and Human Services (HHS)
EXPIRED
OBESITY AND THE BUILT ENVIRONMENT RELEASE DATE: August 20, 2004 RFA Number: RFA-ES-04-003 EXPIRATION DATE: December 18, 2004 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Institutes of Health (NIH) (http://www.nih.gov) Centers for Disease Control and Prevention (CDC) (http://www.cdc.gov) COMPONENTS OF PARTICIPATING ORGANIZATIONS: National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov/) National Cancer Institute (NCI) (http://www.nci.nih.gov/) National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov) Office of Behavioral and Social Sciences Research (OBSSR) (http://obssr.od.nih.gov/) National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) (http://www.cdc.gov/nccdphp/) National Center for Environmental Health (NCEH) (http://www.cdc.gov/nceh/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.113, 93.114, 93.115 (NIEHS); 93.864, 93.865, 93.929 (NICHD); 93.399 (NCI) LETTER OF INTENT RECEIPT DATE: November 17, 2004 APPLICATION RECEIPT DATE: December 17, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA This initiative will support R01 and R21 studies in two specific areas related to the built environment and obesity: First, understanding the role of the built environment in causing/exacerbating obesity and related co-morbidities; and second, developing, implementing, and evaluating prevention/intervention strategies that influence parameters of the built environment in order to reduce the prevalence of overweight, obesity and co-morbidities. This RFA will support projects that delineate the significance and impact of the built environment on overweight and obesity by enhancing our understanding of the roles played by city and regional planning, housing, transportation, media, access to healthy foods and availability of public and green spaces (such as playgrounds, walking paths, etc.) as determinants of physical activity and nutritious dietary practices. Currently, there is insufficient research that delineates the influence of the built environment on nutritional factors and physical activity. One intended outcome of this program is the development of models of health-promoting communities that provide access to a wide variety of foods that are consistent with current dietary guidelines, physical activity patterns that are consistent with current recommendations, and how this impacts overweight and obesity. These community-based environmental interventions would serve as models for management and prevention of overweight, obesity, and co-morbidities across other communities in need of change. Of particular interest are studies conducted in vulnerable populations (such as children, the aging population, low socioeconomic status (SES) communities, racial/ethic minorities, persons with disabilities that require use of assistive mobility devices such as wheelchairs and prostheses). Definition of the Built Environment: It encompasses all buildings, spaces and products that are created, or modified, by people. It includes homes, schools, workplaces, parks/recreation areas, greenways, business areas and transportation systems. It extends overhead in the form of electric transmission lines, underground in the form of waste disposal sites and subway trains, and across the country in the form of highways. It includes land-use planning and policies that impact our communities in urban, rural and suburban areas. Definition of overweight and obese: Body Mass Index (BMI) is a common measure expressing the relationship (or ratio) of weight-to-height. It is a mathematical formula in which a person's body weight in kilograms is divided by the square of his or her height in meters (i.e., wt/ht). The BMI is highly correlated with body fat. Adults with a BMI of 25 to 29.9 are considered overweight, while individuals with a BMI of 30 or higher are considered obese. According to the CDC Growth Charts: United States 2000, children and adolescents with a Body Mass Index (BMI) between the 85th and 95th percentile are currently defined as at risk for overweight. Those with a BMI above the 95th percentile are overweight (http://www.cdc.gov/nccdphp/dnpa/bmi/00binaries/bmi-checkbook.pdf). It is important to note that, because of the wide range of built environmental issues to be addressed and the diversity of communities, this RFA requires interdisciplinary partnerships. These teams must consist, at a minimum, of a scientist with expertise in health research (e.g., an epidemiologist, behavioral or social scientist), a clinical specialist (e.g., a nutritionist, pediatrician, cardiovascular specialist, healthcare provider, occupational therapist, nurse) and an expert on planning, design, or transportation (e.g., representative of a local or state planning, transportation agency, zoning departments). Other scientists and experts (e.g., in economics, health policy, community health, housing, education, recreation, psychology, universal design) as well as those with scientific expertise in diseases and conditions that are co-morbidities of obesity should be considered to complement, but will not substitute for, those mentioned above. Partnerships with state and local health departments working in the area of obesity, prevention and control through promotion of improved physical activity and nutrition may also be considered. These personnel must be listed on Page 2 of the PHS 398 application, and a biographical sketch must be provided for each. The role of each member of the team in carrying out the project should be well described. The inclusion of one or more subcontract arrangements may be helpful in defining all parties' programmatic and budgetary roles. RESEARCH OBJECTIVES Background Obesity is an important area of health and disease that is related to the built environment. In the United States, obesity and overweight have risen to an epidemic rate during the past 20 years and are among the most important health challenges of our time. Obesity in adults, particularly abdominal or upper-body obesity, is associated with increased risk of a number of diseases and metabolic abnormalities including coronary heart disease, hyperinsulinemia, insulin resistance, type 2 diabetes, certain cancers and osteoarthritis. It has also been observed that most of the conditions associated with obesity are also associated with increasing age. In the US, there is a general increase in body weight and body mass index with age, until approximately 60 years of age. In addition, the proportion of intra-abdominal fat, which is related to increased morbidity and mortality, progressively increases with age. Weight loss in the elderly can reduce morbidity from arthritis, and also cardiovascular risk factors. Overweight among children (6-19 years of age) currently stands at 15 percent. Risk factors for heart disease, such as high cholesterol and high blood pressure, occur with increased frequency in overweight children and adolescents compared to children with a healthy weight. Type 2 diabetes, previously considered an adult disease, is increasingly observed in overweight children and adolescents. Other diseases in children and adults that are associated with unhealthy diet include dental diseases. Preliminary studies on weight loss in children have resulted in better overall school performance. Research indicates that rates of obesity and overweight are increasing. One of the national health objectives for the year 2010 is to reduce the prevalence of obesity among adults to less than 15 percent. Obesity- associated health care costs currently account for approximately 7 percent of national expenditures, approximately $75 billion. Obesity is an enormous public health challenge for Americans of all ages, especially for children and minorities. Many educational programs targeted to individuals to affect changes in obesity and weight gain have not been successful. However, environmental changes that reinforce factors supporting healthy lifestyles and reduce barriers to healthy lifestyles may serve to diminish health disparities. Access to healthy foods and opportunities to impact physical activity are factors that have been considered both at the community and individual levels. Approaches that modify the environment to promote healthful eating practices (such as increases in fruits and vegetable intake, lower caloric intake, and increases breast feeding practices), increase physical activity, and decrease sedentary behaviors offer the potential for safe and effective programs for obesity prevention that could be widely disseminated. Investigators applying to this RFA may propose collaborations with organizations/institutions such as schools, supermarkets, restaurants, religious organizations, recreation facilities, industry, governmental, public health, or community groups, worksites, and so forth, to develop approaches that, if successful, could potentially be translated into larger-scale prevention/intervention programs. Persons who have physical disabilities and require the use of assistive devices such as wheelchairs and lower limb prostheses are especially vulnerable to inaccessible or inadequately designed home, school and work environments, transportation systems and equipment. They frequently encounter unavailable or inadequate access to fitness options. At the same time they face serious health challenges that are greatly exacerbated by the prevalence of obesity. Obesity coupled with impaired mobility can easily lead to an increase in functional limitations and a decrease in the quality of life. For example, elevated obesity can result in the inability to use lower limb prosthesis, the need for a wider wheelchair that cannot pass through a standard doorway or greater difficulty in transferring to and from the wheelchair. In addition there is a limited understanding of energy metabolism and nutritional needs of persons with impaired mobility due to neurological conditions such as spinal cord injury. Obesity in persons with these types of disabilities is frequently associated with a more rapid onset of medical conditions such cardiovascular disease, dyslipidemia and diabetes. Research on the connections between the built environment and health has shown that the burden of illness has been greater on lower socioeconomic strata and minority/vulnerable populations (including persons who have impaired mobility and use assistive devices such as wheelchairs and lower limb prostheses). Understanding linkages between socioeconomic inequity and health is essential to reducing exposures to environmental hazards as well as disparities in health. Increased environmental pollutants have resulted in lifestyle changes especially with regard to diet and physical activity. For example, the increased pollution in Alaskan waters has led to some Native American communities substituting their traditional diets with more foods bought at the grocery stores. This also has had a negative impact on their traditional fishing and hunting activities. Lower socioeconomic status communities usually have limited access to quality housing stock and live in neighborhoods that do not facilitate outdoor activities and provide an uneven mix of healthy and unhealthy food outlet choices such as few supermarkets but many low-cost restaurants. Inequities in construction and maintenance of low income housing, especially for racial and ethnic minorities, older persons, and immigrants have resulted in insufficient housing, poor quality housing, overcrowding, and higher levels of population density and health problems. Also, studies have consistently shown an association between a deteriorated physical environment and higher rates of crime, making neighborhoods less safe for walking and in some cases resulting in greater social isolation. Most studies to date have solely focused their efforts in urban environment, while there are several unattended issues in the rural areas. While the connections between the built environment and health are more clearly delineated in urban areas, these issues are obscured in rural areas. For example, greater pesticide use in rural areas has resulted in people remaining indoors for longer periods of time and decreasing non-motorized travel. One of the consequences of motorized ways of living in rural areas has been decreased levels of physical activity and concomitant increases in obesity. Though the built environment is one of our most important habitats, current research in the area has focused mainly on the challenges of balanced transportation (e.g., roads, highways, infrastructure, public transportation), urban sprawl, air pollution due to increased traffic, and the diminishing natural environment. However, more concerted research is needed to identify mechanisms by which the built environment adversely and positively impacts health and to develop appropriate interventions to reduce or eliminate harmful health effects. Such research efforts are required because of the growing health burden and attendant economic costs associated with growing incidence of complex disease (e.g., cardiovascular disease, diabetes, cancer). While many of these complex diseases are attributable to an interaction of genetic, behavioral, and environmental influences over time, it may, at this point be more effective to modify the built environment to impact overweight, obesity and co-morbidities. Some recent research explores the effect of improved built environments or sustainable communities (where long-term benefits outweigh potential negative impacts) on physical activity, asthma, obesity, cardiovascular disease, lung cancer mortality, and mental health. The President’s Council on Sustainable Development in 1993 (Executive Order 12852) offered a working definition for sustainable communities as "healthy communities where natural and historic resources are preserved, jobs are available, sprawl is contained, neighborhoods are secure, education is life-long, transportation and health care are accessible, and all citizens have opportunities to improve the quality of their lives." While much research indicates the negative health impact of a poor built environment, there is very limited research on the health benefits of promoting sustainable communities to reduce overweight, obesity and related co-morbidities. The sparse research on sustainable communities suggests that diligent planning is needed to create an environment that is conducive to the mental and physical well being of humans as well as the natural environment. Most of the research in this area is based on cross-sectional studies, while studies that establish the associations between built environment and overweight, obesity and related co- morbidities that can used to develop concrete interventions are limited. Scope This RFA will support both R21 and R01 mechanisms. To understand the wide variety of issues relating to the built environment and obesity, studies that combine qualitative and quantitative methodologies are strongly encouraged. This combination of methodologies will allow for diverse perspectives to be incorporated in the studies. Studies can be conducted at the micro (individual/familial), meso (interpersonal and community), and macro (societal, policy) levels. Intervention projects must incorporate multilevel approaches. The Community Guide developed by the Community Preventive Services (Task Force), appointed by the Director of the Centers for Disease Control and Prevention (CDC) provides recommendations regarding population-based interventions for physical activity (see http://www.thecommunityguide.org/pa/default.htm). Intervention projects supported by this RFA must build upon and advance these recommendations and should not duplicate the Task Force efforts. For the purposes of this RFA to develop and include new and improved objective measures that link the built environment to biology wherever appropriate, such as endothelium dependent dilation, serum glucose, cholesterol, insulin, energy balance, oxidative stress, body composition, lipid profile. Few successful models exist for treatment and prevention of obesity. The Surgeon General’s Report on overweight and obesity (http://www.surgeongeneral.gov/topics/obesity/calltoaction/CalltoAction.pdf. ) indicates that environmental modifications offer the best opportunity for the treatment and prevention of obesity. Given this, multisite and multilevel environmental interventions including schools, worksites, communities and a variety of larger social settings would be appropriate. Single site based interventions have been shown to be effective in improving diet and physical activity levels of children for a short period of time through changes in school lunch and vending machine contents and levels of physical activity. Thus, the most effective strategy would be studies that address both energy intake and expenditure and combine different levels and settings. Across all settings, interventions submitted in response to this RFA may address food access and availability (e.g., at schools, worksites; ala carte foods, community restaurants, convenience stores, grocery stores), opportunities for physical activity (e.g., organized school, worksite, community activities; recreational facilities; enhancing physical activity in daily routines and lifestyles), and the policies that connect energy intake and expenditure to the built environment (e.g., land use planning; social marketing; financial incentives at multiple levels). So for the purposes of this RFA, multisite and multilevel proposals are encouraged. Evaluation is an essential component for all intervention studies and proposed studies should include both process and outcome measures. The latter could also include appropriate biological measures. While it is important that both quantitative and qualitative measures are included, wherever possible the adoption of objective measures is encouraged. The R21 mechanism (see http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html) is limited to two years of funding and is intended to encourage new exploratory/developmental research projects by providing support for the early stages of their development. For example, such pilot/exploratory projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area will not be considered for R21 awards. Applications submitted under the R21 mechanism should be exploratory and novel and may include development of new methods and measurements. Under these provisions these R21 proposals should evaluate the validity and reliability of the measures and when appropriate also ensure that they are linguistically and culturally relevant. Some areas of interest for R21 submissions include but are not limited to the following: o At the macro-level, the development and validation of reliable measures/indicators for assessing the means by which the built environment impacts food availability/access and physical activity to promote healthy behaviors and lifestyles and reduce obesity and related co-morbidities. o At the meso-level the development of measures of neighborhood characteristics that promote healthy lifestyles and mediate the effect of built environment on overweight, obesity and related co-morbidities. o At the micro-level, the development of valid and reliable measures for behaviors that moderate obesity such as physical activity, nutrient intake, etc. It is also important that these measures are linguistically and culturally validated. o Feasibility studies that identify and quantify built environment related risk factors and variables that mediate and moderate built environment health effects for public health interventions and outcomes to reduce overweight, obesity and related comorbidities. o Pilot studies that assess the impact of state, local and institutional policy changes in the built environment on overweight, obesity and related co-morbidities. These could be an evaluation of natural experiments such as comparing differently designed communities; examining before and after events (such as physical activity and driving levels before and after new transit system is opened and nutritional changes with the removal of unhealthy foods from schools or the opening/closing of a grocery in a community). o Studies to identify environmental and social conditions of people’s work and living choices that may influence physical activity and dietary intake. For example, do healthy people choose to live in healthy environments or do healthy environments differentially attract healthy people? o Evaluate the health impact assessment instrument as an appropriate and useful tool for local and state health officials to provide information to decision makers about the health consequences of proposed built environment projects and policies. o Studies, such as the above examples, that include or focus on obesity concerns and needs of persons who have impaired mobility and use assistive devices such as wheelchairs and lower limb prostheses. R01 applications have to be well-developed, known to be feasible and hypothesis driven based on preliminary data and may request a project period of up to five years. Some areas of interest for R01 submissions include, but are not limited to the following: o Assess the means by which the built environment and/or sustainable communities influences overweight, obesity and related co-morbidities. These studies should be multilevel and simultaneously account for individual, community, and systemic factors including biological, socioeconomic, neighborhood, and physical environment factors. These studies must be designed to establish concrete patterns of association among various factors so that they can be used in developing tangible interventions. o Intervention studies that implement and evaluate the efficacy of establishing environments that are supportive of both physically active and healthful dietary lifestyles to prevent or reduce overweight, obesity and related comorbidities. These interventions can include evidence-based strategies. Multilevel and multisite (e.g., school, home, work, community, state) interventions should be emphasized to have environmental changes. o Examine differences in response among vulnerable populations to the built environment changes designed to reduce obesity and related co- morbidities. o Assess how existing models enhance our ability to understand how and when a combination of environmental factors (such as use of sidewalks, accessibility to grocery stores and nutritious foods, green spaces, land zoning, media, etc.) affect overweight, obesity and related co- morbidities. o Identify and quantify risk factors that mediate and moderate built environment health effects for public health interventions and outcomes, e.g., nutrition and dietary intake, physical activity, genetic factors. These studies could also include individual level factors such as lifestyle choices and behaviors as well as both energy intake and expenditure that can prevent or reduce obesity. o Intervention studies that examine the role of the social environment (including but not limited to, social capital, challenges of living in isolated communities) in connection with the physical/chemical environment in determining access to nutritional foods and also improving physical activity to reduce morbidity. o Studies that assess the impact of state, local and institutional policy changes in the built environment on overweight, obesity and related co-morbidities. These could be an evaluation of natural experiments such as comparing differently designed communities; examining before and after events (such as physical activity and driving levels before and after new transit system is opened and nutritional changes with the removal of unhealthy foods from schools or the opening/closing of a grocery in a community). MECHANISM OF SUPPORT This RFA will use the NIH research project grant (R01) and the exploratory/developmental research 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 June 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. This RFA 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. If you are submitting a R21 application, use the modular budget format. 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 participating institutes intend to commit approximately $5M in FY 2005 to fund 10 to 12 new grants in response to this RFA. An applicant using the R01 mechanism may request a project period of up to five years and a budget for direct costs of up to $400,000 per year, excluding Fiscal and Administrative costs (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html). R21 applications 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, requests can be $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. R21 applications must adhere to the page and budgetary limitations described in the trans-NIH R21 program announcement (PA-03-107) available at: http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html. Although the financial plans of the participating institutes 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(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 Although a single institution or organization must be the applicant, a multi-institutional arrangement (consortium) is possible. Such consortia, entailing active participation by more than one organization, are encouraged if there is clear evidence of close interaction and responsible partnership among the participants. 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. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS This RFA requires interdisciplinary partnerships: These teams must consist, at a minimum, of a scientist with expertise in health research (e.g., an epidemiologist, behavioral or social scientist), a clinical specialist (e.g., a nutritionist, pediatrician, cardiovascular specialist, healthcare provider, occupational therapist, nurse) and an expert on planning, design, or transportation (e.g., representative of a local or state planning, transportation agency, zoning departments). Other scientists and experts (e.g., in economics, health policy, community health, housing, education, recreation, psychology, universal design) as well as those with scientific expertise in diseases and conditions that are co-morbidities of obesity should be considered to complement, but will not substitute for, those mentioned above. Partnerships with state and local health departments working in the area of obesity, prevention and control through promotion of improved physical activity and nutrition may also be considered. These personnel must be listed on Page 2 of the PHS 398 application, and a biographical sketch must be provided for each. The role of each member of the team in carrying out the project should be well described. The inclusion of one or more subcontract arrangements may be helpful in defining all parties' programmatic and budgetary roles. Applications without these required personnel will be returned without review. To encourage applicants to share information gained via these grants, the research teams as stated above, i.e., the scientist with expertise in health research, the clinical specialist and the expert on planning, design, or transportation, for each project will be asked to attend at least annual meetings over the course of the grant in the Research Triangle Park, North Carolina area. R21 applicants and their collaborators will be required to attend a maximum of two meetings and R01 applicants and collaborators will be required to attend at least four meetings over the entire granting period. Applicants should include such travel in their budget requests. The NIEHS may provide supplemental funds for logistical arrangement for the meeting. This meeting will convene all the grantees and will serve to inform other grantees and the research community of the progress to- date. NIEHS may provide supplemental funds to the selected host institution, after the receipt of an appropriate application and review by Program Staff. Applicants are still expected to provide travel for the required personnel on each project in their grant budget. 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: Shobha Srinivasan, Ph.D. Scientific Program Administrator Susceptibility and Population Health Branch National Institute of Environmental Health Sciences (NIEHS) P.O. Box 12233, MD EC-21 111 T.W. Alexander Drive Research Triangle Park, NC 27709 Telephone: (919) 541-2506 Fax: (919) 316-4606 Email: [email protected] Deborah H. Olster, Ph.D. Senior Advisor Office of Behavioral and Social Sciences Research (OBSSR) National Institutes of Health (NIH) Bldg. 1, Room 256 One Center Drive Bethesda, MD 20892-0183 Telephone: (301) 451-4286 Fax: (301) 402-1150 Email: [email protected] Harold W. (Bill) Kohl, III, Ph.D. Lead Epidemiologist/Team Leader Centers for Disease Control and Prevention (CDC) Physical Activity and Health Branch National Center for Chronic Disease Prevention and Health Promotion Division of Nutrition and Physical Activity 4770 Buford Highway, NE, MS K-46 Atlanta, Georgia 30341-3717 Telephone: (770)488-5481 Fax: (770) 488-5473 Email: [email protected] Dr. Andrew Dannenberg Centers for Disease Control and Prevention (CDC) Division of Emergency Environmental Health Services National Center for Environmental Health 4770 Buford Highway, NE, MS F-30 Atlanta, Georgia 30341 Telephone: (770) 488-7108 Email: [email protected] Gilman D. Grave, M.D. Chief, Endocrinology, Nutrition and Growth Branch Center for Research for Mothers and Children National Institute of Child Health and Human Development (NICHD) 6100 Executive Boulevard; Suite 4B-11 Bethesda, MD 20892-7510 Telephone: 301-496-5593 Fax: 301-480-9791 E-mail: [email protected] Louise C. Masse, Ph.D. Health Promotion Research Branch Behavioral Research Program Division of Cancer Control and Population Sciences National Cancer Institute (NCI) 6130 Executive Blvd., MSC 7335 Executive Plaza North, Room 4076 Bethesda, MD 20892-7335 Telephone: (301) 435-3961 Fax:(301) 480-2087 Email: [email protected] o Direct your questions about peer review issues to: Leroy Worth, Jr., Ph.D. Scientific Review Administrator National Institute of Environmental Health Sciences (NIEHS) P.O. Box 12233, MD EC-30 111 T.W. Alexander Drive Research Triangle Park, NC 27709 Telephone: (919) 541-0670 Fax: (919) 541-2503 Email: [email protected] o Direct your questions about financial or grants management matters to: Ms. Pam Evans Grants Management Specialist National Institute of Environmental Health Sciences (NIEHS) P.O. Box 12233, MD EC-22 111 T.W. Alexander Drive Research Triangle Park, NC 27709 Telephone: (919) 541-7269 Fax: (919) 541-2860 Email: [email protected] Sharron P. Orum Grants Management/Contracting Officer Centers for Disease Control & Prevention (CDC) Procurement & Grants Office, AABB 2920 Brandywine Road Atlanta, Georgia 30341 Telephone: (770) 488-2716 Fax: (770) 488-2777 Email: [email protected] Angelos Bacas Grants Management Branch National Institute of Child Health and Human Development (NICHD) 6100 Executive Blvd., 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-7010 Fax: (301) 402-7827 E-mail: [email protected] Crystal Wolfrey Team Leader, DCCPS Team Grants Administration Branch National Cancer Institute (NCI) 6120 Executive Blvd., Suite 243 Bethesda, MD 20892 (for regular mail) Rockville, MD 20852 (for hand delivered mail) Telephone: (301) 496-8634 Fax: (301) 496-8601 Email: [email protected] 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 IC 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: Leroy Worth, Jr., Ph.D. Scientific Review Administrator Division of Extramural Research and Training National Institute of Environmental Health Sciences (NIEHS) P.O. Box 12233, MD EC-30 111 T.W. Alexander Drive Research Triangle Park, NC 27709 Telephone: (919) 541-0670 Fax: (919) 541-2503 Email: [email protected] 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: [email protected]. 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/labels.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: Leroy Worth, Jr., Ph.D. Scientific Review Administrator Division of Extramural Research and Training National Institute of Environmental Health Sciences (NIEHS) P.O. Box 12233, MD EC-30 79 T.W. Alexander Drive, 4401 Building, 3rd Floor (courier/express) Research Triangle Park, NC 27709 Telephone: (919) 541-0670 Fax: (919) 541-2503 Email: [email protected] 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 8 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 NIH and CDC. Incomplete and/or nonresponsive applications will not be reviewed. 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 NIEHS 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 the National Advisory Environmental Health Sciences 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 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 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). 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. 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 EVALUATION: Plans for evaluation of factors contributing to the effectiveness of interventions should be included. These should include both process and outcome measures. The latter could also include appropriate biological measures. While it is important that both quantitative and qualitative measures are included, wherever possible the adoption of objective measures is encouraged. Applications proposing intervention studies should include an evaluation component. 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: November 17, 2004 Application Receipt Date: December 17, 2004 Peer Review Date: February 2005 Council Review: May 2005 Earliest Anticipated Start Date: July 2005 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities REQUIRED FEDERAL CITATIONS ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable. 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 SHARING RESEARCH DATA: 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 or 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.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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