RFA-HD-04-020: PREVENTION AND TREATMENT OF CHILDHOOD OBESITY IN PRIMARY CARE SETTINGS

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.

PREVENTION AND TREATMENT OF CHILDHOOD OBESITY IN PRIMARY CARE SETTINGS RELEASE DATE: July 20, 2004 RFA NUMBER: RFA-HD-04-020 (see Amendment NOT-HD-04-008) EXPIRATION DATE: November 24, 2004 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) National Center for Complementary and Alternative Medicine (NCCAM) (http://nccam.nih.gov/) National Center on Minority Health and Health Disparities (NCMHD) (http://ncmhd.nih.gov/) National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov) National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov/) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/) National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov/) NIH Office of Behavioral and Social Sciences Research (OBSSR) (http://obssr.od.nih.gov/) NIH Office of Disease Prevention (ODP) (http://odp.od.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.865; 93.213; 93.307; 93.837; 93.121; 93.848; 93.361 LETTER OF INTENT RECEIPT DATE: October 25, 2004 APPLICATION RECEIPT DATE: November 23, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanisms of Support o Funds Available 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 Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA Research projects responsive to this solicitation would test intervention programs delivered in primary care practices, including dental practices, to improve dietary and physical activity behaviors of pediatric patients in order to prevent excessive weight gain in children at risk for obesity and/or to prevent further weight gain or to promote weight loss in children who are already obese. Intervention programs to be tested should be feasible for delivery in a wide range of primary care practice settings, such as a pediatrician's office, a family physician's office, a dentist's office, a managed care organization, or a primary care clinic. Interventions should promote reduction in dietary energy intake, increased energy expenditure through physical activity, increased physical fitness, decreased sedentary behaviors, and/or modification of other behaviors that would lead to an increase in the proportion of children with age-appropriate body weight for stature when evaluated against a control/comparison group not exposed to the intervention. RESEARCH OBJECTIVES Background Levels of childhood overweight have nearly tripled since 1970. Approximately 15 percent of children and adolescents ages six to 19 years are now overweight, with an additional 15 percent considered at risk for overweight. For children ages two to 19 years, overweight is defined as a BMI equal to or greater than the 95th percentile of the 2000 CDC growth charts for age and gender based on previous national surveys, and, at risk for overweight is defined as a BMI equal to or greater than the 85th percentile to less than the 95th percentile. For purposes of this RFA, the terms overweight and obese are used interchangeably. Research has shown that obesity in childhood tracks into adulthood, carrying along with it increased susceptibility to hypertension, dyslipidemia, and glucose intolerance. In fact, the striking increase in the prevalence of childhood obesity over the past 30 years has been associated with a marked increase in the incidence of type 2 diabetes among adolescents. In order to slow or reverse the increase in childhood obesity and the health risks associated with pediatric obesity, it will be necessary to treat childhood obesity as soon as it is detected. Even more appealing would be the prevention of childhood obesity entirely by identifying children at risk and providing interventions designed to prevent inappropriate weight gain. Because almost all children receive their health care in primary care settings, development of effective and feasible strategies for prevention and treatment of childhood obesity that could be initiated and/or delivered primarily within those settings represents an important opportunity for addressing this major public health problem. The development of overweight in children and adolescents has a multi- factorial etiology. Therefore, the prevention and management of pediatric overweight will require a multi-faceted approach. Family/home, school, community, media/advertising, and other environments all may play a role in influencing children's energy intake and expenditure. Because overweight is recognized as a health condition that poses increased risks for other adverse health conditions, greater attention must be given to the role of the primary pediatric health care provider as a key agent in the prevention, treatment, and management of overweight among children and adolescents. Although involvement of the primary care provider may seem obvious, there are various barriers and challenges to effective overweight prevention and treatment by this sector. The primary care provider may be a pediatrician, family physician, nurse practitioner, dentist, or physician's assistant. Primary health care providers generally do not receive comprehensive training in the intensive behavioral intervention approaches that are recommended for the successful prevention or treatment of overweight. Primary health care providers generally do not have the time required to assess, intervene, and monitor progress related to dietary preferences and practices, physical activity and sedentary behaviors, and the underlying socio-cultural, familial, psychological, economic, behavioral, environmental, and other determinants of children's diet and physical activity. Health care providers generally are not reimbursed by third party payers to provide preventive or therapeutic counseling services for obesity, or to employ a multi-disciplinary team within their practices to provide appropriate services. Although the challenges are many, research is needed to enhance the role of the pediatric primary care provider as an influential agent for the prevention and treatment of pediatric overweight. Scope Intervention programs to be tested should be feasible for delivery in a wide range of primary care practice settings and should target obesity prevention or weight reduction in already overweight pediatric patients. Children and adolescents who are overweight (BMI equal to or greater than the 95th percentile for sex and age), at-risk for overweight (BMI equal to or greater than the 85th percentile to less than the 95th percentile for sex/age), or at increased risk due to their trajectory of weight gain, parental obesity, or maternal history of gestational or type 2 diabetes mellitus will be targeted. Applications focusing on minority populations at increased risk for obesity, as well as underserved populations (such as families in rural areas), are encouraged. The initial evaluation and at least some aspects of the intervention should be carried out by the primary care provider (physician, nurse practitioner, dentist, or physician's assistant), but other types of providers and settings could be included in the intervention (for example, classes run by a behaviorist; referral to a hospital-based dietitian; referral to a community recreation center, to a school-based intervention program, or to a commercial weight loss program). Linkage to ongoing primary care research networks, where available, is encouraged, as is interaction with community- based health coalitions and with schools that have initiated intervention programs. It is likely that the type and intensity of interventions proposed will be dependent on whether the goal is primary prevention in children who are at increased risk for overweight or treatment of a child who is already overweight and who may have comorbid conditions. All intervention packages must be feasible to institute in a primary care pediatric practice (for example, a small-group practice or larger clinic). Interventions that take place entirely within specialized pediatric obesity treatment centers will not be considered responsive to this RFA. Interventions should be hypothesis-driven and based on previous research, and should be appropriate to the developmental stage of the at-risk child or adolescent. To be considered responsive, proposed studies should be designed to test interventions at the individual/family-level (e.g., patient education and counseling programs delivered directly to the patients and their families) and/or to test institutional or clinic-based interventions, i.e., interventions that target the process and delivery of care, such as screening and charting approaches for overweight/obesity, referral processes for education/counseling (e.g., to dietitians or nurses), policies about appointment duration, individualized case management systems, approaches to follow-up scheduling, etc. Because family-based behavioral approaches relevant to adoption and maintenance of healthful diets and physical activity are crucial to successful long-term behavior change, such approaches should be incorporated in the proposed intervention(s). Examples of such approaches include individualized goal setting, self-monitoring, and enhancement of social support. Each application must propose its own specific research question and methods, including specific aims, description of and justification for the proposed intervention program and to whom it is directed, the primary and other outcomes to be measured, intervention process measurements, the informed consent processes, and statistical methods to be used, including justification of the sample size and power. The R21 (exploratory/developmental) mechanism may be used for applications that propose smaller studies to test the acceptability and feasibility of intervention programs in clinical practice settings. For exploratory/developmental studies, the intervention must be carried out for a minimum of 12 weeks, with a minimum follow-up of one year. Identification of barriers to treatment (health care provider-related, child-related, and parent-related) and development of appropriate barrier-reducing strategies are encouraged. These smaller studies may use intermediate outcome measures, such as degree to which screening and counseling are delivered or patient-centered outcomes such as quality of life or satisfaction with treatment, which may be obtained from surveys of patients, chart reviews, and/or surveys of providers. Wherever feasible, R21 studies should attempt to collect data on objective outcome measures such as change in BMI (or BMI SD), body composition, physical activity (as measured through fitness testing, accelerometer, or pedometer use), as well as collection of data on dietary intake and behavior change through the use of well-validated self-report measures. The NIDCR will only accept R21 applications in response to this RFA and only those that fit these requirements and do not propose to conduct small clinical trials. Full-scale trials supported by the R01 mechanism must include an intervention of at least 12 weeks and follow-up of at least two years, and the primary outcome must be change in BMI (or BMI SD) and/or body composition. For R21s and R01s, secondary outcomes might include (but are not limited to) variables such as changes in plasma lipids, insulin resistance, or blood pressure, biomarkers indicative of changes in fruit/vegetable consumption, quality of life, assessment of psychiatric co-morbidity, changes in knowledge, attitudes, and behaviors, etc. Evaluation of the impact of weight management interventions on the psychosocial well-being of children and families, including evaluating the impact of the intervention on eating disordered behaviors and/or body dissatisfaction, is also encouraged. All applicants for an R01 are encouraged to describe plans for a cost-effectiveness evaluation of the intervention. All studies, regardless of the funding mechanism, must include a control/comparison group to enable a valid assessment of the effects of the intervention being tested. To ensure proper attention to ethical considerations, it is desirable that the control/comparison group receive a minimal intervention, or at least recommendations or materials regarding the standard of care. For studies testing institutional or clinic-based interventions, investigators are encouraged to allocate physicians or practices, rather than individuals, to intervention and control/comparison conditions as the unit of randomization to avoid contamination of the control/comparison group; if this approach is taken, the application must address statistical and consent issues related to the unit of assignment. Examples of research projects that are responsive to this RFA include, but are not limited to, the following: o Office-based programs providing on-site dietary and/or physical activity intervention designed to prevent weight gain in children at risk for obesity. o Family-based interventions carried out in a primary care setting to promote weight loss or limit weight gain in overweight children/adolescents. o Office-based interventions designed to limit sedentary behaviors and/or to increase physical activity. o Collaborations between primary health care providers/clinics and non-clinic sites, such as hospital-based dietitians, a community recreation center, a qualified complementary or alternative practitioner or a commercial weight- loss program. o Carefully controlled pharmacological interventions carried out in a primary care setting in combination with lifestyle interventions that are designed to induce or sustain weight loss in obese children. o Projects designed to detect synergistic interactions between dietary interventions and interventions that involve decreased sedentary behavior and/or increased physical activity. o Interventions designed to improve screening for obesity in primary care settings. o Interventions to address physician, parent, and child barriers to acceptance of weight management interventions and to improve adherence to dietary and physical activity recommendations. o Studies that evaluate the impact of weight management interventions on the psychosocial well-being of children and families, including quality of life and measures evaluating the development of eating disordered behaviors and/or body dissatisfaction. o Office-based projects that include components of behavior modification, particularly projects designed to reduce sedentary activities, especially time spent watching television, surfing the internet or playing videogames, and those designed to encourage children to be more physically active. o Projects in which providers of dental care offer counseling to reduce the use of calorically dense snack foods and sugar-sweetened beverages. o Studies of existing interventions that have demonstrated either prevention or treatment efficacy (e.g., increase in proportion achieving target BMI percentile) adapted from the research setting for translation or dissemination in the primary care setting. Such studies must include a plan to evaluate cost-effectiveness. o Studies evaluating complementary or alternative medicine (CAM) approaches to weight maintenance and the prevention and treatment of overweight or obesity in children. Of particular interest are those CAM approaches used by qualified practitioners of CAM (e.g., meditation, naturopathy, acupuncture, etc.) in a primary care setting. MECHANISM OF SUPPORT This RFA will use the NIH Research Project Grant (R01) and Exploratory/Developmental Grant (R21) award mechanisms. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is August 1, 2005. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. The Exploratory/Developmental (R21) grant mechanism is used to support exploratory and developmental research projects by providing support for the early and conceptual stages of these projects. Applications submitted under this mechanism should be exploratory and novel. More information about the R21 mechanism can be obtained at http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html. The Research Project Grant (R01) mechanism is used to support larger scale studies that require more than two years of support. Investigators applying for an R01 grant in response to this RFA may request support of up to $500,000 per year in direct costs for a period of up to five years. This RFA uses just-in-time concepts. It also uses the modular 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 format. Otherwise follow the instructions for non- modular 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. FUNDS AVAILABLE The NICHD intends to commit approximately $3 million, the National Center for Complementary and Alternative Medicine intends to commit approximately $250,000, the National Center on Minority Health and Health Disparities intends to commit approximately $250,000, the National Heart, Lung, and Blood Institute intends to commit approximately $1 million, the National Institute of Dental and Craniofacial Research intends to commit approximately $500,000, the National Institute of Nursing Research intends to commit approximately $500,000, the Office of Behavioral and Social Sciences Research intends to commit approximately $250,000, and the NIH Office of Disease Prevention, Office of the Director, intends to commit approximately $10,000 in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2005 to support five to 12 new and/or competing continuation grants in response to this RFA. An applicant for an R01 may request a project period of up to five years and budget for direct cost of up to $500,000 per year. An applicant for an R21 may request a project period of up to two years with a combined budget for direct costs of up $275,000 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 may be requested in any single year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the ICs 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 meritorious applications. ELIGIBLE INSTITUTIONS You may submit an application 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 or foreign institutions/organizations 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 his/her institution 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 inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Gilman Grave, M.D. Endocrinology, Nutrition and Growth Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, 4B11, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5593 FAX: (301) 480-9791 Email: graveg@mail.nih.gov Marguerite Klein National Center for Complementary and Alternative Medicine 6707 Democracy Boulevard, Suite 401, MSC 5475 Bethesda, MD 20892-5475 Telephone: (301) 402-5860 FAX: (301) 480-3621 Email: me16o@nih.gov or kleinm@mail.nih.gov Mireille Kanda, Ph.D. National Center for Minority Health and Health Disparities 6707 Democracy Boulevard, Suite 800, MSC 7565 Bethesda, MD 20892-7565 Telephone: (301) 402-1366 FAX: (301) 402-7040 Email: kandam@mail.nih.gov Denise Simons-Morton, M.D., Ph.D. Director, Clinical Applications and Prevention Program National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7936 Bethesda, MD 20892-7936 Telephone: (301) 435-0384 FAX: (301) 480-1669 Email: simonsd@nhlbi.nih.gov Maria Teresa Canto, D.D.S., M.P.H. National Institute of Dental and Craniofacial Research Natcher Building, Room 4AS43B, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-5497 FAX: (301) 480-8322 Email: cantom@mail.nih.gov Robert Kuczmarski National Institute of Diabetes and Digestive and Kidney Diseases 2 Democracy Plaza, Room 673 Bethesda, MD 20892 Telephone: (301) 451-8354 FAX: (301) 480-8300 Email: rk191r@nih.gov Yvonne Bryan, Ph.D., R.N. Office of Extramural Programs National Institute of Nursing Research 6701 Democracy Blvd, Room 710, MSC 870 Bethesda, MD 20892-4870 Telephone: (301) 594-6908 FAX: (301) 480-8260 Email: Bryany@mail.nih.gov Deborah H. Olster, Ph.D. Senior Advisor Office of Behavioral and Social Sciences Research Office of the Director National Institutes of Health Building 1 Center Drive, Room 256, MSC 0210 Bethesda, MD 20892-0210 Telephone: (301) 451-4286 FAX: (301) 402-1150 Email: olsterd@od.nih.gov Martina Vogel-Taylor, Ph.D. Office of Disease Prevention Office of the Director National Institutes of Health 6100 Executive Boulevard, Room 2B-03B, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-6614 Email: vogelm@mail.nih.gov o Direct your questions about peer review issues to: Robert Stretch, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, 5B01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1485 FAX: (301) 402-4104 Email: stretchr@mail.nih.gov o Direct your questions about financial or grants management matters to: Angelos Bacas Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-7010 FAX: (301) 402-7827 Email: ab329b@nih.gov George A. Tucker, M.B.A. Acting Chief Grants Management Officer Grants Administration Branch National Center for Complementary and Alternative Medicine 6707 Democracy Boulevard, Room 401, MSC 5475 Bethesda, MD 20892-5475 Telephone: (301) 594-9102 FAX: (301) 480-1552 Email: tucker@nih.hhs.gov Bryan S. Clark, M.B.A. Chief Grants Management Officer National Center on Minority Health and Health Disparities 6707 Democracy Boulevard, Suite 800, Room 835 Bethesda, MD 20892 Telephone: (301) 594-8412 FAX: (301) 480-4049 Email: clarkb1@mail.nih.gov Holly Atherton Senior Grants Management Specialist National Heart, Lung and Blood Institute 6701 Rockledge Drive, Rockledge 2, MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0177 FAX: (301) 480-3310 Email: athertoh@nhlbi.nih.gov Robert L. Tarwater Grants Management Branch Division of Extramural Activities National Institute of Dental and Craniofacial Research Building 45, Room 4AS51, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-4836 FAX: (301) 480-3562 Email: tarwater@nih.gov Sharon Bourque Grants Management Specialist National Institute of Diabetes, Digestive, and Kidney Disease 2 Democracy Plaza, Room 719 Bethesda, MD 20892 Telephone: (301) 594-8846 FAX: (301) 480-3504 Email: bourques@ep.niddk.nih.gov Lawrence Haller Grants Management Specialist Office of Grants/Contract Management National Institute of Nursing Research 6701 Democracy Boulevard, Room 710, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 402-1878 FAX: (301) 451-5652 Email: HALLERL@mail.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA 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 NICHD staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Gilman Grave, M.D. Endocrinology, Nutrition and Growth Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, 4B11, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5593 FAX: (301) 480-9791 Email: graveg@mail.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 D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The D&B number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document 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. SUPPLEMENTARY INSTRUCTIONS: All instructions for the PHS 398 (rev. 5/2001) must be followed, with these exceptions: Exploratory/Developmental Grant (R21) Applications: o Research Plan Items a - d of the Research Plan (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) may not exceed a total of 15 pages. No preliminary data is required, but may be included if it is available. Please note that a Progress Report is not needed; competing continuation applications for an exploratory/developmental grant will not be accepted. o Appendix: Use the instructions for the appendix detailed in the PHS 398 except that no more than five manuscripts, previously accepted for publication, may be included. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs 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. USING THE RFA LABEL: 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. 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, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to: Robert Stretch, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, 5B01, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) APPLICATION PROCESSING: Applications must be received on or before 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. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight weeks. 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NICHD. 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 NICHD in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o 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 and assigned a priority score o Receive a written critique o Receive a second level review by an 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. The scientific review group will address and consider each of these 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. The NIH R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools or technologies that have the potential to significantly advance our knowledge or the status of health- related research. Because the research plan is limited to 15 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications. 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: o Evidence of intent and ability to evaluate the cost-effectiveness of interventions under study. 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.) 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.) ADDITIONAL CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: October 25, 2004 Application Receipt Date: November 23, 2004 Peer Review Date: March/April 2005 Council Review: June 2005 Earliest Anticipated Start Date: August 01, 2005 AWARD CRITERIA 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 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). 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 is 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. 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. 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. 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). 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 RFA 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 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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices