Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Funding Opportunity Title

Biomedical and Behavioral Research Innovations to Ensure Equity (BRITE) in Maternal and Child Health (R15)

Activity Code

R15 Academic Research Enhancement Award (AREA)

Announcement Type

Reissue of PAR-12-093

Related Notices
  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)
  • NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015)
  • NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015)
Funding Opportunity Announcement (FOA) Number

PAR-15-319

Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.865

Funding Opportunity Purpose

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) seeks to increase the diversity of the pool of researchers involved in health equity research related to NICHD mission areas including: preterm birth; infant mortality; sudden infant death syndrome (SIDS); maternal mortality; reproductive health; uterine fibroid tumors; childhood, adolescent, and/or adult obesity; violence prevention; perinatal HBV and HIV/AIDS prevention; HIV/AIDS prevention; asthma; intellectual and developmental disabilities; pediatric injury prevention; and medical rehabilitation. The goal of the Biomedical and Behavioral Research Innovations To Ensure Equity (BRITE) in maternal and child health program is to stimulate maternal and child health equity research within institutions eligible for the Academic Research Enhancement Award (AREA) R15 program.

Key Dates
Posted Date

August 6, 2015

Open Date (Earliest Submission Date)

October 18, 2015

Letter of Intent Due Date(s)

30 days before applicable receipt date.

Application Due Date(s)

November 18, 2015; July 7, 2016; July 7, 2017, by 5:00 PM local time of applicant organization. All types of applications allowed for this funding opportunity announcement are due on these dates.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

November 18, 2015; July 7, 2016, July 7, 2017, by 5:00 PM local time of applicant organization. All types of applications allowed for this funding opportunity announcement are due on these dates.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. 

Scientific Merit Review

March 2016, November 2017, November 2018

Advisory Council Review

May 2016, January 2017, January 2018

Earliest Start Date

July 2016,  April 2017, April 2018

Expiration Date

July 8, 2017  

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options to submit your application to the agency through Grants.gov. You can use the ASSIST system to prepare, submit and track your application online. You can download an application package from Grants.gov, complete the forms offline, submit the completed forms to Grants.gov and track your application in eRA Commons. Or, you can use other institutional system-to-system solutions to prepare and submit your application to Grants.gov and track your application in eRA Commons. Learn more.

Problems accessing or using ASSIST should be directed to the eRA Service Desk.
Problems downloading forms should be directed to Grants.gov Customer Support.
Table of Contents

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

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) seeks to increase the diversity of the pool of researchers involved in health equity research related to NICHD mission areas including preterm birth; infant mortality; Sudden Infant Death Syndrome (SIDS); maternal mortality; reproductive health; child, adolescent, and/or adult obesity; uterine fibroids; pediatric and maternal HBV and HIV/AIDS prevention; violence prevention; asthma; intellectual and developmental disabilities; pediatric injury prevention; and medical rehabilitation. The goal of the Biomedical and Behavioral Research Innovations To Ensure Equity (BRITE) in maternal and child health program is to stimulate maternal and child health equity research within institutions eligible for the Academic Research Enhancement Award (AREA) R15 program.

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. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral and social sciences, such as:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27) and the report Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders.

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended. See NSF data at http://www.nsf.gov/statistics/wmpd/2013/pdf/tab7-5_updated_2014_10.pdf.

C. Individuals from disadvantaged backgrounds, defined as:

1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml.

2. Individuals who come from an educational environment such as that found in certain rural or inner-city environments that has demonstrably and directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.

The disadvantaged background category (C1 and C2) is applicable to programs focused on high school and undergraduate candidates.

Literature shows that women from the above backgrounds (categories A, B, and C) face particular challenges at the graduate level and beyond in scientific fields. (See, e.g., Inside the Double Bind, A Synthesis of Empirical Research on Undergraduate and Graduate Women of Color in Science, Technology, Engineering, and Mathematics http://her.hepg.org/content/t022245n7x4752v2/fulltext.pdf).

The NICHD seeks to increase the diversity of the pool of scientists involved in health equity research related to NICHD mission areas including preterm birth; infant mortality; Sudden Infant Death Syndrome (SIDS); maternal mortality; reproductive health; child, adolescent, and/or adult obesity; uterine fibroids; pediatric and maternal HBV and HIV/AIDS prevention; violence prevention; asthma; intellectual and developmental disabilities; pediatric injury prevention; and medical rehabilitation. While the Institute currently promotes diversity in the workforce by engaging AREA-eligible institutions in NICHD research mission areas, there is a critical need to broaden the NICHD AREA grant portfolio to include a greater representation of institutions with students from diverse backgrounds underrepresented in research as a strategy for further increasing the diversity of the scientific research workforce and reducing health inequities.

Many AREA-eligible institutions provide unique opportunities for access to students from diverse backgrounds underrepresented in biomedical and behavioral research. For example, in 2008, the National Science Foundation (NSF) reported that 20% of bachelor’s degrees in science and engineering granted to African Americans were received at Historically Black Colleges and Universities and 32% of bachelor’s degrees in science and engineering granted to Hispanics were received in high-Hispanic enrollment institutions. However, the majority of these institutions with largely untapped talent pools of students from underrepresented groups have not been major recipients of NIH support, thus limiting opportunities for students to benefit from exposure and participation in biomedical and behavioral research.

Further, individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from economically, or educationally disadvantaged backgrounds are disproportionately burdened by health disparities. There is limited evidence that individuals who have participated in the NIH diversity administrative supplement program preferentially conduct research in areas related to health disparities or minority health. Various approaches to increase undergraduate student persistence in the STEM-related fields have been implemented (Graham et al., Science, 341, 1455-1456). Student participation in research experiences has been associated with improved academic performance and sustained interest in research careers in the basic and biomedical sciences (for example, see Fechheimer et al., CBE--Life Sciences Education, 10, 156-163; Russell et al., Science, 316 (5824), 548-549); and Salto et al., PLoS ONE, 9(9), e10849). Expanding NICHD mission-related research opportunities for AREA-eligible institutions to seek new knowledge in maternal and child health equity research is an important strategy for increasing the pool of researchers involved in research pertinent to the NICHD mission.

BRITE Program Goals and Objectives

The overall goal of the NICHD BRITE Program is to stimulate maternal and child health equity research in AREA-eligible institutions. The objectives of the program are to: (1) provide support for investigators to conduct independent research pertinent to the NICHD mission; (2) encourage and enable the use of innovative ways to strengthen the research environment and investigator record of research accomplishments; and (3) expose students from diverse backgrounds underrepresented in biomedical and behavioral research to meritorious maternal and child health equity research.

BRITE grant awards will support meritorious small-scale, new and renewal projects in biomedical and behavioral maternal and child health equity research, including:

  • Pilot research projects and feasibility studies
  • Secondary analysis of available data sets

To increase opportunities for student exposure to research, investigators are strongly encouraged to implement one structured activity during each year of the grant award that extends research exposure to students outside of the investigator's normal laboratory and classroom setting. This annual structured activity may include journal clubs and research seminars on current topics and research opportunities in maternal and child health equity research. Applicants must provide plans for recruitment of students from diverse backgrounds underrepresented in research for participation in BRITE activities.

The AREA R15 program is a research grant program and not a training or fellowship program. Thus, applications should not focus on training objectives and training plans should not be provided.  However, it is important for the applicant to describe the research activities in which students will participate.  

Outcomes and Evaluation

To ensure the BRITE Program goals and objectives are being met, the NICHD will conduct a program evaluation five to seven years after the release of this FOA. At its discretion NICHD may continue, modify, or terminate the program at that time if it is determined that the need no longer exists or that the program is not making progress towards the goal of stimulating maternal child health equity research in AREA-eligible institutions. The program evaluation will focus on investigator accomplishments and level of student exposure to maternal and child health equity research.

Key metrics to measure investigator accomplishments will include:

  • Refereed articles as measured by citations and other indicators of recognition
  • Presentations at national meetings that help enhance the reputation of the investigator’s research program and the NICHD relevant area of research
  • Evidence of active pursuit of extramural grants and contracts to support future research goals

Key metrics to measure exposure to maternal and child health equity research will include:

  • Characteristics of students participating in BRITE activities (e.g., gender, race/ethnicity, disability status, class level, major course of study)
  • Extent to which participation in BRITE activities increased interest in NICHD mission-related research
  • Types of outreach activities used to recruit students from diverse backgrounds underrepresented in research for participation in BRITE activities
  • Student attendance and presentations (poster and oral) at scientific/research conferences
  • Publications (peer-reviews and non-peer-reviewed) with students as coauthors,
Research Areas of Emphasis

Area of research emphasis include, but are not limited to, the following:

  • Preterm birth
  • Infant mortality
  • Sudden Infant Death Syndrome (SIDS)
  • Maternal mortality
  • Reproductive health
  • Uterine fibroid tumors
  • Childhood, adolescent, and/or adult obesity
  • Violence prevention
  • Perinatal HBV and HIV/AIDS prevention
  • HIV/AIDS prevention
  • Asthma
  • Intellectual and developmental disabilities
  • Pediatric injury prevention
  • Medical rehabilitation (e.g., spinal cord injury, TBI, stroke)

More than one area of research focus may be addressed only when scientifically appropriate.  Health literacy and techniques for outreach and information dissemination may only be addressed in conjunction with one of the identified areas of research focus.

An application for a BRITE award could include applications for biomedical and/or behavioral research focused on the following:

  • Studies that evaluate the role of individual-level health behaviors in disparate maternal and child health outcomes
  • Studies that elucidate the role of social determinants (e.g., poverty) in disparate maternal and child health outcomes
  • Studies that investigate the role of interactions among multiple factors in maternal and child health outcomes
  • Studies that identify culturally- and age-appropriate strategies for improving health literacy and increasing dissemination of prevention messages among populations disproportionately affected by disparate maternal child health outcomes (e.g., racial/ethnic minority, low-income, disability, and underserved)
Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Applicants may request a maximum of $300,000 direct costs plus applicable Facilities & Administrative (F&A) costs/indirect costs for the entire project period of up to three years. No more than $150,000 may be spent in any single year without prior approval from NICHD.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 3 years.

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.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

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)

While this funding opportunity is available to all AREA-eligible institutions, NICHD strongly encourages applications from the following institutions:  Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Hispanic-Serving Institutions (HSIs), and Alaska Native and Native Hawaiian-Serving Institutions.

In addition, all organizations must meet the following two criteria:

  • The applicant organization must offer baccalaureate or advanced degrees in biomedical or behavioral sciences
  • The applicant organization may not receive research support from the NIH totaling more than $6 million per year (in both direct and F&A/indirect costs) in each of 4 of the last 7 years.
    • Note that the following activity codes are excluded: C06, S10, and all activity codes starting with a G.

Institutions with Multiple Schools or Colleges

For institutions composed of multiple schools or colleges, the criterion of financial eligibility is based on the amount of NIH research grant monies received, not by the institution (university or college) as a whole, but by the individual school/college or aggregation of "other academic components" (as defined in this section) where the PD/PI has an appointment (e.g., School of Medicine, College of Nursing, etc.). Thus, each of the following should be considered independently when determining the financial eligibility of the applicant organization.

  • Health professional school/college: Accredited public or non-profit private school that provides a terminal degree related to the health sciences granted by that school (e.g., PhD, MD, DDS, MPT, DC, ND, BSN).  The term "accredited" means a school or program that is accredited by a recognized body or bodies approved for such purpose by the Secretary of Education.
    • Includes schools or colleges of medicine, dentistry, osteopathy, pharmacy, nursing, veterinary medicine, public health, optometry, allied health, chiropractic, naturopathy and podiatry. 
  • Other academic component: Once the health professional schools have been excluded, “other academic components” refers to all remaining schools, colleges, and free-standing institutes of the institution taken as a single component.
Additional Eligibility Guidance

To determine the eligibility of an institution, applicants should consult the list of ineligible institutions  on the AREA program. If the name of the school does not appear on the list, it is likely eligible to apply for AREA grants.  Applicants should check with their own institutions if unsure.

An AREA grant is permitted to have a subcontract to a non-AREA-eligible institution. However, applicants should keep the goals of the AREA program in mind when preparing the application, which include strengthening the research environment of the institution and exposing students to research. 

Foreign Institutions

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.

Required Registrations

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.
  • 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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities and women 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 SF424 (R&R) Application Guide.

For institutions proposing multiple PDs/PIs, all PDs/PIs must have a primary  appointment at an AREA-eligible institution.

To be eligible for an AREA grant, the PD(s)/PI(s) must meet the following additional criteria:

  • The PD(s)/PI(s) must have a primary appointment at an AREA eligible institution.
  • The PD(s)/PI(s) may not be the PD(s)/PI(s) of an active NIH research grant, including another AREA grant, at the time of award of an AREA grant (although he or she may be one of the project personnel for an active NIH grant held by another PD/PI).
  • The PD(s)/PI(s) may not be awarded more than one AREA grant at a time (although he or she may hold successive new or competing renewal AREA grants).

Note: These eligibility criteria only apply to the PD(s)/PI(s) of the application, not to other key personnel such as collaborators and consultants.)

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  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).
Section IV. Application and Submission Information
1. Requesting an Application Package

Applicants must download 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.

2. Content and Form of Application Submission

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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Regina Smith James, MD
Director, Office of Health Equity (OHE)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 5E03A, MSC 7510
Bethesda, Maryland 20892-7510
Rockville, Maryland 20852 (for express/courier service)
Telephone: 301-435-2692
Fax: 301-480-0393
Email: rjames@mail.nih.gov

Page Limitations

All page limitations described in the SF424 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.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Facilities and Other Resources:

  • A profile of available students of the applicant school/academic component and any information or estimate of the number who have obtained a baccalaureate degree and gone on to obtain an academic or professional doctoral degree in the health-related sciences during the last five years.
  • Applicants are strongly encouraged to include a description of the distribution of students from diverse backgrounds underrepresented in biomedical and behavioral research as part of the profile of available students of the applicant school/academic component.
  • A description of the special characteristics of the school/academic component that make it appropriate for an AREA grant, where the goals of the AREA program are to: (1) provide support for meritorious research; (2) strengthen the research environment of schools that have not been major recipients of NIH support; and (3) expose available undergraduate and/or graduate students in such environments to research. Include a description of the likely impact of an AREA grant on the PD(s)/PI(s) and the research environment of the school/academic component.
  • Although it is expected that the majority of the research will be directed by the applicant investigator and conducted at the grantee institution, limited use of special facilities or equipment at another institution is permitted.  For any proposed research sites other than the applicant institution, provide a brief description of the resources.  If relevant, a statement of institutional support for the proposed research project (e.g., equipment, laboratory space, release time, matching funds, etc.).
SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed. 

Biographical Sketch:  The PD(s)/PI(s) should include a summary of his or her previous and/or current experience in supervising students in research in the Personal Statement. The PD(s)/PI(s) should indicate which peer-reviewed publications involved students under his or her supervision.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

  • The total budget for all years of the proposed project must be requested in Budget Period 1.  Do not complete Budget Periods 2 or 3.  They are not required and will not be accepted with the application.
  • Complete only Budget Period 1 of either the PHS 398 Modular Budget component or the R&R Budget component. 
  • Applicants submitting an application with direct costs of $250,000 or less (total for all years, excluding consortium Facilities and Administrative [F&A] costs) must use the PHS 398 Modular Budget component.
  • Applicants submitting an application with direct costs of $250,001 - $300,000 (total for all years) must use the Research & Related (R&R) Budget component.

PHS 398 Modular Budget (direct costs of $250,000 or less):

Follow all instructions in the SF424 (R&R) Application Guide, noting the following specifications for R15 applications.

Budget Period 1: Direct Costs

  • Direct Costs less Consortium F&A: Select the appropriate dollar amount from the drop-down list. This number must NOT EXCEED $250,000.
  • Consortium F&A: If applicable, enter the actual consortium F&A (e.g., $3,271).
  • Total Direct Costs: This field auto-calculates so no data entry is required.

Budget Period 1: Indirect Costs:

  • If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs.
  • If the F&A rate has not been established, enter “None-will negotiate” and include information for a proposed rate.  Use the budget justification if additional space is needed. 

Budget Justification: Please attach the Personnel Justification and Consortium Justification.  If the requested budget requires any additional justification, attach an Additional Narrative Justification. 

  • Personnel Justification: Follow all instructions in the SF424 (R&R) Application Guide. Since a primary objective of the AREA program is to expose students to meritorious research, PD(s)/PI(s) must include undergraduate (preferably, if available) and/or graduate students in the proposed research. Indicate aspects of the proposed research in which students will participate. If participating students have not yet been individually identified, the number and academic level of those to be involved should be provided. If there are any Collaborators or Consultants for the project, provide their names, organizational affiliations, and the services they will perform.
  • Consortium Justification: Follow all instructions in the SF424 (R&R) Application Guide, but note that the Letter of Intent to establish a consortium must also be included in the Consortium Justification attachment.
  • Other Costs: In addition to requesting costs to support the research project, applicants may request direct costs to support planning and evaluation of activities to increase student exposure to maternal and child health equity research. These costs may include, but are not limited to: administrative assistance to plan and coordinate annual structured activities (e.g. journal club, research seminar); purchase of software and supplies to be used for tracking and evaluating student participation (e.g. surveys, database).

R&R Budget (direct costs of $250,001 to $300,000):

Follow all instructions in the SF424 (R&R) Application Guide, noting the following specifications for R15 applications.

Budget Period 1: Direct Costs

  • Direct Costs less Consortium F&A: This number must NOT EXCEED $300,000.
  • Consortium F&A: If applicable, enter the actual consortium F&A (e.g., $3,271).

Budget Period 1: Indirect Costs:

  • If the F&A rate agreement has been established, indicate the type of agreement. All appropriate exclusions must be applied in the calculation of the F&A costs.
  • If the F&A rate has not been established, enter “None-will negotiate” and include information for a proposed rate.  Use the budget justification if additional space is needed. 

Budget Justification: Follow all instructions in the SF424 (R&R) Application Guide. Since a primary objective of the AREA program is to expose students to meritorious research, PD(s)/PI(s) must include undergraduate (preferably, if available) and/or graduate students in the proposed research. Indicate aspects of the proposed research in which students will participate. If participating students have not yet been individually identified, the number and academic level of those to be involved should be provided. If there are any Collaborators or Consultants for the project, provide their names, organizational affiliations, and the services they will perform.

Applicants may request direct costs to support planning and evaluation of activities to increase student exposure to maternal and child health equity research. These costs may include, but are not limited to:

  • Administrative assistance to plan and coordinate annual structured activities (e.g. journal club, research seminar)
  • Purchase of software and supplies to be used for tracking and evaluating student participation (e.g. surveys, database)
R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.  

PHS 398 Research Plan

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

Research Strategy: Applicants should provide a description of one annual structured student activity designed to expand exposure to maternal and child health equity research beyond the investigator’s normal laboratory and classroom setting. This annual structured activity may include journal clubs and research seminars on current topics and research opportunities in maternal and child health equity research. Applicants must provide plans for recruitment of students from diverse backgrounds underrepresented in research for participation in BRITE activities.

In addition to the evaluation plan for the research project, applicants should also describe how student exposure to maternal and child health equity research will be measured. These evaluation plans should address characteristics of students participating in BRITE activities (e.g., gender, race/ethnicity, disability status, class level, major course of study), the extent to which participation in BRITE activities increased interest in NICHD mission-related research, types of outreach activities to recruit students from diverse backgrounds underrepresented in research for BRITE activities, and participation of students in manuscripts and scientific/research conferences. Where appropriate, applicants are encouraged to include plans to obtain feedback from participants to help identify weaknesses and to provide suggestions for program activity improvements.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.

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.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. Other Submission Requirements and Information

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.

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. See Section III of this FOA for information on registration requirements.

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. 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.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

1. Criteria

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.

For this particular announcement, note the following:

The objectives of the R15 program are to (1) provide support for meritorious research, (2) strengthen the research environment of schools that have not been major recipients of NIH support, and (3) expose available undergraduate and graduate students in such environments to meritorious research. Preliminary data are not required for an R15 application; however, they may be included if available

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to make an important scientific contribution to the research field(s) involved, to provide research opportunities to students, and to strengthen the research environment of the institution, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

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. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? If funded, will the AREA award have a substantial effect on the school/academic component in terms of strengthening the research environment and exposing students to research? Does the main theme of the application address an important area of maternal and child health equity research?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the PD(s)/PI(s) have suitable experience in supervising students in research? Do the PD(s)/PI(s), collaborators and other researchers demonstrate adequate knowledge of the maternal and child health equity area of research emphasis targeted as part of the research application? Do the PD(s)/PI(s) demonstrate that all of the necessary techniques and methods can be performed based on his/her previous experience and/or letters of collaboration?  

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Does the application provide sufficient evidence that the project can stimulate the interests of students so that they consider a career in the biomedical or behavioral sciences? 

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

In the absence of preliminary data, do the PD(s)/PI(s) demonstrate that the proposed techniques are feasible, reliable, and will yield interpretable data, based on his/her experience (i.e., published studies) or peer-reviewed studies published in the field? Is the proposed structured activity to address student research exposure adequate to stimulate interest and knowledge regarding maternal and child health equity research among students participating in BRITE activities? Will the recruitment plans for engaging students from diverse backgrounds underrepresented in research increase likelihood of participation of students from those groups in BRITE activities? Is the evaluation plan for measuring the extent to which participation in BRITE activities increased interest in maternal and child health equity research adequate? 

Environment

Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Does the application demonstrate the likely availability of well-qualified students to participate in the research project? Does the application provide sufficient evidence that students have in the past or are likely to pursue careers in the biomedical or behavioral sciences? Does the application demonstrate the diversity of the student population? Will the environment be appropriate for stimulating interest in maternal and child health equity research among faculty and students at the institution?

Additional Review Criteria

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

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

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 committee will consider the progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations

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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (CSR) 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 . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Child Health and Human Development (NACHHD) Council. 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.
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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information
1. Award Notices

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.

2. Administrative and National Policy Requirements

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

Progress reports for multi-year funded awards are due annually on or before the anniversary of the budget/project period start date of award. The reporting period for multi-year funded award progress report is the calendar year preceding the anniversary date of the award. Information on the content of the progress report and instructions on how to submit the report are posted at http://grants.nih.gov/grants/policy/myf.htm.

A final progress report, invention statement, 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.

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.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Scientific/Research Contact(s)

Reiko Toyama, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-2723
Email: toyamar@mail.nih.gov

Peer Review Contact(s)

Gabriel Fosu, PhD
Center for Scientific Review (CSR)
Telephone: 301-435-3562
Email: fosug@mail.nih.gov

Financial/Grants Management Contact(s)

Bryan Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

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.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 74 and 92.

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