a letter of institutional commitment.

Institutions with Existing Federal Training Programs

Institutions that already have Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other Federally funded training programs are still eligible to apply for a Career Program 16 research education grant. However, a critical condition is that the proposed educational experiences within Career Program 16 must be demonstrably distinct from those already supported by existing federal training programs. In many cases, it is anticipated that Career Program 16 will complement ongoing research training activities at the applicant institution, providing unique and value-added educational opportunities.

Foreign Institutions and Components

Foreign Institutions (non-domestic, non-U.S. entities) are explicitly not eligible to apply for Career Program 16. Similarly, non-domestic (non-U.S.) components of U.S. Organizations are also ineligible. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed within Career Program 16 projects, ensuring that funding is directed to domestic institutions.

Required Registrations for Applicant Organizations and PD/PIs

Applicant Organizations

To be eligible to apply for and receive a Career Program 16 award, applicant organizations must complete and maintain several essential registrations, as detailed in the SF 424 (R&R) Application Guide. All registrations must be fully completed prior to application submission. The registration process can take 6 weeks or longer, so applicants are strongly advised to begin the registration process as early as possible. The NIH Policy on Late Submission of Grant Applications clearly states that failure to complete registrations in advance of a due date is not considered a valid reason for late submission. Required registrations include:

• System for Award Management (SAM)
• Grants.gov
• eRA Commons

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) applying for Career Program 16 must have an eRA Commons account. PD(s)/PI(s) should collaborate with their organizational officials to either create a new account or affiliate their existing account with the applicant organization within eRA Commons. If the PD/PI also serves as the organizational Signing Official, they must maintain two distinct eRA Commons accounts, one for each role, to ensure proper segregation of responsibilities. Obtaining an eRA Commons account can take up to 2 weeks, so early action is recommended.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) possessing the skills, knowledge, and resources necessary to effectively lead and carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is encouraged to work with their organization to develop a Career Program 16 application. The NIH actively encourages applications from individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women, reinforcing its commitment to inclusivity in the scientific workforce.

For institutions proposing multiple PDs/PIs, applicants should consult the NIH’s Multiple Program Director/Principal Investigator Policy and the detailed submission instructions within the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

The PD/PI for Career Program 16 should be an established investigator with a strong scientific track record in the area relevant to the application. They must demonstrate the capacity to provide both robust administrative and scientific leadership for the development and effective implementation of the proposed program. The PD/PI will be responsible for diligent monitoring and rigorous assessment of program progress and outcomes, as well as ensuring timely submission of all required documents and reports to the NIH.

2. Cost Sharing for Career Program 16

This specific Funding Opportunity Announcement (FOA) for Career Program 16 does not mandate cost sharing as defined in the NIH Grants Policy Statement. Cost sharing, while sometimes encouraged or required in other grant programs, is not a prerequisite for applying to or receiving funding under Career Program 16.

3. Additional Information on Eligibility for Career Program 16

Number of Applications Per Institution

To ensure focused and strategic program development, only one Career Program 16 application is permitted per institution. For the purpose of this limitation, an institution is typically identified by having a unique DUNS number or NIH IPF number. This policy is intended to encourage institutions to develop a single, well-integrated, and comprehensive Career Program 16 proposal, rather than submitting multiple, potentially overlapping applications.

The NIH will not accept duplicate or highly overlapping applications that are under review simultaneously. This strict policy is designed to prevent redundancy in the review process and ensure efficient allocation of review resources. Specifically, the NIH will not accept:

• A new (A0) application submitted before the summary statement is issued from the review of a previously submitted overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application submitted before the summary statement is issued from the review of the preceding new (A0) application.
• An application that exhibits substantial overlap with another application that is currently pending appeal of its initial peer review. (Refer to NIH Notice NOT-OD-11-101 for further details on application overlap policies).

Program Faculty and Mentors

Career Program 16 strongly encourages the active participation of researchers from diverse backgrounds as preceptors and mentors within the program. This includes individuals from racial and ethnic minority groups, persons with disabilities, and women, all of whom bring valuable perspectives and experiences to the mentoring process. Mentors should possess demonstrated research expertise and experience directly relevant to the proposed program’s focus areas. A critical requirement for mentors is a firm commitment to maintain their involvement and guidance throughout the entirety of their mentee’s participation in Career Program 16, ensuring consistent and sustained mentorship.

Program Participants

Career Program 16 participants are defined as those individuals who will receive direct support in the form of salaries or wages under this program. A key eligibility requirement for participants is that they must be U.S. citizens or permanent residents, ensuring that program funds support the development of the U.S. research workforce.

The program is designed to include junior faculty and postdoctoral candidates who are pursuing a combination of their clinical doctorate degree with a Master of Science in Clinical Research, Master of Public Health, or Master in Population Health. These participants are aspiring independent clinical investigators seeking to establish research careers focused on clinical and translational research. Relevant clinical doctorate degrees for Career Program 16 participants include: M.D., D.D.S., D.M.D., D.O., O.D., N.D. (Doctor of Naturopathy), Ph.D. with clinical responsibilities, or Pharm.D. Postdoctoral appointees eligible for participation may include junior faculty members who are within seven years of their first faculty appointment, targeting early-career researchers. Individuals holding a Ph.D. in nursing, clinical psychology, or related fields who are committed to pursuing clinical research are also eligible to participate in Career Program 16, reflecting the program’s interdisciplinary scope.

V. Application and Submission Information for Career Program 16

1. Requesting an Application Package for Career Program 16

Applicants seeking to apply for Career Program 16 funding must obtain the official SF424 (R&R) application package specifically associated with this funding opportunity announcement (FOA). This can be accessed directly through the “Apply for Grant Electronically” button prominently displayed within the FOA itself. Alternatively, applicants can follow the detailed directions provided on the Grants.gov website, the central portal for federal grant applications. Using the correct application package is crucial to ensure compliance and successful submission.

2. Content and Form of Application Submission for Career Program 16

It is absolutely essential that applicants meticulously follow all instructions detailed in the SF424 (R&R) Application Guide, including any Supplemental Grant Application Instructions. These guidelines provide comprehensive information on the required content and format for NIH grant applications. Strict adherence to these requirements is not merely recommended but is mandatory and rigorously enforced. Applications that fail to comply with these instructions, whether in content or format, will be deemed non-compliant and will not proceed to the scientific review process.

For detailed information and guidance on Application Submission and Receipt, applicants should consult the “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications” resource, available through the NIH grants website. This resource offers valuable insights and answers to common questions about the electronic submission process.

Letter of Intent (LOI) for Career Program 16 (Optional but Encouraged)

While a formal Letter of Intent (LOI) is not a mandatory requirement for Career Program 16 applications, submitting an LOI is strongly encouraged. Although non-binding and not factored into the subsequent review of the application, the information provided in an LOI is highly valuable to NIH staff. It allows the Institutes and Centers to accurately estimate the potential review workload associated with Career Program 16 and to effectively plan the review process, ensuring sufficient resources are allocated for a thorough and timely evaluation of all submitted applications.

Prospective applicants are kindly requested to submit a Letter of Intent by the date specified in Part 1. Overview Information of the FOA. The LOI should include the following essential information:

• Descriptive Title of Proposed Activity: A concise and informative title that accurately reflects the scope and focus of the proposed Career Program 16 project.
• Name(s), Address(es), and Telephone Number(s) of the PD(s)/PI(s): Complete contact information for the Program Director(s) and Principal Investigator(s) who will be leading the project.
• Names of Other Key Personnel: Identification of other individuals who will play key roles in the design, implementation, and management of the Career Program 16 program.
• Participating Institution(s): The name(s) of the institution(s) that will be submitting the application and administering the grant funds.
• Number and Title of this Funding Opportunity: Clearly state the Funding Opportunity Announcement (FOA) number (PAR-16-350) and the full title of the Career Program 16 program to ensure proper identification and tracking.

The Letter of Intent should be submitted electronically to the designated contact person, as specified in the FOA, to facilitate efficient processing and review planning.

Page Limitations for Career Program 16 Applications

All page limitations specified in the SF424 (R&R) Application Guide and the comprehensive Table of Page Limits must be strictly adhered to for Career Program 16 applications. These page limits are in place to ensure concise and focused applications and to facilitate equitable review. Applicants should carefully consult these resources to confirm the page limits for each section of the application and plan their content accordingly. Exceeding page limits can result in applications being deemed non-compliant and excluded from review.

Instructions for Application Submission Components: SF424 (R&R) and PHS 398

The following section provides supplementary instructions that are specific to Career Program 16 applications and are intended to be used in conjunction with the general instructions found within the SF424 (R&R) Application Guide. In cases where these program-specific instructions deviate from the general Application Guide instructions, the program-specific instructions outlined below take precedence.

SF424(R&R) Cover Component

Applicants must meticulously follow all instructions provided in the SF424 (R&R) Application Guide for completing the Cover component of the application. This component captures essential administrative and identifying information about the applicant institution and the proposed project.

SF424(R&R) Project/Performance Site Locations Component

Applicants must adhere to all instructions provided in the SF424 (R&R) Application Guide for detailing Project/Performance Site Locations. This section specifies where the proposed Career Program 16 activities will be conducted and is important for logistical and administrative purposes.

SF424 (R&R) Other Project Information Component

Applicants must follow all instructions provided in the SF424 (R&R) Application Guide for the Other Project Information Component, with the following specific additions and modifications for Career Program 16:

• Facilities & Other Resources: Within this section, applicants must provide a comprehensive description of the educational environment that will support the proposed Career Program 16. This includes detailing the facilities, laboratories, participating departments within the institution, available computer services, and any other institutional resources that will be utilized in the development and effective implementation of the proposed program. Crucially, applicants must also list all thematically related sources of support for research training and education that are currently available at the institution. This should be presented following the standard format for “Current and Pending Support,” providing reviewers with a clear picture of the existing research education landscape at the applicant institution and how Career Program 16 will complement or enhance it.
• Other Attachments: In the “Other Attachments” section, applicants are required to provide a detailed plan for the establishment and operation of a Career Program 16 Advisory Committee. This committee is essential for monitoring the progress of the research education program and providing expert guidance. The plan must clearly outline:
  • Composition of the Advisory Committee: Specify the disciplines, departments, and schools that will be represented on the committee, ensuring a multidisciplinary perspective.
  • Roles and Responsibilities: Clearly define the specific roles and responsibilities of committee members in advising and overseeing Career Program 16.
  • Desired Expertise of Committee Members: Describe the specific expertise and experience that will be sought in individuals invited to serve on the committee, ensuring they possess the knowledge necessary to effectively guide the program.
  • Frequency of Committee Meetings: Indicate how often the Advisory Committee will convene to review program progress, typically at least annually.
  • Evaluation of Program Effectiveness: Detail how the Advisory Committee will systematically evaluate the overall effectiveness of the Career Program 16 program in achieving its stated goals and objectives.
  • Proposed Committee Members: If potential Advisory Committee members have already been identified and invited to participate at the time of application submission, their names should be included in the application, demonstrating proactive planning. For renewal applications, which are building upon existing programs, the names of all committee members who served during the past project period must be listed to provide continuity and context.

When uploading the Advisory Committee plan as an “Other Attachment,” the file should be clearly named “Advisory_Committee.pdf” to facilitate easy identification and organization within the electronic application system.

The CRECD Advisory Committee plays a pivotal role in program oversight and participant support:

• Multidisciplinary Representation: Committee membership should adequately represent the diverse disciplines, departments, and schools involved in the Career Program 16 program, fostering a holistic perspective. External advisors may also be included to bring additional expertise.
• Key Responsibilities: The CAC’s core responsibilities include:
  • Recommending strategies for participant recruitment and selection to ensure a diverse and highly qualified participant pool.
  • Evaluating the establishment and ongoing effectiveness of the Career Program 16 courses and curriculum in meeting program objectives.
  • Reviewing and approving the educational and research plans developed for each participant, ensuring alignment with program goals and individual career development.
  • Conducting interim monitoring of participant progress throughout both Phase I and Phase II of the program, providing timely feedback and guidance.

The application must provide a clear and detailed description of how the CAC will function in providing comprehensive oversight of the Career Program 16 program. This includes:

• Participant Progress Evaluation: Detail the processes the CAC will use to rigorously evaluate the progress of each participant, both in Phase I and Phase II. This includes assessing progress towards degree completion in Phase I and accomplishments such as abstracts, publications, and efforts to secure external grant funding in Phase II.
• Program Improvement Recommendations: Explain how the CAC will provide recommendations for program enhancements and modifications based on their ongoing evaluations, ensuring continuous program improvement and adaptation to participant needs and evolving research landscapes.
• Participant Termination (if necessary): Describe the procedures the CAC will follow in the rare event that a participant is not making adequate progress within the program, including recommendations for potential termination of support, ensuring responsible stewardship of program resources.
• Overall Program Effectiveness Monitoring: Detail how the CAC will monitor the overall effectiveness of the Career Program 16 program in achieving its stated goals and objectives, using defined metrics and evaluation strategies.

Following NIH guidelines for electronic application submission, the filename used for each “Other Attachment” will automatically become the bookmark name for that attachment within the electronic application in eRA Commons, facilitating navigation and review.

SF424(R&R) Senior/Key Person Profile Expanded Component

Applicants must meticulously follow all instructions provided in the SF424 (R&R) Application Guide for completing the Senior/Key Person Profile Expanded component. This section collects detailed biographical and role information for all key personnel involved in the Career Program 16 project.

Key Personnel for Career Program 16 applications must include, at a minimum:

• Program Director/Principal Investigator (PD/PI): The individual(s) who will bear overall responsibility for the program’s direction and management.
• Other Key Persons: Any other individuals who are considered integral to the proposed research education program’s success. This includes those involved in the program’s development, implementation, direction, monitoring, and evaluation. Examples include curriculum developers, program coordinators, and evaluation specialists.

Specifically, for Career Program 16, the Senior/Key Person Profile should include:

• PD/PI(s)
• Mentors: All faculty members who will serve as research mentors for program participants.
• Other Participating Faculty: Faculty members who will contribute to the Career Program 16 program through teaching specialized courses, leading workshops, or other significant roles.

For each individual listed as Key Personnel, the application must include:

• Degree(s) Held: Specify the highest degree(s) earned by the individual (e.g., PhD, MD, MS).
• Departmental Affiliation (or Equivalent): Indicate the department or organizational unit within the institution where the individual is primarily affiliated. If the Career Program 16 involves a consortium of institutions, the institutional affiliation of each key person must be clearly stated.
• Biographical Sketches: A concise biographical sketch (typically in NIH format) must be provided for the PD/PI, mentors, and all other participating faculty members. These sketches should highlight their relevant experience, expertise, and qualifications for their roles within Career Program 16.

R&R Budget Component for Career Program 16

Applicants must carefully follow all instructions provided in the SF424 (R&R) Application Guide for completing the R&R Budget component, with the following specific modifications and clarifications for Career Program 16:

• Other Personnel Section: In the “Other Personnel” section of the budget form, applicants should include all personnel associated with the Career Program 16 project who are not classified as PD/PI(s). This includes, but is not limited to, clerical and administrative staff who will provide essential program support.
• Participant/Trainee Support Costs Section: The “Participant/Trainee Support Costs” section is specifically designated for including all allowable categories of funds requested to directly support participants within the Career Program 16 program. This section should encompass costs such as participant stipends or salaries, tuition remission, fees, travel to meetings, and research-related expenses for participants.
• Travel Funds: Travel funds requested for senior/key persons and other personnel directly associated with the Career Program 16 program should be detailed within the budget. This may include travel for program staff to attend relevant conferences, workshops, or meetings. Crucially, funds requested to support participants’ travel to the annual meeting in Bethesda, Maryland, should also be included in this section.
• Participant Costs – Itemization and Justification: For “Participant Costs,” applicants must include all allowable categories of funds requested to support participants in the research education program. If the standard budget categories provided in the form are insufficient to capture all necessary participant costs, applicants should utilize the “Other” category and provide a clear and detailed description of these additional costs. For budget categories other than participant salary or stipend, applicants must specifically identify the requested costs under each budget category (e.g., supplies, travel, tuition) for each participant. This should be done either by name if participants are already identified, or by position if the positions are yet to be filled. The total requested costs for each individual participant should be clearly stated and must not exceed $20,000 per participant per year (unless otherwise justified and allowable under program guidelines). Applicants must also state the total number of participants that the proposed Career Program 16 program intends to support over the project period, providing context for the requested participant support costs.

PHS 398 Cover Page Supplement Component

Applicants must adhere to all instructions provided in the SF424 (R&R) Application Guide for completing the PHS 398 Cover Page Supplement component. This form collects additional administrative information and certifications related to the application.

PHS 398 Research Plan Component: The Research Education Program Plan for Career Program 16

All instructions within the SF424 (R&R) Application Guide pertaining to the PHS 398 Research Plan Component must be followed. However, for Career Program 16 applications, the “Research Strategy” section of the Research Plan component is specifically designated for uploading the comprehensive Research Education Program Plan. This plan is the core of the application and must include all of the following critical components, each described in detail below:

• Proposed Research Education Program: A detailed description of the overall program design and activities.
• Program Director/Principal Investigator: Information about the leadership and management of the program.
• Program Faculty: Details about the faculty involved, including mentors and course instructors.
• Program Participants: Description of the target participants and selection criteria.
• Institutional Environment and Commitment: Evidence of institutional support and resources.
• Diversity Recruitment Plan: Strategies for recruiting participants from underrepresented groups.
• Plan for Instruction in the Responsible Conduct of Research: Plan for ethics training.
• Evaluation Plan: Methods for assessing program effectiveness.
• Dissemination Plan: How program outcomes and best practices will be shared.

Research Education Program Plan Details for Career Program 16

Proposed Research Education Program:

• Value-Added and Distinction: While the proposed Career Program 16 program is encouraged to complement existing research training and education activities at the applicant institution, it is absolutely essential that the proposed educational experiences are demonstrably distinct from any research training and research education programs already receiving federal funding. If research training programs are already ongoing within the same department or institution, the applicant organization must clearly and explicitly differentiate between the activities proposed in Career Program 16 and the research training supported by those existing programs. The application must clearly articulate the “value-added” of Career Program 16 to the participating institution, demonstrating how it provides unique and enhanced opportunities beyond existing programs.

• Rationale and Programmatic Detail: Applicants must provide a concise but compelling rationale that clearly explains:

  • The specific needs and areas identified for improvement at the participating institutions that led to the development of the proposed Career Program 16.
  • The reasons for incorporating particular courses for skills development and research experiences into the proposed program design, aligning program activities with identified needs.
  • Detailed programmatic information about the special activities proposed within Career Program 16, including but not limited to:
    • Specific courses to be developed or enhanced, including course descriptions, learning objectives, and instructional methods.
    • Curricula to be implemented, outlining the sequence and integration of courses and research experiences.
    • Seminars, workshops, and other training activities that will be offered to participants, describing their content and intended learning outcomes.

• Phase I (Didactic Courses for Skill Development in Clinical Research) – Education and Research Experience Plan: For applications proposing a Phase I component focused on didactic courses and skill development, the Education and Research Experience Plan must comprehensively address the following elements:

  • Background, Purpose, and Objectives of Career Program 16: Clearly articulate the overall background, purpose, and specific, measurable objectives of the proposed Career Program 16 program, aligning them with the goals of the FOA and the needs of the target participant population.
  • Degree Requirements: Provide a detailed description of the specific requirements that participants will need to successfully complete to earn either a Master of Science in Clinical Research, Master of Public Health, or Master in Population Health degree through Career Program 16. This includes outlining required coursework, research project expectations, thesis or dissertation requirements (if applicable), and any other degree-specific milestones.
  • Description of Proposed Courses: Provide a comprehensive description of all proposed courses for skill development within Phase I. This description must include:
    • A clear explanation of how each course directly links to the overarching purpose and objectives of the Career Program 16 program.
    • A detailed explanation of how each course contributes to the research career development of program participants, building essential knowledge and skills.
    • A compelling rationale for why the proposed Career Program 16 courses are innovative and represent a value-added component relative to other courses already available at the applicant institution(s), highlighting unique features or content.
  • Didactic Opportunities Utilizing Existing Courses: Describe any existing courses or curricula within the applicant institution(s) that will be leveraged and integrated into Career Program 16 to provide broader didactic opportunities for participants, maximizing resource utilization.
  • Research Activities and Experiences: Provide a thorough description of the research activities and hands-on research experiences that will be offered by faculty mentors to participants within the program. This should include the types of research projects available, the level of mentor supervision, and the expected learning outcomes for participants.
  • Multidisciplinary Clinical Research Preparation: Detail the specific plans in place to provide examples of education and research experiences that will effectively prepare participants to design, implement, and actively participate in multidisciplinary clinical research projects. This should emphasize collaborative research skills and the ability to work effectively in diverse research teams.
  • Participant Progress Monitoring: Outline the detailed plans and procedures that will be implemented to systematically monitor the progress of participants throughout Phase I of Career Program 16. This should include milestones for degree completion, research project benchmarks, and mechanisms for providing feedback and support to participants.

• Phase II (Mentored Phase) – Mentored Research Experience Plan: For applications that include a Phase II component focused on mentored research experiences, the application must provide a comprehensive description of the mentored phase, including:

  • Participant and Mentor Selection Process: Detail the rigorous process that will be used for the selection of participants for Phase II, including eligibility criteria and selection procedures. Also, describe the process for selecting and assigning mentors, including the requirements for mentors (e.g., research expertise, mentoring experience, commitment to diversity) and the matching process.
  • Mentor Requirements and Research Plans: Clearly articulate the specific requirements and expectations for mentors participating in Phase II, including their roles in guiding participant research, providing career advice, and fostering independent research skills. Describe the types of research plans and mentored research experience activities that will be available to Phase II participants, aligning them with the program’s research scope and NIH priorities.
  • CAC Role in Phase II Participant Selection and Evaluation: Provide a detailed description of the critical role the CRECD Advisory Committee (CAC) will play in recommending the selection of participants for Phase II and in the ongoing evaluation of participants who continue their mentored training through the Career Program 16 award. This should include the CAC’s review process, evaluation criteria, and mechanisms for providing feedback to participants and mentors.

Program Director/Principal Investigator (PD/PI):

• Administrative Arrangements: Thoroughly describe the administrative arrangements that will be put in place to ensure the effective management and operation of the Career Program 16 program. This includes outlining the organizational structure, reporting lines, and key administrative personnel involved.
• PD/PI Qualifications and Leadership: Provide compelling evidence that the Program Director/Principal Investigator (PD/PI) is exceptionally well-qualified to lead Career Program 16. This evidence should demonstrate that the PD/PI:
  • Is actively engaged in research and/or teaching within an area directly related to the mission of the NIH and the goals of Career Program 16.
  • Possesses the strong organizational, administrative, and leadership skills necessary to effectively organize, administer, monitor, and rigorously evaluate the research education program.
• Multiple PD/PI Leadership Approach: For programs proposing multiple PDs/PIs, the application must clearly describe:
  • The complementary and integrated expertise that each PD/PI brings to the leadership team, demonstrating synergistic leadership.
  • The proposed leadership approach for the multiple PD/PI team, including how responsibilities will be shared and coordinated.
  • The governance structure that will be implemented to ensure effective decision-making and program management across the multiple PD/PI leadership structure.
• PD/PI Role and Effort Commitment: Provide a detailed description of the specific roles and responsibilities of the PD/PI in providing both strong scientific leadership and effective administrative management and coordination of the Career Program 16 program. Explicitly state the level of effort (in person months or percentage effort) that the PD/PI will dedicate to Career Program 16, providing evidence that an appropriate level of effort will be committed by program leadership to ensure the successful achievement of the program’s objectives.

Program Faculty:

• Diversity Encouragement: Career Program 16 strongly encourages the participation of faculty members from diverse backgrounds as program faculty, including racial and ethnic minorities, persons with disabilities, and women. This diversity enriches the program and provides valuable role models for participants.
• Faculty Expertise and Commitment: Provide a comprehensive description of the faculty members who will serve as research mentors within Career Program 16. This description must demonstrate:
  • That faculty mentors possess robust research expertise and substantial experience directly relevant to the proposed program’s focus areas and the conduct of clinical research.
  • That faculty mentors have a demonstrated history of, or clear potential for, success in their intended roles within the program, including mentoring experience and commitment to participant development.
  • Evidence of the availability and firm commitment of the faculty mentors to actively participate in Career Program 16 for the entire duration of the proposed program, ensuring sustained mentorship for participants.

Program Participants:

• Target Participants and Eligibility: The application must clearly and comprehensively describe the intended participant pool for Career Program 16. This includes:

  • Defining the specific types of individuals the program aims to recruit (e.g., junior faculty, postdoctoral fellows, clinical fellows).
  • Articulating the precise eligibility criteria that participants must meet to be considered for the program (e.g., degree requirements, research interests, career goals).
  • Specifying any specific educational background characteristics that are deemed essential for successful participation in the proposed research education program, ensuring a well-matched participant cohort.
  • Clearly identifying the career levels for which the proposed program is specifically designed (e.g., postdoctoral, early career faculty).

• Recruitment, Selection, and Retention: Provide a detailed description of the strategies and procedures that will be employed for:

  • Identification: How potential participants will be identified and reached, including outreach methods and recruitment materials.
  • Selection: The specific criteria and rigorous procedures that will be used to select participants from the applicant pool, ensuring a fair and merit-based selection process.
  • Retention: The strategies and support mechanisms that will be put in place to effectively retain participants in the program through completion, addressing potential challenges and promoting participant success.
  • Recruiting Strategies and Participant Pool: Describe the specific recruiting strategies that will be implemented to attract a diverse and highly qualified pool of applicants. Estimate the anticipated size of the participant pool expected to be generated through these strategies.
  • Addressing Competition for Participants: If there are any other institutional programs that might compete for the same pool of potential participants (e.g., other training programs, fellowships), explicitly describe the strategies that will be used to effectively address this competition and ensure successful recruitment for Career Program 16.

Institutional Environment and Commitment:

• Environmental Description: Thoroughly describe the institutional environment that will support Career Program 16. Reiterate the availability of key facilities and educational resources (as detailed separately under “Facilities & Other Resources” in the SF424 (R&R) Other Project Information component) that will directly contribute to the success of the planned Research Education Program. This section should paint a picture of a supportive and resource-rich environment for participant training and research.
• Evidence of Institutional Commitment: Strong evidence of the institution’s unwavering commitment to the proposed research educational program is absolutely required. This commitment is typically demonstrated through a formal letter of institutional commitment, which must be attached as part of the “Letters of Support” section of the application (see below). Appropriate institutional commitment encompasses the provision of:
  • Adequate and qualified staff dedicated to program administration and support.
  • Appropriate and well-maintained facilities for program activities, including classrooms, research labs, and meeting spaces.
  • Sufficient educational resources, such as library access, online learning platforms, and access to relevant software and databases.

Crucially, if the required letter of institutional commitment is not included with the application, the application will be deemed incomplete and will be administratively withdrawn from consideration, regardless of its scientific merit.

Progress Report (For Renewal Applications Only):

For institutions submitting renewal applications for Career Program 16 (Type 2 applications), a detailed Progress Report is a mandatory component of the application. If the program has been funded for more than one previous funding cycle, the Progress Report must provide comprehensive information covering all past consecutive funding cycles, demonstrating the program’s longitudinal track record. The Progress Report should systematically address the following:

• Original Goals and Specific Aims: Clearly restate the original goals and specific aims of the Career Program 16 program as outlined in the initial application for the prior funding period.
• Anticipated Milestones and Outcomes: Summarize the key milestones and anticipated outcomes that were projected for the program during the previous funding period, providing a benchmark for evaluating progress.
• Summary of Specific Accomplishments: Provide a detailed and data-driven summary of the specific accomplishments and successes of the Career Program 16 program during the previous funding period. This should include quantifiable outcomes and qualitative achievements, demonstrating the program’s impact.

Specifically, the Progress Report must include detailed information on:

• Overall Program Success in Diversity: Quantitatively and qualitatively describe the accomplishments and successes of the overall Career Program 16 program in increasing diversity within the clinical research workforce. Provide data on participant demographics, recruitment efforts, and program outcomes related to diversity enhancement.
• Phase I Participant Information: Provide specific information highlighting the Phase I participants who attended and successfully graduated from the program during the previous funding period. Include data on graduation rates, time to degree completion, and participant demographics.
• Current Status and Career Plans of Participants: For both Phase I and Phase II participants who have completed the program, provide their current status and career plans. This should include information on:
  • Current employment status and positions held.
  • Career trajectories and progression in research or related fields.
  • Grants awarded to program alumni, including the source of funding and grant title.
  • Publications resulting from program participation, including a list of peer-reviewed publications.
• Course Evaluation and Development: Provide a detailed assessment of the courses that are currently in place within Career Program 16. Identify:
  • Courses that are effectively meeting the needs of participants and program objectives.
  • Courses that need to be further developed or adapted to better address participant needs and align with program goals, providing justification for proposed changes.
• Novel Course Development: Highlight any novel and innovative courses that have been developed and implemented within Career Program 16 that are considered critical to the education and training of clinical investigators, particularly those working in the area of health disparities. If proposing substantial changes to existing Career Program 16 courses or the development of new courses, provide a comprehensive justification for these proposed modifications, explaining how they will enhance the program and benefit participants.

Recruitment Plan to Enhance Diversity:

• NIH Diversity Imperative: Emphasize that fostering diversity within the scientific research workforce is not merely a desirable goal but a core strategic imperative for the NIH. Highlight that the NIH is deeply committed to identifying, developing, supporting, and sustaining the highest quality scientific human capital, and that diversity is essential to achieving this goal. Refer to NIH Notice NOT-OD-15-053, which underscores the NIH’s commitment to diversity.

• Benefits of Diversity in Research: Articulate the compelling rationale for why diversity is so critical to scientific progress and innovation. Explain that:

  • Every facet of the U.S. scientific research enterprise, from basic science to clinical and translational research and policy development, demands exceptional intellect, creativity, and a wide spectrum of skills and viewpoints.
  • The NIH’s ability to ensure that the nation remains a global leader in scientific discovery and innovation is fundamentally dependent on a robust pool of highly talented scientists from diverse backgrounds who can contribute unique perspectives and expertise to advance the NIH’s mission.
  • Research consistently shows that diverse teams, working collaboratively and leveraging innovative ideas and distinct perspectives, demonstrably outperform homogenous teams in problem-solving and scientific discovery.
  • Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, enhanced creativity, and individual enterprise to the complex challenges of scientific inquiry.
  • A diverse NIH-supported scientific workforce yields numerous tangible benefits, including: fostering scientific innovation, enhancing global competitiveness, contributing to richer learning environments, improving the overall quality of researchers, increasing the likelihood that underserved or health disparity populations will participate in and benefit from health research, and ultimately enhancing public trust in science.

• Addressing Unequal Opportunity: Acknowledge that, despite significant advancements in scientific research, access to information, educational opportunities, and research opportunities is not yet equally available to all segments of the population. Reiterate that the NIH actively encourages institutions to proactively diversify their student and faculty populations to significantly enhance the participation of individuals from groups who are demonstrably underrepresented in the biomedical, clinical, behavioral, and social sciences. Specifically, identify the underrepresented groups that are the focus of Career Program 16 diversity efforts, aligning with NIH guidelines and data from the National Science Foundation (NSF). These groups typically include:

  A. Racial and Ethnic Groups Underrepresented in Biomedical Research: Explicitly list the racial and ethnic groups that the NSF has identified as demonstrably underrepresented in health-related sciences on a national basis. Refer to current NSF data and reports such as “Women, Minorities, and Persons with Disabilities in Science and Engineering” for the most up-to-date list. Typically, these groups include: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, and Native Hawaiians and other Pacific Islanders.
  B. Individuals with Disabilities: Define “individuals with disabilities” according to the Americans with Disabilities Act of 1990, as amended, as those with a physical or mental impairment that substantially limits one or more major life activities. Refer to NSF data on the representation of individuals with disabilities in STEM fields.
  C. Individuals from Disadvantaged Backgrounds: Define “individuals from disadvantaged backgrounds” according to NIH guidelines, which typically include:

  1. Individuals who come from families with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census, adjusted annually for changes in the Consumer Price Index, and further adjusted by the Secretary of HHS for use in health professions programs. Provide a link to the HHS website where these income levels are periodically published.
  2. Individuals who come from educational environments, such as those found in certain rural or inner-city areas, that have demonstrably and directly inhibited the individual from acquiring the knowledge, skills, and abilities necessary to successfully develop and participate in a research career.

  Reiterate that while the disadvantaged background category (C1 and C2) is more directly applicable to programs focused on high school and undergraduate candidates, Career Program 16 still prioritizes outreach to individuals who may have faced socioeconomic or educational disadvantages that could impact their access to research careers.

  Acknowledge that literature consistently demonstrates that women from the above-listed underrepresented backgrounds (categories A, B, and C) often face particular and compounded challenges at the graduate level and beyond in scientific fields. Cite relevant reports and research, such as “Inside the Double Bind, A Synthesis of Empirical Research on Undergraduate and Graduate Women of Color in Science, Technology, Engineering, and Mathematics,” to support this point.

• New Application Recruitment Plan: For new Career Program 16 applications, a detailed description of the institution’s comprehensive plans to enhance recruitment of participants from underrepresented backgrounds is mandatory. This recruitment plan must explicitly outline the specific strategies that will be actively used to enhance the recruitment of trainees from underrepresented groups. Applicants are encouraged to include any relevant data that may support their past accomplishments in diversity recruitment, if available.

• Renewal Application Recruitment Report: For Career Program 16 renewal applications, a detailed account of the institution’s experiences in recruiting individuals from underrepresented groups during the previous funding period is required. This report must include specific information on both successful and unsuccessful recruitment strategies that were implemented. Furthermore, renewal applications must include aggregate data on the distribution of:

  • Individuals from underrepresented groups who formally applied for admission to the Career Program 16 research education program.
  • Individuals from underrepresented groups who were offered admission to the Career Program 16 research education program.
  • Individuals from underrepresented groups who actually participated in the Career Program 16 research education program.

  For those individuals from underrepresented groups who participated in the research education program, the report should further include:

  • The duration of their participation in the program.
  • Aggregate data on the number of individuals from underrepresented groups who successfully finished the program in good standing, including degree completion or program completion metrics.

  Refer applicants to the NIH “Frequently Asked Questions: Recruitment and Retention Plan to Enhance Diversity” (Diversity FAQs) for additional guidance and resources on developing effective diversity recruitment and retention plans.

Applications that lack a robust and well-articulated diversity recruitment and retention plan will not be reviewed. This underscores the critical importance of this component in the application evaluation process.

Plan for Instruction in the Responsible Conduct of Research (RCR):

• NIH RCR Requirement: Emphasize that all Career Program 16 applications must include a comprehensive and well-defined plan to fully address NIH requirements for instruction in the Responsible Conduct of Research (RCR). This training is essential to ensure the ethical and responsible conduct of research by all program participants.

• Five Required Instructional Components: Clearly state that the RCR instruction plan must, at a minimum, address all five of the required instructional components as explicitly outlined in NIH policy. These five components are:

  1. Format of Instruction: The required format of RCR instruction must be specified. Acceptable formats include face-to-face lectures, formal coursework, and/or real-time discussion groups. A plan that relies solely on online instruction, without any in-person or real-time interactive components, is explicitly not acceptable to meet NIH requirements.
  2. Subject Matter: The plan must describe the breadth and depth of subject matter that will be covered in the RCR instruction. Provide examples of essential RCR topics that must be included, such as: conflict of interest, authorship and publication practices, data management and responsible data sharing, ethical considerations in research involving human subjects and animal welfare, laboratory safety, policies and procedures regarding research misconduct, and broader issues of research ethics and integrity.
  3. Faculty Participation: The plan must clearly articulate the role of the Career Program 16 program faculty in providing RCR instruction. This should detail how faculty members will be actively involved in delivering RCR training, such as serving as course directors, guest speakers, lecturers, discussion leaders, or mentors in RCR-related activities.
  4. Duration of Instruction: The plan must specify the total number of contact hours of RCR instruction that will be provided to participants. This duration should be appropriate and reasonable, taking into careful consideration the overall duration of the Career Program 16 program itself and the career stage of the participants.
  5. Frequency of Instruction: The plan must ensure that RCR instruction is not a one-time event but is integrated into the program at appropriate intervals. RCR instruction must occur during each career stage of participants and, at a minimum, must be provided at least once every four years to ensure ongoing reinforcement of ethical research principles. Refer to NIH Notice NOT-OD-10-019 for further details on RCR policy.

  Emphasize that the RCR instruction plan must be appropriately tailored and demonstrably reasonable given the specific nature and duration of the proposed Career Program 16 program and the experience level of the intended participants. For renewal (Type 2) applications, the RCR plan must also:

  • Describe any substantive changes that have been made to the formal RCR instruction provided over the past project period, reflecting program evolution.
  • Outline specific plans to address any weaknesses or areas for improvement that have been identified in the current RCR instruction plan, demonstrating a commitment to continuous improvement.
  • For renewal applications, explicitly name all participating faculty members who served as course directors, speakers, lecturers, and/or discussion leaders in RCR instruction during the past project period, providing transparency and accountability for RCR training.

Applications that lack a comprehensive and acceptable plan for instruction in the responsible conduct of research will not be reviewed. This underscores the non-negotiable nature of this requirement for NIH funding.

Evaluation Plan:

• Process and Outcome Evaluation: Applicants are required to develop and describe a detailed and robust evaluation plan that will be used to rigorously review and determine the overall effectiveness of the Career Program 16 program. This evaluation plan must include both:

  • Process Evaluation: A plan to systematically examine the program’s operations to determine if activities are being conducted as planned, whether program outputs are being produced as intended, and how program processes can be improved for greater efficiency and effectiveness. This is a formative evaluation focused on program implementation.
  • Outcome Evaluation: A plan to assess the actual outcomes and impact of the Career Program 16 program in achieving its stated goals and objectives. This summative evaluation focuses on measuring the program’s success in producing desired changes in participants and the broader research environment.

  The evaluation plan must include clearly defined and measurable milestones for each key activity within the Career Program 16 program. This allows for tracking progress and identifying areas needing adjustment. The evaluation plan should also incorporate a systematic process for actively soliciting and receiving feedback directly from program participants. This feedback is invaluable for identifying program weaknesses, gathering suggestions for program improvements, and ensuring the program is responsive to participant needs.

• Baseline Metrics and Success Measures: The application must explicitly specify:

  • Baseline Metrics: The key baseline metrics that will be used to characterize the participant cohort at the start of the program. Examples include: the number of participants, their prior educational levels, and relevant demographic characteristics. These baseline data points are essential for tracking change and impact over time.
  • Success Measures: The specific measures and indicators that will be used to gauge both the short-term and long-term success of the Career Program 16 award in achieving its stated objectives. These measures should be aligned with the program’s goals and be quantifiable wherever possible. Applicants are strongly encouraged to incorporate mechanisms for obtaining ongoing feedback from participants throughout the program to help proactively identify program weaknesses and generate actionable suggestions for continuous program improvements.

• Evaluation Parameters, Timeline, and Benchmarks: The evaluation plan must clearly specify:

  • Evaluation Parameters: The specific parameters and criteria that will be used to evaluate the success of the Career Program 16 program.
  • Evaluation Timeline: A detailed timeline outlining when and how often different evaluation activities will be conducted throughout the project period.
  • Evaluation Benchmarks: Clearly defined benchmarks and targets that will be used to assess the program’s progress and success against its stated goals. The evaluation plan must include specific milestones for the overall program in terms of tracking the long-term career outcomes of program participants. Examples of outcome measures for participants include:
    • Progression of Phase I participants towards successful completion of their degree program (Master’s degree).
    • Progress of both Phase I and Phase II participants towards establishing a productive and independent research career in clinical research.
    • Number of peer-reviewed journal papers authored or co-authored by participants, demonstrating research productivity.
    • Number of grant proposals submitted and successfully funded by participants, indicating progress towards independent funding.

Letters of Support:

• Institutional Commitment Letter (Required): As previously emphasized, a formal letter of institutional commitment from a high-level institutional official (e.g., Dean, Provost, Vice President for Research) is an absolutely mandatory component of the Career Program 16 application. This letter must be attached as part of the “Letters of Support” section of the application and must explicitly demonstrate the institution’s firm commitment to the proposed research educational program, including the provision of essential resources (staff, facilities, educational resources). Applications submitted without this required letter of institutional commitment will be deemed incomplete and administratively withdrawn from review.

Resource Sharing Plans:

• NIH Resource Sharing Policy: Applicants are required to fully comply with all instructions for Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, including the specific guidelines outlined in the NIH Grants Policy Statement.
• Software Dissemination Plan (If Applicable): When relevant to the proposed Career Program 16 project, particularly if the application requests support for the development, maintenance, or enhancement of software, applicants are expected to include a detailed software dissemination plan. While there is no single prescribed software license mandated by the NIH, the software dissemination plan should, as appropriate, address the following key goals:
  • Open Source Code Availability: Software source code should be made freely and readily available to the broad biomedical research and education community within the non-profit sector. This includes institutions of education, research institutions, and government laboratories, promoting broad access and use.
  • Code Modification and Sharing Permitted: Users should be explicitly permitted to modify the software code to suit their specific needs and to freely share their modifications and enhancements with others in the research community, fostering collaborative development and improvement.
  • Commercialization Terms: The terms of software availability should be designed to permit the commercialization of enhanced or customized versions of the software, or the incorporation of the software or components of it into other software packages. This allows for the potential translation of research software into commercial products and broader dissemination.
  • Software Transferability and Sustainability: To ensure the long-term utility of the software to the research community, the dissemination plan should address software transferability. This means ensuring that the software is structured and documented in a way that allows another individual or research team to readily continue its development and maintenance in the event that the original investigators are unable or unwilling to do so, promoting long-term sustainability and impact.

Appendix:

• No Appendix Allowed: For Career Program 16 applications, the use of an Appendix is explicitly not permitted. Applicants should not use the Appendix to circumvent page limitations or include any supplementary materials. Applications that submit an appendix will be deemed non-compliant and will not be reviewed. All essential information must be contained within the main body of the Research Plan and other required application components, adhering to all page limits.

PHS Inclusion Enrollment Report Component

When the proposed Career Program 16 project involves clinical research (as defined by NIH), applicants must meticulously follow all instructions for completing the PHS Inclusion Enrollment Report as detailed in the SF424 (R&R) Application Guide. This report collects crucial data on the inclusion of women, minorities, and children in clinical research studies, reflecting NIH’s commitment to ensuring representative participation in research.

PHS Assignment Request Form Component

Applicants must follow all instructions in the SF424 (R&R) Application Guide for completing the PHS Assignment Request Form. This form allows applicants to request assignment to a specific NIH Institute or Center and/or Scientific Review Group, if appropriate, although final assignment decisions rest with the NIH.

3. Unique Entity Identifier and System for Award Management (SAM) for Career Program 16

Refer to Part 1. Section III.1 of the Funding Opportunity Announcement for detailed information regarding the mandatory requirements for obtaining a Unique Entity Identifier (UEI) and for completing and maintaining active registrations in the System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov. These registrations are prerequisites for application submission and award receipt.

4. Submission Dates and Times for Career Program 16

Refer to Part I. Overview Information of the FOA for key dates and times related to Career Program 16 application submission, including the application due date. Applicants are strongly encouraged to submit their applications well in advance of the official due date to ensure they have ample time to address any potential application errors or system issues that may arise during the submission process and to resubmit a corrected application if needed. Submitting early significantly reduces the risk of late submission due to unforeseen technical problems.

When an application submission date falls on a weekend or a Federal holiday, the application deadline is automatically extended to the next business day, as per NIH policy.

Organizations must submit their Career Program 16 applications electronically through Grants.gov, the central online portal for finding and applying for grants across all Federal agencies. After initial submission via Grants.gov, applicants must then complete the application submission process by diligently tracking the status of their application within eRA Commons, the NIH’s electronic system for grants administration. Both Grants.gov and NIH systems conduct automated checks of the application against many of the application instructions upon submission. If any errors are detected during these checks, applicants must promptly correct these errors and submit a changed/corrected application to Grants.gov on or before the official application due date and time. If a changed/corrected application is submitted after the deadline, it will be considered a late application and may not be accepted for review, according to the NIH Policy on Late Application Submission.

It is the sole responsibility of the applicant organization to thoroughly view their application in eRA Commons before the application due date to definitively ensure accurate and successful submission. This final verification step is crucial to avoid any misunderstandings or technical issues that could jeopardize the application’s timely submission.

Comprehensive information on the application submission process, including a precise definition of on-time submission, is provided in the SF424 (R&R) Application Guide, which applicants should consult carefully.

5. Intergovernmental Review (E.O. 12372) for Career Program 16

This specific Career Program 16 initiative is not subject to the requirements of intergovernmental review as outlined in Executive Order 12372. Applicants are not required to contact State Single Point of Contact (SPOC) offices to comply with this executive order for Career Program 16 applications.

6. Funding Restrictions for Career Program 16

All Career Program 16 awards, like all NIH awards, are subject to the comprehensive terms and conditions, applicable cost principles, and other important considerations detailed in the NIH Grants Policy Statement. Applicants should thoroughly familiarize themselves with the NIH Grants Policy Statement to ensure full compliance with all applicable regulations and guidelines.

Pre-award costs, which are costs incurred by the applicant institution prior to the official Notice of Award date, are allowable only under very specific and limited circumstances as explicitly described in the NIH Grants Policy Statement. Applicants should carefully review the policy on pre-award costs before incurring any such expenses.

7. Other Submission Requirements and Information for Career Program 16

Applications for Career Program 16 must be submitted electronically through Grants.gov, following the detailed instructions provided in the SF424 (R&R) Application Guide. Paper applications will not be accepted under any circumstances.

It is absolutely mandatory that applicants complete all required registrations (SAM, Grants.gov, eRA Commons) well before the application due date. Section III. Eligibility Information of this FOA provides comprehensive details about these registration requirements and the time typically needed for registration completion. Applicants should initiate the registration process as early as possible to avoid potential delays that could jeopardize timely application submission.

For applicants who require assistance with the electronic application process or who seek more detailed information on electronic submission, the NIH provides extensive resources and support. Applicants should visit the “Applying Electronically” section of the NIH grants website for comprehensive guidance, FAQs, and troubleshooting tips. If applicants encounter a system issue that is demonstrably beyond their control and that genuinely threatens their ability to complete the submission process on time, they must immediately follow the specific “Guidelines for Applicants Experiencing System Issues” detailed on the NIH website. For direct assistance with application submission, applicants can contact the Application Submission Contacts listed in Section VII of this FOA.

Important Reminders for Applicants:

• eRA Commons ID for PD(s)/PI(s): It is absolutely essential that all PD(s)/PI(s) include their valid eRA Commons ID in the designated “Credential” field within the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in eRA Commons and to include a valid PD/PI Commons ID in the credential field will definitively prevent the successful electronic submission of an application to the NIH.
• DUNS Number Consistency: The applicant organization must rigorously ensure that the DUNS number they provide on the Career Program 16 application is precisely the same DUNS number that is officially registered in the organization’s profile within eRA Commons and in the System for Award Management (SAM). Any inconsistencies in DUNS numbers will cause submission errors. Additional information on DUNS number verification can be found in the SF424 (R&R) Application Guide.
• Common Errors to Avoid: Applicants are strongly encouraged to review the “more tips” section on the NIH grants website for valuable guidance on avoiding common errors that can lead to application rejection or delays.

Upon receipt by the NIH Center for Scientific Review, all Career Program 16 applications will undergo an initial evaluation for completeness and strict compliance with all application instructions. Applications that are found to be incomplete or non-compliant with the specified instructions will not be reviewed and will be returned to the applicant institution.

Post-Submission Materials for Career Program 16

Applicants are required to adhere to the specific instructions regarding the submission of post-submission materials, as detailed in NIH Notice NOT-OD-13-030. Post-submission materials are generally limited to very specific types of information and are only accepted under narrowly defined circumstances and within specified timeframes after the application submission deadline. Applicants should carefully review NOT-OD-13-030 to understand the permissible types of post-submission materials and the procedures for submission.