Full Text DK-92-17 DIABETES IN NATIVE AMERICANS AND ALASKA NATIVES NIH GUIDE, Volume 21, Number 34, September 25, 1992 RFA: DK-92-17 P.T. 34, FA, FE Keywords: Diabetes National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: November 12, 1992 Application Receipt Date: December 8, 1992 PURPOSE This Request for Applications (RFA) invites new and experienced investigators to submit clinical research applications designed to develop and validate intervention approaches to the amelioration or prevention of diabetes mellitus and/or its complications among American Indians and Alaska Natives. This RFA is a follow-up to the RFA (DK-91-01) Collaborative Research Planning Grant-Diabetes in American Indians and Alaska Natives. However, respondents to this RFA are not restricted to those having previously received a planning grant under the prior RFA. Applications are encouraged from any interested investigators regardless of their prior record of grant support. 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, Diabetes Mellitus in Native Americans and Alaska Natives, is specifically targeted at diabetes mellitus and its complications as a major public health problem. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or 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 domestic and foreign, non-profit and for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments and eligible agencies of the Federal government. Teams of applicants are encouraged, which could include universities, public health departments, Indian Health Service (IHS) hospitals, voluntary organizations, health clinics, and Federally recognized Indian tribe or tribal organizations as defined in P.L. 93-638 and amended by P.L. 100-472, or combinations thereof. Among a team of applicants, one institution must be proposed as the lead organization to serve as the Grantee Institution and assume responsibility for the fiscal and programmatic conduct of the project. Other members of the team should be proposed based on individual consortium agreements (subcontracts) with those organizations. The grantee organization and any proposed consortium must have the staff and facilities required for the proposed program. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The support mechanism for this research will be the individual research grant (R01) and the First Independent Research Support and Transition (FIRST) Award (R29). This is a one time solicitation. Subsequent unsolicited competing continuation applications will compete with all investigator-initiated applications and will be reviewed according to customary peer review procedures. This RFA will provide the opportunity for investigators to establish support for periods up to five years for meritorious research projects designed to develop and validate intervention approaches to the amelioration or prevention of diabetes mellitus and/or its complications among American Indians and Alaska Natives. Foreign institutions are not eligible for FIRST awards. FUNDS AVAILABLE The National Institute of Diabetes and Digestive and Kidney Disorders (NIDDK) plans to support approximately eight to ten applications submitted in response to this solicitation and $2 million total costs (direct and indirect costs) for this program have been included in the financial plans for fiscal year 1993. The number of awards to be made is dependent upon receipt of a sufficient number of applications of high scientific merit and upon availability of funds. In order to help meet NIDDK goals for managing the costs of biomedical research, applicants must limit their request to not more than $160,000 direct costs for the initial budget period, and normal biomedical inflation increments in future years will be allowed. Although this program is provided for in the financial plans of the NIDDK, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Diabetes mellitus and its complications are major public health problems in the United States today. The National Institutes of Health (NIH) has encouraged research into the cause, cure, and prevention of diabetes and its related endocrinologic and metabolic disorders. The Report of the Secretary of Health and Human Services Task Force on Blacks and Minority Health (1) identified non-insulin dependent diabetes mellitus (NIDDM) and its complications as major public health problems in several minority populations. In the U.S., the rates of NIDDM are often two to five times higher among American Indians than among the general U.S. population. For example, population based surveys have shown that the incidence of diabetes in the Pima Indians of Arizona is 19 times greater than in Caucasians of Rochester, Minnesota, and the difference continues to increase with time. A partial explanation of this disproportionate occurrence may be related to obesity. It is well established that obesity is a major risk factor for NIDDM, and certain Indian populations have a much higher prevalence of obesity than the majority of the U.S. population. With respect to diabetes associated complications, diabetic end-stage renal disease (ESRD) is five times more common in American Indians than in the U.S. Caucasian population. Diabetes is a major risk factor for heart disease, the leading cause of death in the American Indian community. In aggregate, rates of mortality associated with diabetes in American Indians are almost three times greater than for the U.S. as a whole. In addition, currently 4.1 percent of all births at IHS facilities are complicated by diabetes. In the U.S., approximately half of the people with NIDDM do not know they have the disease; however, the proportion of American Indians and Alaska Natives with unrecognized NIDDM is unknown. Among American Indians and Alaska Natives, as in other populations, the symptoms of NIDDM can be very subtle and remain undetected for a long time. When diagnosed, NIDDM is usually treated with diet and exercise to control blood glucose levels. Oral hypoglycemic agents or insulin injections are employed if necessary. A variety of other interventions are also employed to help prevent or delay the chronic complications of diabetes that affect organs and tissues throughout the body. American Indians have undergone rapid cultural changes during this century, with many changes having taken place during the last 40 to 50 years. These changes may account for part of the apparent tribal and geographic variation in reported diabetes rates. A frequently overlooked but potentially important distinction is the interplay of the genetic, cultural, and historical heterogeneity of the American Indian populations. Tribal groups now living within U.S. borders originated from several distinct migrations from Asia into North America over a 40,000-year period. Distinct subgroups of American Indians of different origin can be identified by cultural descriptions, linguistic analyses, and determination of genetic markers (3). Multiple factors may contribute to current levels of risk for diabetes in American Indians. Variations may exist among tribal groups, secondary to genetic admixture, to both the degree and duration of acculturation and to attained socioeconomic status. It is important to recognize that generalizations about risk factors for diabetes and its complications in American Indians may be inappropriate and that extant data may only be valid in groups with similar origins and history. Many studies have been conducted on individual tribes and have never been repeated; therefore, data on temporal trends in diabetes incidence, prevalence, and morbidity in American Indians and Alaska Natives are limited. The NIDDK and the IHS co-sponsored a conference, entitled "Diabetes in American Indians and Alaska Natives," to review the state of the science and to assess related progress, needs, and opportunities for future research. During fiscal year 1991, the NIDDK awarded Collaborative Research Planning Grants to support the development of collaborative research projects that address critical questions related specifically to the etiology, pathogenesis, diagnosis, treatment, cure, and prevention of diabetes mellitus and its complications in Native Americans and Alaska Natives. Research Goals and Scope The overall objective of this RFA is to stimulate original and innovative studies directed at the elucidation of practical methods for the reduction of the public health burden of diabetes in Native American and Alaska Native populations. Applicants must demonstrate that their research teams have an understanding of and are sensitive to the target populations. Any proposed intervention must be culturally relevant and acceptable. Special consideration will be given to investigators with demonstrated access, knowledge, and cultural sensitivity to American Indians and Alaska Natives. Examples of possible research topics relevant to this RFA include, but are not limited to: o Development and validation of interventions designed to prevent NIDDM or its major risk factors, such as obesity, on a community wide basis. o Development and validation of interventions designed to prevent NIDDM in targeted high risk subgroups (e.g., documented impaired glucose tolerance, history of gestational diabetes, obese children or young adults) within the population. o Development and validation of interventions designed to improve the care of patients with NIDDM. o Development and validation of interventions designed to reduce or prevent the long-term complications of diabetes among those with the disease. o Clinical studies of the physiologic effects of alternative pharmacologic and non-pharmacologic interventions for the treatment of NIDDM. SPECIAL REQUIREMENTS The research team, composed of the Principal Investigator and/or collaborators, must include individual(s) who are experienced in clinical research. Involvement of individuals who have demonstrated experience working with or delivering health services to Alaska Native or American Indian populations is highly desirable. The application should include a succinct discussion of previous relevant investigational and health care activities. Letters of collaboration must be included for all proposed consultants. The applicant must demonstrate that the research team has an understanding of and sensitivity to the target population. Where specific language or cultural barriers are important, the applicant must provide a plan for addressing these barriers. Letters must be provided from the tribal leadership to document that they have agreed to participate in the proposed research. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS. NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research grants and cooperative agreements are required to include 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 in studies of diseases, disorder and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women are excluded or inadequately represented in clinical research, 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. 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. Since evidence exists of geographic variation in diabetes rates and risk-factor levels among American Indians and Alaska Natives, NIDDK staff may take into account demographic and geographic distribution of peer reviewed and approved applications in the final selection process in order to support the development of research projects involving an appropriate distribution of populations from different geographic locations. LETTER OF INTENT Prospective applicants are asked to submit, by November 12, 1992, a letter of intent that includes a descriptive title of the proposed research, the name and address of the Principal Investigator, the names of key personnel, the participating institutions, and the number and title of the RFA to which the applicant is responding. Such letters are requested for the purpose of obtaining an indication of the number and scope of applications to be received. The letter is not binding, is not a requirement for submission, and does not enter into the review of the application. The letter of intent is to be sent to: Robert Hammond, Ph.D. Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used. This form is available from most institutional offices of sponsored research, and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, 5333 Westbard Avenue, Bethesda, MD 20892, telephone (301) 496-7441. The RFA label available in the form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of your application such that it may not reach the review committee in time for review. In addition, the number and title of the RFA must be typed on line 2a of the face page on the application form. Applications must be received by December 8, 1992. The original and three copies of the application must be sent to: Division of Research Grants National Institute of Health Westwood Building, Room 240 Bethesda, MD 20892** Two additional copies of the application must be sent under separate cover to: Robert Hammond, Ph.D. Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 If an application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been 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. FIRST Award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award applications submitted without the required number of reference letters will be considered incomplete and be returned to the applicant without review. REVIEW CONSIDERATIONS Applications that are not responsive to the research goals and scope of this RFA will be returned to the investigator. 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) to eliminate those applications that are clearly not competitive. Those applications will be withdrawn from further review and the applicant and institutional business office will be notified. Responsive applications received in response to this RFA will first be reviewed for scientific and technical merit by an Initial Review Group convened by the Review Branch, Division of Extramural Program Activities, NIDDK. A secondary review for policy and program relevance to the NIDDK mission will be made by the National Diabetes and Digestive and Kidney Diseases Advisory Council. AWARD CRITERIA Applications will compete for available funds with all other applications submitted in response to this RFA. The following will be considered when making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Programmatic balance among the applications competing INQUIRES Written and telephone inquires 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 A. Wells, Ph.D. Diabetes Research Program Director Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 622 Bethesda, MD 20892 Telephone: (301) 402-2599 Direct inquiries regarding fiscal matters to: Betty E. Bailey Grants Management Specialist Grants Management Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Disorders 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 93.847, Diabetes Endocrinology and Metabolism Research. 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. REFERENCES 1. U.S. Department of Health and Human Services. Report of the Secretary's Task Force on Black and Minority Health. Vol. VII, U.S. Government Printing Office, Washington, D.C., January 1986. 2. U.S. Department of Health, Education, and Welfare. Indian Health Trends and Services. U.S. Government Printing Office. Washington, D.C. 1978. HSA 78-12009. 3. Williams RC, Steinberg AG, Gershowitz H, Bennett PH, Knowler WC, Pettitt DJ, Butler W, Baird R, Dowda-Rea L, Burch TA. GM allotypes in American Indians: evidence for three distinct migrations across the Bering land bridge. Am J Phys Anthropology 1985, 66:9-19. .
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