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 (http://www.ncmhd.nih.gov/)

Title: Research Infrastructure in Minority Institutions (RIMI)

Announcement Type
This is a modification of RFA-MD-04-003, which was previously released February 9, 2004.

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

Request For Applications (RFA) Number: RFA-MD-05-004

Catalog of Federal Domestic Assistance Number(s)
93.307

Key Dates
Release Date: February 28, 2005
Letters of Intent Receipt Date(s): March 29, 2005
Application Receipt Dates(s): April 29, 2005
Peer Review Date(s): July, 2005
Council Review Date(s): September, 2005
Earliest Anticipated Start Date: September 30, 2005
Expiration Date: April 30, 2005

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

The 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 purpose of this RIMI initiative is to expand the number of NCMHD RIMI projects. NCMHD now invites applications to establish new RIMI projects under the P20 funding mechanism. The RIMI program seeks to strengthen the integration of teaching and research at predominantly minority-serving academic institutions. The ultimate aims of RIMI are to:

  1. foster and facilitate faculty preparedness and readiness to conduct independent investigator initiated sustainable research, especially research in areas that address the elimination of health disparities;
  2. 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 life sciences, behavioral sciences or related allied health areas;
  3. 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
  4. build an academic infrastructure that benchmarks cutting-edge and innovative instruction and research training while taking into account the uniqueness and/or special needs of health disparities populations.

The intent of this RIMI grant program is to establish, strengthen and/or improve the scientific infrastructure and environment of predominantly minority-serving academic institutions through grant support to develop and/or expand existing capacities and programs for institutional and individual faculty initiated basic, biomedical, clinical and/or behavioral research and research training programs that contribute to building a cadre of research scientists in the elimination of health disparities. Applicants have the flexibility not to address all four areas of concentration. But rather, an applicant may choose to develop a program that addresses any combination of at least two of the ultimate aims or core components of the research infrastructure concentration areas. The underlying assumption is that all grants that are funded under this effort will advance the nation towards the elimination of disparities in healthcare among racial and ethnic minorities and other health disparity populations, including the medically underserved that reside in the Southwest Border States; rural communities, such as the Appalachia Region, Mississippi Delta, and Frontier States; tribal reservations and urban centers of the Nation. More specifically, this RFA MD-05-004 is intended to help non-research intensive minority-serving institutions solidify and strengthen their academic infrastructure and capacity to add to the critical mass of research trained professionals who are able to conduct basic, clinical, biomedical and/or behavioral science research that will reduce and ultimately eliminate health disparities.

The NCMHD intends to commit approximately $3 million dollars in FY 2005 to fund six to eight new grant awards (including at least two to three grant awards to two-year colleges) in response to this RFA

Eligible applicant organizations include: Domestic predominantly minority-serving academic institutions that offer one or more associates, baccalaureate and/or master's degrees in allied health, behavioral science, social science, and/or life and related sciences. The President of the applicant institution or a designated senior representative must serve as the Principal Investigator for the proposed RIMI project.

Each applicant may submit only one application in response to this RFA. Application materials are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance, contact GrantsInfo Telephone: (301)710-0267; email: GrantsInfo@nih.gov.

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

For more information about this RFA contact 301-402-1366 at the NCMHD, Scientific Program Operations.

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 and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
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. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
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

A key component of the mission of the National Center on Minority Health and Health Disparities (NCMHD) is to support the NIH in reducing and ultimately eliminating health disparities by providing assistance to institutions for conducting basic biomedical and behavioral, clinical, social, and community-based participatory research on health disparities, improving institutional infrastructures for conducting research on health disparities and for providing research training, disseminating health information, and conducting outreach to health disparity communities.

During the past three years, the NCMHD RIMI Grant Program has supported grants to domestic predominantly minority-serving colleges and universities that offer one or more baccalaureate and master's degrees in the life sciences and related sciences. This RFA has been modified from the previously announced RFA (MD-04-003) for establishing a NCMHD funded Research Infrastructure in Minority Institutions Project in several significant ways:

The core areas and expectations are described in the following sections.

The objective of this RFA is to contribute to the NCMHD's long-term goal of developing a cadre of clinical, biomedical and behavioral research scientists that possess the skills, knowledge, and abilities necessary to engage in leading innovative research training and research that will contribute to reducing and ultimately eliminating health disparities in the United States. In order to reach this goal, the NCMHD invites innovative applications, with the Administrative and Faculty Research Development required Cores, plus any combination of two or more of the remaining Core components, to support the following types of research infrastructure and capacity-building programs:

Thus, the NCMHD will support programs that are designed to: 1) strengthen an institution's research training infrastructure and capacity to enrich fundamental science and other allied health degree programs, 2) advance the academic career development of faculty and students undertaking basic science, biomedical, social and/or behavioral research and research training; and 3) support individual faculty initiated research projects in order to develop research scientists to conduct small grant research activities that can lead to successful applications for future funding in health disparities research under more traditional research grant mechanisms.

Therefore, this grant program will establish building blocks that support the NIH-NCMHD long-term strategy to create a cadre of biomedical, clinical, behavioral and social science researchers that possess the understanding and the competencies necessary to engage in leading innovative research that will contribute to reducing and eliminating health disparities in the United States. However, in order to achieve the goal of the RIMI Program, there are critical research training, facilities infrastructure and curricula development capacity gaps and shortfalls that must be closed, ameliorated and/or removed. Many of these areas of concerns have been exacerbated by the lack of adequate faculty and students' research training programs and/or strong academic research infrastructure at many of the nation's two and four year non-research intensive minority serving academic training institutions, especially Tribal Colleges and Universities (TCU), Historically Black Colleges and Universities (HBCU) and Hispanic-Serving Institutions (HSI).

Background

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 predominantly 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/).

Scientific knowledge to be achieved through research supported by the RIMI program includes, but is not limited to, a greater understanding of the essentials and principles for scholarly development of faculty-initiated research and research training mentoring activities; development of academic departments engaged in research, research education and research training of students and junior faculty; strengthening faculty and students' ability to identify appropriate use of research methodologies and their applications, especially research that advances knowledge of the biological and behavioral mechanisms by which the broader environment contributes to the disparities in disease and disease progression.

Objectives of this research program

The areas of concentration for this RFA are captured in three major program areas: 1) institutional infrastructure and capacity-building, 2) advancement of faculty research and research training, and 3) academic/career development. The specific programmatic objectives for these areas are the following:

1. Institutional Infrastructure and Capacity-Building:

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.

2. Advancement of Faculty Research and Research Training:

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.
e) To enhance research related skills, including the development of grant applications, writing peer-reviewed research papers for publication, management of research programs, etc.

3. Academic/Career Development for Students and Faculty:

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 life 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 advancement, including but not limited to: developing bridging programs for students with research intensive institutions, implementing innovations for increasing time commitment for faculty related research and training activities, developing thematic approaches to build marketable institutional niches in health disparities research and research training to address shortfalls and gaps in science and research infrastructure in minority institutions; providing technical assistance in research to faculty and students, and decreasing the digital divide by utilizing cutting-edge multi-faceted instructional approaches, diverse learning environments and computer technology.

Examples of Type of Approaches that are Being Sought to Achieve the Objectives

Where appropriate, examples of potential research topics that faculty and students are likely to pursue should be included in the applicant's proposal. A number of research topical areas, suggestions and recommendations for consideration were provided in the Mid-Term Evaluation of previously established RIMI Programs, 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.).

Based on the recommendations and suggestions that were cited in the above-mentioned reports, the following programmatic components are just a few examples of some possible activities/efforts that an applicant may choose to consider for inclusion in his/her application as potential RIMI program components:

Institutional Role Modeling: In particular, a RIMI funded institution may benefit from developing a mentoring relationship between its Office of Sponsored Program and such an entity at a collaborating research intensive institution. One possible approach to alleviating barriers to success in key areas is to identify a role model institution to emulate, particularly as related to best practices for addressing such barriers (i.e., time and effort for faculty research, balancing teaching and research workloads, grants administration and enhancing and developing effective offices of sponsored research, etc.). Support for institutional role modeling, research strategic planning, and related training activities are allowable costs.

Renovations: This RFA will provide a one-time cost expenditure for renovations and alterations, up to $150,000 for a 4-year institution and up to $100,000 for a 2-year institution. This one-time request can be requested 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 academic research training at the applicant institution. Requested research equipment/instrumentation for enhancement of laboratories and facilities must be justified based on the proposed related programmatic core(s). Additionally, this RFA will not provide support for the completion of shell space. Equipment intended for basic teaching and non-research related activities for student academic development and training will be supported. Additional opportunities for the renovation and modernization of facilities will likely be made available through competitive supplements to funded RIMI programs.

Partnerships and Collaborative Intra- and Inter-Departmental Activities: Allowable costs for technical support for faculty and student research training and faculty initiated research subprojects can be used to encourage intra- and/or inter-departmental collaborations. In such cases, the total level of faculty support on a subproject may not exceed 75 percent effort. For example, if the PI of a subproject requests 25 percent effort, a co-investigator on the project may request up to 25 percent effort. In such cases, only 25 percent technical support may be provided beyond that obtained through the potential use of shared resources or through student researchers-in-training assistance on the project.

Productivity Incentives: Pending the availability of funds, RIMI supported faculty members that publish papers in a peer reviewed journal (or minimally have manuscripts approved for publication in peer-reviewed journals) during a given budget period may request support for travel to a scientific meeting in the annual non-competing renewal application. If there is more than one author, support may be requested for no more than two primary authors on the publication. For each new public or privately funded peer-reviewed research project resulting from an initial RIMI funded research subproject, the RIMI program may request support for the PI and/or Co-PI to attend and present their research findings at a domestic scientific meeting.

Transitional Bridge Preparedness Activities: the RIMI can support activities that will enable graduates of two-year colleges' science, mathematics or social science degree programs to succeed in their transition into an accredited baccalaureate degree program in basic science, biology, chemistry, allied health, nursing or behavioral science). Additionally, this RFA can provide support for supplementary course materials in basic science, mathematics, behavioral science and/or allied health, including specific equipment intended for developmental and advanced teaching and non-research related activities that prepare students for the baccalaureate academic training experience.

Institutional Research Infrastructure Enhancement: The plans for enhancing research infrastructure must be consistent with the long-range goals and institutional plan of the applicant institution. The NCMHD recognizes that the nature and scope of the applications from the various institutions will vary widely, depending on individual institutional settings. Note that funds may be used for faculty expansion (i.e., recruitment of additional faculty who complement the scope of the proposed program) up to $75,000 per year for each position at a four-year institution and up to $50,000 per year at a two-year institution. The funds may be used for basic salary support only. Salaries must be commensurate with the established levels for like positions at the applicant institution.

Developmental /Collaborative Research: The purpose of the faculty research core is to facilitate the development of independent faculty initiated investigator and/or sustainable departmental research programs in the health disparities research area. Institutions may provide up to 50 percent time and effort for subproject faculty investigators, thus permitting a significant time commitment to development of the academic research enterprise. The requested support for a developmental /collaborative research core activity must not exceed 50 percent of the total direct costs of the RIMI grant award. A plan describing the long-term goals, with measurable objectives and timelines for transitioning RIMI supported subproject research to competitive grant support through applications submitted by faculty members to relevant public and private research funding sources is required. The plan should also include measures of success with specific milestones and projected outcomes.

Shared Resources: The shared resources 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. While, research per se is not conducted as part of the shared resource 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 shared resources cores typically provide 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 rationale for the establishment of the shared 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.

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the P20 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated award date is September 30, 2005. This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

The NCMHD intends to commit approximately $3 million dollars in FY 2005 to fund six to eight new grant awards (including at least two to three grant awards to two-year colleges) 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 $300,000 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 plan of the NCMHD provides support for this program, awards pursuant to this RFA 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 5-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 a $100,000 for renovations may be added to the $300,000 maximum for two-year colleges. Facilities and Administrative costs (F&A) will be provided.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application if your organization has any of the following characteristics:

1.B. Eligible Individuals

The President of the applicant institution or a designated senior representative with the skills and knowledge to provide leadership and authority to make high-level decisions regarding faculty time commitment, curricula and research administration-related decisions must serve as the lead Principal Investigator for the proposed RIMI project. The RIMI program director must also be appointed by the Principal Investigator and be a senior fulltime faculty member at the applicant institution. This is a special requirement of the RIMI program. Such a policy is intended to ensure that the infrastructure and capacity building activities proposed in the application are consistent with the long-term institutional plan, vision and mission of the applicant institution. Thus, any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution 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 programs.

2. Cost Sharing or Matching

There is no required cost sharing, matching, or cost participation without which an application would be ineligible. Cost sharing is not required. Cost sharing as an eligibility criterion includes requirements based in statute or regulation, as well as those imposed by administrative decision of the agency.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

An institution may no longer apply for and/or receive two RIMI Grant awards. An applicant institution can be awarded only one RIMI Grant. Existing RIMI and Project EXPORT grantees are not eligible to apply for a new RIMI grant.

An applicant institution can submit only one grant application in response to this announcement.

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) 710-0267, 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 on line 2 of the face page of the application form and the YES box must be checked. For example, Research Infrastructure in Minority Institutions (RIMI) Program, RFA-MD-05-004.

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

Letter of Intent Receipt Date: March 29, 2005
Application Receipt Date(s): April 29, 2005
Peer Review Date: July, 2005
Council Review Date: September 2005
Earliest Anticipated Start Date: September 30, 2005

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 at the beginning of this document to:

Lorrita Watson, Ph.D.
Review Branch
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
Email: WatsonL@ncmhd.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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)

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

Lorrita Watson, Ph.D.
Review Branch
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
Email: WatsonL@ncmhd.nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf. Personal deliveries of applications are no longer permitted.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NCMHD. Incomplete and 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.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

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 http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3. Reporting).

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 http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

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 must be the applicant institution's president, chief academic officer, or academic dean. 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 program. 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 board comprised of both internal and external experts who are knowledgeable about research capacity building in post-secondary institutions, minority health and health disparities. 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 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 faculty 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.

Institutional Research Infrastructure

The application must describe how requested resources will be used to build and/or enhance existing research infrastructure, advance the academic preparation and training of students, implement a faculty research program that is consistent with and meets the long term objectives of the institutional plan. When appropriate, the applicant should discuss what role the collaborative partnership(s) will play in helping the applicant create and maintain an environment and framework suitable to achieve the objectives of the RIMI program. Funds up to $100,000 at a 4-year institution and up to $75,000 per year at a two-year college may be used to support each RIMI appointed faculty salary, supplies, and equipment costs.

Developmental/Collaborative Research

The purpose of the faculty research development core is to facilitate the development of independent faculty initiated investigations and sustainable research programs in health disparities research. This core provides an opportunity for faculty to develop independent research subprojects as part of the RIMI Program. RIMI institutions may provide up to 50 percent time and effort for subproject investigators, thus permitting a significant time commitment to the development of a research enterprise at the applicant institution. The requested support for a developmental/collaborative research core must not exceed 50 percent of the total direct costs of the RIMI grant award. For each subproject that is included in the application, a plan describing the long-term goals for transitioning RIMI research subproject(s) support to competitive grant support through applications submitted by faculty members to relevant public and private research funding sources is required. This plan should include measurable objectives, measures of success with specific milestones and expected outcome(s). Prospective subproject investigators must have a junior or mid-level full-time faculty appointee at the applicant institution. The proposed research plan for each subproject (10 pages maximum per subproject) should include the following:

Shared Resources - The applicant must include a descriptive plan that illustrates how the shared resources support 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 resources core will expand research training, opportunities and benefit the faculty and students at the applicant institution.

Supplementary Instructions

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

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 30, 2005.

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/partnering institution(s), if applicable.

Consolidated RIMI Budget. The consolidated budget should consist of a compilation of the individual budgets for the administrative core and each area of emphasis. Except in the first year of the project, direct costs may not exceed $650,000 per year for 4-year institutions and $300,000 for two-year colleges. (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 for its director 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 in the following in the administrative budget: the Principal Investigator(s), the Program Director, administrative support personnel and other budgetary items needed for central coordination of the program. The need for each budget item requested and its cost must be thoroughly documented in the section labeled: Budget Justification.

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 Infrastructure and 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" is considered as an area of emphasis, 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?

In addition to the 35-page limit, applicants may use up to 10 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.

Overall Proposed Five Year Plan for the RIMI Program, including specific measurable objectives, action plan(s), timelines, expected outcomes, -- Maximum of 20 pages.

Overall Proposed Five Year Evaluation Plan for the RIMI Program, including specific measurable objectives, process and outcome measures, timelines, expected outcomes, -- Maximum of 12 pages.

Organizational Structure and Administrative Core Activities. (Limit narrative to 5 pages.)

Describe the essential elements of the collaborative agreements between the applicant institution and its partner(s). When there is only one partner, the collaborator must be a doctoral degree-granting institution (in a related area of research concentration). In cases where there is more than one partner, only one of the collaborators must meet the aforementioned criterion. If modifications, improvements, or expansion of these agreements are planned or proposed, describe each agreement in detail. Address any anticipated or potential problems and describe proposed alternative plans to resolve them. Include a copy of the current or proposed Memorandum of Understanding/Agreement(s) between the partnering institutions in this section of your application.

Areas of Emphasis Limit narrative to 15 pages.

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:

Candidate

Career development plan

Research plan, including a scientific literature review

Mentor/collaborator(s)

Proposed Research Environment

Level of Institutional commitment

Technical Support (up to 50% support for a technician)

Budget (up to 50% effort for the PI and support for supplies small instrumentation, etc.)

Limit the description of EACH research subproject to be supported to 10 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. List in the Table of Contents any items included in the Appendix.

Specific Instructions for Modular Grant applications.

Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardees recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. The following will be considered in making funding decisions:

2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NCMHD. Incomplete and/or non-responsive applications will not be reviewed.

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NCMHD in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

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 high priority score. For example, a principal investigator may propose to carry out work that by its nature is not innovative, but important and is essential to building research capacity and enhancing research infrastructure at academic institutions such that advancements in scientific knowledge in a specific field of study will address research areas related to the elimination of health disparities.

1. Significance. Does this infrastructure and capacity-building plan address research areas such as strengthening faculty research capacity, institutional research acumen, student preparedness in mathematics and science, minority health and/or the elimination of health disparities research? If the aims of the application and its subprojects are achieved, how will the institution's research infrastructure be strengthened? Does the proposed plan provide a foundation for scientific knowledge or clinical practice to be advanced to support the research advancement of minority-serving institutions, their faculty, students and their constituency? What will be the expected effect of the applicant's core areas/programs on the concepts, 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.

2. Approach. Are the conceptual, training or research framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the RIMI Program and each subproject? Does the applicant acknowledge potential problem areas and consider alternative approaches? Is the applicant's plan reasonable and adequate to enhance the research infrastructure in the areas of concentration(s) and training capacity of academic unit, faculty and students? Does the applicant provide a clear plan for executing the daily oversight of the RIMI program and for working with the Subproject (s) Principal Investigator(s). Is the applicant's proposed plan congruent with the institution's overall 5-year research capacity-building plan for the academic unit? Does the applicant present a plan for working with other academic enrichment components of the institution to avoid duplication of services that advance the academic preparedness of students to pursue research careers in the basic, biomedical, or behavioral sciences.

3. Innovation. Is the project original and innovative? For example: Does the project challenge existing paradigms or practice for building research infrastructure in minority serving institution; 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.

4. Investigators. Are the 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)?

5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success and strengthen the academic unit of the researcher's placement? Do the proposed subproject studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional and academic departmental support? Does the scientific environment offer any special or specific research training opportunities for students and other faculty?

6. Appropriateness of 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 will be evaluated.

Accordingly, the following are additional considerations for each of the proposed core activities and research subprojects.

Areas of Emphasis: Assessments of each area of emphasis will be based upon the specific evaluations of the proposed core action plans (i.e., planned core activities) for that area and the feasibility of Research Infrastructure in Minority Institutions achieving what is proposed for the overall area with the resources requested. Accordingly, the criteria for review of the proposed plan for each area of emphasis include:

Note that the above assessments should be made for each core area of emphasis in the proposed RIMI Program.

Also, when applicable, the review of proposed individual faculty research subprojects in the Developmental/Collaborative Faculty Research" Core area of emphasis will not be based entirely on the traditional considerations for peer evaluation of scientific merit. But rather, reviewers will also take into consideration the preliminary nature of the proposed research and, in a broader sense, the extent to which the proposed research activity will contribute to the goals and expected outcome(s) of the RIMI Program.

Overall RIMI Program

Major factors to be considered in the overall assessment of the plans for the proposed RIMI Programs will include:

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 priority score:

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 E on Human Subjects in the PHS Form 398).

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 E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

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. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Reviewers will be asked to assess the adequacy of the applicant's plan and NCMHD program staff will be responsible for the administrative review of the plan for sharing research resources before making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of the applicant's application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates
Earliest Anticipated Start Date: September 30, 2005

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA 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.

The Notice of Grant Award will be sent either electronically or via US postal system. It will be sent to the business official indicated on the front page of the application.

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 grant award. 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).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award
Not applicable

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590, and information requested from supplemental instructions to the Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

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.
Director, Division of Research and Training Activities
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
Email: Hunterd2@mail.nih.gov

2. Peer Review Contacts:

Lorrita Watson, Ph.D.
Review Branch
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
Email: Watsonl@mail.nih.gov

3. Financial or Grants Management Contacts:

Bryan S. Clark, MBA
Chief, Grants Management Office
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
Email: ClarkB@ncmhd.nih.gov

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.

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.

Public 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 PA 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.

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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to 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 PA 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/.

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