Part 1. Overview Information

Key Dates

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

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.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Other Award Budget 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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

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 the 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 NOFO 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. 

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.

 Background

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 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. 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 individuals with MDs/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 those with MDs/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 NOFO 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.

Program Components

Institutional Programs

This NOFO will support Institutional Programs that propose to engage Resident-Investigators in research. Institutional Programs applications submitted in response to this NOFO must include:

• Research projects that include concepts of hypothesis-based, rigorous and reproducible research, the fulfillment of discovery, and achievement of designated research milestones
• Support for Resident-Investigators for 80% of Post-Graduate Year (PGY) salary for a minimum of one contiguous year of research and a maximum of two years during residency training
• Support for a minimum of two and a maximum of four Resident-Investigators each year

Applications requesting support for only one resident per year will be considered non-responsive and will be withdrawn without review.

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.

Institutional Awards

This NOFO will provide support for supplementary research and professional development activities that will contribute to successful research, including:

• Research supplies and technical support, including but not limited to biostatistics consultation and/or research technician effort to complete research objectives
• Registration and material for short-term courses or workshops that provide research skills such as data science, implementation science or clinical trials, or others as necessary for the project
• Participation in workshops on oral and written communication of research and grant writing related to the research project
• Travel to attend scientific conferences and NIH-sponsored workshops and present research findings
• Support for skill-building needed for research supervision and effective mentoring of clinician-investigators for research preceptors; preceptor skill-building should include topics such as aligning goals and expectations, effective communication, time management, mentoring, understanding the flow of research funds in an academic health center, building a successful research team, job negotiation, identifying grant opportunities, and navigating an IRB and/or animal protocol, as appropriate for the research project

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 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 K01, 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.

Special Note: Because of the differences in individual Institute and Center (IC) program requirements for this NOFO, 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.

Section II. Award Information

Other Award Budget Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions - Includes all types

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

The 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 Organizations) 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

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• Unique Entity Identifier (UEI) – A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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 their organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

Multiple PD/PIs are allowed.

The Institutional MPI/PD/PI (or one of the PIs in an MPI application) 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 MPI/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, DO, OD, 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 MPI/PD/PI will design and provide oversight for the entire program. The MPI/PD/PI is expected to monitor and assess the program annually and submit all documents and reports as required.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications)

Research Preceptors

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. Clinician-investigators from all backgrounds should have opportunities to serve as preceptors and/or meet with both preceptors and Resident-Participants to discuss effective research career strategies.

Resident-Investigators

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.

Level of Effort

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.

Section IV. Application and Submission Information

1. Requesting an Application Package

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 NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed in this Notice of Funding Opportunity to do otherwise. Conformance to the requirements in the How to Apply - 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 How to Apply - Application Guide and the Table of Page Limits must be followed.

The Research Strategy is limited to 25 pages.

The following section supplements the instructions found in the How to Apply - Application Guide and should be used for preparing an application to this NOFO.

Follow all instructions provided in the How to Apply - Application Guide.

Follow all instructions provided in the How to Apply - Application Guide.

Follow all instructions provided in the How to Apply - Application Guide with the following additional modifications:

Facilities & Other Resources. Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education 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.

Other Attachments

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 demographic information, (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.

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 How to Apply - Application Guide.

Follow all instructions provided in the How to Apply - Application Guide with the following additional modifications:

• Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.

• Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.
• Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support Resident-Investigator participants in the program.
• A single consolidated budget is required, with each item clearly justified.

Research Funds provided to supplement research supply costs and professional development activities may include:

• Research supplies including biostatistics consultation, technician time, core facility use, or other technical components needed to complete research activities
• Fees for short duration courses or workshops that provide exposure to fundamental concepts of study design and analysis appropriate for the research project as well as contemporary approaches to scientific rigor (for details, see NOT-OD-16-011)
• Fees for workshops to develop research skills including clinical trial design, bioinformatics use of large databases, or other specific training related to the research project
• Fees for workshops to develop research-related presentation skills, publication preparation, grant-finding and grant-writing and other professional activities related to the research project
• Fees for workshops to develop skills needed for effective research supervision of clinician-investigators, including support for effective mentoring; workshop topics might include aligning goals and expectations, effective communication, time management, mentoring, understanding research funds flow in an academic career, building a successful research team, job negotiation, identifying grant opportunities, navigating an IRB and/or animal protocol, as appropriate for the research project

Follow all instructions provided in the How to Apply - Application Guide.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Research Strategy

Research Strategy section must be used to upload the Research Education Program Plan, which must include the following components described below:

• Proposed Institutional Research Program and Milestones
• Program Director/Principal Investigator
• Program Research Preceptors
• Program Resident-Investigators
• Institutional Environment and Commitment
• Plan for Instruction in the Responsible Conduct of Research
• Evaluation Plan

Research Education Program Plan

Proposed Research Education Program. While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the training program. As a reminder, applicants may choose to address one or more of the activities listed in Section I. Funding Opportunity Description.

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:

• Completion of research skill-building activities.
• Assessment of research competencies.
• PD/PI evaluation letter to include a written review of each Resident-Investigator's progress and promise.

Assistance to Resident-Investigators in the identification of an appropriate subsequent clinical fellowship and any other career milestones.

Program Director/Principal Investigator. Describe arrangements for administration of the program.  Provide evidence that the Program Director/Principal Investigator is actively engaged in research and/or teaching in an area related to the mission of NIH, and can organize, administer, monitor, and evaluate the research education program. For programs proposing multiple PDs/PIs, describe the complementary and integrated expertise of the PDs/PIs, their leadership approach, and governance appropriate for the planned project.

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. This section should not duplicate information provided elsewhere.

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.

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 also NOT-OD-10-019 and NOT-OD-22-055. The plan should be appropriate and reasonable for the nature and duration of the proposed program. Renewal (Type 2) applications must, in addition, describe any changes in formal instruction over the past project period and plans to address any weaknesses in the current instruction plan. All participating faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.

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:

• Presentation of research completed in this program
• Authorship of scientific publications in a STEM field
• Participation in further research or career development training programs (e.g., T32)
• Completion of a subsequent research training or career development appointment or award
• Application of and awards granted for research funding
• Subspecialty board passage rate
• Subsequent employment in a research or research-related field
• Percentage of professional effort in research

Dissemination Plan. A specific plan must be provided to disseminate nationally any findings resulting from or materials developed under the auspices of the research education program, e.g., sharing course curricula and related materials via web postings, presentations at scientific meetings, workshops.

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". A letter is required from each Board mentioned in the application. 

Resource Sharing Plan
Note: Effective for due dates on or after January 25, 2023, a Data Management and Sharing Plan is not applicable for this NOFO.

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - 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:

• Software source code should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. Users should be permitted to modify the code and share their modifications with others.
• The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
• To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

Appendix

Only limited Appendix materials are allowed. Follow the instructions for the Appendix as described in the How to Apply - Application Guide.

PHS Human Subjects and Clinical Trials Information

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 How to Apply - 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 How to Apply - 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 How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

Foreign Organizations

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.

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

See Part 2. 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

4. Submission Dates and Times

Part I. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply - Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - 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.

Important reminders:

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 provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - 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.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected]. 

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Section V. Application Review Information

1. Criteria

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 NOFO, 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 research 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.

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.

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.

2. Review and Selection Process 

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by CSR, in accordance with NIH peer review policies and practices, 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 will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

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 NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 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.

3. Anticipated Announcement and Award Dates

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 Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

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. 

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Institutional Review Board or Independent Ethics Committee Approval: Recipient 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 recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols. 

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH: 

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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.  

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

Not Applicable

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting.  To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting. 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 in accordance with the RPPR Instruction Guide.

NIH NOFOs 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 2 CFR 200.301.

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.

Other Reporting Requirements

• The institution must submit a completed Statement of Appointment (PHS Form 2271) for each participant appointed full time for eight weeks or more or the equivalent. Recipients must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
• Participant Termination Notice: Within 30 days of the end of the total support period for each participant, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each participant appointed full time for eight weeks or more, or the equivalent.

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 Section 8.6 Closeout.

5. Evaluation

In carrying out its stewardship of human resource-related programs, 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 participants themselves. Where necessary, PD/PIs and participants may be contacted after the completion of a research education experience for periodic updates on participants’ 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 expect to use the following evaluation measures:

• Aggregate number and demographic characteristics of Resident-Investigators
• Subsequent educational/career progress, including:
  • Subsequent presentations of research completed in this program
  • Subsequent authorship of scientific publications in a STEM field
  • Subsequent participation in research
  • Subsequent application/award for research funding
  • Subsequent board passage rate
  • Subsequent employment in a research or research-related field
  • Subsequent independent research grant support from NIH or another source

Section VII. Agency Contacts

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://www.era.nih.gov/need-help (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 grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

SBA Company Registry (Questions regarding required registration at the SBA Company Registry and for technical questions or issues)
Website to Email: http://sbir.gov/feedback?type=reg

David Schopfer, M.D.
National Heart Lung and Blood Institute (NHLBI)
Telephone: 301-402-3833
Email: [email protected]

Ed Clayton, Ph.D.
National Eye Institute (NEI)
240-987-8255
Email: [email protected]

Neeraj Agarwal
NEI - NATIONAL EYE INSTITUTE
Phone: 301-435-8155
E-mail: [email protected]

NIA Training Office
National Institute on Aging (NIA)
Email: [email protected]

Carmen P. Moten, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-594-5945
Email: [email protected] 

Jyothi Arikkath, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-594-5945
Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Office of Grants Management
National Heart, Lung, and Blood Institute (NHLBI) 
Email: [email protected]
Subject: RFA-HL-26-012

Karen Robinson Smith
NEI - NATIONAL EYE INSTITUTE
Phone: 301-435-8178
E-mail: [email protected]

Jessi Perez
National Institute on Aging (NIA)
Telephone: 301-403-7739
Email: [email protected]

Jackie Verrecchia
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-6652
Email: [email protected] 

Section VIII. Other Information

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 2 CFR Part 200.