CENTERS OF BIOMEDICAL RESEARCH EXCELLENCE (COBRE) Release Date: December 21, 1999 RFA: RR-00-003 (Limited competition for competing continuation applications, see NOT-RR-05-007) National Center for Research Resources Letter of Intent Receipt Date: February 10, 2000 Application Receipt Date: March 8, 2000 PURPOSE The purpose of the Institutional Development Award (IDeA) Program is to foster health-related research and increase the competitiveness of investigators through support for faculty development and enhancement of the research infrastructure of institutions located in states with historically low aggregate success rates for grant awards from the National Institutes of Health (NIH). In FY 1998, investigators from the 23 eligible IDeA states and Puerto Rico accounted for only 8 percent of the total number of NIH research grant applications, most likely reflecting that there are too few investigators trained to conduct biomedical research in those states. To address this need, 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 is to augment and strengthen the institutional biomedical research capabilities by providing support to expand and develop biomedical faculty research capability through support of a multi- disciplinary center, led by a peer-reviewed, NIH-funded investigator with expertise central to the grant proposal. The application is to have a thematic science focus in one research area such as neuroscience, cancer, structural biology, immunology, or bioengineering that 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 different disciplines and to enable the institution to develop the critical mass of investigators and enhance their competitiveness in a 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. NCRR held a workshop on December 16,1999, to provide information and assistance to potential COBRE applicants. A summary of the presentations and issues discussed will be available on-line at http://www.ncrr.nih.gov/research_infra.asp or provided upon request for those unable to attend. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2000, a PHS-led national activity for setting priority areas. This Request for Applications (RFA), entitled CENTERS OF BIOMEDICAL RESEARCH EXCELLENCE (COBRE), is related to many priority areas. Potential applicants may obtain a copy of "Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000. ELIGIBILITY REQUIREMENTS In making its assessment for eligibility, NCRR included all states 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 1994-1998. Also included are those states which had higher success rates, but had less than $60 million average NIH funding over the five year period. Under these criteria, the following states 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 As noted above, Puerto Rico is included in these eligibility criteria. Up to two applications may be submitted from each IDeA eligible state. The applicant organization must be a domestic, public or private, non-profit independent biomedical research institution or biomedical research institution that awards doctoral degrees in the health sciences or sciences related to health within IDeA eligible states. A coordinating committee must be established by the eligible institutions in order to determine the lead applicants. Those states with Experimental Program to Stimulate Competitive Research (EPSCOR) committees are encouraged to use them. If an EPSCoR Committee is not available in an IDeA-eligible state, a comparable Committee is to determine priorities for proposal submission. Collaboration between the eligible institutions is encouraged. The Principal Investigator must be an established research scientist with the ability to ensure high quality research and the experience to administer effectively and integrate all components of the program. A minimum time commitment of 25 percent is expected for this individual, however, up to 50 percent effort will be supported. An award pursuant to this RFA will not be made until and unless the institution has appointed a COBRE Director who is an established biomedical scientist with an active research program that is supported by peer-reviewed NIH and/or NSF investigator-initiated research support in the scientific area of the Center and has the professional skills needed to direct the Program. If this individual 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. The administrative and leadership skills of the established investigator, research productivity, and capacity to obtain and effectively use the resources will be assessed. (See REVIEW CONSIDERATIONS) MECHANISM OF SUPPORT This RFA will use the exploratory grant award mechanism (P20). Responsibility for the planning, directing and execution of the proposed project will be solely that of the applicant. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded under this RFA. The anticipated award date is September 30, 2000. FUNDS AVAILABLE The NCRR plans to make up to 15 awards in Fiscal Year 2000. An applicant may request a project period of five or fewer years and a budget for direct costs of up to $1,500,000 per year, excluding F&A costs on consortium arrangements. Funds will not be provided for renovation of research facilities through this RFA. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the NCRR financial plans provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of applications of outstanding scientific and technical merit. At this time, it is not known if competing renewal applications will be accepted and/or 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 thematic science focus must be evident in the application, which includes 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/. Questions may be directed to the fiscal contact identified below under Inquiries. 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 cuts across 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 that the institutions in IDeA eligible states can make are important and essential in fulfilling the promise of the NIH research agenda. The intent of this RFA is to help these institutions develop and use the technologies and other resources needed to conduct state-of-the-art biomedical research with the ultimate goal of their competing independently for NIH research grants. Prime objectives of this program will be accomplished by providing support to a magnet investigator as well as support of three to five research projects with a thematic science focus. With respect to the former, the principal investigator will enhance the institution(s) ability to compete for complementary NIH individual research grant support as well as serve as a mentor for more junior faculty at the institution(s). RESEARCH PLAN Describe an overall research plan that is sufficiently long term (5 years) to justify support of a multi-disciplinary COBRE Program. The research plan of an application must contain the description of at least three and up to five multidisciplinary, collaborative research projects. Describe the Specific Aims in the selected area of research and the goals for the first year and for the long term. Delineate the design principle(s) supporting the research or the hypothesis(es) to be tested. 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. Describe the area of multi-disciplinary research that is the focus of the COBRE. Critically assess existing knowledge and approaches that have been or are being directed in the area, and specifically describe how the multi- disciplinary COBRE approach will advance the field. State concisely the importance and health relevance of the proposed research to the Specific Aims. Clearly indicate what unique research opportunities will be provided by the proposed COBRE. If the proposed COBRE research is closely related to ongoing research or an existing Center, explain how the research activities of the COBRE will complement but not overlap with existing research. Describe the efforts of each member of the multi-disciplinary research team and how they will be integrated and organized to accomplish the specific aims of the project. Provide a tentative sequence or timetable for the project. Include how the data will be collected, analyzed, and interpreted. Describe how the data and technological advances will be disseminated to other investigators. Clearly describe the qualifications of the COBRE director selected for this effort. 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 for 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. As appropriate, 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 project to the core should be described. Finally, a plan should be presented detailing the long-term goals as to how the institution intends to transition the research support of the multi- disciplinary COBRE to competitive grant support through applications submitted by its faculty members to relevant NIH institutes and centers. This must include both formative and summary evaluation strategies with specific milestones. BIOGRAPHICAL SKETCHES For the Principal Investigator, Co-Investigator(s), and non Co-Investigator Senior Personnel, provide a brief biographical sketch or curriculum vitae which includes a list of the five most recent or significant publications. This section must not exceed two pages per person. OTHER SUPPORT Provide a complete listing of current and pending support for the Principal Investigator, Co-Investigator(s), and non Co-Investigator Senior Personnel only using the format suggested in the PHS 398 (revised 4/98). RESOURCES Facilities and Equipment. Describe the equipment and facilities available to the proposed COBRE. SPECIAL REQUIREMENTS The COBRE Director should budget for an annual two-day meeting in Bethesda, Maryland with NCRR staff. Each COBRE application must include an Advisory Committee, comprised of at least three scientists, with national scientific reputations in their field, their expertise must be directly relevant to the scientific theme of the COBRE. The Advisory Committee critiques scientific progress of the COBRE and also offers advice on scientific matters to the COBRE Director who will share that advice and critique with center-based investigators. The Committee must meet at least twice per year on average. Minutes are to be recorded and available for review by NCRR program staff who are responsible for COBRE. 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 is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. Adequate plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research must be included. Plans for recruitment and retention of subjects will be evaluated. 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 NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research, which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994 available on the web at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. NIH POLICY AND GUIDELINES ON THE 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) must be included in all human subjects research, conducted or supported by the NIH, unless there is scientific or ethical reasons not to include them. This 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. LETTER OF INTENT Prospective applicants are asked to submit, by February 10, 2000, a letter of intent that includes a descriptive title of the proposed research, 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 in response to which the application may be submitted. 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 NCRR staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Dr. Sybil Wellstood Office of Review National Center for Research Resources National Institutes of Health 6705 Rockledge Drive, Room 6104 Bethesda, MD 20892-7965 Telephone: (301) 435-0811 FAX: (301) 480-3660 E-mail: [email protected] APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, Email: [email protected], and from the NIH program administrator listed under INQUIRIES. An application for a COBRE award must include the following: o The application must clearly define the nature and extent of research collaboration, such that they fully explain the necessary administrative, fiscal, and scientific aspects of the proposed COBRE, o A research plan for up to 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 Principal Investigator 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, and o A description of the infrastructure for conducting studies aimed at developing a nationally competitive biomedical research program. 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 RFA number must be typed on the label as well. 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 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 must be sent to: Dr. Sybil Wellstood Office of Review National Center for Research Resources 6705 Rockledge Drive, Room 6104 Bethesda, MD 20892 Telephone: (301) 435-0811 FAX: (301) 480-3660 E-mail: [email protected] Schedule Letter of Intent Receipt Date: February 10, 2000 Application Receipt Date: March 8, 2000 Council Review: September 15, 2000 Earliest Award Date: September 29, 2000 Applications must be received by March 8, 2000. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept an application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by NCRR staff. Applications that are incomplete and/or non- responsive to this RFA, or exceed the maximum first year direct cost limit of $1,500,000, 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 a Special Emphasis Panel convened by NCRR in accordance with the review criteria stated below. 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. The review of the COBRE application is based not only on the traditional review criteria for research projects, but also considers the qualification and stature of the Principal Investigator to provide leadership, both scientific and administrative, and the feasibility and potential for investigators to gain scientific independence. The following criteria will be used to evaluate the 1) administration and the overall potential for enriching the intellectual milieu for doing research, and 2) scientific merit of the individual biomedical research projects. Administration of the Center 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, 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 the academic qualifications, experience with biomedical , expertise and research productivity, o The level of institutional commitment with regard to commitment of resources and facilities to sustain the COBRE program, 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. Scientific Merit of the individual proposals will be evaluated using the following review criteria: (1) Significance: Does this project address an important biomedical research question? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the research project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the research 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? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this research project? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the research project will be performed 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? Overall Evaluation: A research project does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative, but is essential to move a field forward. An assessment of the merit of the COBRE’s evaluation plans, including formative and summary evaluation strategies, will be taken into account in the overall evaluation of the proposal. In addition to the above criteria: 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. 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. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. 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: [email protected] For information on budget and fiscal matters, contact: Mr. Paul Karadbil 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: [email protected] 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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