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	November 17, 2017 - This RFA has been reissued as RFA-MD-18-001.
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.

Posted Date	June 6, 2012
Letter of Intent Due Date	July 9, 2012
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.

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

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:

• Leadership and project management for the administrative, research coordinating and data coordinating functions;
• An Administrative Core that provides both an organizational and administrative structure that is conducive for ensuring collaborative efforts and interaction among all RTRN stakeholders;
• Administrative support for RTRN activities including, but not limited to scheduling and hosting teleconferences, web meetings, and face-to-face meetings;
• Coordination of Steering Committee (SC) and External Advisory Committee activities including, but not limited to organizing teleconferences and in-person meetings, and maintaining documentation such as meeting minutes;
• Coordinating the activities of Steering Sub-committees and Working Groups;
• Preparation of reports to NIH and other funding or regulatory agencies;
• Coordinating evaluation of RTRN activities;
• Coordinating and enhancing communication, marketing and outreach of the RTRN including management of the public RTRN website content.

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

• Engaging RCMI Institutions and scientists in the translational research process;
• Facilitating collaboration and resource sharing within the RTRN partner sites including the RCMI G12 Centers and RCMI Centers for Clinical and Translational Research (RCTR);
• Facilitating collaboration of the RTRN with other academic institutions, community-based organizations, federal agencies or programs, and industry partners who are engaged in research, training and educational activities focused on reducing disparities and improving the health status of minority populations;
• Establishing standardized master trial agreements and other agreements with the network study sites and developing and implementing a plan to reduce the start-up time of each network project through the use of these standardized agreements as well as helping to resolve any issues associated with these agreements;
• Coordinating, documenting, and tracking all communication, and reporting between the RCC, network study sites, central IRB or IACUC of record, and local IRBs and IACUCs, which includes but is not limited to maintaining documentation of initial approvals, amendment approvals, and adverse event reports, Good Clinical Practice (GCP) and training certifications, and other reports;
• Registering all trials with http://www.clinicaltrials.gov;
• Providing leadership to the study sites, including potential ad-hoc sites with respect to performance monitoring and potential interventions, and clinical coordination and project management;
• Coordinating study drug management for network clinical trials;
• Working with the project investigators and Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) sponsor (investigator or industry partner) on obtaining FDA regulatory approval for the trial (IND approval or IDE), and on reporting, documenting and coordinating follow-up correspondence;
• Working closely with the DCC in a collaborative and interactive manner and developing RCC standard operating procedures (SOPs).

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

• Working with potential project investigators in facilitating the determination of the appropriateness of their project for network infrastructure access;
• Providing information necessary to the potential project investigators as they apply for grant funding (e.g., review protocol synopsis and schedule of activities, create project work scope and timeline, ensure the feasibility of the proposed projects by analyzing the numbers of potentially eligible participants at the proposed sites and by including community representatives in the conceptual process);
• As required, the RCC will support project investigators in the IND/IDE submission.

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

• Working with project lead team of investigators to finalize protocols and consent forms;
• In collaboration with the DCC, working on case report forms (CRFs);
• Assisting in developing a written, detailed patient recruitment plan, with attention to adequate minority recruitment;
• Monitoring the IRB approval process and promoting rapid approval through well-developed and complete documentation at the initial submission, and through rapid and comprehensive responses to any IRB comments or concerns;
• Collecting regulatory documents (1572 forms, curricula vitae, Good Clinical Practice [GCP] certifications, etc.);
• Coordinating study drug management;
• Convening investigator meetings and ensuring initial study personnel training for GCP and protocol adherence;
• Working with the DCC as they establish a study database.

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

• Tracking enrollment and retention and assisting sites in developing outreach interventions as needed;
• Coordinating study drug management;
• Working with sites to ensure appropriate protocol implementation and adherence to protocol and GCP;
• Answering queries from the sites regarding protocol, drug dose adjustments, adverse events, premature withdrawals, etc.;
• Conducting site visits, as required;
• Supporting the DCC in their monitoring and data quality assurance procedures.

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

• Assisting the DCC and sites in resolving final queries, finalizing reporting to the FDA and IRBs as applicable;
• Coordinating the communication of the study results to the investigators, patients and public;
• Working with the DCC and network investigators in the publication of the primary and, if applicable, secondary manuscripts.

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

3.3.1 Data Management

• Providing DCC Standard Operating Procedures (SOPs) including, but not limited to all aspects of data management;
• Finalizing scope of work documents in collaboration with the RCC that clearly delineate RCC and DCC tasks, respectively, and documenting a communication plan;
• Providing an experienced data management team that is expected to include an experienced programmer and project manager.

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

• Reviewing the protocol/study synopsis and creating the scope of work, budget and timelines for database building or other services, so that the investigators have material for their application;
• Working with investigators on statistical design as needed with the help of the DCC statistician, or working with project specific statisticians, when applicable.

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

• Working with the project lead team of investigators to finalize data management aspects of the project;
• Working with investigators and RCC to create a database for each study in a timely manner;
• Developing Case Report Forms (CRFs), finalizing randomization scheme/process, developing a data quality assurance plan, and developing a data monitoring plan for all clinical studies.

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:

• Establishing a web-based, user-friendly database for each study;
• Incorporating security features consistent with the guidelines of the U.S. DHHS, including but not limited to secure, password protected database access, and audit trails for database changes;
• Implementing procedures for backing up the programs clinical and administrative data, including intermittent duplication of the database with storage at a remote facility;
• Ensuring all human subjects data is handled securely to ensure privacy and confidentiality;
• Protecting patient confidentiality at all steps in the submission and analysis of clinical study data and ensuring the technical integrity and security of the data management systems;
• Providing in a timely manner data and reports at the request of the data and safety monitoring board (DSMB), the Food and Drug Administration (FDA), or the NIH;
• Providing in a timely manner true copies of data files and supporting documentation for all network-supported projects;
• Supporting web-based or other mode of central randomization;
• Establishing quality assurance procedures for data quality and completeness;
• Answering database questions and resolving technical issues for database users;
• Providing efficient project management for data management projects;
• Promoting standardization of data collection across clinical studies, including using Common Data Elements (CDE), when available, or helping develop common data elements by working with NIH ICs on submitting data elements and meta-information for use in CDE initiatives;
• Working with the RCC to report and track trial status in terms of enrollment and retention;
• Transferring data to statisticians and others for interim analysis as needed, and at the end of follow-up, cleaning and closing-out the database.

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

• Resolving final queries, finalizing reporting to the DSMB and other boards as applicable;
• Working with the RCC and network investigators in the publication of the primary and, if applicable, secondary manuscripts.

3.3.2 Data Quality Assurance

• Overseeing data quality control, including but not limited to regular data queries and data monitoring and cleaning to assure data completeness and quality.

3.3.3 Data Sharing

• Supporting and promoting data sharing after study completion by preparing a final data set in a format appropriate for data sharing, for submission to a secure data repository after publication of the primary study results or after 18 months, whichever comes first.

3.3.4 Communication

• Working with the RCC and study sites to support study communication, including, but not limited to an investigator communication platform/website where the study documents, the protocol and amendments, the manual of procedures, and the other study communications are stored;
• Providing staff training in database use and answering questions regarding database use;
• Working with the RCC to ensure that the trial status and results are posted on clinicaltrials.gov;
• Working with the RCC, study sites, and network members, to create a public website as platform for recruitment and outreach efforts for all network projects.

3.3.5 Monitoring

• Identifying an experienced clinical monitor to conduct at least annual site visits to monitor the quality of record keeping, source documentation and the accuracy of data entry.

3.3.6 Statistical Support

• Providing statistical input to potential network project applicants;
• Providing statistical expertise to the clinical trial design in the planning and protocol development phase, and statistical oversight in the implementation phase;
• Providing interim analyses as requested, and final analyses per protocol/study;
• Collaborating with investigators in the preparation of presentations of primary and secondary publications;
• Providing additional analyses at the request of the DSMB, the FDA, or the NIH;
• Working closely with project-specific statisticians in a collaborative manner and under a pre-specified statistical leadership plan as appropriate. Under this scenario, the project statistician leads the statistical design, analysis plans, and the final analysis for publication, remaining blinded during the course of the trial. The DCC statistician leads the data management and preparation of unblended reports and analyses. In the Conceptual and Planning phases, all statisticians associated with a study will work together to ensure the design is suitable for implementation through the network.

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:

• increased collaborative clinical and translational research to address minority health and health disparities through implementation of pilot/developmental studies, NIH-funded studies and studies funded by other government agencies, industry or foundations;
• increased efficiency of collaborative clinical and translational research involving RCMI institutions by implementation of material transfer agreements, central IRBs and/or other collaborative agreements;
• contributions made by investigators at RCMI institutions that address the health of minorities and health disparities in general;
• engagement of a broader spectrum of scientists and community partners in the translational research process, dissemination of research findings and development and adoption of best practices to improve health outcomes.

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.

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.

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)

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.

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.

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.

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.

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

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.

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 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:

• Descriptive title of Application
• Name, address, and telephone number of the PD(s)/PI(s)
• Names of other key personnel
• Description of the Research Coordinating Activities proposed
• Description of the Data Coordinating Activities proposed
• Participating institutions
• Number and title of this funding opportunity announcement

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

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

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.

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

• Applicants must state the overall goals of the RTRN, specific aims of this proposed program and how the proposed activities will address an important problem(s) or critical barrier(s) for implementing multi-site pre-clinical, clinical and translational research, particularly research focused on addressing health disparities.

Section 1.2 Innovation

• Applicants must describe the innovation of the proposed activities/functions.

Section 1.3 Approach

Applicants must use this section of the application to:

• describe the overall plan for achieving the specific aims proposed;
• Describe activities of the proposed plan and how they will be coordinated to achieve the administrative, research coordinating functions and data coordinating functions of the network during the conceptual, planning, implementation, analysis and publication phases of RTRN studies.

Section 1.4 Environment

• Applicants must describe and justify how existing and requested resources will be utilized to implement the proposed activities.

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:

• the intervention;
• the number and location of sites;
• the number of patients;
• the length of follow-up;
• time to first IRB approval at any consortium site;
• time to last IRB approval at a consortium site;
• time to first patient screened;
• time to first patient randomized;
• overall recruitment rate;
• proportion of patients lost to follow-up;
• time from last patient's last visit to database lock.

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

• The start-up time in terms of establishing a database and other tools (including CRFs, randomization mechanism);
• Time from database lock to final primary analysis.

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:

• the intervention;
• the number and location of sites;
• the number of patients;
• the length of follow-up;
• time to first IRB approval at any consortium site;
• time to last IRB approval at a consortium site;
• time to first patient screened;
• time to first patient randomized;
• overall recruitment rate;
• proportion of patients lost to follow-up;
• time from last patient's last visit to database lock.

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

• The start-up time in terms of establishing a database and other tools (including CRFs, randomization mechanism);
• Time from database lock to final primary analysis.

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:

• Collect data in a user-friendly manner, with a user interface directed at the experience and knowledge of users (rather than that of programmers, data managers or statisticians);
• Collect data in a manner appropriate to the source of data (i.e., data collected by people should be entered by people, data generated by machines should be imported from the machine, data generated in a lab should be entered by the lab, etc.);
• Integrate data from disparate sources seamlessly;
• Validate data as thoroughly as possible on collection and/or entry;
• Validate data completely, on an ongoing basis;
• Have a rigorous error and query resolution process, which monitors data quality throughout the collection process;
• Allow for the easy dissemination of data to statisticians and other analysts, in a variety of tab delimited formats;
• Allow for the easy production of regular reports on trial status and progress;
• Ensure that data security and privacy will be safeguarded;
• Have graduated, role-based security, which permits varying degrees of access to data based on an individual’s role in the study;
• Secure and protect any personal health information (PHI) collected from unauthorized access, and create a log of all authorized access;
• Assemble all study data in a well-documented central store, to facilitate data sharing and dissemination.

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:

• a clear description of interim objectives to be achieved for each activity during the course of the project;
• potential impediments that could require a revision of the milestones with a discussion of possible solutions;
• detailed quantitative and/or concrete criteria by which milestone achievement will be assessed;
• detailed schedules or timelines for the anticipated attainment of each milestone in each RCMI component and overall RTRN goals with alternatives should milestones not be reached (e.g., GANTT Charts).

Required Institutional Letters

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

• commit the institution(s) to the RTRN goals, indicating that the program will be integral to their broad vision of translational research;
• commit to notify NIMHD of adverse events in all clinical studies supported by the RTRN that are serious, unexpected, and related to participation in research. A reiteration to notify NIMHD of all unanticipated problems as outlined in OHRP guidance (http:www.hhs.gov/ohrp/policy/advevntguid.html) on studies supported by RTRN resources would satisfy this requirement. These notifications include all adverse events as noted above as well as other reportable unanticipated problems.

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:

• Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable for this FOA.

Appendix

Appendix materials will not be accepted for this FOA.

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 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.

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 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).

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?

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.

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.

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:

• 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 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:

• 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.

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

• Supporting the Key Component Activities;
• Working towards developing, adopting and implementing the agreed on policies, procedures, best practices, or other measures;
• Providing information to the NIH Program Officer(s) and Project Scientist(s) concerning progress;
• Participating in the overall coordination of NIMHD efforts in translational research; this participation may include collaboration and consultation with other translational research awardees, and the sharing of information, data and research materials.

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:

• coordinate activities with other ongoing studies supported through statewide, regional, or national programs to avoid duplication of efforts and encourage sharing and collaboration in the development of new clinically useful resources and methodologies;
• review and comment on critical stages in the program implementation;
• assist in the interaction between the awardee and investigators at other institutions to promote collaborations;
• coordinate access to other resources available through statewide, regional, or national specialized technology cores;
• retain the option of recommending termination of support if technical performance or implementation falls below acceptable standards, or when specific key resources cannot be effectively implemented in a timely manner;
• retain the option to recommend additional infrastructure support within the constraints of the approved research and negotiated budget;
• convene meetings/workshops to address emerging areas of high priority.

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:

• enforce general statutory, regulatory or administrative assistance policy requirements;
• evaluate progress by reviews of technical or fiscal reports or by site visits to determine that performance is consistent with objectives, terms and conditions of the award;
• ensure that activities proposed for development or implementation do not overlap or duplicate activities supported by other peer reviewed funding mechanisms;
• provide assistance in reviewing and commenting on all major transitional changes of RTRN activities prior to implementation to ensure consistency with the goals of this FOA;
• link the approaches developed from RTRN to other NIMHD supported networks to ensure that information is shared and utilized on the widest basis possible;
• monitor institutional commitments and resources to ensure that RTRN receives the maximum chance of stabilization and success;
• Provide financial oversight of the Program.

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.

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.

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

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


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

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

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.