Full Text DK-92-19 RESEARCH TRAINING AND CAREER DEVELOPMENT AWARDS IN NUTRITION AND OBESITY RESEARCH NIH GUIDE, Volume 21, Number 18, May 15, 1992 RFA: DK-92-19 P.T. 34, 44 Keywords: Nutrition/Dietetics Obesity Clinical Medicine, General National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Child Health and Human Development Letter of Intent Receipt Date: September 18, 1992 Application Receipt Date: October 16, 1992 PURPOSE The Division of Digestive Diseases and Nutrition of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Institute of Child Health and Human Development (NICHD) invite applications: (1) for post-doctoral Individual National Research Service Awards (NRSA) (F32s) from individuals trained in the clinical or basic sciences and (2) for Clinical Investigator Awards (K08s) and Physician Scientist Awards (K11s) from individuals with doctoral degrees in the clinical sciences. Proposed projects must be in the broad areas of nutrition, nutrient metabolism, obesity, and related research. The intent of this Request for Applications (RFA) is to provide research training and career development support for individuals with a strong commitment to a research career in the areas of nutrition, nutrient metabolism, obesity, eating disorders, energy metabolism/regulation, and maternal-fetal, infant, and childhood nutrition. 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, Research Training and Career Development Awards in Nutrition and Obesity Research, is related to the priority area of nutrition. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by any domestic 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. Women and minority investigators are encouraged to apply. Applicants applying for Physician Scientist (K11) and Clinical Investigator (K08) awards must have completed, by the time an award would be activated, a residency in internal medicine, surgery, or pediatrics. While physicians may be enrolled in a medical or surgical subspeciality training program that relates to the nutrition/obesity program of the NIDDK and the NICHD, a full-time commitment to research training is required. Grant funds are for research training and career development only, and may not be used for the support of clinical training or clinical services. Such clinical subspeciality activities must be supported from other funding sources. Potential candidates must be citizens or non-citizen nationals of the United States or its possessions and territories or must have been lawfully admitted to the United States for permanent residence at the time of the application. Applicants applying for an individual NRSA fellowship (F32) must have received the Ph.D, M.D., or equivalent degree prior to the beginning date of the appointment. MECHANISMS OF SUPPORT Support of this program will be through the Individual NRSA (F32), the Physician Scientist Award (K11), and the Clinical Investigator Award (K08). Complete information pertaining to the K08 and K11 awards is given in the pamphlet "The K Awards." These publications are available from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda MD 20892, telephone (301) 496-7441. Responsibility for the planning, direction, and execution of the proposed project will be that of the applicant in conjunction with his/her sponsor(s). Except as otherwise stated in this announcement, awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. F32 applicants should be aware that, prior to an award being made, they must sign an agreement that they will fulfill the legislatively mandated payback requirements. More information on payback may be obtained from the Program Directors listed below. (see INQUIRIES) Grant funds are for research training and career development only, and may not be used for the support of clinical training or clinical services. Such subspeciality activities must be supported from other funding sources. This RFA is a one-time solicitation. The total requested project period for F32 applications submitted in response to this RFA may not exceed three years; the total requested project period for K08 and K11 applications may not exceed five years. The earliest possible award date will be July 1, 1993. FUNDS AVAILABLE For FY 1993, the NIDDK and the NICHD each plan to make two to three K08 and/or K11 awards and four to six F32 awards for applications submitted in response to this RFA. However, this funding level is dependent upon the receipt of a sufficient number of highly meritorious applications. Stipend levels for the NRSA awards are in accordance with those established by the PHS. Salary support for K08 and K11 awards is limited to $50,000 per year plus either $10,000 or $20,000 per year for other expenses, depending upon the mechanism. Although this program is provided for in the financial plans of the NIDDK and the NICHD, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES The objective of this solicitation is to increase the number of physicians and basic scientists who can conduct high-quality research in the areas of nutrition and obesity, compete for NIH grant support, and provide leadership in the areas of clinical nutrition/obesity research. It is particularly important to increase the number of underrepresented minority persons and women being trained to pursue research careers and provide leadership in the areas of nutrition and obesity. Potential applicants are encouraged to read the guidelines for each mechanism and to identify the most appropriate mechanism for their needs and experience. SPECIAL REQUIREMENTS Investigators receiving support under any of the award mechanisms offered here also may be enrolled in a medical or surgical subspeciality training program that relates to the nutrition/obesity program of the NIDDK and the NICHD. However, a full-time commitment to research training is required. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS It is NIH and ADAMHA policy that clinical research studies include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of women and minorities in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in a clinical research project, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, the NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the application will be returned without review. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by September 18, 1992, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the applicant, the name of the sponsor, the names of all participating institutions, and the number and title of the RFA in response to which the application is being submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIDDK staff to estimate the potential review workload and to avoid possible conflicts 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 Westwood Building, Room 605 Bethesda, MD 20892 Telephone: (301) 496-7083 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for the K awards. The fellowship application form PHS 416-1 (rev. 4/89) must be used in applying for the F32 awards. These forms are available from most institutional business offices and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 496- 7441). The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of K08 and K11 applications. Failure to use this label could result in delayed processing of an 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 2a of the face page of the application form, and the YES box must be checked. NRSA applications must indicate the RFA number on the face page under item 3. For K award applications, submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package, to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, two additional copies of the application also must be sent under separate cover to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 For F32 applications, submit a signed, typewritten original of the application and two signed, exact, clear, single-sided photocopies in one package along with the Checklist, the Personal Data form, appendix material, and sealed reference reports to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892 No copies should be sent to the Review Branch. Applications must be received by October 16, 1992. If an application is received after that date, it will be returned to the applicant. The DRG 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 DRG also will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of applications previously reviewed that have since been substantially revised. Such applications must not only include an introduction addressing the previous critique, but also must be responsive to this RFA. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed initially by the Division of Research Grants (DRG) for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NIDDK staff function. If the application is not responsive to the RFA, NIDDK staff will contact the applicant to determine whether it should be returned to the applicant, or whether it should be held until the next receipt date and reviewed in competition with all other unsolicited applications. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIDDK. Applications may be subjected to triage by an NIDDK peer review group to determine scientific merit relative to other applications received in response to this RFA. If the number of applications is large compared to the number of awards to be made, the NIDDK may conduct a preliminary scientific peer review (triage) and withdraw applications from further competition if they are not competitive for the award. The NIDDK will notify the applicant and institutional official of any such action. Those applications judged to be competitive will be reviewed for scientific and technical merit by an NIDDK initial review group (IRG) specifically convened for this RFA. Following this review, NRSA applications will be given a secondary review by committees of NIDDK and NICHD program staff; K08 and K11 applications will be given a secondary review by the National Diabetes and Digestive and Kidney Diseases Advisory Council and the National Child Health and Human Development Advisory Council. Applications not recommended for further consideration by the IRG will not undergo secondary review. The review criteria for applications received in response to this RFA are the same as those for unsolicited F32, K08, and K11 applications. Generally stated, these include: o applicant's potential for and commitment to a research career in the areas specified by this RFA; o scientific merit of the proposed research; o potential of the proposed research in developing the applicant as an independent investigator; o qualifications, research expertise, and training experience of the sponsor along with adequate institutional commitment to ensure completion of the proposed training; o for those applications involving activities that could have an adverse effect upon humans, animals, and the environment, the adequacy of the proposed means for protecting against or minimizing such effects. Schedule Letter of Intent: September 18, 1992 Application Receipt: October 16, 1992 Initial Review: Feb/Mar 1993 Second Level Review: May/Jun 1993 Anticipated Award: July 1, 1993 AWARD CRITERIA Applications will compete for available funds with all other recommended applications received in response to this RFA. 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 the research areas of this RFA. INQUIRIES Written and telephone inquiries about this RFA and the opportunity to clarify any issues or questions from potential applicants are encouraged. Direct requests for the RFA and inquiries regarding programmatic issues to: Judith M. Podskalny, Ph.D. Director, Research Training and Career Development Program Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A15 Bethesda, MD 20892 Telephone: (301) 496-7455 or Ephraim Y. Levin, M.D. Medical Officer National Institute of Child Health and Human Development Executive Plaza North, Room 637 Bethesda, MD 20892 Telephone: (301) 496-5593 Direct inquiries regarding fiscal matters to: Mrs. Nancy Dixon Supervising Grants Management Specialist Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 649 Bethesda, MD 20892 Telephone: (301) 496-7467 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93-848 and No. 93-855. 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, 42 CFR 66, and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. .
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