Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide including the Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application, 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 may be delayed or not accepted for review.

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 NIH Ruth L. Kirschstein National Research Service Award (NRSA) program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. In order to accomplish this goal, NRSA training programs are designed to train individuals to conduct research and to prepare for research careers. More information about NRSA programs may be found at the Ruth L. Kirschstein National Research Service Award (NRSA) website.

Purpose and Background

Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.

Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the researchers, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. This program encourages institutions to diversify their student and faculty populations and thus to enhance the participation of individuals currently underrepresented in the biomedical, clinical, behavioral and social sciences research enterprise, as described in NOT-OD-15-053.

The mission of the National Institute of General Medical Sciences (NIGMS) is to support research that increases our understanding of life processes and lays the foundation for advances in disease, diagnosis, treatment, and prevention. To ensure the vitality and continued productivity of the research enterprise, NIGMS provides leadership in the areas of (a) training the next generation of scientists in basic and general biological and biomedical sciences, (b) enhancing the diversity of the scientific workforce, and (c) developing research capacities throughout the country. To accomplish these objectives, NIGMS supports a variety of capacity building and training programs with the ultimate goal of developing a diverse pool of well-trained scientists available to address the nation’s research needs.

NIGMS seeks to enhance the number of individuals from groups underrepresented in the biomedical workforce by providing training opportunities during multiple training and career stages at varied institutions and educational settings across the country. By increasing the number of students from underrepresented groups pursuing advanced training in the biomedical sciences, NIGMS strives to ensure that the future generation of researchers draws from the entire pool of talented individuals, bringing different aptitudes, perspectives, creativity, and experiences to address complex scientific problems. Training and retaining a diverse workforce ensures that the nation remains a competitive global leader in discovery and innovation in biomedical research.

Need for the Program

Underrepresentation of certain groups in science, technology and engineering (STEM) fields increases throughout the training stages. For example, students from certain racial and ethnic groups including, Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders, currently comprise ~39% of the college age population (Census Bureau), but earn only ~17% of bachelor’s degrees and ~7% of the Ph.D.’s in the biological sciences (NSF, 2015). Active interventions are required to prevent the loss of talent at each level of educational advancement. For example, a report from the President’s Council of Advisors on Science (PCAST Report) recommended support of programs to retain underrepresented undergraduate science, technology, engineering and math students as a means to effectively build a diverse and competitive scientific workforce (PCAST Report, 2012).

Programmatic Approach

NIGMS provides leadership in supporting interventions at important stages throughout the educational process, including the Maximizing Access to Research Careers (MARC) Undergraduate Student Training in Academic Research (U-STAR) Program. The MARC U-STAR program provides institutions the resources to support and train underrepresented, research-oriented students, who upon completion of their undergraduate STEM degree are likely to successfully complete a Ph.D. program in a biomedical science field relevant to the NIH.

The PCAST report provided evidence that financial concerns and a deficit of peers from similar backgrounds can erode self-confidence and the will to remain in STEM majors (PCAST Report, 2012). The MARC U-STAR program supports underrepresented, full-time honors students majoring in biomedically relevant fields. The funds offset the cost of stipends, tuition, fees, and health insurance for the appointed trainees in accordance with approved NIH support levels. Students in the MARC U-STAR programs form a cohort of research-oriented students and are provided with programmatic activities, including authentic research experiences, academic enhancements, skills development, and mentoring - activities proven to increase persistence in STEM fields (PCAST Report, 2012).

Goals

The overarching goal of the NIGMS MARC U-STAR Program is to significantly increase the number of students from underrepresented groups who successfully complete baccalaureate and Ph.D. biomedical degrees. Ultimately, the program goal is to increase the diversity of the biomedical scientific workforce.

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

Higher Education Institutions

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

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

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

Only domestic, non-profit, private or public institutions that confer the baccalaureate degree in subjects related to biomedical science.

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.

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

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) 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.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 DUNS number and 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 training program as the Training Program Director/Principal Investigator (Training PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH 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 SF 424 (R&R) Application Guide.

The Training 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 Training PD/PI will be responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program. The Training PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. 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 NOT-OD-11-101).

Program faculty should have strong records as researchers in the area of the proposed research training program. Program faculty should also have a record of research training, including successful, former trainees who have established productive careers relevant to the NIH mission. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors.

Mentors may be members of faculty at the applicant institution or external faculty who participate in the proposed program. All mentors must be committed to continue their involvement throughout the entire period of the MARC U-STAR award.

The MARC U-STAR program is intended to support full-time honors students from underrepresented groups majoring in a STEM field. It is the responsibility of the applicant institution to establish the qualifications of students prior to their selection for the MARC U-STAR Program.

Students appointed to the MARC U-STAR training program must be a citizen or a noncitizen national of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additional details on citizenship, training period, and aggregate duration of support are available in the NIH Grants Policy Statement.

MARC U-STAR students must matriculate as full-time honors students at the applicant institution in science majors relevant to biomedicine. Full-time effort is normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies.

MARC U-STAR trainees are expected to be appointed to two consecutive 12-month appointments during the final two years of undergraduate training, typically called the junior and senior years. On an annual basis, trainee appointments for less than 12 months require prior written approval by NIGMS.

Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide including Supplemental Grant Application Instructions 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 may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

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 .

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design of the research training program, as well as key activities in the training plan. Indicate the planned duration of appointments, the projected number of MARC trainees and intended trainee outcomes.

Other Attachments.

Tables. MARC U-STAR is an institutional program and as such applicants must provide details about the institution and its setting. Such details may be described using the required Training Tables 2, 4 and 8D.

The following Tables are required and must be in the MARC USTAR application:

Training Table 2. Participating Faculty Members, Undergraduate Training

Training Table 4. Research Support of Participating Faculty Members and Undergraduate Training

Training Table 8D. Program Outcomes: Undergraduate

Advisory Committee Plan. A plan must be provided for the appointment of an Advisory Committee to monitor program and trainee progress. Composition, responsibilities, frequency of meetings, and other relevant information should be included. Describe the composition of the Advisory Committee, identifying the role and the desired expertise of members. For instance, a MARC U-STAR Advisory Committee might include a dean, chairpersons of participating MARC U-STAR departments, the MARC U-STAR PD(s)/PI(s), intramural research faculty mentors, extramural research faculty mentors from host institutions, NIH predoctoral T32 program director(s) within the local region, etc. Describe how the Advisory Committee will function in providing oversight of the development, implementation, and evaluation of recruitment strategies, the recruitment and retention of participants, and the evaluation of the overall effectiveness of the program. A plan for Advisory Committee selection and approval of MARC U-STAR participants should be included. Please name your file Advisory_Committee.pdf .

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.

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:

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

The PHS 398 Research Training Program Plan Form is comprised of the following sections:

• Training Program
• Faculty, Trainees, and Training Record
• Other Training Program Sections
• Appendix

All Supplemental Instructions to the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Training Program

Background

MARC U-STAR applications must describe the need for the proposed academic and research training program as well as the feasibility of success in the context of the institutional setting. NIGMS recognizes and values the heterogeneity in undergraduate institutional settings. Each application should emphasize the significant enrollment of underrepresented students as well as the unique environment and strengths of the institution. Applicants must provide their institution type according to the Carnegie Basic Classification system and describe their distinctive educational research environment. The institutional self-assessment should include baseline data regarding the student population, graduation rates, and relevant science programs. Specifically, applicants should provide information regarding STEM enrollments, graduate rates and subsequent completion of Ph.D. or combined M.D.-Ph.D. degrees for all students and for underrepresented students. Applicants may use suggested Tables A-C to provide the data to support the institutional self-assessment narrative; these suggested formats are found at the NIGMS TWD/MARC website.

The institutional assessment should inform the design of the MARC U-STAR program. After supplying the institutional baseline data as a starting metric, applicants should state the MARC U-STAR Program goals with respect to graduation rates, matriculation into biomedical Ph.D. graduate programs, and earned higher degrees, particularly doctoral degrees. In the following sections, the applicants should describe the feasibility of achieving the program goals in the institutional context.

Program Plan

Program Administration.

Describe the acknowledged strengths, leadership and administrative skills, training experience, scientific expertise, and active research of the PD/PI. Relate these strengths to the proposed management of the training program. Describe the planned strategy and administrative structure to be used to oversee and monitor the program. If there are multiple PDs/PIs, then the plan for Program Administration is expected to synergize with the Multiple PD/PI Leadership Plan section of the application.

If a program coordinator or administrator position is planned, a description of the person's administrative capabilities essential to coordinate the program must be included in the application.

Program Faculty.

The application must include information about the program faculty who will be available to serve as mentors and provide guidance and expertise appropriate to the level of the MARC trainees (Table 2). Describe in general terms the expertise and experiences of the proposed mentors. Provide an overview of their active research (Table 4) and other scholarly activities, as well as track records of mentoring and training. The application must include information about the program faculty who will be available to serve as research mentors (either during the academic year or during the summer term) to provide guidance and expertise to MARC U-STAR students. The mentors should have strong records as researchers and experience mentoring undergraduates, especially those from underrepresented backgrounds.

Proposed Training.

Proposed MARC U-STAR programs must provide a structured training program to prepare underrepresented STEM students for doctoral study. Programmatic activities should include authentic research experiences, academic enhancements, skills development, and mentoring described in more detail below.

Research Training. Because of the heterogeneity of institutional settings, different strategies for research training may be utilized to achieve the MARC U-STAR Program's objective. NIGMS expects research-intensive institutions (those considered to have "higher research activity" or "highest research activity" in the Carnegie Basic Classification system) to offer hands-on "traditional" research training experiences to MARC U-STAR trainees with research-active (e.g., NIH R01 or equivalent) internal faculty mentors during the academic year. Institutions and limited internal research-active may offer:

• Intramural hands-on "traditional" research training with faculty who have NIH SCORE, IDeA, or equivalent funding;
• Extramural hands-on "traditional" research training at a nearby partner research-intensive host institution(s), and/or
• Course-based undergraduate research experience (CURE) instruction.

MARC U-STAR applicants that propose to offer course-based undergraduate research experience instruction as the means of intramural research training must provide a full description of the activity including learning objective(s), participating faculty, training frequency and other relevant information.

In addition to academic year research training, both research-intensive and primarily teaching institutions are expected to provide each MARC scholar with at least one summer research training experience (as a rising junior and/or a rising senior) at a research-intensive site. Summer experiences should enhance the trainees ability to conceptualize and think through research problems with increasing independence and present and/or publish their research findings. Preferable sites are graduate institutions that offer NIH T32 predoctoral programs. To assist with this interaction, NIGMS maintains a list of NIGMS-funded T32 programs. Other NIH Institutes and Centers also support the T32 predoctoral training program in various research areas. For a query search to identify such programs, visit the NIH Research Portfolio Online Reporting Tools (RePORT) website. A summer at a T32 Predoctoral awardee institution will provide MARC scholars with networking possibilities and a working knowledge of a rigorous graduate training environment prior to application submission.

Academic Enrichment and Skills Development. NIGMS provides MARC grantee institutions with funds that may be used to initiate new activities or to expand, enhance, or improve existing training activities. In addition, interventions to raise consciousness and equip students with strategies to overcome barriers while pursuing graduate training and beyond are encouraged. Potential training activities are listed below. The list is not required or exhaustive; any activities that lead to enhanced training and persistence may be proposed.

• Development of critical-thinking and problem-solving skills;
• Development of oral and writing communication skills;
• Incorporation of quantitative sciences (math, chemistry, physics, engineering, and/or computer science) into the study of biology;
• Implementation of innovative teaching strategies for improved learning such as active learning, inquiry-based learning, problem-based learning, peer collaborative/group assignments, etc.;
• Utilization of supplemental instruction, tutoring and learning communities;
• Utilization of service learning, a strategy that integrates meaningful, scientifically relevant community service with instruction;
• Promotion of student self-efficacy;
• Workshops on stereotype threat, the imposter syndrome and implicit bias;
• Promotion of networking and presentation opportunities (national meetings, workshops, webinars, etc.);
• Introduction to the culture and requirements of competitive Ph.D graduate programs, particularly those with NIH funded T32 Predoctoral Training Programs;
• Seminars on securing independent predoctoral funding such as individual NIH F31 predoctoral fellowships, Individual NSF Graduate Research Fellowship Awards, etc.); and
• Encouraging self-advocacy through workshops, discussions and Individual Development Plans.

Mentoring and Advising. Mentoring and regular guidance are critical for advancement and success in science. MARC U-STAR applications are encouraged to include programmatic activities to help accomplish this goal. Such activities might include, but are not limited to, 1) providing guidance regarding what is necessary to succeed as independent scientists, 2) discussing milestones, achievements and activities that promote success as independent scientists, 3) providing opportunities to improve and/or complement the mentorship provided by research faculty (preceptors) and other mentors and 4) offering formal educational activities or events that inform students of the variety of research-related career opportunities for which Ph.D. training would be beneficial.

For renewal applications, highlight how the training program has evolved in response to changes in relevant scientific and technical knowledge, educational practices, and to evaluation of the training program.

Program Evaluation.

MARC U-STAR applications must include a plan for self-assessment of the stated goals. The assessment of the goals should be conducted in the context of the baseline institutional data regarding graduation rates and successful matriculation and completion of Ph.D. programs. Additional metrics may be included (for example research experiences, program activities completed, publications, presentations at national meetings, and fellowships/honors). The plan should also describe a mechanism to obtain feedback from current and former trainees to help identify weaknesses and to provide suggestions for program improvements.

Applicants with previous MARC U-STAR support should include a "Previous Program Outcome" section describing the past trainee outcomes and list the data in Table 8D. Applicants should provide an evaluation of the effectiveness of the supported training program in achieving the training objectives of the prior award period(s) for 5, 10, or 15 years as applicable. To facilitate the discussion of program outcomes, the applicants may use the suggested formats for tables found at the NIGMS TWD/MARC website (Tables D.1-D.3 and Table E).

Evaluation results should also be included in progress reports.

Trainee Candidates.

Applicants should state the student selection criteria in the application. The MARC U-STAR program is intended to support full-time honors students from underrepresented groups majoring in a STEM field. The MARC U-STAR students should also display an expressed interest in pursuing a Ph.D. in a biomedical field. Student appointment to the program is for a consecutive 24-month period during the final two years of undergraduate training, typically called the junior and senior years.

Proposals should include a description of the size and qualifications of the potential pool of trainees. Names of prospective trainees should not be included. The specific plans for selecting the trainees should be described.

Institutional Environment and Commitment to the Program.

Institutions with existing similar undergraduate biomedical research training and/or research education programs must explain what distinguishes the proposed MARC U-STAR program from the related programs and how the programs will synergize with one another. Include a justification that the pool of faculty, potential trainees, and resources are robust enough to support the proposed MARC U-STAR Program.

The application must include a statement from the applicant institution describing the commitment to the planned program. The institution must confirm that sufficient time will be allowed for the PD(s)/PI(s), other faculty, staff and participating students to contribute to the proposed program. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the proposed research training program. A signed letter, on institutional letterhead, that describes the applicant institution’s commitment to the planned program is required. The letter must also include a plan for the use of institutional resources to further enhance the training program, which may include support for additional student positions, and/or to enhance the institution’s ability to attract, retain, and develop underrepresented students engaged in biomedical research.

Letters of Support.

An institutional letter of support confirming the commitment to the goals and success of the MARC U-STAR program should be provided. Additionally, if research-intensive partner institutions are integral to the success of the program, official letters of support should be provided.

Recruitment Plan to Enhance Diversity

MARC U-STAR programs are expected to offer various recruitment activities to enhance the MARC U-STAR trainee pool. Describe steps to be taken during the proposed award period regarding the identification and recruitment of research-oriented honors students from underrepresented groups. Consider the success and/or failures of recruitment strategies used in the past. In particular, describe the specific efforts to be undertaken by the training program and how these might relate to the recruitment efforts of the institution. Institutional efforts alone will not satisfy the requirement to recruit individuals from underrepresented groups.

Plan for Instruction in the Responsible Conduct of Research

Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in Chapter 8 of the SF424 (R&R) Application Guide.

NIGMS provides guidance on training in the responsible conduct of research. Visit: http://www.nigms.nih.gov/training/pages/responsibleconduct.aspx.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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. The National Research Service Award (NRSA) policies apply to this program. An NRSA appointment may not be held concurrently with another Federally sponsored fellowship, traineeship, or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement. Note, however, that pre-award costs are not allowable charges for stipends or tuition/fees on institutional training grants because these costs may not be charged to the grant until a trainee has actually been appointed and the appropriate paperwork submitted to the NIH awarding component. Any additional costs associated with the decision to allow research elective credit for short-term research training are not allowable charges on an institutional training grant.

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 Component of the SF424(R&R) Application Package. 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 DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide. Applicants are advised to refer to Agency Contacts for exceptions.

Applicants are required to follow our Post Submission Application Materials policy.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood that the proposed training program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained influence on the research field(s) involved, 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 the merit of the training program, and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Training Program and Environment

• Is the level of institutional commitment to the training program sufficient to ensure the success of the program?
• Will the academic environment and proposed training program facilitate completion of the baccalaureate degree?
• Will the academic environment and proposed training program prepare students for successful graduate careers in the biomedical sciences?
• What is the added-value in having the proposed MARC U-STAR Program at the institution, particularly if other student development programs with similar objectives exist?
• Will the academic and research training program lead to an increase over the current institutional baseline in the number of underrepresented alumni earning STEM baccalaureate degrees and biomedical Ph.D. degrees?

Training Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))

• Does the PD/PI have the scientific background, expertise, and administrative and training experience to provide strong leadership, direction, management, and administration of the proposed research training program?
• Does the PD/PI plan to commit sufficient effort to ensure the program s success?
• What is the evidence that the MARC U-STAR PD(s)/PI(s) will provide a high-quality training program?
• Does the PD(s)/PI(s) demonstrate the ability to work effectively with staff, administrators and faculty both at the proposed MARC U-STAR institution and with individuals at host institutions for summer research and graduate (Ph.D. level) training?
• For applications designating multiple PDs/PIs:
  • Is a strong justification provided that the multiple PD/PI leadership approach will benefit the training program and the trainees?
  • Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the training program and the complementary expertise of the PDs/PIs?

Mentors

• Are sufficient numbers of experienced mentors with appropriate expertise and funding available to support the number and level of trainees proposed in the application?
• Do the research mentors have strong records as scientists, including recent publications and successful competition for research support in areas directly related to the proposed research training program?
• Do the mentors have strong records of training undergraduate individuals from underrepresented backgrounds?
• What is the evidence that effective research training will be provided by the faculty?
• Applicant institutions with primarily teaching missions that are classified as non-research intensive by the Carnegie system are not required to propose "traditional" research training for MARC U-STAR participants on the campus, but they must provide intramural research training by other means, such as course-based undergraduate research experience (CURE) instruction. For such institutions, what type of intramural research training is proposed? What is the evidence that effective training will be provided by the faculty and staff? What is the experience of faculty and/or staff in providing academic and career advice?
• If academic year extramural research training is proposed at a nearby institution, what is the evidence that the mentors of the host site have strong records of training undergraduates from underrepresented groups? What is the evidence that effective research training will be provided by host research faculty?
• For the required summer of research-intensive training, what is the evidence that the research mentors of the host institution have strong records of training undergraduates from underrepresented groups?
• What is the evidence that effective research training will be provided by host research faculty?

Trainees

• Is a recruitment plan proposed with strategies likely to attract well-qualified candidates for the training program?
• Are there well-defined and justified selection and re-appointment criteria as well as retention strategies?
• Are the recruiting procedures and trainee selection criteria appropriate and well defined?

Training Record

• Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the training?
• Does the applicant provide the historical record of the institution in training underrepresented students?
• What is the record of the applicant institution in sending underrepresented alumni on to biomedical Ph.D. programs?
• What is the evidence that the proposed plan will be an improvement over past training activities?
• Are effective mechanisms in place for obtaining feedback from current and former trainees to allow for programmatic improvements?
• How will the evaluation plan be used to determine if the program is effective in meeting its objectives?

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.

Protections for Human Subjects

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Children

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Resubmissions

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.

Renewals

For Renewals, the review committee will consider the progress made in previous funding periods including Training in the Responsible Conduct of Research.

Review questions for renewals include:

Is the program achieving its training objectives? How successful are the trainees in completing the program and earning a baccalaureate degree? How successful are the trainees in earning biomedical Ph.D. degrees?

Has the program evaluated the quality and effectiveness of the training experience, and is there evidence that the evaluation, outcomes and feedback from trainees have been acted upon?

Are changes proposed likely to improve or strengthen the research training experience and outcomes during the next project period?

Does the program continue to evolve for continual improvement in meeting the objective of the MARC U-STAR Program?

Revisions

For revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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.

Recruitment Plan to Enhance Diversity

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 individuals from underrepresented groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the training program, the level of trainee experience, and the particular circumstances of the trainees, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? For renewal applications, are all training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application? 4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?

For renewal applications, does the progress report document acceptable RCR instruction in the five components described above? Does the plan describe how participation in RCR instruction is being monitored? Are appropriate changes in the plan for RCR instruction proposed in response to feedback and in response to evolving issues related to responsible conduct of research?

Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

Select Agent Research

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Budget and Period of Support

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), convened by NIGMS 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:

• 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.
• Will receive a written critique.

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 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.

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 grantee’s business official.

Awardees 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.

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Institutional NRSA training grants must be administered in accordance with the current NRSA section of the NIH Grants Policy Statement - Institutional Research Training Grants.

The taxability of stipends is described in the NIH Grants Policy Statement. Policies regarding the Ruth L. Kirschstein-NRSA payback obligation are explained in the NIH Grants Policy Statement.

In general, trainees may receive stipends during the normal periods of vacation and holidays observed by individuals in comparable training positions at the sponsoring institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday. Trainees may receive stipends for up to 15 calendar days of sick leave per year. Under exceptional circumstances, this period may be extended by the NIH awarding IC in response to a written request from an AOR. Sick leave may be used for the medical conditions related to pregnancy and childbirth. Trainees may receive stipends for up to 60 calendar days (equivalent to 8 work weeks) of parental leave per year for the adoption or the birth of a child when individuals in comparable training positions at the grantee organization have access to this level of paid leave for this purpose. Either parent is eligible for parental leave. The use of parental leave must be approved by the PD/PI (see also: NOT-OD-08-064).

A period of terminal leave is not permitted, and payment may not be made from traineeship funds for leave not taken. Trainees requiring periods of time away from their research training experience longer than specified here, i.e., more than 15 calendar days of sick leave or more than 60 calendar days of parental leave, must seek approval from the NIH awarding component for an unpaid leave of absence. Approval for a leave of absence must be requested in advance by an AOR on behalf of the trainee. Trainees supported by academic institutions should refer to the NIH Institutional NRSA training grant guidelines in the NIH Grants Policy Statement for further guidance regarding vacations and requested leave.

Awards made primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required, as described in the NIH Grants Policy Statement.

Not Applicable

When multiple years are involved, awardees 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.

Failure by the grantee 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.

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 awardees 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 $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

• The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant. Grantees must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). Annually, the period of trainee appointment (or reappointment) for the MARC U-STAR program is June - September 30 as per the MARC U-STAR Trainee Appointment Policy. An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
• A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving support.

A final Progress Report, the expenditure data portion of the Federal Financial Report, and Termination Notices for all Trainees, are required for closeout of an award as described in the NIH Grants Policy Statement. Evaluation results should be included as part of the final progress report.

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

Within ten years of making awards under this program, NIGMS will assess the program’s overall outcomes, gauge its effectiveness in enhancing diversity, and consider whether there is a continuing need for the program. Upon the completion of this evaluation, NIGMS will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program.

In evaluating this research education program NIGMS expects to use the following evaluation measures:

• MARC U-STAR trainees are expected to earn a baccalaureate degree in a science field relevant to the NIH mission;
• The majority of MARC U-STAR trainees should enroll in a biomedically-relevant Ph.D. program after earning a baccalaureate degree;
• The MARC U-STAR trainees who enter Ph.D. programs should have a completion rates equivalent or better than the national average for all biomedical predoctoral trainees;
• The MARC U-STAR Program should contribute to an increase in the number of underrepresented individuals receiving a baccalaureate degree in science areas relevant to the NIH; and
• The MARC U-STAR Program should contribute to an increase in the number of underrepresented individuals entering and completing a PhD degree in science areas relevant to the NIH.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Alison Gammie, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3900
Email: [email protected]

Richard Okita, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3900
Email:[email protected]

Helen R. Sunshine, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-2881
Email: [email protected]

Ms. Lori Burge
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-3781
Email: [email protected]

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 Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66.