CENTERS OF BIOMEDICAL RESEARCH EXCELLENCE (COBRE) RELEASE DATE: September 24, 2002 RFA: RR-02-007 National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov) LETTER OF INTENT RECEIPT DATE: December 18, 2002 APPLICATION RECEIPT DATE: January 22, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations: 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 research capacity, the National Center for Research Resources (NCRR) of the National Institutes of Health invites applications for Centers of Biomedical Research Excellence (COBRE) from investigators at independent biomedical research institutions or biomedical research institutions that award doctoral degrees in the health sciences or sciences related to health within IDeA eligible states. Collaboration with other non-doctoral degree granting and research performing institutes or institutions is encouraged. The purpose of this Request for Applications (RFA) is to augment and strengthen the institutional biomedical research capacity through flexible support to expand and develop biomedical faculty research capability and enhance research infrastructure through support of a multi-disciplinary center, led by a peer-reviewed, funded investigator with expertise central to the research theme of the proposal. The application must have a thematic scientific focus in a specific research area, such as neuroscience, cancer, structural biology, immunology, or bioengineering, and may use basic, clinical or both research approaches to attain the goals of the proposed center. The scientific leadership provided by one or more established biomedical research faculty is critical to the success of this initiative, especially for the mentoring of promising junior investigators. The center is intended to support investigators from several complementary disciplines. It will enable the institution to develop a critical mass of investigators and enhance their competitiveness in a specific research area that accelerates the rate at which those investigators compete for other complementary NIH research grant support. It is also anticipated that, in some instances, the support through this initiative will facilitate the development of new disease specific research centers or augment the capability of existing centers. RESEARCH OBJECTIVES This program seeks to promote the initiation and development or 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 also includes cellular and molecular biology, biophysics and biotechnology, genetics and developmental biology, pharmacology 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 research. The objectives of this program are (1) to enhance the ability of investigators to compete independently for complementary NIH individual research grant or other external peer-reviewed support and (2) to strengthen an institution"s biomedical research infrastructure through the establishment of a multi-disciplinary center. This goal is accomplished through the direction provided by a Principal Investigator (PI), who provides leadership to junior investigators (defined below) and has the primary responsibility for administering the program and for overseeing the development of the center and its associated core facilities. The PI of the COBRE application must be an established biomedical or behavioral research scientist who will ensure that high quality research be performed and who has the experience to effectively administer and integrate all components of the program. The PI must have an active biomedical or behavioral research program that receives NIH, NSF or other peer-reviewed support in the scientific area of the center and have the requisite administrative experience to direct the program. A minimum time commitment of 25 percent is required for this individual, however, up to 50 percent effort will be supported for mentoring and administrative oversight of the COBRE. If the PI is not in place at the institution at the time of review or award, a plan to recruit such an individual must be included in the application. An award pursuant to this RFA will not be made until and unless the institution has appointed a permanent COBRE PI. Each COBRE program should include three to five research projects that stand alone, but share a common thematic scientific focus. Each research project should be supervised by a single junior investigator who is responsible for insuring that the specific aims of that project are met. For the purpose of eligibility a junior investigator is defined either as (1) an individual who does not have or has not previously had an external, peer-reviewed Research Project Grant from either a Federal or non-Federal source that names that investigator as the PI or (2) an established investigator who is making a significant change to his/her career. With respect to the item (1), grants that name an individual as a co- investigator, collaborator or consultant do not disqualify that investigator. Starter grants (such as NIH"s FIRST award mechanism, R29), Academic Research Enhancement Award grants (AREA, R15), or exploratory/pilot project grants (such as NIH R03 or R21 awards) also do not disqualify the investigator. The investigator must hold either a tenure track or non-tenure track faculty appointment of any rank at the time that the award is made. Furthermore, a clear commitment to support this faculty appointment must be demonstrated from the institution by a letter(s) from the appropriate senior institutional official(s). Postdoctoral fellows or other positions that do not carry independent faculty status will disqualify that individual and his/her research project from further consideration. With respect to the item (2), support may be provided to an individual who is making a significant change to his/her career goals by initiating a new line of research that is distinctly and significantly different from his/her current investigative program. In this case a current or previous history of independent peer-reviewed research support in a different investigative area from that proposed in this application does not disqualify the investigator. Moreover, this individual can be of any faculty rank. This initiative is not intended to replace support for ongoing investigator- initiated research programs of established investigators, nor are established investigators eligible for support. Instead, established investigators should serve as mentors to advance the junior investigators" careers. RESEARCH PLAN: Each application should describe an overall research plan to justify support of a multi-disciplinary COBRE program for five years. It is recommended that the research plan contain the descriptions of at least three and up to five research projects. In addition, the establishment of core facilities necessary to carry out the objectives of a multi-disciplinary, collaborative program may be proposed. Each individual research project should describe the Specific Aims in the selected area of research and the goals for the first year and for the long term. The design principles supporting the research or the hypotheses to be tested should be delineated. Preliminary studies are not required for COBRE 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. Furthermore, each research project should describe the area of multi-disciplinary research that is the focus of the COBRE and critically assess the existing knowledge and approaches that have been or are being directed in the area with an emphasis on specifically how the multi-disciplinary COBRE approach will advance the field. Moreover, the importance and health relevance of the proposed research to the Specific Aims should be concisely stated. With respect to the overall COBRE program the PI should describe the unique research opportunities that will be provided to the junior investigators and to the institution. If the proposed COBRE research is closely related to ongoing research or an existing center, an explanation how the research activities of the COBRE will complement but not overlap with existing research should be described. In addition, the PI should describe how the efforts of each junior investigator will assist in the establishment of a multi-disciplinary research center. The qualifications of the COBRE PI selected for this effort should be clearly described. If that individual is not a member of the faculty at the time of review of the application, include a detailed plan that will result in having that individual on the full-time faculty within one year from the date of peer-review of the institution"s application. Although no non-federal matching funds are required for these applications, clear evidence of institutional 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. At a minimum, a letter of support from a senior institutional official (e.g., President or Dean) should outline the commitment of resources and facilities to sustain and support the COBRE throughout the period of funding. The institutional environment and resources that are available to investigators must be briefly described. Available resources (e.g., laboratory facilities, patient populations, geographic distributions of space and personnel) and collaborative resources should be described. If core facilities are included for support, the relationship of each component research project to the core(s) should be described. A clear plan for the development and graduation of investigators who are provided research support from the COBRE program should be included. This plan should detail the long-term goals as to how the institution intends to make the transition from the research support of multi-disciplinary COBRE projects to competitive grant support through applications submitted by its faculty members to relevant NIH institutes and centers or to other appropriate Federal or non-Federal agencies or organizations. This must include both formative and summative evaluation strategies with specific milestones. Faculty development should include a mentoring plan that involves oversight by established senior faculty members assigned as mentors, constructive evaluations by members of the External Advisory Committee (EAC) (see below under Special Requirements), and coordinated management of all of these individuals by the PI of the COBRE program. Additional oversight may be augmented through the use of an internal advisory committee, but this committee should not act as substitute for the EAC. 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 applicant"s institution and it is therefore acceptable to enlist appropriate mentors from outside institutions. Mentors may request between 10 and 15 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. The award of a Research Project Grant (RPG) to a junior investigator should be viewed as a milestone and a basis for graduation of that investigator from the COBRE program. In addition, a junior investigator may be graduated from the COBRE program if the PI and/or the EAC deem that the investigator has achieved independent status. The receipt of an award that overlaps or is significantly similar to that described in the COBRE program is sufficient justification to graduate a junior investigator from the program. However, if the specific aims of the junior investigator"s RPG are significantly different from the project described in the COBRE, then the junior investigator has an obligation to remain in the program to complete his/her COBRE project. Following the graduation of a junior investigator from the COBRE program, the PI can appoint another investigator to assume the vacated slot. The appointment of a replacement investigator should involve review and recommendation of that investigator"s project by the EAC. The PI should communicate the EAC"s recommendations to NCRR Program staff to review and approve the appointment of new investigators (and possibly new mentors) to the program. BIOGRAPHICAL SKETCHES: The Principal Investigator, co-investigator(s), junior investigators, and mentors must provide a biographical sketch as initiated in the PHS 398 instructions. This section must not exceed four pages per person. RESOURCES: The application must describe the equipment and facilities available to the proposed COBRE. ALTERATION AND RENOVATION: Alteration and Renovation (A&R) costs to improve existing research laboratories or animal facilities are allowed. This RFA will provide up to $500,000 in direct costs in year one only of the award as a one-time cost expenditure. Alteration and renovation projects must be relevant to the scope of the proposed research and at the institution. 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 its 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, or for movable research equipment/instrumentation or for equipment intended for teaching or other non-research related purposes. Please note that alteration and renovation costs will only be approved for facilities improvements at the applicant"s organization. Proposed improvements at consortia sites is disallowed. For any proposed A&R, a narrative summary (as outlined below), line drawings, and cost estimates must be provided. The following sample format is suggested: o NARRATIVE SUMMARY (1) Relate the proposed renovations to the research projects that will use the facility. If renovations to animal facilities are proposed, relate the proposed renovations to the projected animal populations (by species). If renovations to animal facilities are proposed, please include the lines of authority and responsibility for administering the institution"s animal care and use program. The role and composition of the Institutional Animal Care and Use Committee (IACUC) and how compliance with relevant laws, policies, and guidelines is achieved should also be included. (2) 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. (3) List engineering criteria applicable to each component (mechanical, electrical, and utilities). Include information such as the number of air changes per hour, electrical power, light levels, hot and cold water, steam. (4) List appropriate architectural criteria (such as width of corridors and doors, surface finishes). (5) List and justify all fixed equipment items requested for the renovated area. o LINE DRAWINGS (1) 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. (2) The line drawings of the proposed renovation must be at a scale adequate to explain the project. The drawings should indicate size (dimensions), function, and net and gross square feet of space for each room. The total net and gross square feet of space to be renovated should also be given. (3) The plan should indicate the location of the proposed renovation area in the building. (4) Include the as-built drawings of the proposed renovation area and indicate any areas which will be demolished. (5) 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. (6) Indicate the type(s) of new finishes to be applied to room surfaces. o COST ESTIMATES Detailed cost estimates must be included. Provide vendor quotes when available. Those individuals interested in seeking additional funds for facilities improvements are referred to the NCRR Research Facilities Improvement Program, that accepts applications for construction and for extensive renovation. Please refer to the NCRR Website: http://www.ncrr.nih.gov/. MECHANISM OF SUPPORT 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 September 2003. All budget requests should be submitted in non-modular format. Individual project and core facility budgets should be grouped together with justifications and prefaced by a summary budget for the entire program. FUNDS AVAILABLE The NCRR intends to commit approximately $35 million in FY03 to fund 15 to 20 new grants in response to this RFA. An applicant must request a project period of 5 years and may request a budget for direct costs of up to and no more than $1.5 million per year, excluding facilities and administrative (F&A) costs on consortium arrangements. The applicant may also request additional direct costs in year one only of up to $500,000 as a one-time expenditure for alteration and renovation of laboratory or animal facilities. If alteration and renovation costs are requested, then the total budget request for year one must not exceed $2 million in direct costs, excluding F&A costs on consortium arrangements. Regardless whether alteration and renovation costs are requested, budget requests for years two through five cannot exceed $1.5 million per year, excluding F&A costs on consortium arrangements. Funds may be used to develop Offices of Sponsored Programs and for faculty expansion (i.e., recruitment of additional faculty who complement the scope of the proposed program) up to $100,000 per year for each position. These funds may be used for salary, supplies and equipment costs. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size 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 a sufficient number of meritorious applications. At this time, it is not known if this RFA will be reissued. 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 COBRE 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 COBRE"s thematic scientific focus must be evident in applications that include consortia arrangements. Applicants for COBRE 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 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. Questions may be directed to the fiscal contact identified below under Inquiries. ELIGIBLE INSTITUTIONS o CRITERIA FOR ELIGIBILITY OF AN IDeA STATE In making its assessment for eligibility, NCRR included all states/commonwealths with a success rate for obtaining NIH grant awards (number of applications awarded vs. number of applications approved) of less than 20 percent over the period of 1997-2001. Also included are those states that had higher success rates, but received less than $75 million average NIH funding over the five-year period. Under these criteria, the following states/commonwealth are eligible IDeA states: Alaska Arkansas Delaware Hawaii Idaho Kansas Kentucky Louisiana Maine Mississippi Montana Nebraska Nevada New Hampshire New Mexico North Dakota Oklahoma Puerto Rico Rhode Island South Carolina South Dakota Vermont West Virginia Wyoming o CRITERIA FOR INSTITUTIONAL ELIGIBILITY An eligible institution must be within an IDeA state. An eligible institution must either be (1) a domestic, public or private, or non-profit research institution that awards doctoral degrees in health sciences or sciences related to health, or (2) an independent biomedical research institute. Applications will be accepted from institutions that do not currently hold a COBRE award. Applications will also be accepted from institutions that hold one active COBRE award. However, applications will NOT be accepted from institutions that hold two or more active COBRE awards. These institutions are disqualified from this competition and cannot submit applications. Applications are encouraged from veterinary and dental schools in IDeA states. Applications will be accepted from veterinary and dental schools regardless of the number of active COBRE awards held by that institution. Applications are also encouraged from eligible institutions in IDeA states that propose research that relates to the scope and mission of the National Institute on Deafness and Other Communication Disorders (NIDCD). o RESTRICTIONS FOR SUBMITTING AN APPLICATION No eligible institution, including veterinary and dental schools, can submit more than one application in response to this RFA. Multiple applications received from these institutions or applications received from disqualified institutions (those that hold two or more active COBRE awards) will be returned without further consideration. If an institution is writing more than one application, it is the responsibility of that institution to appoint a steering or selection committee to decide which single application to submit in response to this RFA. 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 their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. The PI of the COBRE application must be an established biomedical or behavioral research scientist who has demonstrated the administrative abilities to effectively carry out the objectives of the COBRE program and meet its goals. The qualifications of the PI have been previously described. SPECIAL REQUIREMENTS The COBRE PI should budget for an annual two-day meeting in Bethesda, Maryland with NCRR staff. Each COBRE application must include an External Advisory Committee (EAC), comprised of at least three to five scientists, with national scientific reputations in their field, their expertise must be directly relevant to the scientific theme of the COBRE. The EAC critiques scientific progress of the COBRE and also offers advice on scientific matters to the COBRE 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 other investigators at the center. The EAC will also review and approve candidates for replacement/substitute 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 made available for review by NCRR program staff responsible for the COBRE. 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. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Dr. Lawrence N. Yager Division of Research Infrastructure National Center for Research Resources National Institutes of Health 6705 Rockledge Drive, Suite 6030 Bethesda, MD 20892-7965 Telephone: (301) 435-0760 FAX: (301) 480-3770 E-mail: lawrencey@ncrr.nih.gov o Direct your questions about peer review issues to: Dr. Sheryl K. Brining Office of Review National Center for Research Resources National Institutes of Health 6705 Rockledge Drive, Room 6018 Bethesda, MD 20892 Telephone: (301) 435-0809 FAX: (301) 480-3660 E-mail: sb44k@nih.gov o Direct your questions about financial or grants management matters to: Ms. Irene Grissom Office of Grants Management National Center for Research Resources National Institutes of Health 6705 Rockledge Drive, Room 6086 Bethesda, MD 20892 Telephone: (301) 435-0844 FAX: (301) 480-3777 E-mail: grissomi@ncrr.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Dr. Sheryl K. Brining Office of Review National Center for Research Resources National Institutes of Health 6705 Rockledge Drive, Room 6018 Bethesda, MD 20892 Telephone: (301) 435-0809 FAX: (301) 480-3660 E-mail: sb44k@nih.gov SUBMITTING AN APPLICATION 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 a COBRE award must include the following: 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 COBRE. o A research plan for five years that includes the proposed organization and component functions of the COBRE. The plan should demonstrate the applicant"s knowledge, ingenuity, practicality, and commitment to developing a significant, productive, research program. o A description of and justification for 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 center. Applicants are required to propose at least three and up to five meritorious research projects and must describe the nature and scope of any scientific research collaborations. o A description of the research and research training or career development goals and capabilities of the proposed COBRE. 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 COBRE award. o A description of the infrastructure for conducting studies aimed at developing a nationally-competitive biomedical research program. o A narrative summary, line drawings and cost estimates must be provided for any proposed alteration and renovation project. An itemized budget and justification of the impact that this alteration and renovation would have on the COBRE activities must also be provided. 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 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, two additional copies of the application and five copies of any appendices must be sent to: Dr. Sheryl K. Brining Office of Review National Center for Research Resources National Institutes of Health 6705 Rockledge Drive, Room 6018 Bethesda, MD 20892 Telephone: (301) 435-0809 FAX: (301) 480-3660 E-mail: sb44k@nih.gov APPLICATION PROCESSING: Applications must be received by 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. PEER REVIEW PROCESS 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 first year direct cost limit of $1.5 million (or $2 million, if requesting first year alteration and renovation costs), excluding F&A costs for consortium budgets, 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 initial merit review, all applications will: o receive a written critique, o undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score, o receive a second level review by the National Advisory Research Resources Council. REVIEW CRITERIA 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 are asked to discuss the following aspects of an application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The review of the COBRE 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 subproject leaders. 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: 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 COBRE, and establishing thematic collaborative research efforts. The Principal Investigator must be an established biomedical or behavioral research scientist. He/she should be supervising an active research laboratory that is supported by relevant, peer-reviewed, research grants (NIH, NSF or other peer-reviewed research awards). o The significance, approach, and innovation of the proposed research projects and of the COBRE 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 and research productivity. o The level of institutional commitment with regard to assuring that the resources and facilities to sustain the COBRE program are present, including, but not restricted to, existing relevant equipment, animal, and/or computer resources, and departmental or interdepartmental 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 institutional biomedical research capability. o The ability to provide support for the development of a multidisciplinary center. o The means by which basic or clinical research is encouraged. o The establishment and maintenance of a scientific thematic focus. o The suitability of the External Advisory Committee. 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. o SIGNIFICANCE: Does the study address an important problem? If the aims of the application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? o APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Are potential problem areas acknowledged and alternative tactics considered? o 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? o 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 to that of other researchers (if any)? o 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: The reviewers will be asked to use the following criteria in evaluating this criterion: o The quality of the research training, career development and mentoring plan for junior investigators of the center. o The plan for development and graduation of junior investigators. o The suitability of the plan for recruiting new faculty. ADDITIONAL REVIEW CRITERIA: 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. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: December 18, 2002 Application Receipt Date: January 22, 2003 Peer Review Date: June 16, 2003 (subject to change) Council Review: September 11, 2003 Earliest Anticipated Start Date: September 30, 2003 AWARD CRITERIA 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 institution, and the availability of funds. REQUIRED FEDERAL CITATIONS 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: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the 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 are 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. 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. 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 http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.389. 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 and are not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards made under these authorizations are administered under NIH grants policies described 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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