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: NIMHD Research Centers in Minority Institutions Infrastructure for Clinical and Translational Research (RCTR) [U54]

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

Reissue of PAR-09-261

Related Notices

  • February 21, 2014 - See Notice NOT-MD-14-001. Notice to Extend Expiration Date.
  • October 18, 2013 - See Notice NOT-OD-14-003. Guidance on Resumption of NIH Extramural Activities Following the Recent Lapse in Appropriations.

Funding Opportunity Announcement (FOA) Number

PAR-13-279

Companion Funding Opportunity

None

Number of Applications

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

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

93.307

Funding Opportunity Purpose

The National Institute on Minority Health and Health Disparities (NIMHD) seeks to support the development of infrastructure required for the conduct of clinical and translational research in institutions funded via the Research Centers in Minority Institutions (RCMI) program. The purpose is to facilitate and broaden opportunities for clinical and translational research activities focused on minority health and/or health disparities in these institutions, foster collaborations and partnerships with other institutions, improve efficiency in the management of clinical and translational research, and enhance professional development of researchers.

Key Dates
Posted Date

July 19, 2013

Letter of Intent Due Date(s)

 (New Date 30 days before the application due date per NOT-MD-14-001), Originally September 17, 2013 and January 14, 2014

Application Due Date(s)

 (Extended to November 1, 2013 per NOT-OD-14-003), Originally October 17, 2013 and February 14, 2014, (New Date June 11, 2014 per NOT-MD-14-001)

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

 December, 2013; March 2014; (New Date August 2014 per NOT-MD-14-001)

Advisory Council Review

 February 2014; June 2014; (New Date October 2014 per NOT-MD-14-001)

Earliest Start Date

 April 2014; July 2014; (New Date October 2014 per NOT-MD-14-001)

Expiration Date

(Extended to June 12, 2014 per NOT-MD-14-001), Originally February 15, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

Note:  A new version of the paper PHS 398 application form and instructions (revised 8/2012) must now be used. Download the new application form and instructions from http://grants.nih.gov/grants/forms.htm.

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


Background and Purpose

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.

Academic institutions supported by NIMHD’s Research Centers in Minority Institutions (RCMI) program—established by NIH in 1985 in response to congressional interest in expanding the nation’s capacity for research in the health sciences—train a disproportionately large number of scientists from underrepresented backgrounds in the biomedical research workforce. Moreover, these institutions historically have trained clinician scientists and other health care professionals who devote their careers to serving health disparity populations. A key conclusion from “Unequal Treatment: Confronting Racial and Ethnic Disparities in Healthcare,” a 2002 report from the Institute of Medicine, was that part of the solution is to increase the proportion of underrepresented U.S. racial and ethnic minorities among the health professions, an important point echoed in “Missing Persons: Minorities in the Health Professions,” a 2004 report by the Sullivan Commission on Diversity in the Healthcare Workforce.

The Department of Health and Human Services (DHHS) is focusing on areas that have the highest level of disparities related to health access and outcome, including cancer, cardiovascular diseases (heart disease and stroke), diabetes, HIV/AIDS, infant mortality, mental health disorders, hepatitis, syphilis, tuberculosis, and chronic kidney disorders. Eliminating these and other health disparities requires research on the underlying causes of these diseases and development of new, cost-effective approaches for diagnosis, prevention, and treatment to improve patient outcome for these diseases.

Minority institutions are uniquely positioned to engage minority populations both in research and in translating research advances into culturally competent, measurable and sustained improvements in health outcomes. Development of research infrastructure in minority institutions greatly enhances their ability to contribute to the national effort to eliminate health disparities.

Improving minority health and ultimately eliminating health disparities require a trans-disciplinary framework and strong collaborations between researchers, community organizations, service providers and other stakeholders to ensure that contextually appropriate and relevant research is conducted and that findings can translate into sustainable individual-, community- and systems-level changes that improve population health. Culturally appropriate, community- driven prevention and intervention programs are also important for eliminating racial and ethnic disparities in health.   Addressing this need, the RCMI Infrastructure for Clinical and Translational Research (RCTR) program was established in 2009 to facilitate and broaden opportunities for conducting clinical and translational research within RCMI institutions by:

The purpose of the RCTR initiative is to provide infrastructure to:

The RCTR program will improve coordination of clinical and translational research programs and result in more efficient management of clinical and translational research activities; facilitate and broaden the opportunities to conduct clinical and translational research, with an emphasis on improving minority health and reducing health disparities; develop synergy between clinical and translational research activities in the RCMI program and leverage NIH investments across other programs in these institutions.

Definitions for the purpose of this initiative: ‘Clinical research’ comprises studies and trials in human subjects meeting the NIH definition in the PHS 398 instructions.  ‘Translational research’ includes research that ranges from the translation of basic to clinical research, to research aimed at the adoption of best practices in community healthcare.

Key Activities/Cores of an RCTR

Each RCTR must support clinical and translational research focused on minority health and/or health disparities, and the needs of its researchers.  The RCTR must include infrastructure and/or activities that will support:

In addition to these requirements, applicants must also develop their own list of activities/cores that will develop and enhance the infrastructure at their institution to achieve the specific objectives of the RCTR award. Examples of potential activities/cores may include but are not limited to:

Acknowledging that existing resources vary among applicant institutions, the support requested for each of the proposed components is expected to vary, reflecting current and projected needs.  If an institution has an RCMI Center (G12) award that supports core infrastructure for basic research, Center of Excellence, or other NIMHD award, the applicant must demonstrate how these awards interface with the RCTR.  The RCTR is intended to complement, but not duplicate activities funded via these awards. 

Descriptions of Required RCTR Cores

Administrative Core

The Administrative core must be directed by the Program Director(s)/Principal Investigator(s) of the RCTR.  The Administrative Core director is also responsible for ensuring that RCTR-supported research is carried out in compliance with applicable federal regulations and policies. The Administrative Core will manage, coordinate and supervise the entire range of RCTR activities, ensure that all activities are implemented, coordinate evaluation of the program, and monitor progress. 

Collaborations and Partnerships Core

A key component of the RCTR is the integration of clinical and translational research through fostering collaborations between basic, clinical, and translational researchers from different disciplines, departments and/or programs within the institution, as well as collaborations with investigators at other institutions. Applicants are encouraged to partner with other domestic institutions that may include Federal or non-federal, public or private, for profit or non-profit organizations as appropriate. 

Professional Development Core

The RCTR environment must provide professional development activities in clinical and translational science for investigators across the institution, and enhance synergy with the Clinical Research Education and Career Development (CRECD) R25 awards and/or other research training programs at the institution. Professional development activities should promote the recruitment, training, advancement, and retention of new investigators in clinical and translational science careers.

Evaluation Core

Applicants must develop a comprehensive evaluation to be used to monitor the conduct (process) and track the progress (outcomes) of proposed RCTR activities.  The major purpose of the evaluation is to provide information to assist with RCTR planning and management, and to determine the effectiveness of various components of the RCTR, and the extent to which RCTR program goals are achieved.  RCTRs may also be called upon to gather data and participate in the NIMHD RCTR Program evaluation.  

Descriptions of Optional Activities/Cores

Recruitment Core

This may include hiring of clinical and translational investigators who have a track record of independent research support that includes current or recent support (within the last two years) by NIH R-series, P-series, and/or U-series awards, or other comparable federal or non-federal awards and can serve as mentors to junior investigators.  These new faculty may receive support to establish their research laboratories, acquire specialized equipment, and support postdoctoral fellows and technical assistants. 

Biomedical Informatics Core

Applicants may propose a core for the organization and analysis of biological and related information, involving the use of computers to develop databases, retrieval mechanisms and data analysis tools.  Supporting infrastructure may be proposed that includes but is not limited to computing hardware, data analysis and informatics tools, software and middleware, high-bandwidth network connectivity and technical support.

Research Design and Biostatistics Core

Cores must provide investigators with expertise and assistance on, but not limited to, the following: developing, validating and integrating research designs and biostatistical methodologies essential to clinical and translational studies; preventing bias in research methodology; developing innovative methods of enhancing the power of studies; capturing appropriate data; and developing design and analysis plans for studies of unique or vulnerable populations or very small numbers of subjects. 

Clinical Research Resources and Facilities Core

Clinical Research Resources and Facilities must provide an environment that promotes participation in out-patient clinical and translational research, especially outreach that fosters participation of underrepresented minorities, in addition to providing resources for cost-effective research participant interactions.  Examples of resources that may be requested include (but are not limited to) the provision of out-patient or community-based exam rooms, medical vans, temporary research participant recruitment/enrollment sites, research nurses, research coordinators, phlebotomists, scheduling services and services for research specimen collection and shipping.

Community-Based Research Core

Community based research (CBR) core must facilitate planning, implementing, evaluating, and disseminating effective preventions and interventions for diseases, with an emphasis on those diseases that disproportionately affect racial and ethnic minorities. Any proposed CBR activities must include partnerships between community members, and/or community health providers and academic researchers with the aim of improving minority health and reducing health disparities.

Regulatory Knowledge and Support Core

Regulatory knowledge and support cores should promote the protection of human subjects and facilitate regulatory compliance. Institutions should develop best practices that reduce or remove institutional impediments to clinical and translational research and enhance inter-institutional collaborations.

Technologies and Resources for Core Laboratories

Core laboratories must be for multiple users, include infrastructure applicable to various disciplines in the institution, and benefit research projects across disease areas. Participation in national or international quality control and standardization efforts where appropriate, is required. Plans to acquire new technologies should be fully justified within the context of the overall proposed program goals, and not duplicate local resources. Laboratory equipment, supplies, and personnel are all acceptable costs. 

Clinical and Translational Pilot Project Program

Pilot project programs must allow clinical and translational researchers to generate preliminary data for submission of grant applications particularly those that focus on research in minority health and/or health disparities; facilitate development of new technologies; or achieve other goals, as defined by the applicant, that will better position the institution to conduct clinical and translational research on minority health and/or health disparities.  Pilot Project Programs  must have an organizational structure that supports full compliance with regulatory requirements.

Program Evaluation by NIMHD

The RCTR program will undergo evaluation and assessment by NIMHD.  The evaluation of the RCTR program 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), and have different timelines and metrics (PD/PI defined vs. programmatic goals specified below).  The evaluation of the RCTR will be carried out five 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 RCTR is continued as configured, continued with modifications, or discontinued.  Should the findings indicate that the program is no longer needed or is not effective enough, NIMHD may consider terminating the program.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

 

New
Renewal
Resubmission

The OER Glossary and the PHS 398 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.   

Award Budget

The budget cannot exceed $3.1 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:

  Eligibility for this FOA is limited to institutions with current RCTR awards.

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 PHS 398 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 Directors/Principal Investigators (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 least6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

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 PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS 398 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

 Only one application per institution, identified by a unique DUNS number, is allowed.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

  

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 PHS 398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

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

The letter of intent should be sent to:

Robert Nettey, MD
Office of Extramural Research Administration
National Institute on Minority Health and Health Disparities (NIMHD)
6707 Democracy Boulevard, Suite 800
Bethesda, MD 20892
Telephone: 301-496-3996
Email: netteyr@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 and all copies of the Appendix files must be sent to:

Robert Nettey, MD
Office of Extramural Research Administration
National Institute on Minority Health and Health Disparities
6707 Democracy Boulevard, Suite 800
Bethesda, MD 20892
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Page Limitations

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, in addition to the following page limitations to the Research Strategy section of each component of the application.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the PHS398 Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Overall Component

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: The overall table of contents should list the names and page numbers for all of the components in the application.

Detailed Budget for Initial Budget Period (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:  The overall detailed budget should summarize the total budget for all of the components in the application.

Budget for Entire Proposed Period of Support (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: The overal detailed budget should summarize the total budget for all of the components in the application for the entire proposed period of support.

Biographical Sketch (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:  Biographical sketches are required for the Program Director(s)/Principal Investigator(s) and other executive level key personnel who are responsible for the day to day operations of the overall RCTR. Other biographical sketches should be included in their respective components.

Resources (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Resources for the overall center should be included in this section.

Research Plan (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Research Strategy: The overall research strategy section must include a Program Overview.   

The Program overview must describe:

Report on Performance During Prior Project Period

The report on performance during the prior project period must:

Human Subjects Protections, Vertebrate Animals

Because of the possibility for delayed on-set of research that may involve human subjects, vertebrate animals and/or biohazards, applicants must address the following topics: Protection of Human Subjects from Research Risk; Care and Use of Vertebrate Animals in Research; Use of Biohazards; and Inclusion of minorities, women, and children in research.  All instructions in the PHS 398 Application Guide must be followed.

Letters of Support: Applicants must provide letters from the appropriate high-ranking institutional official(s) that:

If the institution has a Clinical Research Education and Career Development Award (CRECD), a letter must be included from the Program Director/Principal Investigator indicating the CRECD program’s role in supporting the RCTR goals for clinical and translational research development. 

In cases where an institution has an NIMHD G12, P20, U54 or other awards, a letter must be included from the Program Director/Principal Investigator that indicates the program’s role in supporting the institution’s broader vision of clinical and translational research and how investigators from this program will be engaged in RCTR key functions/activities.  These letters must be co-signed by the Program Director/Principal Investigator of each specific award, the institutional business official and the Program Director/Principal Investigator of this RCTR application.  Applications lacking these letters will not be reviewed.

Separate letter(s) co-signed by the PD/PI and all the appropriate technology transfer offices must be provided to acknowledge that they will abide by the data and resource sharing plans specified in the application.  Applications lacking these letters will not be reviewed.

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 PHS 398 Application Guide.

Administrative Core

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Administrative Core)

Do not complete.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.

Key Personnel: The PD/PI(s) may be assisted by Program Directors the same institution or an affiliated institution. Deputy Program Director(s) must also be experienced investigators who have administrative skills and backgrounds that complement those of the PD(s)/PI(s).  The Directors of the activities/cores of the RCTR must be experienced personnel who possess the stature, knowledge, authority, leadership, administrative skills and capabilities necessary to direct the resource, and to speak on behalf of the RCTR institution in national forums.

Table of Contents (Administrative Core)

Do not Complete

Detailed Budget for Initial Budget Period (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.

The PD/PI must commit at least three person months to this position, in addition to any involvement in other RCTR activities.

Budget for Entire Proposed Period of Support (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.

The PD/PI must commit at least three person months to this position, in addition to any involvement in other RCTR activities.

Biographical Sketch (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed , with the following additional instructions: Include the biographical sketches for the Administrative Staff, and members of the internal advisory committee and other significant internal committees.  Do not include biographical sketches for external advisory committee members or any individuals who do not have direct roles in the proposed RCTR.

Resources (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed .

Research Plan (Administrative Core)

Specific Aims: Describe the specific aims of the Administrative Core.

 Research Strategy : Applicants must describe how the Administrative Core will manage, coordinate and supervise the entire range of proposed RCTR activities, monitor progress and ensure that component plans are implemented.  Applicants must explain the roles and responsibilities of Administrative Core personnel. 

A Management Plan describing the RCTR’s organizational and governance structure must be included. Plans to manage and, where necessary, reassign institutional resources and RCTR resources among the schools, departments, specialties, affiliated hospitals, and affiliated independent research institutions that participate in the RCTR; and between the RCTR and outside foundations and/or industry should be described.

The plan should describe the composition and roles of any committees proposed to help manage RCTR activities. Each RCTR must have an Internal Advisory Committee (IAC).   Depending on the scope and complexity of the RCTR program, the IAC may consist of six to eight members.  The IAC members and the frequency of IAC meetings should be included in the application.

The RCTR must also have an External Advisory Committee (EAC) that meets at least annually to review structure and progress and offer recommendations to the PD/PI(s). Any existing EAC membership should be listed and their role on 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.  Applicants must describe the type of expertise of the members that will be recruited for the EAC. Depending on the scope and complexity of the RCTR program, the EAC may consist of eight to ten members. Ideally, the members should be appointed on a rotating basis. 

Resource Sharing Plan: Do not complete.

Collaborations and Partnerships Core

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Collaborations and Partnerships Core)

Do not complete.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Collaborations and Partnerships Core)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Collaborations and Partnerships Core)

Do not complete.

Detailed Budget for Initial Budget Period (Collaborations and Partnerships Core)

All instructions in the PHS 398 Application Guide must be followed.

Budget for Entire Proposed Period of Support (Collaborations and Partnerships Core)

All instructions in the PHS 398 Application Guide must be followed.

Biographical Sketch (Collaborations and Partnerships Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Provide biographical sketches for the core director and other key personnel for the Collaborations and Partnership component.

Resources (Collaborations and Partnerships Core)

Do not complete.

Research Plan for Collaborations and Partnerships (Collaborations and Partnerships Core)

Specific Aims: Describe the specific aims for this component.

 Research Strategy: Applicants must describe how the RCTR environment facilitates intra-institutional collaborations.  In cases where an institution has a G12 award and/or other NIH-funded research capacity-building programs, RCTR grantees must demonstrate that there are collaboration and synergy between these program activities.  In addition, applicants must describe how collaborations and partnerships will be leveraged to enhance the professional development of junior investigators at the institution, and implementation of other RCTR key activities.  Resources may be requested to support mentored professional development activities for post-doctoral level professionals and junior faculty from a variety of disciplines and clinical specialties (MD, DDS, PhD, Pharm D, RN).  Applicants must describe the academic qualifications, research experience, and productivity of collaborators from other institutions and describe their contributions to the success of the RCTR.

Applicants must describe their roles in the RCMI Translational Research Network (RTRN) and how they will leverage the network to facilitate collaborations, enhance professional development of the researchers and the achievement of the RCTR goals and objectives.  Applicants must describe how they will utilize the RTRN in the conduct of multi-site clinical or translational research.  This may include but is not limited to how the RTRN will be utilized in the development of research study plans; planning and conducting biostatistical analyses; developing and implementing a data entry and management plan across participating sites; developing clinical research protocols, informed consent documents and case report forms for multi-site studies and developing and implementing quality control and quality assurance components of the project.  Applicants must include any costs associated with accessing RTRN resources in the associated budgets for these activities. 

If partnering institutions/organizations are proposed, there should be a thorough description of the partnership as well as the administrative and fiscal relationships that have been established between the RCTR and the collaborating institution(s)/organizations. Plans must be included to describe how regulatory hurdles related to collaborations will be addressed locally.  These partners must agree to follow NIH policies with respect to (1) listing of clinical trials at http://www.clinicaltrials.gov/; (2) sharing of resources; (3) data sharing and public access; and (4) establishing policies in support of investigator academic independence, reporting of patents or patentable concepts, and publication rights.

 Resource Sharing Plan: Do not complete.

Professional Development Core

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Professional Development Core)

Do not complete.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Professional Development Core)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Professional Development Core)

Do not complete.

Detailed Budget for Initial Budget Period (Professional Development Core)

All instructions in the PHS 398 Application Guide must be followed.

Budget for Entire Proposed Period of Support (Professional Development Core)

All instructions in the PHS 398 Application Guide must be followed.

Biographical Sketch (Professional Development Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Include biographical sketches for the Core director (s) and other key personnel.

Resources (Professional Development Core)

Do not complete.

Research Plan for Professional Development Core (Professional Development Core) 

Specific Aims: Describe the specific aims of the Core.

 Research Strategy: Applicants must provide programmatic detail on the activities proposed (e.g., seminars, mentoring plans, workshops or other professional development activities) to support professional development for post-doctoral level professionals and junior faculty from a variety of disciplines and clinical specialties (MD, DDS, PhD, Pharm D., RN).  In addition, the applicants must describe the plans for the administration of the proposed activities, and provide a description of the qualifications and role of the individual(s) providing scientific leadership, and administrative management and coordination of the proposed activities.  Applicants must provide evidence of how the proposed activities will be integrated across the institution.

Funds should not be requested to cover the cost of tuition, fees or stipends.  If the institution currently has a Clinical Research Education and Career Development (CRECD) in Minority Institutions award, or other training programs, applicants must describe these programs and indicate the program’s role in supporting the RCTR goals for clinical and translational research education and training.  Applicants must also describe how the proposed RCTR key functions/activities enhance the research training of the CRECD and other scholars.

If no currently funded training program exists at the institution, applicants should describe how the proposed RCTR activities will enhance their ability to apply for training awards, or partner with other institutions to leverage existing training activities.

Resource Sharing Plan: Do not complete.

Evaluation Core

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Evaluation Core)

Do not complete.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Evaluation Core)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Evaluation Core)

Do not complete.

Detailed Budget for Initial Budget Period (Evaluation Core )

All instructions in the PHS 398 Application Guide must be followed.

Budget for Entire Proposed Period of Support (Evaluation Core)

All instructions in the PHS 398 Application Guide must be followed.

Biographical Sketch (Evaluation Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Include biographical sketches for all key personnel in the Evaluation Core.

Resources (Evaluation Core)

Do not complete.

Research Plan for the Evaluation Core (Evaluation Core) 

Specific Aims: Describe the specific aims of the core.  

Research Strategy: Applicants must list performance milestones for each activity or core, and a timeline that will be used by the evaluator to measure progress in each budget period towards the achievement of performance goals.  The application must include a detailed evaluation plan to assess progress in implementation of the short-term and long-term RCTR goals, including implementation of specific program activities (process); and document the accomplishments anticipated for each budget period and within the total award period (outcomes).  For each proposed activity or core, the plan should include the objectives of the evaluation or tracking activities, the principal measures or indicators, and potential data sources.

This section must include:

Examples of evaluation objectives for illustrative activities or cores:

Research Design and Biostatistics

Clinical Research Resources and Facilities

Overall Operational Functions

Resource Sharing Plan: Do Not complete.

Optional Cores or Activites

For each optional core or activity, a complete component, consisting of all the PHS 398 forms below, must be completed.

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted. 

Face Page (Optional Cores or Activites)

Do not complete.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Optional Cores or Activites)

This information must be completed for each optional core or activity proposed. All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Optional Cores or Activites)

Do not complete.

Detailed Budget for Initial Budget Period (Optional Cores or Activites)

A detailed budget for the initial budget period must be completed for each proposed optional core or activity. All instructions in the PHS 398 Application Guide must be followed.

Budget for Entire Proposed Period of Support (Optional Cores or Activites)

A budget for the entire proposed period of support must be completed for each proposed optional core or activity.  All instructions in the PHS 398 Application Guide must be followed.

Biographical Sketch (Optional Cores or Activites)

Biographical sketches of the key personnel for each proposed core or activity must be included in the description of the core or activity.  All instructions in the PHS 398 Application Guide must be followed.

Resources (Optional Cores or Activites)

Do not complete for individual cores or activities.

Research Plan (Optional Core or Activity)

Specific Aims: Each core or activity must include specific aims.  

Research Strategy: Each optional core or activity must include a research strategy section. Examples include:

 Recruitment Core 

If proposed, applicants should describe plans in the research strategy for recruiting and hiring additional research personnel that may be required to accomplish the goals of RCTR.  This may include hiring of senior or mid-career clinical and translational investigators who have independent research support and can serve as mentors to more junior investigators.  These new faculty may receive support to establish their research laboratories, acquire specialized equipment, and support postdoctoral fellows and technical assistants.  If junior faculty members are hired, the application must contain detailed professional development plans.  The professional development section will count against the page limit. Applicants must include a proposed timetable specifying the expected hiring date for each new faculty and/or staff member.

Biomedical Informatics Core

If proposed, applicants should describe:

Research Design and Biostatistics Core

If proposed, applicants should describe:

Clinical Research Resources and Facilities Core

If proposed, applicants should describe:

Community-Based Research Core

If proposed, applicants should describe:

Regulatory Knowledge and Support Core

If proposed, applicants should describe:

Technologies and Resources for Core Laboratories

For each core laboratory proposed, applicants should describe:

Clinical and Translational Pilot Project Programs

Applicants should describe the plan to solicit proposals, prioritize the projects and to review their methodology and research performance.  The description of the Pilot Project program should include the scope; eligibility requirements; the limit on the dollars available and the number of years of support per project; the solicitation, submission, review, and selection criteria and process; oversight and evaluation procedures; and assurances that all projects supported from this grant will comply fully with all applicable Federal policies, rules, and guidelines for research involving human subjects.  Applicants should not submit individual research projects. 

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 PHS 398 Application Guide.

Clinical and Translational Pilot Project Programs, Biomedical Informatics and Technologies and Resources Cores should include resource sharing plans.

Appendix for the Entire Application

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS 398 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, NIH. Applications that are incomplete 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 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 RCTR have benefit on the overall quality of clinical and translational research at the applicant institution? Are the overall program vision and strategy adequate to facilitate and sustain clinical and translational research in minority health and/or health disparity areas? Will the proposed RCTR have potential to enhance the competitiveness of the awardee institution to obtain additional funding for clinical and translational research?  

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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the PD(s)/PI(s) have the experience, authority, and committed time to administer the proposed RCTR? Will the PD(s)/PI(s) have sufficient authority and credibility in the institution to work across institutional boundaries? Does the program leadership and management team bring complementary and integrated expertise to the project?  Have the Directors of the activities/cores committed sufficient time to implementing proposed activities? 

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Does the application identify key obstacles to the performance of translational and clinical research and then propose plans or means to overcome these? Will the proposed RCTR include relevant scientific disciplines and collaborations to maximize productivity? Does the application make efficient use of potentially unique resources, such as access to certain human subject populations or the provision of pre-clinical resources? Are plans included to address potential regulatory hurdles? 

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Will the RCTR enhance, complement, or extend the applicant's current resources for clinical and translational research in minority health and/or health disparity areas? Does the RCTR environment facilitate intra-institutional collaboration?   

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 score, but will not give separate scores for these items.

Activities or cores that are not listed in the FOA will be reviewed using the standard review criteria.

Institutional Commitment

Is there institutional commitment to establishing the RCTR program as an integral part of its overall clinical and translational research environment?  Is the institutional leadership committed to this program and its goals in terms of providing specific assets for the program, such as financial support, faculty support, specific equipment, dedicated space, as a few examples?

Collaborations and Partnerships

Do the investigators from the collaborating institution(s) have the appropriate academic qualifications, research experience, and productivity to make contributions to the success of the RCTR?  Has the applicant described how they will use the RCMI Translational Research Network (RTRN) to facilitate collaborations focused on minority health and/or health disparity research?  Are plans included to address regulatory hurdles for collaborations? Is there a plan to leverage collaborations and partnerships to enhance the RCTR key activities?

Professional Development

Is there evidence of appropriate collaboration among programs and departments to integrate clinical/translational research training and professional development activities across the institution?

Evaluation Core

Is the evaluation plan adequate to evaluate the short-term and long-term goals for each of the key proposed activities/cores? Are the measures valid for the programs' goals to be assessed and how accessible and practical are the available data sources? Do the milestones and timelines provide feasible objectives, and detailed quantitative and/or concrete criteria by which milestone achievement will be assessed?

Recruitment Core

Is the recruitment of additional faculty appropriately justified?  Will the new faculty/staff improve the capability of the RCTR to conduct research on diseases, with an emphasis on those that disproportionately affect minority populations or research on health disparities?  Is there adequate potential for newly hired junior investigators to achieve scientific independence under the mentorship of senior clinical investigators within or affiliated with the RCTR?  Has the applicant provided a timetable with appropriate expected hire dates for new staff?

Biomedical Informatics

Will the biomedical informatics resources offered be commensurate with the breadth of the RCTR program? Will the Biomedical Informatics support services provided by the RCMI Translational Research Network (RTRN) be utilized for multi-site studies on minority health and/or health disparities research?  Will data security and privacy be safeguarded? Will the institution work toward interoperability of the informatics systems and participate in the development of national data standards? Will the Biomedical Informatics Director have the necessary authority to ensure the implementation of best practices? As applicable, will this resource be sufficient for intra- and inter-institutional operations?  

Research Design and Biostatistics

Will the support and resources proposed ensure all clinical and translational research designs are sound and that statistical analyses are appropriate and rigorous? Will the Research Design and Biostatistics components of the RCMI Translational Research Network (RTRN) be leveraged for multi-site studies?

Clinical Research Resources and Facilities

Has the applicant adequately described and justified the resources to be provided? Will these resources meet the highest standards for subject safety, quality of science and statistical and ethical design? Is the application of Good Clinical Practices guidelines appropriate? Will resource utilization be tracked and are mechanisms proposed to adapt resources to the needs of investigators? Will the resources provided serve small as well as large studies or trials? Will participation of underrepresented minorities in clinical research protocols be encouraged?

Community-Based Research (CBR) Core

Will the CBR effectively involve the community in which the RCTR institution resides, both the public and/or providers, in clinical and translational research priority setting, participation, and follow-up? Will the resource foster long-term bidirectional relationships between the RCTR institution and the community for their mutual benefit?

Regulatory Knowledge and Support

Will this resource provide “researcher-focused” support for regulatory compliance and management, including the development of data safety and management plans? Is the resource well integrated with the Clinical Research and Resources and Facilities Core ? Will RCTR staff members be available with the necessary experience in working with the FDA and in ensuring that standards for reporting adverse events are met? Are criteria for identifying a research participant advocate sound? Will training be offered on topics such as conflict of interest, federal codes requirements, guaranteeing privacy and safety of research participants, especially as pertaining to vulnerable populations? 

Technologies and Resources for Core Laboratories

Is the plan to identify technologies and or core resources to be offered appropriate? Will resource utilization and evaluation be adequate? Is there flexibility in types of resources to be offered?  

Clinical and Translational Pilot Project Program

Is there an adequate plan to solicit proposals, to prioritize the projects and to review their methodology and research performance? Will the expected benefits to the RCTR and to the wider research community be measured and tracked?

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

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 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), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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 . 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/PI 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, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

Prior Approval of Pilot Projects

Awardee-selected pilot research projects require prior approval by NIMHD prior to initiation. For research projects that involve human subjects:

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 OMB administrative guidelines, HHS 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.

The PD(s)/PI(s) of the Coordinating Center will have the primary responsibility for:

The Program Director/Principal Investigator will have the primary responsibility to define objectives and approaches of the RCTR. The primary responsibilities of the awardees are to:

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 has 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 RCTR.

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

Additionally, the RCTR Program Official may recommend the termination or curtailment of an investigator or project/program (or an individual award) in the event the partnerships fail to evolve within the intent and purpose of this initiative.

An NIH Project Scientist(s) will have substantial scientific involvement during the conduct of this activity, through technical assistance, advice, and coordination above and beyond normal program stewardship for grants. NIH Project Scientists(s) will:

Collaborative Responsibilities

The goal of the RCTR program is to facilitate the development of each awardee institution’s clinical and translational research capacity. To assist RCTR institutions in achieving this goal, RCTR awardees are strongly encouraged to participate in national committees convened to advance collaborative clinical and translational research. Each RCTR institution must agree to work toward developing, adopting, and implementing the best practices and policies identified through the RCMI Translational Research Network (RTRN) and other national consortia.

Co-funding or matching funds from other sources (including industry) are encouraged, as long as these funds do not limit faculty research, communications, and implementation at any point and there are methods in place to ensure transparency, prevent misuse of federal funds, and ensure that NIH policies with respect to sharing of data and resources, academic freedom, and publication rights are not violated.

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 arbitration. 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 regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16ot Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) 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)
Telephone: 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
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone:  301-451-6536
Email:  mcclursh@mail.nih.gov

Peer Review Contact(s)

Robert Netty, MD
National Institute on Minority Health and Health Disparities
Telephone: 301-496-3996             
Email: netteyr@mail.nih.gov

Financial/Grants Management Contact(s)

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: pg38h@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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