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

Limited Competition: Research Centers in Minority Institutions (RCMI) Translational Research Network (RTRN) (U54)

Activity Code

U54  Specialized Center-Cooperative Agreement

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-MD-12-005

Companion FOA

None

Number of Applications

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

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

93.307

FOA Purpose

The Research Centers in Minority Institutions (RCMI) Translational Research Network (RTRN) was established in 2007 to enhance collaboration across RCMI institutions.  It includes multiple academic institutions, clinical sites, community health care providers, and community groups that have a goal of developing and conducting clinical and translational research on those diseases that disproportionately impact minority populations, and on health disparities in general.  The network is designed to engage all stakeholders in the translational research process, increase the quality and efficiency of clinical and translational studies, facilitate study participant recruitment and retention, and increase the efficiency of the implementation and dissemination of research advances to improved health outcomes.

The purpose of this funding opportunity announcement (FOA) is to provide infrastructure to support overall network coordination, expand the Research Coordinating Center (RCC) functions, and support Data Coordinating Center (DCC) functions of the RTRN. Applications responding to this FOA are limited to grantees currently funded via the Research Centers in Minority Institutions (RCMI) Infrastructure for Clinical and Translational Research (RCTR) and /or the Research Centers in Minority Institutions (RCMI) G12 Centers programs.

Key Dates
Posted Date

June 6, 2012

Letter of Intent Due Date
Application Due Date(s)

August 9, 2012

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

August 2012

Advisory Council Review

August, 2012

Earliest Start Date(s)

September, 2012

Expiration Date

August 10, 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

1. BACKGROUND

The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; improve the quality of the educational and training environment; balance and broaden the perspective in setting research priorities; improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and improve the Nation's capacity to address and eliminate health disparities. To address this compelling need, the National Institute on Minority Health and Health Disparities provides laboratory scientists and clinical researchers in minority institutions with the environments, tools and training they need to understand, detect, treat and prevent a wide range of diseases with the goal of building capacity to bring effective prevention and treatment strategies more quickly into practice.   

Minority institutions historically have trained professionals who provide health care to minority populations and they are uniquely positioned to engage minority populations in research and in the translation of research advances into culturally competent, measurable and sustained improvements in health outcomes.  The Research Centers in Minority Institutions (RCMI) program was established by NIH in 1985 as a result of congressional interest in the development of a program to expand the national capability for research in the health sciences.  Through the development of research infrastructure in minority institutions, their potential to contribute to research advances that are necessary to eliminate disparities in health and disease experienced by members of minority communities is greatly enhanced.  The RCMI Translational Research Network (RTRN) was established in 2007 to enhance collaboration across RCMI institutions.  It includes multiple academic institutions, clinical sites, community health providers, and community groups that have a goal of developing and conducting pre-clinical, clinical and translational research on those diseases that disproportionately impact minority populations, and on health disparities in general. 

Translating recent discoveries into better treatments for people disproportionately burdened by diseases, requires a different approach, not the least of which are efficient clinical trials requiring collaboration, cooperation and coordination among investigators, research participants and other members of the local community, health care providers, funding agencies and industry partners.  Typically, a consortium of clinical sites is created for each new multi-center study.  This causes redundancy, delays, and excess costs because infrastructure is duplicated.  Further delays in implementing studies include, but are not limited to, approvals at multiple Institutional Review Boards (IRBs); loss of expertise as experienced research coordinators or other trained members of the research team move to other fields or positions after a trial is completed; and failure to enroll and retain the number and diversity of participants needed.  A translational research network can increase the efficiency of research by providing infrastructure, centralized resources, and access to study participants; however, with the vast array of health outcomes that disproportionately impact minority populations creating multiple specialized research networks for each disease entity will not be feasible.   

2. OBJECTIVE

The objective of the RCMI Translational Research Network (RTRN) is to increase the efficiency of clinical and translational research through a single network that leverages shared infrastructure for NIH studies.  RTRN is not specific to one disease, but rather shares expertise and infrastructure across diseases and disciplines, leverages research resources at RCMI sites, and enables the flexibility to take advantage of research opportunities and address research needs as they arise in different disease areas. RTRN is a resource to support both exploratory studies and large studies.  In addition, it is a resource for engaging a broader spectrum of scientists and community partners in the translational research process, in the dissemination of research findings, and in the development and adoption of best practices to improve health outcomes.

The purpose of this funding opportunity announcement (FOA) is to provide infrastructure to support overall network coordination, expand the Research Coordinating Center (RCC) functions, and support Data Coordinating Center (DCC) functions of the RTRN. 

For the purposes of this initiative, the following definitions will apply:

”Clinical research” comprises studies and trials in human subjects as defined in the PHS 398 instructions (http://grants.nih.gov/grants/funding/phs398/phs398.pdf).

”Translational research” includes research that aims to convert basic research advances to practical applications in humans, and research aimed at the adoption of best practices in community healthcare.

The FOA provides funding through the U54 cooperative agreements mechanism. As a cooperative agreement, implementation will involve participation of NIMHD program staff in the planning and execution of the proposed activities.  During the execution of the project, NIMHD staff will assess progress toward and achievement of milestones prior to releasing funding for each year of the award. 

NIMHD will accept applications that name Multiple Program Director(s)/Principal Investigator(s) http://grants.nih.gov/grants/multi_pi/ as key personnel on applications. Applications designating multiple PD(S)/PI(s) should include a section of the research plan, entitled “Multiple PD(s)/PI(s) Leadership Plan” (Section I of the Research Plan in the PHS 398). A rationale for choosing a multiple PD(S)/PI(s) approach should be described.  The amount of effort for the PD(s)/PI(s) must be commensurate with the requirements of the position and not less than 20% each and sum to not less than 50%. This level of effort is required whether or not salary is requested. If budget allocation is proposed, the distribution of resources to specific components of the project or the individual PD(s)/PI(s) must be delineated in the Leadership Plan. 

The governance and organizational structure of the leadership team should be described, including communication plans, process for making decisions regarding the RTRN, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities should be delineated for the leadership team. 

The Program Director(s)/Principal Investigator(s) should budget for an annual meeting in Bethesda, Maryland with NIMHD staff. These meetings will provide a forum for the exchange of ideas, and to address any concerns, needs, and problems that arise. In addition, NIH staff will provide updates on policies and regulations that relate to the conduct of clinical and translational research. 

3. ACTIVITIES

The activities described in response to this FOA must include plans for the organization and management of the RTRN and infrastructure for overall network coordination, research study coordination, and data coordination.  Shared network infrastructure will consist of centralized management functions, Research Coordinating Center (RCC) functions, and Data Coordinating Center (DCC) functions.  The PD(s)/PI(s) must describe how multi-center studies will be facilitated by the network.

3.1 The organization and management functions must include, but are not limited to:

3.2 RCC functions must include, but are not limited to:

During the Conceptual Phase of each potential network project, the RCC is responsible for:

During the Planning Phase of approved network projects that are clinical in focus, the RCC is responsible for:

During the Implementation Phase of clinical studies, the RCC is responsible for:

During the Analysis and Publication Phase for all studies, the RCC is responsible for:

3.3 The Data Coordinating Center’s (DCC) functions include, but are not limited to:

3.3.1 Data Management

During the Conceptual Phase of each potential network project, the DCC is responsible for:

During the Planning Phase of approved network projects, the DCC is responsible for:

During the Implementation Phase of approved network projects, the DCC responsibilities are to support all data management aspects of study implementation including but not limited to:

During the Analysis and Publication Phase for all studies, the DCC is responsible for:

3.3.2 Data Quality Assurance

3.3.3 Data Sharing

3.3.4 Communication

3.3.5 Monitoring

3.3.6 Statistical Support

3.3.7 Collaborating with Other Network Components

The DCC leader will be a member of the Steering Committee (SC) and will be serving as the DCC member on network protocol development working groups. The DCC leader and team will be working with PIs of potential new projects during the conceptual phase and with PIs of network projects during the protocol development and planning phase. The DCC leader and team will be working with the project specific SC sub-committees/workgroups during the implementation and analysis/publication phase. 

The RCC and DCC will work in a collaborative and interactive manner. The respective Standard Operating Procedures (SOPs) of the RCC and DCC must be based on their jointly developed collaboration plan. It is essential that the tasks required in planning and executing a complex, multi-centered study be clearly defined, and that the responsibilities of the RCC and DCC be delineated.

4. Network Projects

Over the 5-year project period, the network will conduct at least 20 pilot/developmental projects, and will promote the implementation of ongoing NIH-funded studies, and other government, industry or foundation-funded studies.  A subset or all of the RCMI Clinical Sites will participate in a given clinical project, depending on their capacity, interest, and patient population relevant to the specific protocol. It is also possible that non-network sites may be added ad-hoc for a specific project, for their expertise and/or patient population to complement network sites.

The RTRN Research Coordinating Center (RCC) must coordinate a central IRB of record and manage all required IRB communication and documentation including but not limited to tracking approval, maintaining regulatory documents, communicating with the local IRBs, and handling adverse event reporting and notifications.

The network will give preference to clinical sites agreeing to use a central IRB of record, to accelerate IRB approval in multi-center studies.  To that effect, the network will use a “federated" IRB model.  This model gives participating institutions the option to choose one of three tiers of IRB review: 

Tier 1 indicates the reliance on a central IRB as IRB of record; 

Tier 2 indicates an option to designate a central IRB as IRB of record in addition to a local IRB;

Tier 3 indicates the reliance on local review.

5. Evaluation

Applicants must include a detailed process and outcome evaluation plan.  The plan should be designed to determine the effictiveness of various components of the RTRN, and the extent to which program goals are achieved.  It must include milestones for each RCC and DCC activity, and milestones for the overall program. The RTRN should have an External Advisory Committee (EAC) that meets at least annually to review structure and progress and offer recommendations to the PD(s)/PI(s). Any existing EAC membership should be listed and their role in the committee described. Potential new members of an EAC should not be named and should not be contacted prior to the review of an application.  In addition to the EAC, the RTRN must assess implementation of activities and achievement of performance milestones.

Applicants should note that the RTRN will undergo evaluation and assessment.  The evaluation of the RTRN is distinct from the individual award’s outcome evaluation ( described in Section IV.).  While both evaluations address “success”, they differ in scope ( individual award vs. national program, different timelines) and metrics (PD/PI defined vs. programmatic goals specified below).  The evaluation of RTRN will be carried out four years after the release of this FOA.  Assessment will be developed based on the metrics that will include, but are not limited to:

The findings of this evaluation will determine whether the RTRN is continued as configured, continued with modifications, or discontinued.  Should the findings indicate that the program is no longer needed or is ineffective, then NIMHD may consider terminating the program.

Section II. Award Information
Funding Instrument

Cooperative Agreement

Application Types Allowed

New
Renewal
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.

NIH intends to fund one award, corresponding to a total of $3.5 million for fiscal year 2012. Future year amounts will depend on annual appropriations.

Award Budget

The budget cannot exceed $3.5 million in total costs per year.

Award Project Period

Applicants may request up to 5 years of support.  The scope of the proposed project should determine the project period.

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

Eligibility for this FOA is limited to those institutions currently funded via the Research Centers in Minority Institution (RCMI) Infrastructure for Clinical and Translational Research (RCTR) and/or the Research Centers in Minority Institutions (RCMI) G12 Centers programs.

Foreign Institutions

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.     

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

 Applicant organizations may submit only one application in response to this FOA.

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.

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:

Shelia McClure, PhD
Division of Scientific Programs
National Institute on Minority Health and Health Disparities (NIMHD)
6707 Democracy Blvd. Suite 800
Bethesda, MD  20892-5465
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: 301-451-6536
Email: mcclursh@mail.nih.gov

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 must be sent to:

Robert Nettey, MD
Chief, Scientific Review Branch
Office of Extramural Research Administration
National Institutes on Minority Heath and Health (NIMHD)
6707 Democracy Blvd. Suite 800, mSC 7710
Bethesda, MD 20892-4874
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: 301-496-3996
Fax: 301-480-4049
Email: netteyr@mail.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements for this multi-component application:

Section 1. Network Overview (12 pages, total)

This section includes the following: a) significance of the program and how the proposed program will address an important problem(s) or critical barrier(s) for multi-site pre-clinical, clinical and translational research focused on health disparities; b) innovation of the proposed activities/functions; c) the general approach proposed to address this problem(s) or barrier(s) for multi-site research; and d) description of the environment, and how existing resources will be utilized to implement the plan.

Section 2. Report on performance (during the prior project period for renewal/revision applications or prior performance of research and data coordination for new applications, 6 pages total).

Section 3. Organization and Management (12 pages, total)

This section includes the following sub-sections: a) description of the administrative core; b) governance plan for the network; c) leadership plans for the RCC functions; d) leadership plans for the DCC functions; and e) network communications plan.

Section 4. Research Coordinating Center Activities (12 pages maximum, per activity)

Section 5. Data Coordinating Center Activities (12 pages maximum, per activity)

Section 6.  Evaluation Plan (12 pages, total)

Tables . Tables can be distributed throughout the application.  Tables should be associated with their respective sections and should appear at the end of that section. Tables will count against the page limits specified in these sections. The organization and content of the tables are left up to the applicant.

The application must present all the proposed activities within the page limits shown above. Note that these are upper page limits.  Applicants are urged to be concise and to present information in tables where possible. According to NIH policy, applicants should not provide programmatic URL's in their applications.

Research Plan

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

Description of Special Programmatic Requirements of the Research Strategy Sections

Section 1.  Network Overview (12 pages, total)

Section 1.1  Significance

Section 1.2 Innovation

Section 1.3 Approach

Applicants must use this section of the application to:

Section 1.4 Environment

Section 2. Report on Performance in Prior Project Period (for renewals/resubmissions 6 pages, total)

This section should outline the specific aims of the previous award cycle and report progress on each of these aims.  The progress report should also include a table with an example of a pilot study that the RTRN coordinated, indicating:

For the example provided, the DCC should provide a detailed record indicating the following, in a table or bulleted format:

Report on Performance (for new applications 6 pages, total)

An example of a multi-site pilot study that has been coordinated by the institution must be provided, indicating:

For the example provided, the data center should provide a detailed record indicating the following, in a table or bulleted format:

Section 3. Organization and Management (12 pages, total)

Section 3.1 Administrative Core

The Administrative Core is responsible for the overall administration, coordination and management of the RTRN.  The PD(s)/PI(s) of the application must be the Administrative Core leader(s).  The Administrative Core will be responsible for managing and coordinating the entire range of RTRN activities, monitoring progress, and ensuring that the RTRN milestones are being met and are being implemented effectively within the proposed timelines. A well-developed administrative plan must be clearly defined in the application. The plan should include a discussion of the structure and roles of administrative staff, and a discussion on how effective and timely communications between the RTRN partners, investigators, and NIMHD Program staff will occur. Applicants must describe the project management plans for RTRN operations, including a list of key documents used by the RTRN including but not limited to general SOPs, Conflict of Interest policy and other documents governing RTRN operations.

Section 3.2 Governance

Applicants must describe a governance structure designed to ensure both accountability and integration of the components of the RCC and DCC into a coherent program. Plans for constituting a Steering Committee and External Advisory Committee to provide critical, stimulating, and thoughtful advice for the overall performance of the network must be included in the application.  A  process to resolve conflicts and a plan to implement recommendations must be described.

Section 3.3 Leadership Plan for the RCC Functions

Applicants must describe the expertise of the leader(s) of RCC activities and other staff, and how the team will communicate.

Section 3.4 Leadership Plan for the DCC Functions

Applicants must describe the expertise of the leader(s) of the DCC activities and other staff, and how the team will communicate.

Section 4. Research Coordinating Center Activities (12 pages maximum, per activity)

Section 4.1 Engaging RCMI Institutions and scientists in the RCMI Translational Research Network (12 pages, total)

Applicants must state their plans for facilitating collaboration and resource sharing within the RTRN partner sites including the RCMI G12 Centers and RCMI Centers for Clinical and Translational Research (RCTR).  In addition, applicants must describe plans to engage scientists across the RCMI sites during the conceptual, planning, and implementation phases of studies, as well as in educational and training activities.

Section 4.2 Engaging Other Stakeholders in the RTRN (12 pages, total)

Applicants must indicate how outreach to the local community at the clinical sites and to community health care providers will be accomplished.  They must also describe how members of the lay community will be included in the conception, planning and implementation of studies so that a strong partnership between investigators and members of the community can serve as a foundation for successful study design and implementation, recruitment and retention and dissemination.

The applicant must also indicate how potential network project investigators (from academia or industry) will be engaged to work with the RTRN in the conceptual phase of studies, and integrated into the network in the planning and implementation phases.

Section 4.3 Plan to Increase the Quality and Efficiency of Clinical and Translational Research (12 pages total)

Applicants must describe plans to reduce start-up time of multi-site studies by increasing the efficiency of IRB review through use of standardized master trial agreements and federated IRB models.  For clinical studies, applicants must describe plans to support recruitment of participants at the study sites, including efforts to optimize minority recruitment, and describe how protocol adherence and data quality will be maximized in collaboration with the study sites. 

Section 4.4 Performance Monitoring and Potential Interventions Plan (12 pages total)

For new and ongoing RTRN studies, the application must describe how the RCC will monitor performance and collect data on start-up, recruitment and retention, as well as data quality for NIH-funded clinical trials at the study sites.

Section 4.5 Clinical Coordination and Project Management Plan (12 pages total)

Applicants must include a summary of the standard operating procedures (SOPs) used by the RCC in collaboration with the DCC in the implementation of multi-center studies, including, but not limited to SOPs describing regulatory document collection, IRB approvals, study drug management, procedures to minimize bias and maintain blinding, data sharing plans, safety monitoring plans, etc.  Plans directly related to participants such as adverse event monitoring, must be included in the Human Subjects section. 

Section 5. Data Coordinating Center Activities (12 pages maximum, per activity)

Section 5.1 Data Management, Quality Assurance and Monitoring Plan (12 pages, total)

Applicants must describe how the data management, quality assurance and monitoring programs and data security for RTRN projects will be supported. A description of the data management system/software the applicant uses currently or proposes to use for supporting the proposed activities must be described.  Applicants must describe how the DCC will:

Section 5.2 Statistical Support Plan (12 pages, total)

Applicants must describe how all statistical aspects of studies from the pre-application conceptual phase, the planning phase, the implementation phase and the analysis and publication phase will be supported. It is anticipated that the DCC will provide full statistical support for all RTRN studies. However, the PD(s)/PI(s) should also describe how a non-DCC statistician would be integrated in DCC operations of their project.

Section 5.3 DCC Project Management and Coordination Plan (12 pages, total) 

Applicants must describe the work flow for the implementation and completion of studies.  Applicants must include a summary of key documents used by the DCC in the implementation of multi-center studies, including but not limited to providing the general SOPs describing database access, data quality control, data queries with audit trails, Conflict of Interest policy, etc.

Section 5.4 Collaboration and Communications Plan (12 pages, total)

Applicants must describe the DCC communications plan with the RCC and with the study sites. Applicants are encouraged to describe any special expertise or unique strengths they can offer to the collaborative effort (e.g., established database tools, hardware, software, quality control tools, monitoring expertise, team leadership and training, communications platforms, website design and management) that will support collaboration and communication across all phases of study development, implementation and analysis.

Section 6. Evaluation (12 pages, total)

An internal evaluation is required. Specific plans and procedures must be described to capture, analyze and report short and long-term outcome measures that would determine the success of the network in achieving its objectives.  Where appropriate, applicants are encouraged to include plans to obtain feedback from participants to help identify weaknesses and provide suggestions for program improvements.   Applicants must provide detailed performance milestones and a timeline that will be used to measure progress in each budget period toward the goals of each activity.  This section must include:

Required Institutional Letters

Applicants must provide letters from the appropriate high-ranking institutional official(s) from RCMI institutions that:

FORMAT AND ORGANIZATION OF THE APPLICATION

Applicants must consecutively number the pages throughout the application. Do not include unnumbered pages and do not use suffixes, such as 5a, 5b, etc. Applicants must adhere to NIH format described in the PHS 398 instructions for font, line spacing and margins. The application should be organized as follows:

A. Face Page: Use Form Page 1 of the PHS 398.

B. Description, Performance Sites, and Key Personnel: Key personnel include the Principal Investigator(s) and other key professional and administrative members of this program. Do not include external advisory committee members. Only include named individuals for whom salary support is requested in the application.

C. Table of Contents: Applicants should provide a customized Table of Contents that properly reflects the organization of their application. Applicants should use inclusive numbering of sections (i.e., provide start and end pages for each section).

D. Detailed Budget for the Initial Budget Period; Budget for the Entire Proposed Period of Support

The budget section should begin with the summary or composite budget for the Network, followed by the individual budgets for all activities and consortia and contractual arrangements. Do not separate the individual budgets into each activity section.

E. Biographical Sketch

Biographical sketches and research support in standard NIH format for PD(s)/PI(s) and other listed key professional and administrative members of this program, and named members of significant internal committees. Do not include biographical sketches for external advisory committee members, or those who are not directly involved in the RTRN.  All Biographical Sketches should be grouped together with the PD(s)/PI(s) biographical sketch(es) presented first followed by all other sketches in alphabetical order. Do not separate the biographical sketches into each activity section.

F. Research Strategy

Section 1. Network Overview (12 pages, total)

Section 2. Report on Performance (6 pages, total)

Section 3. Organization and Management (12 pages, total)

Section 4. Research Coordinating Center Activities (12 pages maximum, per activity)

Section 5. Data Coordinating Center Activities (12 pages maximum, per activity)

Section 6. Evaluation Plan (12 pages, total)

G. Literature cited

(a) Bibliography and References Cited – Provide a bibliography of any references cited in the Research Strategy. Each reference must include names of all authors (in the same sequence in which they appear in the publication), the article and journal title, book title, volume number, page numbers, and year of publication. Include only bibliographic citations. Follow scholarly practices in providing citations for source materials relied upon in preparing any section of the application.

While there is not a page limitation, it is important to be concise and select only those literature references pertinent to the proposed activities.

(b) Progress Report Publication List – For Renewal applications list the titles and complete references to all appropriate publications, manuscripts accepted for publication, patents, and other printed materials that have resulted from the project since it was last reviewed competitively.

H. Required institutional letters (see Special program requirements above)

I. Protections for Human Subjects

J. Inclusion of Women, Minorities, and Children

K. Vertebrate Animals

L. Biohazards

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 modification:

Appendix

Appendix materials will not be accepted for this FOA. 

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.

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.  

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.

Overall Impact - Overall

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 - Overall

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 proposed activities significantly enhance the ability of RTRN to achieve its goals and objectives? Will the proposed activities have potential to enhance collaborations across RCMI sites?

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?  

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? Is the program likely to develop novel approaches to increasing the efficiency of planning and implementing multi-site projects across RCMI sites?

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? Does the applicant describe and justify how existing and requested resources will be utilized to implement plans to develop an environment and framework suitable for achieving the objectives of the RTRN? Do the proposed activities foster collaboration among investigators across disciplines and institutions? Does the application identify key obstacles to the performance of multi-site research, and then propose plans or means to overcome these? Is an implementation phase well described? Is the timeline for implementation feasible and are specific goals and milestones set? Are alternatives proposed should the goals and milestones not be reached in a timely manner?

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 application make efficient use of potentially unique resources at the consortium sites? Will the proposed activities enhance, complement, and extend the current resources for biomedical research at institutions in the consortium?

In addition to the above criteria, the following components of the application will be considered in the determination of the overall impact/priority score for the application.

 Organization and Management

Will the Steering Committee and External Advisory Committees be constituted to provide critical, stimulating, and thoughtful advice for the overall performance and RCC and DCC activitiesIs the governance structure designed to ensure both accountability and integration of the components of the RCC and DCC into a coherent program? Are plans for leadership and management of specific RCC and DCC activities adequate?  

Research Coordinating Center Activities

Engaging Scientists across RCMI Institutions and Other Stakeholders in the Translational Research Process and RTRN:

Are plans to reach out to and engage scientists across the RCMI institutions in RTRN activities adequate? Are plans described that will result in outreach to investigators outside of the RTRN institutions?  Are the outreach plans proposed likely to increase interest and participation in RTRN activities or studies?  Are activities that target community members likely to forge strong partnerships between investigators and members of the lay community?            

Plan to Increase the Quality and Efficiency of Clinical and Translational Research:

Are the proposed plans likely to reduce start-up time of multi-site studies through the use of standardized master trial agreements, federated IRB models or other agreements?  Are the proposed plans likely to optimize minority recruitment in clinical studies?  Are plans for monitoring protocol adherence and data quality at the study sites adequate to ensure quality control?

Performance Monitoring and Potential Interventions Plan:

Are general plans for monitoring performance, study start-up, recruitment and retention and data quality adequate for assessing performance and implementing potential interventions? 

Clinical Coordination and Project Management Plan:

Are the proposed list of standard operating procedures (SOPs) or workflows used by the RCC comprehensive and likely to lead to successful clinical coordination and project management?  

Data Coordinating Center Activities

Data Management, Quality Assurance and Monitoring Plan:

Will data be collected in a user-friendly manner, with a user interface directed at the experience and knowledge of users?  Will there be seamless integration of data from disparate sources? Are plans to validate data comprehensive?  Is there a rigorous error and query resolution process, which monitors data quality throughout the collection process? Are procedures for security and protection of personal health information well-developed?  Are measures to facilitate data sharing and dissemination appropriate? Will data security and privacy be safeguarded?

Statistical Support Plan:

Will the statistical aspects of studies from the pre-application conceptual phase, the planning phase, the implementation phase and the analysis and publication phase be appropriately supported by the DCC? Are the plans to integrate a non-DCC statistician in DCC operations appropriate?

Project Management and Coordination Plan:

Will the list of SOPs and other documents used by the DCC in the implementation of multi-center studies foster effective project management and coordination?

Collaboration and Communications Plan:

Are the DCC plans for communication with the RCC and study sites within the network appropriate?  Are there unique strengths or special expertise to enhance collaborative efforts (e.g., established database tools, hardware, software, quality control tools, monitoring expertise, team leadership and training, communications platforms, website design and management)?

For new applications, has the applicant demonstrated that multi-site studies can be effectively implemented?  Are databases and other tools available to support studies?  Does the applicant have a strong track-record in engaging developing institutions, underrepresented minority investigators, community partners and other stakeholders in collaborative research activities? 

Evaluation

Does the application include an evaluation plan that includes key milestones for the overall program and for each proposed activity? Is the plan adequate to evaluate the short-term and long-term goals for each of the proposed activities? Do the milestones and timelines provide feasible objectives, and detailed quantitative and/or concrete criteria by which milestone achievement will be assessed? Are the measures valid for the program’s goals to be assessed and how accessible and practical are the available data sources? 

Additional Review Criteria - Overall

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.   

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

For Renewals, the committee will consider the progress made in the last funding period.  Has the applicant made significant progress in achieving the specific aims of the previous award cycle?  Have challenges been identified and solutions to address those challenges been implemented or proposed?  Did the DCC identify and hire experienced personnel?  Were RTRN activities implemented to engage investigators from institutions receiving funding from the RCMI Program in collaborative activities and/or projects? Did the data center develop an appropriate database and other tools to support the study?  Did the data center develop operational procedures for data management, quality assurance and monitoring?  Was a multi-site proof-of-concept project successfully initiated?  Were the study sites able to achieve recruitment goals? 

Revisions

Not Applicable.

Additional Review Considerations - Overall

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 response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines 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

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.

Project Director(s)/Principal Investigator(s) (PD(s)/PI(s)) will have the primary responsibility for:

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.

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

NIMHD will assign a Program Official, Project Scientist(s), and a Grants Management Specialist to the RTRN.

NIH Project Scientist(s) will have substantial scientific involvement during the conduct of this activity, through technical assistance, advice, and coordination.  NIH Project Scientists(s) will:

An NIH Program Official will be responsible for the normal programmatic stewardship of the award and will be named in the award notice. The program official(s) will:

Additionally, the NIH Program Official(s) may recommend the termination or curtailment of an activity in the event the proposed activities fail to evolve within the intent and purpose of this initiative.

Areas of Joint Responsibility include:

Awardees agree to governance, through voting and decision making, of the RTRN through a Steering Committee.  Steering Committee voting membership shall consist of the Principal Investigator(s), NIMHD Program staff [Program Official and Project Scientist(s)].   Quarterly meetings of the Steering Committee will be held in the first year of the award.  One of these meetings must be an in-person meeting in Bethesda, MD.  Frequency of meetings in succeeding years will be decided by the Steering Committee at the beginning of each budget period.  Each member of the Steering Committee will have one vote.  The RTRN leadership will be required to accept and implement policies approved by the Steering Committee.

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.

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 301-435-0714
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

Scientific/Research Contact(s)

Shelia McClure, PhD
Division of Scientific ProgramsNational Institutes on Minority Heath and Health Disparities (NIMHD)
6707 Democracy Blvd Suite 800
Bethesda, MD  20892-5465
Telephone: 301-451-6536
Email: mcclursh@mail.nih.gov

Peer Review Contact(s)

Robert Nettey, MD
Office of Extramural Research Administration
National Institutes on Minority Heath and Health Disparities (NIMHD)
6707 Democracy Blvd. Suite 800
Bethesda, MD  20892-5465
Telephone: 301-496-3996
Fax: 301-480-4049
Email: netteyr@mail.nih.gov

Financial/Grants Management Contact(s)

Priscilla Grant, JD, CRA
Chief, Grants Management Officer
National Institute on Minority Health and Health Disparities (NIMHD)
6707 Democracy Boulevard, Suite 800, MSC 5465
Bethesda, MD 20892-5465
Phone: 301-594-8412
Fax:  301-480-4049
Email:  grantp@mail.nih.gov

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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