The final receipt date for this Program Announcement will be October 1, 2005 (per Notice NOT-DK-04-009), unless reissued. NIDDK SMALL GRANTS FOR UNDERREPRESENTED INVESTIGATORS Release Date: December 6, 2001 PA NUMBER: PAR-02-032 (see Notice of receipt date extension, NOT-DK-04-009) National Institute of Diabetes and Digestive and Kidney Diseases (http://www.niddk.nih.gov) THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER YEAR. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT https://grants.nih.gov/grants/funding/phs398/phs398.html. 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, hepatology, obesity, nutrition, kidney, urology, or hematology research. 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 Program Announcement (PA), NIDDK Small Grants for Underrepresented Investigators, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. 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. On a national level, the groups considered to be underrepresented in the biomedical and behavioral sciences are African Americans, Hispanics, American Indians, Alaskan natives, and Pacific Islanders. 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 https://grants.nih.gov/grants/guide/pa-files/PA-00-104.html), the NIDDK Mentored Research Scientist Development Award (K01, see https://grants.nih.gov/grants/guide/pa-files/PA-99-069.html), the Mentored Clinical Scientist Development Award (K08, see https://grants.nih.gov/grants/guide/pa-files/PA-00-003.html), or the Mentored Patient-oriented Research Career Development Award (K23, see https://grants.nih.gov/grants/guide/pa-files/PA-00-004.html). 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 strongly encouraged to apply for other research project grants during the course of, or following, this award. 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 up to $100,000, in modules of $25,000, 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 that have been adopted by the NIH. Complete and detailed instructions and information on Modular Grant applications have been incorporated into the PHS 398 (rev. 5/2001). Additional information on Modular Grants can be found at https://grants.nih.gov/grants/funding/modular/modular.htm. 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 their 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 and be available to the applicant. A letter from this recognized expert must accompany the application along with his/her 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 clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS 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: https://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may 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 https://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: https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this 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. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.html must be used in applying for these grants and will be accepted at the standard application deadlines (https://grants.nih.gov/grants/dates.htm) as indicated in the application kit. This version of the PHS 398 is available in an interactive, searchable format. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS 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 NIH staff. The research grant application form PHS 398 (rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.html must be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. 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: Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd Room 752, MSC 5452 Bethesda, MD 20892 (For FedEx and UPS: use 20817) Telephone: 301-594-8897 Fax: 301-480-3505 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDK. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened by NIDDK 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, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. 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. (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 method? 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 addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The 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 in relation to the proposed research o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. 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 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. o applicant's history of research training and research support. INQUIRIES Inquiries are encouraged. We welcome the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues to one of the following staff members, as appropriate for your area of research interest: James Hyde, Ph.D. Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 603 MSC5460 Bethesda, MD 20892-5460 Telephone: (301) 594-7692 E-mail: email@example.com Judith Podskalny, Ph.D. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 667 MSC 5450 Bethesda, MD 20892-5450 Telephone: (301) 594-8876 E-mail: firstname.lastname@example.org Terry Rogers Bishop, Ph.D. Division of Kidney, Urology, and Hematology National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 619 MSC5458 Bethesda, MD 20892-5458 Telephone: (301) 594-7721 E-mail: email@example.com Direct inquiries regarding fiscal matters to: Donna Huggins Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 637 MSC 5456 Bethesda, MD 20892-5456 Telephone: (301) 594-8848 E-mail: firstname.lastname@example.org AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. . 93.847, 93.848, and 93.849. Awards are made under authorization of sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 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, and 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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