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 Cancer Institute (NCI) (http://www.cancer.gov/)
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/)
Office of Behavioral and Social Sciences Research (OBSSR) (http://obssr.od.nih.gov/content)

Title: NIH-Supported Centers for Population Health and Health Disparities (CPHHD) (P50)

Announcement Type
This funding opportunity announcement (FOA) is a reissue of RFA-ES-02-009.

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

Request For Applications (RFA) Number: RFA-CA-09-001

Catalog of Federal Domestic Assistance Number(s)
93.393, 93.394, 93.395, 93.396, 93.397, 93.398, 93.399, 93.837

Key Dates
Release Date: December 23, 2008
Letters of Intent Receipt Date: April 29, 2009
Application Receipt Date: May 29, 2009 
Peer Review Date: September/October 2009
Council Review Date: January 2010
Earliest Anticipated Start Date: April 2010
Additional Information To Be Available Date (URL Activation Date): January 2009
Expiration Date: May 30, 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
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 funding opportunity announcement (FOA) solicits grant applications for the Centers for Population Health and Health Disparities (CPHHD) Program.  The CPHHD Program is designed to promote transdisciplinary research in the area of health inequities with the purpose of contributing directly to improved health outcomes and quality of life.  Whereas this FOA is a continuation of the CPHHD Program, the solicitation is based on an open competition to fund new multidisciplinary specialized research centers under the NIH P50 mechanism as well as to continue support for the best of the existing centers.

This initiative is sponsored jointly by the National Cancer Institute (NCI) and the National Heart Lung and Blood Institute (NHLBI), and the Office of Behavioral and Social Science Research (OBSSR).  The focus of the proposed centers and the scope of their research should be relevant to the respective areas of interests of the NCI or NHLBI.  Thus, under this FOA, the National Cancer Institute (NCI) will support CPHHD focused on health disparities related to cancer, including the differences in the incidence, prevalence, mortality, and burden of cancer and related adverse health conditions that exist among specific population groups in the United States (U.S.). Centers proposed for funding by the NHLBI must target disparities in cardiovascular diseases. The development of interventions to reduce these health disparities must be the primary objective of the research proposed for support by the NHLBI. 

The goals of this FOA reflect the importance of understanding the pathways by which health inequities arise and the development and implementation of necessary interventions to mitigate them.  Research outcomes emerging from this initiative are also expected to include the development of multilevel intervention models and testing interventions at various levels to establish optimal strategies for reducing/eliminating health disparities/inequities.

The NIH P50 mechanism used in this FOA provides support for a broadly based, multidisciplinary, innovative research programs consisting of related research endeavors and an associated administrative core infrastructure to ensure their effective and synergistic functioning.

Background

Health disparities are defined as the differences in the incidence, prevalence, mortality, and burden of a disease (e.g., cancer, obesity, infant mortality, low birth weight, diabetes, coronary heart disease, asthma) and related adverse health conditions.  Population groups may be characterized by gender, age, race, ethnicity, education, income, social class, disability, geographic location, or sexual orientation. Health Disparities in the US encompasses the concepts of both Health Inequality and Health Inequity. 

Health inequities arise from the inequitable distribution of resources and the structural factors that perpetuate these problems in society.  Examples of such factors include inadequate housing, unsafe environments, lack of safe water, lack of access to standard health care, etc.  While others have distinguished between health inequality and health inequity, in this FOA, we use all three terms (Health Disparities, Health Inequality, and Health Inequity) interchangeably. 

The Need for Transdisciplinary and Multilevel Research on Health Disparities.  The difficulty of reducing and eliminating health disparities has been largely attributed to the complex interactions among various determinants, including biological, genetic, behavioral, socioeconomic, and environmental factors.  Yet, these complex interactions and the pathways through which they may affect health outcomes are understudied and remain poorly understood.  More comprehensive understanding can be effectively achieved but it requires transdisciplinary and multilevel research that could address the roles of multiple diverse factors simultaneously.

Remarkable advances in understanding human biology and its interaction with behavior and social factors have been made in recent decades.  The mapping of the human genome provides a platform for further discovery and progress in disease prevention, early detection, diagnosis, treatment, and promises for increasing active life expectancy.  For example, identification of specific genes and mutations involved in a disease may lead to new preventive, diagnostic, and/or therapeutic approaches pertinent to that disease.  However, the impact of these discoveries may be limited without an effective long-term strategy for linking the knowledge of the disease biology and genomics with the knowledge of factors that affect prevention, diagnosis, and/or treatment of a disease at the population level.  Therefore, it is essential to integrate research in the natural, behavioral, and social sciences to create a more comprehensive understanding of disease pathways from a molecular to a societal level.  Such integration is expected to lead to more effective measures to prevent disease occurrence and progression, and enhance well-being in all population subgroups, especially those at higher risk and those experiencing the greatest burden of disease.

Overview of the CPHHD Program. In the first funding period of CPHHD, which began in 2003, the NIH established eight centers sponsored by the National Institute of Environmental Health Sciences (NIEHS), the NCI, the National Institute on Aging (NIA), and the OBSSR.  Through these centers, the program promoted and supported interdisciplinary research to examine how the social and physical environment, behavioral factors, and biologic pathways interact to determine health and disease in populations.

The first funding period of the CPHHD Program has enabled us to understand the persistence of health disparities and to begin to identify approaches to address these inequities.  Thus, the scientific findings emerging from the CPHHD Program offer new opportunities for transdisciplinary research.  The recent publication in American Journal of Public Health by Warnecke et. al. (2008) outlines the vision of the CPHHD and the NIH’s impetus for the transdisciplinary agenda.  Some of these studies have begun to explain how the social and built environments impact biological processes, such as epigenetic modifications, gene expression, endocrine function, inflammation, tumor growth, and cancer-related health outcomes.  These types of information are crucial in developing appropriate prevention, early detection, and treatment intervention programs to mitigate cancer disparities.  The information can allow for integration of personalized clinical approaches for prevention, early detection, and treatment.  Some of these recent scientific accomplishments, from the first funding period for the CPHHD Program, have been summarized in the report Cells to Society: Overcoming Health Disparities (http://cancercontrol.cancer.gov/populationhealthcenters/cphhd/documents/CPHHD_report.pdf).

Prior to the initiation of the CPHHD, approaches aimed at understanding and eventually eliminating) health disparities were largely based on analysis or intervention carried out at only at a single level.  Consequently, these approaches have had limited effectiveness.  The transdisciplinary CPHHD Program has been expressly designed to address health inequities and health disparities using multilevel approaches based on rigorous scientific methods.  By combining approaches from the various disciplines (e.g., those in the physical, biological, social, and behavioral sciences), the CPHHD Program can advance research on disparate health outcomes and probe more deeply into the causes of these outcomes, develop interventions and identify practice and policy approaches to addressing them.  These multilevel approaches are thus expected to inspire: (a) meaningful interventions; and (b) sustainable, evidence-based policies that will eventually lead to the elimination of health disparities and the improvement of health outcomes.

One broad question that requires multilevel approaches to address is how population risks relate to individual risks.  CPHHD-directed research is expected to increase our understanding of the complex relationship(s) between these risks.  This knowledge should help CPHHD and other researchers to design intervention models and test intervention strategies at multiple levels in search for those strategies that would have the greatest impact in terms of reducing/eliminating disparate health outcomes.  The CPHHD studies will employ comprehensive models of how various social, economic, cultural, environmental, biobehavioral, physiological, and genetic factors affect individual health outcomes and their distributions in populations.  This comprehensive approach will aid planners, policymakers, and health professionals responding to differences and disparities in the distribution of health outcomes.  Ultimately, these efforts should result in the development of effective interventions that are capable of addressing both contextual and individual factors.

Specific Research Objectives and Scope

Research programs for the proposed CPHHD are expected to provide a comprehensive model of how various social, economic, cultural, environmental, biobehavioral, physiological, and genetic factors affect individual health outcomes and their distribution in populations.  The proposed research should address both individual and contextual factors underlying health disparities.

Targeted Outcomes. To be responsive to this RFA, each proposed CPHHD must be focused on:

Examples of population groups to be investigated include (but are not limited to):

Applicants must provide an evidence-based rationale for the target population to be studied.

Programmatic Goals and the Required Components of the Proposed P50 Centers

Research activities to be supported by CPHHD program are expected to be: (a) innovative; (b) multidisciplinary in approach and leadership; and (c) thematically integrated and synergistic.

Each proposed center is expected to consist of the following components:

It is important that applicants do not simply propose a collection of independent research projects that are only loosely related.  Each individual research component is expected to be systematically related to other components and to the administrative core infrastructure.  Training and mentoring to enhance junior researchers' or other researchers' skills should be conducted in the context of the research, but funds may not be used for training stipends or training not required to conduct the research.

The NIH specialized center (P50) grant mechanism is being used to promote interdisciplinary research and training.  For this FOA, the term “interdisciplinary” refers to the strategy of drawing from, and integrating, two or more academic disciplines, fields, or departments in order to develop a greater understanding of a problem that is too complex to be understood by one discipline alone.

Applicant teams responding to this FOA should include specialists from a number of different disciplines, such as basic (including biology and genetics), clinical, and social sciences research.  This multidisciplinary approach should allow planners, policymakers, and health professionals to respond to differences and disparities in the distribution of health outcomes, and ultimately develop effective interventions that are capable of addressing both contextual and individual factors.  These multidisciplinary teams should propose an integrated research program for the proposed CPHHD Program to examine how various social, economic, cultural, environmental, biobehavioral, physiological, and genetic factors can affect individual health outcomes and their distribution in populations.  The center grant mechanism will allow grantees to collectively evaluate research questions from a broader and more generalizable perspective.  The training component of the center grant will prepare a new generation of transdisciplinary scientists.

The overall focus of a proposed CPHHD may be to investigate either:

All CPHHD applications submitted in response to this FOA must conform to the following requirements:

  1. Investigator team should include specialists from multiple and relevant disciplines, such as social science, behavioral science, biology, genetics, medicine, public health, and health systems-- the team should include scientists from the following areas of study: basic (genetics and biology, basic behavioral sciences), clinical, and social sciences;
  2. The focus of the research project can be on a specific underserved population or involve a comparison among more than two groups based on gender, age, race, ethnicity, education, income, social class, or geographic location;
  3. A minimum of three and no more than five full research projects must be proposed (and present in any funded CPHHD) for the duration of the funding;
  4. The work of the center has to be situated within one or several community context(s) and thus incorporate the principles of community-based participatory research in the center — applications neglecting this consideration will be considered nonresponsive and will be returned to the applicants without being reviewed;
  5. At least one of the three required research projects must be an intervention directed at more than two factors (such as both individual level and social context) and more than just individual behavior change — applications without such projects will be considered nonresponsive and will be returned to the applicants without being reviewed;
  6. Appropriate career development opportunities must be proposed for new investigators or established investigators who wish to pursue careers in transdisciplinary health inequities/disparities research; and
  7. Interactions (on a regular basis) must be planned with other centers (within the CPHHD Program) to share information, participate in NIH-directed evaluation activities, promote and coordinate collaborative efforts, identify opportunities for common measures in the field, and review areas of growth and opportunity in the field of health disparities and health inequities.

Applicants should anticipate the use of shared measures, protocols and methodologies across the CPHHD.  The intention of this sharing is to benefit collaborative efforts in evaluating the efficacy and effectiveness to address health inequity both at the individual and community levels. 

The cancer-focused CPHHD will be expected to work with the NCI in extending the benefits of the cancer Biomedical Informatics Grid (caBIG) into the population and behavioral sciences, and to work together in identifying shared vocabularies and ontologies in the areas influenced by cancer research.  The centers are encouraged to form partnerships with industry, universities, hospitals, health departments, and/or other entities needed to facilitate high-quality, and potentially even life-saving, changes in addressing health inequities and disparate health outcomes.

Specific types or areas of research that may be appropriate as relevant projects include, but are not limited to, the following examples:

A. Social Determinants of Health

B. Biologic/Genetic/Clinical Factors

C. Interventions.

Development or testing of interventions may be proposed for any CPHHD.  However, for centers proposed to target disparities in cardiovascular diseases (i.e., those to be considered for funding by the NIHLBI) the development of interventions to reduce health disparities must be the primary objective. 

For the purpose of this FOA, intervention development does not have to involve the conduct of late-stage controlled clinical trials.  Early phase trials, pilot studies, and other preparatory work including the study of relevant principles of behavior change at individual or group levels, and other preparatory work needed to lay the foundation for definitive trials may be proposed and addressed in the application. These efforts should recognize the complexities of the multi-factorial origins of health disparities, and target one or more of the following:

D. Methodological Issues.

Integration of multiple levels of analysis, as previously described, may warrant the refinement of existing methodological approaches or the development of novel methodological approaches in the conduct of center’s research projects.  Methodological research is supported by this FOA to the extent that it is requisite to the achievement of specific aims outlined in CPHHD applications. Research at various levels of analysis could be facilitated by advances in methodology in areas such as the following:

E. Results Dissemination. 

One of the goals of the CPHHD Program is to “close the gap between research discovery and program delivery by getting evidence-based information and interventions into use” (see http://cancercontrol.cancer.gov/d4d/about.html).  Applicants are encouraged to familiarize themselves with the resources being developed by the NCI’s own “Research Dissemination and Diffusion Team” at http://cancercontrol.cancer.gov/d4d/.

CPHHD awardees will be expected to facilitate dissemination of evidence emerging from CPHHD projects. Therefore, applicants should plan for results dissemination, including the following aspects:

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

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the NIH specialized center (P50) grant mechanism.

This funding opportunity will use the P50 center grant 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.  It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

Each applicant institution may submit only one application.  Both new applications and competitive continuation applications (from previous CPHHD awardees) may be submitted.  Resubmission applications will not be accepted.

Funds Available

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 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

Number of Applications. Each applicant institution may submit only one application. 

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

Renewals. Renewal applications are allowed in response to this FOA.

Foreign sites may not apply for funding in connection with this FOA and they cannot constitute part(s) of Domestic (U.S.) application(s).

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) 435-0714; Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5939.

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.

Consortium/Contractual Arrangements: If multiple institutions are involved, the project will be administered through a traditional consortium/contractual arrangement, and the usual documentation is required as per the PHS 398 research grant application instructions).

For all P50 applications submitted in response to this FOA, the standard PHS 398 instructions are modified.  In particular, Research Plan (Items 2-5 as per Revision 11/07 of the PHS 398 Table of Contents, previously known as “Sections A-D”) is altered as follows:

Other sections of the standard PHS 398 Research Plan (Sections E-L) remain unchanged and must be completed following the PHS 398 instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

Section 1.  Overall Center Description (up to 10 pages suggested)

This section should be used to present the overall vision for the proposed center.  This summary should contain the long- and short-term scientific objectives, specifically addressing how health equities/disparities activities supported through the center will impact population health.  The center description should serve as an overview, with a more detailed description of each component to be presented in a later section.  Of importance is the discussion of the interdisciplinary expertise of CPHHD teams.  As with the first round of CPHHD, the rationale for funding P50 grants is to create a critical mass of interdisciplinary researchers all focused on the common problem of advancing the science of health disparities/inequities in order to reduce the national burden of disease.  Each center will be expected to have its own set of unifying themes, through which participating center investigators will contribute in an organized fashion toward solutions on a common piece of the health inequities puzzle.  The Center plans should have a thematic focus, and should show a clear logic for how the activities within the center will achieve national goals.

Within this section, all applicants should include a separate segment “Background/Progress Report”.   New applicants should describe in this segment relevant background information on their main accomplishments pertinent to the goals of this round of funding for the CPHHD and the specific research theme proposed by the applicant team.  Both new applicants and current CPHHD awardees submitting renewal applications should describe highlights of their published contributions to health disparities and population science within the past 3 years and other strengths of their team pertinent to the goals of the current CPHHD (e.g., new investigators, new relevant peer-reviewed funding, initiated pilot projects, etc.).

For current CPHHD awardees, this segment should largely amount to a succinct Progress Report summarizing their accomplishments towards the original goals of their original CPHHD project in the current funding period, including summary of publications, career development, and new peer-reviewed research funding resulting from the original CPHHD.  (The description should list the objectives of the originally funded CPHHD to help reviewers assess how well these goals were accomplished.)

Section 2.  Administrative Core (up to 6 pages suggested).

It is expected that each center will organize an administrative core.  Summarize in this section the proposed administrative structure for the center, concisely defining the leadership structure and the integration of the required research projects, the shared resources component, and the training components, and their relationships to each other.  In addition, relationships between the proposed center and other research, academic, and administrative units of the applicant institutions (such as institutes, medical or public health departments) and the central administration should be described in this section.

Attendance at CPHHD grantee meetings and cross-center activities.  Plans should be made (and appropriate funds budgeted) for the participation for at least four investigators from each proposed center to attend semi-annual grantee meetings throughout the duration of the award.  Locations will vary, depending on sites funded through the initiative.  The meetings will provide a venue for presenting scientific findings from each of the funded centers and are intended to facilitate synergistic interactions between the CPHHD within the evolving community of scientists.  PIs will be expected to participate in conference calls for planning purposes at monthly or other appropriate intervals.  Other investigators should set time aside as needed to participate in cross-cutting “research interest groups” and other collaborative activities as a way of advancing transdisciplinary health disparities and population health as a science.

Participation in evaluation activities.  Each center award and the entire CPHHD program will be periodically evaluated by the NIH.  Applicants should acknowledge their readiness to participate in such evaluation.  Objective criteria to guide the evaluation of CPHHD program by the NCI may include: (a) evidence of success in advancing the knowledge base of the science of addressing health disparities/inequities (e.g., publication in peer-reviewed journals) through the use of transdisciplinary team science; (b) evidence of contribution to individual (e.g., patient measures) or public (e.g., population measures) outcomes in health and quality of life; (c) demonstration of improvement in reach, efficiency, and/or effectiveness for communication programs and/or activities; (d) innovation in content and/or methodology; and (e) potential dissemination of results to real-world settings.

Section 3. Individual Full Research Projects (up to 20 pages suggested for each project).

No fewer than three (and not more than five) full research projects providing a sufficient level of multidisciplinary interactions must be described in the application.  Each applicant must propose research on evidence-based approaches to eliminating disparate health outcomes that would be immediately relevant to practice.

At least one of the three required projects must be designed to obtain results that will be directly relevant and useful in practice (in the community or in clinical settings).

Describe each research project in sufficient detail to enable reviewers to judge the scientific merit from the written application.  Each project should have a single theme and budget consistent with the priorities outlined in Section II.

Each Research Project must contain the following elements:

Section 4. Shared Resources (i.e., Cores) (up to 10 pages total suggested)

In addition to the Administrative Core (described in New Section 2), each center is expected to establish appropriate (one or more, as needed) shared technical resources, or cores.  The structure and administration of these cores will be left to the discretion of the applicant.  Activities for consideration may include: (a) a statistical or methods component to ensure that all projects adhere to an equally stringent level of scientific research and which will lead to activities to harmonize measurement and data collection strategies across the various components; (b) a policy and dissemination component which will lead participation in activities to connect with other partners.  These cores must not duplicate analogous resources already established in the applicant institutions (although supplemental funding to such existing resources may be requested).

Requirements to be supported by the overall center, and that may be supported by activities in the cores, are as follows:

Harmonizing measurement and data.  In order to increase research efficiency and rapidly move science forward, partners in the cancer research paradigm must work together to solve complex health problems using standard vocabularies, data standards, and ontologies (see https://cabig.nci.nih.gov/ for an example).  Eligible applicants must be willing to participate in activities to harmonize data collection strategies across the various components that comprise population research.  Viable approaches may include, but are not limited to: (a) selecting existing measurement definitions from an NCI-approved “common data standards repository” compliant with caBIG requirements; (b) participating in the harmonization of data elements across centers; (c) identifying minimum data set standards to enable “prospective meta analyses” in common areas of science; or (d) demonstrating psychometric equivalency for alternative measurements of the same construct.

Section 6. Training and Career Development Program (up to 6 pages suggested).

Training and Career Development opportunities sponsored by CPHHD will provide a limited number of trainees with access to a highly trans-disciplinary experience.  The extent of the training activities is to be defined by the applicant, based on the needs and capabilities of the center participants.  Applicants must demonstrate a consistent and significant commitment to a career development program in health disparities research.  This activity may focus on graduate students, post-doctoral candidates, junior faculty, and/or established investigators who wish to develop or refocus their careers on health disparities/inequities research and learn to function in a transdisciplinary manner.  The application should include the policies, criteria, and processes for selecting candidates, including special efforts to recruit qualified women, minorities, and individual from underrepresented or underserved communities.  Mentors proposed are expected to have appropriate experience in training/mentoring junior researchers.  The plan should include the number and types of positions that will be made available, the criteria for eligibility and selection of candidates, and a description of the selection process. Salaries and research costs for candidates may be requested, but stipends and trainee costs are unallowable.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs  

More than one principal investigator may be designated on the application as center director, although the multiple PD/PI option applies only to the center as a whole.  Multiple PDs/PIs cannot be proposed in the capacity of scientific director for any project.  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.

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
Letters of Intent Receipt Date: April 29, 2009
Application Receipt Date: May 29, 2009
Peer Review Date: September/October 2009
Council Review Date: January 2010
Earliest Anticipated Start Date: April 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 NIH 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:

Shobha Srinivasan, Ph.D.
Health Disparities Research Coordinator
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, Room 6126
Bethesda, MD 20892-7338 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Phone: 301-435-6614
Fax: 301-594-6787
Email: ss688k@nih.gov

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 (for U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for non-USPS delivery)

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

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: 301-496-3428
Fax: 301-402-0275
Email: ncirefof@dea.nci.nih.gov

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 PD(s)/PI(s) 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 at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

6. Other Submission Requirements and Information

Research Plan Page Limitations

For page limits and content of Research Plan, see Section IV.2. Content and Form of Application Submission of this FOA.

Other Requirements

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 observe 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 of, and advance 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 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 NIH Guide 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 (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information, see the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

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

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NCI 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 following will be considered in making funding decisions:

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 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 core review criteria, and additional review criteria (as applicable for the project proposed).

Core 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?

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?

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?

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?

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? 

In addition to the standard NIH-wide criteria, the following FOA-specific criteria will be used to evaluate specific aspects/components of the P50 applicationThe overall CPHHD application will be evaluated as an integrated research effort focused on a central theme.  Individual research projects, administrative and resources cores, and the administrative structure are collectively considered.

The review criteria for evaluation of the CPHHD program are as follows:

A. Criteria for Overall Program Organization, Integration, and Capability

Significance: Does the proposed CPHHD address an important health disparity/inequity research problem?  Will the research have an impact (either direct or indirect) on disparities in health care and prevention?

Approach: Are the activities of the proposed center truly transdisciplinary?  Are the individual components appropriately integrated?  If multiple PDs/PIs are proposed, does the applicant ensure that there will be sufficient coordination and communication among the PDs/PIs and with other CPHHD?

Innovation: Does the proposed center offer innovative approaches to mitigating the burden of health disparities?  How likely is the overall plan for center to shorten the time from research to practical solutions to mitigating disparate health outcomes?  Will the proposed center employ novel approaches or methods for facilitating scientific interaction in the health disparities research?

Investigators: Are the PD(s)/PI(s), Project Leaders, and other key personnel appropriately trained and well suited to the organizational and scientific responsibilities of the proposed CPHHD?  Do recent publications by the investigators in the team demonstrate background and knowledge pertinent to the themes of the proposed CPHHD?  Is there evidence that the investigators are committed to productive, interdisciplinary interactions?  Do research projects have the appropriate mix of co-investigators from different disciplines?  Do the applicants propose (and document) appropriate collaborations with other scientists in the field, and with other community and medical partners?

Environment: Is there evidence of significant commitment of the participating institution(s) to fulfilling the objectives of the CPHHD?  Do the proposed research projects take advantage of any unique features of the environment that may facilitate the development of effective multilevel interventions?

Leadership and Administrative Core.  Is the leadership structure of the proposed center clearly defined and well-suited to the organizational and scientific responsibilities associated with the Center?  Is the organizational, scientific, and operational framework reasonable, well-integrated, and appropriate to the aims of the proposed CPHHD?  Is there sufficient oversight of Research Projects and Training Programs to ensure their integration for the overarching goals of the center?

Progress (for renewal applications only). How significant is the contribution of the applicants’ currently funded CPHHD to scientific knowledge in the field of health disparities and population health?  How well have the applicants accomplished the specific objectives proposed in the original CPHHD application?

B. Criteria for Individual Research Projects.

Overall Impact.  Reviewers will provide an overall impact 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 core review criteria, and additional review criteria (as applicable for the project proposed).

Core 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 or community interventions be advanced?  What will be the effect of these studies on the concepts, methods, technologies, treatments, services, and/or preventative interventions that drive this field?  How well will the multilevel interventions proposed translate into tangible benefits for the public and patients in terms of preventing or reducing the disparate burden of a disease?

Approach: Are the conceptual 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?  Is the approach sustainable in real-world settings such as the clinic, the hospital, the community, and the environment beyond the current study?

Innovation: Is the project original and innovative?  For example: Does the project challenge existing paradigms and/or community/clinical practice; address an innovative hypothesis and/or critical barrier to progress in the field?  Does the project develop or employ novel concepts, approaches, methodologies, tools, and/or technologies for this area?  Do the projects reflect awareness of national trends in health policy? 

Investigators: Are the investigators 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?  Does the investigative team bring complementary and integrated expertise to the project?  Do the investigators have a record of participation in multidisciplinary research?  Are co-investigators representing complementary disciplines enlisted for the projects, when appropriate?

Environment: Does the scientific environment in which the work will be conducted contribute to the probability of success?  Do the proposed studies benefit from unique features of the scientific environment, or employ useful collaborative arrangements?  Is there evidence of institutional support?  Is the project interactive with other components of the proposed center, conceptually, experimentally, and translationally?

C. Criteria for the Shared Resources Core(s) (all Shared Resources Cores will be assessed jointly).  How well do the proposed cores fit in the overall goals of the proposed center without overlaps or unaddressed needs?  Will the cores allow the proposed center, as a whole, to be responsive to the technical and scientific challenges that each of the individual projects may face?  Are the functions of the cores appropriately articulated?  How will the shared resources help the center meet requirements for dissemination and data harmonization as outlined in Section IV of this FOA?

D. Criteria for Training and Career Development Program. Is the interdisciplinary Training Program well justified, and does it describe a program that will successfully train investigators capable of establishing independent multidisciplinary health disparities research programs?  Are the proposed mentors in the Training Program experienced in the types of training proposed?  Is the process for selecting candidates for training adequate, and does it seek out and include qualified minorities, women, and individuals from underrepresented and underserved communities?

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.

Renewal Applications.  When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

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 score.

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

Select Agent 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).

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 (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) 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/archive/grants/policy/nihgps_2003/index.htm).

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:

Shobha Srinivasan, Ph.D.
Health Disparities Research Coordinator
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, EPS Room 6126, MSC 7338
Bethesda, MD 20892-7338 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: 301-435-6614
Fax: 301-594.-6787
Email: ss688k@nih.gov

Peter G. Kaufmann PHD, FABMR
Deputy Chief, Clinical Applications and Prevention Branch
Division of Prevention and Population Sciences
National Heart, Lung, and Blood Institute
6701 Rockledge Drive msc 7936
Bethesda, MD 20892-7936 (for U.S. Postal Service express or regular mail)
Bethesda MD 20817 (for non-USPS delivery)
Telephone: 301-435-2467
Fax: 301-480-5158
Email: kaufmannp@nhlbi.nih.gov

2. Peer Review Contacts:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: 301-496-3428
Fax: 301-402-0275
Email: ncirefof@dea.nci.nih.gov

3. Financial or Grants Management Contacts:

Ms. Crystal Wolfrey
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, EPS Suite 243, MSC 7150
Bethesda, MD 20892-7340 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: 301-496-8634
Fax:  (301)496-8601
E-mail: crystal.wolfrey@nih.gov

Ms. Gayle Jones
Grants Management Specialist
NIH/NHLBI/DERA/OGM
6701 Rockledge Drive, Suite 700, Room 7127
Bethesda, MD 20892
Phone number: 301-435-0166
Email: jonesgt@nhlbi.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 (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/archive/archive/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 on-line 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% 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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