DEPRESSION AND MENTAL DISORDERS IN DIABETES, RENAL DISEASE, AND OBESITY/EATING DISORDERS Release Date: September 28, 2001 RFA: RFA-DK-02-009 National Institute of Diabetes and Digestive and Kidney Diseases (http://www.niddk.nih.gov) National Institute of Mental Health (http://www.nimh.nih.gov) Letter of Intent Receipt Date: January 18, 2002 Application Receipt Date: February 20, 2002 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING LESS THAN $250,000 PER YEAR IN ALL YEARS. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html. PURPOSE There is substantial evidence that severe chronic illness may be associated with and exacerbated by co-existent mental disorders such as depression, anxiety disorders, schizophrenia, and eating disorders. Nonetheless, few studies have addressed the natural history and consequences of co-existent mental disorders on chronic diseases of interest to the NIDDK, such as diabetes mellitus, chronic renal disease and obesity and eating disorders. Similarly, few studies have addressed the natural history and consequences of co-existent diabetes, chronic renal disease, and obesity on mental disorders such as depression, anxiety disorders, schizophrenia, and eating disorders. In addition, the effect of treating and reducing mental disorders on the outcomes of chronic medical illnesses, and the effect of good management of the medical illness on the outcome of mental disorders have not been delineated. The effects of intervening to prevent or treat chronic medical illness on mental disorder outcomes have not been adequately investigated. The purpose of this RFA is to increase research activity in the field of mental disorders in relationship to diabetes mellitus, chronic renal disease and obesity and eating disorders. This RFA is based on recommendations made by a recent NIDDK/NHLBI/OBSSR Working Group and Conference on Depression and Mental Disorders in Diabetes, Renal disease, and Obesity/Eating disorders. 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 Request for Applications (RFA), Depression and Mental Disorders in Diabetes, Renal Disease, and Obesity/Eating Disorders, is related to one or more of the priority areas. Potential applicants may obtain a copy of Healthy People 2000 at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by 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. Foreign institutions are not eligible, however, foreign organizations may participate if they are components of domestic, U.S. organizations or via contractual or consortium agreements with domestic, U.S. organizations. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01) award mechanism and the R21 exploratory/developmental grant award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed five years for the R01 and two years for the R21. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The anticipated award date is September 2002. 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 http://grants.nih.gov/grants/funding/modular/modular.htm FUNDS AVAILABLE The ICs intend to commit approximately $1,500,000 in FY 2002 to fund 4 to 8 new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to five years for the R01 mechanism and two years if the R21 mechanism is used. The requested budget for an R21 may not exceed $150,000 in direct costs per year. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of applications of outstanding scientific and technical merit. At this time, it is not known if competing renewal R01 applications will be accepted and/or if this RFA will be reissued. RESEARCH OBJECTIVES Background Relatively little is known about the epidemiology of depression and other mental disorders among individuals with diabetes mellitus, chronic renal disease and obesity and eating disorders. Depression is common in patients with both end stage renal disease and diabetes, and there is some evidence that depression may sometimes antedate the development of diabetes mellitus. Although preliminary data suggest an association between obesity and depression, causal relationships between these two conditions are unclear. The role of genetic factors, which may confer joint susceptibility to chronic medical illness and mental disorders is unknown. Observed racial/ethnic differences in the prevalence of mental disorders are probably not attributable to intrinsic differences between races, but are likely attributable to socioeconomic factors, such as those affecting access to care. The multiple demographic, biological, behavioral, psychosocial, and environmental risk factors for the development of co-morbid medical and mental disorders have not been clarified in well-characterized populations. In addition, the diagnosis of mental disorders in children poses specific challenges related to the definition and measurement of these disorders and to developmental changes. Data regarding the prevalence and the course of mental disorders in children with diabetes mellitus, chronic renal disease and obesity/eating disorders are sparse. Stress, including symptoms of depression and anxiety disorders, may interfere with the hypothalamic/pituitary/adrenal axis to result in disordered carbohydrate and lipid metabolism. Some symptoms of major depressive disorder, such as fatique, insomnia, and reduced appetite, may be similar to symptoms of chronic illnesses. Mental disorders may make the diagnosis and treatment of chronic medical disorders more difficult, and may interfere with the ability to treat them. Similarly, chronic medical disorders may make diagnosis, prevention, and treatment of mental disorders more difficult, and interfere with interventions aimed at mental disorders. In addition, mental disorders may affect the ability of a patient to effectively adhere to the medical regimen and maintain healthy behaviors, or may be associated with abnormal regulation of neuroendocrine, cardiologic, metabolic and immunologic factors. The influence of effective treatment of chronic medical illnesses on the course of mental disorders, and the effect of successful treatment of mental disorders on the outcome of chronic medical illnesses are largely unknown. In addition, whether mental disorder renders medical illness more difficult to treat, and whether medical illness impacts the course of mental disorders is unknown. Recent data suggest that certain treatments for mental disorders such as schizophrenia, in particular, may be associated with abnormal glucose metabolism. This RFA is intended to expand understanding of the epidemiology of co-morbid mental disorders and selected chronic diseases, the risk factors associated with development of illness in vulnerable populations, the association of genetic factors with the presence or outcomes of co-morbid medical and mental illness, the association of mediators with outcomes in patients with mental disorders and chronic medical illnesses, and the results of preventive interventions and treatment of medical and/or mental disorders in patients with coexistent medical illnesses. Topics of interest include, but are not limited to: What is the prevalence of co-morbid mental disorders and diabetes mellitus, renal disease, and obesity/eating disorders? Are there identifiable patterns of distribution in the population that might guide targeted intervention efforts? What are the biological, behavioral, psychosocial, cultural, and environmental risk and protective factors linking mental and medical disorder. Which of these factors account for the greatest relative variance in the prevalence of the disorders. And, which of these factors are modifiable through intervention? o Does treatment of depression decrease morbidity/mortality in patients with diabetes, chronic renal disease or obesity and what methods of treatment are most effective? Do interventions for diabetes, chronic renal disease, or obesity reduce the risk for mental disorders? Which preventive interventions or treatments are most effective? Does the depression/diabetes relationship differ for type 1 and type 2 diabetes? o What is the role of diabetes complications in the depression/diabetes relationship? o What is the role of obesity in the depression/diabetes relationship? o Are there subgroups in which depression is related to obesity and what are the common physiological or psychological mechanisms, and symptom profiles for these groups? o Does treatment for depression prevent or delay diabetes onset or diabetes complications? Do preventive or treatment interventions for diabetes, renal disease, and obesity reduce the risk for mental disorders? o What factors permit an individual who experiences one episode of depression in the context of diabetes, renal disease or obesity, to recover? o Based on controlled studies, it is known that diabetes doubles the likelihood of co-morbid depression. What are the mechanisms involved? o What is the role of depression in the nutritional disorders associated with chronic renal failure? Does treatment of depression improve nutritional parameters? Of particular interest are studies that address these or related topics in children, the elderly, women, and underserved, racial/ethnic minority populations. SPECIAL REQUIREMENTS It is expected that successful applicants will meet once a year in the Washington DC area to share knowledge and details of their research progress with each other and with NIDDK and NIMH staff. Specific plans for the Principal Investigator to attend such an annual two-day meeting over the life of the grant must be outlined in the budget. 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, which was published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994, available on the web at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.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 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: http://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 http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm Applicants may wish to place data collected under this RFA 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. LETTER OF INTENT Prospective applicants are asked to submit 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 to which the application is responding. 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 IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to the program staff listed under INQUIRIES by the letter of intent receipt date listed in the heading of this RFA. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable PDF format. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov All application instructions outlined in the PHS 398 application kit are to be followed, with the following requirements for R21 applications: 1. R21 applications will use the MODULAR GRANT and JUST-IN-TIME concepts, with direct costs requested in $25,000 modules, up to the total direct costs limit of $150,000 per year. 2. Although preliminary data are not required for an R21 application, they may be included. 3. Sections a-d of the Research Plan of the R21 application may not exceed 15 pages, including tables and figures. 4. R21 appendix materials should be limited, as is consistent with the exploratory nature of the R21 mechanism, and should not be used to circumvent the page limit for the research plan. Copies of appendix material will only be provided to the primary reviewers of the application and will not be reproduced for wider distribution. The following materials may be included in the appendix: o Up to five publications, including manuscripts (submitted or accepted for publication), abstracts, patents, or other printed materials directly relevant to the project. These may be stapled as sets. o Surveys, questionnaires, data collection instruments, and clinical protocols. These may be stapled as sets. o Original glossy photographs or color images of gels, micrographs, etc., provided that a photocopy (may be reduced in size) is also included within the 15 page limit of items a-d of the research plan The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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 RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 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 http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. 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 Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health 6707 Democracy Boulevard, Rm. 752 Bethesda, MD 20892-5452 Bethesda, MD 20817 (for express/courier service) Applications must be received by the application receipt date listed in the heading of this RFA. 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 already reviewed, but such applications must include an Introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDDK and NIMH staff. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications 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 NIMH and the NIDDK in accordance with the review criteria stated below. As part of the initial merit review, a process will be used by the initial review group in which applications 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 the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Council or Board for the relevant Institute. 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. The initial review group will also examine the provisions for the protection of human subjects and the safety of the research environment. SCHEDULE Letter of Intent Receipt Date: January 18, 2002 Application Receipt Date: February 20, 2002 Peer Review Date: June/July 2002 Council Review: September 2002 Earliest Anticipated Start Date: September 2002 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. INQUIRIES 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: Sanford Garfield, Ph.D. Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 685 Bethesda, MD 20892-5460 Telephone: (301) 594-8803 FAX: (301) 480-3503 E-mail: sg50o@nih.gov Peter Muehrer, Ph.D. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Blvd., Room 6189 Bethesda, MD 20892-9615 Telephone: (301) 443-4708 FAX: (3010 443-4415 E-mail: pm29v@nih.gov Direct inquiries regarding fiscal matters to: Cheryl Chick Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 606 Bethesda, MD 20892-5456 Telephone: (301) 594-8825 FAX: (301) 480-3504 E-mail: cc149o@nih.gov Diana S. Trunnell Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-2805 FAX: (301) 443-6885 E-mail: dt21a@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847 (NIDDK) and 93.242 (NIMH). Awards are made under the authority 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 Part 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 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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