DIABETES RESEARCH AND TRAINING CENTERS Release Date: September 10, 2001 RFA: RFA-DK-02-005 National Institute of Diabetes and Digestive and Kidney Diseases (http://www.niddk.nih.gov) Letter of Intent Receipt Date: February 19, 2002 Application Receipt Date: March 19,2002 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for Diabetes Research and Training Center (DRTC) grants to support research on diabetes mellitus and its complications, and related areas of endocrinology and metabolism. The NIDDK anticipates the award of five DRTCs from applications submitted in response to this solicitation. DRTCs are intended to facilitate progress in research with the goal of developing new methods to treat, prevent and ultimately cure diabetes mellitus and its complications. DRTCs support Research Cores that provide shared resources to enhance the efficiency of biomedical research and foster collaborations within and among institutions with established, comprehensive bases of research relevant to diabetes mellitus, a Pilot and Feasibility Program, and an Enrichment Program. A separate RFA, DK-02-004, is being issued simultaneously inviting applications for up to four Diabetes Endocrinology Research Center (DERC) grant awards. Both DRTCs and DERCs support Research Cores, a Pilot and Feasibility Program and an Enrichment Program. In addition to the requirement, common to both DERCs and DRTCs, for a substantial base of basic and clinical research, DRTCs must have a substantial base of research on translation of research advances into clinical practice. DRTCs must also request substantial support for cores and pilot and feasibility projects directed at translational research for the prevention and control of diabetes. The cores and pilot and feasibility projects directed at prevention and control of diabetes should focus on translation of research advances into clinical practice. This includes the identification of barriers to widespread adoption of new science and the development and testing of interventions to overcome these barriers under real world conditions. Applicants are encouraged to focus on underserved populations disproportionately affected by diabetes in the cores and pilot and feasibility projects directed at prevention and control of diabetes. Institutions cannot apply for both a DRTC under this RFA and a DERC under RFA DK-02-004. Since an application for DRTC support includes all the elements of a DERC, applicants responding to this RFA, DK-02-005, will be given priority scores for both the entire DRTC and the subset of DRTC components required for a DERC. Applications that are not competitive for a DRTC award will also be considered for a DERC award under RFA DK02-004 based on the scientific merit of the components of the DRTC application that are also components of the DERC application. 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 Request for Applications (RFA), Diabetes Research and Training Centers, is related to the priority area of chronic diseases. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic nonprofit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for center grants. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Applicant institutions must have a strong existing base of high quality basic and/or clinical research relevant to diabetes mellitus, including substantial diabetes research support awarded through peer reviewed competition. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) core centers grant (P60) award mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Applicants from institutions which have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. In such a case, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. This RFA is a one-time solicitation. The NIDDK accepts P30 and P60 applications only when submitted in response to an RFA. The receipt of competing continuation applications from five P60 centers is anticipated. These applications will compete for the five anticipated awards along with other applications received in response to this RFA. The total requested project period for applications submitted in response to this RFA may not exceed five years. The maximum dollar request in any budget period is limited to $1,250,000 in direct costs with the following exceptions. Not included in these direct cost limits are: 1) requests for equipment in the first year of a competitive award, 2) direct costs on subcontracts for the purpose of establishing collaborations and providing access to the research infrastructure to investigators at historically black colleges and universities (HBCU s), health departments, community health centers or other agencies that focus on underserved populations and offer special opportunities to foster research to reduce or eliminate health disparities in populations disproportionately affected by diabetes, and 3) Facilities and Administrative (F&A) Costs associated with any subcontract. Approximately 20-25% of the direct costs requested, exclusive of equipment, should be for support of a Pilot and Feasibility program. Future budget period escalations may not exceed a 3 percent increase over the previous budget period. The anticipated award date is September, 2002. FUNDS AVAILABLE The NIDDK intends to commit approximately $9.4 million in FY 2002 to fund five new and/or competing continuation P60s in response to this RFA. An applicant may request a project period of up to 5 years and a budget for direct costs of up to $1.25 million per year, excluding F&A costs on consortium arrangements, first year equipment and direct and F&A costs on subcontracts directed at underserved populations. 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 financial plans of the NIDDK 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 applications of outstanding scientific and technical merit. RESEARCH OBJECTIVES The Diabetes Research and Training Centers (DRTCs) are part of an integrated program of support provided by the NIDDK for research in diabetes and related areas of endocrinology and metabolism. Development of new methods to prevent, treat or cure diabetes and its complications will depend on multidisciplinary collaborations among clinical and basic scientists. DRTCs provide a focus for enhancing such collaborations among investigators at institutions with an established, comprehensive, federally supported diabetes research base. DRTCs are intended to improve the quality and multidisciplinary nature of diabetes research by providing shared access to specialized technical resources and expertise. The overall goal of the DRTC is to bring together clinical and basic science investigators, from relevant disciplines, in a manner that will enhance and extend the effectiveness of research related to diabetes and its complications. A DRTC must be an identifiable unit within a single institution such as a university medical center or a consortium of cooperating institutions, including an affiliated university. DRTC applications require an existing program of excellence in biomedical research in the area of diabetes and related areas of metabolism and endocrinology and an existing program of excellence in translational research directed at prevention and control of diabetes. This research should be in the form of NIH-funded research projects, program projects, or other peer-reviewed research that is in existence at the time of submission of a center application. Close cooperation, communication, and collaboration among all involved personnel of all professional disciplines are essential to the success of a DRTC. Accordingly, the applicant must clearly state the considerations for center membership. It is also appropriate and beneficial to define one or more central themes around which DRTC investigators are focused. Diabetes research involves many specialized technologies and other resources, which must be integrated into a cohesive research program. The objectives of the DRTC are to make these technologies and resources available to many investigators and to promote a multifaceted approach to diabetes research by providing shared resources to investigators with a wide variety of expertise. These centers are based on the core concept. Cores are defined as shared specialized technical resources and/or expertise that enhance efficiency, productivity, multi-disciplinary collaboration, or in other ways benefit a group of investigators working in diabetes or diabetes-related areas to accomplish the stated goals of the center. Examples of possible biomedical core resources that would be considered responsive to this Request for Applications include: molecular biology, islet isolation, cell and tissue culture, transgenic, animal models, genetics, gene transfer, immunology, protein chemistry and macromolecular structure, analytical biochemistry, cytohistochemistry, protein expression, metabolism, mass spectrometry, immunoassay, morphology and image analysis, monoclonal antibody/hybridoma, computer resource, bioinformatics, biostatistics, and clinical research. DRTCs must also propose specialized cores to develop and provide tools and technologies for intervention, measurement and evaluation to support an ongoing translation research. Such cores could provide access to telemedicine, behavioral or psychological assessment, nutrition or physical fitness assessment, patient identification and characterization, expertise and techniques for developing and conducting interventions, data management, study design and analysis, and other cores to support population based multidisciplinary research. These possible cores are not listed in any particular order nor do they represent a comprehensive list of cores that could be supported under this Request for Applications. Applicants are encouraged to propose other cores that address the program objectives as stated above, based on the requirements of the investigators at the applicant institution. In addition to biomedical cores, DRTC applications must include an administrative core that will be responsible for allocation of resources within the Center and distribution of resources to Center participants. The Administrative core will also be responsible for planning an enrichment program and convening a committee to oversee the solicitation, review and selection of the pilot projects. The DRTCs also support a pilot and feasibility program. The pilot and feasibility program provides modest support (up to $50,000 direct costs per year for up to two years for each project) for new diabetes initiatives or feasibility studies. This program is directed at new investigators or established investigators in other research disciplines whose expertise may be applied to diabetes research. Established diabetes investigators exploring a new research direction related to diabetes are also eligible, but the great majority of Pilot and Feasibility project support should be directed at new investigators or investigators new to diabetes research. DRTCs should include pilot and feasibility projects directed at basic biomedical or clinical research relevant to diabetes and its complications. In addition, DRTCs should propose one or more pilot and feasibility projects directed at translational research, such as studies of interventions in health care settings and communities. These pilot and feasibility projects may subsequently be extended as R18s (See PA-01-069). DRTCs may also include limited funds for an enrichment program to facilitate the exchange of information between investigators who have research interests in the areas of diabetes, endocrinology and metabolism. The enrichment program can support activities such as seminars, guest speakers, visiting scientists, consultants, and workshops. Although funds are not provided directly for training purposes, applicants may wish to describe how the core laboratories and program enrichment activities will provide training opportunities for center members. DRTC applicants are encouraged to consult with NIDDK staff concerning plans for the development of a Diabetes Research Center and to request the NIDDK Administrative Guidelines for preparing a Diabetes Research Center application (See Application Procedures.) SPECIAL REQUIREMENTS DRTC applications require an existing program of excellence of biomedical research in the area of diabetes and related endocrinology and metabolism research as well as an existing program of excellence in translational research relevant to diabetes and its complications. A substantial research base, consisting of NIH and other peer-reviewed funded research projects, is required to justify the requested Center support. Suggestions for describing and presenting this research base in the application are included in the Administrative Guidelines for NIDDK Diabetes Research Centers (See Application Procedures). The proposed budget should include travel for the Principal Investigator and the Associate Director, or another key personnel, for an annual one-day meeting in Bethesda. The application should include a statement of willingness to attend an annual meeting of Diabetes Research Center Directors. The DRTC grants provide support for enrichment activities to foster multi- disciplinary approaches to diabetes research and to attract new investigators or investigators with relevant expertise to diabetes research. While many of these activities occur at the grantee institution, applicants are encouraged to suggest coordinated efforts, such as educational activities, that might involve multiple Diabetes Research Centers. The application should include a statement regarding willingness to participate in such activities. 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) 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 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. Investigators may also obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS All investigators proposing research involving human subjects should read the policy that was published in the NIH Guide for Grants an Contracts, June 5, 2000 (Revised August 25, 2000), and is available at the following URL address http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.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. 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 (PA) 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. LETTER OF INTENT Prospective applicants are asked to submit, by February 19, 2002, 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 NIDDK staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities, NIDDK 6707 Democracy Boulevard, Rm. 653 MSC 5452 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) Telephone: (301) 594-8885 FAX: (301) 480-3505 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/01) 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: GrantsInfo@nih.gov. Applicants should request a copy of Administrative Guidelines for NIDDK Diabetes Research Centers. These guidelines contain important additional suggestions and information on the format, content, and review of applications and review criteria. Prospective applicants may obtain guidelines from staff listed under INQUIRIES or at: http://www.niddk.nih.gov/fund/other/guidelines.doc 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. 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 time of submission, two additional copies of the application must be sent to: Chief, Review Branch Division of Extramural Activities, NIDDK 6707 Democracy Boulevard, Rm. 752 MSC 5452 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) Applications must be received by the application receipt date listed in the heading of the RFA. If an application is received after that date, it will be returned to the applicant without review. Supplemental documents containing significant revision or additions will not be accepted, unless applicants are notified by the Scientific Review Administrator. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. 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 previously reviewed, but such applications must include an Introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDDK. Incomplete and/or non-responsive applications 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 NIDDK in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. Review Criteria The goals of the DRTCs are to advance our understanding of biological systems relevant to diabetes and its complications, and to facilitate development of new methods to treat, prevent and ultimately cure diabetes and its complications. DRTCs have the additional goal of improving the control and prevention of diabetes and its complications and enhancing health by facilitating translational research, particularly in underserved populations and populations disproportionately affected by diabetes. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighing them as appropriate for each application. The most important component of DRTCs is the quality (strengths, breadth and depth) of its established, independently supported, ongoing base of diabetes research at the institution(s) to be served by the center. For the DRTC this research base must include translational research in addition to the biomedical research base required for DERCs. Specific review criteria are: o Scientific excellence of the Center"s research base that must have a broad and central focus in diabetes and may extend to related research in metabolism and endocrinology. The relevance of the separately funded research to the Center objectives (see above) and the likelihood for meaningful collaboration among Center investigators must be demonstrated. o Potential of the cores for contribution to ongoing research, including their appropriateness, impact, relevance, uniqueness, modes of operation, and suitability of facilities. Renewal applications must document the use, impact, quality control, and cost effectiveness of each core, and demonstrate progress of any developmental research in the cores. Progress will be judged in part by the publications supported by the cores. While a minimum of two users (exclusive of Pilot and Feasibility projects) are required to establish a core, a greater number of users will be considered to be more cost effective. o Scientific and administrative abilities of the Center Director and Associate Director and their commitment and ability to devote adequate time to the effective management of the Diabetes Research Center. o The qualifications, experience, accomplishments, and commitment of the Center investigators and their inter-relatedness and collaborations. o For new applications, the pilot and feasibility program is judged on the basis of: (1) scientific merit of the studies as submitted and (2) the merit of the administrative process for selecting subsequent studies. The scientific merit of the submitted pilot and feasibility studies will be evaluated for: (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) 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? (4) 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 principal investigator and other researchers (if any)? (5) 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? In competing renewal applications, emphasis is placed on the pilot and feasibility program as a whole, including past track record and management of the program. o The Administrative organization proposed, including: coordination of ongoing research, establishment and maintenance of internal communication and cooperation among DRTC investigators, mechanisms for prioritizing usage of shares resources, mechanisms of selecting and replacing essential personnel within the Center, mechanisms for reviewing the use of and administering funds for the pilot and feasibility program, and management capabilities. o The appropriateness of the DRTC budgets for the proposed and approved work to be done in core facilities, for pilot and feasibility studies, and for enrichment in relation to the total Center program. o Institutional commitment to the program, including lines of accountability regarding management of the DRTC grant and a commitment to establish new positions as necessary. o Although the DRTCs do not specifically support research training, demonstration of accomplishments and future plans related to the training of investigators necessary to conduct research in diabetes and related metabolic and endocrine disorders will be considered in assessing the potential to meet Center objectives. The integration of these efforts into the overall Center, including core facilities is of particular importance. Efficient and effective use and/or planned use of the limited enrichment funds, including the contribution of these activities in enhancing the objectives of the Center will also be considered. In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o Adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration to the proposed research. o The adequacy of the proposed protection of humans, animals, or the environment, to the extent that they may be adversely affected by the project proposed in the application. o The adequacy of the proposed plan to share data. Schedule Letter of Intent Receipt Date: February 19, 2002 Application Receipt Date: March 19,2002 Peer Review Date: July, 2002 Council Review: September, 2002 Earliest Anticipated Start Date: September, 2002 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit as determined by peer review, o Availability of funds, o Programmatic priorities. 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: Judith Fradkin, M.D. Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 689 MSC 5460 Bethesda, MD 20892-5460 Telephone: (301) 594-8814 FAX: (301) 480-3503 E-mail: jf58s@nih.gov Direct inquiries regarding fiscal matters to: Kieran Kelley Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 636 MSC 5460 Bethesda, MD 20892-5460 Telephone: (301) 594-0417 FAX: (301) 480-3504 E-mail: kk27g@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847. Awards are 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 Parts 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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