Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH)  (http://www.nih.gov)

Components of Participating Organizations
National Center on Minority Health and Health Disparities (NCMHD) (http://www.ncmhd.nih.gov)

Title:   NCMHD Research Infrastructure in Minority Institutions (P20)

Announcement Type
This is a reissue of RFA-MD-07-002 which was released on February16, 2006

Update: The following update relating to this announcement has been issued:

Request For Applications (RFA) Number: RFA-MD-08-002

Catalog of Federal Domestic Assistance Number(s)
93-307

Key Dates
Release Date: April 8, 2008
Letters of Intent Receipt Date: May 10, 2008
Application Receipt Date: June 10, 2008
Peer Review Date:  July 2008
Council Review Date: August 2008
Earliest Anticipated Start Date: September 2008
Expiration Date: June 11, 2008

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

The NCMHD Research Infrastructure in Minority Institutions (RIMI) Program focuses on building research capacity in predominantly minority-serving academic institutions that offer one or more associates, baccalaureate and/or master's degrees in the life sciences, behavioral sciences and/or other health related areas.  The RIMI program seeks to strengthen the integration of teaching and research at predominantly minority-serving academic institutions.

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 and Information

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

Background

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 (See, http://www.nih.gov/about/hd/strategicplan.pdf, page 7).  The specific population groups are 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 in rural and urban areas). These populations are hereafter referred to as health disparity populations.

Historically, the RIMI Grant Program was developed and implemented 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), February 1992.  This meeting produced the “Minority Programs Fact-Finding Teams Recommendations” publication.  These recommendations gave guidance for future development of policies on the support for minority programs and initiatives at the NIH.  One of the overall 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 gave notice of 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 engineering workforce would enable society to better address its diverse needs and the needs of health disparities populations.

In addition, the NCMHD acknowledges that RIMI-eligible and other minority-serving academic institutions play an important role in the early training of minority scientists.  Thus, continued support for the development of sustainable research programs at non-research intensive institutions of higher education, is expected to have a three-fold impact on the discovery of new knowledge in science and technology, possible refinement and greater understanding of the nature of health disparities; and the development of a knowledge infrastructure that contributes to the intellectual development of researchers and health professionals that are trained at such institutions. History has shown also that many of healthcare researchers and future professionals who graduate from minority institutions are likely to devote their careers providing biomedical and behavioral services in minority communities. (Public Law 106-525; Allocating Federal Funds for Science and Technology, Supplement 4, http://bob.nap.edu/html/fedfunds/).

The NCMHD RIMI Program

The major goal of this FOA is to build, strengthen and/or enhance the research infrastructure and research training capacity of minority-serving institutions.  This includes establishing a program with benchmarks for developing a cadre of clinical, biomedical and behavioral research scientists who possess the skills, knowledge and abilities to engage in leading edge research and innovative research training that ultimately will contribute to reducing and eliminating health disparities in the United States.  In order to reach the goals of this grant program, the NCMHD invites new and renewal applications.

In order to achieve the goals of the RIMI Grant Program, there are critical research training, facilities infrastructure and curricula development capacity gaps and shortfalls that must be closed, ameliorated and/or eliminated.  Many of these areas of concern have been exacerbated by the lack of research infrastructure and adequate faculty and students’ research training programs at many of the nation’s two- and four-year minority-serving non-research intensive academic institutions, especially the designated Tribal Colleges and Universities (TCU), Historically Black Colleges and Universities (HBCU) and Hispanic-Serving Institutions (HSI).  These institutions are encouraged to apply for grants under this FOA.

The RIMI grant award provides a means by which an institution can: 1) strengthen its basic research infrastructure and capacity to improve and/or strengthen the institution’s basic, life or biomedical science, mathematics and 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, as part of the training process and under the clear supervision of a senior research mentor, individual faculty-initiated research subprojects that ultimately can lead faculty trainees to successful independent research in minority health and/or research that addresses 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 RIMI 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; mini faculty and/or student research initiatives; research journal club; research faculty loan program; research curriculum enhancement; and academic developmental and enrichment courses. Additional examples of acceptable approaches can be founded 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 RIMI grant funds will afford an institution the resources that are needed to establish a cadre of research trained faculty who are able to provide a strong academic foundation for students who can successfully pursue post-baccalaureate research degrees that address issues related to minority health and the elimination of health disparities.  Further, it is expected that RIMI funding should allow an institution to build a research infrastructure that is capable of supporting the requirement of more advanced NCMHD research grant programs, e.g., P20 Centers of Excellence, P60 Centers of Excellence and the Community-Based Participatory Research Grant Programs.  In sum, the RIMI Grant Program serves as the foundational research training building blocks that support the NIH-NCMHD long-term strategy to create a well trained cadre of biomedical, clinical, behavioral and social science researchers who possess the competencies necessary to prepare students for research career paths as well as engage in leading edge or innovative research that will contribute to reducing and eliminating health disparities in the United States. 

The RIMI Grant Program focuses on three major program areas: 1) institutional research infrastructure and research administration enhancement; 2) faculty research development and research training; and 3) academic preparation of students in pursuit of research careers. Within each of these components, the specific objectives for program concentration are delineated within the confines of five core areas: 1) Institutional Research Administrative and Infrastructure Capacity Building; 2) Faculty Research Development and Training; 3); Academic Enrichment Programs in Basic Research Methodologies for Students 4) Research Facilities and Technology Enhancement; and 5) Shared Intra-or Inter-Departmental Research and Research Resources.  The aforementioned objectives have been translated into the five critical core areas that can solidify an academic research training and research mentoring program.

Four-year institutions must include at least the Institutional Research Administrative and Infrastructure Capacity Building, Faculty Development and Research Training, and the Academic Enrichment Program in Basic Research Methodologies for Students cores in their scope of work (research plan). In addition, the four-year institutions must include one of the remaining two optional cores for a total of four cores.  The required cores for two-year institutions are the Institutional Research Administrative and Infrastructure Capacity Building and the Academic Enrichment Program in Basic Methodologies for Students cores.  In addition, the two-year institutions need only include one of the three remaining optional cores, for a total of three cores, within their proposed RIMI project. 

The entire list of possible Core areas includes:

1.  Institutional Research Administrative and Infrastructure Capacity Building Core

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 health disparities populations, and those of eligible institutions.

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.

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, etc

Applicants should describe the administrative structure of the RIMI Project and the roles and responsibilities of all key personnel.  The Research Administrative and Infrastructure Capacity Building core is responsible for: 1) the allocation and oversight of all RIMI program activities, projects and resources; 2) establishing and maintaining all partnerships, advisory committees, cores, training and evaluation activities essential to the success of the RIMI project; 3) the coordination of all RIMI sponsored research to be supported under the auspices of the RIMI grant program; and 4) overseeing the process for the solicitation, review, and selection of all approved faculty research subprojects.  All RIMI grantees are encouraged to establish and maintain a RIMI Informational website.  Additionally, through the efforts of the administrative core, each NCMHD funded project is expected to become a valued, trusted, institution-wide resource for expanding the capacity and competence of the institution, and that of NIH funded researchers and students in conducting minority health and health disparities research.  A RIMI program director, appointed by the PI, is expected to maintain close ties with the PI and interact with all the administrative leadership of the institution to enhance the success of the RIMI project. Further, the project director will provide oversight for the entire grant, and monitor the implementation of the Faculty Research Development and Training Core, including the progress of each individual research subprojects.

The applicant must identify and clearly describe both, the overall and the specific project goals, academic discipline(s) that the project will address and describe the proposed plan, both operationally and theoretically, that will be implemented during the duration of the project. The overall project evaluation is required.  The evaluation plan should clearly explain how program progress will be measured, formatively and summatively. The applicant must clearly illustrate how the receipt of RIMI funding will strengthen its research capacity foundation for students and faculty at the institution.  This includes outlining measurable objectives, action steps, timelines and expected accomplishments and successes.  Funds up to $200,000 at a four-year institution and up to $120,000 per year at a two-year college may be used to support senior research faculty appointments. These funds may be used to cover full or partial costs related a faculty member’s salary, research portfolio and supplies, and/or research lab and equipment costs.

Activities required for the smooth operation of the RIMI project should be included in the administrative core, if not appropriate for inclusion as another core area activity.

2.     Faculty Research Development and Training Core

The purpose of this Core is to facilitate the long-term development of independent faculty initiated investigations, and to create an environment for sustainable faculty research training programs in minority health and health disparities research. Two-year institutions applicants are not required to engage in individual faculty-initiated research sub-projects.  Four year institution applicants are required to include this core area as a component of there application.

This Core provides, per year, an opportunity for a maximum of three sub-projects, one senior level faculty and up to two junior or mid-level faculty members, during any giving project period.  Sub-projects are designed to allow faculty to develop independent research projects as part of the RIMI Project. An applicant may provide up to 40 percent time and effort for subproject investigators during the academic year and 70 percent time and effort during a summer session. This will allow a subproject PI to make a significant commitment to the development of a research development training portfolio at the applicant institution. The requested support for faculty initiated research subprojects must not exceed 50 percent of the total direct costs of a RIMI grant award. The specific objectives for this core area are:

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

b)  To encourage the establishment of research mentoring between the academic departments of the applicant institution and a research intensive institution partner to enhance research opportunities and training for junior faculty and students in research related skills areas, including the development of grant applications, writing peer-reviewed research papers for publication as well as the development and management of research grants and programs.

c)  To facilitate investigator networking through research interest or working groups aimed at facilitating collaborative research project development and raising awareness of emerging technologies and areas of emphasis in research, especially health disparities research.

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

This core is intended to facilitate the long-term development of independent faculty initiated investigations and to create an environment for sustainable faculty research training programs in minority health and health disparities research.

Sub-Projects:  Each faculty initiated research subproject that is included in the application should be related improving minority health or eliminating health disparities. The plan should describe the long-term goals for transitioning a RIMI supported research subproject(s) to independent competitive grant support through applications submitted by faculty members to relevant public and private research funding sources.  This plan should include measurable objectives, measures of success with specific milestones and expected outcome(s).  Prospective subproject investigators must have at least a junior or mid-level full-time faculty appointment at the applicant institution.  The proposed research plan for each subproject should not be more than 8 pages each.  The proposed research plan should include the following:

3.  Research Facilities and Technology Enhancement Core

This core is designed to provide an opportunity for an institution to establish a “state of the arts” basic research and technological environment for training student and faculty as they learn the fundamentals and essentials of research methods and approaches to studying minority health and factors which can impact or influence the elimination of health disparities among medically under-served populations.  The applicant must describe how this proposed plan fits within the institution’s overall mission and capacity building goals, including 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/or implement a sustainable faculty research program that is consistent with, and meets the long term objectives of the institutional overall plan.  When appropriate, the applicant should discuss what 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 RIMI Grant Program. 

4.  Academic Enrichment Programs in Basic Research Methodologies for Students Core

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, social sciences, behavioral sciences or related allied health areas;

b)  To promote educational experiences and opportunities that encourage students and faculty to pursue clinical, biomedical and behavioral science research careers that will contribute to the elimination of health disparities in the United States; and

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

The objective of this core is to strengthen the pipeline of biomedical and behavioral science related graduates from underrepresented groups and/or health disparities populations, a necessary first step in increasing diversity in professional personnel investigating health disparities. The applicant’s proposed plan should provide students with the necessary academic coursework, training and skills that will enable the student’s transition to the next highest level of preparatory 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 in pursuing advanced studies in the sciences, bioengineering and/or mathematics; and essential skill courses such as time management, test taking, note taking and independent learning required to pursue an advanced degree in the sciences. 

Although the RIMI program provides no direct support for student participation in research, this core is designed to allow RIMI applicants to institute an enrichment program to prepare students for entering a research career path in science.  Under this core an applicant may support and sponsor academic preparedness courses, basic science and mathematics readiness courses for students at two-year colleges, mentoring activities, such as pre-graduate school workshops, GRE preparation training, and counseling activities.  Such activities should be designed to support and/or facilitate the students' pursuit of enrollment into baccalaureate, master or doctoral programs. One question the applicant should address is, are there identifiable linkages between the availability of RIMI support and the number of students who pursue an advance research postsecondary degree program(s), in particular at mentoring institutions or in the departments that are directly supported by RIMI or other NIH funding?

5. Shared Intra- and Inter-Departmental Research and Research Resources Core

This core is intended to enhance opportunities for faculty investigators at the applicant institution to take advantage of improved facilities and new technologies that could enhance or broaden the research experience and initiatives. This core should support an academic unit research plan for faculty and students. While research per se is not conducted as part of the shared research resources core, quality assurance activities that evaluate the operation, resources, quality and utilization of the core and that are directed at problem identification and improvement of core functioning are appropriate.  Some examples of support that this core typically provides are: a) technology that implements automation of large batch preparations; b) complex instrumentation, e.g., electron microscopy, mass spectrometry, electro-physiology; c) information processing, data management, d) statistical services, and e) networking activities including the establishment of scientific working groups, etc.

The applicant must include a 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 RIMI Project is housed within the applicant institution. The applicant must explain how the shared research resources core will expand research training opportunities and benefit the faculty and students at the applicant institution.

The rationale for the establishment of the shared research resources component is to ensure adequate research resources for projected use by RIMI and/or non-RIMI investigators (e.g., MBRS Score (Support of Continuous Research Excellence) at the grantee institution.  Accordingly, the minimum requirement for establishing a shared resource component is that significant usage of the shared resource (activities or facility) will be by two or more faculty investigators with RIMI and/or independently supported peer-reviewed projects. 

Renovations and Alterations

This RFA provides for a one-time cost expenditure for renovations and alterations, up to $150,000 for a four-year institution and up to $125,000 [to match the available funds section] for a two-year institution.  This one-time request can be for work that will be completed in year one or year two of the award, providing the alterations and renovation projects are necessary and relevant to the overall scope of the proposed departmental research program, the proposed faculty research, and/or academic research training at the applicant institution.  These funds are not to be used as a construction grant for completion of shell space.  As part of the renovations and alterations, essential research equipment and/or instrumentation for enhancement of the renovation space, laboratories or facilities are permitted.  However, the proposed renovation/alterations must be justified, based on the proposed capacity-building infrastructure plan and related programmatic core(s). 

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. All alterations and renovations must be consistent with the institutional research infrastructure development plan. Renovation and alteration funds are not intended to provide support for:  General operational support for the resource (e.g., funding for personnel, consumable supplies for routine animal care, or small equipment items); specialized research equipment or facilities for use by only a few investigators; new construction, including the completion of shell space; equipment intended for teaching or non-research purposes; office and research equipment, computers or data processing items; nor physical security systems.

Relate the proposed alterations and renovations to projected animal populations (by Species) and/or research projects that will use the facility; (2) list 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; (3) list engineering criteria applicable to each component (mechanical, electrical, and utilities).  Include information such as the number of air changes per hour, electrical power, light levels, hot and cold water, steam, etc.; (4) list appropriate architectural criteria, such as width of corridors and doors, surface finishes, etc.; (5) list all fixed equipment items requested for the renovated area; and (6) list all movable equipment items requested for the renovated area.

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

Evaluation Plan

Each application must include an evaluation plan for assessing the overall success of the RIMI project in achieving its program goals and objectives. Benchmarks should be identified and specific plans and procedures must be described to capture, analyze and report outcome measures that would determine the success of the research infrastructure and capacity building plan for achieving the RIMI goals. A comprehensive evaluation should include the following:

Since the RIMI Program seeks to determine the long impact of this investment in building a solid research infrastructure and research training at its grantee institutions, the applicant should describe a system for tracking faculty progress toward independent research funding and the students’ transfer rates to the next higher-degree program, and graduation rates from the next higher-degree program.  Applications that do not include an evaluation plan will be considered non-responsive and will be returned to the without review.

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 will use the P-20 award mechanism(s).
The applicant will be solely responsible for 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 http://grants.nih.gov/grants/funding/phs398/phs398.html). 

2. Funds Available

The NCMHD intends to commit approximately $4 million dollars in FY 2008 to fund approximately four to five new and renewal grant awards in response to this RFA.  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.  Although the financial plans of the NCMHD 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.  In the first year of support for the new five-year project period a one-time allocation of $150,000 for renovations may be added to the $650,000 maximum for four-year institutions and $125,000 for renovations may be added to the $420,000 maximum for two-year colleges.  Facilities and Administrative costs (F&A) will be provided.  Two and four year college renewal applicants may apply for a one time cost expenditure for renovation and alteration in the amount of $50,000 and $75,000 respectively.

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 costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

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

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

The President of the applicant institution or the president’s designated senior representative must serve as PI for the proposed RIMI project. If a senior representative is designated as PI, the individual must have the skills and knowledge to provide leadership and authority to make high-level decisions regarding faculty time commitment, curricula, and research administration-related decisions for the proposed RIMI project.  Each PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports.

The RIMI program director must be appointed by the PI and must be a senior fulltime faculty member at the applicant institution.  This is a special requirement of the RIMI program.  This requirement is necessary in order to ensure that the program 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 RIMI project director is considered as key staff and has oversight for the day-to-day management of the grant.  He/she may also be designated as a co-investigator (not co-PI) 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 All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm 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

Applicants are not permitted to submit a resubmission application in response to this FOA.

Renewal applications will be permitted for this FOA.

Academic institutions and/or health professions schools that award the Ph.D., Psy.D., Sc.D., M.D., D.D.S., Pharm. D., D.V.M. or other equivalent doctoral degrees are not eligible to apply.  However, such institutions may serve as collaborating research partners to applicant institutions.

An institution may not apply for and/or be awarded two RIMI Grant awards for the same grant period. Existing NCMHD Centers of Excellence (P20 and P60) grantees are not eligible to apply for a RIMI grant prior to the last year of their existing P-20 or P-60 grant. 

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

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 http://www.dnb.com/us/. 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.

Research Infrastructure in Minority Institutions program, RFA-MD-08-002.

Applications with Multiple PDs/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: May 10, 2008  
Application Receipt Date): June 10, 2008
Peer Review Date:  June 2008
Council Review Date:  August 2008
Earliest Anticipated Start Date:  September 2008

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.
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
Email: watsonl@mail.nih.gov    

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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

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

Lorrita Watson, PhD
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
Email: watsonl@mail.nih.gov    

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 the reviewing Institute Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity 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 funding opportunity, 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: https://commons.era.nih.gov/commons/.

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 renewal or continuation 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 http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements and Information

SPECIAL REQUIREMENTS

Program Governance

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

Principal Investigator (PI) and Program Director (PD)

The PI for the proposed RIMI project must be the applicant institution’s president or the president’s designated senior representative. If a senior representative is designated as PI, the individual must have the skills and knowledge to provide leadership and authority to make high-level decisions regarding faculty time commitment, curricula, and research administration-related decisions for the proposed RIMI project. Co-PIs and multiple PIs are not eligible under this solicitation. 

The PD must be a senior faculty member, appointed by the PI, willing and able to devote the time and effort necessary for effective implementation and management of the RIMI grant. The PD may be designated as a co-investigator, but not co-PI, for the RIMI. The PD has oversight 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, provisions for faculty training and research, capacity building needs in minority-serving institutions, and be an experienced biomedical, bio-behavioral, or social scientist and an effective administrator.

RIMI Advisory Committee

The RIMI Project must have an Advisory Committee, comprised of both internal and external experts who are knowledgeable about scientific research and health disparities, that reports directly to the RIMI PI.  The Advisory Committee should consist of eight to twelve members and must include a cross-section of qualified faculty and appropriate members external to the institution; its role is to advise the PI, PD and RIMI Project. If the RIMI Project has a collaborating partner, at least one-third 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 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 research infrastructure in minority institutions in relevant scientific disciplines.  It is essential that the Advisory Committee have representatives that are knowledgeable about the applicant institution's strengths and weaknesses in biomedical and related research training, capabilities and needs, and overall academic goals.  Guidance from such a group ensures the critical input necessary to develop and maintain a competitive RIMI program.  The Committee should oversee progress toward the full implementation of the institution's plan for developing research infrastructure and for developing and enhancing collaborative relationships among institutions and faculty members.  Competing or conflicting interests must be carefully considered when developing the operational procedures for the Committee.  The Committee should meet at least twice annually.  RIMI funds can be used to support travel and per diem for Advisory Committee meetings.

Research Plan Page Limitations

Applicants should thoroughly review and follow the instructions accompanying the PHS 398 Form and the following:

Face Page

Item 1. Title of Project. The title should reflect the overall research emphasis of the RIMI Program.

Item 2. Response to a Specific RFA. Check "YES" and type in the number and title of this announcement.

Item 6. Dates of Proposed Period of Support. Up to five years of support may be requested. The start date should be September , 2008

Form Page 2, Description, Performance Site(s) and Key Personnel.

Program Overview. Provide an overview of your proposed program, including the objectives and specific aims and areas of emphasis. Summarize your approach for enhancing the proposed areas of emphasis.

Performance Sites. Include all locations, whether at the applicant site or the collaborating institution(s)

Key Personnel. Under key personnel, include the Principal Investigator, the Program Director, and any other individuals with a significant role in carrying out the RIMI action plan, including faculty investigators for each subproject. This should also include mentors and mentoring personnel at the collaborating institution, if applicable. All research subproject PIs are considered key staff and should be included in this section.

Form Page 3, Table of Contents.

Modify the table of contents to reflect the content and sequence outlined in the instructions in the RFA.

Form Page 4, Detailed Budget for Initial Budget Period, and

Form Page 5, Budget for Entire Period.

Consolidated RIMI 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 Areas of Emphasis. Use form pages 4 and 5 to develop separate budgets for the administrative core and each core area of emphasis.  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 area of emphasis.  Support for staff from the applicant institution, if applicable, should be listed as personnel, and support for other personnel should be listed under consultants (including consulting fees and travel expenses, or under consortium/contractual costs).  Include the following in the administrative budget: the Principal Investigator, the Program Director, 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 must be thoroughly documented in the section labeled: Budget Justification.

Form Page 6, Biographical Sketch.

Include for the Principal Investigator and the Program Director in this section.  Biographical sketches for other key personnel, including specific activity or project leaders, should be included in the section describing that activity.  The biographical sketch should list the most recent or significant publications, and overall, must not exceed four pages per person.

Infrastructure and Capacity Building Plan

Do not follow the outline in Form PHS 398. Develop the application according to the following format: Page Limitations. DO NOT EXCEED 35 PAGES FOR ITEMS 1-3 OF THE OVERALL CAPACITY BUILDING PLAN.

All tables, graphs, charts, figures and diagrams must be included in the 35-page limit. Applicants are encouraged to be succinct and are reminded that there is a requirement not to exceed the 35 pages allotted to items 1-3 of the Capacity Building Plan Description of Applicant Institution:

Note that if "preparation of students for pursuit of graduate degrees and/or doctoral programs" was considered as an area of emphasis in the Academic Career Development Core, the following section also applies.  Although the RIMI program provides no direct support for student participation in research, the RIMI program may support and sponsor academic preparedness courses, basic science and mathematics readiness courses for students at two-year colleges, mentoring activities such as: pre-graduate school workshops, GRE preparation training, and counseling activities.  Such activities should be designed to support and/or facilitate the students' pursuit of enrollment into baccalaureate, master or doctoral programs.  One question the applicant may want to address is: Are there identifiable linkages between the availability of RIMI support and the number of students who pursue an advance postsecondary degree program(s), in particular at mentoring institutions or in the departments that are directly supported by RIMI funding?

An applicants may use up to 8 pages (excluding the biographical sketches, budget pages, and references) to describe each of the research sub-projects under item 3, Research Infrastructure in Minority Institutions. Institutional Setting and Overview of General Plan -- Limit the narrative for items 1 and 2 to a total of 15 pages.

Overall Proposed Five Year Plan for the RIMI Program, including specific measurable objectives, action plan(s), timelines, expected outcomes, etc.

Organizational Structure and Administrative Core Activities.  Outline the organizational structure of the institution, showing how the RIMI PD will interface with the administrative leadership of the applicant institution.  Describe the lines of authority and indicate how the proposed organizational structure will allow the PD to best accomplish the goals and objectives identified for the RIMI program.

Areas of Emphasis

Provide a separate detailed plan for EACH CORE AREA OF EMPHASIS. In describing each area of emphasis, follow the PHS 398 instructions (pp. 17 -20) for the Research Plan and use form page 2 and forms 4 through 8. Be sure to address the important items noted below:

Narrative.  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.  Explain the management structure, and outline the corporate plan to achieve non-RIMI institutional support over time.

Shared resources/facilities.  Shared resources/facilities may comprise an independent area of emphasis or activity component within an area of emphasis.  Identify the user community and explain in detail the nature and extent of utilization by each participant, current and proposed.

Developmental/Collaborative Research.  Whether an independent area of emphasis or an activity component within an area of emphasis, in addition to the above, clearly describe the importance and relevance of the proposed collaborative projects to the applicant institution's RIMI program goals.  Also for each research subproject supported, address the following:

Limit the description of EACH research subproject to be supported to 8 pages, excluding the biographical sketches, references, and budget pages.  This is in addition to the 20-page maximum allotted to describing the plans for and management of the Cores/Areas of Emphasis.

Appendix Materials

All paper PHS 398 applications submitted for May 25, 2008 and subsequent due dates must provide appendix material on CD only, and include five identical CDs in the same package with the application.  Paper applications submitted for due dates prior to May 25, 2008 may voluntarily provide the appendix on five identical CDs; if submitting CDs it is not necessary to include a paper appendix. (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)

Do not use the Appendix to circumvent the page limitations of the Research Plan component. 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 http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Regardless of the amount requested, investigators 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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(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 http://grants.nih.gov/grants/gwas/.

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

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 NCMHD and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

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

The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. The overall grant application will be reviewed based on the following:

Significance: Does this project address an important research infrastructure problem? If the aims of the application are achieved, how will scientific knowledge or areas of professional research preparedness be advanced? What will be the effect of the research capacity-building on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? 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? How will the applicant’s proposed program contribute to developing a cadre of minority health and health disparities future researchers? Does the proposed plan provide a foundation for increasing scientific inquiry and research training to support the research plan for advancement of science among minority-serving institutions, their faculty, students and their constituency? Are the expected outcomes of the applicant’s core areas reasonable?  Do proposed activities and programs support research career training so that trainees grasp methods, technologies, treatments, services, or preventative interventions that are likely to advance the field of elimination of health disparities among racial and ethnic minorities and other medically underserved populations?  To what extent does the proposed RIMI project strengthen and/or enhance 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 mathematic and science, minority health and/or elimination of health disparities research?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are the administrative activities, research plan/ framework, design, methods, and analyses adequately developed, well integrated and appropriate to achieve the aims of the RIMI Program and each proposed subproject? Has the applicant adequately considered alternative approaches or tactics as ways to address potential problems?  Is the applicant’s overall plan reasonable, adequate and provides the needed foundation for the research infrastructure in the areas of concentration(s) or academic unit? Is this plan supported and balanced faculty and students research training?  Is the applicant’s proposed plan congruent with the institution’s overall 5-year research capacity-building plan for the focused academic unit?  Has the applicant included a well developed project formative and/or summative program evaluation plan?  Does the applicant’s evaluation plan include measurable objectives, timelines and reporting requirements?  Does the proposed research subprojects address issues related to improving minority health or eliminating health disparities?  If not, is there sound justification why a proposed research subproject does not focus on minority health or elimination of health disparities?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?  Is the project original and innovative? For example: Does the project challenge existing paradigms or practice for building research infrastructure in minority serving institutions; address an innovative approach(es) or critical barriers to progress in the field of building research capacity and infrastructure among faculty and students at minority serving two-year and four-year postsecondary institutions? Does the proposed project develop or employ novel concepts, approaches, methodologies, tools, or technologies for training to pursue degree opportunities in the area research related to minority health and the elimination of the disparities in health care among racial and ethnic minorities.

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?  Are the mentoring and/or subproject investigators appropriately trained and well suited to carry out the work that is proposed in the subproject(s)? Does each subproject PI have a senior research mentor overseeing the research study?  Is the work (research) proposed appropriate to the experience level of the subproject principal investigator and other supporting researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Does the scientific environment in which the research work will be done contribute to the probability of success and strengthen the academic unit of the RIMI project? Is there evidence of institutional and academic departmental support for the RIMI project and the faculty initiated research subprojects program?  Does the scientific environment offer any special or specific research training opportunities for students and other faculty of the RIMI focused academic area(s)?

Other major factors that will be considered in the overall evaluation of the research capacity-building and infrastructure plan for the proposed RIMI Project include:

In addition to the aforementioned review criteria, each proposed RIMI supported subproject will be evaluated based on the following criteria:

Significance:  If the proposed aims of the proposed subproject (s) study are achieved, how will scientific knowledge be advanced?  Is there a clear and appropriate career development plan for students and/or faculty associated with a research subproject(s)?Does the proposed research subproject address an area of emphasis related to improving minority health and/or eliminating health disparities?

Approach:  Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of each of the research subproject(s)? Is there a research training components for both faculty and students associated with the subproject? Is there a plan toward soliciting external funding for faculty initiated research?   Does the applicant provide a clear plan for executing the daily oversight for working with the subproject (s) PIs.  Is there a clearly delineated oversight plan for faculty research supervision?  Are students involved in faculty initiated research? If not, is there a plan for students to be introduced to research training activities?

Innovation:  Does the research subproject employ novel concepts, approaches or methods? Are the aims original and innovative? Do the concepts challenge existing paradigms or propose to develop new methodologies or technologies?

Investigators: Is each subproject investigator(s) appropriately trained, well suited and/or mentored to carry out the proposed scientific research investigation?  Are the qualifications, experience, commitment and scientific competences of the RIMI project director and the research subproject PIs adequate to carry out the proposed work?  Is there a time commitment plan for each key personnel to achieve the stated research and program goals of the proposed RIMI project?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success of the overall program and research subprojects?  Does the proposed faculty research take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support and oversight of the RIMI supported faculty research subproject(s)?

Is the proposed budget and duration, including the justification for requested items in terms of the aims and methods of the proposed programmatic cores and research studies appropriate

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the rating:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Resource Sharing Plan(s)   

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

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 NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 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 NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

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 Blvd., Suite 800 MSC 5465
Bethesda, MD 20892-5465
Telephone: (301) 402-1366
FAX: (301) 480-4049
Email: Hunterd2@mail.nih.gov

2. Peer Review Contacts:

Lorrita Watson, Ph.D.
Division of Extramural Activities and Scientific Programs
National Center on Minority Health and Health Disparities
6707 Democracy Blvd., Suite 800 MSC 5465
Bethesda, MD 20892-5465
Telephone: (301) 402-1366
FAX: (301) 480-4049
Email: WatsonL@mail.nih.gov

3. Financial or Grants Management Contacts:

Priscilla Grant, J.D., C.R.A.
Division of Extramural Activities and Scientific Programs
National Center on Minority Health and Health Disparities
National Institutes of Health
6707 Democracy Blvd., Suite 800 MSC 5465
Bethesda, MD 20892-5465
Telephone: (301) 402-1366
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 (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) 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 (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

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, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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 (http://grants.nih.gov/grants/policy/data_sharing).

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. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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 http://grants.nih.gov/grants/gwas/.

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 public 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 http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. 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 http://grants.nih.gov/grants/policy/model_organism/index.htm). 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 http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). 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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. 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 (http://grants.nih.gov/grants/funding/children/children.htm).

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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). 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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) 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 (http://www.pubmedcentral.nih.gov/), 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 http://publicaccess.nih.gov/.

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 (http://www.hhs.gov/ocr/) 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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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 http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 http://grants.nih.gov/grants/policy/policy.htm.

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: http://www.lrp.nih.gov.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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