PAR-03-060: PLANNING GRANTS FOR TRANSLATIONAL RESEARCH FOR THE PREVENTION AND CONTROL OF DIABETES

Department of Health
and Human Services (HHS)

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PLANNING GRANTS FOR TRANSLATIONAL RESEARCH FOR THE PREVENTION AND CONTROL OF DIABETES RELEASE DATE: January 22, 2003 PA NUMBER: PAR-03-060 EXPIRATION DATE: February 2, 2006, unless reissued. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov) National Eye Institute (NEI) (http://www.nei.nih.gov/) Centers for Disease Control and Prevention Division of Diabetes Translation (CDC-DDT) (http://www.cdc.gov) THIS PAR CONTAINS THE FOLLOWING INFORMATION o Purpose of the PAR o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Eye Institute (NEI), and the Centers for Disease Control and Prevention -- Division of Diabetes Translation (CDC-DDT) seek to foster the development of innovative programs to translate recent advances in the prevention and treatment of diabetes and its complications into clinical practice for individuals and communities at risk. An ongoing program announcement, PA 02-153 (http://grants.nih.gov/grants/guide/pa-files/ PA-02-153.html), established a diabetes prevention and control program, and seeks applications for public health, clinical or behavioral studies to develop and test 1) improved methods of health care delivery to patients with or at risk of diabetes, 2) improved methods of diabetes self management, and 3) cost effective community-based strategies to promote healthy lifestyles that will reduce the risk of diabetes and obesity. This PAR establishes a small grant program to fund pilot studies that would lead to full-scale trials under the parent program announcement. Studies submitted to this program should focus on developing preliminary data of feasibility of a proposed approach, or other information needed for the development and assessment of an application for a full-scale trial. The trials should test strategies for achieving objectives that have already been proven beneficial, such as 1) control of glycemia and other risk factors for diabetic complications, including hypertension and dyslipidemia and 2) altering life style to prevent or delay the onset of type 2 diabetes in at risk populations, including children and adolescents. Of particular interest are interventions that focus on translating new advances into practice in underserved and minority populations. RESEARCH OBJECTIVES Background Several large, controlled clinical trials have established "gold standard" approaches for treating type 1 and type 2 diabetes, and for preventing type 2 diabetes in individuals at high risk for developing the disorder. Programs are needed to translate the results of these trials into widespread practice. Translational research related to prevention and therapy of obesity, a major risk factor for type 2 diabetes, is also needed. In particular, fostering wider use or more cost effective methods of delivery of established approaches for treating childhood obesity, as well as programs for preventing regain of weight after weight loss treatment, are appropriate targets for translational research. The Diabetes Control and Complications Trial (DCCT), for type 1 diabetes, and the United Kingdom Prospective Diabetes Study (UKDPS), for type 2 diabetes, established the importance of intensive glycemic control in dramatically reducing the devastating complications that result from poorly controlled diabetes. Both the DCCT and the UKPDS demonstrated the efficacy of intensive glucose control in reducing the risk for the microvascular complications of diabetes, such as retinopathy, neuropathy, and nephropathy. In addition, results from the UKPDS and other trials demonstrate that cardiovascular events are reduced in patients with type 2 diabetes through rigorous control of blood pressure and LDL-cholesterol. Unfortunately, the therapies proven to delay or prevent complications in these studies have not been widely incorporated into general health care practice. Prevention and treatment of long-term micro- and macrovascular complications remain a critical problem in the management of type 1 and type 2 diabetes mellitus. In the United States, diabetes is the leading cause of new blindness in working-age adults, of new cases of end stage renal disease and of non-traumatic lower leg amputations. In addition, cardiovascular complications are now the leading cause of diabetes-related morbidity and mortality, particularly among women and the elderly. In adults with diabetes, the risk of cardiovascular disease (CVD) is two to four fold greater than in nondiabetics. Comorbid conditions (hypertension, dyslipidemia and smoking) combine with hyperglycemia to contribute to accelerated atherosclerosis. Hypertension also contributes substantially to development of microvascular complications, and clinical trial data has established unequivocal benefit of rigorous control of blood pressure in preventing both micro- and macrovascular complications of diabetes. Smoking cessation, aspirin therapy and lipid control have also been shown to prevent morbidity. Despite clear-cut evidence of benefit, recently available data demonstrate that patients with diabetes are not achieving the recommended levels of comprehensive risk factor management. Underutilization of current knowledge was highlighted in recent studies of diabetic individuals that demonstrated a low frequency of achievement of targets for management of glycemia, blood pressure, and lipids, aspirin use, self-monitoring of blood glucose, regular foot care, and ophthalmic examinations, all of which markedly reduce the incidence and progression of diabetic complications. Alarmingly, less than 2% of adults with diabetes receive the level of care that has been recommended by the American Diabetes Association (ADA), with self-monitoring of blood glucose following the ADA guidelines performed by only one in five adults with diabetes. Thus, it is clear that effective mechanisms for diabetes treatment, shown by the DCCT, the UKPDS and other clinical trials to reduce the burden of diabetes, are not being implemented. The difficulties inherent in achieving good glucose control and preventing diabetes complications make prevention a compelling strategy. This is particularly true for type 2 diabetes, which is clearly linked to modifiable risk factors e.g., overweight or obesity and a sedentary lifestyle. The Diabetes Prevention Program (DPP) tested strategies to prevent or delay the development of type 2 diabetes in individuals at high risk for its development by virtue of their having impaired glucose tolerance (IGT). The DPP demonstrated that intensified lifestyle or drug intervention in individuals with IGT, prevented or delayed the onset of type 2 diabetes. The results were striking. Lifestyle intervention reduced diabetes incidence by 58% and the drug metformin by 31% compared with placebo. The effects were similar for men and women and for all racial and ethnic groups. Similar effects of lifestyle intervention were seen in another recent study conducted in Finland. Cost-effective strategies for promoting lifestyle modification in these high-risk individuals, outside the setting of a controlled, clinical trial, need to be established. Population-based, as well as generalizable, clinic-based, strategies are needed to establish cost-effective programs to 1) identify individuals at high risk who could benefit from prevention programs, and/or 2) successfully promote lifestyle change. Childhood obesity, the prevalence of which has more than doubled in the past two decades, is a major risk factor for type 2 diabetes. Indeed, the increase in childhood obesity has been linked to an alarming rise in type 2 diabetes in the pediatric population. Family-based behavioral interventions have been shown to have a long-term impact on degree of overweight. However, cost- effective interventions in primary care and community-based settings are needed. In addition, while behavioral treatment of obesity in adults leads to clinically significant weight loss, prevention of weight regain remains an elusive goal for many. Continuing care models show promise in promoting long- term weight maintenance and cost-effective means of providing such care need to be developed. Finally, the results of ongoing clinical trials that also address the prevention and/or treatment of type 1 or type 2 diabetes and/or obesity (e.g., Look-AHEAD, ACCORD, TrialNet) are likely to become available in the future. In the event of positive outcomes in any of these studies, it will be even more crucial that effective translation strategies be developed and adopted to improve adherence to accepted standards of diabetes care, and to overcome barriers to the translation of scientific advances into clinical practice. Objectives and Scope The NIDDK, the NEI, and the CDC-DDT seek to enhance diabetes prevention and control research. The overall objective of this program announcement is to support research to develop and test intervention strategies that will enhance health promotion in those with or at risk of diabetes, diabetes self management and reduction in risk at the community, health care system, provider, and/or patient level. This PAR establishes a small grant program to fund pilot studies to develop innovative research protocols to translate recent advances in the prevention and treatment of diabetes and its complications into clinical practice for individuals and communities at risk. It is anticipated that studies funded under this program will form the basis for applications for full-scale trials that would be submitted as research demonstration and dissemination projects (R18) under PA 02-153 (http://grants.nih.gov/grants/guide/pa-files/PA-02-153.html). Studies proposed under this program should test 1) improved methods of health care delivery to patients with or at risk of diabetes, 2) improved methods of diabetes self management, and 3) cost effective community-based strategies to promote healthy lifestyles that will reduce the risk of diabetes and obesity. Generally, these studies will take interventions that have been demonstrated to be beneficial by controlled clinical investigations (e.g., intensive glycemic, blood pressure or lipid control in individuals with diabetes, or increased physical activity in individuals at risk for diabetes), and extend or adapt these interventions to larger populations or other settings or more cost effective methods of delivery. The translation of new science to patient care would occur more rapidly if it were not for the existence of certain barriers, which impede the adoption and implementation of current knowledge. Such barriers include but are not limited to: o health care provider knowledge, o communication between patient and health care provider, o attitudes and beliefs of the patient, community/culture, health care provider and health care system o racial and ethnic disparities, o variations in settings, including the health care system, o clinical traditions, o socioeconomic status, o cost. Proposed research studies should be designed to overcome these barriers. Topics of interest include, but are not limited to: o strategies to enhance glycemic, blood pressure, and lipid control or reduce risk factors for the development of the complications of type 1 or type 2 diabetes, o strategies to promote the adoption of healthy lifestyles, which will reduce obesity and diabetes, o strategies for less burdensome and more cost effective methods to identify those with or at risk of type 2 diabetes, o studies that test interventions to enhance long-term maintenance of weight loss and prevention of weight regain after weight loss, o studies that test interventions within the changing health care delivery system and changing patient demographics, o studies to determine the role of patient/provider communication on diabetes outcomes, and strategies to facilitate such communication, o strategies to enhance patient or provider education, o studies of information technology and decision-support to facilitate evidence-based prevention and management, o the testing of community-based programs to provide education and behavior modification at lower cost, o studies that test interventions to treat childhood and adolescent obesity in primary care or community settings, o strategies to alter health care system features that reduce the efficiency or effectiveness of patient/provider interaction and health outcomes. Of particular interest are studies to improve self-management and enhance health care delivery to underserved and minority populations. Such studies may seek to improve outcomes in populations (with either type 1 or type 2 diabetes) that historically have had poor glycemic, blood pressure, and other risk factor control, or promote effective prevention strategies in minority populations known to be at high risk for the development of type 2 diabetes and/or its complications. These studies will provide pilot and feasibility data to be used in developing full-scale trials that would be submitted as research demonstration and dissemination projects (R18) under PA 02-153 (http://grants.nih.gov/grants/guide/pa-files/PA-02-153.html). These R18 projects should be effectiveness trials and will generally have the same research design as a single-center randomized clinical trial. The R34 submitted in response to this PAR should be designed to develop convincing preliminary data that show that the intervention has the potential to alter behavior or impact care, that the intervention can feasibly be carried out, and/or provide other data needed for the design of the full-scale trial. Applicants are encouraged to review the guidance regarding the requirements for the R18 to help investigators understand the long-terms goals of the R34 project. Clearly, some of the information required for the R18 will not be necessary in the R34 application, but an outline of the key features of the subsequent full-scale trial that is envisioned should be included together with a discussion of how the R34 project addresses a key issue regarding feasibility of the subsequent R18 proposal. Applicants who do not require support for a feasibility study may apply for an R18 directly under PA 02- 153. The rationale for the future large-scale intervention should be clearly described. Applicants should provide a description of key elements of the design of that study, including the population to be studied, the setting for delivery of the intervention, primary and secondary outcomes to be assessed, the duration of follow-up, and the statistical analysis to be employed. Investigators may wish to consider assessment of cost-effectiveness as a secondary outcome measure. Applicants should discuss how the proposed pilot and feasibility study, planning project or other effort for which R34 support is requested is related to the full scale trial envisioned under the subsequent R18. For the project to be supported under the R34, applicants should provide a detailed description of the target population to be studied, with justification, including a definition of the cohort by age, gender, sex and race/ethnicity. The ability to recruit this target population and the methods to be used should be described. Sample size needs and the assumptions and calculations used to estimate sample size should be detailed. Applicants must state their plans for reporting accrual by gender, race and ethnicity and for the reporting of results that examine differences in treatment effects across these subgroups (see below, "Inclusion of Women and Minorities in Research Involving Human Subjects"). Methods for assuring privacy and maintaining confidentiality should be included. There must be a data and safety monitoring plan. Studies may utilize methodology from the fields of biomedical, social or behavioral sciences, epidemiology (including clinical trials), and health services research. The primary outcome will generally be some form of behavior change, health care status, or health care use. An intervention aimed at producing a behavioral change should be grounded in behavior change theory, which should be incorporated into the intervention. The application will be strengthened by the inclusion of a process evaluation i.e., an evaluation of whether the intervention is actually delivered as intended. Investigators should provide detailed evidence that the research team has the experience and expertise to conduct the research study. Most translation research will require a multidisciplinary research team. Thus, a variety of researchers may be required for these studies, including, but not limited to, endocrinologists, public health physicians, primary care physicians, epidemiologists, statisticians, psychologists, health educators, sociologists, nurses, nutritionists and other health related professionals. The interdisciplinary nature of the research team should be fully described and justified. Brief descriptions, as appropriate, of the process for biologic sample collection, storage and handling; the laboratory tests that are needed; physical facilities, data management and computer resources, and facilities for data retrieval and storage; and a plan for randomization of patients or settings for delivery of interventions into protocols should be provided. Investigators located at existing Diabetes Research and Training Centers (DRTC) should include a complete description of how the research being proposed in response to this PA will utilize the core facilities funded through the their DRTC. A central purpose of the DRTCs is to support translation research into the barriers that restrict the adoption of advances in diabetes treatment into practice. It should therefore be made clear how the research being proposed integrates into the DRTC, its cores and overall biomedical research focus. Investigators who are not affiliated with a DRTC may, but are not required to, form collaborations with such centers in order to utilize the core resources, which may provide support for such aspects of the proposed research as statistical analysis and instrument development. A list of DRTCs is available at http://www.niddk.nih.gov/fund/other/centers.htm. Potential applicants are also encouraged to develop collaborative relationships with CDC-supported Diabetes Control Programs (DCPs) that offer access to high risk populations in community-based research settings. Investigators located at existing CDC-DDT supported "Translating Research into Action for Diabetes (TRIAD)" sites should include a full description of how the TRIAD sites will be advantageously utilized. TRIAD investigators should also describe how they will integrate the TRIAD sites and cohort without adversely affecting or overlapping the current and future multicenter collaborative goals of the TRIAD Study (e.g., primary hypotheses, cohort follow-up). The testing of interventions to prevent or treat disease among individuals from the TRIAD cohort is encouraged. SPECIAL REQUIREMENTS Upon initiation of this program, annual meetings will be held to encourage exchange of information among investigators. These meetings will include grantees awarded R18s under PA 02-153, as well as DRTC investigators conducting translation research. A goal of these meetings would be to foster collaborative efforts among program grantees, and to enhance dissemination of successful translation research programs by sharing of study designs, data and experiences. Applicants must budget for travel funds that will allow principal investigators to participate in these one-day meetings in Bethesda, Maryland. MECHANISM OF SUPPORT This PAR will use the National Institutes of Health (NIH) clinical trial planning grant (R34) award mechanism, which will provide up to $150,000 in direct costs per year. The total project period for an application submitted in response to this PAR may not exceed 2 years. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. These grants may not be renewed. It is anticipated that the data collected using these grants will provide the basis for a full- scale trial, which would be submitted as a research demonstration and dissemination project (R18) under PA 02-153 (http://grants.nih.gov/grants/guide/pa-files/PA-02-153.html). This PA uses just-in-time concepts. It also uses the modular budgeting format. (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic o Foreign Institutions are not eligible o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Investigators new to diabetes and digestive and kidney diseases are encouraged to apply. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage inquiries concerning this PAR and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research, and financial or grants management issues. o Direct your questions about scientific/research issues to: Sanford Garfield, Ph.D. Senior Advisor for Biometry and Behavioral Research Program 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 Barbara Linder, M.D., Ph.D. Clinical Endocrinology and Diabetes Complications Program Director National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 699 Bethesda, MD 20892-5460 Telephone: (301) 594-0021 FAX: (301) 480-3503 E-mail: bl99n@nih.gov Peter Dudley, Ph.D. Vision Research Program National Eye Institute Executive Plaza South, Rm. 350 Bethesda, MD 20892 Telephone: (301) 496-0484 FAX: (301) 402-0528 E-mail: pd8n@nih.gov Venkat Narayan, M.D. Center for Disease Control Division Of Diabetes Translation 4770 Buford Highway NE Atlanta, GA 30341 Telephone: (770) 488-1051 FAX: (770) 488-1148 E-mail: kav4@cdc.gov o Direct your questions about peer-review issues, to: Francisco O. Calvo, Ph.D. Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 752 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) 301-594-8897 (voice) 301-480-3505 (fax) fc15y@nih.gov o Direct your questions about financial or grants management matters to: Florence Danshes Grants Management Specialist Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 734 Bethesda, MD 20892-5456 Telephone: (301) 594-8861 FAX: (301) 480-3504 E-mail: fd39j@nih.gov Margie Baritz Division of Extramural Activities National Eye Institute Executive Plaza South, Rm. 350 Bethesda, MD 20892-6600 Telephone: (301) 496-5884 FAX: (301) 496-9997 E-mail: mb615b@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: All application instructions outlined in the PHS 398 application kit are to be followed, with the following requirements for R34 applications: 1. R34 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 R34 application, they may be included. 3. Sections a-d of the Research Plan of the R34 application may not exceed 15 pages, including tables and figures. 4. R34 appendix materials should be limited, as is consistent with the exploratory nature of the R34 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. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications with direct costs in each year of $250,000 or less must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SENDING AN APPLICATION TO THE NIH: 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 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and all appendix material must be sent to: Francisco O. Calvo, Ph.D. Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 752 Bethesda, MD 20892-5452 Telephone: (301) 594-8885 FAX: (301) 480-3505 Email: fc15y@nih.gov APPLICATION PROCESSING: Applications must be received by/or mailed before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Applications submitted for this PAR will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection 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 o 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: o Significance o Approach o Innovation o Investigator o Environment (1) Significance: Does this study address an important problem? If the aims of your 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? Do you 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: Are you appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) Environment: Does the scientific environment in which your 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? (6) Translation: Does the intervention strategy proposed have the ability to be translated into primary care, community, family or other patient care/support settings? The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your 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. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: 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. INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below). BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA The following will be considered in making funding decisions: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities The NIDDK has recently announced it will decrease the use of one time solicitations (i.e., the request for application, or RFA, mechanism) and substitute use of special emphasis funding for selected program announcements (PA) to stimulate research in areas of particular importance. Applications in response to these Special Emphasis PAs will receive automatic consideration for funding beyond the regular grant payline. The NIDDK is strongly committed to the support of translation research and has selected this PAR to be a special emphasis PA. Further information about NIDDK Special Emphasis PAs can be found at: http://grants.nih.gov/grants/guide/notice-files/ NOT-DK-03-001.html. Funding will also depend on the receipt of applications of high scientific merit and the availability of funds for this purpose. REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and audit procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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 UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on October 9, 2001 http://grants.nih.gov/grants/guide/notice-files/ NOT-OD-02-001.html; a complete copy of the updated Guidelines are available at http://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 is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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 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. 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. HEALTHY PEOPLE 2010 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 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. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847 (NIDDK), 93.837 (NEI), 93.988 (CDC) and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulation 42 CFR 52 and 45 CFR Parts 74 and 92. 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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