HEALTH DISPARITIES IN NIDDK DISEASES RELEASE DATE: March 11, 2004 PA NUMBER: PA-04-074 (see Amendment NOT-DK-04-015) March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. Accordingly, this funding opportunity expires on the date indicated below. Replacement R01 (PA-06-182) and R21 (PA-06-183) funding opportunity announcements have been issued for the submission date of June 1, 2006 and submission dates thereafter. See NOT-OD-06-048 for information on May 1, 2006 Submission Date for AIDS and AIDS-related R03 and R21 Applications. EXPIRATION DATE: March 2, 2006 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institute of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATIONS: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.847, 93.848 and 93.849 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) seeks research to understand and mitigate issues of health disparities in high priority diseases within its scope, including diabetes, obesity, nutrition-related disorders, hepatitis C, gallbladder disease, H. Pylori infection, sickle cell disease, kidney diseases, and metabolic, gastrointestinal, hepatic, and renal complications from infection with HIV. RESEARCH OBJECTIVES Background It is recognized that there are many diseases and disorders that disproportionately affect the health of racial and ethnic minority populations in the United States. It is evident that African-Americans, Hispanic Americans, American Indians, Alaska Natives, some Asian-Americans, and Native Hawaiians and other Pacific Islanders experience much higher risks and poorer health status than the general population. Several of the diseases that disproportionately afflict minorities are high priority research areas for NIDDK, including diabetes, obesity, nutrition- related disorders, hepatitis C, gallbladder disease, H. Pylori infection, sickle cell disease, kidney diseases, and metabolic, gastrointestinal, hepatic, and renal complications from infection with HIV. NIDDK encourages efforts health disparity research to reduce the human and economic costs resulting from inequities in health care and health outcomes. Specific examples of health disparities in these areas include the following: Type 2 Diabetes: o African-Americans, Hispanic/Latino Americans, American Indians, Alaska Natives, some Asian-Americans, Native Hawaiians and other Pacific Islanders are at particularly high risk for the development of type 2 diabetes. Diabetes prevalence rates among American Indians are two to five times those of whites. On average, African-American adults are 1.7 times as likely and Mexican-Americans and Puerto Ricans are twice as likely to have the disease as non-Hispanic whites of similar age. Japanese Americans and Samoans have elevated rates of diabetes. o All patients with diabetes are at high risk for microvascular complications affecting the eyes, nerves, and kidneys; for lower extremity amputations; and for coronary heart disease. Patients with diabetes from racial and ethnic minorities are more likely to develop the microvascular complications of diabetes and to have more lower extremity amputations compared with non- Hispanic white patients with diabetes. o Diabetes in pregnancy is associated with increased risk of congenital malformations and of complications during delivery and in the perinatal period. Women from minority groups, especially American Indian women, are much more likely to have type 2 diabetes during their childbearing years. In American Indian populations, maternal diabetes during pregnancy increases the risk of type 2 diabetes in childhood tenfold and is the most important risk factor for the development of type 2 diabetes in childhood. o Type 2 diabetes, once considered a disease of adults only, has been increasing in children and adolescents. Childhood diabetes clinics have reported that as many as one-third of their new onset diabetes patients have type 2 diabetes. More than three-quarters of these children are minorities. Rates of type 2 diabetes in adolescent Pima Indians have doubled in the past 30 years. Type 2 diabetes in childhood and adolescence leads to the development of serious kidney, eye, and heart disease in young adulthood for many of these children. Obesity: o Obesity is more common among minority individuals in the United States. More than 70 percent of African-American and Mexican-American women are overweight as defined by a body mass index (BMI) above 25. The prevalence of obesity (BMI above 30) in the United States is increasing in all racial and ethnic groups, but it affects minority populations disproportionately. More than 15 percent of non-Hispanic black women are severely obese, with BMIs above 40. o Rates of overweight in children and adolescents more than doubled from 1980 to 2000 in the United States. Rates of obesity in American Indian children are more than twice as high as in the nation’s population as a whole. Obesity in childhood is associated with higher cholesterol levels and higher rates of hypertension, type 2 diabetes, orthopedic problems, and gallstone disease. End-stage renal disease: o End-stage renal disease (ESRD) is a major public health problem in the United States. The adjusted incidence rate has steadily increased over the past decade, from 238 per million population in 1992 to 334 in 2001. Similarly, the adjusted point-prevalence rate has increased from 886 per million population in 1992 to 1,392 in 2001. There are striking racial and ethnic differences in the incidence and prevalence rates. Racial/ethnic minorities, specifically African-Americans, American Indians and Alaska Natives, Native Hawaiians and other Pacific Islanders, and Hispanic Americans, have disproportionately greater incidence and prevalence rates. For example, in 2001 the incidence rates were 254 per million population in Caucasians, 988 per million in African-Americans, 395 per million in Asian- Americans and Native Hawaiians and other Pacific Islanders, and 696 per million in American Indians and Alaska Natives. Eleven percent of all new ESRD patients were Hispanic Americans. o The four leading causes of ESRD include diabetes mellitus (primarily type 2), hypertension, glomerulonephritis, and cystic renal disease. However there is significant variability in the cause of ESRD among the various racial and ethnic groups. Diabetic nephropathy is a predominant cause of ESRD in all racial and ethnic groups. However, the rate of diabetic nephropathy is highest in American Indians and Alaska Natives. Hypertensive nephropathy is more prevalent in African-Americans than in other groups. o Other diseases causing ESRD in which African-Americans and other racial and ethnic minorities show a disproportionate increase over Caucasians include systemic lupus erythematosus; focal and segmental glomerulosclerosis, especially in children; and AIDS. Hepatitis C and Liver Disease: o Hepatitis C affects 1.5 percent of the U.S. population and is twofold to threefold more common among African-Americans and Hispanic Americans than among Caucasians. o Therapy for hepatitis C is evolving; current recommended regimens are effective in only 40 percent of patients. The response rate in African- Americans is lower than in Caucasians. o The only therapy for end-stage liver disease is liver transplantation. At present, approximately 4,000 liver transplants are done yearly, but waiting lists are lengthening, and a shortage of organs has caused an increase in deaths among patients awaiting transplantation. Although end-stage liver disease is more common in minority individuals, those individuals are less likely to undergo liver transplantation. After liver transplantation, the survival rate appears to be lower for African-Americans than for Caucasians. Aquired immuno-deficiency syndrome (AIDS): o More than 600,000 persons have been diagnosed with AIDS in the United States. A larger number are infected with HIV, many of whom are not yet diagnosed. In the United States, African-Americans and Hispanic or Latino Americans are disproportionately infected with HIV. o Persons infected with HIV often develop a multisystem dysfunction, and those with AIDS typically have severe abnormalities in many organ systems. Persons infected with HIV with or without AIDS may develop significant metabolic abnormalities and alterations in body composition, which impact quality of life and longevity. Individuals co-infected with hepatitis C may follow a more virulent course to severe morbidity and/or death. Patients with HIV infection may also experience chronic diarrheal syndrome, AIDS enteropathy, for which no etiologic agents is identified other than HIV infection. Development of HIV-related nephropathy may occur early in the course of the disease, with or without AIDS, and may progress to end-stage renal disease. In the period 1997-2001, AIDS nephropathy was the reported cause of ESRD in 1 percent of all incident ESRD patients. Diseases of the Prostate: o Although the available data show that prostate cancer has a higher prevalence in African-Americans, the racial disparities for nonmalignant diseases have never been accurately assessed. However, it is assumed that they follow a pattern similar to that of prostate cancer. o In addition to racial disparities in disease prevalence, the disparities in types of therapy, effectiveness of therapy, and effectiveness of screening programs have not been studied or evaluated. Gallbladder Disease: o In the United States, more than 600,000 cholecystectomies are performed yearly to treat symptomatic gallstone disease with resulting costs approaching $10 billion. The disease is more common in women and increases with age. Information on ethnicity as related to gallstones has been limited by insufficient or inaccurate characterization of ethnicity. Recent population based ultrasonographic studies have revealed substantial ethnic differences in risk of gallstones. Risk is highest among American Indians followed by Hispanics in Chile, Mexican American women in the United States, and Polynesians. o Among women, risk of gallbladder disease is highest among American Indians, followed by Hispanics, non-Hispanic whites and non-Hispanic blacks. o Higher case fatality occurs among non-Hispanic blacks than non-Hispanic whites suggesting that blacks may have inadequate access to medical care for gallbladder disease. Peptic Ulcer Disease and H. Pylori: o Peptic ulcer disease is a chronic gastrointestinal disease that affects over ten percent of the population in the United States. It is estimated that more than 50% of peptic ulcer diseases is caused by H. Pylori infection and that H. Pylori is more prevalent among minority populations. The prevalence of H. Pylori infection is reported to be about 62% in Mexican Americans and 53% in non-Hispanic blacks compared to 26% in non-Hispanic whites. o H. Pylori infection increases the risk for stomach cancer, which is twice as high among non-Hispanic blacks as it is among non-Hispanic whites. Native American and Mexican Americans are also at increased risk. Sickle Cell Disease: o Sickle cell disease affects more than 70,000 Americans. The disease exhibits the highest frequency in people of African descent. In African Americans, one in 600 persons has the disease, and an additional one in 12 is a carrier for sickle cell trait. Scope: The overall objective of this Program Announcement is to understand and mitigate health disparities in the development, diagnosis, and treatment of diseases of high priority to NIDDK, i.e., diabetes, obesity, nutrition- related disorders, hepatitis C, gallbladder disease, H. Pylori infection, sickle cell disease, kidney diseases, and metabolic, gastrointestinal, hepatic, and renal complications from infection with HIV. It is recognized that both biologic and non-biologic factors may be operating in these populations. Approaches may include metabolic, genetic, clinical and/or epidemiologic studies in representative populations. Advantage might be taken of extant cohort studies that have been established for investigation of diabetes or other diseases. Collaboration among investigators of these established cohorts would be desirable, so that these studies might jointly develop protocols and evaluate findings. Alternatively, investigators may propose to start a new cohort, appropriately powered, to capture the current risks and outcomes in the era of new medications for some of the diseases. Such studies of current risks might appropriately be based in large HMOs or clinical practices with structure and data management practices conducive to efficient and cost-effective analyses. Appropriate topics for investigation would include but are not limited to: o Studies on the impact of medical services for the prevention and treatment of diabetes, obesity, nutrition-related disorders, hepatitis C, gallbladder disease, H. Pylori infection, sickle cell disease, kidney diseases, and complications from infection with HIV the in diverse racial/ethnic groups. o Studies are needed to better understand racial and ethnic differences in the incidence and prevalence of these diseases and whether there are differences among sub-groups in the rates of progression. o Studies to determine if there are disparities in the diagnosis of diabetes and pre-diabetes and the effect, if any, on onset of complications and their progression. o State-of-the-art, hypothesis-driven metabolic studies to determine whether there are differences in metabolism, insulin sensitivity, energy expenditure, beta cell function, and body composition that might influence glycemic control or development of obesity and risk of complications in different populations. Such studies might determine, for example, whether some groups are at greater risk for type 2 diabetes from insulin resistance or from reduced beta-cell reserve; whether fat content and distribution differ among race-ethnic groups, and what metabolic or physiologic processes are responsible in the pathogenetic pathway leading to type 2 diabetes. o Studies of pregnancy in mothers with pre-existing or gestational diabetes and risk for diabetes and obesity in children in minority populations and potential mechanisms for any increase in risk. Studies of the role of the in utero environment on the subsequent development of pre-diabetes or diabetes. Studies are needed to assess whether abnormalities in the uterine environment contribute to ethnic/racial disparities in the incidence of type 2 diabetes, and, conversely, whether there are racial/ethnic differences in the response to a given in utero milieu. o Epidemiologic studies to determine the rates of microvascular (nephropathy, retinopathy, and neuropathy) and macrovascular (cardiovascular disease and stroke) diabetic complications in appropriate representative samples of contemporary populations. o Studies to identify genes, which might affect the development and progression of micro- and macrovascular complications in different populations. o Studies to compare the contribution of glycemia versus other risk factors (e.g., smoking, dyslipidemia, body composition, blood pressure, markers of inflammation) in the development of micro- and macrovascular disease in patients with diabetes, and to study how treatment of these factors may influence rates of development of complications in different racial/ethnic groups. o Studies to investigate environmental or behavioral factors, such as medical care, lifestyle, and socioeconomic status that may contribute to risk for development and progression of obesity or diabetes and its complications. Such studies could incorporate culturally specific lifestyle factors into treatment and prevention strategies to reduce risk across racial and ethnic groups. o Studies to determine whether different pathophysiologic mechanisms or risk factors are operative among subgroups within racial/ethnic minorities (e.g., different subgroups of Hispanic Americans, such as Mexican Americans, Puerto Ricans, Caribbean Hispanics, Cuban Americans). o Studies of intervention to reduce or prevent weight gain in children or adults of minority populations. o Studies of effects of medications or other therapies for prevention or treatment of type 2 diabetes, obesity or their complications in racial or ethnic minority populations, including children. o Studies of the reasons for the racial and ethnic disparities in the incidence and prevalence rates of ESRD. o Studies of the basic mechanisms, and differential causes and progression of kidney disease to end-stage renal disease in racial and ethnic groups. o Studies to explore the mechanism for greater resistance to therapy and to find more effective regimens for the treatment of hepatitis C in African- American and Hispanic-Americans. o Studies of mechanisms for poorer survival after liver transplantation and methods to improve survival. o Studies to explore severe metabolic abnormalities of AIDS or hepatitis C or AIDS nephropathy. o Studies of racial disparities in prevalence of diseases of the prostate (especially non-malignant) and type and effectives of therapies. o Studies to further explore ethnic differences in prevalence of gallbladder disease and disparities in health care access and utilization. Environmental, biological or genetic studies are needed to understand underlying mechanisms for ethnic difference in development of gallbladder disease. o Studies to explore differences in H. Pylori infection in ethnic groups and the relationship ethnic differences in the development of stomach cancer in persons infected with H. Pylori. o Studies to identify genetic modifiers to the phenotypic expression of sickle cell disease. Studies to investigate possible new targets for therapeutics for sickle cell disease. MECHANISM(S) OF SUPPORT This PA will use the National Institutes of Health (NIH) research project grant (R01) and the Exploratory/Development Research Grant (R21) award mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an R01 application submitted in response to this PA may not exceed 5 years. The R21 awards are to demonstrate feasibility and to obtain preliminary data testing innovative ideas that represent clear departure from ongoing research interests. These grants are intended to: 1) provide initial support for new investigators; 2) allow exploration of possible innovative new directions for established investigators; and 3) stimulate investigators from other areas to lend their expertise to research within the scope of this solicitation. Applicants for the R21 must limit their requests to $275,000 direct costs for the two year period. For example, the applicant may request $100,000 in the first year and $175,000 in the second year. The request should be tailored to the needs of the project. Normally no more than $200,000 will be requested in a single year. These R21 grants will not be renewable; continuation of projects developed under this program will be through the regular research grant (R01) program. This PA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats. (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 budget format. Otherwise follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm. 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 institutions/organizations o Foreign institutions are not eligible to apply o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS All individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institutions to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA 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: Myrlene Staten, M.D. Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 6107 Bethesda, MD 20892-5460 Telephone: (301) 402-7886 FAX: (301) 480-3503 Email: ms808k@nih.gov Lawrence Agodoa, M.D. Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 653 Bethesda, MD 20892-5460 Telephone: (301) 594-5454 FAX: (301) 594-9358 Email: la21j@nih.gov Marva Moxey-Mims, M.D. Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 639 Bethesda, MD 20892-5460 Telephone: (301) 451-5037 FAX: (301) 480-3510 Email: mm726k@nih.gov Frank Hamilton, M.D. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 669 Bethesda, MD 20892-5460 Telephone: (301) 594-8877 FAX: (301) 480-8300 Email: fh14e@nih.gov o Direct your questions about financial or grants management matters to: Kathleen J. Shino Supervisory Grants Management Specialist National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 708 Bethesda, MD 20892-5456 Telephone: (301) 594-8869 FAX: (301) 480-3504 E-mail: ks48e@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact Grants Info, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. In addition, the PA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked SUPPLEMENTARY INSTRUCTIONS 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 $275,000 for the two year period. 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. Use the instructions for appendix detailed in the PHS 398 except that no more than 5 manuscripts, previously accepted for publication, may be included. Further details regarding the purpose and format of R21 applications can be found by reading the NINDS guidelines describing the R21 program (http://www.ninds.nih.gov/funding/r21guidelines.htm). All R21 applications submitted in response to this Program Announcement should follow the NINDS guidelines, regardless of Institute assignment. Applicants may also contact one of the Program Officials listed under "Inquiries" for further information. If there is other important information it should be included in the PA. R21 applications deemed not to be responsive to this program announcement will be returned. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget grant format. The modular budget 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. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five 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) APPLICATION PROCESSING: Applications must be mailed on or 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 unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups 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 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 written critique o Receive a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council 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 evaluate application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment 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. 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? 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? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 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)? 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. http://grants.nih.gov/grants/policy/data_sharing BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants.(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). SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (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: The NIH maintains a policy 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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. 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. 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.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. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. 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.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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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