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
This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (http://commonfund.nih.gov/) through the NIH Office of the NIH Director, Office of Strategic Coordination (http://dpcpsi.nih.gov/osc/).  The FOA will be administered by the National Institute on Aging (NIA), (http://www.nia.nih.gov) on behalf of the NIH.

Title:  Science of Behavior Change: Finding Mechanisms of Change in the Laboratory and the Field (R01)

Announcement Type
New

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

Request for Applications (RFA) Number: RFA-RM-10-002

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.310

Key Dates
Release/Posted Date: February 4, 2010
Opening Date: 
March 26, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s):
March 29, 2010
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Due Date(s): April 26, 2010
Peer Review Date(s): June-July, 2010
Council Review Date(s): August 2010
Earliest Anticipated Start Date(s): September 30, 2010
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date:
April 27, 2010

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 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. 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. Submitting an Application Electronically to the NIH
    C. Application Processing   
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices

2. Administrative and National Policy Requirements 3. Reporting

Section VII. Agency Contacts
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 funding opportunity announcement (FOA) is intended to stimulate investigations of basic mechanisms of behavior change at the social, contextual, behavioral, psychological, neurobiological or genetic level of analysis. The purpose of this initiative is to establish the groundwork for a unified science of behavior change that capitalizes on emerging basic science to accelerate investigation of common mechanisms of behavior change applicable across a broad range of health-related behaviors. Mechanisms of interest are those that may play a role in reducing or eliminating health-challenging behaviors and/or initiating health-promoting behaviors) or maintaining behavior change (including adherence to behavioral and biomedical regimens). Candidate mechanisms of behavior change include, but are not limited to, aspects of executive control, emotion regulation, metacognition, interoception, social regulation of behavior, and decision-related processes, such as valuation, risk perception, temporal discounting and social influence. Proposals are encouraged from scientific teams with the expertise necessary to conduct studies across scale and bridge approaches from the laboratory and the field. It is expected that this collaborative approach linking basic science research on mechanisms of change to real world contexts – will advance several goals, including: the identification of the optimal targets and timepoints in the lifecourse for intervention; the identification of common mechanisms of change related either to multiple independent health behaviors or bundled (i.e., commonly co-occurring) behaviors; the ability to tailor interventions to particular at-risk individuals or groups; and the identification of individuals or groups most likely to benefit from specific behavior change interventions. Applications that (1) examine mechanisms responsible for individual differences or socioeconomic, racial or ethnic disparities in behavior change, or (2) apply new technologies to enhance measurement of behavior and behavior change mechanisms are strongly encouraged. Descriptive research documenting differences in behavior change without investigating the mechanisms explaining these differences will be considered non-responsive to this FOA. Applications applying approaches from behavioral economics; the social, behavioral, cognitive and affective neurosciences; neuroeconomics; behavior genetics and genomics; and systems science are specifically encouraged. By focusing basic research on the mechanisms of behavior change, and by integrating work across laboratory and field contexts, it is hoped that this initiative will lead to an improved understanding of the underlying principles of behavior change. This should drive a transformative increase in the efficacy, effectiveness, and cost efficiency of many behavior change interventions.

This initiative is funded through the NIH Common Fund (http://commonfund.nih.gov/), which supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress.   

Background

Although population health in the United States continues to improve, the rate of improvement has recently fallen behind that of almost all other high income nations. It is widely suspected that the increased prevalence of unhealthy behaviors plays a significant role in challenging the health of Americans. Indeed, it has been estimated that approximately 40% of all premature deaths are due to behavioral patterns that are potentially modifiable (Schroeder et al., 2007). The dangerous health effects of inactivity, poor diet, lack of sleep, chronically stressful environments, smoking and other substance use are now also widely appreciated. In addition, people are often unable or unwilling to adhere to medically prescribed treatments and preventative behavioral regimens for a wide variety of conditions including diabetes, hypertension, oral disease, drug addiction, skin cancer, and HIV/AIDS.

The potential role of behavioral science in the prevention and treatment of disease and reducing future rates of disability is often underestimated. Behavior change interventions to address many health issues have favorable side effect profiles and can complement other treatments. For example, Knowler et al. (2002) found that a lifestyle intervention reducing body weight by 7% and increasing physical activity by only 2.5 hours per week reduced the risk of type 2 diabetes in overweight individuals by 58%. Yet the goals of long-term, sustained behavior change in areas such as over-eating and inactivity that are essential for reducing health risks in the population remain elusive. This is true despite the fact that many know what they should be doing and desire to change their behavior. Moreover, even in individuals who do make initial changes, adherence to treatment regimens and maintenance of behavior over time represents a formidable challenge.

The NIH has long supported research addressing specific problem behaviors that are relevant to the missions of various institutes, but progress has been slow and improvements have occurred primarily at the margins. More recently, the NIH has begun investing in research in emerging basic biobehavioral science in areas such as the social, behavioral, cognitive and affective neurosciences, behavioral economics, neuroeconomics, behavior genetics, and social network analysis. Discoveries in these areas related to, for example, the role of executive control processes in impulse regulation, the influence of choice framing on decision making, and the impact of social environments on genetic and neural pathways associated with stress and coping, are increasingly relevant to our understanding of how to effect positive behavior change. To date, progress has been slow in translating these basic science advances to behavior change research. Researchers in the field of behavior change often work on disease- or condition-specific problems in relative isolation. Further, fundamental work on the general mechanisms of behavior change may have broad relevance to NIH but no close match to the interests of any one institute or center. Finally, despite the fact that risk behaviors have been observed to occur in “bundles” at points in the lifespan and may have common underlying processes, current disease-specific research tends to focus on one problem in isolation, both in terms of basic science attempts to understand the proximal influences of discrete behaviors and in intervention efforts that address a single problem rather than a cluster of related behaviors.

With its broad range of missions focused on improving public health, the NIH is uniquely poised to facilitate a unified science of behavior change, with the goals of decreasing isolation among disease-specific behavior change research, increasing the application of basic science approaches to understanding mechanisms of behavior change, and bridging laboratory and field-based approaches to the study of mechanisms of behavior initiation and maintenance (including adherence), to produce potent behavior change interventions to improve the public health.

In June, 2009, the NIH held an interdisciplinary meeting on the Science of Behavior Change (see the SOBC Meeting report available at http://nihroadmap.nih.gov/documents/SOBC_Meeting_Summary_2009.pdf) that highlighted the need for greater integration of basic and translational science to advance these goals. This meeting identified the limited understanding about the basic mechanisms of behavior change or the mediators of interventions as a fundamental barrier to progress. There is limited understanding of the psychological, social, behavioral, neurobiological and/or genetic mechanisms of behavior initiation, change, and maintenance; it is unknown whether mechanisms governing these stages of behavior change are even the same; and there is limited understanding of the nature and extent of individual variation in capacities (e.g., self-regulation) with regard to these mechanisms. Loosely-defined constructs such as “motivation,” “stress,” and “self-control” are considered key drivers of behavior change, but the mechanisms underlying these concepts are not clear. Candidate mechanisms of behavior change include, but are not limited to, aspects of executive control, emotion regulation, metacognition, interoception, social regulation of behavior, and decision-related processes, such as valuation, risk perception, temporal discounting, and social influence. Furthermore, most health behavior change occurs outside the context of professional interventions, posing a challenge to the study of behavior change in the field. In addition, given that behaviors that are clustered likely share common mechanisms, considerable support emerged from this meeting for approaches that examine multiple behaviors simultaneously. The meeting highlighted a significant need for more sophisticated examination of mechanisms of change as an end in itself. It is clear that breakthroughs in understanding these basic mechanisms of behavior change could lead to substantial improvements in public health.

However, numerous impediments to progress were identified. Key among these was the lack of integration of findings from the basic and applied sciences, and the difficulty of conducting research across the basic/applied continuum. Investigations that take a mechanistic approach to understanding processes of change and test models of change using both laboratory and field-based approaches hold promise. Insights from the field can inform and refine the design of experiments to study mechanisms of change, while insights from the laboratory can facilitate more precise identification of appropriate targets for intervention.

Nature of the research opportunity

This FOA targets research projects examining basic mechanisms of behavior change that adopt approaches from the following emerging basic science areas:

The social, behavioral, cognitive and affective neurosciences examine the mechanisms and correlates of social behavior (i.e., behaviors influenced by others or by features of the social context or behaviors occurring in the presence of others), affective processes (e.g., motivation, valuation, hedonics) and behavioral and cognitive functions (e.g., learning, memory, executive control functions), including the neurobiological and genetic foundations of these mechanisms. Applications of these approaches to understanding mechanisms of health behavior change has been limited to date and are encouraged by this announcement.

Behavioral economics seeks to understand how human social, cognitive, and emotional factors affect economic decisions. It considers the values assigned to all aspects of a choice, acknowledges the important role that a specific context (or frame) may have on decisions, and takes into account people’s apparently irrational preferences (e.g., losses count more than gains, an object that is owned is more valuable than the same object that is not owned). By examining how characteristics of choice environments or features of incentives manipulate individuals’ behaviors, behavior economics opens opportunities to subvert individuals’ entrenched biases or subtly manipulate incentives to alter behavior. To date, however, the possible contributions that behavioral economics could make to improving health have not been systematically investigated.

Neuroeconomics applies the theories and methodologies of behavioral economics, game theory, psychology, and cognitive, social and affective neuroscience to the study of economically relevant behavior. Neuroeconomics seeks to explain economic behavior in terms of the psychological mechanisms that guide valuations, choices, and decision making, and the neurobiological mechanisms that underlie them. Recent investigations in neuroeconomics have focused on the neural correlates phenomena such as reward processing, temporal discounting, subjective and objective valuation, overconfidence, delay of gratification, decision-making under risk and uncertainty, and social and affective influences on choice. Application of these approaches to understand mechanisms of health behavior change is encouraged by this announcement.

Behavior genetics and genomics, and related areas of inquiry such as neuroimaging genetics, hold the potential to shed light on the genetic and environmental sources and extent of individual variation in complex traits related to behavior change - including personality characteristics, emotional regulatory abilities, cognitive control functions, as well as susceptibility to social influence. There is growing evidence regarding specific genetic variants that affect specific social, cognitive, and affective behaviors, and accumulating data suggesting that social behaviors and environments may induce or affect gene expression in these pathways. Genetic difference may predispose someone to engaging in multiple health endangering behaviors.

Systems science approaches, including systems dynamics modeling, agent based modeling, and social network analysis enable investigators to assess the impact on the behavior of dynamic features of the system in which it is embedded. Such techniques are particularly well-suited for understanding connections between a system’s structure and its behavior over time. For example, social network modeling can be useful as a way to understand health behavior acquisition, prevention, change, and maintenance within social systems. Promising research avenues may involve studying networks as complex adaptive systems, using sensors to measure behavior/actions and network connections, and harnessing networks for interventions. Basic scientists are challenged to examine the mechanisms of behavior change using system science tools to explore complex models of change.

Application of new technologies

An individual’s ability to change and maintain behavior is affected by numerous variables including physiological, cognitive, and emotional states, acute stressors, specific environmental exposures and social contexts that are highly variable over short time periods but are conventionally measured over days, weeks, or months. Advances in multiple areas of technology and the increasingly ubiquitous nature of these technologies in daily life (e.g. smart phones) have created opportunities for advances in the study of mechanisms of behavior change that were not previously possible.  Applicants are strongly encouraged to consider novel applications of new technologies to measure, change, or maintain health behaviors that have not previously been applied in the behavioral research area of interest, and that address important methodological limitations of current behavioral assessments and/or interventions.  For additional discussion see the Science of Behavior Change Meeting Report (http://nihroadmap.nih.gov/documents/SOBC_Meeting_Summary_2009.pdf).

Candidate mechanisms of behavior change

Basic mechanisms of behavior change of relevance to this announcement include mechanisms at the social, contextual, behavioral, psychological, neurobiological and genetic levels of analysis. Mechanisms of interest are those that may play a role in initiating or maintaining behavior change (including adherence to behavioral and biomedical regimens) over time. A deeper understanding of common mechanisms in associated with multiple health behaviors across individuals or with co-occurring behavior “bundles” within an individual is also needed.

Examples of candidate mechanisms include:

1. Mechanisms of decision-making including risk perception, temporal discounting, susceptibility to framing effects, and cognitive or affective heuristics and biases;

2. Mechanisms of control and self-monitoring, including executive function, metacognition, interoceptive awareness, and emotion regulation;

3. Mechanisms of social and cultural transmission of behaviors and of interpersonal transaction, such as contagion, mimicry, modeling, norms, peer effects, competition;

4. Structural mechanisms such as features of choice architectures, defaults, mechanisms of institutional (including healthcare systems and providers) or cultural practice, environmental affordances;

5. Neurobiological and genetic mechanisms related to these behavioral, psychological, social or environmental processes, including those associated with individual differences in biophysiologic capacity or psychological resilience/vulnerability.

For further discussion of mechanisms of behavior change, behavior bundles, approaches from emerging biobehavioral sciences, applicants are encouraged to review the Science of Behavior Change Meeting Report (http://nihroadmap.nih.gov/documents/SOBC_Meeting_Summary_2009.pdf)

Scope and Specific Requirements

Applications in response to this FOA are expected to propose projects that will further our understanding of the basic social, contextual, behavioral, psychological, neurobiological, or genetic mechanisms underlying behavior change, using approaches from emerging basic science areas including, but not limited to: behavioral economics, neuroeconomics, the social, behavioral, cognitive and affective neurosciences, behavior genetics/genomics and systems science.

Applications should clearly articulate the potential for the proposed research to lead to an improved understanding of the underlying principles of behavior change of potential relevance to multiple domains of health- and life-course-related research, as well as the potential of the proposed research to lead to identification of optimal intervention targets, timepoints, methods and populations. The health behavior domains to be studied should be well-specified and precisely defined, and may include adherence to treatments or regimens, the initiation or acquisition of behavior, reducing or eliminating health-challenging behaviors, or maintenance of one or more health behaviors in domains of broad relevance to physical and mental health, functionality, and psychological well-being.

Research teams are strongly encouraged to include expertise spanning both basic and applied science of relevance to the behavior change topic under study. The bridging of perspectives from both basic science and applied areas of relevance to the mechanisms and health behaviors under study is critical to advancing the NIH goal of developing a unified science of behavior change. It is anticipated that all applications will employ experimental, observational, or analytical tools designed to pinpoint mechanisms of behavior change around specified health behaviors. Applications may propose to conduct observational and/or experimental studies in either laboratory settings, field settings (clinical, community, family, school, workplace), or both (e.g., experimental findings may then be validated in field studies, or observations within a clinical or community setting may be brought into the lab for further study). Applicants are encouraged, where feasible, to conduct studies in both laboratory and field settings to better delineate how the mechanisms of behavior change under study respond in both the well-defined research context of the laboratory and in the clinical, community, family, school, workplace or other context in which the behavior naturally occurs.

Applications including an intervention component will be considered responsive only if they include a plan to examine the basic mechanism(s) through which the intervention has its effects, using the approaches from the basic biobehavioral and social sciences discussed above. Applicants proposing field-based components must also show they have access to communities (individuals, families, schools, workplaces, neighborhoods) and/or clinical care settings (primary care and specialty clinics) in which field testing can take place. 

Any population could be the focus of a study of basic behavioral or social mechanisms of change, provided that the population is appropriate to the research question and design. Populations of interest include healthy individuals across the lifespan, those at high risk for a particular disease or condition, and those with an existing disease or with specific age- or condition-related psychological profiles. Applications will usually target human populations, but applications employing animal models are acceptable if they clearly define the relevance of the model used to the individual and social human behavior change being targeted, and findings are subsequently tested in humans.

Applications that (1) examine mechanisms responsible for individual differences or socioeconomic, racial or ethnic disparities in behavior change, or (2) apply new technologies to enhance measurement of behavior and behavior change mechanisms are strongly encouraged. Descriptive research documenting differences in behavior change without investigating the mechanisms explaining these differences will be considered non-responsive to this FOA.

Because this FOA targets basic research approaches to understanding mechanisms of change, areas of research that will NOT be considered responsive to the FOA include, but are not limited to:

Research Topics

Examples of research topics that are relevant to this FOA include, but are not limited to:

Social and Contextual Mechanisms

Psychological Mechanisms of Decision Making

Biobehavioral Mechanisms of Self-control related to Behavior Initiation,

Maintenance and Adherence

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

Section II. Award Information


1. Mechanism of Support

This FOA will use the R01 award mechanism.

The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses “Just-in-Time” information concepts (see SF424 (R&R) Application Guide). It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, a U.S. organization submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) must use the PHS398 Modular Budget component.

U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component.

2. Funds Available

The NIH will commit up to $4 million to this funding initiative in 2010, allowing the support of 6-7 new R01 applications, for a total of approximately $20 million over the next 5 years.

For this funding opportunity, budgets with direct costs ranging from $200,000 to $400,000 per year and time periods up to five years may be requested.

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(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization 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 support.

More than one PD/PI (i.e., 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 and 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 electronic Research Administration (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. When considering the multiple PD/PI option, 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

Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.

Resubmissions. Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications are not permitted in response to this FOA.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an applicationSeveral of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered “on-time” (see 3.C.1 for more information about on-time submission).

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:  

1) Organizational/Institutional Registration in Grants.gov/Get Registered

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential.  Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number.  Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone 301-435-0714; Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY: (301) 451-5936

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget, as appropriate (See Section IV.6 regarding appropriate required budget component.)  

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Foreign Organizations (Non-Domestic [non-U.S.] Entities)

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:

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 (U.S.) or that augment existing U.S. resources.

SPECIAL INSTRUCTIONS

Applications Involving Federal Agencies

The requests from federal agencies, including the NIH intramural program, will not include any salary and related fringe benefits for career, career conditional or other federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative costs).

In general, the budget requests will be limited to the incremental costs required for carrying out the proposed work. These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. While support for extramural collaborators may be requested in a separate grant application, funds can be requested for services by an external investigator or contractor as a subcontract/consortium including the applicable indirect (F&A costs) of the contractor/collaborating institution.

Justification must be provided for all requested support and for the Federal employees who will be committed to the project although no funds are requested in the application.

Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact” PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered on the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of “PD/PI.” Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the “Credential” field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the Research Plan section and the “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 (NoA).

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions 

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form. 

When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: March 26, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s):
March 29, 2010
Application Due Date(s): April 26, 2010
Peer Review Date(s):
June-July 2010
Council Review Date(s):
August 2010
Earliest Anticipated Start Date(s): September 30, 2010

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:

Jonathan W. King, Ph.D.
Division
of Behavioral and Social Research
National Institute on Aging
7201 Wisconsin Ave. #533
Bethesda, MD 20892-
9205
Telephone: (301) 402-4156
Fax:
(301) 402-0051
Email:
kingjo@nia.nih.gov

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp  and follow Steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED.  All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

3.C. Application Processing

3.C.1 Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered “on-time”:

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step – applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons.  The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays.  All errors must be corrected to successfully complete the submission process.  Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday – Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and/or non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

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.

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.
 

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 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 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 

Annual Investigators Meeting.  Note that the principal investigator will be required to attend the annual investigators meeting in the Washington, DC area and that travel funds to attend this meeting should be included in the proposed budget.

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

PHS398 Research Plan Component Sections

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

Budget Component

U.S. applicants submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) must use the PHS398 Modular Budget component.

U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component.

Applicants should include in their budgets sufficient funds for the principal investigator to attend a two-day annual Investigators’ Meeting in the Washington, DC area.

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations. 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 1-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/gwas/.)

Foreign Applications (Non-Domestic [non-U.S.] Entities)

Indicate how the proposed project has specific relevance to the mission and objectives of the NIH/IC and has the potential for significantly advancing the health sciences in the United States. 

Section V. Application Review Information


1. Criteria 

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

2. Review and Selection Process

Review 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 Center for Scientific Review 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:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. 

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed). 

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.  An application does not need to be strong in all categories to be judged likely to have major scientific impact.  For example, a project that by its nature is not innovative may be essential to advance a field.

Significance.  Does the project address an important problem or a critical barrier to progress in the field?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Will the proposed research significantly advance understanding of a precisely specified mechanism of behavior change? Does this work have the potential to advance one or more of the following goals: identify optimal developmental targets and/or timepoints in the lifecourse for intervention; identify common mechanisms of change related to multiple health behaviors or to bundled (i.e. co-occurring) behaviors; increase our ability to tailor interventions to particular at-risk individuals or groups; offer innovations in application of novel technologies to behavioral assessment and change; or identify individuals or groups most likely to benefit from specific behavior change interventions?

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the investigator or team possess the expertise needed to bridge approaches from the laboratory and the field and/or link basic science research on mechanisms to behavior change targets in real world contexts?

Innovation.  Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?  Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?  Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the application have the potential to identify common mechanisms of change that may be associated with multiple health behaviors and/or overcome barriers that tend to isolate disease- or condition-specific approaches to behavior change?

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Are the specific health behavior(s) and the specific mechanism(s) of behavior change under study precisely defined?  Is there a sophisticated incorporation of basic science approaches or insights (from fields such as behavioral economics; the social, behavioral, cognitive and affective neurosciences; neuroeconomics; behavior genetics and genomics; systems science/network analysis) to understanding mechanisms of change associated with the targeted behaviors? Is there evidence of bridging of approaches and insights from basic and applied research around identified behavior change targets?  

Environment.  Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects.  For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals.  The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.  For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards.  Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations.  As applicable for the FOA or submitted application, reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans.  Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:  1) Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Budget and Period of Support.  Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Selection Process

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:

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 NIH 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.

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 Section IV.5., “Funding Restrictions.”       

2. Administrative and National Policy Requirements

Note that funded projects requiring the use of human subjects will need appropriate approvals to use such subjects (e.g., IRB approval) at the time of the award. Investigators will be required to fulfill the data sharing agreements described above. Also note that the principal investigator will be required to attend the annual investigators meeting in the Washington, DC area, and that funds to attend this meeting should be included in the proposed travel budget.

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.

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 (program), peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

Jonathan W. King, Ph.D.
Division of Behavioral and Social Research
National Institute on Aging
7201 Wisconsin Ave. #533
Bethesda, MD 20892-9205
Telephone: (301) 402-4156
Fax: (301) 402-
0051
Email: kingjo@nia.nih.gov

2. Peer Review Contact(s):

Melissa Gerald, Ph.D.
Scientific Review Officer
Biobehavioral and Behavioral Processes Integrated Review Group
Center for Scientific Review
Rockledge II; Room 3172
6701 Rockledge Drive
Bethesda, MD 20892-7848
Telephone:  (301) 408-9107
Fax:  (301) 435-0014
Email: geraldmel@csr.nih.gov

3. Financial/Grants Management Contact(s):

Lesa McQueen, M.Sc.
Grants & Contracts Management Branch   
National Institute on Aging
7201 Wisconsin Avenue, Room 2N212
Bethesda, MD 20892-9205
Ph: 301-496-1472
Fax: 301-402-3672
Email:
McQueenL@nia.nih.gov  

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 (45 CFR 46) 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 institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

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/.

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. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal 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.

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.

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 SF424 (R&R) application; 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-09-116.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.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). 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 (HHS) 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 HHS 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) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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 Part 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 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% 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/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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