Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Neurological Disorders and Stroke (NINDS)
Funding Opportunity Title	Stroke Prevention/Intervention Research Program (SPIRP) (U54)
Activity Code	U54 Specialized Center- Cooperative Agreements
Announcement Type	New
Related Notices	December 20, 2011 - See Notice NOT-NS-12-006. Notice of Technical Assistance Workshop.
Funding Opportunity Announcement (FOA) Number	RFA-NS-12-007
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.853
FOA Purpose	The National Institute of Neurological Disorders and Stroke (NINDS) invites applications for participation in the Stroke Prevention/Intervention Research Program (SPIRP). The goal of the program is to develop high-impact stroke disparities interventions and research projects that have the ability to reduce stroke disparities in minority communities in the United States using effective and culturally appropriate methods. Required components include: (1) an intervention or prevention project to reduce stroke disparities in minority communities; (2) at least one additional stroke disparities research project that will address knowledge gaps or opportunities to improve the understanding of stroke disparities (race/ethnicity, rural, or low socio-economic); (3) resource-related cores that are essential to accomplishing the Specific Aims of the proposed research project and provide training/education. This FOA will utilize the U54 activity code. The U54 mechanism is a solicited, multi-component award mechanism in which substantial NIH scientific and/or programmatic involvement is anticipated throughout the program.

Posted Date	December 6, 2011
Letter of Intent Due Date	March 3, 2012
Application Due Date(s)	April 3, 2012
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	June-July, 2012
Advisory Council Review	August, 2012
Earliest Start Date(s)	September 30, 2012
Expiration Date	April 4, 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.

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

The purpose of this funding opportunity announcement (FOA) issued by the National Institute of Neurological Disorders and Stroke (NINDS) is to solicit exceptional research applications for the Stroke Prevention/Intervention Research Program (SPIRP) that will directly and demonstrably contribute to the reduction of stroke disparities. This program will implement several scientifically rigorous stroke prevention/intervention projects in minority communities in the United States in addition to multiple research projects that address major contributors to stroke disparities. Another important goal is to train individuals or groups that will significantly contribute to stroke disparities research or significantly contribute to the implementation of stroke disparities intervention/prevention strategies.

This FOA directly responds to the recommendations provided by the NINDS Advisory Panel on Health Disparities (http://www.ninds.nih.gov/about_ninds/plans/NINDS_health_disparities_rpt.pdf) and the Health and Human Services plan for addressing health disparities (http://www.minorityhealth.hhs.gov/npa/files/Plans/HHS/HHS_Plan_complete.pdf).

Specific instructions are provided for the application submission and should be followed closely.

BACKGROUND

Stroke is the fourth leading cause of death and a leading cause of long-term disability. Stroke disparities are a major public health problem in the United States due to the higher incidence and prevalence of disease, excess mortality, and worse outcome in minority populations. To address these disparities, effective strategies that will directly reduce the incidence, morbidity, and mortality of stroke in racial/ethnic minority communities that are within the programmatic priority of NINDS are needed.

Scientific discovery, implementation of stroke prevention guidelines, and technological innovation have contributed to the reduction of stroke in the general population; however, racial/ethnic minorities (African Americans, Hispanic/Latinos, Asian American, American Indians/Alaska Natives, Native Hawaiians and other Pacific Islanders) continue to experience more strokes, worse outcomes, and more disability from stroke. Numerous valuable epidemiologic studies have documented the disproportionate burden of disease in these racial/ethnic groups; these studies have also identified potential intervention targets and areas for additional research. The knowledge gained from these epidemiology studies will be critically important to identifying comprehensive targets for prevention/intervention studies.

Developing and implementing prevention strategies or interventions that address health disparities, in general, and stroke disparities, specifically, are challenging. The underlying causes of the observed disparities are frequently complex and require multiple strategies or approaches to provide long-term solutions; therefore, we anticipate trans-disciplinary research will be needed for effective initiation and implementation of the proposed intervention/prevention research projects.

Purpose

The overarching goal of the NINDS Stroke Prevention/ Intervention Research Program is to develop high-impact stroke disparities interventions and research projects that have the ability to reduce stroke disparities in minority communities in the United States, using effective and culturally appropriate methods.

Overview of Program Structure

For the purposes of this announcement, stroke is defined broadly and may address ischemic or hemorrhagic stroke disparities in minority communities. The NIH has identified the following types of health disparities populations in the United States and its territories: race/ethnicity (African Americans, Hispanic/Latinos, Asian American, American Indians/Alaska Natives, Native Hawaiians and other Pacific Islanders), low socioeconomic status and rural populations. This announcement is to solicit two types of projects:

(1) a prevention/intervention project which must address racial/ethnic stroke disparities.

(2) stroke disparities research projects (up to four projects) which may address multiple types of health disparities (race/ethnicity, low socioeconomic status, and rural disparities).

Each SPIRP application (or program) must contain at least one stroke prevention/intervention project directly addressing racial/ethnic stroke disparities and at least one additional stroke disparities research project. (Programs may contain more than one prevention/intervention project.) The proposed components of each application should be designed to optimize the accomplishments of the program and the advancement of the SPIRP program goals.

Projects may use tools such as community engagement, decision analysis, economic analysis, and patient-centered outcomes to enhance the overall SPIRP. Behavioral and social sciences, including studies of the social determinants of health, are important and are encouraged. All projects must be stroke projects and relevant to the NIH and NINDS mission.

Numerous large-scale epidemiologic studies have documented the disproportionate burden of stroke and risk factors contributing stroke racial/ethnic disparities. These studies have also identified potential intervention targets and areas for additional research. The knowledge gained from these studies is critically important to identifying comprehensive targets for intervention studies. Therefore, we strongly encourage research projects that address prevention/intervention targets identified in large-scale epidemiology studies such as Reasons for Geographic And Racial Differences in Stroke (REGARDS), Brain Attack Surveillance In Corpus Christi (BASIC), Northern Manhattan Stroke Study (NOMAS), Atherosclerosis Risk in Communities (ARIC), and Greater Cincinnati/Northern Kentucky Stroke Study.

We encourage prevention/intervention projects and stroke disparities projects that include children.

Mobile technologies/devices are of particular interest to the NINDS.

Applications that do not contain a prevention/intervention project to address the racial/ethnic disparities of stroke will not be considered responsive to the FOA.

Stroke Prevention/Intervention Project

For each of the stroke prevention/intervention studies, the research team should include appropriate experts in subject areas such as stroke neurology, epidemiology, social and behavioral sciences, health policy, economics, biostatistics, and dissemination/implementation research. For the prevention/intervention project, applicants should clearly identify the scope and breadth of the targeted stroke disparities issues, the health and non-health components that contribute to the disparity, and the mechanisms that the intervention addresses. The applicant should quantify the expected improvement in the stroke disparity as measured by stroke reduction, lives saved, or reduced morbidity/mortality. Conceptual models identifying the cause and effect relationships of these elements should be included. The applicant should discuss the target population and expected populations for generalization of the intervention. Applications that include modeling that predicts the direct and indirect disparities reduction due to the intervention or prevention strategy are encouraged.

The primary outcome of this research must be clinically meaningful stroke reduction or stroke risk reduction in the defined population, clinical setting, or community setting. This improvement must be documented by reliable, objective and quantifiable measures. The adherence to the intervention must be documented and evaluated in the research design.

Research findings and interventions that work are not always implemented effectively. Therefore, the intervention/prevention project should include a plan to disseminate the project broadly which may include implementation at the state, regional, or national level. The plan should identify the principles used, potential to generalize, and scientific challenges of prevention/intervention scale-up. (More instructions regarding this section may be found in Section IV.2. Section II.)

Stroke Disparities Projects

The stroke disparities project(s) may range from basic science through outcomes research. There should be at least one stroke disparities project but no more than four. Additional prevention/intervention projects are of interest. The project(s) should aim to identify, monitor or target biologic, environmental, social, or healthcare system factors that result in stroke disparities due to racial/ethnic, rural, or socioeconomically disadvantaged populations.

Cores

Applications may have cores that are directly related and essential to the administration, training/education, or scientific function of the program. Cores that increase the impact or accelerate the research goals of the subprojects within each SPIRP are encouraged. The Administrative Core is a required element of the application. Other than the Administrative Core, all other Cores must be significant to the support of at least two of the proposed research projects.

Examples of the responsibilities of the Administrative Core and other potential types of cores are:

• Administrative Core (required) has personnel that includes a SPIRP Administrator, who will dedicate substantial effort to the administrative core activities and who will collaborate closely with the SPIRP Director. Functions of this core should include, but are not limited to, the following:
  • promote the integration and function of the SPIRP components and activities;
  • coordinate meetings with the NINDS or SPIRP meetings;
  • facilitate timely information and sample transfer to fulfill data sharing goals;
  • provide assurance of compliance with NIH policy requirements;
  • maintain the program website.
• Clinical Recruitment and Resource Core (CRRC) (optional) can provide support for clinical research projects of the SPIRP. This core cannot be proposed as a stand-alone entity without substantial contributions to the SPIRP projects. Responsibilities may include:
  • identify and follow a defined cohort of patients and/or control subjects;
  • collect standardized clinical data conforming to NINDS and NIH requirements;
  • collect efficiency and productivity metrics for accrual and retention;
  • provide standardized recruitment tools to participating sites;
  • enhance the efficiency of site activation;
  • lead development of communication plans and recruitment/retention strategies such as development of a recruitment mission statement, message development, message dissemination strategies, and specify target recruitment efforts;
  • promote patient education and community outreach, in the absence of a separate core.

Unique aspects of the assembled cohort must be described. Importantly, the CRRC must be utilized only to support components for which other funding or institutional resources are not available. Plans for any non-SPIRP research projects or trials that will utilize Core resources should be detailed within the application. Applicants must include a timeline of CRRC activities planned within the 5 years of SPIRP funding and describe any potential plans beyond this period of support.

• Research Cores (optional) must be integral to the aims of the SPIRP and of common utility. Applicants may propose additional research cores that provide specialized support to advance the aims of the SPIRP.

Proposed resource-related research cores should not include general resources that could be provided at an institutional level, nor should cores replace or centralize resources supported by individual projects. SPIRP applicants may, as needed, budget for use of institutional facilities (e.g. fees for shared equipment usage) or personnel (e.g. partial effort for technical assistance) within the research cores. However, there should be no functional overlap between proposed core facilities and other pre-existing core facilities at the applicant institution.

Research Education and Training Plan: (required) The NINDS requires that the SPIRP will play an important role in education and training that will contribute to stroke disparities research. This may be accomplished in several valuable ways including:

• Training the next generation of investigators;
• Training to support scientific research personnel (particularly in the Alaska Native, Native Hawaiian, and American Indian communities);
• Educating key community members or stakeholders such as community physicians, community health workers, or community health advocates/organizations so that they substantially contribute to stroke disparities research.

The proposed Research Education and Training Plan must include a plan of action and a defined goal to be accomplished. This goal must contribute to decreasing stroke disparities or significantly enhancing the ability to perform stroke disparities research in a stated community. The application should clearly define the value of the undertaken activities to stroke disparities research, the SPIRP, and the NINDS; these activities may address barriers to the advancement of stroke disparities research or the understanding of stroke disparities research.

Applications lacking a plan for research training and education will not be considered responsive to this FOA.

The SPIRP PD(s)/PI(s), project leaders, or core leaders must have an excellent record in successful mentoring or educating which must be documented within the overall education/training plan. Proof of institutional support for these efforts should be included.

Although the NIH does not require a specific format, each SPIRP is encouraged to consider instruction in the following areas: policies regarding the use of human and animal subjects; data acquisition, management, sharing and ownership; publication practices and responsible authorship; collaborative science; conflict of interest, responsible authorship and policies for handling research misconduct. The application should describe as appropriate the relationship to existing training resources and the resources available to assist transition to independence such as grant writing and mentorship.

The roles of SPIRP faculty within these education/training activities should be defined; optimally, all investigators will participate actively in these cross-training efforts. The proposed Research Education/Training Plan budget should not request funds for trainee or junior faculty slots.

Public Outreach and Dissemination: (required) Applicants must include outreach efforts as an integral part of the SPIRP. Outreach and dissemination activities should be detailed within the budget, whether included as part of the Administrative Core, Clinical Resource Core, or as a core. Planned activities should inform and educate the local patient or participant community about stroke or stroke disparities and the research efforts of the SPIRP, while in turn assisting each SPIRP in the design of studies that target outreach and research to the needs of people with stroke and their caretakers. Planned or established methods for effective outreach should be detailed. Where applicable, these activities should be coordinated with the SPIRP’s CRRC to recruit, retain and inform the patient cohort. Evidence of service to the local community should be documented.

Program Components

The SPIRP will be comprised of an Executive Committee, an Administrative Director for the Administrative Core, an external Program Advisory Committee (PAC), and the NINDS Program Director. In instances where the SPIRP has multiple PD(s)/PI(s), they will share responsibilities for ensuring their SPIRP meets the goals, objectives, and measurements for success proposed in the application and project periods; however, one PD/PI must be designated as the SPIRP Director.

SPIRP Director

The SPIRP Director must be an established leader in scientific research with appropriate expertise for the proposed SPIRP and have a proven expertise in research project and personnel management. The SPIRP Director must lead a project and/or core within the program. Other qualifying factors include current research funding, current productivity, and a capacity for visionary leadership of a trans-disciplinary team. The success of the program will require significant scientific and managerial oversight by the SPIRP Director, who will have overall administrative and scientific responsibility for overseeing the research design, implementation, and timely dissemination of results as well as for the proposed goals, outreach. The SPIRP Director will also be responsible for implementing the education and training plan, developing strategies for dissemination, and implementing a management plan, and will assume responsibility and accountability to the applicant institution and to the NINDS for the performance and proper conduct of the research in accordance with the Terms and Conditions of Award. The SPIRP Director should significantly contribute to the success of the program with responsibilities and effort clearly outlined in the application.

Administrative Director

Due to the size and scope of the program, each SPIRP must have an administrative director with expertise in grants management, who can demonstrate the ability to coordinate large research projects, and who has the ability to improve the efficiency of the program. The Administrative Director will be responsible for the activities of the Administrative Core and should not be the SPIRP Program Director. The Administrative Director should have expertise in the areas outlined in the Administrative Core description and should coordinate effectively with research projects and personnel, the cores, and educational activities of the program.

Research Project and Core Leaders

Project and core leaders must demonstrate a successful and meaningful history of leading scientific projects. The investigator should demonstrate excellent scientific productivity as supported by publications and contributions to science. These leaders should significantly contribute to the success of the program with responsibilities and efforts clearly outlined in the application.

Executive Committee

The SPIRP application should identify the leadership structure of the program which will comprise an Executive Committee, which will be the primary leadership structure of the program and will include the Program and Administrative Directors, project leaders and core directors. The Chair of the Executive Committee will be the SPIRP Program Director. The NINDS Scientific Program Director will be a voting, ex officio member of the Executive Committee. The Executive Committee will be responsible for regularly contributing to scientific and administrative decisions. The Executive Committee will meet annually in a face-to-face meeting with the Program Advisory Committee.

Program Advisory Committee

The independent and external Program Advisory Committee (PAC) is responsible for providing advice and guidance to the SPIRP. The PAC will conduct, at a minimum, an annual review of the goals of the SPIRP including goals related to training and career development, implementation of outreach activities, progress towards reaching the goals of the SPIRP as a whole, and progress towards reaching the goals of the individual projects. The PAC will generate a written report summarizing its evaluations and recommendations which will be advisory to the SPIRP. The NINDS Scientific Program Director is an ex officio member of the PAC.

The PAC is composed of at least three external advisors who will provide unbiased recommendations to the SPIRP. The composition of the PAC should include at least an expert performing research in the proposed minority community, a stroke expert, a statistician, and an expert in each of the proposed project areas so that there can be appropriate evaluation. The Program may consider having a community member or community health leader as a PAC member or PAC advisor.

A description of the PAC activities, including at least an annual face-to-face meeting, should be included in the application. Funds for the annual meeting will come from the SPIRP and should be budgeted through the Administrative Core. To avoid impacting the pool of potential peer reviewers or conflict of interest, PAC members should not be named, contacted, or selected until an award has been made.

Institutional Commitment

The institutional commitment will be important to each funded program. Letters from a high-level institution official(s) (e.g., Dean of the School of Medicine, Vice President for Research) should be attached confirming this commitment. If the proposed SPIRP involves a consortium arrangement between two or more institutions, the institution that submits the SPIRP application must receive formal written agreement(s) from the other participant organization(s). This agreement should clearly delineate the institutional commitment of the participating organization(s) (in the ways outlined above) to the Program. The institution should provide a statement that includes information regarding:

• how the program fits within the larger goals of the institution;
• support for activities integral to the scientific and administrative success including timely provisions for space and support personnel hires;
• use of valuable and necessary resources within the institution;
• time by the investigators to conduct the proposed research;
• plans for the support commitment to foster core and other activities including training, education and community outreach; and
• plans for institutional officials to interact with the program and PAC.

Other Special Requirements

Annual Stroke Disparities Meeting

To foster an environment for learning about stroke disparities research and activities, an annual meeting will be held to discuss scientific outcomes, administrative challenges, best practices for recruitment, and emerging issues. Participants will include each SPIRP PD(s)/PI(s), Administrative Director, the leaders for each research project, as well as NIH officials and invited participants from other government agencies and non-governmental organizations. The project leaders are expected to participate in the development of the agenda and to serve as the representative of his/her program at the meeting. Applicants should budget for travel to the annual meeting as a line item in the budget section entitled Annual Meeting. (This meeting is in addition to the annual PAC face-to-face meeting.

SPIRP Website

The SPIRP programs and their outcomes will be of interest to the scientific community. The Administrative Core for each program is expected to develop and maintain a website for use by the SPIRP program and interested parties. Website components should describe the scientific, educational, and outreach activities of the program. Applicants should budget for website development and maintenance in the Administrative Core budget entitled SPIRP Website.

Funding Instrument	Cooperative Agreement
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	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications. The NINDS intends to fund up to two awards, corresponding to a total of $1.5 million per year direct cost per program, for fiscal year 2012. Future year amounts will depend on annual appropriations.
Award Budget	Application budgets are limited to $1.5 million direct costs per program per year. The budget needs to reflect the actual needs of the proposed program.
Award Project Period	This is a one-time solicitation to fund programs for up to 5 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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Foreign institutions are eligible to apply; however, the participant population must be in the United States of America and the measures of efficacy or effectiveness for the project must be stroke reduction or stroke risk reduction in the United States of America.

Foreign (non-US) Institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the PHS398 Application Guide.

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.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• eRA Commons

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.

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.

The PD(s)/PI(s) of the program must be an established leader in scientific research with proven expertise in research project and personnel management. SPIRP Directors must lead a project and/or core within the program. Other qualifying factors include current research funding, current productivity, and capacity for visionary leadership of a trans-disciplinary team. The success of the program will require significant scientific and managerial oversight by the PD(s)/PI(s).

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. The multiple PD(s)/PI(s) strategy is allowed; however, it is the responsibility of the investigators and the applicant organization to make this determination. This decision should be determined by the scientific goals of the project. The structure and governance of the PD(s)/PI(s) leadership team as well as the skills, knowledge, and experience of the individual PD(s)/PI(s) will be factored into the review process as determined by the overall scientific merit of the application.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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. NIH will not accept any application that is essentially the same as one already reviewed.

The NINDS encourages collaboration between institutions for the submission of individual applications. There are no limitations on the number of inter-institutional partnerships that an institution may establish. An institution may be the lead organization on an application and the non-lead partner or consortium member on a separate and scientifically distinct application. Duplicative costs are not allowed. Applicants will be required to declare and resolve any real or potential scientific or budgetary overlap issues prior to the award.

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

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.

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 NINDS 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:

• Descriptive title of proposed research
• Name, address, and telephone number of the PD(s)/PI(s)
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

The letter of intent should be sent to:

Salina Waddy, MD
Program Director, Health Disparities
National Institute of Neurological Disorders and Stroke, NIH
Office of Clinical Research
6001 Executive Blvd, NSC, Suite 2205
Bethesda, MD 20892-9525
Rockville, MD 20852 (for Express/Courier Service)
Telephone: (301) 496-9135
Email: waddysp@mail.nih.gov

Pre-Application Meeting: The SPIRP staff is planning to host a technical assistance discussion in February 2012 for applicants to discuss this FOA and to ask specific questions. The time and format of this discussion will be announced in a separate Notice in the NIH Guide.

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:

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 3201
Bethesda, MD 20892-9529
Telephone: (301) 496-9223
Email: nindsreview.nih.gov@mail.nih.gov

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the exception of Project I as described in the second bullet below:

• The overview of the proposed SPIRP application is limited to 12 pages.
• The stroke disparities prevention/intervention project, which should be labeled as Project I, may include a Research Strategy section of up to 30 pages. The additional pages were permitted because of the required sections listed below in Section IV.2.Research Plan Subsection II.2.
• Project I is also required to have a Study Protocol. The completed Study Protocol for Project I should be included in the Appendix and should follow the Protocol Template at http://www.ninds.nih.gov/research/clinical_research/toolkit/protocoltemplate.htm.
• For each scientific project (up to 4 stroke disparities projects), the research strategy section is limited to 12 pages per project. If the program has more than one prevention/intervention project, the additional project is limited to 12 pages.
• The Administrative Core and Research Education/Training Plan may be up to 12 pages. All other Cores are limited to 6 pages.

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

Applications should include the following information in the relevant subsections:

Section I: Administration and Budget

1. Face Page (Form Page 1): Complete all items on the application's face page. For Item 2, check Yes, enter the number of this FOA and the title, "Stroke Prevention/Intervention Research Program (SPIRP) (U54)". The applicant should number succeeding pages consecutively with integers.

2. Description (Form Page 2): Project Summary and Relevance, Project/Performance Site(s), Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells

Describe briefly the proposed research program, indicate the research emphasis of the component Research Projects, and identify the purpose of the proposed core units. As well, list the relationship between each core and its corresponding projects; for example, Administrative Core (Core A) supports all projects and the overall SPIRP Accrual Resource (Core C) supports Project I Title (Project I) and Project IV Title (Project IV) Outreach Core (Core D) supports Project II Title (Project II) and Project III Title (Project III).

List all Senior/Key personnel and Other Significant Contributors engaged in the program. Use continuation pages as necessary, numbering consecutively.

3. Table of Contents: Do not use Form Page 3 of the PHS 398; a more comprehensive table of contents is needed for a multi-project application.

Bearing in mind that the application will be scientifically reviewed project by project and core by core, the Table of Contents should enable reviewers to readily locate specific information pertinent to the overall application as well as to each component research project and core. Each research project should be identified by number (e.g. Project I), title, and responsible Project Leader, and each Core should be identified by letter (e.g. Core A), title, and responsible Core Leader.

4. Budget (Form Page 4): prepare a series of composite budget tables for the U54 application as requested below, followed by a detailed budget for each Research Project component and each Resource Core.

A. Composite Budget

Use PHS-398 Form Page 4, "DETAILED BUDGET FOR INITIAL BUDGET PERIOD," to present the total budget for all requested support for the first year. For each category, such as "Personnel," "Equipment," etc., provide the amount requested for each Research Project component and each Core unit, with subtotals.

If consortium arrangements involving other institutions or organizations are proposed, include total (direct and indirect) costs associated with such third-party participation in the Consortium/Contractual Costs category. Costs for purchased services should be itemized under the "Other Expenses" category.

Use PHS-398 Form Page 5, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," to prepare a budget, by category, that provides totals for each year of requested support. Requests for any increases in succeeding years must be justified in the individual Research Project and Core budgets.

B. Budgets for Individual Research Project Components and Core Components

Detailed Budget for Initial Budget Period (use PHS-398 Form Page 4 for each)

Budget for Entire Proposed Project (use PHS-398 Form Page 5 for each)

Budget Justifications and Explanations:

Describe the specific functions of all key personnel, consultants, collaborators, and support staff. For all years, explain and justify any unusual items such as major equipment or alterations and renovations.

PLEASE NOTE: Consortium budgets (if applicable) should be presented as described in A, including budget for the entire proposed project period. Total direct and indirect costs of sub-awardees are to be shown under Consortium/Contractual costs on the individual component budget and a detailed sub-award budget is to be placed following the appropriate Research Project or Core budget.

5. Biographical Sketch:

Follow the instructions on the Biographical Sketch Format Page. This section must contain the biographical sketches of all individuals listed as Senior/Key Personnel and Other Significant Contributors, following the order listed on Form Page 2. Biographical sketches are required for all key personnel participating in the Research Project components and Cores. Begin with the U54 overall PD/PI and thereafter, in alphabetical order, submit biographical sketches as described in the Instructions for Form PHS-398.

6. Resources:

Complete the "Resources & Facilities" page of PHS-398 for the overall project. Briefly describe the features of the institutional environment that are or would be relevant to the effective implementation of the proposed program. As appropriate, describe available resources, such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographical distribution of space and personnel, and consultative resources.

SECTION II - RESEARCH PLAN

Include a detailed Table of Contents with pagination (numeric only) at the beginning of Section II.

Identify each Research Project and each Core by title. Assign each Research Project component a Roman numeral (I, II, III) and assign each Core unit a capital letter (A, B, C) that reflects the order in which they are presented. The required prevention/intervention project should be identified as Project I. The required Administrative Core should be identified as Core A. The Research Education/Training Plan should be designated Core B.

For each Research Project and Core, provide the name of the responsible investigator, and biographical sketches for personnel not identified previously.

1. Overview of the SPIRP Program (12 pages)

A. Purpose of the Program. Discuss the overall SPIRP's objectives and general plans for the proposed grant period. Include a vision statement for the program, including overarching goals to be achieved. Justify the proposed multi-disciplinary or trans-disciplinary approach and the use of the specialized Center mechanism (U54) to achieve stated goals.

B. Administration, Organization, and Operation. The PD(s)/PI(s) should describe how the Scientific Leadership, Administrative Leadership, and Project Leadership will be coordinated. Include information on the support and commitment of the parent institution for the program, the authority of the PD(s)/PI(s), the use of program advisory committee (PAC), and space assignment. Describe the organizational framework and provide an organizational chart. The expertise to be represented in the PAC should be described, but potential members of the committee should NOT be named and letters from such individuals should NOT be included.

C. Research Program. Discuss the proposed research program. Describe the relationship between the projects and the Cores and their relationship to the goals of the program. Detailed descriptions of preliminary data for projects should be included within the relevant subproject section, not in the Overview. Provide summary evidence for feasibility and preliminary findings that support the formation of a SPIRP. The application should present compelling evidence that the assembled research team will work together effectively to accomplish the goals of the proposed program and advance research in stroke disparities including intervention/prevention research. Highlight the potential to collaborate with existing stroke disparities investments. Provide examples of contributions to cardiovascular, stroke, and stroke disparities research.

D. Description of Assurances and Collaborative Agreements. Provide an overview and rationale for any collaborative and cooperative endeavors or subcontracts. Cost sharing or institutional support, if any, should be described in this section. When multiple institutional sites are involved, a detailed description of the cooperative administrative arrangements should be included. Letters of agreement for these arrangements are included in Item 4. Letters of Assurance/agreement as described below.

2. Research Projects

Identify each project by a Roman numeral (I, II, III...) and a title. The required stroke disparities prevention/intervention project should be labeled as Project I.

Follow the format and instructions for Form PHS-398 (http://grants.nih.gov/grants/funding/phs398/phs398.html).

Begin the presentation of each Research Project component on a separate page, and include the following:

A. Research Project Cover Page (1 page) with Title of Project, Project Leader Name, Title, and Affiliation of Research Project Leader, and then names titles, and affiliations of other investigators

B. Description: Project Summary and Relevance (1 page; use PHS-398 Form Page 2): Discuss the purpose and nature of the project and its relevance to the SPIRP.

C. Content of Research Plan (Begin each section with a section header)

Specific Aims (1 page)

Research Strategy (30 pages for Project I; 12 pages for all other projects); Significance, Innovation, and Approach): Start each section with the appropriate section heading Significance, Innovation, Approach.

The topics below should be incorporated into the projects as appropriate. Some topic areas are required by the program or by the projects. Please follow the instructions carefully. In the application, please include the section heading.

(A) Culturally-Tailoring the Projects

Culturally-tailoring a project can contribute to program effectiveness. Cultural tailoring is the application of cultural competence to a project by anticipating, planning and addressing the needs, preferences or circumstances of a specific group. Culturally-tailored projects address the barriers that have been shown to contribute to lack of acceptance or lack of participation in research.

These barriers may also be important confounders in the proposed research project. For these reasons, the proposed projects (when appropriate) should be culturally-tailored so that the end product may be accurately evaluated and accepted by the target community. Methodologies can include the use of focus groups, patient interviews and surveys, cultural adaptation of process (e.g., engaging treatment delivery system, community leaders, community advisory committee, or family), or content adaptation (e.g., using appropriate language, concepts, or goals).

Culturally-tailored considerations and methods are a necessary and required element and should be a highlighted section of the intervention/prevention project. This is a critical element in the application; applications without this section may be considered not responsive to the initiative. The plan for cultural tailoring should be included in the Approach section of the Research Strategy.

(B) Recruitment and Outreach Plan

Applicants should provide details regarding their ability to recruit in the study population. This is a required element of Project I. This description may be as a separate core or described in the body of the research plan. (Please see Clinical Recruitment and Resource Core description.) A detailed subject recruitment and retention strategy is required, including strategies for outreach to minority communities and for retention of minority subjects. Details including (1) individual site projections, (2) efficiency and productivity metrics such as tracking the effectiveness and outcomes of recruitment strategies employed, (3) strategies for efficient site activation, and (4) use of standardized recruitment tools for participating sites should be included. Applications should demonstrate access to the population through letters from key population leadership that the community is accessible and willing to work with the investigative team. These letters may be included in the Appendix and referred to in the research plan or core. Accessibility can be best demonstrated by previous publication and research track record for the stroke disparities research in the population proposed.

The application should provide details regarding community outreach to support enrollment and to foster the community engagement that is frequently needed for successful stroke disparities research. This may include how participants will be included in the conception, planning and implementation of the studies so that a stroke partnership between investigators and the community can foster successful recruitment. The applicant organization may consider working with key community stakeholders including community health care providers and community health leaders. This plan should be included in the Approach section of the Research Strategy with corresponding letters of support. The letters of support should be included in the Appendix. Details should be provided that identify the structure/mechanisms for providing research information back to the community.

(C) Understanding Assumptions, Measurements and Influences

Please provide information that addresses Assumptions, Measurements and Influences in the Approach section of the Research Strategy. This is a required element of Project I.

The applicant should include details of potential and known mediators and moderators that may influence the intervention's success as well as provide a discussion regarding their presumed mechanisms. Please denote which are mediators and which are moderators. Also discuss how mediators and moderators will be measured and included in the analysis.

If the intervention is a multi-component intervention, please discuss the design, process and methods that will be used to test individual components and the impact of the multiple components as a whole. Describe the process that will be used to determine the active elements for effectiveness (e.g. describe the process to identify which elements are the critical elements that must be included for dissemination).

Lastly, clearly identify the appropriate measurements that are needed to support the theory or hypothesis. Applications should include a discussion of the timing of the measurements.

(D) Future Directions Plan

In the Approach section, the application should include a plan for how the intervention can be implemented in other communities, regionally, or nationally. This section is important and should discuss the next steps for the prevention/intervention strategy if it is found to be successful. The plan should identify the principles used, potential to generalize, and scientific challenges of prevention/intervention scale-up including the barriers and facilitators, potential community targets, comparisons between the scale-up communities and the studied community, and stakeholders for implementation. Additionally, this section should include the aspects of the program that are flexible and adaptable as well as the limitations to adaptation, discuss the components that can to be applied to other communities of the same or different racial/ethnic groups, how the barriers to scale-up/dissemination will be identified, the methods/tools for dissemination, and anticipated scientific challenges to dissemination. This is a required element of Project I.

Also include a plan to use the information learned through the intervention/prevention project that will inform (1) the next steps and (2) the processes that will be undertaken to adjust theories/assumptions that were made in the proposed project.

(E) Common Data Elements

To increase the yield of the programs and improve comparisons between studies funded by the SPIRP initiative and other funded programs, the NINDS common data elements (CDEs) which promote standardization should be used. More information about NINDS CDEs can be found at http://www.commondataelements.ninds.nih.gov/Stroke.aspx . A plan to incorporate the NINDS CDEs should be included in the Approach.

(F) Study Protocol for Project I

Project I is also required to have a Study Protocol which should follow the Protocol Template at http://www.ninds.nih.gov/research/clinical_research/toolkit/protocoltemplate.htm. The completed Study Protocol for Project I should be included in the Appendix.

Additional Instructions

The application should include a description of the anticipated barriers to recruitment and the plans (including novel approaches) for addressing these barriers. The proposed solutions to recruitment may not include the request of additional funds under this FOA.

Projects should include information on Preliminary Studies. Provide the supportive rationale for use of specific core services including why the core services are needed and the advantages and cost effectiveness of core usage for the project.

For off-site projects, justification should be provided for the project's location and plans for interaction and cooperation with the other components of the program should be addressed.

3. Cores

Identify each proposed Core by a letter (A, B, C...) and a title (e.g., Administrative Core, Clinical Core, etc.). The Administrative Core should be designated Core A. The Research Education/Training Plan should be designated Core B. A full description of each core is to be provided following the format presented in Form PHS-398. Begin the presentation of each Core on a separate page.

Include the following:

A. Core Cover Page (1 page) that includes the title of the core, and the name, title, and affiliation of the Core Director.

B. Description: Project Summary and Relevance (1 page; use PHS-398 Form Page 2): Include an Abstract that identifies and describes the purpose of the proposed Core. Summarize the Core overall objectives.

C. Specific Aims (1 page)

D. Core Structure, Administration and Services Provided (12 pages for Administrative Core; 6 pages for any other cores): include justification of services provided in terms of planned contribution to the SPIRP productivity and quality. Include organizational charts as needed. For research-related cores, list research projects that will utilize the core, and provide the percentage use by each subproject. Each core must support at least two projects (except the Administrative Core which supports the entire SPIRP). The relationship of the core to the corresponding projects should be described in the core description and supported in the corresponding Research Strategy of each supported project.

4. Research Education/Training Plan

The NINDS expects that the SPIRP will play an important role in education and training that will contribute to stroke disparities research. The Research Education/Training Plan may be up to 12 pages and should be labeled as Core B.

Research education and training may be accomplished in several valuable ways:

• training the next generation of investigators;
• training to support scientific research personnel (particularly in the Alaska Native, Native Hawaiian, and American Indian communities);
• educating key community members or stakeholders such as community physicians, community health workers, or community health advocates/organizations so that they substantially contribute to stroke disparities research.

The application should include the plans to include research education and training in the program.

Research training plan may be supported by a track record of successful cardiovascular/stroke disparities research training or research education training. A table to support this training/education track record may be included in the Other Attachments section of the application. The table should include the name of the trainee, level of training and duration, name of mentor/advisor, and current position. Please provide information to assess the outcomes of trainees and note which trainees are members of any of the following groups: individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Applications should include the performance and outcomes for diversity workforce efforts in cardiovascular/stroke disparities research training or research education training at a given Institution for review.

5. Letters of Assurance/Agreement: any arrangements for collaborative and cooperative endeavors or subcontracts should be highlighted. Include letters of agreement from consultants. For projects to be conducted off site, i.e., at an institution other than the applicant institution, a PHS-398 face page or other documentation, signed by the off-site institutional officials, must be submitted with the application.

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, with the following modifications:

• All applications, regardless of the amount of direct costs requested for any one year, should address Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan).
• Information sharing is an important element of the program. Applications should include in the Resource Sharing Plan strategies that will support sharing activities. This may include, but is not limited to, language in the consent form that allow for shared data, shared samples, or data access.

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, with the following modifications:

• The study protocol (required and formatted using the NINDS protocol template: http://www.ninds.nih.gov/research/clinical_research/toolkit/protocoltemplate.htm), Clinical Investigator’s Brochure or equivalent, as well as any of the other items relevant to the protocol (e.g., the consent form, documentation to access the study population, etc.), are to be submitted as appendices. The study protocol should be inserted as the first item in the appendix.
• Applications are expected to include letters of support for the Recruitment and Outreach Plan.

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.

This initiative is not subject to intergovernmental review.

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.

Applications must be received on or before the due date in Part I. Overview Information.

If an application is received after that date, it will not be reviewed.

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

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

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.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the program 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 program proposed).

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 program/project address an important problem or a critical barrier to progress in the field? If the aims of the program/project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

• Will the proposed research program/project have a clinically meaningful effect on racial/ethnic stroke disparities that will influence clinical practice, clinical guidelines, or community action?
• Are the overall goals for the SPIRP clearly defined? If the goals of the program/project are reached, how will stroke disparities research be advanced?
• To what extent can the findings be applied to similar communities or other populations?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the program/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?

• Are the SPIRP Director and leadership capable of providing the scientific leadership and administrative oversight required to lead the SPIRP?
• Does the SPIRP Director have sufficient leadership experience with trans-disciplinary teams or multidisciplinary teams and with disparities research?
• Are the PD(s)/PI(s) and other key personnel appropriately trained and well suited to carry out this work?
• Is the work proposed appropriate to the experience level of the PD(s)/PI(s) and other researchers? Do the PD(s)/PI(s) and the investigative team bring complementary and integrated expertise to the project (if applicable)?
• Are the process and procedures for the governance and organizational structure complete and feasible?
• Is there evidence that the SPIRP research team has sufficient knowledge of contemporary stroke disparities and intervention research approaches, appropriate expertise in the key cultural and community factors that can influence the success of the research projects, as well as sufficient interactions with key stakeholders in the community or target population to successfully implement the research projects?
• Is there a clear and appropriate delineation of the roles and responsibilities in the Program and are the duties appropriate?
• Is there a sufficient commitment made by each of the investigators and staff members to ensure the success of the individual projects and the SPIRP as a whole?
• If the program/project includes multiple PD(s)/PI(s), is there a sound rationale for the use of the multiple PD(s)/PI(s) option that will enhance the SPIRP? Are the roles and responsibilities clearly defined?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

• Does the program test at least one intervention that is innovative or essential to address a known racial/ethnic disparity?
• Is the proposed intervention research (Project I) focused on making a clinically meaningful impact on stroke disparities in a health disparity population? Will Project I influence any of the following: clinical practice, health policy, community and/or individual action?
• Does the program use a mobile technology or device as an important part of the intervention or project?
• Do the projects test new or tailored/targeted interventions, new combinations of interventions, and/or apply or translate existing interventions to the health disparity population/care providers/stakeholders for the first time?

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?

• Is the intervention/prevention research project culturally-appropriate and culturally-tailored?
• Are the methods used for cultural-tailoring appropriate, and do they enhance the research project?
• Are the mediators, moderators, and measurements appropriate for the project and hypotheses?
• Are the data points sufficient and project design appropriate to inform the next steps for scientific study or dissemination?
• Is the future directions plan thoroughly developed? Does it address the anticipated challenges for broad dissemination of interventions? Are there plans to collect data that will identify effective strategies for the dissemination of new interventions?

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?

• Does the proposed SPIRP have the resource commitments from the institution or other organizations to provide appropriate support for the SPIRP and outreach to the community regarding the proposed program?
• Are the processes for coordinating, maintaining partnerships with the community appropriate?
• Are the roles and responsibilities of the Program Advisory Committee clearly defined and appropriate?
• Is the process for forming and maintaining the Program Advisory Committee appropriate?
• Is there evidence of institutional support?

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.

Research Education/Training Plan

• Is the research education/training plan appropriate and does it identify/address the major need of the stroke disparities research field?
• Do the personnel identified within the plan have the appropriate expertise to carryout the research education/training activities?
• Is there a plan to provide opportunities outside of the applicant organization such as through collaborating organizations, national meetings, or across health systems?
• Does the applicant propose innovative methods in identifying sources of trainees, and in recruiting, training and providing career development of new stroke disparities investigators including junior investigators, individuals from diverse backgrounds?
• Is there a successful track record for training individuals including diverse individuals in cardiovascular disease/stroke disparities? (See table in Appendix)
• Is there a plan to train diverse individuals in the proposed program?
• Are projections of the numbers of trainees or those to be educated realistic?

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.

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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select 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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NINDS, 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:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

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 Neurological Disorders and Stroke (NANDS) Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

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.

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.

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

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

Awardees are hereby notified that they may be contacted during or after the completion of this award for information and assistance in assessing the overall impact of the program

Future year funding is contingent upon persistent satisfactory performance with respect to the goals of the SPIRP. The NINDS reserves the right to curtail, withhold, or terminate support for the SPIRP overall, or for individual participating projects or allied participant recruitment centers in situations including: a) inadequate recruitment, follow-up, data reporting, or quality control; b) a major breach of a study protocol; c) a substantive change in the agreed-upon protocol to which the NINDS does not agree; d) statistical evidence that a major study endpoint has been reached ahead of schedule in a clinical trial or clinical study; or, e) human subject concerns or ethical issues that dictate a premature termination. Prior to taking such actions, NINDS will consult with and receive recommendations from an advisory group.

The PD(s)/PI(s) will have the primary responsibility for the program and projects as outlined above.

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

NINDS staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• The NINDS will be involved substantially with the awardees as a partner in providing overall scientific guidance and support consistent with the cooperative agreement mechanism. The NINDS Scientific Program Director will review the scientific progress and may recommend to the NINDS to withhold support, suspend, or terminate an award for lack of scientific progress. The NINDS Administrative Program Director, together with the NINDS Grants Management Specialist, will provide fiscal and administrative oversight of the Center.
• The NINDS Scientific Program Director whose name appears on the Notice of Award will be responsible for the normal stewardship responsibilities such as routine performance monitoring of the projects and cores, including matters of quality control within and among various components, progress of studies and components, and in evaluating patient recruitment and compliance with protocol of studies conducted by the SPIRP. The NINDS Scientific Program Director will have overall responsibility to assure the scientific and technical integrity of the SPIRP on behalf of the Institute.
• The NINDS Scientific Program Director will have substantial scientific-programmatic involvement that is above and beyond the normal stewardship. It is the role of the NINDS Scientific Program Director to act as a facilitator and partner and not to direct the activities of the study investigators.
• The NINDS Scientific Program Director will participate with and assist:
  • the Executive Committee, as a voting, ex officio member in performance monitoring of the entire study including matters of quality control within and among various components, and in the determination of inadequate patient recruitment, failure to comply with the protocol on the part of participating centers, failure to meet goals and measure of success for any of the SPIRP components;
  • the Executive Committee, as applicable, in oversight of all participant safety monitoring activities;
  • the SPIRP researchers in technical aspects of protocol design and implementation as well as in the design of other research activities;
  • the SPIRP in the preparation and review of study results for publication; and
  • as an ex officio member of the PAC.
• The NINDS Scientific Program Director will have access to data generated under the cooperative agreement. Information obtained from the data may be used by NINDS for the preparation of internal reports on research activities. However, awardees will retain custody of and have primary rights to the data developed under the cooperative agreement.
• The NINDS will be responsible for approving all new projects prior to their initiation, major changes to existing projects (alterations in scope and effort), and termination of projects.

Areas of Joint Responsibility include:

• participation on the Executive Committee and
• development of the annual meeting.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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.

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

Pre-Application Meeting: The SPIRP staff is planning to host a technical assistance discussion in February 2012 for applicants to discuss this FOA and to ask specific questions.

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

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: commons@od.nih.gov

Salina Waddy, MD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: (301) 496-9135
Email: waddysp@mail.nih.gov

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: (301) 496-9223
Email: nindsreview.nih.gov@mail.nih.gov

Tijuanna DeCoster, MPA
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: (301) 496-9231
Email: decostert@ninds.nih.gov

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.

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.