Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of General Medical Sciences (NIGMS)

Funding Opportunity Title

IDeA Networks of Biomedical Research Excellence (INBRE) [P20]

Activity Code

P20 Exploratory Grants

Announcement Type

Reissue of PAR-08-150

Related Notices
  • May 19, 2014 - This PAR has been reissued as PAR-14-233.
  • May 1, 2014 - See Notice NOT-GM-14-119. Notice of Expiration.
  • March 26, 2014 - See Notice NOT-GM-14-111. Notice of Clarification of Information for NIGMS Prior Approval of Pilot Projects Proposed for Support by IDeA Program Grants.
  • February 22, 2013 - See Notice NOT-GM-13-102. Notice of Modification of Evaluation Plan and Milestones.
  • September 28, 2012 – See Notice NOT-OD-12-161. NIH Announces Plans to Transition to Electronic Submission of Multi-Project Applications
Funding Opportunity Announcement (FOA) Number

PAR-12-205

Companion Funding Opportunity

None

Number of Applications

Only one application per IDeA eligible state is allowed as defined in the Section III. 3. Additional Information on Eligibility.

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

93.859 

Funding Opportunity Purpose

The purpose of the Institutional Development Award (IDeA) Networks of Biomedical Research Excellence (INBRE) program is to augment and strengthen the IDeA-eligible state's biomedical research capacity. The grant awards are made to independent biomedical research institutes and/or biomedical research institutions that award doctoral degrees in the health sciences or sciences related to health within IDeA-eligible states. The INBRE program must represent a collaborative effort to sponsor research with other research intensive institutions and institutes, primarily undergraduate institutions, community colleges, and minority serving institutions (hispanic-serving institutions, historically black colleges and universities, tribally controlled colleges and universities, Alaska native and native Hawaiian serving institutions).

The primary goals of the INBRE program are to: 1) build on the established multi-disciplinary research network with a scientific focus to strengthen the lead and partner institutions' biomedical research expertise and infrastructure; 2) build and increase the research base and capacity by providing support to faculty, postdoctoral fellows and graduate students at the participating institutions; 3) provide research opportunities for students from primarily undergraduate institutions, community colleges and minority serving institutions and serve as a "pipeline" for these students to continue in health research careers within IDeA states; 4) enhance science and technology knowledge of the state's workforce.

Key Dates
Posted Date

June 12, 2012

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

August 15, 2012; June 20, 2013; and June 20, 2014

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

September/October, 2012; August/September, 2013; and August/September, 2014  

Advisory Council Review

January 2013; January 2014; and January 2015.

Earliest Start Date(s)

May 2013; May 2014; and May 2015

Expiration Date

(Now Expired May 1, 2014 per NOT-GM-14-119), Originally June 21, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The National Institute of General Medical Sciences (NIGMS) of the National Institutes of Health (NIH) invites applications for competing continuation of Institutional Development Award (IDeA) Networks of Biomedical Research Excellence (INBRE) grants to independent biomedical research institutes and/or biomedical research institutions that award doctoral degrees in the health sciences or sciences related to health within IDeA-eligible states. INBRE applications must be a collaboration between research intensive universities and other research intensive institutions and institutes, primarily undergraduate institutions, community colleges and minority serving institutions (hispanic-serving institutions, historically black colleges and universities, tribally controlled colleges and universities, Alaska native and native Hawaiian serving institutions).

This Funding Opportunity Announcement (FOA) is to provide an opportunity to build on the successes of the INBRE program to augment and strengthen the state's biomedical research capacity. The primary goals of the INBRE program are to: 1) build on the established multi-disciplinary research network with a scientific focus to strengthen the lead and partner institutions' biomedical research expertise and infrastructure; 2) build and increase the research base and capacity by providing support to faculty, postdoctoral fellows and graduate students at the participating institutions; 3) provide research opportunities for students from primarily undergraduate institutions, community colleges and minority serving institutions and serve as a "pipeline" for these students to continue in health research careers within IDeA states; 4) enhance science and technology knowledge of the state's workforce.

The INBRE program seeks to promote the development and expansion of unique, innovative, state-of-the-art biomedical and behavioral research at institutions in IDeA-eligible states, encompassing the full spectrum of basic, clinical and translational sciences. The NIH recognizes that the contributions from the institutions in IDeA-eligible states are important and essential in fulfilling the promise of the NIH research agenda. The intent of this FOA is to continue assisting these institutions to implement and use the technologies and other resources needed to conduct state-of-the-art biomedical and behavioral research and provide research experiences to students at baccalaureate institutions, community colleges, and minority serving institutions. The application must include an evaluation plan to determine the effectiveness of various components to achieve the program goals.

Renewal applications will be accepted from institutions that currently hold an INBRE award (http://grants.nih.gov/grants/guide/pa-files/PAR-08-150.html). The renewal applications should describe progress and accomplishments made to date to achieve the goals of the statewide research network. Progress must include accomplishments in the following areas:

Background:

The IDeA Program was authorized by Congress for the purpose of broadening the geographic distribution of NIH funding for biomedical and behavioral research by enhancing the competitiveness for research funding of institutions located in states in which the aggregate success rate for grant applications to the NIH historically has been low. Disparate funding distributions may stem in part from having relatively few competitively supported biomedical and behavioral investigators in IDeA states. Statewide IDeA Networks of Biomedical Research Excellence (INBRE) supported through this FOA are intended to develop the research resources and modern laboratories needed to attract established investigators, and to develop and enhance the research skills of talented investigators and promising students within each state.

The INBRE program began in 2001 by providing planning grants for three years. These programs were competed in 2004 and 2008 to establish inclusive statewide multidisciplinary research networks with scientific foci to promote the development, coordination, and sharing of research resources and expertise that will expand the research opportunities and increase the number of competitive investigators in the IDeA-eligible states. INBREs also were intended to enhance the caliber of scientific faculty at research institutions and primarily undergraduate schools, thereby attracting more promising students to these organizations. The purpose of this FOA is to build on the successes of the existing INBREs to augment and strengthen biomedical research capacity within IDeA states. Each INBRE is a statewide network to be composed of doctoral degree-granting institution(s) or research institute as the lead institution, and include primarily undergraduate institutions, community colleges and minority serving institutions as partner institutions appropriate to the state.

The NIH recognizes a unique and compelling need to promote diversity in biomedical, behavioral, and clinical sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups that are under-represented in biomedical sciences; improve the quality of the educational and training environment; balance and broaden the perspective in setting research priorities; improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and improve the Nation's capacity to address and eliminate health disparities. The inclusion of investigators and institutionsin the network that serve the under-represented minorities in biomedical and behavioral research within the INBRE is strongly encouraged.

Program Description:

The purpose of INBRE program is to:

The FOA is intended to strengthen the basic science departments of primarily undergraduate institutions, community colleges and minority serving institutions. This Program provides opportunities for primarily undergraduate institutions, community colleges, and minority serving institutions to support and retain current productive faculty and recruit outstanding faculty who conduct research in the specific proposed thematic areas and can attract promising students to health-related science through both didactic training and research experiences. These institutions may develop new courses or improve the existing ones to augment the science curriculum, and stimulate and strengthen the role of research into curricula traditionally limited to classroom instruction.

Students who are well trained in science and technology can enhance the quality of the workforce, which in turn can attract biotechnology industries and enhance the economies within IDeA states. With better employment opportunities, more students may choose to stay within the state. The primarily undergraduate institutions also serve as an important pipeline to the science departments of graduate schools within IDeA states for students to pursue graduate education. With access to promising, biomedically-trained students, the graduate schools in the IDeA states can more readily build a critical mass of investigators to conduct biomedical research by recruiting competitive investigators from other institutions as well as recruiting some of their own graduates.

The application must include a scientific focus in one or more thematic areas, such as neuroscience, cancer, genomics, proteomics, developmental biology and genetics, toxicology or any of the biomedical and behavioral scientific areas relevant to the mission of NIH, and may include basic, clinical, and/or translational research approaches to attain the goals of the proposed network. The broad thematic areas will encourage and facilitate interactions and cross-collaborations among INBRE, Center of Biomedical Research Excellence (COBRE) and other NIH supported programs; and will promote data and resource sharing within the statewide network and the region. It is also anticipated that, in some instances, support through this FOA will facilitate the development of new disease-specific research programs or augment the capability of existing programs.

Scientific leadership provided by one or more established biomedical research faculty members is critical to the success of the INBRE initiative, especially for the mentoring of promising investigators, postdoctoral fellows, and students. Some applicant institutions may have faculty who hold significant peer-reviewed funding from either Federal or private sector sources to conduct research. Those faculty members may be included as mentors, collaborators, and scientific members of a multidisciplinary steering committee. The network is intended to support investigators from several complementary disciplines at the grantee and partner graduate and primarily undergraduate institutions, community colleges and minority serving institutions. The focus of the planned research network will determine the need for core research facilities and modern instrumentation. Faculty at participating institutions will receive support to establish or enhance existing research laboratories, acquire specialized equipment, and hire postdoctoral fellows, students and technical assistants.

The NIH is committed to working toward elimination of health disparities among racial and ethnic minority populations. Investigators proposing research that involves human subjects are strongly encouraged to include representation from the unique and diverse populations within the IDeA states for valid analyses of factors that may influence health disparities. INBREs are encouraged to interface and collaborate with other appropriate programs that address health disparities and health issues in underserved communities.

INBRE Network Characteristics:

The statewide network is to be composed of baccalaureate, master's level degree-granting institutions, non-profit research institutes, community colleges, and/or minority serving institutions that will provide the sites for the conduct of thematic, multidisciplinary, biomedical and behavioral research. An INBRE scientific network must include a doctoral degree-granting institution or research institute as the applicant institution in the eligible IDeA states and ideally six to eight baccalaureate, master's level degree-granting institutions and community colleges or minority serving institutions participating in the thematic research activity. One or two additional biomedical research-intensive institutions may participate in the network and share in the portion of the budget dedicated to the lead institution. New undergraduate institutions that have not been a part of the network previously but contribute to the thematic research effort may be included, if appropriate, in the proposed scientific network. The states that elect to do so or states that do not have appropriate eligible undergraduate/graduate institutions with focus on the scientific area relevant to the thematic focus proposed in the application may include partner institutions from other IDeA states and in that case the IDeA funds may be transferred to the partner institution in another IDeA state via subcontract. The inclusion of minority-serving institutions as well as diversity among faculty and students included in the INBRE is encouraged. Inclusion of minority-serving institutions is an effective means of developing a diverse scientific and academic workforce.

The six to eight baccalaureate, master's level degree-granting institutions, community colleges or minority serving institutions that participate in the thematic multidisciplinary research activity can serve as a pipeline for future independent biomedical investigators. Undergraduate institutions that are a component of a university that includes a graduate school that confers doctoral degrees in one or more sciences, but are not research intensive or do not conduct biomedical research as a principal activity, are eligible to participate as a network partner institution. Faculty at the undergraduate colleges of research-intensive institutions who do not have appointments in the graduate school may receive research support via this initiative. Further, new primarily undergraduate institutions and community colleges or minority serving institutions that have not been a part of the original network but could contribute to the proposed thematic research and/or efforts to address the health needs of the community may be included in the scientific network.

The network may involve institutions in other IDeA states to achieve specific objectives if the applicants' state has no other appropriate institutions to include within its boundaries. The funds may be transferred via subcontract to the consortium partner institution. Collaborations between or among IDeA eligible states as well as collaborations with institutions in other non-IDeA states are allowable. However, grant funds awarded to an IDeA-eligible institution may not be transferred via subcontract to a non-IDeA state. IDeA funds may be used in non-IDeA states for fee-for-service type of activities that include activities associated with collaborative projects, attending instructional activities and learning new techniques, sample and data analysis, workshops and mentoring efforts etc.

It is the responsibility of INBRE leadership to define an effective statewide partnership and collaboration. The network is to include undergraduate and graduate students and postdoctoral fellows, undergraduate and graduate science department faculty, and faculty and students from community colleges and minority serving institutions. Special efforts must be undertaken to enhance the recruitment and career development of participating students, fellows and faculty. This FOA strongly encourages forging interactions and cross-collaborations among INBRE and COBRE programs to enhance communication among programs, leverage resources where appropriate, and provide students a broad continuum of research opportunities.

Administration of INBREs:

Program Director/Principal Investigator:

The goals of this program are accomplished through the direction provided by a Program Director/Principal Investigator (PD/PI) at the lead institution, who has the primary responsibility for administering the program and for overseeing the scientific network and its associated core facilities. The PD/PI of the INBRE application must be an established biomedical or behavioral research scientist with expertise directly related to the research theme(s) of the grant application. The PD/PI will ensure that high-quality research is performed and has the experience to administer effectively and integrate all components of the program. The PD/PI must have the requisite administrative experience and leadership skills to direct this multi-faceted program.

The PD/PI at the lead institution will serve as the director of the INBRE and will coordinate its activities. This person must devote a minimum time commitment for mentoring and administrative oversight of the INBRE of 3.6 person months per year, however up to 6.0 person months will be supported. The PD/PI will also direct the Administrative Core and will establish an administrative structure that will ensure efficient implementation of all the activities within the network. The PD/PI is responsible for management, staffing and resource allocation, and for administering the award in accordance with NIH policies. The PD/PI will serve as Chairperson of the INBRE Steering Committee and in consultation with this committee select the core directors.

The NIH recognizes a compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.

Accordingly, the NIH continues to encourage institutions to diversify their trainee and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:

A.   Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/statistics/).  Nationally, groups found to be underrepresented in biomedical and behavioral research include, but are not limited to, African Americans, Hispanic Americans, Native Americans (including Alaska Natives), and natives of the U.S. Pacific Islands.  In addition, it is recognized that underrepresentation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.

B.   Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C. Individuals from disadvantaged backgrounds who are defined as:

1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/indix.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.

Other Key Personnel:

Support will be provided at 3.6 - 6.0 person months annually for an additional faculty member within the INBRE network to serve as a Program Coordinator (PC). The PC will complement the administrative efforts of the PD/PI and act as a liaison between the lead institution and the partner institutions in the network. The PC must have demonstrated ability to organize, administer, and stimulate collaborative initiatives in the planned network.

While the PD/PI and PC positions are considered mandatory for carrying out the INBRE mission, support for other scientific or staff positions can also be requested as long as their role in the program is justified.

Descriptions of Cores:

Each network must have an Administrative Core and a Bioinformatics Core. Training and mentoring aspects of the program are to be included under the Administrative Core. Applications may include additional cores, such as centralized research facility and instrumentation cores. Several research projects may need access to one or more technologies included in such research core facilities, so each core facility must include professional technical expertise to optimize use of the available technology.

Administrative Core (Mandatory):

The Administrative Core will be directed by the PD/PI of the INBRE and will provide the logistical support for the network and to the External Advisory Committee. The Administrative Core will also develop programs to meet the training and mentoring needs of the research faculty, fellows, and graduate, undergraduate, community and students from minority serving institutions. For example, training activities may be designed for students, fellows and faculty to hone their investigative skills. Support also may be provided for attending national scientific meetings and workshops to interact with the scientific leaders in the field and learn about the most current research advances in the field. Salary support will be provided for mentors, based on their level of effort for mentoring promising students and investigators. Salary support may be provided for an administrative assistant if required and justified.

The Administrative Core will serve to oversee ongoing research activities, any clinical studies, analysis of research results, other funding sources, and other information relevant to the thematic scientific focus that is being investigated within the Network. Additionally, regional scientific grantsmanship and scientific presentation workshops, seminar and lecture series, and visiting faculty programs can be organized as a part of the Administrative Core's scope of training and mentoring activities.

The Administrative Core may include a number of role-modeling and related training activities for four-year primarily undergraduate institutions, community colleges, and minority serving institutions. INBRE programs are encouraged to develop mentoring and training activities designed to increase the number and quality of graduate program applications submitted by students. Activities to these institutions through mechanisms such as (but not limited to) seminars, lectures, workshops or short courses are encouraged. Activities could also include sponsorship of graduate school workshops and networking activities, career counseling, and laboratory/research experiences at network research laboratories or field sites (e.g., community sites).

As communication among investigators within the research network is essential, the Administrative Core may provide electronic networking to inform investigators both within and outside the network of the availability of and access to modern technologies at research core facilities both within the network and located at other NIH-supported sites around the country.

The PD/PI and PC should budget for an annual meeting in Bethesda, Maryland with NIGMS staff. These meetings will provide a forum for the exchange of ideas, information and address their concerns, needs and problems that arise. In addition, NIH staff will provide updates on policies and regulations that relate to the conduct of research, including discussions of NIH Electronic Research Administration, ethics, and protection of human subjects to strengthen the program and the network. Applicants are to include in their requested budgets the cost of attending these meetings in the Bethesda area.

Institutional Commitment:

While non-Federal matching funds are not required, the application must show clear evidence of strong and specific institutional commitment.  It is recognized that the availability of resources is variable among institutions. Consequently, the level of institutional commitment will differ among applicant institutions. At a minimum, the application should include communication from a senior institutional official from the lead institution (e.g., President or Dean) outlining the resources and facilities that will be committed by the institution to support and sustain the INBRE program throughout the period of funding. Some examples of institutional commitments that may be documented include financial support, adequate space, release time agreements, core consolidation and maintenance. As appropriate, letters of support with institutional commitment from partner institutions in the network should also be included.

Required Committees under Administrative Core:

Steering Committee:

The PD/PI will serve as Chairperson of the Steering Committee (SC). The PD/PI, PC and representatives from network partner institutions must agree to participate as members of the INBRE SC. The SC will consist of no more than 20 members and will include up to two members from each network partner institution, one is a senior administrative person, the other one can be someone with scientific expertise and background. The Vice President for Research of the awardee institution, or their surrogate, must participate as a member of the SC. The members of the SC will establish the policies and operating procedures of both the Steering Committee and the INBRE. The SC will meet at least three times during the first year of the award and at least semi-annually thereafter. The SC will develop strategies as to how it will interact with the External Advisory Committee, the other mandatory committee described below. The Administrative Core will provide logistical support to the SC. The PC, in conjunction with SC, will provide management oversight for the development of an Evaluation Plan to determine the impact of the INBRE program. The PD/PI in consultation with this committee will select the core directors. Collaborations with investigators from outside an IDeA state are permissible, but must be agreed upon by the INBRE Steering Committee.

The members of the SC will regularly review the progress of faculty investigators and their career development plans in terms of their research projects and providing research experiences to the students. This oversight and input are in addition to that provided by the External Advisory Committee (EAC) and may not act as a substitute for the EAC.

External Advisory Committee:

Each INBRE application must include an EAC. The SC should establish rules governing the composition of the EAC and the tenure of the Chairperson. The composition of the EAC is to include at least three to five members with appropriate scientific expertise in the thematic focus area(s), who can provide advice to the SC for scientific, administrative, and other matters. Expenses of the EAC, including travel and consultant fee, are to be included in the budget request. The EAC must meet at least twice per year. The EAC critiques the scientific progress of the INBRE and also offers advice on scientific matters to the INBRE PD/PI. The EAC activities include developing and planning concepts and programs, encouraging and assisting faculty development and mentoring, identifying resources, evaluating the development of the network, and evaluating progress of the individual research projects as well as the overall INBRE program. The PD/PI will share the advice and critiques provided by the EAC with other INBRE investigators and the Steering Committee of the network. The EAC also will review and recommend candidate investigators for replacement/substitute projects, as required, before such requests are forwarded to the NIGMS for Programmatic Review. Video-, teleconferencing or other means may be used in situations where it would be difficult to hold an in-person meeting. A summary of the issues discussed at each EAC meeting, recommendations made, and actions taken must be included in the yearly progress reports submitted to the NIGMS.

The established External Advisory Committee members should be identified and named in the application. However, potential new members should not be contacted or identified.

Bioinformatics Core (Mandatory):

Bioinformatics includes organization and analysis of biological and related information involving the use of computers to develop databases, retrieval mechanisms, and data analysis tools, especially in the fields of molecular biology, genomics, proteomics, structural biology, and genetics. The Bioinformatics Core will provide resources and tools that fall under three categories: Research, Training, and Education. For research, the Core will provide investigators access to the technical expertise and data management and analysis tools required for competitive, multidisciplinary biomedical research. Careful consideration must be given to optimizing access to bioinformatics and other related tools for investigators in the network. This core will have a substantial impact on enabling the pursuit of research areas by the faculty and students participating in the network. This core may promote informatics training and education, and development of Bioinformatics curriculum and degree programs as well as understanding of approaches and methods for data management, develop methods for multi-center research and resource sharing, and provide methods for secure and confidential data sharing.

Access to and utilization of bioinformatics tools and resources rely on a comprehensive supporting infrastructure (often termed cyberinfrastructure) that integrates data-gathering facilities, computing hardware, data analysis and informatics tools, software and middleware, high-bandwidth network connectivity, and technical support. Robust network connectivity facilitates research collaboration and sharing of resources across geographical boundaries and provides access to rural areas and other hard-to-reach populations. Enhanced network connectivity also broadens access to education and training programs that further national efforts to strengthen the biomedical research workforce. Under this Core, applicants may request funds to enhance network connectivity and high-end computational power within their state. Applicants within a common geographical region may also develop a multi-state plan to collectively address research cyberinfrastructure needs and gaps. Such efforts should seek to leverage funds from other federal, state, and local sources to the greatest extent possible. The Bioinformatics Core may also provide resources to enhance communications within the state and with the rest of the world, including, but not limited to, library access to research journals and video-teleconferencing services, and the development of telemedicine networks.

Optional Cores:

Under this FOA, institutions may also request additional cores such as a Community-Based Participatory Research (CBPR) Core, to facilitate the conduct of new research projects or to expand ongoing projects in community-based research, with an emphasis on those diseases that disproportionately affect racial and ethnic minorities and rural and other medically underserved populations. A community-based participatory collaborative approach involves partners, community residents and scientists in the research process and recognizes the unique strengths that each brings to research. The CBPR Core can help develop critical infrastructure in medically underserved communities to increase their involvement in clinical and translational research and mentor investigators in the conduct of this research modality.

Other optional cores may include Centralized Research Facility, Instrumentation Core, Genomics and Proteomics Core or others as needed.

If core research resources are requested, they must be for multiple users, including infrastructure applicable to various disciplines in the lead or partner institutions for the benefit of researchers and research projects.  The level of support requested must be justified by the projected use by researchers from among the lead or partner institutions.  The applicant should describe the standard operating procedures of each core, how state-of-the-art techniques will be maintained, how quality control will be managed, how disputes concerning core usage will be resolved, and how research investigators will be trained in the capabilities of the core and the techniques required. 

Developmental Research Project Program (Mandatory):

Each INBRE program must have a Developmental Research Project Program with an internal mechanism (internal Funding Opportunity Announcement) for obtaining and awarding multidisciplinary developmental research projects.  The description of the Developmental Research Program must include a plan for obtaining applications, their review and funding prioritization, general mentoring plan, oversight and evaluation procedures, and assurance of full compliance with all applicable federal policies, rules, and guidelines for research involving human subjects, vertebrate animals, and/or biohazards.

The PD/PI must communicate the EAC's recommendation along with the research/pilot projects to the NIGMS for administrative review.

The projects, including research projects or pilot projects, should be collaborative and stand-alone, but share common scientific themes. A single investigator at the awardee or network institutions should supervise each research project. Each investigator is responsible for ensuring that the project's specific aims are met. The research excellence of these projects will be enhanced by effectively using the scientific and technical strengths of collaborating investigators and/or mentors. Promising investigators who are resident at institutions in IDeA states but are not a part of the scientific network of the INBRE may receive research support through an adjunct appointment at one of the partner institutions or as collaborators on research projects.

Each faculty investigator of a developmental project should be assigned at least one mentor. Mentors should have research expertise relevant to the scientific area(s) to be developed within the INBRE. The mentor may be a collaborator on the faculty investigator's research project. Mentors will help oversee the proposed training and career development of promising investigators. The mentor is an established faculty member experienced in obtaining external support and maintaining an independent research laboratory. In some instances a suitable mentor may not be available within the investigator's institution; therefore it is acceptable to enlist appropriate mentors from outside institutions. Mentors may be supported for up to 2.4 person months.

In some cases, COBRE investigators, where appropriate, may serve as mentors to INBRE investigators and/or students.

Attaining R01 support is not a criterion for evaluation of investigators located at primarily undergraduate institutions. Some research support may be attained by investigators at primarily undergraduate institutions, community colleges or TCU, i.e., Academic Research Enhancement Award (AREA, R15) grants, R03s, even R01s but that is not a requirement of this program.

The award of a Research Project Grant or a major grant award to a faculty investigator from the lead or primarily undergraduate institutions should be viewed as a milestone and a criterion for changing the status of an investigator from mentored support via the INBRE to independent investigator. Investigators who have acquired independent status or completed a research project should not be excluded from Network activities. These investigators should be allowed access to core facilities and should be encouraged to participate in collaborative research efforts. If appropriate, an investigator who has acquired independent research support may direct a core facility or serve as a mentor to other investigators and students. INBRE support cannot be provided in instances where an investigator receives a new award and that award overlaps or is significantly similar to that described in the INBRE application. However, if the specific aims of the investigator's grant application are significantly different from the project described in the INBRE, then the investigator should complete his/her INBRE project and provide research experiences to the students. In this latter case, continued support for personnel (e.g., postdoctoral fellows, graduate and undergraduate students, technicians, etc.) associated with the INBRE project can be provided.

An investigator who leaves the Network may be replaced by a new investigator. Replacement investigators and new research projects may be substituted following review by the PD/PI and the EAC. The PD/PI must communicate the EAC's recommendation along with the research project to the NIGMS for Programmatic Review.

In some instances, an investigator may be placed on probation or considered for removal from the INBRE program if a review by the EAC indicates a failure by the investigator to make significant progress toward achieving the specific aims of his/her project and/or achieving the goals and objectives of the INBRE program to provide research experiences to students.

Alteration and Renovation:

Alteration and Renovation (A&R) costs to improve existing core laboratories and/or research laboratories at the partner institutions are allowed. This FOA will provide up to $250,000 in direct costs only in year one of the award as a one-time cost expenditure. Direct costs requested for A&R are not subject to F&A. A&R costs will be approved for facilities improvements ONLY at the consortia sites (the primarily undergraduate institutions, community colleges and minority serving institutions). A&R projects must be relevant to the scope of the proposed research at the institution involved in the research network. Sufficient details must be provided to estimate the cost and suitability of the project. All alteration and renovation must be complete within the first three years of the award. Failure to adequately justify A&R requests will likely result in their deletion from the requested budget. Proposed renovations in successful applications will subsequently require the submission of design documents for administrative review by NIH staff before the renovation project may commence. The funds provided under this FOA will not support new construction, including completion of shell space, or the purchase of movable research equipment or instrumentation.

A narrative summary, line drawings and cost estimates must be provided for any proposed A&R project. The following sample format is suggested:

Narrative summary:

Line drawings:

Cost estimates:

Evaluation Plan and Milestones:

An evaluation component is to be included in the application to assess whether the effectiveness of the approach taken will meet the goals or benchmarks for building an effective institutional and statewide scientific network. The application is to describe the development and implementation of the plan for formative and summative evaluations of the network along with strategies for implementing required network modifications, if deemed necessary. In addition, the evaluation plan is to set benchmarks for the network's impact on recruitment and retention of outstanding faculty and students at participating undergraduate and graduate institutions, community colleges and minority serving institutions. There may be other elements that the applicant may choose to include in the evaluation plan, such as quality and number of students, productivity of the mentors and investigators, and impact on state's biotechnology industry, economy and workforce.

Students who are receiving biomedical research experiences and training should be tracked for 5 years after leaving the program, for example total number of students who had research experiences, have gone to graduate and professional schools, or have entered the workforce.

One of the objectives of INBRE is to provide undergraduate faculty and students research support and serve as a pipeline for undergraduate students to continue in health research careers. The mission of most primarily undergraduate institutions and liberal arts colleges is teaching and in some cases teaching and research to provide students experiences and exposure to research. The intent of INBRE is not to transform liberal arts primarily undergraduate institutions into biomedical research centers but rather to augment the science curriculum. Obtaining R01 support by investigators at these institutions is not expected and is not a criterion for evaluation. However, these investigators may seek and obtain research support via mechanisms such as Academic Research Enhancement Award (AREA) and NIMHD Building Research Infrastructure and Capacity (BRIC) (previously known as the NIMHD Research Infrastructure in Minority Institutions (RIMI) program) grants. However, at the lead institutions, investigators may apply for and obtain R01 and Program Project grant support and in some cases faculty at the primarily undergraduate institutions (PUIs) may participate as investigators in these Program Project grants.

INBREs that include minority serving institutions as partners are encouraged to develop activities that focus on enhancing the quality of instruction and providing research experiences relevant to students and their communities. This may include activities that focus on incorporating new courses in science curricula, and involving their students in research projects that are linked to reducing health disparities and developing interventions to improve the health status of their communities.

The success of PUI, community colleges and TCU researchers may be measured by attainable metrics that are appropriate to the missions of their institutions. Criteria for evaluating the progress of these researchers may include evidence of scholarly activities including publications, offering of new courses and programs, providing research experiences to students, impact on the community, attending and presenting research findings at scientific meetings and conferences, submission of external grant applications to NIH and other Federal and non-Federal agencies, and acquisition of awards such as AREA (R15), exploratory/pilot project grants (R03 and R21), career development awards (K01 and K08) or other Federal or non-Federal Agency awards.

Allowable Costs:

Funds will be provided to strengthen research infrastructure and capacity at the lead and partner institutions, including instrumentation for Core laboratories, optional cores such as for Community Based Participatory Research, and support for investigators, postdoctoral fellows, graduate and undergraduate students, students from community colleges and minority serving institutions, and technical assistants.

The maximum allowable direct cost for the INBRE program is $2.5 million per year of which $1.0 million is available to support the Administrative and Bioinformatics Cores, Core facilities, training and mentoring activities, and research activities at the awardee institution and at other research-intensive institutions in the network.

The remaining direct costs, up to a maximum of $1.5 million, are to be distributed among the participating network partner institutions including baccalaureate/master's degree institutions, community colleges, and minority serving institutions as consortium arrangements and/or subcontracts to build infrastructure and research capacity for the proposed multidisciplinary research projects. Funds allocated to partner institutions are to cover expenses including but not limited to salary, research support, and equipment acquisition. Individual research projects may be funded at a level not to exceed $125 thousand per year in direct costs. A maximum of 15% of the total direct cost requested at each partner institution may be used for administrative costs. Funds allocated to community colleges and minority serving institutions may be used to establish science programs/courses and conduct meaningful research projects relevant to their communities during the summer and academic year. A Memorandum of Understanding (MOU) must clearly describe the arrangements between the network partner institutions and the grantee institution and must provide for release time for investigators.

This FOA will provide an additional one time cost of up to $250,000 in direct costs in Year One for Alteration and Renovations (A&R) to improve existing core laboratories and/or research laboratories at the primarily undergraduate institutions, and community colleges and minority serving institutions.

It is not required or expected that each applicant will request the categorical maximum allowable costs stated herein. These numbers are provided as a guide for purposes of developing the INBRE network. The actual costs requested will be based on the INBRE network (i.e., number of participating institutions) and activities (i.e., number of scientific projects in the Developmental Research Project Program, core support costs) providing the justification for the appropriate expenditure of proposed costs.

Sharing resources among INBRE and COBRE investigators is strongly encouraged. If a core facility already exists for equipment and instrumentation supported by a COBRE program, these should not be proposed de novo in the INBRE application. However, if duplicate equipment is to be requested under this FOA, it should be appropriately justified. Under this FOA, COBRE investigators are not eligible for research funding from INBRE as project investigators. Similarly, INBRE investigators may not receive simultaneous research project support from a COBRE program. COBRE investigators may serve and be supported as mentors in INBRE programs as appropriate.

The applicant institution for an INBRE scientific network that is located in a state that has no medical school and fewer than four additional accredited undergraduate institutions that award degrees in both biology and chemistry, may consider the budgetary allocation guidelines regarding the available $2.5 million direct costs to be flexible.

Salary costs are allowable to the extent that they are reasonable; conform to the established policy of the organization consistently applied regardless of the source of funds; and reflect no more than the percentage of time actually devoted to the NIH-funded project. If full-time 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary.

It is expected that the research project investigators at the awardee and network partner institutions will devote at least 50 percent of their professional effort (equivalent to 6.0 person months) to career development and research activities. Institutions must provide release time for project investigators, thus permitting a significant time commitment to the research enterprise. To allow flexibility to investigators who cannot devote 6.0 consecutive months throughout the year, the effort can be distributed over the year to achieve a total of 6 person months (for example, 3.0 person months during academic year and 3.0 person months in summer (up to three months) to account for a yearly 6.0 person months effort).

There will be an annual meeting of the leadership of the grantee networks. The costs to support and attend this meeting should be included in the travel budget section of the application. Estimate the costs for key staff to attend this meeting annually. The key staff may include PD/PI, PC and Bioinformatics Core Director.

Tuition Remission and other forms of compensation paid as, or in lieu of, wages to students  is allowable provided:

Ancillary Personnel Support: Salary support for mentors is allowed as long as the mentors are members of the established investigator pool, and interact directly with and mentor the faculty and investigators at the primarily undergraduate institutions, community colleges and minority serving institutions. The mentor may request up to 2.4 person months if he/she will be extensively involved in this INBRE activity.

Salary and research support will be provided for participating graduate, undergraduate and community college and minority serving institutions students, and postdoctoral fellows. A budget to support EAC activities should also be included.

Other Allowable Costs Include:
Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

Renewal only for recipients of awards from PAR-08-150.
Resubmission
The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

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

Award Budget

Direct costs are limited to $2.5 million per year, excluding facilities and administrative (F &A) costs on consortium arrangements. In addition, this FOA will provide one time cost of up to $250 thousand in direct costs in year one for A&R to improve existing core laboratories and/or research laboratories at the primarily undergraduate institutions, community colleges, and minority serving institutions.

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.

Award Project Period

The scope of the proposed project should determine the project period. The maximum period is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

Criteria for Eligibility of an IDeA State to participate in this INBRE competition: In making its assessment for eligibility, NIGMS included all states/commonwealths with a success rate for obtaining NIH grant awards (number of applications awarded vs. number of applications approved) of less than 20 percent over the period of 2001-2005 or received less than an average of $120 million per year during that time period.  Under these criteria, the following states/commonwealth are the IDeA states eligible to respond to this FOA:

Alaska, Arkansas, Delaware, Hawaii, Idaho, Kansas, Kentucky, Louisiana, Maine, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Dakota, Oklahoma, Puerto Rico, Rhode Island, South Carolina, South Dakota, Vermont, West Virginia, Wyoming.

Criteria for Institutional Eligibility: Applications will be accepted from institutions in IDeA states that currently hold an INBRE award (http://grants.nih.gov/grants/guide/pa-files/PAR-08-150.html). No new application in response to this FOA will be accepted.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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

The PD(s)/PI(s) must be an established biomedical or behavioral scientist with expertise related to the research theme(s) of the grant application and who has the administrative abilities to carry out effectively the objectives of the INBRE program. S/he must have strong scientific credentials. 

Multiple PD(s)/PI(s) are not allowed for this FOA.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Only one application per IDeA eligible state is allowed. 

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review..

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and 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)

At the time of submission, two additional paper copies of the application must be sent to:

Helen R. Sunshine, Ph.D.
Chief, Office of Scientific Review
National Institute of General Medical Sciences
National Institutes of Health
45 Center Drive, Room 3An.12F, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-2881
Email: sunshinh@nigms.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

Face Page

Use Form 1 of the PHS 398 and follow the Instruction.

Description Page

Use Form 2 of the PHS 398. An abstract describing INBRE program is required and should be placed in the Project Summary area.  The length of the abstract must not exceed the space provided.

Key Personnel including the Program Director/Principal Investigator, core directors, research project leaders, and other key professional and administrative members of this Program should be placed in the area of Performance Sites and Key Personnel.  Do not separate key personnel into each project section.

Table of Contents

Applicant should customize the PHS 398 Table of Contents to specifically identify the sections of the application.

Detailed Budget Pages for Initial Budget Period and Entire Proposed Period of Support

The Budget section should begin with the summary or composite budget for the network, followed by the individual budgets for all cores, consortia and contractual arrangements, and Developmental Research Project Program. Individual core facilities and research project program that are proposed to begin in Year One should have corresponding 5-year individual budgets.  Each detailed budget page should be clearly labeled with the name of the core or research project program, and location. The detailed justification for each item requested, including personnel, supplies, and equipment, must be provided. The justification should be placed immediately after each detailed budget page.

An applicant may request a budget for direct costs of up to and no more than $2.5 million per year, excluding facilities and administrative (F&A) costs on consortium arrangements. The applicant may also request additional direct costs in Year One only of up to $250 thousand as a one-time expenditure for Alteration and Renovation of laboratory or animal facilities at PUIs, community colleges and minority serving institutions. If Alteration and Renovation costs are requested, then the total budget request for year one must not exceed $2.75 million in direct costs, excluding F&A costs on consortium arrangements. Regardless whether Alteration and Renovation costs are requested, budget requests for Years two through five cannot exceed $2.5 million per year in direct costs, excluding F&A costs on consortium arrangements.

If requesting items that are normally treated as F&A costs (for example, computers and general office supplies) as direct costs, the applicant must provide a strong justification for those items and demonstrate that the cost is commensurate with the benefit that particular item of cost will have on the associated project .

The PD/PI of the INBRE is not eligible for research project support, nor can he/she use INBRE funds to supplement research activities within his/her laboratory.

Funds cannot be used at collaborative institutions in non-IDeA states via subcontracts.  However, funds may be used in other IDeA and non-IDeA states for fee-for-service activities that include activities such as learning new techniques, sample and data analysis, workshops, paying for the mentoring efforts etc.

Biographical Sketches

All Biographical Sketches should be grouped together with the PD/PI's biographical sketch presented first followed by all other sketches in alphabetical order. Do not include biographical sketches with individual components or cores.

Resources

Resources including existing equipment, instrumentation, collaborative resources and laboratory space at the lead and network institutions to support INBRE research activities should be described using the PHS398 Resources form page and instructions. Although there is no page limit for resource section, it should be concise and contain only information that is not included in the Research Strategy section for that corresponding core. Do not include information required by the FOA that belongs in the page-limited Research Strategy sections. Do not include Resources form in individual components.

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Cover page (Do NOT use PHS 398 face page)

Description page (PHS 398 Form 2)

Introduction (Resubmission Applications only, 1 page for each section)

The Introduction must include responses to the criticisms and issues raised in the prior Summary Statement, which summarizes the substantial additions, deletions, and changes. Insert the Introduction before the Research Strategy of each section, identifying within the Research Strategy the changes made by clearly bracketing, indenting, or changing typography, unless the changes are so extensive as to include most of the text. This exception should be explained in the Introduction. Do not underline or shade changes.

Progress Report (12 pages, total)

A description of accomplishments made during the current INBRE; the strongest and most relevant parts of the network accomplishments should be identified and included in the application. Include a summary of the evaluation report and provide recommendations and corrective actions taken. Progress should include accomplishments in the following areas:

Publications generated from the current INBRE should be listed in “Literature Cited/Reference List” section, which does not count toward 12-page limit.

Overall Network Organization and Management Plan (12 pages, total)
Cores

(1) Administrative Core (Required): (12 pages, total)

(2) Bioinformatics Core (Required): (12 pages, total)

(3) Optional Research Cores such as Centralized Research/Instrumentation Facility, Community-Based Participatory Research or others as proposed: (12 pages, total, per core)

Alteration and Renovation: (12 pages, total)
Developmental Research Project Program (12 pages, total)

Applicants should not propose individual research projects in the application. However, applicants

should describe the plan to solicit applications, prioritize the projects and review their methodology and research performance. The description of the Developmental Research Project program should include the scope; eligibility requirements; the limit on the dollars available and the number of years of support per project; the solicitation, submission, review, and selection criteria and process; oversight and evaluation procedures; and assurances that all projects supported from this grant will comply fully with all applicable Federal policies, rules, and guidelines for research involving human subjects. The projects should focus on the broad, multidisciplinary research theme(s) of the network and include projects from both the research-intensive institutions as well as primarily undergraduate and other institutions involved in the INBRE. Projects selected should reflect the structure and breadth of the INBRE Network with the focus on the infrastructure to provide research opportunities to students.

Letters of Support

Letters indicating institutional commitment and any letter of support for the Network and research

core (if applicable) should be placed immediately after the Research Strategy of the overall Network organization and management plan and corresponding core, respectively.  As necessary, Developmental Research Project Program section can be concluded with letters of commitment from mentors and/or from collaborators and/or consultants.

Memorandum of Understanding

A memorandum of understanding (MOU) clearly describing the arrangements between the baccalaureate institutions, community colleges and minority serving institutions and the awardee institution. Faculty at 4-year baccalaureate institutions must have a commitment for 50% release time (equivalent to 6.0 person months) for the conduct of research as part of the MOU. Women, minorities and individuals with disabilities are strongly encouraged to participate.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS398 Application Guide, with the following modification:

Appendix

Appendix material is not allowed.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

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

Overall Impact - Overall

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

The review of the INBRE application is additionally based on the qualification and stature of the PD/PI to provide both scientific and administrative leadership and on the feasibility and potential for investigators to obtain independent grant support and provide research experiences to students to develop a pipeline to health research careers.

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the program address an important problem or a critical barrier to progress in the field? If the aims of the program are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Are the overall program vision and strategy adequate to continue to build multi-disciplinary research network?  Will the proposed INBRE network augment and strengthen the IDeA-eligible state's biomedical research capacity at the lead and partner institution?   

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the program? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Do the PD(s)/PI(s) have the qualifications to provide scientific and administrative leadership in developing and directing the INBRE, and to continue building on the established thematic, multi-disciplinary research network with a scientific focus?

Do the PD(s)/PI(s) and PC have the experience and committed time to administer the proposed INBRE program? Do the program leadership and management team bring complementary and integrated expertise to the network? 

Have the PD(s)/PI(s) shown effective leadership in developing, directing and enhancing activities of the Cores and network? Do the PD(s)/PI(s) present a plan for the continued development of investigators and managing successfully mentoring faculty, students and postdoctoral fellows in the network? Do the PD(s)/PI(s) demonstrate leadership by showing that the infrastructure necessary for the proposed network (e.g., facility improvements, modernization/acquisition of equipment, implementation of administrative resources, etc.) is in place, and that the network is committed to support the resources and infrastructure?

Will the proposed INBRE program have the professional staffing to benefit significantly the overall network and quality of biomedical research? Do the Directors of the cores have the appropriate training, experience and resources to assume leadership roles? Have the core Directors committed sufficient time to this Program? Will the Directors have the authority to implement best practices identified at Steering Committees at their Institution? Are the administrative and professional staff appropriately trained and well suited to carry out this work?  

Innovation

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

Is the program likely to develop novel approaches to increasing the research opportunities for faculty, postdoctoral fellows, graduate students and undergraduate students at the participating institutions?  

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the program? Are potential problems, alternative strategies, and benchmarks for success presented? If the  program is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the program involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Will the proposed INBRE program include relevant scientific disciplines and collaborations to strengthen the network and increase the productivity?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the  program proposed? Will the  program benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Will the PD/PI have the environment and institutional support necessary to be responsible for the resources committed by the institution(s) for the INBRE program? Will the INBRE program enhance, complement, and extend the applicant's current resources for biomedical research to address health concerns and provide research opportunities to students and faculty in the participating institutions?

Review Criteria for Components

Each of the following components of the application will be assessed and given a score; the component scores will also be considered in assigning an Overall Impact score to the overall application.

Network Organization and Management Plan

Does the application describe how the state's biomedical research capacity will be augmented and strengthened? How will basic and/or clinical research be encouraged? How will a scientific thematic focus be established and maintained? Are the nature, scope, and effectiveness of the plans for coordination and cooperation among institutions appropriate and will they contribute to the establishment of the network?

Does the application describe the nature, scope, and effectiveness of the plans for coordination and cooperation among research project investigators?

Is the level of institutional commitment sufficient to assure that the resources and facilities to sustain the INBRE program are present, including, but not restricted to, existing relevant equipment, animal, and/or computer resources, and departmental or inter-departmental cooperation?

Does the applicant describe the plans to develop undergraduate and graduate educational opportunities, ranging from formal programs to courses and seminars, visiting scientist programs and other similar activities?

Does the applicant describe the plans to establish a formalized agreement (MOU) among institutions that are to constitute the scientific network? Does the MOU describe the recourse available to arbitrate differences in the event that disputes arise? Are issues such as tenure, promotion, release-time, and other personnel matters pertaining to the success of the INBRE addressed?

Will the INBRE Award contribute to salaries and startup funds for promising investigators? Are there other sources of support for salaries and startup funds?

Does the applicant describe plans to reach institutions and programs outside the scientific network?  Are plans for networking, sharing of resources and cross-collaborations with COBREs, other INBREs, and other NIH-supported Centers, as appropriate, described?

       Does the applicant describe plans to encourage basic, clinical and /or translational research   

       acroos the network?

Administrative Core

Are plans to direct and manage the research training, career development and mentoring of investigators, postdoctoral fellows and students of the institutions involved in the network well-described? Will these plans be effective in meeting the program's goals? If there are plans to recruit new faculty at the lead or partner institutions, are these plans reasonable and suitable and consistent with the effective growth and development of the network to make meaningful and significant contributions?

Are plans to be undertaken for capacity building at the lead and participating institutions in the network appropriate and reasonable?

Is the quality of the plan to develop an effective research network for faculty and students that will contribute significantly to the state's research base appropriate?

Will the External Advisory Committee be constituted to provide critical, stimulating, and thoughtful advice for the overall network performance?

Are the structure, composition and organizational plans for the External Advisory Committee and Steering Committee to effectively provide advice and recommendations to the participating institutions in the network appropriate?

Are evaluation strategies to achieve the specific goals of the INBRE program appropriate and suitable? Are there appropriate and suitable evaluation strategies and specific milestones to measure progress, not only of the junior investigators, but of the network as a whole, toward attaining its long-range goals?  In addition to the SC and EAC, does the applicant identify an independent external evaluator, not a part of the INBRE program, who will perform the evaluation?

Bioinformatics Core

Are key personnel and the Core Director qualified to lead in developing and enhancing research activities of the Cores and network?

Are provisions described for familiarizing investigators and students with bioinformatics tools and resources?

Are there adequate plans to maintain the security and confidentiality of personally-identifiable information?

Developmental Research Project Program

Is the Developmental Research/Pilot Program well integrated into the overall INBRE goals and objectives?  Is the program designed to serve the needs of investigators from a variety of research areas?  Will the expected benefits to the lead and partner institutions be measured and tracked?

Is there a pool of qualified investigators from network institutions to solicit applications?  Are the plans for constituting the review panel, their qualifications and expertise, appropriate to evaluate research/pilot project applications?

Is there an adequate plan to solicit proposals, to prioritize the projects and to review their methodology and research performance? Are plans adequate to assure compliance with applicable federal policies and guidelines for research and research protections, and to review their methodology?

Research Core Facilities (If included)

Need. Are the proposed Research Core Facilities well matched to the needs of the overall program? Will the proposed core enhance the statewide network research effort?

Quality. What is the overall quality of the proposed core service(s)?  Are adequate quality control processes proposed for the facilities or services provided by the Research Core Facility (including procedures, techniques, and quality control)? What are the criteria for prioritization and usage of Core products and/or services?

Investigators. Are the qualifications, experience, and commitment of the leader of the Research Core Facility and other key personnel adequate and appropriate for providing the proposed facilities or services?

Cost Effectiveness. Will the proposed Research Core Facility provide cost-effective services to the Network?

Environment. Is the environment for the Research Core Facility adequate to support the Network as proposed? Does the applicant indicate any institutional commitment to support and maintain the ongoing and proposed core facilities?

Community Engagement and Outreach Research (If included)

Are there clear and detailed plans for identifying a health issue that fits community priorities and academic capacity to respond? Are there plans for developing a coalition of community and academic stakeholders and for implementing evaluation strategies for the proposed projects?  Is the research characterized by substantial community input in the development of the proposed study? Are community members, persons affected by the health condition, disability or issue under study, or other key stakeholders in the community’s health, full participants in each phase of the research, including conception, design, conduct, analysis, interpretation, drawing of conclusions and communication of results?

Alteration and Renovation (If included)

Are requested alteration and renovation projects relevant to the scope of the proposed research? Are the costs and suitability of the project justified? Do the proposed renovations relate to the research projects that will use the facility?  If renovations to animal facilities are proposed, do the proposed renovations relate to the projected animal populations (by species)? If renovations to animal facilities are proposed, are the lines of authority and responsibility for administering the institution's animal care and use program indicated?  Are there lists of the functional components, including the size (dimensions) and square footage of each component (room, alcove or cubicle) that will be directly affected by the renovation project?  Are there appropriate descriptions of the engineering criteria applicable to each component (mechanical, electrical, and utilities) including information such as the number of air changes per hour, electrical power, light levels, hot and cold water, and steam, as well as the appropriate architectural criteria (such as width of corridors and doors, surface finishes)? Is justification provided for all fixed equipment items requested for the renovated area?

Are legible line drawings provided for all floor plans with the scale clearly indicated? Are the line drawings of the proposed renovation drawn to a scale adequate to explain the project? Do the drawings indicate size (dimensions), function, and net and gross square feet of space for each room?  Are the total net and gross square feet of space to be renovated provided? Does the plan indicate the location of the proposed renovation area in the building? Does the plan include the as-built drawings of the proposed renovation area and indicate any areas that will be demolished? Do the plans indicate changes or additions to existing mechanical and electrical systems in notes made directly on the plan or attached to the plan? Do the plans indicate the type(s) of new finishes to be applied to room surfaces?

Additional Review Criteria - Overall

As applicable for the program proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

When the proposed program or component involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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

Biohazards

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

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the program.

Renewals

For Renewals (recipients of awards under PAR-08-150), the committee will consider the progress made in the last funding period.

Revisions

Not Applicable.

Additional Review Considerations - Overall

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the NIGMS,  in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the NIGMS Advisory Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the 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 the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

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

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Yanping Liu, MD, PhD.
National Institute of General Medical Sciences
Democracy I, Room 930
6701 Democracy Blvd.
Bethesda, MD 20892
Telephone: (301) 451-4217
FAX: (301) 480-3770
Email: liuyanp@mail.nih.gov

Peer Review Contact(s)

Helen R. Sunshine, Ph.D.
Chief, Office of Scientific Review
National Institute of General Medical Sciences
National Institutes of Health
45 Center Drive, Room 3An.12F, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-2881
Email: sunshinh@nigms.nih.gov

Financial/Grants Management Contact(s)

Courtney Tardd-Wright
Grants Administration Branch
National Institute of General Medical Sciences
National Institutes of Health
45 Center Drive, Room 2An.32C, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-3918
FAX: (301) 480-3777
Email: tarddwrightc@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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


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