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Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Minority Health and Health Disparities (NIMHD)

Funding Opportunity Title

NIMHD Community-Based Participatory Research (CBPR) Initiative in Reducing and Eliminating Health Disparities: Planning Phase (R24)

Activity Code

R24 Resource-Related Research Projects

Announcement Type

Reissue of RFA-MD-05-002

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-MD-12-006

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.307

Funding Opportunity Purpose

The National Institute on Minority Health and Health Disparities (NIMHD) invites applications for this Funding Opportunity Announcement (FOA) to plan the development of effective interventions using community based participatory research (CBPR) approaches. Support will be provided to develop and strengthen partnerships between researchers and health disparity communities to plan and pilot interventions for a disease or condition to reduce health disparities.

Key Dates
Posted Date

April 24, 2012

Letter of Intent Due Date

May 27, 2012

Application Due Date(s)

June 27, 2012

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

July 2012

Advisory Council Review

August 2012

Earliest Start Date(s)

January 2013

Expiration Date

June 28, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose and Background

The goal of this FOA is to support partnerships between health disparity communities and researchers to engage in community-based participatory research (CBPR) to plan and implement interventions to reduce health disparities. Community-based participatory research is defined as scientific inquiry conducted in communities and in partnership with researchers. The process of scientific inquiry is such that community members, persons affected by the health condition, or other key stakeholders in the community’s health have the opportunity to be full participants in each phase of the research (from conception-design-conduct-analysis-interpretation-conclusions-communication of results). CBPR is characterized by substantial community input in the development of the grant application.

The benefits of the CBPR are numerous and include the creation of bridges between scientists and communities that facilitate the transfer of knowledge and skills. CBPR results in the creation of culturally-appropriate and effective interventions that improve a community s health and well-being when done successfully. The ultimate outcome of CBPR is to foster sustainable efforts at the community level that will accelerate the translation of research advances to health disparity populations and eliminate health disparities.

The National Institute on Minority Health and Health Disparities (NIMHD) is interested in supporting applications that propose to develop and strengthen partnerships between health disparity communities and researchers to plan the implementation of effective health interventions that will improve community health and reduce health disparities. For the purposes of this FOA, the following definitions apply:

Research Objectives

The NIMHD Community-Based Participatory Research (CBPR) Initiative was designed to support community-based participatory research in planning, implementing, evaluating and disseminating effective interventions for diseases disproportionately affecting racial and ethnic minority populations, populations with low socioeconomic status, and medically underserved populations living in rural areas in the U.S. The NIMHD CBPR Initiative has three phases: Planning, Intervention, and Dissemination. The initial phase, the CBPR planning phase, is a three-year grant followed by a competitive five-year intervention grant, and concludes with a competitive three-year dissemination grant. Subsequent grant awards will be based on scientific merit, progress, quality of the research proposal, and availability of funds. In 2005, NIMHD (then NCMHD) invited applications for the very first CBPR planning phase (RFA-MD-05-002).

Applicants of this FOA should submit an application proposing a three-year plan to develop and strengthen a partnership with a defined health disparity community and a plan for intervention research using the principles of CBPR. The three-year CBPR plan should include: community needs assessment, plans to identify the disease/condition for intervention research, and plans to develop the intervention methodology during the first year of the grant. During the second and third year, a pilot intervention research study must be conducted. The pilot should assess the feasibility/acceptability of the developed intervention as well of the process of conducting a CBPR intervention study, including collaborative oversight of data collection, sharing of interim data, and disseminating results to community stakeholders and scientific audiences. The project must include co-leadership by research and community partners, and all activities proposed in the application must include substantial input from the targeted community using CBPR principles.

Specific Areas of Research Interest

Appropriate topics include, but are not limited to those listed below:

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIMHD intends to commit $10,000,000 in FY 2013.

Award Budget

Application budgets need to reflect actual needs of the proposed project and are limited to $250,000 direct costs per year. Facilities and administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation; see NOT-OD-05-004 .

Award Project Period

The maximum project period is three years.

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

Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

Eligible individuals must have experience working with health disparity populations as evidenced by previous community activities and/or evidence of previous partnerships with community-based organizations.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Only one application per institution is allowed. For the purposes of this FOA, separate institutions of higher education are those entities governed by different Chancellors or Presidents.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Although a single institution or organization must be the applicant, one or more partners or multi-institutional arrangement (consortium) is required. Such an arrangement must include a:

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

Robert Nettey, MD
Office of Extramural Research Administration
National Institute on Minority Health and Health Disparities (NIMHD)
6707 Democracy Boulevard, Suite 800
Bethesda, MD 20892
Telephone: 301-496-3996
Email: [email protected]

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

Robert Nettey, MD
Office of Extramural Research Administration
National Institute on Minority Health and Health Disparities (NIMHD)
6707 Democracy Boulevard, Suite 800
Bethesda, MD 20892
Telephone: 301-496-3996
Email: [email protected]

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed.

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Research Strategy

Letters of Support

Letters of support and/or Memorandum of Agreement (MOA) or Memorandum of Understanding (MOU) from each partnering organization that describe the working relationships with the applying organization must be provided.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS398 Application Guide.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates.

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

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 only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Key Personnel

Applications in which the PD/PI is not from a community-based organization, must include at least one personnel from the partnering community-based organization as key personnel with a minimum of 3 calendar months per calendar year or equivalent effort for academic calendars or other appointments (compensated or contributed)

Community Advisory Board

Applicants must have an established or plans to establish a community advisory board (CAB) consisting of community members and scientific representation to facilitate dissemination, implementation, and evaluation efforts.

Meeting

Program Director(s)/Principal Investigator(s) (PD/PIs) will be expected to attend an investigator's meeting to share concerns, measurement and design strategies, and methods and approaches to planning and implementing interventions with health disparity communities. This meeting is expected to take place in the spring of 2014 in the Washington DC area. Funds for travel to this meeting should be included in the application budget request. Applicants are strongly encouraged, but not required, to plan and budget for other senior/key staff to also attend the meeting.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NIMHD, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Responsiveness criteria include, but are not limited to:

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

It is essential that applicants for this FOA for the three-year planning phase of the NIMHD CBPR Initiative demonstrate competencies in applying the CBPR approach and a history of working with health disparity communities. Applications should include plans to facilitate substantial community involvement in all aspects of the research project. Demonstrated understanding of the target community's assets and probable health needs or concerns for which to plan an intervention research study is crucial for the evaluation of the application's merit.

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

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific 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 project improve the methods of intervention approaches, particularly with health disparity populations? What is the potential impact of the project in reducing health disparities through increased knowledge and/or social change resulting from the community partnerships?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, 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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?Does the investigative team have experience in prior CBPR efforts? Are the community partners representative of and engaged with the targeted community?

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?Will innovative ideas result from community participation in developing methods, and/or intervention approaches? How will community input generate innovative approaches to overcoming research challenges?

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 there plans to involve the community in all phases of the research effort? Will the strategy for community involvement enhance recruitment, retention, measurement design, data collection, and analysis/interpretation? Is there a discussion of potential limitations of the study design and/or the CBPR approach and plans to address these concerns?

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?Will the proposed study take advantage of the unique features and assets of the community environment? Is there evidence of institutional and community support through letters or descriptions of prior collaborations?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Translation Potential

Will the proposed project and plans for community involvement foster the community's acceptance and adoption of the intervention? Are adequate supports and resources (including community compensations) in place to ensure that community partnerships will be sustained throughout the research process? Will the proposed CBPR approach enhance the potential for dissemination and long-term sustainability?

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. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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 on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider 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

Not Applicable

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; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s)convened by the NIMHD, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Minority Health and Health Disparities. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, 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 the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Scientific/Research Contact(s)

Paula Y. Goodwin, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8770
Email: [email protected]

Peer Review Contact(s)

Robert Nettey, MD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-496-3996
Email: [email protected]

Financial/Grants Management Contact(s)

Priscilla Grant, JD, CRA
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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.


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