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Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov)
National Cancer Institute (NCI) (http://www.nci.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov)
Office of Behavioral and Social Sciences Research (OBSSR) (http://obssr.od.nih.gov)

Title: Translating Basic Behavioral and Social Science Discoveries into Interventions to Reduce Obesity: Centers for Behavioral Intervention Development (U01)

Announcement Type
New

Update: The following update relating to this announcement has been issued:

Request For Applications (RFA) Number: RFA-HL-08-013

Catalog of Federal Domestic Assistance Number(s)
93.837

Key Dates
Release Date: September 9, 2008
Letters of Intent Receipt Date: December 16, 2008
Application Receipt Date: January 13, 2009
Peer Review Date(s): June/July 2009
Council Review Date: August 2009
Earliest Anticipated Start Date: September 30, 2009
Additional Information To Be Available Date (URL Activation Date): N/A
Expiration Date: January 14, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

This FOA solicits cooperative agreement (U01) applications from institutions/organizations that propose to translate findings from basic research on human behavior into more effective clinical, community, and population interventions to reduce obesity and improve obesity-related behaviors. This FOA will support Centers for Behavioral Intervention Development (CBIDs) in which interdisciplinary teams of basic and applied behavioral and social science researchers develop and refine novel interventions to reduce obesity and alter obesity-related health behaviors (e.g., diet, physical activity).

The interventions to be developed include any of a wide range of strategies aimed at promoting weight loss and/or preventing weight gain. Interventions can be targeted to the individual, family, social network, community, environmental, clinical or population level, or combinations of these, and to any age group. Investigators at each CBID will conduct several types of studies during the funding period, including laboratory experimental studies, formative research, early phase trials and pilot/feasibility studies, in order to create promising new avenues for reducing obesity and improving obesity-related behaviors. Because the emphasis is on accelerating the translation of discoveries in basic biological, behavioral and social science research to facilitate the prevention and treatment of obesity, this FOA seeks to fund research aimed at developing, characterizing and refining new, innovative obesity-reducing strategies rather than evaluating the effectiveness of already well-defined or proven strategies. At the end of the period of support, the strategies that have been developed should be well characterized and demonstrated to be safe, feasible to implement, effective in small-scale trials, acceptable to the target populations of interest, and ready to be tested in large-scale randomized clinical and community trials.

Background

Behaviors such as smoking, sedentary lifestyles, unhealthy diets, and poor adherence to medical and behavioral treatments are major contributors to cardiovascular disease, cancer, type 2 diabetes and other chronic conditions. The most sophisticated advances in prevention and treatment are dependent on individual behaviors. For example, individuals must recognize, correctly interpret and act on symptoms of heart disease to be treated, and patients must participate in all aspects of care in order to derive its benefits. In particular, the rapid rise in obesity over the past several decades threatens to reverse recent gains in life expectancy. Adopting and maintaining healthful dietary habits and a physically active lifestyle remain fundamental to preventing and treating obesity.

Randomized controlled trials such as the Trials of Hypertension Prevention, Weight Loss Maintenance, PREMIER, the Women’s Health Initiative dietary trial, and the Diabetes Prevention Program have shown that behavioral interventions can improve dietary patterns and physical activity levels, reduce body weight, lower blood pressure, reduce LDL levels, and prevent the onset of diabetes. However, even the most successful behavior change interventions are limited in their ability to induce long-term behavioral changes in most people. Often change occurs only for the highly motivated and is limited to a single health behavior rather than multiple behaviors. Only 3 percent of the U.S. adult population have adopted all of the multiple behavioral components (nonsmoking, healthy weight, achieving recommended diet and physical activity goals) that characterize a heart-healthy lifestyle and that are associated with low rates of cardiovascular events. Even individuals committed to making behavioral changes find it hard to maintain a healthy lifestyle over time. Most weight loss studies show that after six months, participants begin to gain back lost weight, with most people regaining all of the weight lost by five years.

As with development of more effective drugs, surgical techniques and medical devices, the development of better behavioral interventions for preventing and treating obesity depends on improving our understanding of human behavior, and then translating that knowledge into interventions. This FOA seeks to promote an intervention development process for the behavioral and social sciences that are analogous to Type I translation in the biomedical sciences with the ultimate goal of achieving greater effectiveness for obesity-related behavior change strategies.

Translational research is the process of applying ideas, insights, and discoveries generated through basic scientific inquiry to the treatment or prevention of human disease . Translational research consists of two stages: Translation I (T1), in which basic science discoveries are used to develop new treatments for disease ( bench to bedside ); and Translation II (T2), which is aimed at improving utilization of proven therapies in clinical practice and community settings ( bedside to public health ).

Translation I research (treatment development) includes the conduct of small human trials or series (Phase I & II clinical trials) in which data on the safety of the drug and the dosages needed to obtain effects on biomarkers of the disease being studied are collected. In Phase I safety studies, the purpose is to gather information on which dosages are well tolerated by patients with minimal toxicity; in Phase II studies, the goal is to test for and characterize effects of the treatment, for example, to determine the amounts of treatment needed to produce biologic responses, such as reduction in the size of a tumor or lesion. If the treatment is found to be safe and effective in these early phase studies, large-scale randomized clinical trials or RCTs (Phase III studies) are then conducted to test the effects of the treatments developed on health outcomes such as blood pressure, lipid levels, morbidity or mortality. Often, prior to instituting a full-scale RCT, a pilot or feasibility study is conducted in the population and setting of interest in order to assess feasibility and acceptance of the approach used, refine intervention and measurement procedures, gain experience in and information concerning screening, recruitment and retention of the target population (e.g., estimates of yield, pre-testing of screening/recruitment procedures), and determine estimates of variability and levels of response in the target population.

The translation process is most often thought of in the context of biomedical research but it can also be applied to the development of behavioral treatments or interventions. For example, one can think about Translation I or intervention development research in the behavioral and social sciences as a phased approach aimed at determining the safety profile of a treatment, the dosages required (i.e., intensity, frequency, duration of intervention) to effect change in the intermediate outcomes of interest that are related to the health condition under study, whether and how a treatment works in specific patient groups under well-specified conditions, and the feasibility and acceptance of the intervention in the target population, culminating in Phase III trials that test the intervention in a large-enough sample of patients to determine its effects on health outcomes.

Basic behavioral and social science research is concerned with uncovering the fundamental principles & processes which govern how human beings perceive the environment, process information, make decisions, experience, express and regulate emotion, form and change attitudes, beliefs and values, and become and remain motivated to change behavior. As defined by the NIH’s Office of Behavioral and Social Sciences Research (OBSSR), basic behavioral and social science research can involve research at the individual, small group, institution, organization, and community or population level. At the individual level, this research may involve the study of behavioral factors such as cognition, memory, language, perception, personality, emotion, motivation, and others. At higher levels of aggregation, it includes the study of social variables such as the structure and dynamics of small groups (e.g., couples, families, work groups, etc.); institutions and organizations (e.g., schools, religious organizations, etc.); communities (defined by geography or common interest); and larger environmental, demographic, political, economic, and cultural systems.

Basic behavioral and social science research may also involve biopsychosocial or biobehavioral research, which concerns the study of the interactions of biological factors with behavioral or social variables and how they affect each other (i.e., the study of bi-directional multilevel relationships). Additional details and examples of basic behavioral and social science research can be found on the OBSSR website at http://obssr.od.nih.gov/Content/About_OBSSR/BSSR_Definition/.

Significant advances in basic behavioral and social science research are contributing to a more sophisticated understanding of the fundamental biological, cognitive, emotional, and social underpinnings of human behavior. Recent discoveries in fields such as cognitive and affective neuroscience, communication science and social marketing, decision-making, food choice and the formation of habits, the psychophysiology of stress and eating behavior, behavioral economics, and the nature and impact of social networks, coupled with the development of more sophisticated tools for understanding psychosocial determinants and physiologic concomitants of human behavior (e.g., brain imaging, systems dynamics theories, geospatial methods), are yielding new and important insights about human cognition, affect, motivation and behavior. These findings suggest promising new directions for developing interventions to reduce obesity and promote the public health.

For example, animal and human studies have shown that stress increases the salience and ingestion of highly palatable foods, and in combination with a high-calorie diet, triggers signaling pathways that promote abdominal fat deposits. The prefrontal cortex has been implicated in the cognitive control of food intake and activity levels, possibly through influences on decision-making, perceptions of body image, and motor planning and execution. Recent research suggests that many of the neural and hormonal influences on obesity-related behaviors may be modified by genetic makeup. For example, studies have shown that without leptin, even unpalatable foods can become desired in the satiated state, and that genetics influence taste variation, which may have a large impact on food selection behavior. In addition, there are genetic influences on ad lib running behavior in animal models and on non-exercise energy expenditure, as well as candidate genes for sedentariness. Clearly, research concerning neural, hormonal and genetic influences on obesity has relevance for the design of weight control interventions, yet little research is being done to channel these findings into weight loss programs.

Advances have also been made in understanding the influences of social, economic, geographic and environmental factors on physical activity and diet. For example, research has suggested that social networks may play a role in promoting obesity. Data from the Framingham Heart Study revealed a strong propensity for the spread of obesity within social groups. This finding suggests the intriguing possibility that social networks, which can promote unhealthy, obesigenic behaviors, might also be used to promote healthy lifestyles. Studies using GIS and census data have also demonstrated that features of the built environment (access to recreational facilities or grocery stores that stock healthy and affordable food options) interact in complex ways with other factors (ethnicity, socioeconomic status) to influence obesity. Can these findings, together with data from disciplines that seek to better understand the interaction of individuals and their environments (e.g., environmental cognition, human ecology, urban planning, and human factors/ergonomics) be used to build obesity-reducing as opposed to obesity-promoting environments?

The potential for translational behavioral science research is well illustrated by breakthroughs in related fields, such as mental health and drug and alcohol abuse. A striking example is the discovery of the synergistic effects of an antibiotic, D-cycloserine (DCS), originally developed to treat tuberculosis, and cognitive behavior therapy (CBT) for treating anxiety disorders. Animal studies had shown that DCS is an agonist of the glutamatergic N-methyl-D-aspartate (NMDA) receptor that operates at the level of the amygdala and prefrontal cortex to mediate learning, memory and the extinction of conditioned fear responses. Other animal and human studies showed that DCS promotes the extinction of fear when administered prior to fear exposure. Based on these findings, randomized clinical trials demonstrated that DCS, when administered with CBT but not alone, greatly increased success rates for treating anxiety disorders. The breakthrough established a new paradigm for treating other anxiety and fear-based conditions, such as post-traumatic stress disorder.

This new approach to treatment would not have been possible without basic behavioral research in learning, memory, extinction and the emotions, and its integration with behavioral neuroscience, and illustrates the advances that can be made when basic science findings are used to generate innovative approaches to treating challenging behavioral problems, such as obesity. This FOA seeks to fund systematic collaborations between basic and applied biological, behavioral and social scientists from diverse disciplines and in doing so, to encourage the kind of high-risk, potentially high-impact research needed to develop innovative new strategies for reducing obesity and improving obesity-related behaviors.

Objectives and Scope

The purpose of this FOA is to fund up to eight Centers for Behavioral Intervention Development (CBID). Each CBID will support interdisciplinary project teams that include basic and applied biological, clinical, behavioral and social scientists who will adapt findings from basic behavioral and social science research to develop behavioral interventions aimed at improving obesity-related behaviors. The interventions to be developed will be based on basic behavioral and social science research findings from studies of individuals (e.g., studies of cognition, memory, language, perception, attitude formation and change, emotion regulation, motivation); social groups (e.g., research on the structure and dynamics of small groups such as couples and families, or social networks); institutions and organizations (e.g., worksites, schools, health care systems); and/or demographic, economic, environmental and cultural systems that have a significant role in obesity-related behaviors of interest. The proposed interventions may target any one or more of these levels (i.e., individuals, social groups, institutions/ organizations, environments or systems), and any age group. Populations of interest include healthy individuals, those at high risk for a particular disease or condition, and those with an existing disease (e.g., cardiovascular disease, cancer or diabetes).

Behavioral targets of the interventions being developed may be any one or more of the behaviors thought to be important for the treatment or prevention of obesity, including, but not limited to, energy intake, physical activity, sedentary lifestyle, and adherence to specific behavioral strategies used in weight control programs (e.g., self-monitoring of eating and physical activity levels). Broader social, organizational or systems level interventions that involve changing aspects of the social environment (behavior of individuals within social networks), cultural environment (norms or values of worksites or schools) and/or physical environments (features of neighborhoods) may use aggregate measures of behavior as outcomes (e.g., use of walking and bike paths, purchases of fruits and vegetables or other healthy foods).

The behavioral target(s) of the intervention should be well-specified and precisely defined. For example, the distinction between sedentariness and physically active lifestyle is important as these two behaviors may not represent opposite points along the same continuum, and both are known to contribute to obesity. This type of distinction has important implications for how basic behavioral research is used to inform translational efforts, since basic research may inform intervention development in different ways depending upon whether the target of the intervention is promoting physical activity versus preventing or reducing sedentary behavior (e.g., strategies that involve motivation, affective response, reinforcement and incentivizing behavior may be structured differently when the goal is to reduce sedentary behavior rather than to promote physical activity). Similarly, different intervention strategies may be more effective when the behavioral target involves initial adoption of a dietary or physical activity behavior than when the goal is maintenance of the behavior over time.

Depending on the types of interventions being developed, it is expected that CBIDs will need to conduct several types of studies to translate basic science findings into behavioral interventions, including: (1) experimental studies of behavioral, cognitive and/or emotional responses to stimuli aimed at characterizing the behavioral responses that will form the basis of an intervention; (2) formative research to determine attitudes and preferences with regard to specific intervention approaches and intervention components; (3) proof of concept and small-scale safety/efficacy studies (early phase trials) that translate the concepts and findings from previous basic science research into specific, novel interventions, demonstrate safety, and characterize the interventions and their effects in controlled settings; and (4) pilot/feasibility studies to test and refine intervention procedures to be used in the specific populations of interest and to determine the acceptability and feasibility of interventions in clinical and community settings.

Applicants may propose the use of innovative study designs for building and optimizing behavioral and systems interventions, for example (1) adaptive treatment designs that customize an intervention strategy to the individual, evaluate for whom a treatment should be employed, or when it should change over time in order to maximize its effects; or (2) systems science approaches that determine how, when and with whom to intervene in a social group, family, health care setting, neighborhood, community, or other system.

Selected Research Examples

The following are intended only as conceptual examples of the types of topics and approaches relevant to the proposed FOA, and should not be regarded as a call to pursue any specific line of investigation:

The emphasis in these CBIDs is on development of behaviorally-based interventions to reduce obesity and improve obesity-related behaviors; however, interventions that incorporate the use of biological agents (drugs, devices) are allowed, as long as the biological features of the intervention being developed occur in the context of or in combination with a behavioral strategy, and not as stand-alone interventions.

Plan for Intervention Development

Projects submitted must include an overall plan for intervention development, which will include a timeline or flow chart showing types, sequence, and duration of each study and the milestones to be achieved for each study within the Intervention Development plan. The plan will describe the particular problem or focus of study concerning obesity prevention or treatment for which their intervention will be developed; provide a detailed description of the basic biological, behavioral and/or social science research findings being used to inform intervention development and (where relevant), the theoretical model that will be applied to development of the intervention; describe key features of the intervention to be developed, phases of the intervention development process and specific studies to be conducted in developing the intervention; outline the goals and objectives of the intervention, describe the population and behaviors that are targets of the intervention, the hypotheses to be tested, the specific outcomes to be assessed and the criteria or milestones to be achieved in determining progress and/or intervention success at each stage of the intervention development process.

Stages of Intervention Development. The following presents the stages of research and the types of studies within each stage that should be included as part of the applicant’s intervention development proposal; for each stage, the approximate expected duration of the stage is given:

(1) Defining the Intervention (6 months 1 year)

During this stage, applicants may conduct foundational studies to refine understanding of the basic biological, behavioral or social science research finding(s) or concepts being used in relation to the particular intervention (e.g., dietary or physical activity behaviors) and/or population of interest. These experimental, observational and/or formative studies must be related to the development of the proposed intervention(s), (e.g., to elucidate the behaviors being targeted for intervention, the characteristics of individuals for whom the intervention is being developed, and/or the psychophysiologic processes involved in the intervention process being studied).

The types of studies to be proposed for this stage include:

In addition to the above types of studies, secondary analyses of existing data (qualitative or quantitative) may be used as an additional (but not the sole) source of information to aid in defining the intervention and to guide later stages of the intervention development process.

(2) Characterizing the Intervention’s Effects (2 3 years)

This stage consists of safety, proof of concept and small-scale efficacy studies that translate the concepts and findings from previous basic science research into specific, novel interventions in the areas of dietary behavior and physical activity. In this stage, applicants should propose any one or more of the following types of studies which are aimed at developing, refining and characterizing the intervention:

1. Phase I studies to determine the safety of the intervention or intervention components, and Phase II research that investigates: effects of the intervention on the outcomes of interest; effects of individual components of an intervention versus combinations; effects of varying an intervention’s content, timing, mode of delivery, duration and frequency of contact; and dose-response relationships (effects of varying the intensity of an intervention or its components on outcomes of interest).

2. Studies using adaptive designs and pre-specified decision rules based on participant characteristics and responses to treatment to customize the intervention strategy to the individual, evaluate for whom a treatment should be employed, or when it should change over time in order to maximize its effects.

3. Studies using modeling techniques and systems science approaches (e.g., network analyses and systems dynamics approaches) to develop interventions and suggest how, when and where they should be targeted within a social group, family, health care or other system to achieve maximum benefit.

(3) Assessing Feasibility and Refining the Intervention (1 - 2 years)

In this stage, applicants will conduct pilot/feasibility studies to ensure the intervention procedures can be performed in the specific populations and settings of interest, to refine the intervention, and to gather data in preparation for future RCTs of the intervention. These studies may use combinations of qualitative (focus groups, ethnographic interviews) and quantitative (small-scale pilot studies) methods to determine the acceptability and feasibility of the intervention within the populations and setting(s) of interest, and to evaluate the effects of tailoring interventions to subpopulations of interest.

These studies may also be used to refine intervention and measurement procedures, gain experience in and information concerning screening, recruitment and retention of the target population (e.g., estimates of yield, pre-testing of screening/recruitment procedures), determine estimates of variability and levels of response in the target population, obtain preliminary information about sustainability and cost-effectiveness of the intervention, and engage community residents and leadership in preparation for future large-scale randomized trials of the intervention.

Timeline, Goals and Milestones. The intervention development plan should be based on a clearly stated project timeline that includes practical, achievable goals, and project milestones. Milestones toward intervention development are goals that create go/no-go decision points in the project, including quantitative success criteria. Applications should include a linear timeline or flowchart of project tasks and milestones, including the stages and types, sequence and expected duration of studies to be performed, and the milestones/criteria needed to proceed to the next stage.

It is understood that during the intervention development process, some deviation from this timeline may occur based on study results; for example, findings at one stage may require a return to an earlier stage to further refine an intervention or its conceptual basis. In addition, although studies are expected to be conducted in sequential fashion, some projects may be performed concurrently, as when multiple components of an intervention are being developed simultaneously, or tools and materials relevant to several aspects of an intervention are being evaluated in separate, concurrent studies. Applicants should propose their best estimate of the sequence of studies, timeline and milestones needed to develop the proposed intervention.

Applicants should also provide preliminary evidence of their ability to recruit participants, to provide appropriate oversight of participants, and to maintain high rates of participant follow-up throughout the intervention development process. Studies should incorporate quality control procedures for measurements, data collection, and data management, as well as for assuring fidelity to intervention delivery.

Protocol and manual of procedures development. At the beginning of the intervention development process, Investigators will be expected to develop, and then to refine during subsequent stages, an intervention protocol and an intervention procedures manual. These documents will include a detailed description of the rationale, theoretical basis and basic science findings guiding development of the intervention; a set of proposed procedures to be developed, evaluated and finalized during subsequent stages; description of the development or adaptation of relevant measures including diagnostic, screening and outcome assessment tools; and description of quality control procedures and measures to be used to ensure and assess intervention fidelity, including intervention delivery and adherence to the protocol. Components of the intervention to be developed should be in operation in the manual of procedures in as much detail as appropriate commensurate with its present state of development. These documents (protocol and manual of procedures) are to be finalized at the end of the intervention development period.

Facilities and Environment

All applicants must provide evidence that the institution or institutions in which the research will take place have the infrastructure, resources and institutional support needed to facilitate interdisciplinary, collaborative research across basic and applied research boundaries. Applicants must demonstrate the availability of adequate laboratory, clinical, office and other facilities needed to carry out the objectives of the proposed Centers for Behavioral Intervention Development program. To the extent possible it is desirable for CBIDs to have a commitment for sufficient contiguous space so that the Center has a high degree of cohesion and visibility. Internet access to scientific literature and other information must be readily available. Relevant support services, including for example adequate data processing facilities, must also be readily accessible and documented in the proposal.

Successful applicants will provide evidence that the research teams assembled as part of the CBID span at least three separate disciplines in areas relevant to the topic of investigation, including the social and behavioral sciences (e.g., psychology, sociology, anthropology), medical fields of study (e.g., neurosciences, metabolic biology, behavioral genomics, cardiovascular medicine, pharmacology, nutrition science), and related fields such as economics, business (marketing), health policy, environmental redesign, urban planning, engineering, informatics, communication sciences, humanities, exercise sciences, and other disciplines.

Applicants must show they have access to communities (e.g., individuals, families, schools, neighborhoods) and/or clinical care settings (primary care and specialty clinics) in which the interventions will ultimately be used. Applicants should outline the community and clinical engagement activities to be conducted to ensure that the proposed obesity-related intervention(s) can be developed with community involvement and evaluated for acceptability and feasibility within non-academic (i.e., community and clinical practice) settings.

Applicants from institutions housing transdisciplinary, translational programs (such as Clinical and Translational Science Awards [CTSAs], NIH Roadmap Interdisciplinary Research Center Awards, Individual IC Transdisciplinary Centers and similar programs) are encouraged to apply, although applicants need not be from these programs and institutions to be successful.

The NHLBI Clinical Research Guide at http://www.nhlbi.nih.gov/crg/index.php provides helpful information for preparation of clinical study applications.

Areas of research that will not be considered responsive to the FOA include:

Program Organization and Coordination

The studies supported by this FOA will not use a common study protocol. However, after awards are made, investigators may wish to collaborate on developing and reporting standardized measures of key common variables, such as height, weight, dietary intake, physical activity, smoking status, and population characteristics. Investigators may also collaborate in the development of formative assessment measures, such as interview or survey instruments and focus group guidelines. The use of common study variables, criteria, and protocols to facilitate meta-analysis of the studies when possible is highly encouraged.

Investigators should indicate in their application their willingness to collaborate on the development and use of standardized measurement protocols, where applicable, identification of eligibility criteria, formative assessment methods, data analysis, and their willingness to collaborate with NHLBI and NIH scientists in all aspects of the study. The cooperative agreement mechanism will be used and a Steering Committee formed to facilitate collaboration (see Section VI.2.A, Cooperative Agreement Terms and Condition of Award.)

Each awardee is responsible for refining and finalizing his/her protocols and for conducting the research. Awardees should oversee implementation of the development of their interventions and adherence to their protocols, and assure appropriate quality control procedures are in place. Each awardee will be responsible for training and certification of his/her personnel.

The NHLBI will be substantially involved with the awardees in a partnership. The NHLBI Program Scientist will monitor patient recruitment and study progress, ensure disclosure of conflicts of interest, and assure adherence to NHLBI policies. NHLBI will appoint a Data and Safety Monitoring Board (DSMB) and appoint a chairperson of the Steering Committee among Principal Investigators.

A Steering Committee will be an important body for this project. The Steering Committee is composed of the Principal Investigators of the CBID and the NHLBI Program Scientist, each of whom will have one vote. The Steering Committee will meet in-person three times a year through the project. The Committee will meet by teleconference on at least a monthly basis.

A DSMB will be established to monitor data and oversee participant safety in all of the studies supported by this initiative. At the first meeting, the DSMB will review the awardees protocols. Subsequently, the DSMB will monitor and review recruitment, adverse events, data quality, outcome data, and overall awardee performance. It has the responsibility to review interim data and final data, and recommend whether protocols should be modified, and whether studies should be continued or should be terminated early. Thus, its ethical responsibilities to the participants, as well as to the integrity of the study, are of paramount importance to the NHLBI. The DSMB will meet at least twice each a year, and more frequently if needed. At least one of the meetings each year will be in person.

A DSMB will be responsible for monitoring the funded projects and will report to the Director of the NHLBI. Therefore, applicants should not appoint DSMB members in advance of the peer review, or even inquire about the interest of possible DSMB members, because anyone so contacted would not be eligible to serve as a member of the peer review committee that will evaluate the applications for scientific merit.

In addition to the DSMB meetings, each awardee will be required to attend Steering Committee meetings in which study plans, findings, and issues of common interests and concerns will be shared and discussed. Each applicant must include in his/her budgets funds for attending these meetings. For budgeting purposes, the applicants should assume that in addition to DSMB meetings, in-person meetings will be convened three times during the first funding year and twice a year for each funding year thereafter. Applicants should assume for budgeting purposes that the meetings will be for two days in the Washington, DC, metro area and will require the attendance of the Principal Investigator and one other person.

Research and Coordination Unit

To facilitate coordination of research activities between awardees, this FOA will also support the costs of a Resource and Coordination Unit (RCU) by one of the awardees for this FOA. In consultation with the awardees and NIH, the RCU will be responsible for conducting a number of tasks, including the following:

Applicants are strongly encouraged to apply for both the research and RCU components of this FOA. Applicants wishing to do so should propose to perform the resource and coordination functions in addition to conducting their own study. Applicants proposing to perform the resource and coordinating unit function should describe how these activities will be performed in a separate section of the application that addresses the critical elements for these functions specified in this FOA. Up to five additional pages will be allowed to describe these functions. Applicants should submit a separate budget for the RCU, including the cost of meeting rooms and equipment for in-person meetings. The budget and budget narrative should include the direct and facility and administrative (F&A) costs for the RCU component not to exceed the funding levels provided in Section II.2.

Please Note: The evaluation of the RCU will be separate from the overall review of the scientific merit of the application (see Section IV. 2.B).

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award."

At this time, it is not known if this FOA will be reissued.

2. Funds Available

The NHLBI intends to commit up to $5 million in total costs in FY09 to fund four to six applications in response to this FOA; NCI intends to commit up to $1 million in total costs in FY09 to fund one application; NIDDK intends to commit up to $750,000 in total costs in FY09 or FY10 to fund one application; and OBSSR intends to commit up to $200,000 in total costs in FY09 to co-fund one application. Each applicant may request a project period of five years and a budget for direct costs of up to $3,750,000 over the five-year period, with a limit of $750,000 in direct cost for any single year. One of the awards will serve additionally as a Resource and Coordination Unit (RCU) to facilitate cross-study activities. It is anticipated that the maximum award for the RCU will be approximately $1,000,000 in direct costs over five years. The RCU costs are in addition to the intervention development costs. Applicants are strongly encouraged to apply for both the research and RCU components of this FOA. A total of up to $25 million in total costs is available from NHLBI over the five-year period for the program, up to $5 million in total costs is available from NCI, up to $3,750,000 in total costs is available from NIDDK , and up to $1 million in total costs is available from OBSSR.

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 IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI 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.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Due to the unique requirements of this FOA, applicants are strongly encouraged to consult with NHLBI Program Staff as plans for an application are being developed. This early contact will provide an opportunity to clarify the applicant's understanding of program goals and guidelines, including the scope of projects within the program and program requirements.

Any collaborators, consultants, or subcontractors should be identified no matter when during the conduct of the activity the proposed interaction occurs. Since translational research is intrinsically interdisciplinary, this plan will often involve cooperation among basic and applied researchers as well as clinicians, and may include the participation of private-sector companies and voluntary organizations.

Applicants are not permitted to submit a resubmission application in response to this FOA.

Renewal applications are not permitted in response to this FOA.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a 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.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form, and the YES box must be checked.

Foreign Organizations (Non-domestic [non-U.S.] Entity)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Applications from foreign organizations must:

In addition, for applications from foreign organizations:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

Applications with Multiple PDs/PIs

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a 3h for all PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: December 16, 2008
Application Receipt Date: January 13, 2009
Peer Review Date(s): June/July 2009
Council Review Date: August 2009
Earliest Anticipated Start Date: September 30, 2009

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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 in Section IV.3.A.

The letter of intent should be sent to:

Chief, Review Branch
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: 301-435-0270
FAX: 301-480-0730
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. 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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Chief, Review Branch
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: 301-435-0270
FAX: 301-480-0730
Email: [email protected]

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity 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 a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity 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.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: (1) are necessary to conduct the project, and (2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see the NIH Grants Policy Statement).

6. Other Submission Requirements and Information

Applications must include the following:

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information."

Research Plan Page Limitations

N/A

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. (See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not comply with the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief one-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources or state appropriate reasons why such sharing is restricted or not possible (see Sharing Model Organisms Policy, and NOT-OD-04-042).

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (go to NOT-OD-07-088, and http://grants.nih.gov/grants.

Specific Instructions for Foreign Applications

All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.

Section V. Application Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NHLBI and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

Applications submitted in response to this FOA will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, and weighted as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious 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 or clinical practice advance? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventive interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs? Does the applicant provide a detailed description of the basic biological, behavioral and/or social science research findings being used to inform intervention development and the theoretical model that will be applied? Does the applicant propose a phased approach to translating basic behavioral, biological and/or social science findings into interventions? Is the phased approach aimed at determining the safety profile of the treatment and characterizing the effects of the intervention including the dosages required (i.e., intensity, frequency, and duration of intervention) to effect change in the intermediate outcomes in specific patient groups under well-specified conditions? Does the applicant include studies from all three phases described in the FOA (defining the intervention, characterizing the intervention’s effects, and refining and assessing feasibility of the intervention) to include a combination of the following: experimental or observational studies and/or formative research; proof of concept and small-scale safety/efficacy studies (early phase trials) or, alternatively, adaptive treatment designs or systems science approaches; and pilot/feasibility studies? Does the applicant adequately describe key features of the intervention to be developed, phases of the intervention development process and specific studies to be conducted in developing the intervention? Are the goals and objectives of the intervention, the hypotheses to be tested, the population and behavioral targets of the intervention, and the outcomes to be assessed for each study proposed clearly described? Does the applicant include a clearly stated project timeline or flow chart that includes a logical progression of studies through the stages of intervention development described in this FOA, the applicant’s best estimate of the sequence and duration of studies, as well as practical, achievable goals, and clear, objective criteria or milestones to be achieved in determining progress and/or intervention success at each stage of the intervention development process? Are sample sizes justified and adequate to achieve the goals of each study? Does the applicant provide evidence of his or her ability to recruit participants, to provide appropriate oversight of participants, and to maintain high rates of participant follow-up throughout the intervention development process? Are quality control procedures for measurements, data collection, data management, as well as for assuring fidelity to intervention delivery, adequately described? Are the informed consent procedures, selection or randomization procedures, and statistical analyses appropriate for the study designs selected?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Does the project seek to develop, characterize and refine new, innovative obesity-reducing strategies rather than evaluating the effectiveness of already well-defined or proven strategies?

Investigators: Are the PD(s)/PI(s) and other key personnel 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? Do(es) the PD(s)/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)? Does the research team span at least three separate disciplines in areas relevant to the topic of investigation, including the social and behavioral sciences (psychology, sociology, anthropology), medical fields of study (neurosciences, metabolic biology, behavioral genomics, cardiovascular medicine, pharmacology, nutrition science), and related fields such as economics, business (marketing), health policy, environmental redesign, urban planning, engineering, informatics, communication sciences, humanities, exercise sciences, and other disciplines? Does the research team have sufficient formative, experimental and clinical trial experience? Does at least one member of the research team have appropriate experience with targeting interventions to minorities and women, as appropriate, and/or to the specific age groups or other populations targeted? Do(es) the Principal Investigator(s) have prior experience with collaborative research?

Environment: Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Does the applicant provide evidence that the institution or institutions in which the research will take place have the infrastructure, resources and institutional support needed to facilitate interdisciplinary, collaborative research across basic and applied research boundaries and across diverse scientific disciplines? Are adequate laboratory, clinical, office and other facilities needed to carry out the objectives of the proposed program available? If interventions are environmental or involve an environmental component, are collaborations and ties with the community/institutions to host the intervention sufficiently demonstrated, e.g., in letters of support? Does the applicant show access to communities (individuals, families, schools, neighborhoods) and/or clinical care settings (primary care and specialty clinics) in which the interventions will ultimately be used? Are the community and clinical engagement activities to be conducted to ensure that the obesity-related intervention(s) developed can be evaluated for acceptability and feasibility within non-academic (i.e., community and clinical practice) settings adequately outlined?

In addition to the above review criteria, the following criteria will be addressed and considered in the determination of scientific merit and the rating.

Collaboration: Have the investigators stated their willingness to collaborate with NHLBI and NIH scientists and staff and with Investigators and staff from other grants supported by this initiative? Is there evidence that the applicant is willing to collaborate on the development and use of key common measures and measurement protocols, such as height, weight, adherence to dietary and physical activity behaviors? Is there evidence the applicant is willing to collaborate, where applicable, on identification of eligibility criteria, formative assessment methods, identification of criteria/milestones to guide progression through the stages of intervention development, and data analysis, and to provide information and data for Steering Committee and DSMB reports?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the rating:

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 the Research Plan section on Human Subjects in the PHS 398 instructions).

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 the Research Plan section on Human Subjects in the PHS 398 instructions).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Resource and Coordination Unit (RCU): The adequacy of the plan for the Resource and Coordination Unit (RCU) will be assessed by the reviewers. However, reviewers will not factor the proposed RCU plan into the determination of scientific merit or the priority score. Each plan will receive a secondary priority score specific to the RCU which is separate from the primary priority score of the parent application. The following criteria will be used:

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. The priority score should not be affected by the evaluation of the budget.

Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.

2.C. Resource Sharing Plan(s)

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps%20_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when state and local governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2. A.1. Principal Investigator Rights and Responsibilities

The PD(s)/PI(s) will have the primary responsibility for: The awardee(s) will have lead responsibilities in all aspects of the study, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, and collaboration with other investigators, unless otherwise provided for in these terms or by recommendation of the Steering Committee.

Study investigators are encouraged to publish and to release publicly and disseminate results and other products of the study, in accordance with study protocols and governance. Within three years of the end of the period of NIH support for the project, data not previously released and other study materials or products not previously distributed are to be made available to individuals who are not study investigators, provided such release is consistent with the study protocol and governance and with 2.A.2, paragraph 3 below. In addition, study investigators must establish a plan for making data sets and materials available to the scientific community and to the NIH immediately upon completion of the three year period following the end of the period of NIH support.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

2. A.2. NIH Responsibilities

An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

The NIH Project Scientist will serve on the Steering committee; he/she or other NIH scientists may serve on other study committees, when appropriate. The NIH Project Scientist (and other NIH scientists) may work with awardees on issues coming before the Steering Committee and, as appropriate, other committees, e.g., recruitment, intervention, follow-up, quality control, adherence to protocol, assessment of problems affecting the study and possible changes in protocol, interim data and safety monitoring, final data analysis and interpretation, preparation of publications, and development of solutions to major problems such as insufficient participant enrollment.

Final decision-making authority on matters of budgetary and funding actions, grants management actions, and management of intellectual property issues is assigned to NHLBI staff other than the Project Scientist. The responsibility for final decision making may reside with Senior Institute management, separate organizational components and/or oversight committees. Because it is anticipated that the Project Scientist will participate in activities that rise to a level of involvement that results in conflicts of interest, for example, co-publication, etc., other staff members such as direct line supervisors and/or other Senior NHLBI Program management staff will serve as agency Program Officials and will be responsible for the normal scientific and programmatic stewardship of the award. The NHLBI policy on authorship and manuscript review of NHLBI sponsored extramural research protects against conflicts of interest with the Program Officer.

The NIH reserves the right to withhold funding or curtail the study (or an individual award) in the event of (a) failure to develop or implement a mutually agreeable collaborative protocol; (b) substantial shortfall in participant recruitment, follow-up, data reporting, or quality control; (c) major breach of the protocol or substantive changes in the agreed-upon protocol with which NIH cannot concur; (d) attainment of a major study endpoint before schedule with persuasive statistical significance; or (e) human subject ethical issues that may dictate a premature end of the award.

Support or other involvement of industry or any other third party in the study -- e.g., participation by the third party; involvement of study resources or citing the name of the study or NIH support; or special access to study results, data, findings or resources -- may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by NIH.

Additionally, an agency program official or NIH program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

The assigned program director may also serve as an NIH Project Scientist.

2.A.3. Collaborative Responsibilities

Awardee(s) agree to the governance of the study through a Steering Committee. Steering Committee voting membership shall consist of the principal investigators (i.e., cooperative agreement awardees), the NIH Project Scientist, and the Chairperson. Meetings of the Steering Committee will ordinarily be held by telephone conference call or in the metropolitan Washington Area.

A Data and Safety Monitoring Board will be appointed by the Director, NIH to provide overall monitoring of interim data and safety issues; the Steering Committee will nominate members for this Board. Meetings of the Data and Safety Monitoring Board will ordinarily be held in Bethesda. An NIH scientist other than the NIH Project Scientist shall serve as Executive Secretary to the Board. An independent Protocol Review Committee, established by the NIH, will provide peer review for each protocol. Because the Board serves as an independent group advisory to the NIH, study investigators will not communicate with Board members regarding study issues, except as authorized by the Board s Executive Secretary.

The collaborative protocol and governance policies will call for the continued submission of data centrally to the coordinating center for a collaborative database; the submittal of copies of the collaborative datasets to each principal investigator upon completion of the study; procedures for data analysis, reporting and publication; and procedures to protect and ensure the privacy of medical and genetic data and records of individuals. The NIH Project Scientist, on behalf of the NIH, will have the same access, privileges and responsibilities regarding the collaborative data as the other members of the Steering Committee.

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity 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:

1. Scientific/Research Contacts:

Susan M. Czajkowski, Ph.D.
Program Director
Clinical Applications and Prevention Branch
Division of Prevention and Population Sciences
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Suite 10118, MSC 7936
Bethesda, MD 20892-7936
Telephone: (301) 435-0406
Fax: (301) 480-1773
Email: [email protected]

Frank M. Perna, Ed.D., Ph.D.
Program Director
National Cancer Institute
Division of Cancer Control & Population Sciences
Behavioral Research Program
Health Promotion Research Branch
6130 Executive Blvd., EPN 4070
Bethesda, MD 20852
Telephone: (301) 451-9477
Fax: (301) 480-2087
Email: [email protected]

Christine Hunter, Ph.D., ABPP
Director, Behavioral Research
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes & Digestive & Kidney Diseases
6707 Democracy Blvd, Room 605
Bethesda, Maryland 20892-5460
Phone: (301) 594-4728
Fax: (301) 480-3503
Email: [email protected]

Deborah H. Olster, Ph.D.
Deputy Director
Office of Behavioral and Social Sciences Research (OBSSR)
National Institutes of Health
Suite B1C19, Bldg. 31; MSC 2027
31 Center Drive
Bethesda, MD 20892-2027
Telephone: 301 402-1147
FAX: 301 402-1150
Email: [email protected]

2. Peer Review Contact(s):

Chief, Review Branch
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214, MSC 7924
Bethesda, MD 20892-7924 (Express zip: 20817)
Telephone: (301) 435-0270
Fax: (301) 480-0730
Email: [email protected]

3. Financial or Grants Management Contacts:

Mr. James E. Huff
Senior Grants Management Specialist
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7129, MSC 7926
Bethesda, MD 20892-7926
Telephone: (301) 435-1498
Fax: (301) 451-5462
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
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).

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). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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 and 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.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

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 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 funding opportunity 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.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004, receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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 (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 Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical 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 (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 applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008, to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) must be used for publicly accessible online journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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 FOA 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. 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.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50 percent of their time (at least 20 hours per week based on a 40-hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.

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NIH Funding Opportunities and Notices


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