NIDDK SMALL GRANTS FOR UNDERREPRESENTED INVESTIGATORS Release Date: December 12, 2000 PA NUMBER: PA-01-031 National Institute of Diabetes and Digestive and Kidney Diseases THIS PA 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 PA. PURPOSE The National Institute of Diabetes and Digestive and Kidney Disease (NIDDK) recognizes the need to increase the racial and ethnic diversity of the pool of scientists in research areas important to the NIDDK. This program is aimed primarily at recently trained M.D. and/or Ph.D. investigators. The program will enable the applicant to accept a tenure-earning position, gain additional research experience while transitioning to independence, and obtain preliminary data on which to base a subsequent research grant application in an area of diabetes, endocrinology, metabolism, digestive diseases, obesity, nutrition, kidney, urology, or hematology research. This announcement replaces the former yearly RFA for these applications. 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 PA, NIDDK Small Grants for Minority Investigators, is related to the priority areas of chronic kidney disease, diabetes, food safety, and nutrition and overweight. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. ELIGIBILITY REQUIREMENTS For the purpose of this announcement, underrepresented investigators are defined as individuals belonging to a particular ethnic or racial group that has been determined by the applicant institution to be underrepresented in biomedical or behavioral research. In addition, applicants must have a doctoral degree (M.D., Ph.D., D.O., D.V.M.) and at least 2-4 years of postdoctoral research experience at the time of application. This training should have been in an area applicable to the research supported by the NIDDK. Individuals with less than this amount of postdoctoral training are encouraged to apply for an Individual National Research Service Award fellowship (F32, see PA-00-104), the NIDDK Mentored Research Scientist Development Award (K01, see PA-99-069), the Mentored Clinical Scientist Development Award (K08, see PA-00-003), or the Mentored Patient-oriented Research Career Development Award (K23, see PA-00-004). The applicant must 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 project. Applicants may not hold, nor concurrently apply for, any other PHS research project grants at the time of this application. While priority will be given to applicants who have not previously been a Principal Investigator on a major research project grant, applicants are encouraged to apply for other research project grants during the course of, or following, this award. Applications may be submitted by domestic for-profit and nonprofit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) Small Research Grant (R03) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Total direct costs may be requested in the amount of either $25,000 or $50,000 (one or two modules) per year. The total project period for an application submitted in response to this PA should, in general, be two years, however, if necessary and justified for the proposed project, three years may be requested. The award is not renewable and individuals are only eligible for this award once in their careers. 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 Grants can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. FUNDS AVAILABLE For each Fiscal Year, approximately $750,000 in total direct costs for new awards will be available. This level of support depends upon the receipt of a sufficient number of applications of high scientific merit. This Program Announcement replaces the yearly RFA for this initiative, the level of available funding is consistent with that formerly committed to the RFA. DURATION OF PROGRAM ANNOUNCEMENT This PA will remain active for one year, through November 2001, at which time applications may no longer be submitted in response to this announcement. It is anticipated that this PA will be re-issued at that time, however. RESEARCH OBJECTIVES The primary purpose of this PA is to foster the research careers of underrepresented minority investigators conducting research in areas of interest to the NIDDK. Individuals who have received training through individual postdoctoral fellowships or institutional training grants still require a transition period to demonstrate independence and to generate the preliminary data necessary for obtaining independent funding. This small grant program is meant to provide this transitional support and to encourage minority investigators to pursue research careers and become independent scientists. 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 for the expert to be at the same institution as the applicant, but he/she should be within a reasonable proximity to be available for guidance and consultation. A letter from this recognized expert must accompany the application along with a current biographical sketch. The letter should indicate the expert’s willingness to provide counsel and advice to the applicant and an initial plan for ongoing communication with the applicant. In addition, as part of the application, the applicant must provide a brief summary of his/her long-term career plans and objectives. This summary should state how this award would contribute to his/her development as a scientist. A letter from the appropriate Department Chair or Division Chief, in support of the applicant, must also accompany the application. 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. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are 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: GrantsInfo@nih.gov 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 requested for each year. This is not a Form page. o Under Personnel, list all 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. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of all personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. 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. Submit the signed, original, single-sided application, including the Checklist, along with five signed photocopies and five collated sets of appendix materials 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) The Center for Scientific Review (CSR) will not accept any application in response to this PA 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 Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with the standard 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, generally the top half of applications under review, will be discussed and assigned a priority score. 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 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 a field forward. o 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? o 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? 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 principal investigator and 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? 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. For this PA, all applications will also be reviewed with respect to the following: o The applicant’s plans and career goals. o The availability of a recognized expert in the area of the proposed research for advice as indicated by a letter of support. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the National Institute of Diabetes and Digestive and Kidney Diseases. 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 priority, o The applicant’s history of research training and research support. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Judith Podskalny, Ph.D. Division of Digestive Diseases and Nutrition, NIDDK 6707 Democracy Boulevard, Rm. 667 MSC 5450 Bethesda, MD 20892-5450 Telephone: (301) 594-8876 E-mail: jp53s@nih.gov James Hyde, Ph.D. Division of Diabetes, Endocrinology, and Metabolic Diseases, NIDDK 6707 Democracy Boulevard, Rm. 603 MSC5460 Bethesda, MD 20892-5460 Telephone: (301) 594-7692 E-mail: jh486z@nih.gov Terry Bishop, Ph.D. Division of Kidney, Urology, and Hematology, NIDDK 6707 Democracy Boulevard, Rm. 619 MSC5458 Bethesda, MD 20892-5458 Telephone: (301) 594-7726 E-mail: tb232j@nih.gov Direct inquiries regarding fiscal matters to: Donna Huggins Division of Extramural Activities, NIDDK 6707 Democracy Boulevard, Rm. 637 MSC 5456 Bethesda, MD 20892-5456 Telephone: (301) 594-8848 E-mail: dh48z@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847, 93.848, and 93.849. 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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