Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (

Components of Participating Organizations
National Center on Minority Health and Health Disparities (NCMHD) (

Title: NCMHD Building Research Infrastructure and Capacity (P20)

Announcement Type
This is a reissue of RFA-MD-09-003.

Request For Applications (RFA) Number:

Catalog of Federal Domestic Assistance Number(s)

Key Dates
Release Date:   March 19, 2010
Letters of Intent Receipt Date(s):  April 21, 2010
Application Receipt Dates(s): May 21, 2010
Peer Review Date(s): June-July 2010
Council Review Date(s): August 2010
Earliest Anticipated Start Date: September 2010
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: May 22, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary  

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
   D.  Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

The mission of the National Center on Minority Health and Health Disparities (NCMHD) is to promote minority health and to eliminate health disparities.  The NIH defines health disparities as differences in the incidence, prevalence, morbidity, mortality, and burden of diseases and other adverse health conditions that exist among specific population groups.  The population groups impacted by health disparities include  African Americans, American Indians, Alaska Natives, Asian Americans, Hispanic Americans, Native Hawaiians, Pacific Islanders, subpopulations of all of the above, and medically underserved populations (i.e., socio-economically disadvantaged individuals and those in rural areas). These populations are hereafter referred to as health disparity populations.

Historically, the RIMI grant program was developed in response to recommendations resulting from the proceedings of three regional conferences that were convened by the former NIH Office of Research on Minority Health (ORMH) in February 1992.  These meetings produced the “Minority Programs Fact-Finding Teams Recommendations” publication.  The fact-finding team’s recommendations provided guidance for the development of policies for minority programs and initiatives at the NIH.  One of the major recommendations stated that “NIH must continue and, where possible, expand programs at institutions with significant or predominant enrollment of minorities.”  The fact-finding team further concluded that this enhancement would allow some of these institutions to become research intensive institutions that could provide quality research training in the health sciences field and conduct innovative faculty research. Public Law 106-525 also identified a national need for minority scientists in the fields of biomedical, clinical, behavioral, and health services research. The statute recognized that the inclusion of underrepresented minorities and women in the scientific, technological and bio-engineering workforce would enable society to better address its diverse needs and the needs of health disparities populations.

The successor to RIMI, BRIC will continue support for the development of sustainable research programs at non-research intensive institutions of higher education with the long-term goal of conducting innovative research on emerging issues in health disparities research, and serving as a resource to the health disparity communities that the institutions serve. This grant program is expected to have a three-fold impact on the scientific workforce by: (1) accelerating the discovery of new knowledge in science and technology; (2) refining and increasing the understanding of the nature of health disparities, and (3) developing non-research intensive academic infrastructure that will contribute to the intellectual development of researchers and health professionals that are trained at such institutions. History has shown that many healthcare researchers and future professionals who graduate from non-research intensive institutions are likely to devote their careers providing biomedical and behavioral services in health disparity communities. (Public Law 106-525; Allocating Federal Funds for Science and Technology, Supplement 4).

The Building Research Infrastructure and Capacity (BRIC) Program

The major goal of this FOA is to build, strengthen and/or enhance the research infrastructure and research training capacity of non-research intensive institutions that educate students from health disparity populations as defined by Public Law 106-525.  In order to achieve the goals of the BRIC Program, critical research training, facilities infrastructure enhancements, and academic gaps and shortfalls must be ameliorated and/or eliminated. Many of these areas of concern have been exacerbated by the lack of research infrastructure and inadequate faculty and students’ research training programs at many of the nation’s two- and four-year non-research intensive academic institutions.  By virtue of the unique missions of the following institutions and their demonstrated commitment to the needs of health disparity communities, small private and public colleges and universities in rural and socially disadvantaged areas, Tribal Colleges and Universities (TCU), Historically Black Colleges and Universities (HBCU) and Hispanic-Serving Institutions (HSI) are encouraged to apply for grants under this FOA.

The BRIC grant award provides a means for an institution to: 1) strengthen its basic research infrastructure and capacity in basic, natural, social or biomedical science, mathematics and/or allied health degree programs; 2)  institute a comprehensive research faculty development training program with measurable training outcomes; 3) establish an academic research enrichment  training program for students’ pursuit of research career path(s) in basic, biomedical, social and/or behavioral science; and 4) support individual junior faculty-initiated research subprojects that may ultimately lead to successful independent research in minority health and/or the elimination of health disparities under  traditional entry-level or advanced research grant  funding mechanisms.

Examples of  approaches that can be used to achieve the BRIC program objectives are:  institutional role-modeling and collaborations with research intensive institutions; inter- and intra-departmental partnering on research initiatives; transitional bridge preparation activities; developmental research activities; faculty and/or student mini research initiatives; research journal club; research faculty loan program; research curriculum enhancement; and academic development and enrichment courses. Additional examples of acceptable approaches can be found in a number of research reports including, but not limited to the Sullivan Commission Report on Diversity in the Healthcare Workforce (2004), In the Nation’s Compelling Interest, (2004), Smedley, B. and Bristol, L.R. (eds.) and Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care (2003), Smedley, B, Stith, A., and Nelson, A.R. (eds.)

It is expected that BRIC funds will allow an institution to establish a cadre of trained research faculty who are able to provide a strong academic foundation for students who can successfully pursue post-baccalaureate research degrees, including those who pursue advance degrees that address issues related to minority health and health disparities.  Further, it is expected that BRIC funding will allow an institution to build a research infrastructure that is capable of supporting the requirement of more advanced scientific and research grant programs.  In sum, the BRIC Program is designed to provide foundational research training building blocks that support the long-term NCMHD strategy to create a well-trained cadre of biomedical, clinical, behavioral and social science researchers. This includes providing the resources for funded institutions to establish the competencies necessary to prepare students for research careers in leading edge or innovative areas that will contribute to reducing and eliminating health disparities in the United States.

The BRIC Program focuses on four major aspects: 1) institutional research infrastructure and research administration enhancement; 2) faculty research development and training; 3) academic preparation of students in science and mathematics, and 4) facilities and resources improvement. The integration of the program areas can solidify the achievement of BRIC goals and objectives by implementing a combination of multi-phased research enhancement and research training cores. The NCMHD has identified five core areas that are essentials for achieving the goals and objectives of BRIC. They are: 1) the Administrative and Capacity Building Core; 2) Faculty Research Development and Training Core; 3) Academic Readiness/Strengthening of Students Core; 4) Shared Research Facilities and Resources Enhancement Core, and 5) Renovations and Alterations Core. 

All applicants must develop a comprehensive plan and scope of work that include all five core areas.  Applications that do not include a plan and scope of work that covers all of the required Core areas will be deemed non-responsive to this FOA and will not receive scientific review or possible funding consideration. 

1.  Administrative and Capacity Building Core:

The Administrative and Capacity Building core is responsible for: 1) overseeing all BRIC program activities, projects and resources including advisory committees, cores, training and evaluation activities essential to the success of the BRIC project; 2) establishing and maintaining all partnerships with research intensive entities; 3) coordinating all BRIC sponsored research activities that are supported under the auspices of the BRIC grant program; and 4) providing oversight for all financial matters related to grant activities and all approved faculty research subprojects.  All activities required for the smooth operation of the BRIC project should be included in the Administrative and Capacity Building Core. The specific objectives of this core are, but not limited, to the following:

a)  To strengthen the institution’s research infrastructure and capacity, with special emphasis on the elimination of health disparities, by building or expanding the institution’s academic degree programs in either basic science and mathematics, allied health sciences or social and behavioral science;

b)  To build an academic infrastructure that benchmarks cutting-edge and innovative instruction and research training that takes into account the uniqueness and/or special needs of students from health disparity populations as defined by P.L. 106-525;

c)  To establish an academic research program, with special emphasis on eliminating health disparities that will improve an institution’s basic science, biomedical, clinical or behavioral science research agenda and infrastructure; and

d)  To encourage the creation of supportive research environments by emulating institutions that have demonstrated successful approaches to procurement processes, development/ use/support of core resources, innovative offices of sponsored research, research grants administration.

Further, applicants should describe the organizational, administrative and reporting structure of the BRIC Project, including the roles and responsibilities of all key personnel.  BRIC funds may be used by grantees to establish and maintain a BRIC informational website.  A BRIC program coordinator, appointed by the PI, is expected to oversee the daily operations of the project and maintain close ties with the PI. This senior manager should interact with all the administrative leadership of the institution to enhance the success of the BRIC project. The PI will provide oversight for the entire grant, and monitor the overall implementation of the Faculty Research Development Core. The progress of each  faculty research subproject and career development training plan must have the support of the PI for the grant. The applicant should identify and clearly describe both, overall and the specific project goals, academic discipline(s) that the project will address and the proposed plan.  Applicants should identify the operational and theoretical framework that will guide the project through the duration of the grant period.

The applicant should clearly illustrate how BRIC funding will strengthen its research capacity and enhance research training for students and faculty at the institution.  This includes outlining yearly goals, measurable objectives, action steps, timelines and expected benchmarks for assessing accomplishments and successes.   All activities required for the smooth operation of the BRIC project should be included in the Administrative and Capacity Building core.

Evaluation Plan

Each application must include a five-year process and outcome evaluation plan for assessing the overall success of the BRIC project in achieving its program goals and objectives. Benchmarks must be clearly identified and specific plans and procedures must describe the outcome measures that will determine the yearly and overall success of the proposed plan for achieving the BRIC goals. At a minimum, a comprehensive evaluation must include the following:

Since the NCMHD seeks to determine the long-term impact of BRIC investment in building a solid capacity and infrastructure for research and training at its grantee institutions, the applicant must include and describe their plan for tracking student degree completion rates and faculty progress toward independent research funding.  

Applications that do not include an Evaluation Plan will be deemed non-responsive to this FOA and will not be forwarded for scientific review.  

2.  Research Faculty Development Core

One major goal of the Research Faculty Development Core is to prepare junior faculty (not senior or established faculty members) to conduct scientific research, and facilitate the long-term development of an independent faculty initiated research environment at the applicant institution.  For the purposes of this FOA, junior faculty is defined as individuals who meet the NIH definition of Early Stage Investigators.  The second major goal of this core is to provide the resources for faculty members to strengthen their basic research skills for independent faculty-initiated funded research in minority health and health disparities. This core provides resources so an academic department(s) or program component(s) can train its faculty on how to guide students in their pursuit toward successful completion of the baccalaureate and graduate degrees and career opportunities in biomedical, clinical, behavioral or social research.  The specific objectives for this core are:

a)  To enhance, within a designated academic department, research training opportunities for individual junior faculty members so that they can strengthen their research knowledge and skills in order to successfully compete for independent research funding;

b)  To facilitate investigator networking through research interest or working groups and/or journal clubs aimed at facilitating collaborative research project development and raising awareness of emerging technologies and areas of emphasis in health disparities research; and

c)  To assist faculty researchers in understanding the various uses of emerging research methodologies and their applications in the conduct of independent faculty initiated research projects.

BRIC grant funds may be used by an institution to provide for faculty members to participate in a series of research skills development courses, seminars and/or hand-on workshops. Additionally, this core funding can provide support for a period of supervised mentoring and research supervision of junior faculty members who have the potential to integrate their teaching skills with NCMHD relevant research goals in order to develop productive independent minority health and health disparities research initiatives. 

Mentored Research Career Development of Junior Faculty.  At four-year institutions, funds can provide support for up to two junior faculty members to participate in conducting a subproject, research career development and training.  This includes support for a maximum of two full-time summers and 50% release time for academic semesters for each faculty who demonstrates measured success in the research arena.  That is, BRIC can provide at least 50% of the academic year release time and full-time summer support effort for a junior faculty member to participate in a mentored research phase of this core. In addition, funding up to $25,000 per junior faculty may be used to support release time of a senior research faculty member who serves as mentor for junior faculty that are engaged in research subprojects.  If the applicant institution agrees to establish a partnership(s) with a research university, medical school, or health professional school, the applicant should include written documentation that the proposed partnering institution has a strong, well-established teaching program in mathematics and science and research programs in areas relevant to minority health and the elimination of health disparities.

Each faculty initiated research subproject that is supported by BRIC must be related to improving minority health and/or eliminating health disparities. This plan should include measurable objectives, measures for assessing progress/successes with specific milestones, activities timelines, and expected outcome(s).  The proposed research plan should describe the long-term goals for transitioning a BRIC supported researcher’s subproject(s) to independent competitive grant support through applications submitted by junior faculty members to relevant public and private research funding agencies.    

More specifically, each proposed junior faculty member subproject research plan should include the following:

The proposed research plan for each subproject should not exceed 6 pages per sub-project, excluding the budget. The page limitation will be strictly adhered to for review purposes. 

Two-year institution applicants are not required nor will they be funded to support mentored junior faculty research subprojects as a component of the Faculty Research Development Core.

An applicant must also include in the BRIC application the institution’s plan for adhering to the NCMHD policy on prior approval for all subprojects and pilot projects involving human subject or vertebrate animals that are proposed for delayed onset of the research subproject (see NOT-MD-08-002) in out years of a funded grant. The applicant must show the duration and total number of junior faculty members who will conduct the research subprojects during the life of a funded grant project. Each identified mentoring faculty member must be recognized as an accomplished investigator in the research area proposed by the junior faculty member and be willing to provide supervision, guidance and direction for the mentee’s career development and research plan. However, the mentor cannot be the prime researcher for the proposed research subproject.

All mentored research career development programs must be tailored to meet an individual junior faculty member needs.  Each junior faculty principal investigator and mentor is jointly responsible for preparation of the junior researcher training plan and research protocol.  Faculty applicants must obtain the support of their department chair and justify their commitment and the need for this training.  They must provide a convincing case that the proposed period of support will substantially enhance the junior faculty member’s career as an independent investigator in their chosen area of health disparities research.  Unless extenuating circumstances are justified in the grant application and approved by NCMHD, mentoring of junior faculty should be limited to two years. Both the applicant institution and the sponsoring partner department or institution must demonstrate a commitment to the development of the candidate as a productive, independent investigator.

The commitment of the applicant institution to support the junior faculty career research plan should be clearly stated in the grant application. This should include a statement from the proposed mentor, and academic vice president and/or academic dean that junior faculty will be provided sufficient release time from other duties to accomplish the faculty development goals of BRIC. Applicant institutions may choose to establish faculty research career opportunities that are inter-departmental or external to the applicant institution.  All ongoing capacity building partnership and collaborating relationships activities that will require the use of more that 5% of a funded grant resources annually should be established with research intensive institutions that are within a 50 mile radius of the applicant institution.

3.  Academic Readiness/Strengthening of Students Core

This core provides resources for an applicant institution to develop and implement skill enrichment activities, coursework and/or special academic initiatives that are designed to prepare students for successful completion of remediation, basic or advance level courses necessary for pursuing baccalaureate or graduate degrees in biomedical, clinical, behavioral or social research degree programs. The major objective of this core is to strengthen academic programs to increase the pipeline of biomedical and behavioral science graduates from health disparity populations.  This is a necessary first step to increase diversity of professional personnel investigating health disparities.

The applicant’s proposed plan should provide students with essential academic coursework, training and enrichment skills that will enable them to transition to the next highest level of preparation for a research degree program in either life, biomedical, behavioral or other related science career areas.  These developmental academic activities may include enrichment instructional strategies that inculcate an interest among students in pursuing advanced studies in the sciences, bioengineering and/or mathematics; and essential skill development courses such as time management, test taking, note taking and independent learning required to pursue an advanced degree in the sciences and research. More specifically, the operational objectives of this core are:

a)  To enhance student competencies and preparedness to pursue an advanced course of study following the completion of a two or four year academic degree program in the basic life sciences, biomedical research, social and behavioral sciences or related allied health areas;

b)  To promote educational opportunities that will encourage students and faculty to pursue clinical, biomedical and behavioral science research careers;

c)  To encourage the use of state-of-the-art teaching enterprising methods for building research infrastructure for academic and career pursuits, including providing technical assistance and decreasing the digital divide by utilizing cutting-edge multi-faceted instructional approaches, diverse learning environments and new bioinformatics technologies.

Although the BRIC program does not authorize nor provide stipends, scholarships or direct support for student participation in research, this core will allow BRIC applicants to institute an academic enrichment program that prepares students who wish to enter a research career path in science.  An applicant may request funding to support and sponsor academic preparedness courses, basic science and mathematics readiness courses, mentoring activities, including pre-graduate school workshops, GRE preparation training, and career counseling activities.  Such activities should be designed to support and/or facilitate the students' enrollment into baccalaureate, master or doctoral programs. As part of this core, the applicant must show the relationship between the use and availability of BRIC support and the number of students who successfully pursue postsecondary or graduate science/research degree program(s) including students who enroll in science/research degree programs at research intensive institutions or in departments that are directly supported by the BRIC grant or other NIH funding sources. A grantee will be considered successful if there is at least a 20 – 25% annual increase in the number students from health disparity populations that are successfully pursuing science or mathematics degrees at the applicant institution.

4.  Shared Research Facilities and Resources Enhancement Core

This core is designed to provide an institution with resources to establish a “state of the art” basic science and biotechnological research environment for student and faculty to conduct research projects and/or learn the fundamentals and essentials of research methods and approaches.  The applicant plan must describe how the proposed resources will be used to enhance the academic development and advancement capacity building goals in the academic area of concentration. Answers to such questions as how requested facilities and technology resources will be used to build, sustain and/or enhance existing research training infrastructure, advance academic preparation of students, and how these resource will help the institution build a sustainable faculty research program that is consistent with, and meets the long term objectives of the institutional overall research development plan.  When appropriate, the applicant should discuss the role collaborative institutions (research partners) will play in helping the applicant create and maintain an environment and framework suitable to achieve the objectives of the BRIC Grant Program. 

Further, this core provides opportunities for faculty members and students at the applicant institution to work with improved equipment, enhanced facilities and new technologies that broaden the overall learning and research environment of the institution. While research, per se is not conducted as part of this core, quality assurance activities are appropriate.  Some examples of shared resources that may be supported by this core are:  technology automation equipment for large batch preparations, animal care facilities, complex instrumentation, electron microscopy, mass spectrometry, data and statistical services, and networking and web-based activities. The applicant must include an outcome based descriptive plan that illustrates how the shared resources will enhance the research infrastructure and/or advance the overall strength of the primary academic unit where the BRIC Project will be housed within the applicant institution. The applicant must explain how the shared research resources will expand research and training opportunities and benefit the faculty and students at the applicant institution.

An applicant must show in the proposal that at a minimum, the shared research facilities and resources enhancement core resources will be used for activities or facilities to support the research and/or research training of at least one-third or more of the faculty investigators with BRIC, students and/or other independently supported peer-reviewed research project activities. 

5.   Renovations and Alterations

This FOA provides for a one-time cost expenditure for renovations and alterations by new applicants for up to $150,000 for a four-year institution and up to $125,000 for a two-year institution.  Renewal applicants may only apply for one-time cost expenditure for renovations and alterations for up to $75,000 for four year institutions and up to $50,000 for two-year institutions.  This one-time request can be for work that will be completed in year one or year two of the project. The applicant must show the relevance and need for the alterations and renovations and that they are a necessary capacity enhancement for the overall research program, the proposed faculty research initiatives, and/or academic research training of students at the applicant institution.  The funds of this core are not to be used as a construction grant for completion of shell space in existing buildings.  As part of the renovations and alterations, purchase of essential research equipment and/or instrumentation for enhancement of the renovation space, laboratories or facilities are permitted. 

Equipment intended for basic teaching and non-research related activities or for student non-research, academic development and training will not be supported under this provision.  The purchase of laptop computers must have a strong justification. All proposed alterations and renovations must be justified and consistent with the institution’s research capacity improvement and infrastructure development plan. Renovation and alteration funds cannot be used to provide support for:  general operational expenditures, personnel, consumable supplies for routine animal care, small equipment items, specialized research equipment or facilities for use by only one or two investigators, new construction, equipment intended for only teaching or non-research purposes; and other office equipment, computers, data processing items or physical security systems.

For vertebrate animal research facility, the applicant must relate the proposed alterations and renovations to the animal populations (by species) and/or research projects that will use the facility. Provide a list of the functional components, including the size (dimensions) and square footage of each component (room, alcove, cubicle, etc.) that will be directly affected by the renovation project; and list only preliminary engineering criteria applicable to each component (mechanical, electrical, and utilities).  More specific details can be provided after the grant is awarded.  This includes information such as the number of air changes per hour, electrical power, light levels, hot and cold water, steam, etc., list of appropriate architectural criteria, such as width of corridors and doors, surface finishes, etc, list all fixed equipment items requested for the renovated area; and list all movable equipment items requested for the renovated area.

Applicants should refer to the NIH Grants Policy Statement, Part II, for specific policy guidelines and information on alterations and renovations.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This funding opportunity announcement (FOA) will use the P20 award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project.  The Project Director/Principal Investigator (PD/PI) will be solely responsible for overseeing the planning, directing, and executing the proposed project.

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see 

2. Funds Available

The NCMHD intends to commit approximately $5 million dollars in FY 2010 to fund approximately four to five new and renewal grant awards in response to this FOA.  An applicant may request a project period of up to five years and a budget for direct costs up to $650,000 dollars per year for four-year institutions and up to $420,000 per year for two-year colleges.  Because the nature and scope of the proposed research and related capacity building activities will vary from application to application, it is anticipated that the size and duration of each award will also vary.  In the first year of support for a new applicant, a one-time allocation of $150,000 for renovations/alterations may be added to the $650,000 maximum for four-year institutions and $125,000 may be added to the $420,000 maximum for two-year colleges. However, former RIMI grantees (renewal applicants) may only apply for a one-time award of $50,000 for two-year and $75,000 four-year institutions respectively for renovations and alterations.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitations; see NOT-OD-05-004.

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

The President, Chancellor, or Provost of the applicant institution or this administrator’s senior administrator designee can serve as the PI/PD for the proposed BRIC project. If a senior administrator is delegated as PI/PD, that individual must have the responsibility and authority to make high-level decisions regarding faculty teaching time commitments, curricula, and research administration-related decisions for the proposed BRIC project.  Each PI/PD is responsible and accountable to the grantee institution, or, as appropriate, to a collaborating institution for the proper conduct of the entire project and program activities, including the submission of required reports.

The BRIC project coordinator must be appointed by the PI/PD and must be a full-time academic dean or senior faculty member at the applicant institution.  This is a special requirement of the BRIC program.  This requirement and the PI/PD requirement are necessary in order to ensure that the BRIC project has the oversight of the institution’s chief executive officer, and the proposed infrastructure and capacity-building activities outlined in the application are consistent with the long-term institutional master plan, vision and mission.  The BRIC project coordinator is classified as key personnel and has responsibility for the day-to-day management of the grant.  He/she may also be designated as a co-investigator (not co-PI/PD) for the application.

Thus, any individual with the skills, knowledge, and resources necessary to carry out the proposed research capacity-building plan is invited to work with their institutional leadership 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. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see for instructions).   

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications.  Applicants may not submit more than one application.  For institutions of higher education, separate institutions for purposes of this FOA are entities governed by either a Chancellor or President.

Resubmissions.  Resubmission applications are not permitted in response to this FOA.

Renewals.  Renewal applications are permitted in response to this FOA.

To be eligible for this FOA, applicant institutions must have existing federal research support and/or research infrastructure as reflected in a level of NIH institutional funding of less than or equal to $25 million dollars for the year 2008.  See the following link maintained by the NIH Office of Extramural Research for determining the level of NIH funding for your institution,

Academic institutions and/or health professional schools that award the PhD, PsyD, ScD, MD, DDS, DO, PharmD, DVM, DPT, or other equivalent doctoral degrees in the discipline of science, engineering, public health, mathematics or medicine are NOT eligible to apply for this FOA.  However, such institutions may serve as collaborating research partners to applicant institutions.

An institution/organization may not apply for and/or be awarded two BRIC Grant awards for the same grant period.

Existing NCMHD Centers of Excellence (P20 and P60) or R24 grantees are not eligible to apply for a BRIC grant prior to the last year of their current grant. 

Institutions/organizations may not have a NCMHD BRIC grant and a NCMHD Centers of Excellence grant at the same time. 

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email:

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide (

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

Applications with Multiple PD/PIs are not permissible for this FOA.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: April  21, 2010
Application Receipt Date:  May 21, 2010
Peer Review Date(s):  June-July 2010
Council Review Date(s): August 2010
Earliest Anticipated Start Date: September  2010

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

DeLoris L-James Hunter, Ph.D., M.Ed. 
Division of Extramural Activities and Scientific Programs
National Center on Minority Health and Health Disparities
National Institutes of Health
6707 Democracy Boulevard, Suite 800 MSC 5465
Bethesda, Maryland 20892-5465
Telephone: (301) 402-1366
FAX: (301) 480-4049

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Prabha Atreya, Ph.D.
Chief, Office of Scientific Review
Division of Extramural Activities and Scientific Programs
National Center on Minority Health and Health Disparities

6707 Democracy Boulevard, Suite 800
Bethesda, MD 20892-5465

Telephone: (301)
FAX: (301) 480-4049
3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by NCMHD.  Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a FOA, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at:

4. Intergovernmental Review

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. The Grants Policy Statement can be found at NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement

6. Other Submission Requirements


Program Governance

The governance structure must include a Principal Investigator (PI), Project Director (PD), and a BRIC Advisory Committee.

Principal Investigator (PI) and Project Coordinator (PC)

The PI/PD for the proposed BRIC project must be the applicant institution’s president, chancellor or provost or a senior administrative designee. If a senior representative is designated as PI, the individual must have the responsibility and authority to make high-level decisions regarding faculty time commitment, curricula, and research administration-related decisions for the proposed BRIC project. Co-PIs and multiple PIs are not eligible under this solicitation.

The Project Coordinator (PC) must be an academic dean or full-time senior faculty member, appointed by the PI. The appointed person must be willing and able to devote the time and effort necessary for effective implementation and management of the BRIC grant. The PC may be designated as a co-investigator, but not a co-PI, for the BRIC. The PC will have oversight and responsibility for the day-to-day management of the grant. He/she should be knowledgeable about minority health issues, health disparities among racial and ethnic minorities and other underserved populations, provisions for faculty training and research, capacity-building needs in minority-serving institutions, and be an experienced biomedical, bio-behavioral, or social research scientist as well as an effective administrator.

BRIC Advisory Committee

The BRIC Project must have an Advisory Committee, comprised of both internal and external experts who are knowledgeable about academic infrastructure capacity-building, career development of diverse teaching populations, and scientific research relevant to minority health and health disparities.  The advisory committee should report directly to the BRIC PI. The Advisory Committee should consist of five to seven members and must include a cross-section of qualified faculty and appropriate members external to the institution. The advisory committee role is to provide advice to the PI and PC for the BRIC Project. If the BRIC Project has a collaborating partner, at least two of the members of the Advisory Committee should be from the appropriate academic concentration areas of the collaborating institution. At least 50 percent of Advisory Committee members must be external to the applicant institution. The Advisory Committee should possess, among its members, the experience and knowledge to provide appropriate guidance for the program design, implementation and evaluation, including the building of Building Research Capacity and Infrastructure (BRIC) in relevant scientific disciplines.   

It is essential that the Advisory Committee have representatives that are knowledgeable about the applicant institution's mission, goals, strengths and weaknesses in biomedical and related research training, capabilities and resource needs.  Guidance from such a group should ensure critical input necessary to develop and maintain a comprehensive BRIC program.  Competing or conflicting interests must be carefully considered when developing the operational procedures for the advisory committee.  The advisory committee should meet at least twice annually.  BRIC funds may support travel and per diem for Advisory Committee meetings. However, honorarium and consultant fees for advisory committee members are not allowable costs under this FOA.

Applications that do not include a BRIC Advisory Committee will be deemed non-responsive to this FOA and will not be forwarded for scientific review.

Modify the PHS 398, starting with the Table of Contents, to include the following and in the following order:

Consolidated BRIC Budget.  The consolidated budget should consist of a compilation of the individual budgets for each subproject and each core area of emphasis.  Except in the first year of the project, direct costs may not exceed $650,000 per year for a four-year institution and $420,000 for a two-year college. (See the section on Renovations: Use form pages 4 and 5).

Budgets for Cores and Areas of Emphasis. Use form pages 4 and 5 to develop separate budgets for each of the four Cores.  For each area of emphasis (e.g., facility improvement, developmental/collaborative research, etc.), include the salary support as well as the costs of the activities (i.e., laboratory renovation, research subprojects, etc.) that support that core area of emphasis.  Support for staff from the applicant institution, if applicable, should be listed as personnel, and support for mentoring and other personnel should be listed under consultants (including consulting fees and travel expenses). Resources for partnerships or external academic enrichment may be included under special consortium/contractual costs.  Include the following in the administrative budget: the Program Director/Principal Investigator, Project Coordinator administrative and key support personnel and other budgetary items needed for central coordination of the RIMI Project.  The need for each budget item requested and its cost should be thoroughly explained and documented in the section labeled: Budget Justification.

Supplemental instructions for major areas:

  I.    Narrative Description of the Overall Proposed Infrastructure and Capacity Building Plan (12-page maximum)

Overall, the proposed Five Year Plan for the BRIC Program should include specific measurable objectives, action plan(s), timelines, expected outcomes, and all tables, graphs, charts, figures and diagrams must be included in the 12-page limit.  Applicants are encouraged to be succinct.

II.    Summary Progress Report (required for renewals only) - 6-page maximum

Previously funded NCMHD RIMI grantees must include in this section a summary progress report generally describing how the success of the program has been measured, what the program considers its most important successes and accomplishments and how these accomplishments have contributed to realizing the funded goals and objectives of the program (e.g., describe improvements in the infrastructure and capacity for conducting minority health or health disparities research established at the institution using NCMHD funding).

III.    Administrative and Capacity Building Core -- 12-page maximum

IV.        Other Cores

Provide a separate detailed plan for each of the following Cores:

Clearly describe the objectives, needs, and rationale for the approach selected, implementation timetable in the context of available resources, alternatives considered, and overall program goals and objectives.  Indicate the specific objectives, measurable expected outcome(s) and proposed timeline associated with each goal area (area of emphasis), and describe briefly the action plan for accomplishing these objectives. 

V.         Mentored Research Career Development of Junior Faculty-- 6 page maximum 

Provide the following information for each junior faculty member that will be supported by BRIC for up to two years:

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See

Do not use the Appendix to circumvent the page limitations. All page limitation MUST be adhered to.  An application that does not observe the required page limitations  may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Review Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Center on Minority Health and Health Disparities and in accordance with NIH peer review procedures (, using the review criteria stated below.

As part of the scientific peer review, all applications will:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. 

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed). 

Scored Review Criteria.  Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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?  Does this project address an important research infrastructure problem; namely, does the proposed infrastructure and capacity-building plan address an important research training deficiency at the applicant institution? If the aims of the application are achieved, how will the institution’s research infrastructure be strengthened and to what extent strengthens and/or enhances the academic research capacity of the applicant institution? Do the proposed core components or research subproject(s) address areas of emphasis, such as strengthening faculty research capacity, and institutional research acumen, student preparedness in mathematics and science, minority health and/or elimination of health disparities? 

Investigator(s).  Are the PD/PIs, 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 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?  Are the qualifications, experience and commitment of the PD, and his/her ability to provide effective leadership in implementing proposed institutional capacity-building and infrastructure BRIC plan adequate?

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?

Are the organization and administrative structure that will be established to accomplish BRIC program goals clearly described and appropriate?  Are the conceptual or clinical framework, design, and activities well integrated and appropriate to the aims of the project  Is the applicant’s overall plan reasonable, adequate, and does it provide the needed foundation for the research infrastructure in the areas of concentration(s) or academic unit? Is this plan supported and balanced for faculty and students’ research training  Has the applicant included a well developed formative and/or summative program evaluation plan, and does it include measurable objectives, timelines and reporting requirements? Are the proposed BRIC Advisory Committee and other consultative resources for guiding the implementation of the overall project and the relationship of the proposed BRIC plan to the applicant’s overall five year institutional infrastructure development plan appropriate?

Environment.  Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?  Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?   Does the scientific environment offer any special or specific research training opportunities for students and other faculty of the BRIC focused academic area(s)?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit of the subprojects, if applicable.  Separate scores will be given for the subprojects.

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.

Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

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, see

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.

Resubmission Applications.  Resubmissions are not allowed for this FOA.

Renewal Applications.  When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Revision Applications. Revisions are not allowed for this FOA.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations.  Foreign are not allowed in this FOA.

Select Agents 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 (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (; and 3) Genome Wide Association Studies (GWAS) (

Budget and Period Support.  Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Selection Process

The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates   

Not Applicable

Section VI. Award Administration Information

1. Award Notices

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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the Notice of Award will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Award will be mailed to the business official.

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. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. 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 (

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

DeLoris L-James Hunter, Ph.D., M.Ed.
Division of Extramural Activities and Scientific Programs
National Center on Minority Health and Health Disparities

6707 Democracy Boulevard, Suite 800 MSC 5465
Bethesda, MD 20892-5465
Telephone: (301) 402-1366
Fax: (301) 480-4049

2. Peer Review Contacts

Prabha Atreya, Ph.D.
Chief, Office of Scientific Review
National Center on Minority Health and Health Disparities

6707 Democracy Boulevard, Suite 800
Bethesda, MD 20892-5465
Telephone: (301) 594-8696
FAX: (301) 480-4049

3. Financial or Grants Management Contacts:

Priscilla Grant, J.D., C.R.A.
Chief, Grants Management Office
Division of Extramural Activities and Scientific Programs
National Center on Minority Health and Health Disparities
6707 Democracy Boulevard, Suite 800 MSC 5465
Bethesda, MD 20892-5465
Telephone: (301) 594-8412
FAX: (301) 480-4049

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals ( as mandated by the Health Research Extension Act of 1985 (, and the USDA Animal Welfare Regulations ( as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts,

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (; a complete copy of the updated Guidelines is available at The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at and at Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding ( It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy ( investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (, to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website ( provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at

URLs in NIH Grant Applications or Appendices:

All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at and is not subject to the intergovernmental review requirements of Executive Order 12372. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see:

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