BIOMEDICAL RESEARCH INFRASTRUCTURE NETWORK Release Date: September 28, 2000 RFA: RR-01-005 National Center for Research Resources Letter of Intent Receipt Date: December 1, 2000 Application Receipt Date: January 23, 2001 Purpose This Request for Applications (RFA) is to establish Biomedical Research Infrastructure Networks to further enhance the research capacity of institutions through collaborative partnerships to allow them to more fully participate in the competition for NIH awards. Background The Institutional Development Award (IDeA) program was established within the National Center for Research Resources (NCRR), National Institutes of Health (NIH), in 1993. The purpose of the NIH IDeA program is to provide funding for capacity building assistance for biomedical research in those states which have not previously participated fully in the research programs of the NIH. Funds provided through the IDeA program are intended to help those states build their biomedical research capacities. The current cohort of 23 IDeA- eligible states and Puerto Rico receives about five percent of NIH grant funds annually. Eligibility Requirements Those states that attained either success rates for NIH grant awards lower than 20 percent or received less than $70 million in NIH grant funds over the five year (1995-1999) period constitute the cohort of eligibles for the RFA. Under the two criteria, the following 23 states and Puerto Rico are eligible: Alaska Kentucky Nevada Rhode Island Arkansas Louisiana New Hampshire South Carolina Delaware Maine New Mexico South Dakota Hawaii Mississippi North Dakota Vermont Idaho Montana Oklahoma West Virginia Kansas Nebraska Puerto Rico Wyoming In order to develop a Biomedical Research Infrastructure Network (BRIN), a state-wide IDeA Coordinating Committee, representing all eligible IDeA state institutions of higher education (or their equivalents), will be responsible for selection and inclusion of the institutions within its state and possibly those from other IDeA states. The IDeA Coordinating Committee (ICC) will determine priorities for state proposal submissions as well as provide advice relating to the planning and preparation of applications. The ICC will also be responsible for approving collaborative arrangements with other IDeA states for those cases which require a pro rata commitment of funds to the collaborative arrangement (see below-Funds Available). Institutions in states with Experimental Program to Stimulate Competitiveness in Research (EPSCoR) Committees may choose to use them as their IDeA Coordinating Committee. If an EPSCoR Committee is not available or does not hold the requisite expertise for health-related research in an IDeA-eligible state, a comparable IDeA Coordinating Committee is to be established and to determine priorities for proposal submission. Applications may build the research capacity to address any of the biomedical and behavioral scientific areas relevant to the mission of National Institutes of Health. Potential applicants are encouraged to contact NIH staff listed under INQUIRIES. A technical assistance workshop will be offered on Friday, October 20, 2000, at the Lister Hill Center Auditorium on the main campus of the NIH in Bethesda, MD. Additional information may be obtained and registration may be completed electronically at the NCRR Website, (http://www.ncrr.nih.gov/). A summary of that workshop will be posted on the NCRR Website to assist administrators or investigators who could not attend the workshop. Mechanism of Support The administrative and funding instrument for this RFA is an exploratory grant award mechanism (P20). The total project period for an application submitted in response to this RFA may not exceed three years. BRIN awards will provide the opportunity for planning and implementing a network to significantly enhance the biomedical research capacities of participating institutions. Up to the first six to eight months of funding is to be used in a planning phase to organize the network and to test the feasibility of the organizational structure and operations. The estimated costs for staff, supplies and services related to the establishment for the initial planning phase are to be specifically identified in the application. As a condition of the award, the plan must be approved by NCRR staff before additional funding will be released for implementation of the plan to develop the BRIN (See below: Special Requirements). Funds Available The estimated total funds available in FY2001 for the first year of support for awards under this RFA will be approximately $45,000,000. THE TOTAL AMOUNT OF SUPPORT REQUESTED PER STATE IN RESPONSE TO THIS RFA MAY NOT EXCEED $2,000,000 PER YEAR. Each IDeA state may submit no more than two applications in response to this RFA. Alternatively, a state may elect to submit one application that includes a budget request up to $2,000,000 in total annual costs (Direct, and Facilities and Administrative costs) for each of the three years of funding. If a proposed network includes institutions from another IDeA state, the activity for the out-of-state institution(s) will be adjusted pro rata and assigned to the other IDeA state’s ceiling of funding that may be requested from this program. The number of awards and the level of support will depend upon receipt of applications that meet the goals of the RFA and the level of funds available. Although this RFA is included in the financial plan of NIH, awards are contingent upon the availability of funds. States may receive up to two BRIN awards, assuming two separate applications were submitted in response to this RFA. Applicants are encouraged to discuss their anticipated request, including budgets, with program staff listed under INQUIRIES prior to submission. At this time, it is not known if competing renewal applications will be accepted and/or 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 BRIN throughout the period of funding should be submitted. PROGRAM OBJECTIVES 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 too few investigators in the IDeA states trained to conduct biomedical and behavioral research. The Networks will develop the research resources and modern laboratories needed to attract established investigators, and develop the research skills of talented investigators and gifted students. Objectives and Scope The purpose of each IDeA Network 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. No one approach for developing a BRIN will fit the needs of every state. The size, structure, and operational principles will be determined by factors such as the state of institutional research facilities, access to modern research tools, technical and scientific expertise and critical mass of investigators. Up to the initial six to eight months of a BRIN award may be used for planning the feasibility of the network. The plan for the BRIN must be approved by NCRR staff before funding is approved for implementation. During the implementation phase, the networks are to recruit and integrate scientists from many complementary scientific backgrounds to assure that a competitive multidisciplinary research team is assembled to address important health- related research problems. Other infrastructure research-related needs, including renovation of research facilities, developing shared research cores, purchasing modern research equipment, are to be included during the implementation phase. As an example, a BRIN network may include a doctoral degree granting institution or research institute as the applicant institution along with 3-5 baccalaureate or masters level degree granting institutions. Some networks may choose to include more institutions but the feasibility of the network organizational structure and operation must be established at the end of the 6-8 month planning phase. The inclusion of minority serving institutions is encouraged. The BRIN is also intended to strengthen the basic science departments of undergraduate institutions. This program provides opportunities for undergraduate institutions to recruit outstanding faculty who can pique the interest of their promising students in health-related science through both the classroom and the research laboratory in which students may choose to participate in their professors research. As a consequence, more students---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. With access to more gifted, 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 granting institution serve as the network’s lead institution and also serve as the applicant institution on behalf of the BRIN. The Principal Investigator (PI) is to be selected from the lead institution and need not be an established research scientist, but must have the administrative and leadership skills to direct this multifaceted and highly diverse program. The PI of the lead institution will serve as the director of the BRIN and will coordinate its activities. This person should devote a minimum of 30-50 percent effort to this activity. S/he will also serve as the director of the Administrative Core (additional 10 per cent effort) and will establish an administrative structure that will ensure efficient utilization of the scientific facilities and investigators within the network. S/he is responsible for management, staffing and resource allocation, and for administering the award in accordance with NIH policies. The director must have demonstrated ability to organize, administer, and stimulate collaborative initiatives in the planned network. The director will, in consultation with the Steering Committees, select the directors for the mandatory and other cores; the director may seek advice from the External Advisory Committee for the selection of directors for the other cores. The research capacity building may focus on clinical, basic or both types of research in a creative, integrated approach. Collaborative and cooperative programs 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 an non-IDeA state. The number of other participating institutions in a proposed network will vary since varying numbers of investigators may participate from some institutions. It is the responsibility of the leadership of the BRIN to define an effective partnership. The network is to include undergraduate and graduate students as well as undergraduate and graduate science department faculty. Special programs may be designed to enhance the recruitment and career development of participating students and faculty. Collaborations with investigators from outside the IDeA state are permissible but must be agreed upon by the BRIN Steering Committee. 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 multidisciplinary research team for the next phase of network development. The nature of the planned network will determine the need for core research facilities and modern instrumentation. The research plan for the BRIN may be in basic or clinical or both areas of research. There are unique populations within the IDeA states and investigators are strongly encouraged to include representations of those populations for valid analysis of differences that may affect health disparities. The NIH is committed to working toward elimination of health disparities among racial 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; two are mandatory and the third core is to be chosen to meet investigator needs. The two mandatory cores are the Administrative and the Bioinformatics Cores. In addition, a network must select at least one other core---for example, Training and Mentoring Core, Research Development Core, Centralized Research Facility Core. Applications may include more than three cores and may include cores not described here as examples. All applications must include an evaluation component, described later in this document. At the request of a BRIN awardee, 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 BRIN. This arrangement will provide additional advice by NIH staff in areas directly relevant to the research focus under development. Mandatory Cores: The Administrative Core will be directed by the Principal Investigator of the BRIN and will provide the logistical support for the network. Systematic communication among investigators within the network is essential. Outreach activities to other institutions through mechanisms such as (but not limited to) seminars, lectures, workshops or short courses are encouraged. 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 scientific focus that is being developed 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. Some institutions may need to develop and administer an Office of Sponsored Programs. (Note that the existing NIH Extramural Associates (EA) program can be an adjunct for training institutional officials who may serve as EA management fellows at the NIH for 4 to 5 months and become proficient in pre and post NIH grant award management. Applications to participate in the EA Program are solicited annually by NIH. The next RFA is expected to be published shortly.) Such development of local institutional staff may be an adjunct to network development, but applications for the EA program are reviewed under separate guidelines. Additionally, regional grantsmanship workshops can be organized as a part of the Administrative Core’s scope of 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 BRIN. The Bioinformatics Core is essential to 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 multidisciplinary research team to be developed. 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. Other Cores to be considered: A Training and Mentoring Core provides special programs to develop the research skills of promising investigators through the training and mentoring by an experienced, independent investigator. Special courses may be designed for students 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. A Science Research Core will support research, if reasonable projects are proposed and preliminary research studies of junior faculty and some students. The Core can assist both students and faculty in becoming familiar with technologies that will facilitate their research. The preliminary research may relate to the feasibility of studies to be included in the next stage of BRIN development. The scientific leadership, in conjunction with the principal investigator, will determine the site(s) of the core(s) and whether more than preliminary research is to be hosted in the cores for the more advanced BRINs. The Centralized Research Core Facility will facilitate research among the investigators in the BRIN. Several research projects may need access to one or more technologies included in the Centralized Research Core Facility. The Core Facility is to include professional technical expertise for investigators to optimize use of the Core Facility. These cores may also focus on service functions-for example, mutagenesis, cell culture, gene sequencing, cell sorting and so on. The Steering Committee will determine the focus and scope of one or more Centralized Research Core Facilities to be included in the BRIN. BRIN Committees: Steering Committee The PI will serve as Chairperson of the Network’s Steering Committee, one of two required BRIN committees. The PI and network institutional representatives must form and agree to participate as members of the Network’s Steering Committee. The members of the Steering Committee will establish the policies and operating procedures of both itself and the BRIN. The Steering Committee will meet at least three times during the first year of the award and at least semi-annually thereafter. The Steering Committee will also develop strategies as to how it will interact with the External Advisory Committee, described below. The Administrative Core will provide logistical support to the Steering Committee. External Advisory Committee Each BRIN will include an External Advisory Committee (EAC). Rules governing the composition of the EAC and the tenure of the Chairperson will be established by the Steering Committee. The composition of the EAC is to include at least three permanent members as well as ad hoc members who can provide advice to the Steering Committee for scientific, administrative and other matters. The permanent members can monitor the longitudinal progress of BRIN development. The Administrative Core will provide logistical support. Expenses for 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 who are responsible for working with the leadership of the BRIN. In the application, include a description of the types of individuals to be included along with a budget estimate to support the EAC. Do not include names of individuals. SPECIAL REQUIREMENTS The award mechanism for this RFA is an exploratory grant award mechanism (P20). The following terms and conditions will be incorporated into the award statement and provided to the BRIN Director as well as to the appropriate institutional official(s) at the time of award. The Special Requirements are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant policy statements. There will be national meetings of the leadership of the BRIN networks, initially at 6 month intervals, and at least yearly thereafter. 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 overall and the networks individually. Applicants are to include the cost of attending these two-day meetings in the Bethesda, Maryland, area within their requested budgets. In addition, regional meetings of networks may be held to address administrative or discipline-specific topics. Separately, the BRIN leadershp may wish to confer with NIH program staff at least once or more anually to seek logistical advice as well as to discuss the progress of developing the BRIN. Include the costs of up to two regional meetings in the requested budget as well as the estimated costs of administrative visits with NIH program staff. Up to the first six to eight months of funding is to be used in a planning phase to organize the network and to test the feasibility of the organizational structure and operations. As a condition of the award, the plan must be approved by NCRR staff before additional funding will be released for implementation of the plan to develop the BRIN. Criteria for approval include: 1) likelihood of implementation of the Plan over the reminder of the grant period; 2) evidence of institutional commitment to the BRIN; 3) reasonable recruitment plans for both established and promising researchers; 4) reasonableness of elective cores to complement proposed thematic research area(s); 5) if appropriate, plans for research facilities renovations and adequacy of research space across the BRIN; 6) adequacy of plan for defining needed research tools and instrumentation; 7) reasonableness of plan for identifying an adequate pool of established investigators to mentor junior faculty and students; 8) adequacy of plans for undergraduate institutions; and 9) adequacy of administrative principles and proposed committees to develop an effective BRIN. Letter of Intent Prospective applicants are asked to submit, by December 1, 2000, a letter of intent that includes a descriptive title of the proposed network, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA. Although a letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of a subsequent application, the information that it contains allows NCRR staff to estimate the potential review workload and avoid conflicts of interest in the review. The letter of intent is to be sent to: Dr. Charles Hollingsworth Director, Office of Review National Center for Research Resources National Institutes of Health 6705 Rockledge Drive, Room 6100 Bethesda, MD 20892-7965 Telephone: (301) 435-0807 FAX: (301) 480-3660 E-mail: CharlesH@ncrr.nih.gov Instructions for Preparation of an Application Applications in response to this RFA will be expected to compete for an BRIN award (see below) that will be competitively reviewed, in part, on the effectiveness of the approach for research capacity building along with the organizational and scientific progress to be made during the planning and impementation stages. Preliminary scientific data are not required for the proposals. Research Plan INTRODUCTORY OVERVIEW Discuss the philosophy, priorities and objectives of the network. Address the importance of the funds to develop the several components, including support for promising but not yet established investigators. Describe the potential impact of the proposed plan on the research capacities of participating institutions, faculty and students within the host state. Describe the roles of the BRIN Committees---Steering Committee and External Advisory Committee--- and the approaches to be used to set priorities for future research efforts. Prioritize the needs within the proposed network and how those needs will be met. Describe how the plan will build an effective research base that will eventually lead to competitive research applications from a critical mass of investigators who will form an effective multidisciplinary research team within the BRIN. Finally, describe the anticipated impact on student and faculty from undergraduate institutions on the workforce and as a feeder into the graduate science programs within the state. Infrastructure Needs: Describe 1) the quality of existing institutional research space as well as research facilities needed across the Network to conduct biomedical research for investigators within the BRIN. Describe and justify upgrading of existing laboratories as part of this effort to be undertaken with support through this RFA. Similarly, 2) describe what research equipment is available and can be used by BRIN investigators and students; describe and justify additional research instrumentation needs of the BRIN and how those needs can be addressed through this program. Summarize 3) how a critical mass of investigators is to be developed to build a multidisciplinary research team. 4) Describe the foregoing needs for both graduate school and undergraduate institutions and 5) provide a time line for how the BRIN will address infrastructure needs as well as how the BRIN will prioritize those infrastructure needs. 6) Describe any other sources of support that will contribute to the development of the proposed BRIN. CORE DESCRIPTIONS Mandatory: Administrative Core: Describe the qualifications and role of the Principal Investigator of the lead institution selected collegially from among the participating institutions in the proposed network. Describe the administrative arrangements among the participants and the mechanisms to be used to resolve differences of opinion. Bioinformatics Core: Describe the approach to be undertaken within the proposed 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. Describe how the network will create an infrastructure for bioinformatics and other related tools for investigators in the network and the impact of the Core on multidisciplinary research efforts and the environment in which to develop a new generation of researchers. If access to high end computational power is required, describe how and where investigators can access this capability. Other Cores to be considered: Training and Mentoring Core Describe the network’s plan to develop the research skills of both graduate and undergraduate students and junior faculty. Describe the role of undergraduate faculty. Describe how mentors are to be selected and how they will interact with the junior scientists and students. Provide an estimate of the ratio of funded, established investigators to trainees on the multidisciplinary research team. In parallel, describe how faculty will be recruited for undergraduate institutions and their relative contribution to thematic research planned within the network. Describe plans to attract more gifted students into science majors and their opportunities for exposure to cutting edge research technologies. Describe how approaches can contribute to the research experience to launch an independent research career. Mentors must have research expertise relevant to the scientific area(s) to be developed within the BRIN. Mentors will help oversee the proposed training and career development of promising investigators. The scientific leadership, including mentors, will ensure that participants are coached in state-of-the- art scientific methods, including testing hypotheses, designing valid studies and analyzing data. The application should also describe how junior faculty will be protected for research time. The mentor may be a collaborator on the junior investigator’s research project. Where feasible, women, minorities and individuals with disabilities should be involved as role models, students, or junior investigators. Finally, describe how mentoring will be evaluated to assure students and junior investigators receive effective coaching. Centralized Research Core Facility will facilitate research for investigators not only in the network but also for investigators within the state but at institutions outside the network. Several research projects may need access to one or more technologies included in the Centralized Research Laboratory Core. The Core Laboratory is to include professional technical expertise to optimize use of the Core Laboratory’s technology. Provide the rationale for the Research Core Laboratory/(ies) included in the application, its impact on research, and how the Core Laboratory/(ies) will be professionally staffed. Include justification for the level of funds requested to support the Core Facility(ies). The Science Research Core can support preliminary research studies of promising faculty and selected students. The Core can assist both students and faculty in becoming familiar with technologies that will facilitate their research. Describe how this core may relate to research studies to be included in the next stage of development (beyond the three years support provided by a BRIN award). Describe the rationale for the scope of the Science Research Core requested and the rationale for the site(s) of the core(s). Provide justification for staffing and operational costs and the potential over all impact on the research direction(s) of the BRIN. 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 research 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 institutions. There may be other novel elements that the applicant may choose to include in the evaluation. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed network will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score weighting them as appropriate for each application. The five criteria to be used in the evaluation of grant applications are listed below. 1. Significance. o Will the network provide an integrated approach among the institutions and enhance their research capacity building, including collaborations among the institutions? o Does the proposal include a systematic approach for new ideas, recruitment and support for students, junior and established, funded senior investigators o How will capacity building at participating institutions be undertaken? 2. Approach. o Is the conceptual organizational and operational framework reasonable and appropriate to develop an effective network? Is the time line realistic? o Does the proposal effectively integrate the goals of the participating institutions with that of the proposed network? o Is there a viable strategy for developing a menu of undergraduate and graduate educational opportunities, ranging from formal programs to courses and seminars, visiting scientist programs and other similar activities? Are provisions made for familiarizing investigators and students with bioinformatics tools? 3. Innovation o Does the network incorporate attainable approaches or methods for developing and facilitating interactions among faculty across all institutional levels? Will there be an adequate pool of established, funded investigators to effectively mentor junior colleagues? o Does the proposed network effectively include development of appropriate state-of-the-art core facilities to enable health-related research? o Does the application address the need and key role of bioinformatics to enable research across the network? o What creative plans does the network propose to strengthen the participating institutions? 4. Administration o Does the Principal Investigator have the administrative experience and skills to effectively lead this effort? Are other key personnel in other areas, for example, bioinformatics, well qualified to work in developing the cores and network? o Is the Steering Committee appropriately constituted and empowered to effectively provide advice and recommendations to the participating institutions? o Is there a clear plan for defining sharing and discharging the responsibilities of investigators and operational procedures among institutions? o Does the applicant acknowledge potential problem areas and possible resolutions? o Is there a formalized agreement---for example, memorandum of understanding (MOU)---among institutions that are to constitute the network? In the event that disputes arise and cannot be resolved collegially, what recourse is available to arbitrate those differences? o How and who sets final priorities for the BRIN? What are the priorities and goals of the network? Are proposed time lines appropriate to meet the goals of the BRIN? 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 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 BRIN Award contribute to salaries and start up funds for promising investigators; are there other sources of support for salaries and start-up funds? 5. Environment. o Does the plan increase the likelihood that the network will effectively enhance quality research and research competitiveness for research funds among participating institutions? o Will the network effectively promote research and facilitate interactions across disciplines and institutions? Are there appropriate research cores incorporated into their planned network? o Is there evidence that the institutions or departments that make up the network can work together and develop an effective network? Is the need for upgrading research facilities and instrumentation justified? Is the approach to select sites for renovating laboratories and purchasing research equipment well thought out? Are the needs of the undergraduate BRIN components adequately addressed? o If the network includes electronic communication, what advantages does it provide? Is there adequate technical support to oversee the electronic network? Is it cost effective? What is the primary goal or goals of electronic communication? o Is there evidence of significant administrative and scientific commitment of the participating institutions to fulfill the objectives of the BRIN? Is there evidence of institutional support? o Is there an effective plan to develop a competitive scientific environment, including protected time for faculty participants, and recruitment of competitive promising and established investigators to enhance the probability of meeting the goals of the RFA? Overall Evaluation: The review of the BRIN 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. Innovation is a primary consideration in the review of these applications. The initial review group will also examine: the appropriateness of the proposed project budget and the duration, adequacy of clinical research plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the adequacy of plans for including children as appropriate for the scientific goals of the research, or justification for exclusion; the provisions for the protection of human and animal subjects; and the safety of the research environment. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review and responsiveness by NCRR staff. Applications that are incomplete and/or non-responsive to this RFA, will be returned. Applications that are complete and responsive to the RFA will be evaluated for technical merit by a Special Emphasis Panel convened by NCRR in accordance with the review criteria. As part of the initial review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit, generally the top one half of applications under review, will be discussed, assigned a priority score, and receive a second level of review by the National Advisory Research Resources Council. Applications determined to be of low scientific merit will be withdrawn from further competition and the principal investigator and the official signing for the applicant organization will be notified. In addition to the above criteria: o Applications will be reviewed for potential effectiveness of their organizational structure and operations of the network, merits of proposed capacity building and the proposed evaluation plan. o For research projects involving human subjects, the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The age-appropriate inclusion or exclusion of children in the research project and evaluate the plans for conducting the research in accord with the NIH guidelines on the inclusion of children as participants in research involving human subjects will be evaluated; o For research projects that use animals, the adequacy of the proposed plan for animal welfare and biohazard safety in the research environment; and o The appropriateness of the proposed budget and duration, including the justification for requested items in terms of the aims and methods of the proposed research studies will be evaluated. ALLOWABLE COSTS Awardee's Salary. Up to the legislative maximum for full-time professional effort salary support may be requested. The total salary requested must be based on a full-time 12 month staff appointment. It must be consistent both with the established salary structure at the institution and with the salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. 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. The institution may supplement the NIH contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case, may HHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the award. It is expected that the junior investigators will devote at least 75 per cent of their professional effort to career development and research activities. Bi-annual Meeting Costs and Regional Meetings: There will be a meeting of the leadership of the grantee networks at 6 month intervals. The costs to support and attend these meetings should be included in the application. Estimate costs for key staff to attend at lease two regional meetings annually. Tuition. If essential to the awardee's individual development program, funds for tuition for training courses may be requested on a course-by-course basis. Ancillary Personnel Support. Salary for mentors is not allowed unless the mentors are members of the established investigator pool which is to directly interact and mentor junior investigators. May request up to 25 percent effort for mentors who are extensively involved in this BRIN activity. Facilities and Administrative Cost will be reimbursed at the negotiated rate. Allowable Renovation Costs to improve existing research laboratories or animal facilities, and allowable fees associated with the A&R project. A network may request up to 20 percent of the direct costs awarded over the three years. Proposed renovations that will cost more than $100,000 require special approval from the NCRR Office of Grants Management. Research equipment/instrumentation for laboratories Supplies for research Office supplies Salaries for support and technical staff as well as professional staff who will direct Cores Other costs not specifically excluded This RFA will not provide support for new construction, including the completion of shell space, or for equipment intended for teaching or other non-research related purposes. There is another NCRR program, entitled the Research Facilities Improvement Program, that accepts applications for construction and for extensive renovation. Refer to the NCRR Website: (http://www.ncrr.nih.gov) AWARD CRITERIA BRIN awards will be based on the quality of the proposed network, development of an effective biomedical research base, availability of funds, geographic distribution and program priorities. APPLICATION PROCEDURES The RFA label, available in the PHS 398 (rev. 4/98) application kit, must be affixed to the bottom of the face page of the application. 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 number and title must be typed on line 2 of the face page of the application form and the "YES" box must be marked. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typewritten original of the application, including the Checklist, and two 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 BETHESDA, MD 20817 (for express/courier service) At the time of submission, three additional copies of the application and five copies of any appendices must be sent to: Dr. Charles Hollingsworth Director, Office of Review National Center for Research Resources 6705 Rockledge Drive, Room 6100 Bethesda, MD 20892 Telephone: (301) 435-0807 FAX: (301) 480-3660 E-mail: CharlesH@ncrr.nih.gov Schedule Letter of Intent Receipt Date: December 1, 2000 Application Receipt Date: January 23, 2001 Council Review: September 15, 2001 Earliest Award Date: September 30, 2001 Applications must be received by January 23, 2001. If an application is received after that date, it will be returned to the applicant without review. INQUIRIES Direct inquiries regarding programmatic issues to: Dr. Sidney A. McNairy, Jr. Associate Director, Research Infrastructure National Center for Research Resources National Institutes of Health 6705 Rockledge Drive Bethesda, MD 20892-7965 Telephone: (301) 435-0788 FAX: (301) 480-3770 E-mail: sidneym@ncrr.nih.gov For information on budget and fiscal matters, contact: Ms. Irene Grissom Office of Grants Management National Center for Research Resources National Institutes of Health Bethesda, MD 20892 Telephone: (301) 435-0844 FAX: (301) 480-3777 E-mail: grissomi@ncrr.nih.gov INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.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. Reviewers are cautioned 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, Institutional Development Award (IDeA) Network Program, is related to one or more of the priority areas. Potential applicants may obtain a copy of Healthy People 2010" at http://www.health.gov/healthypeople AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.854. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-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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