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IDeA NETWORKS OF BIOMEDICAL RESEARCH EXCELLENCE (INBRE) RELEASE DATE:
RFA Number: RR-03-010 National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.389 LETTER OF INTENT RECEIPT DATE: September 1, 2003 APPLICATION RECEIPT DATE: October 14, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA The purpose of the Institutional Development Award (IDeA) Program is to foster health-related research and increase the competitiveness of investigators at institutions located in states with historically low aggregate success rates for grant awards from the National Institutes of Health (NIH). To provide flexible support to build and strengthen research infrastructure and increase its capacity to conduct competitive cutting-edge biomedical and behavioral research, the National Center for Research Resources (NCRR) of the National Institutes of Health invites applications for IDeA Networks of Biomedical Research Excellence (INBRE) from 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. These applications must represent a collaborative effort to sponsor research with undergraduate institutions. They may also include outreach activities with other 4-year colleges or tribal or community colleges. Applications will be accepted ONLY from institutions that currently hold a Biomedical Research Infrastructure Network (BRIN) award; the initial support provided through the BRIN award served as a planning grant for INBRE (see http://www.ncrr.nih.gov/resinfra/riidea/brin2001.asp). The purpose of this Request for Applications (RFA) is to augment and strengthen the state's biomedical research capacity and investigator pipeline through flexible support to further expand and develop competitive biomedical research capability for faculty; in addition, support via INBRE is to be used to further enhance the research infrastructure through support of a multi-disciplinary network, led by an established peer-reviewed investigator with expertise directly related to the research theme(s) of the research proposal. The application must include a scientific focus in 1 to 3 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 or both research approaches to attain the goals of the proposed network. The scientific leadership provided by one or more established biomedical research faculty member is critical to the success of this initiative, especially for the mentoring of promising investigators, postdoctoral fellows, and students. The network is intended to support investigators from several complementary disciplines at the grantee's and partner graduate and undergraduate institutions. The network may extend to appropriate institutions in other IDeA states if the applicant state has no other appropriate institutions to include within its boundaries. The faculty at these institutions will receive support to establish their research laboratories, acquire specialized equipment, and hire postdoctoral fellows, students and technical assistance. It will enable the institutions to develop a critical mass of investigators and enhance their competitiveness in a specific research area that positions those investigators to successfully compete for their own competitive NIH research grant awards. It is also anticipated that, in some instances, support through this initiative will facilitate the development of new disease-specific research networks or augment the capability of existing networks. The overarching objectives of this Program are to: 1) establish a multi-disciplinary research network with a scientific focus that will build and strengthen the lead and partner institutions' biomedical research expertise and infrastructure; 2) build and increase the research base and capacity by providing research support to faculty, postdoctoral fellows and graduate students at the participating institutions; 3) provide research opportunities for undergraduate students and serve as a "pipeline" for undergraduate students to continue in health research careers within IDeA states; 4) provide outreach activities to students at undergraduate institutions, community colleges and tribal colleges participating in the state’s network; and 5) enhance science and technology knowledge of the state's workforce For many years, the NIH has made a special effort to stimulate research at educational institutions that traditionally have not received significant levels of competitive research funding through the NIH. The IDeA Program was established 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 applications to the NIH historically has been low. A major factor, which may contribute disparately to the funding distribution, is that there are relatively few investigators in the IDeA states who conduct competitively supported biomedical and behavioral research. The statewide IDeA networks are intended to develop the research resources and modern laboratories needed to attract established investigators, as well as the research skills of talented investigators and promising students. The purpose of each INBRE is 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 within the IDeA states. The size, structure, and operational principles of the emerging networks were essentially established during phase I of the BRIN; by the very nature of the BRIN support, NCRR staff fully recognize that some networks are more advanced than others. An INBRE scientific network must include a doctoral degree-granting institution or research institute as the applicant institution (the current BRIN grantee institution) and ideally three to five baccalaureate or master's level degree-granting institutions participating in the thematic multidisciplinary research activity. New undergraduate institutions that have not been a part of the original BRIN 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. The inclusion of minority-serving institutions is encouraged as well as diversity among faculty and candidates included in the INBRE. The initiative is intended to strengthen the basic science departments of undergraduate institutions. This Program provides opportunities for undergraduate institutions to support current productive faculty and recruit outstanding faculty who can conduct research in the specific proposed thematic area and pique the interest of their promising students in health-related science through both the didactic training and the research experiences. As a consequence, more students who are well trained in science and technology may enhance the quality of the workforce and help attract biotechnology industries that may enhance the economies within the IDeA states in the future. With better employment opportunities, more students may choose to stay within the state. The undergraduate institutions also serve an important "feeder" role to the science departments of graduate schools within IDeA states and Puerto Rico to pursue graduate education. With access to promising, well-educated students, the graduate schools in the IDeA states can more readily build a critical mass of investigators by recruiting competitive investigators from other institutions as well as recruiting their own graduates. Network Characteristics: A network within a state should have a research institute or doctoral degree-granting institution serve as the network's lead institution and also serve as the applicant institution on behalf of the INBRE. For the purposes of this RFA, the applicant institution must be the institution that currently holds a BRIN award. The principal investigator (PI) must have strong scientific credentials. This may require recruiting a new PI if none exists within the research theme of the INBRE; that individual is to be selected from/by the lead institution. 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. The statewide network is to be composed of baccalaureate or master's level degree-granting institutions or non-profit research institutes that will provide the sites for the conduct of the thematic, multidisciplinary, biomedical and behavioral research. The INBRE PI must be an established research scientist and have administrative and leadership skills to direct this multi-faceted program. The PI at the lead institution will serve as the director of the INBRE and will coordinate its activities. This person should devote a minimum time commitment of 30 percent, however up to 50 percent effort will be supported for mentoring and administrative oversight of the INBRE. This individual will serve as a research advocate. The PI will also direct the Administrative Core and will establish an administrative structure that will ensure efficient utilization of the scientific facilities and investigators within the network. The PI is responsible for management, staffing and resource allocation, and for administering the award in accordance with NIH policies. The PI will, in consultation with the Steering Committee, select the directors for the mandatory cores. Support will be provided at a 30-50 percent effort 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 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. The research capacity building may focus on clinical, basic or both types of research in a creative, integrated approach. Collaborations between or among IDeA eligible states as well as collaborations with institutions in other states is allowable, but no IDeA grant funds awarded to an IDeA state may be used for activities in a non-IDeA state. It is the responsibility of the leadership of the INBRE to define an effective partnership and collaboration. The network is to include undergraduate and graduate students and postdoctoral fellows as well as undergraduate and graduate science department faculty. Special efforts must be undertaken to enhance the recruitment and career development of participating students, fellows and faculty. Collaborations with investigators from outside an IDeA state are permissible, but must be agreed upon by the INBRE Steering Committee (see below). 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 and scientific members of a multi-disciplinary steering committee. The focus of the planned research network will determine the need for core research facilities and modern instrumentation. The research plan for the proposed projects may be in basic or clinical or both areas of research, but must be relevant to the proposed thematic focus. There are unique populations within the IDeA states and investigators are strongly encouraged to include representations of those populations for valid analyses of differences that may affect health disparities. The NIH is committed to working toward elimination of health disparities among racial and ethnic minority populations. Since the NIH is concerned about the under-representation of minorities in biomedical and behavioral research, the inclusion of institutions that serve these populations is encouraged. Each network must have at least three cores; Administrative, Bioinformatics, and Outreach Cores. In addition, a network must include a research network with a multi-disciplinary thematic science focus. Training and mentoring aspects of the program are to be included under the Administrative Core. Applications may include additional cores, such as a Centralized Research Facility Core -- several research projects may need access to one or more technologies included in the Centralized Research Facility Core; the Core Laboratory is to include professional technical expertise to optimize use of the Core laboratory's technology. All applications must include an evaluation component, described later in this RFA. Mandatory Cores: The Administrative Core will be directed by the PI of the INBRE and will provide the logistical support for the network. Systematic communication among investigators within the research network is essential. The Administrative Core will also develop programs to meet the training and mentoring needs of the junior research faculty, fellows, and graduate and undergraduate students. For example, special training may be designed for students, fellows and junior faculty to hone their investigative skills. Support may also 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 students and promising investigators. Salary support may also be provided for an administrative assistant if required. The Administrative Core will also serve as a clearinghouse for 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. The Administrative Core may also provide electronic networking to inform investigators both within and outside the network of the availability and access to modern technologies at research core facilities both within the network and located at other NIH-supported sites around the country. 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. Those workshops can provide a forum for Federal and private sector agencies to present their missions and goals and provide updates on research funding opportunities for investigators within the INBRE. The Bioinformatics Core is essential to provide investigators access to the technical expertise and data management and analysis tools required for competitive, multi-disciplinary 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 multi-disciplinary research team of the network. This core will promote informatics training and education 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. The Outreach Core may include a number of role-modeling and related training activities for 4-year undergraduate institutions, junior/community colleges and tribal colleges that are not part of the scientific network. A maximum of $ 250 thousand of the total direct funds awarded to the grantee institution may be expended for the Outreach Core. This core can support research projects of faculty and some students to expose them to and provide them with research experiences. INBRE programs are encouraged to develop mentoring/training activities designed to increase the number and quality of graduate program applications submitted by students in the life and related sciences. Outreach 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 active network research laboratories. INBRE Committees: Steering Committee The PI will serve as Chairperson of the Steering Committee (SC), one of two required INBRE committees. The PI, PC and research network institutional representatives must form and agree to participate as members of the Network's SC. 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 itself 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 also develop strategies as to how it will interact with the External Advisory Committee, the other mandatory committee described below. The members of the SC will oversee the development of relevant workshops, lecture series, etc., and will periodically review the progress of student-mentor teams. The Administrative Core will provide logistical support to the SC. The PC, in conjunction with SC, will design an Evaluation Plan to determine the impact of their program on the development of the participating institutions and investigators' development. External Advisory Committee Each INBRE will include an External Advisory Committee (EAC). The SC will 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. The members can monitor the longitudinal progress of INBRE development. The Administrative Core will provide logistical support to the EAC. Expenses of the EAC, including honoraria, are to be included in the budget request. The EAC must meet at least twice annually and minutes are to be kept and be available for review by NIH program staff that are responsible for working with the leadership of the INBRE. Program Objectives This 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. The research focus of this program encompasses the full spectrum of the basic and clinical sciences and includes cellular and molecular biology, biophysics and biotechnology, developmental biology and genetics, pharmacology, toxicology and others. 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 RFA is to assist these institutions to implement and use the technologies and other resources needed to conduct state-of-the-art biomedical and behavioral research. The goal of this program is accomplished through the direction provided by a PI, who provides leadership to investigators and has the primary responsibility for administering the program and for overseeing the development of the scientific network and its associated core facilities. The PI of the INBRE application must be an established biomedical or behavioral research scientist who will ensure that high-quality research is performed and who has the experience to administer effectively and integrate all components of the program. The PI must have the requisite administrative experience to direct the program. Each INBRE program should include multi-disciplinary, collaborative, developmental research projects that 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 sponsored research projects. At the request of an INBRE grantee, the NCRR will identify one or more program staff from an NIH Institute or Center with a research mission directly relevant to the thematic research area(s) to be developed within the INBRE. This arrangement will provide additional advice by NIH staff in areas directly relevant to the scientific focus proposed in the application. Mentors must have research expertise relevant to the scientific area(s) to be developed within the INBRE. The mentor may be a collaborator on the junior investigator's research project. Mentors will help oversee the proposed training and career development of promising investigators. Each junior investigator should be assigned to at least one mentor. The mentor is an established faculty member who has demonstrated the ability to advise others through the acquisition of external support and the maintenance of 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 request between 10 and 20 percent effort and should be listed in the Administrative Core's budget section of the application and not in the individual projects' budget sections. The junior investigators should clearly designate in the text the identity of their mentors and describe the qualifications, both scientific and advisory, that make them appropriate to assist in the oversight of the project. In some cases, Center of Biomedical Research Excellence (COBRE) graduate investigators may serve as mentors to junior investigators and/or students. Graduate and undergraduate students on various projects must be recruited in the first three years of the program. The NCRR Staff must administratively review the addition of students in Years 4 or 5. Allowable Costs: Funds will be provided for building and strengthening the infrastructure and capacity-building at the lead and partner graduate and undergraduate institutions, including Alteration and Renovation (A&R) of research laboratories and animal facilities, instrumentation for Core laboratories, and staffing (investigators, junior investigators, postdoctoral fellows, graduate and undergraduate students, and technical assistance). The maximum allowable direct cost for the INBRE program is $2.5 million dollars per year. Up to $1.25 million is available to the awardee institution. $1.0 million of those funds may 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. Up to $250 thousand of that $1.25 million may be used to support the Outreach Core to sponsor outreach activities to other institutions in the state that are not part of the research network. A maximum of $1.25 million of the available direct costs may be expended at the baccalaureate/masters degree institutions that are part of the scientific network of INBRE, to build infrastructure and research capacity for the proposed multi-disciplinary research areas. These funds are to be allocated to these institutions as consortium arrangements and/or subcontracts, and are to cover expenses for including but not limited to salary and research support, alteration and renovation of the research and animal facilities, equipment. A MOU must clearly describe the arrangements between the baccalaureate institutions and the grantee institutions and must provide for release time for investigators and consideration of research accomplishments in any advancement/tenure criteria. A maximum of 15% of the total direct cost requested at each baccalaureate institution may be used for administrative costs. Individual research projects may be funded at a level not to exceed $150 thousand/year in direct costs. It is not 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 proposed network. The actual costs requested will be based on the proposed INBRE network (i.e. number of participating institutions) and activities (i.e. number of proposed scientific projects, core support costs) providing the justification for the appropriate expenditure of proposed costs. Salary. 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 project investigators and junior investigators will devote at least 50 percent of their professional effort to career development and research activities. Institutions must provide release time for project investigators, thus permitting a significant time commitment to the research enterprise. Bi-annual Meeting Costs. There will be two annual meetings of the leadership of the grantee networks. The costs to support and attend these meetings should be included in the budget section (travel) of the application. Estimate the costs for key staff to attend at least two meetings annually. Tuition Remission is allowable provided: Ancillary Personnel Support. Salary for mentors is allowed as long as the mentors are members of the established investigator pool, which is to interact directly with and mentor the junior investigators. The applicant may request 10-20 percent effort for mentors who are extensively involved in this INBRE activity. Salary and research support will be provided for participating graduate and undergraduate students, and postdoctoral fellows. Facilities and Administrative Costs (F&A) will be reimbursed at the negotiated rate. Allowable A&R Costs to improve existing research laboratories or animal facilities, and allowable fees associated with the A&R project at the lead and scientific network partner institutions. Up to 10 percent of the direct costs awarded over the first three years may be requested for A&R. Direct costs requested for A&R are not subject to F&A. Installation of fixed equipment or other structural alterations should not commence until architectural documents have been reviewed and approved by NIH staff. Expenditure of funds for all A&R projects in excess of $300 thousand are restricted until project documentation/architectural drawings have been reviewed and approved by NIH staff. Other Allowable Costs Include: o Research equipment and instrumentation for laboratories. ALTERATION AND RENOVATION: A&R costs to improve existing research laboratories or animal facilities are allowed. This RFA will provide up to $750 thousand in direct costs (10% of awarded direct costs) over the period of the first three years. A&R costs will be approved for facilities improvements at the awardee institution as well as at the partner institutions. No more than $250 thousand of that $750 thousand may be used for A&R at the awardee institution. Proposed improvements at consortia sites are allowed. A&R projects must be relevant to the scope of the proposed research and at the institutions involved in the research network. Sufficient detail must be provided to estimate the cost and suitability of the project. 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 review and approval before the renovation project may commence. This RFA will not provide support for new construction, including the completion of shell space. EVALUATION PLAN 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 revisions, if deemed necessary. In addition, the evaluation plan is to set benchmarks for the network's impact on recruitment of outstanding faculty and students at participating undergraduate and graduate institutions. There may be other novel elements that the applicant may choose to include in the evaluation plan, such as quality and number of students, productivity of the mentors and junior investigators, and impact on state's biotechnology industry and workforce. This RFA will use the NIH exploratory grant award mechanism (P20). The applicant will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated award date is June 1, 2004. An applicant may request a project period of up to 5 years and a budget of up to $2.5 million per year in direct costs. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NCRR provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of meritorious applications. At this time, it is not known if this RFA will be reissued. Although no non-Federal matching funds are required for the submission of these applications, clear evidence of institutional and state commitment should be included with the application. The level of institutional commitment will differ among applicant institutions because of the variability of resources available among institutions and states. At a minimum, a letter of support from a senior institutional official (e.g., President or Dean) outlining the commitment for resources and facilities to sustain and support the INBRE throughout the period of funding should be submitted. CONSORTIUM ARRANGEMENTS: When a grant application includes research activities that involve institutions other than the grantee institution, it is considered a consortium effort. Such activities may be included in the INBRE grant application, but it is imperative that a consortium application be prepared so that the programmatic, fiscal, and administrative considerations are explained fully. In addition, the emerging network's thematic scientific focus must be evident in applications that include consortia arrangements. Applicants for INBRE grants should exercise great diligence in preserving the interactions of the participants and the integration of the consortium project(s) with those of the parent institution, because synergism and cohesiveness can be diminished when projects are located outside of the group at the parent institution. For the purposes of this RFA, F&A costs for the parent institution
and consortium organization(s) are excluded from the limit on the amount
of direct costs that can be requested for the entire application. Applicants
are encouraged to review the NIH policy and procedures applicable to
consortium agreements, which are published as part of the NIH Grants
Policy Statement, Part III, available on the NIH homepage at http://grants.nih.gov/grants/policy/nihgps_2001/index.htm. Applications will be accepted ONLY from institutions that currently hold a Biomedical Research Infrastructure Network (BRIN) award (RFA: RR-01-005). INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her institution to develop an application for support. Individuals from under-represented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. The PI of the INBRE application must be an established biomedical or behavioral research scientist who has demonstrated the administrative abilities to carry out effectively the objectives of the INBRE program and meet its goals. The PI must have strong scientific credentials. The application in response to this RFA may be submitted with a surrogate PI, but an award pursuant to this RFA will not be made until a permanent and appropriate PI has been recruited and is on board at the awardee institution. The PI and PC should budget for an annual two-day meeting in Bethesda, Maryland with NCRR staff. These meetings will provide a forum for the exchange of ideas, information and address problems that arise. In addition, NIH staff will provide updates on policies and regulations that relate to the conduct of research, including discussions of conflicts of interests, 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 two-day meetings in the Bethesda area. Each application must include an External Advisory Committee (EAC), comprised of three to five scientists, with national scientific reputations in their field; their expertise must be directly relevant to the scientific themes of the INBRE. The EAC critiques scientific progress of the INBRE and also offers advice on scientific matters to the PI. The EAC activities include concept development, program planning, encouraging and assisting with faculty development and mentoring, identifying resources, and evaluating progress toward stated goals. The PI will share the advice and critiques provided by the EAC with the PC and network investigators. The EAC will also review and approve candidates for additional projects and investigators as required, before such requests are forwarded to NCRR for confirmation and approval. The EAC must meet at least twice per year on average. Minutes are to be recorded and summaries made available to NCRR program staff responsible for the INBRE. 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 NCRR. We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: programmatic, review, and financial or grants management issues: o Direct your questions about programmatic issues to: o Direct your questions about review issues to: o Direct your questions about financial or grants management matters
to: Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research network Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NCCR staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Dr. Sheryl K. Brining Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS: An application for an INBRE award must include the following: o Individual project and core facility budgets should be grouped together
with justifications and prefaced by a summary budget for the entire
program. o A discussion of accomplishments made during Phase I of the BRIN. The strongest and relevant parts of the original BRIN Phase I should be identified and included in the new application. o The PI, PC, investigators, junior investigators, and mentors must provide a biographical sketch as indicated in the PHS 398 instructions. This section must not exceed four pages per person. (1) Discuss the organizational structure established for various cores
and network during BRIN Phase I. o With respect to the overall program, a description of the unique research opportunities that will be provided to the project investigators at the lead and partner institutions. (1) If the proposed research is closely related to ongoing research or an existing center, explain how these research activities will complement but not overlap with existing research. (2) Describe how the efforts of each investigator will assist in the establishment of a multi-disciplinary research network. o A clear description of the qualifications of the PI. If a PI with strong scientific credentials is not in place at the institution at the time of review, a plan to recruit such an individual must be included in the application. o A discussion of the External Advisory Committee. (1) Include a description of the types of individuals to be included, along with a budget estimate to support the EAC. (2) The members of the EAC must be identified and letters of commitment to the INBRE activity must be included. o Present an overall research plan to justify support of the mandatory thematic scientific network for five years, which includes the proposed organization and component functions of the INBRE. The plan should demonstrate the applicant's knowledge, ingenuity, practicality, and commitment to developing a significant, productive, research program. (1) Discuss the philosophy, priorities and objectives of the scientific
network to be developed in the INBRE. (4) Address the importance of the funds to develop the several components, including support for promising but not yet established investigators. (5) Describe the potential impact of the proposed network on the research
capacities of participating institutions, faculty and students within
the host state. (7) Prioritize the needs within the proposed scientific network and
how those needs will be met. o Describe and justify the proposed individual research projects (a ten-page limitation for the Research Plan Section for each project) and core service facilities that collectively will contribute to the network. (1) Applicants must describe the nature and scope of any scientific research collaborations. (2) For each research project: o Describe the specific aims of each individual research project in the selected area of research along with the goals for the first year and for the long term. o Delineate the design principles supporting the research or the hypotheses to be tested. Preliminary studies are NOT required for INBRE applications, but applicants with preliminary results should describe them. In the absence of preliminary results, applicants should describe the rationale and scientific basis for the proposed research. o Describe the areas of multi-disciplinary research that are the focus
of the INBRE. o Concisely state the importance and health relevance of the proposed
research to the specific aims. o The candidate. o Career development plan, including plans for developing a sustainable research program. o Research plan. o Mentor/collaborator. o Research environment. o Institutional commitment. o Technical support. o Budget. o A description of the research and research training or career development goals and capabilities of the proposed INBRE. The PI must establish a time line for supported applicant investigators to prepare and submit proposals for traditional research grant review during the performance period of the award. o A clear definition of the nature and extent of research collaboration, including a full explanation of the necessary administrative, fiscal, and scientific aspects of the proposed INBRE. o A discussion of the proposed scientific theme/themes, and how proposed cores are integrated into the network goals. (1) Administrative Core. o Discuss the qualifications and role of the PI and PC. The PC may
be selected from among the participating institutions in the proposed
scientific network. o Discuss training and mentoring aspects. o Include a clear plan for career development, a mentoring plan that involves oversight by established senior faculty members assigned as mentors, constructive evaluations by members of the SC and EAC, and coordinated management of all of these individuals. o Junior investigators should clearly designate in the text the identity of their mentors and describe the qualifications, both scientific and advisory, that make them appropriate to assist in the oversight of the project. In some cases, COBRE graduate investigators may serve as mentors to junior investigators and/or students. o Describe the network's plan to develop the research skills of both
graduate and undergraduate students, and faculty (both junior and more
established). o Include a mentoring plan for junior investigators, fellows and students. o Describe how mentors are to be selected and how they will interact
with the junior scientists and students. o Describe how junior faculty will be protected for research time. o Describe how mentoring will be evaluated to assure junior investigators
and students receive effective "coaching". o Describe the progress made by the Bioinformatics Core in creating infrastructure and other related tools for investigators in the network during BRIN Phase I. o Describe the new approaches to be undertaken within the proposed scientific network to provide access to bioinformatics tools for data mining and model development, database management of heterogeneous objects of varying size and the need for training investigators in the effective use of those tools. o Describe the impact of the Core on multi-disciplinary thematic research
efforts and the environment in which to develop a new generation of
researchers. (3) Outreach Core. o Describe plans for outreach to other institutions in the state that
do not contribute to the research agenda of the scientific network. (4) Centralized Research Core. o Describe how core facilities will facilitate research for investigators not only in the network but also for investigators within the state at institutions outside the network. o Provide the rationale for the Research Core Laboratories included in the application, their impact on research, and how the Core Laboratories will be professionally staffed. o Include justification for the level of funds requested to support the Core Facilities. (5) Science Research Core -- This Core was a part of many of the Phase I BRIN programs and may be expanded to accommodate needs of the proposed scientific network. o Describe how this Core will support preliminary research studies of promising faculty and selected students and can assist both students and faculty in becoming familiar with technologies that will facilitate their research. o Provide justification for staffing and operational costs and the potential overall impact on the thematic research focus of the INBRE. o A description of the infrastructure -- equipment and facilities -- available at the lead and network institution to support studies aimed at developing a nationally competitive biomedical research program and state research base. (1) Describe the quality of existing institutional research space as well as research facilities needed across the partner institutions to conduct biomedical research for investigators within the INBRE. (2) Describe briefly the institutional environment and resources that are available to investigators. o Describe available resources (e.g., laboratory facilities, patient populations, geographic distributions of space and personnel) and collaborative resources. o If core facilities are included for support, describe the relationship of each component research project to the core(s). (3) Describe and justify upgrading of existing laboratories as part of this effort to be undertaken with support through this RFA. (4) Describe what research equipment is available and can be used by INBRE investigators and students. (5) Describe and justify additional research instrumentation needs
of the INBRE and how those needs can be addressed through this program. (7) Describe the foregoing needs for both graduate school and undergraduate institutions. (8) Provide a time line for addressing the infrastructure needs and describe how the INBRE will prioritize those infrastructure needs. (9) Describe any other sources of support that will contribute to the development of the proposed INBRE. o A memorandum of understanding (MOU) clearly describing the arrangements between the baccalaureate institutions and the awardee institution. Faculty at baccalaureate institutions must have a commitment for release time for the conduct of research as part of the MOU. Women, minorities and individuals with disabilities should be participants. o A narrative summary, line drawings and cost estimates must be provided for any proposed A&R project. (1) Narrative summary. o Relate the proposed renovations to the research projects that will use the facility. o If renovations to animal facilities are proposed relate the proposed renovations to the projected animal populations (by species). o Include the lines of authority and responsibility for administering the institution's animal care and use program. o Include the role and composition of the Institutional Animal Care and Use Committee (IACUC). o Address how compliance with relevant laws, policies, and guidelines are achieved. o List the functional components, including the size (dimensions) and square footage of each component (room, alcove, cubicle) that will be directly affected by the renovation project. o List 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. o List appropriate architectural criteria (such as width of corridors and doors, surface finishes). o List and justify all fixed equipment items requested for the renovated area. (2) Line drawings o Submit line drawings on 8-1/2" x 11" paper only. (DO NOT SUBMIT BLUEPRINTS) These drawings will not be counted against the 25-page limit. All floor plans must be legible, with the scale clearly indicated. o Line drawings of the proposed renovation must be at a scale adequate to explain the project. o The drawings should indicate size (dimensions), function, and net and gross square feet of space for each room. o The total net and gross square feet of space to be renovated should be given. o The plan should indicate the location of the proposed renovation area in the building. o Include the as-built drawings of the proposed renovation area and indicate any areas which will be demolished. o Changes or additions to existing mechanical and electrical systems should be clearly described in notes made directly on the plan or attached to the plan. o Indicate the type(s) of new finishes to be applied to room surfaces. (3) Cost estimates o An itemized budget and justification of the impact that this alteration and renovation would have on the INBRE activities must be provided. o Detailed cost estimates must be included, provide vendor quotes when available. o Applicants interested in seeking additional funds for facilities improvements are referred to the NCRR Research Facilities Improvement Program which accepts applications for construction and for extensive renovation. Please refer to the NCRR Website: http://www.ncrr.nih.gov for more information. APPENDIX MATERIAL: Information essential for the review of the application should not be included in the appendix. Appendix materials submitted with the application must adhere to the PHS 398 requirements. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center For Scientific Review At the time of submission, two additional copies of the application must be sent to: Dr. Sheryl K. Brining APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NCRR. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that exceed the maximum allowable direct cost limits for various cores/categories will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Office of Review, NCRR in accordance with the review criteria stated below. As part of the merit review, all applications will: o Receive a written critique from the Initial Review Group. o Receive a second-level review by the National Advisory Research Resources Council. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance The review of the INBRE application is additionally based not only on these traditional review criteria, but also on the qualification and stature of the Principal Investigator to provide both scientific and administrative leadership and on the feasibility and potential for investigators to become competitive for independent funding. Senior, funded investigators must not be proposed as research project leaders, but they may serve as mentors for junior faculty. The following criteria will be used to evaluate the 1) administrative leadership and overall potential for enriching the intellectual milieu for doing research, 2) scientific merit of the individual biomedical research projects, and 3) effectiveness in training and promoting junior investigators and students at the lead and partner institutions. ADMINISTRATIVE LEADERSHIP AND OVERALL POTENTIAL FOR ENRICHING THE INTELLECTUAL MILIEU FOR DOING RESEARCH: Reviewers will be asked to consider the following: o The qualifications of the Principal Investigator to provide scientific and administrative leadership in developing and directing the INBRE, and establishing thematic, multi-disciplinary collaborative research efforts. The Principal Investigator must be an established biomedical or behavioral research scientist. o Key personnel in other areas, for example, bioinformatics, well qualified to work in developing the cores and network. o The significance, approach, and innovation of the proposed research projects and of the INBRE as a whole. o The nature, scope, and effectiveness of the plans for coordination and cooperation among research project investigators. o The strengths of the applicant investigators and the collaborating researchers, if involved, particularly their academic qualifications, biomedical expertise in the proposed area of research and research productivity. o The level of institutional commitment with regard to assuring 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. o The need for the proposed core facilities and the effectiveness of these facilities to enhance the research effort. o The ability to augment and strengthen the biomedical research capability at the lead and partner institutions. o The ability to develop undergraduate and graduate educational opportunities, ranging from formal programs to courses and seminars, visiting scientist programs and other similar activities. Provisions made for familiarizing investigators and students with bioinformatics tools. o A letter of intent to establish a formalized agreement (MOU) among institutions that are to constitute the scientific network. The MOU must describe what recourse is available to arbitrate differences in the event that disputes arise and cannot be resolved collegially. o If there are plans to recruit investigator(s), are those plans reasonable and necessary and can those efforts be completed in a timely manner, such that the recruited investigator(s) can make meaningful and significant contributions to building the network? Are the time-lines for building the network's biomedical research capacity realistic and attainable with the level of support provided through this program. Will the INBRE Award contribute to salaries and start up funds for promising investigators? Are there other sources of support for salaries and start-up funds? o The plans to develop a competitive scientific environment. Issues such as tenure, promotion, release-time, and other personnel matters pertaining to the success of the INBRE addressed. o The effectiveness of plans to reach institutions outside the scientific network. o The ability to provide support for the development and maintenance of a multi-disciplinary scientific network. o The means by which basic and/or clinical research is encouraged. o The suitability of the External Advisory Committee and Steering Committee to effectively provide advice and recommendations to the participating institutions in the network. o Feasibility of a plan for defining sharing and discharging the responsibilities of investigators and operational procedures among institutions. o The appropriateness and suitability of evaluation strategies and specific milestones necessary to measure progress toward attaining long-range goals. SCIENTIFIC MERIT OF THE INDIVIDUAL BIOMEDICAL RESEARCH PROJECTS: The scientific review group will address and consider each of the below criteria in assigning the project's overall merit and weighting them as appropriate for each project. The project does not need to be strong in all categories to be judged likely to have major scientific impact. For example, important work may be proposed that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the investigator and other researchers/collaborators (if any)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? EFFECTIVENESS IN TRAINING AND PROMOTING JUNIOR INVESTIGATORS, POST-DOCTORAL FELLOWS AND STUDENTS: The reviewers will be asked to use the following criteria in evaluating this criterion: o The quality of the mentoring plans, mentor suitability, plans for recruitment, research training, career development of junior investigators, postdoctoral fellows and students of the institutions involved in the network. o The suitability of the plan for recruiting new faculty, if any. o Plans to be undertaken for capacity building at the lead and participating institutions. OVERALL EVALUATION: The review of the INBRE applications will be based on the review criteria described herein, the administrative qualifications of the Principal Investigator and the quality of the plan to develop an effective research network that will contribute significantly to the state's research base. In addition to the above criteria, the application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below.) o DATA SHARING: The adequacy of the proposed plan to share data. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. Letter of Intent Receipt Date: September 1, 2003 Funding decisions will be based on scientific and technical merit as determined by the Initial Review Group, the National Advisory Research Resources Council, geographic distribution, program balance, the enhancement of the research competitiveness of the institutions in the network, and the availability of funds. HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for Federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. The NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting
priority areas. This RFA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010"
at AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at <http://www.cfda.gov/> and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm> The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility)
in which regular or routine education, library, day care, health care,
or early childhood development services are provided to children. This
is consistent with the PHS mission to protect and advance the physical
and mental health of the American people.
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