It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions will not be reviewed
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The overall goal of the Stimulating Access to Research in Residency (StARR) program is to provide clinicians with in-depth research experiences early in their careers, in order to recruit, retain and accelerate independence of a pool of clinician-investigators with both clinical and research experience necessary to perform basic, clinical and/or translational research.
Applications are encouraged that propose well-designed institutional programs that will provide Resident-Investigators with research opportunities that can stimulate investigative curiosity and foster transition to additional research and career development, while also meeting requirements for medical board, dental or veterinary specialty eligibility. Applicant Institutions must provide written evidence from a Board recognized by the ABMS, the ADA CODA, or the ABVS indicating that the overall structure of research and clinical activities outlined in the application leads to participant eligibility for medical board certification.
This FOA is intended to support Institutional programs that propose effective interactions with the residency director(s), institutional research leaders, and medical boards and optimize access to existing institutional research resources. Program Resident-Investigators identified by the institution will be health professionals with medical, dental or veterinary doctoral degrees (i.e., MD, DVM, DDS, DO, MBBS, or equivalents) with or without additional PhD degrees, with promise and interest in careers as clinician investigators.
This award supports institutional programs of mentored research opportunities designed for Resident-Investigators to engage in research projects with experienced investigators for a minimum of one contiguous year, and a maximum of two years, with the goal of accelerating the transition of participating residents to subsequent research and career development support. The NIH encourages institutions to recruit and retain individuals from groups currently underrepresented in the biomedical sciences, and to enhance the diversity of the clinician-investigator workforce. See, Notice of NIH's Interest in Diversity, NOT-OD-20-031; see also Policy Supporting the Next Generation Researchers Initiative, NOT-OD-17-101.
Institutional Research in Residency programs may complement ongoing research training and education occurring at the applicant institution, but the proposed research experiences must be distinct from those programs currently receiving Federal support (e.g., T32, T90, R25, K12, KL2) and cannot be used to replace or circumvent Ruth L. Kirschstein National Research Service Award (NRSA) programs.
There is a critical workforce need for physician-scientists/clinician-investigators, i.e., those with clinical experience who conduct research and offer skills and perspectives directly related to human health, disease conditions, clinical decision-making, diagnoses, prevention, and improving health outcomes. Relatively few physicians and other health professionals are pursuing research careers, and existing opportunities may not maintain adequate numbers or diversity of physician scientists (Advisory Committee to the Director, Physician Scientist Workforce Report, 2014). The overall size of the current clinician-investigator workforce constitutes only a small proportion of all NIH-funded research investigators, and this is particularly true for early-stage clinician investigators.
Thus new approaches are needed to recruit, prepare and retain more clinician-investigators from the large pool of potential researchers with health professional doctorates. Among today’s NIH-funded clinician-investigators, about 60% hold a single health professional degree and 40% hold both health professional and research doctorate degrees. Women and individuals from underrepresented racial and ethnic groups represent a particularly low proportion of this workforce. Each year in the United States, some 18,000 individuals earn an MD, while 600 individuals earn MD/PhDs; these data suggest that recruitment of even a slightly greater proportion of MDs, and retention of more MDs and MD/PhDs in research careers could significantly enhance the clinician-investigator workforce.
New approaches are also needed to enhance research opportunities during clinical training periods (residency), as this period of graduate medical education typically offers limited opportunities to acquire the research skills and experience needed for a career as a clinician-investigator. To enhance the research experience, several medical board-approved graduate medical residency programs have developed what are variously described as ‘fast track,’ ‘short track,’ ‘accelerated,’ or ‘research pathway’ approaches in their specialties. These programs balance protected time for research with clinical requirements, and medical boards approve either institutional programs or individual plans for board eligibility. Available outcomes indicate that the clinical competency of pathway graduates is comparable to those participating in standard residency programs. Many research pathway graduates subsequently hold positions in academic medicine, report research activity, and contribute substantial professional effort in research as clinician-investigators. However, available information indicates a need for more opportunities to participate in research during residency.
For health professionals who recognize the critical need to develop new understanding and therapeutic modalities for diseases, research in residency can provide valuable experience and an early “on-ramp” to a research career. It is also recognized that many MDs/health professionals as well as MD/PhDs have had previous research experience, and research in residency provides an opportunity to build upon prior research experiences. It is anticipated that Resident-Investigators supported by this FOA will be engaged in experimental approaches, form mentor-mentee relationships and gain additional research experience needed to enhance competitiveness for subsequent individual research and career development awards.
This FOA will support Institutional Programs that propose to engage Resident-Investigators in research. Institutional Programs applications submitted in response to this FOA should be characterized by:
Institutional Programs that propose to support residents from more than one training specialty (e.g., internal medicine, pediatrics, pathology, radiology, etc.) to promote cross-disciplinary interaction are strongly encouraged.
This FOA will provide support for supplementary research and professional development activities that will contribute to successful research, including:
Funded programs are expected to provide evidence of accomplishing their research experience and career development objectives in progress reports and upon renewal, to make participant outcomes outcomes publicly available, and are strongly encouraged to disseminate successful practices for fostering clinician-investigators to the broader training community.
Resident-Investigators are anticipated to have varied research backgrounds, that, in combination with achieving the StARR program objectives, will lead to continued research activity with potential support from the "Stimulating Access to Research in Residency Transition Support" individual K38. Consideration of other career development awards is also encouraged, such as appointment to institutional KL2 or K12 awards, or individual mentored career development awards including the K08 and K23. In some circumstances subsequent postdoctoral T32 or F32 National Research Service Award support may be considered, or other awards as well.
Resident-Investigators are encouraged to apply for loan repayment for qualified educational debt in return for research engagement, if eligibility criteria are met (https://www.lrp.nih.gov/eligibility-programs).
Resident-Investigators may also consider graduate medical research fellowships within the NIH intramural program https://www.cc.nih.gov/training/gme1.html.
Specific Areas of Research Interest of Participating Institutes and Centers
The participating NIH Institutes have provided a brief
outline of their interests as they relate to the goals of this FOA. These
mission statements are intended to indicate the breadth of the biomedical areas
of interest. See Staff Contacts for more details.
The National Heart, Lung, and Blood Institute (NHLBI) supports a broad research and training portfolio in the treatment and prevention of heart, lung, blood, and sleep diseases and disorders. The NHLBI is tasked with combating not only the major causes of death and disability but also rare disorders such as congenital heart disease, sickle cell disease, thalassemia, and pulmonary fibrosis. The NHLBI’s research programs span the entire research spectrum comprising fundamental discovery science, early translation research, clinical investigations, population science research, and translation research that moves fundamental discoveries into clinical and public health practice in real-world settings. Visit "Charting the future together: The NHLBI Strategic Vision for research priorities that will help accelerate research and scientific advances over the next decade" https://www.nhlbi.nih.gov/about/documents/strategic-vision. To achieve the goals related to this FOA, NHLBI is interested in applications from institutions seeking to provide research opportunities to clinician residents (with MD or equivalent degrees) who intend to pursue careers as clinician-scientists committed to research in heart, lung, blood, or sleep diseases or disorders.
The National Cancer Institute (NCI) supports research in all areas of cancer biology and investigates the biological aspects of every form of cancer, carrying out studies that range from targeted, long-running projects that are revealing the microscopic details of cell processes to high-risk, innovative research that holds promise for providing key insights into tumor development; research in cancer surveillance, epidemiology, health services, behavioral science, and cancer survivorship; research to assess a person's risk of developing cancer and to find ways to reduce that risk; research focuses across the continuum between the initiation of the cancer process and the occurrence of the invasive disease, with the goal of detecting changes and intervening early in the cancer process to prevent disease and death; research that facilitates the path to clinical application of promising cancer detection, diagnosis, and treatment methods; it also expedites the initial small-scale and subsequent large-scale testing of new anticancer agents, biomarkers, imaging tests, and other therapeutic interventions in patients; cancer health disparities and community-based participatory research; research in HIV/AIDS and HIV malignancies.
The National Institute of Allergy and Infectious Diseases (NIAID) conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. For more than 60 years, NIAID research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions. Specifically, our areas of study are HIV/AIDS, infectious diseases, and allergy, immunology, and transplantation research. Applications for this program would be appropriate for NIAID if they propose research experiences for clinical residents and fellows in the fields of biomedical research (including translational research) in these NIAID mission-relevant areas.
The National Institute on Aging supports research to advance our understanding of the nature of aging and the aging process, as well as diseases and conditions associated with growing older, in order to extend the healthy, active years of life. NIA’s Division of Aging Biology supports molecular, cellular, and genetic research on the mechanisms of aging. The Division of Behavioral and Social Research supports social, behavioral, and economic research on the processes of aging at both the individual and societal level, including cross-disciplinary research, at multiple levels from genetics to cross-national comparative research, and at stages from basic through translational. The Division of Geriatrics and Clinical Gerontology supports clinical and translational research on health and disease in the aged, and research on aging over the human lifespan, including its relationships to health outcomes, with foci that include translational research for the development of new interventions for age-related conditions, prevention and treatment of multiple chronic conditions in the elderly, and studies that help to promote evidence-based geriatric care and inform policies affecting older adults. The Division of Neuroscience supports collaborative research to further the understanding of neural and behavioral processes associated with the aging brain. Research on dementias of old age—in particular Alzheimer’s Disease and Related Dementias (ADRD) disease—is one of the program’s highest priorities. Note: The NIA will support only investigators in clinical fellowship under this FOA. Investigators interested in research support as early career faculty are encouraged to consider NIA's GEMSSTAR program.
Special Note: Because of the differences in individual Institute and Center (IC) program requirements for this FOA, prospective applicants are strongly encouraged to consult the Table of IC-Specific Information, Requirements and Staff Contacts, to make sure that their application is appropriate for the requirements of one of the participating NIH ICs.
See Section VIII. Other Information for award authorities and regulations.
Administrative Costs for Institutional Program. Up to $20,000 per year may be requested for administrative costs. This could include salary for the institutional PD/PI or support personnel, travel of the institutional PD/PI to the NIH-sponsored workshop, or to defray costs for external advisory committee travel and time (if requested).
Resident-Investigators Compensation in Institutional Program: Remuneration for Resident-Investigators is through salary and fringe benefits. The total salary requested must be based on a full-time appointment, and be consistent with the postgraduate year (PGY) salary structure at the institution. There must be an employee-employer relationship between the Resident-Investigators and the institution. During the research period, Resident-Investigators will be paid 80% of their base PGY salary level set by the Institution. A minimum of two residents should be supported in each year of the program.
Resident-Investigators salary should be calculated for the months of full-time research engagement over a year:
In one example, a participant engages in research for a year at a salary of $60,000, with a monthly salary of $5,000; the award will support 80% effort over 12 months, which equates to 9.6 person-months; the budget figure for this Resident-Investigators would be $48,000 ($5,000 x 9.6).
Resident-Investigators Supplementary Research Funds in Institutional Program: Up to $20,000 per year, per Resident-Investigator, may be requested and must be justified and consistent with the stage of development of the participant and the proportion of time to be spent in research and/or professional development activities. Supplementary Research Funds may be used to defray costs for registration for short-term courses or workshops to obtain research skills, to support skill development for research preceptors of clinician-investigators, research supplies, or where well-justified, for technical support to contribute to the participating Resident-Investigator's research continuity. Funds may NOT be used for tuition for courses leading to a degree, materials leading to clinical qualifications, or equipment.
Other Program-Related Expenses
Resident-Investigators Travel in Institutional Program: Up to $3,000 each year may be requested for each Resident-Investigator to attend or present research findings at domestic scientific conferences, and to support attendance at a NIH-sponsored workshop. Requests for travel to scientific meetings or workshops must be carefully justified, with specific examples. Expenses for foreign travel must be exceptionally well-justified.
Add information as needed
Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
sponsoring institution must assure support for the proposed program.
Appropriate institutional commitment to the program includes the provision of
adequate staff, facilities, and educational resources that can contribute to
the planned program.
Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other Federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving federal support. In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from diverse backgrounds,
including underrepresented racial and ethnic groups, individuals with
disabilities, and women are always encouraged to apply for NIH support. See, Reminder:
Notice of NIH's Encouragement of Applications Supporting Individuals from
Underrepresented Ethnic and Racial Groups as well as Individuals with
Multiple PD/PIs are not allowed.
The Institutional PD/PI should be an established clinician-investigator in a relevant scientific area and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI must have a regular, full-time appointment (i.e., not adjunct, part-time, or emeritus) at the applicant institution. This person should hold a health professional degree (e.g., MD, DVM, DDS or equivalents), have an appointment in a clinical department related to at least one of the residency programs proposed for participation, have clearly demonstrated education/mentoring experience and have a strong recent history of NIH funding. Exceptional individuals without a clinical doctorate and with demonstrated leadership and mentoring experience in clinical departments may also serve as PD/PI. If the sponsoring institution is a hospital affiliated with a medical or dental school, the PD/PI must have an appointment in both the medical/dental school and at the sponsoring institution.
The Institutional PD/PI will design and provide oversight
for the entire program. The PD/PI is expected to monitor and assess the program
annually, and submit all documents and reports as required.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time per 188.8.131.52 Submission of Resubmission Application. This means that the NIH will not accept:
A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
An application that has substantial overlap with another application pending appeal of initial peer review (see 184.108.40.206 Similar, Essentially Identical, or Identical Applications).
Research preceptors should have research expertise and a successful track record of mentoring clinician-investigators. Co-preceptors may be considered whenever one preceptor has limited experience. Where possible, clinician-investigators with various educational backgrounds, as well as those from backgrounds underrepresented in biomedical science should have opportunities to serve as preceptors and/or meet with both preceptors and Resident-Participants to discuss effective research career strategies.
For the purposes of this Funding Opportunity, Resident-Investigators include individuals with health professional doctoral degrees (e.g., MD, DO, MBBS, DDS, DMD, OD, ND, DVM; with or without a research doctorate) engaged in graduate medical education consisting of advanced clinical training (herein referred to as “residency”).
Resident-Investigators are required to have a full-time appointment at the applicant institution, and to commit a minimum of 9.6 person-months (80% effort to research over 12 months) of the residency.
By the time of the appointment to the program, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e. possess a currently valid Permanent Resident Care USCIS Form 1-551, or other legal verification of such status.
Resident-Investigators are required to have a full-time appointment at the applicant institution, and to commit a minimum of 9.6 person-months (80% effort to research over 12 months) of the residency.
The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified in biomedical, behavioral, or clinical research to collaborate with the applicant.
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions will not be reviewed.
All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.
The Research Strategy is limited to 25 pages.
Instructions for Application Submission
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
Follow all instructions provided in the SF424 (R&R) Application Guide.
Follow all instructions provided in the SF424 (R&R) Application Guide.
Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:
Facilities & Other Resources. Describe the institutional resources and environment for clinician-investigator research. Include a description of the laboratories, participating departments, research core facilities, computer services, biostatistics staff, and any other resources to be used in the development and implementation of the proposed program.
Describe the institutional research environment and the clinician-investigator workforce including faculty, research staff, graduate medical staff and students.
Describe the plan for how this program will benefit from any extant NIH research, training and career development programs, affiliations with other institutions, and academic or non-profit partnerships where Resident-Investigators might engage in research.
1. Advisory Committee
An Advisory Committee is not a required component of a Research program. However, if an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the research program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will assess the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. The filename "Advisory Committee.pdf" should be used and the file attached.
2. Data Tables
Tables should be included to show: (a) participating faculty including research preceptors (including their sources of support and records in research training and research education), (b) the potential participant pool and diversity of backgrounds, (c) information about past participants and their subsequent activities. For this purpose, the following Data Tables should be used: Data Tables 2, 3, 4, 5B and 8C, Part III. These tables are not subject to a page limit. They should be compiled as a single pdf file. The filename "Data_Tables.pdf" should be used and the file attached.
The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.
Follow all instructions provided in the SF424 (R&R) Application Guide.
Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:
Research Funds provided to supplement research supply costs and professional development activites may include:
Follow all instructions provided in the SF424 (R&R) Application Guide.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
The Research Strategy section must be used to upload the Research Program Plan and must include the following components described below:
Research Program Plan
Proposed Institutional Research Program and Milestones.
Applications should describe the available research opportunities, including the research problems to be addressed, and the skills in methodology and research technology that Resident-Investigators are expected to acquire in the course of their research experiences, and how that will prepare them for careers as clinician-investigators. Include a description of how available research opportunities contribute to the concepts, treatments, or preventative interventions that drive a field.
Less experienced Resident-Investigators may require a phased developmental period in which the award includes considerable skill-building followed by a period of supervised research. Candidates with more experience at the time of selection may already have an adequate theoretical or practical background and need a shorter developmental period.
Because Resident-Investigators uniquely must fulfill both research goals and clinical duties, it is essential that the program description include an annotated timeline indicating planned periods of research leading to research competencies, as well as periods of clinical duties leading to specialty board-eligibility. Evidence that the proposed institutional plan for clinical and research activities in residency and fellowship is recognized as sufficient to prepare for board eligibility is required at the time of application.
Applicant institutions must provide research and clinical activities that lead to certification. Describe how the overall structure of the proposed Institutional program of research and clinical activities will lead to participant eligibility for certification or endorsement and oversight by a Board recognized by the American Board of Medical Specialties (ABMS), or for dentists, meets the requirements for National Certifying Boards for Dental Specialists established by the Commission on Dental Accreditation (CODA) requirements, or for veterinarians, meets the requirements as recognized by the American Board of Veterinary Specialties (ABVS). The overall structure of the Institutional Program must also include a process for determining if the StARR Resident participants will require additional residency training time to achieve compliance with the respective Boards.
The Research Program section should include a description of the:
Resident-Investigators Research Opportunities:
Plans for recruitment, selection, and matching of Resident-Investigators with available research preceptors and opportunities.
Plans to develop and implement an assessment of research competencies and milestones for Resident-Investigators with and without a research doctorate. Competencies might include analysis of information and formulation of research questions, research collaborations, data acquisition and analysis, and other research professional activities.
Partnership with any existing NIH research programs, other institutions, and academic or non-profit partnerships where health professionals might engage in research. For example, residents might conduct research in global health through international organizations affiliated with their home institutions, or institutions in a geographic region might partner to offer broader research experiences than possible at one institution to support a network of resident researchers.
Participation in local, regional, national scientific meetings and an annual NIH StARR meeting.
Other strategies designed to foster Resident-Investigators success.
Institutional Programs must describe how they will ensure that Resident-Investigators will complete the necessary activities to achieve milestones in research in residency, to include:
Institutional Program Director/Principal Investigator Describe arrangements for the leadership and administration of the program, and how the professional appointments and experience of the PD/PI will enhance these activities. Within the design of the program, the PD/PI must identify the residency director, departmental chairs, and research deans, and their roles in the program with respect to affiliation and responsibility should be clearly described. Provide evidence that the PD/PI is actively engaged as a clinician-investigator in an area relevant to the application, with strong recent history of extramural funding.
The PD/PI may utilize an advisory committee (if requested--see above) to monitor progress, provide recommendations on a periodic basis, and help evaluate the overall effectiveness of the program.
Program Research Preceptors
Describe the available research opportunities with participating preceptors, and their responsibilities to the program. Describe how research preceptors are selected and reviewed, and the timing and types of meetings planned between Resident-Investigators and preceptors to ensure that each Resident-Investigators receives the skills and knowledge he/she requires to achieve the goals of the program. In the case where one preceptor has limited experience and thus co-preceptors are being proposed, describe the expected timing and interactions between co-preceptors and with the Resident-Investigators.
Summarize key data from the Research Training Data Tables that highlight the characteristics of the faculty and their research funding, as well as the educational and career outcomes of previous health professionals sponsored in research in the last five years.
Program Resident-Investigators . Provide details about the recruitment strategies for research in residency participants. Describe recent applicants to the participating residency and fellowship program(s), including the number of applications, interviews and matched residents. Discuss any unfilled residency positions, especially if they were designed to support a research pathway.
For residents who have matriculated to the institution, describe the overall demographic distributions, and the range of previous research and educational experiences among the cohorts. Describe the criteria and strategy for selecting the intended Resident-Investigators for this research program, and the eligibility criteria and/or specific educational background characteristics that are essential for participation.
Institutional Environment and Commitment. Describe any additional aspects of the Institutional Environment and Commitment not addressed under “Facilities & Other Resources” or the required “Institutional Commitment Letter of Support,” described below. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.
In addition, describe the institutional environment for clinician-investigators, including the extant clinician-investigator workforce of participating faculty, research staff, protected time for research, graduate medical staff and students, and how this program is designed to enhance that workforce.
Describe the overall institutional research environment, including research faculty and staff, core facilities, resources, or any unique features available at the institution.
Recruitment Plan to Enhance Diversity
The NIH recognizes a unique interest in the diversity of the biomedical research workforce, including the clinician-investigator workforce (see, e.g., Strategies to Enhance Diversity of the Physician-Scientist Workforce, and Policy Supporting the Next Generation Researchers Initiative, NOT-OD-17-101). Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to enhance the pool of individuals from underrepresented backgrounds in the biomedical research workforce (NOT-OD-15-053).
Applications for this funding opportunity must include a robust Recruitment Plan to Enhance Diversity of the Resident-Investigators pool. Such strategies should be evidence-based and informed by literature, data or other information in the field. Innovative approaches may build upon proven strategies that can be modified for this career/academic level (for information on data and strategies, please see https://extramural-diversity.nih.gov/building-participation/recruitment-retention).
Applicants must formulate their plans based on available national data on diversity in medical and residency program(s), as well as their institutional accomplishments. NIH recognizes that candidates for this program are derived largely from the US medical school graduates, currently reflecting participation that is 6% Black or African American, 5% Hispanic or Latino and 48% female, and lower for American Indians and Alaska Natives, and Native Hawaiians or other US Pacific Islanders (https://www.aamc.org/data-reports/workforce/report/diversity-medicine-facts-and-figures-2019.). The diversity of residency applicants in the Electronic Residency Application Service has differed by medical specialty (https://www.aamc.org/data/facts/eras/).
Programs are encouraged to review their web-based program descriptions to stimulate interest among candidates, to implement holistic review of residency applicants and to consider creative approaches, such as research exposure to medical students, and networking opportunities with professional societies, to build interest in their programs.
Additional information on the required Recruitment Plan to
Enhance Diversity is available at Frequently Asked Questions: Recruitment Plan
to Enhance Diversity (Diversity FAQs).
Applications lacking a diversity recruitment plan will not be reviewed.
Plan for Instruction in the Responsible Conduct of
Research. All applications must include a plan to fulfill NIH
requirements for instruction in the Responsible Conduct of Research (RCR).
The plan must address the five, required instructional components
outlined in the NIH policy: 1) Format - the required format of
instruction, i.e., face-to-face lectures, coursework, and/or real-time
discussion groups (a plan with only on-line instruction is not acceptable);
2) Subject Matter - the breadth of subject matter, e.g., conflict of
interest, authorship, data management, human subjects and animal use,
laboratory safety, research misconduct, research ethics; 3) Faculty
Participation - the role of the program faculty in the instruction;
4) Duration of Instruction - the number of contact hours of
instruction, taking into consideration the duration of the program; and
5) Frequency of Instruction –instruction must occur during each
career stage and at least once every four years. See alsNOT-OD-10-019. The plan
should be appropriate and reasonable for the nature and duration of the
Applications lacking a plan for instruction in responsible conduct of research will not be reviewed.
Evaluation Plan. Applications must include a plan for evaluating the activities supported by the award, and the success of the program in recruiting and retaining clinician-investigators in research-intensive or research-related careers. The goal of this program is to increase the number of clinician-investigators, by enhanced recruitment and retention of talented residents into successful research careers.
Institutions will be responsible for evaluating their own programs. Programs are encouraged to consider the characteristics of anticipated Resident-Investigators, the research experiences and interventions provided in the program to stimulate research careers, as well as the goals and measurable objectives to be used within the context of the NIH expectations and in line with their institutional settings and missions.
It is essential that applications describe goals appropriate for both participants with limited prior research exposure as well as those with substantive research experience including research doctorates, and where possible, information about any appropriate comparison groups.
Programs are also encouraged to use qualitative approaches that measure aspects of participant or preceptor satisfaction, science identity (e.g. psychological processes by which people become inspired by science) or other measures where evidence may support persistence to a clinician-investigator career.
The application must specify baseline characteristics (e.g., Numbers of applicants, educational levels, and demographic characteristics of Resident-Investigators), as well as measures to gauge the short or long-term success of the award in achieving its objectives. Programs are encouraged to collect information to be used for evaluation of the program, including metrics that will include, but are not limited to, the following:
Aggregate number and demographic characteristics of participants
Subsequent educational/career progress, including:
Letters of Support
A letter of institutional commitment must be attached as part of Letters of Support (see section above:”Institutional Environment and Commitment.”
A letter from a Board recognized by the ABMS, the ADA CODA, or the ABVS indicating that the overall structure of research and clinical activities outlined in the application leads to participant eligibility for medical board certification, must be attached as part of Letters of Support (see section above: "Proposed Institutional Research Program and Milestones".
Resource Sharing Plans
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
When relevant, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:
Only limited Appendix materials are allowed. Follow the instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH
Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.
The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following: The objective of this program is to encourage health professionals with a demonstrated potential and interest in pursuing careers as clinician-investigators.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to strongly advance research education by fulfilling the goal of this R25 Education Program, in consideration of the following review criteria and additional review criteria, as applicable for the project proposed.
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.
Does the proposed program address a key audience and an important aspect or important need in research education? Is there convincing evidence in the application that the proposed program will significantly advance the stated goal of the program?
Is the PD/PI capable of providing both administrative and scientific leadership to the development and implementation of the proposed program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal is accomplished? If applicable, is there evidence that the participating faculty have experience in mentoring students and teaching science? If applicable, are the faculty good role models for the participants by nature of their scientific accomplishments? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Specific to this FOA
Taking into consideration the nature of the proposed research education program, does the applicant make a strong case for this program effectively reaching an audience in need of the program’s offerings? Where appropriate, is the proposed program developing or utilizing innovative approaches and latest best practices to improve the knowledge and/or skills of the intended audience?
Specific to this FOA
Does the proposed program clearly state its goals and objectives, including the educational level of the audience to be reached, the content to be conveyed, and the intended outcome? Is there evidence that the program is based on a sound rationale, as well as sound educational concepts and principles? Is the plan for evaluation sound and likely to provide information on the effectiveness of the program? If the proposed program will recruit participants, are the planned recruitment, retention, and follow-up (if applicable) activities adequate to ensure a highly qualified participant pool?
Specific to this FOA
Will the scientific and educational environment of the proposed program contribute to its intended goals? Is there a plan to take advantage of this environment to enhance the educational value of the program? Is there tangible evidence of institutional commitment? Is there evidence that the faculty have sufficient institutional support to create a sound educational environment for the participants? Where appropriate, is there evidence of collaboration and buy-in among participating programs, departments, and institutions?
Specific to this FOA
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
For research that involves human subjects but does
not involve one of the categories of research that are exempt under 45 CFR Part
46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: (1) risk to
subjects, (2) adequacy of protection against risks, (3) potential benefits to
the subjects and others, (4) importance of the knowledge to be gained, and (5)
data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: (1) the justification for the exemption, (2) human subjects involvement and characteristics, and (3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Renewals, the committee will consider the progress made in the last funding period.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of prospective participants from underrepresented groups. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.
Taking into account the specific characteristics of the proposed research education program, the level of participant experience, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction –instruction must occur during each career stage and at least once every four years. See also: NOT-OD-10-019. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan. If support for development, maintenance, or enhancement of software is requested in the application, the reviewers will comment on the proposed software dissemination plan.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the national Advisory Council of the participating Institutes/Centers. The following will be considered in making funding decisions:
After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons. Refer to Part 1 for dates for peer review, advisory council
review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient’s business official.
Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted. Programs that involve participants should report on education in the responsible conduct of research and complete a Training Diversity Report, in accordance with the RPPR Instruction Guide.
NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR 200.301.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.
Failure by the recipient institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.
A final RPPR and the expenditure data portion of the Federal Financial Report are required for closeout of an award as described in the NIH Grants Policy Statement.
In carrying out its stewardship of human resource-related programs, the NIH or its Institutes and Centers will periodically evaluate their R38 research education programs, employing the measures identified below. In assessing the effectiveness of its research education investments, NIH may request information from databases, PD/PIs, and from Resident-Investigators themselves. Where necessary, PD/PIs and Resident-Investigators may be contacted after the completion of a research education experience for periodic updates on Resident-Investigators’ subsequent educational or employment history and professional activities.
Upon the completion of a program evaluation, NIH and its ICs will determine whether to (a) continue a program as currently configured, (b) continue a program with modifications, or (c) discontinue a program.
In evaluating this research education program the participating Institutes/Centers expects to use the following evaluation measures:
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: https://grants.nih.gov/support/index.html(preferred
method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information
(Questions regarding application instructions, application processes, and NIH
Email: GrantsInfo@nih.gov (preferred method of contact)
Grants.gov Customer Support (Questions regarding
Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.
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