SMALL GRANTS FOR UNDERREPRESENTED MINORITY SCIENTISTS IN DIABETES AND DIGESTIVE AND KIDNEY DISEASES Release Date: November 22, 1999 RFA: DK-00-007 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: February 22, 2000 Application Receipt Date: March 22, 2000 THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) recognizes the need to increase the number of individuals from underrepresented minority groups committed to scientific careers in research areas served by the NIDDK. This program is aimed primarily at recently trained M.D. and/or Ph.D. minority investigators. The program will enable the applicant to accept a tenure-earning position, gain additional research experience and obtain preliminary data on which to base a subsequent research grant application in an area of diabetes, endocrinology, metabolism, digestive diseases, and nutrition, kidney, urology or hematology. 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 RFA, Support of Minorities in Diabetes, Digestive and Kidney Disease, is related to the priority area of increasing underrepresented minority health scientists. Potential applicants may obtain a copy of Healthy People 2000 at http://odphp.osophs.dhhs.gov/pubs/hp2000. ELIGIBILITY REQUIREMENTS For the purpose of this announcement, underrepresented minority investigators are defined as individuals belonging to a particular ethnic minority investigators are defined as individuals belonging to a particular ethnic or racial group has been determined by the grantee institution to be underrepresented in biomedical or behavioral research. Awards will be limited to citizens or non- citizen nationals of the United States or to individuals who have been lawfully admitted for permanent residence (i.e., in possession of an Alien Registration Receipt Card) at the time of application. An applicant must have a doctoral degree (M.D., Ph.D., D.O., D.D.S., D.V.M.). He or she should have received at least two years of postgraduate research training in an area of research applicable to research supported in this institute. He/she should have direct access to an expert in the area of the proposed research who can provide guidance or any necessary assistance in carrying out the proposed research. Applicants may not hold, nor apply concurrently for any other PHS research project grant at the time of this application. Priority will be given to those applicants who have not previously been a Principal Investigator on a major research grant. Applicants are encouraged to apply for other research project grants during the course of, or following, this award. MECHANISM OF SUPPORT Support will be provided through the Small Research Grant (R03) program administered by the Division of Diabetes, Endocrinology and Metabolism, the Division of Digestive Diseases and Nutrition, and the Division of Kidney, Urologic and Hematologic Diseases in the NIDDK. Responsibility for the planning, direction, and execution of the proposed project will be that of the applicant. Awards will be administered under NIH grants policy as stated in the NIH Grants Policy Statement. Applicants from institutions that 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. If so, 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. Future unsolicited continuation applications will compete with all investigator- initiated applications and be reviewed according to the customary peer review procedures. Should the NIDDK determine that there is a sufficient continuing program need, a request for new applications will be announced. The total project period for applications submitted in response to the present RFA may be for one or two years. In specific circumstances resulting from the requirements of a particular research project and the applicant’s need to acquire additional skills required for the project, three years may be requested. Direct costs requested must not exceed $50,000 per year. A grant funded from this RFA cannot be renewed. The anticipated award date is September 30, 2000. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm FUNDS AVAILABLE For FY 2000, $250,000 in total direct costs for year 01 will be committed in each of the three research divisions in the NIDDK. It is anticipated that up to five awards will be made in each of the three NIDDK program divisions in FY 2000. This level of support depends on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIDDK, the award of grants pursuant to this RFA is contingent upon the availability of funds for this purpose and the receipt of a sufficient number of applications of outstanding scientific and technical merit. RESEARCH OBJECTIVES The primary purpose of this RFA is to increase the number of underrepresented minority Principal Investigators conducting research in areas supported by the NIDDK. Surveys of research and training programs administered by the NIDDK disclose the need to increase the access to NIDDK support of recently trained minority scientists who are U.S. citizens or permanent residents. Those who receive several years of training via an individual postdoctoral fellowship or an institutional training grant funded by a National Research Service Award may still require additional research experience and preliminary data to support an independent research career at this stage of development. An additional period of training may not be feasible for minority individuals with pressing economic burdens. Such individuals may be lost to academic research through a lack of opportunity to obtain an additional one or two years of support essential for establishing a research career. This program is designed to help alleviate some of the above-noted problems experienced by underrepresented minorities who may wish to pursue a career in research. The program will allow the minority investigator to hold a tenure-earning position, to gain additional research experience and to obtain preliminary data on which to base a subsequent research grant application. SPECIAL REQUIREMENTS Applicants are required to have available a recognized expert in the area of proposed research for guidance and consultation. It is expected that this expert will assist the applicant in the design and conduct of his/her research. It is not necessary that the expert be at the same institution as the applicant, but he/she should be within a reasonable proximity to be available for guidance and consultation. Following the research plan, the applicant is required to provide a brief summary of his/her long-term career plans and objectives. The application should state how this award would make a difference in and enhance the applicant’s development as a scientist. The department chairman/head should provide a brief paragraph indicating his/her plans for the applicant. This official should indicate the extent to which time, space and other necessary support will be provided to the applicant to conduct the proposed investigation(s). A letter from a recognized expert in the area of the proposed research should accompany the application packet. The letter should attest to his/her willingness to provide counsel and advice to the applicant and an initial plan for ongoing contacts with the applicant. 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 subpopulations 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. 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, published in the Federal Register of March 28, 1991 (FR59 14508-14513) and in the NIH GUIDE FOR GRANTS AND CONTRACTS Volume 23, Number 11, March 18, 1994, available on the web at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. 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. LETTER OF INTENT Prospective applicants are asked to submit, by February 22, 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 NIDDK staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-37F, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8885 FAX: (301) 480-3505 APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98). The form is available at most institutional offices of sponsored research, or 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]. The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS Modular grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $50,000 per year. The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $50,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F & A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD: Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT: Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION: Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the Total Direct Costs request for each year. This is not a Form page. o Under Personnel, list key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. o BIOGRAPHICAL SKETCH: The Biographical Sketch provides information used by reviewers in the assessment of each individual’s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm -Complete the educational block at the top of the form page, -List position(s) and any honors, -Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. -List selected peer-reviewed publications, with full citations. o CHECKLIST: This page should be completed and submitted with the application. If the F & A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F & A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The program announcement, 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 available in the PHS 398 (rev. 4/98) application form 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 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 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, exact 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 appendix material, must be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-37F, MSC 6600 Bethesda, MD 20892-6600 Applications must be received by March 22, 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 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 Applications for the R03 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 NIH peer review procedures. 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 will be discussed, assigned a priority score, and receive a second level review by the NIDDK program division to which the application has been assigned. Review Criteria 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, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have 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 the field forward. (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 problems 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 collaborative arrangements? Is there evidence of institutional support? In addition to the noted criteria, 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 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 extent that the proposed research can be completed in the project duration, and the potential of the proposed research to provide the bases for future studies. o The applicant’s plans and career goals, and the availability of a recognized expert in the area of the proposed research for council and advice as attested to by a letter of agreement. AWARD CRITERIA The anticipated date of award is September 30, 2000. Applications will compete for available funds with all other applications submitted in response to this RFA and recommended by the initial review group. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas of the RFA. o The applicant’s history of research support. INQUIRIES Written and telephone 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: Charles H. Rodgers, Ph.D. Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS 19J, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 Email: [email protected] Judith M. Podskalny, Ph.D. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AN 12E, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8876 Email: [email protected] Ronald Margolis, Ph.D. Division of Diabetes, Endocrinology and Metabolism National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 5AN 12J, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8819 Email: [email protected] Direct inquiries regarding fiscal matters to: Ms Nancy C. Dixon Chief, Grants Management Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AN 44C, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8854 Email: [email protected] Schedule Letter of Intent Receipt Date: February 22, 2000 Application Receipt Date: March 22, 2000 Technical/Scientific Review: June/July, 2000 Review by Divisions/NIDDK: September 2000 Anticipated Award Date: September 30, 2000 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.847, 93.848, and 93.849. 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 PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. 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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