NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) 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. 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 the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The mission of the National Institute on Minority Health and Health Disparities (NIMHD) is to lead scientific research to improve minority health and reduce health disparities. NIMHD recognizes the important role that institutions with historical commitment to diverse individuals have played in supporting scientific research and providing health care in underserved communities. These institutions 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, but often lack the research infrastructure and capacity to conduct cutting edge health-related research. The Research Centers in Minority Institutions (RCMI) program was originally 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.

The NIMHD supports research, training, health information dissemination, and other programs with respect to minority health and health disparities. This funding opportunity seeks to facilitate the development of research capacity in diverse institutions and research education of students/faculty to pursue basic biomedical, behavioral, and/or clinical research, particularly on diseases that disproportionately impact racial/ethnic minorities and other health disparity populations.

Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission. See NOT-OD-18-210. This FOA provides support for specialized research centers in institutions that offer doctoral degrees in the health professions or the sciences related to health and have a commitment to educating underrepresented students. The primary goals of the RCMI specialized centers are to: (1) enhance institutional research capacity within the areas of basic biomedical, behavioral and/or clinical research; (2) enable all levels of investigators to become more successful in obtaining competitive extramural support, especially from NIH, particularly on diseases that disproportionately impact minority and other health disparity populations; (3) foster environments conducive to career enhancement with a special emphasis on development of new and early career investigators; (4) enhance the quality of all scientific inquiry and promote research on minority health and health disparities; and (5) establish sustainable relationships with community-based organizations that will partner with the RCMI Institution.

Centers must have an explicit focus on one or more of the following areas: basic biomedical, behavioral, and clinical research based on the type of research project. Behavioral and clinical research areas are expected to emphasize minority health and health disparities, but basic biomedical research area does not have this requirement.

The RCMI program allows flexibility at the applicant institution with respect to the types of research resources required to accomplish research and investigator development goals. The most important criterion for inclusion of any component in the proposed center is the extent to which the activity or resource will enable the institution to achieve the stated goals.

Required and Optional Cores of an RCMI Specialized Center:

The center must enhance institutional research capacity and support the research needs of its investigators. The Center must include the following required components:

• Administrative Core
• Research Infrastructure Core
• Investigator Development Core
• Community Engagement Core
• Research Project(s)

In addition to these requirements, applications may also include the following optional core:

• Recruitment Core

Descriptions of Required Cores:

Administrative Core

The Administrative Core must be directed by the PD(s)/PI(s) of the Center and must provide administrative and logistical support for all Center activities. Further, the administrative core must provide career enhancement activities for post-doctoral fellows and junior investigators and foster synergy with other on-going career development activities at the institution including any funded through NIH grants. Resources may be requested to support seminars, workshops, and/or other career enhancement activities that promote the recruitment, advancement, and retention of investigators in biomedical research careers. In addition, the Administrative Core provides an assessment of each proposed activity/core and assessment of the impact of the Center in terms of: 1) enhancing the institutional infrastructure and environment necessary to facilitate biomedical research in the areas identified by the applicant; 2) increasing productivity of investigators in peer-reviewed publications and discovery; and 3) increasing the institution's overall success in applying for and obtaining extramural research funding.

Research Infrastructure Core: Methodology, Laboratory Technologies, Biostatistics, Informatics, and Core Research Resources

The goal of the Core is to enhance at the applicant institution, the quality and productivity of the research projects proposed, and the pilot projects funded, as well as link RCMI faculty and scholars with other researchers at the institution. Applicants may request resources to assist investigators with developing design and analysis plans for studies. These resources should be in the form of faculty-level expertise in research methodology, specialized laboratory techniques, statistics, bioinformatics and/or health informatics. Applicants may also propose activities that bridge research in study design, biostatistics, and research ethics with other NIH supported centers including those of the Clinical and Translational Science Awards (CTSA), Institutional Development Award (IDeA) Program Infrastructure for Clinical and Translational Research, Resource Centers for Minority Aging Centers (NIA) or other consortia. If biomedical informatics resources are requested, applicants should consider both internal, intra-institution and external interoperability to allow for communication among awardees through the RCMI Research Coordination Network (RRCN) and with other research partners (e.g., universities, government, clinical research networks, and pharmaceutical companies).

If core research resources are requested, they must be for multiple users, including infrastructure applicable to various disciplines in the institution (e.g., medicine, nursing, dentistry, pharmacy, public health, biostatistics, epidemiology, bioengineering, etc.) for the benefit of researchers and research projects. Standard operating procedures are required, and participation in national or international quality control and standardization efforts where appropriate. Proposed resources should be fully justified within the context of the overall program goals, and not duplicate locally available resources. The level of support requested must be justified by the projected use by biomedical researchers from within the applicant institution. Laboratory equipment, supplies, statistical and database software, and personnel are all acceptable costs. Cost recovery for core support should be sought from funded investigators.

• For renewal applicants, it is important that the current requested research infrastructure support builds upon or is complementary to previous RCMI funding.

Minor alteration and renovation (A&R) to improve existing research/core laboratories or animal facilities are allowed. This FOA will provide up to $500,000 in direct costs for A&R in addition to the overall direct cost cap, only in year one of the award period, as a one-time cost expenditure for a center. Funds designated for A&R under this FOA cannot support construction, modernization, or major alterations and renovation of research facilities as defined in Section 10.1 of the NIH Grants Policy Statement. A&R costs will be approved only for facility improvements at the applicant organization. Proposed improvements at consortium sites are not allowed.

Investigator Development Core

An applicant must request support for the Investigator Development Core with a Pilot Project program that: 1) allows the eligible institution’s researchers to generate preliminary data for subsequent submission of grant applications, particularly those that focus on research related to diseases that disproportionately impact minority or other disparity populations, or that address health disparities; or 2) develops new technologies that will better position the institution to conduct basic biomedical research. Such funds must be readily available and be accompanied by an organizational structure that supports full compliance with regulatory requirements.

Community Engagement Core

Applicants must describe activities designed to establish long-term relationships with community-based organizations in order to address their health-related concerns, to promote participation in research and recruitment and retention of study participants, and to disseminate findings from research projects.

Research Project(s)

Applicants should specify the objectives of the research project(s) that account for 20-30% maximum direct costs per year. Up to three research projects may be proposed in the areas of: 1) basic biomedical research, and/or 2) behavioral research, and/or 3) clinical/health services research. In order to receive the maximum Center budget, applicants must propose one project in each of the three scientific focus areas. Any proposed behavioral or clinical/health services project(s) must serve to advance scientific knowledge as it relates to minority health and/or health disparities. Basic biomedical research projects do not have this requirement.

Minority health is the distinctive health characteristics and attributes of racial/ethnic minority groups in the U.S. Minority health research is the scientific investigation of these distinctive health characteristics and attributes of the minority racial and/or ethnic groups. The research questions may focus on protective factors for conditions where outcomes may be better than expected including projects that evaluate mechanisms and interventions to sustain or improve a health advantage. The research questions may also address mechanisms and develop and evaluate interventions to reduce health disparities within a race/ethnic group(s).

A health disparity is defined as a health difference that adversely affects disadvantaged populations based on one or more of the following categories of health outcomes:

• Higher incidence/prevalence
• Pre-mature and/or excessive mortality in diseases where populations differ
• Burden of disease measured by Disability-Adjusted Life Years (DALYS) or similar metrics
• Poorer health related quality of life and/or daily functioning using standardized self-report measures

Health disparities research is a multi-disciplinary field of study devoted to gaining greater scientific knowledge about the influence of health determinants and defining mechanisms that lead to disparities and how this knowledge is translated into interventions to reduce or eliminate adverse health differences.

Applicants may include projects of variable size and duration over the 5 years. While the Pilot Project program in the Investigator Development Core focuses on junior investigators, these research projects may be led by more established investigators or senior scientists at the institution or the most qualified scientist regardless of rank.

Descriptions of Optional Core

Recruitment Core

This core may include hiring of investigators who have track records 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 federal or non-federal awards and who can serve as mentors to junior investigators. Institutions should develop outreach and recruitment strategies to ensure that applicants from underrepresented backgrounds are in the pool of applicants. These new faculty members may be provided up to $100,000 direct costs per year for up to two years to augment institutional support to establish their research laboratories or program, acquire specialized equipment or partially support a specialized collaborator, and support postdoctoral fellows and technical assistants.

Program Evaluation by NIMHD

The RCMI Specialized Research Centers program will undergo evaluation and assessment by the NIMHD. The evaluation of the program is distinct from the individual award’s outcome evaluation (described in Section IV.). While both evaluations address center outcomes, 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 will be carried out within four years after the release of this FOA. Assessment will be developed based on metrics that will include, but are not limited to:

• Increased collaborative basic biomedical, clinical, and/or behavioral research to improve minority health and/or reduce and eliminate health disparities through implementation of pilot/developmental studies, NIH-funded studies and studies funded by other federal and non-federal agencies;
• Development of innovative research programs, new tools and technologies, and publications in high impact journals;
• Enhancement of institutional infrastructure for conducting biomedical research including but not limited to: development of new cores and biomedical resources, development of research capacity to support multi-disciplinary research, leveraging of resources with institutional and other NIH funded programs or consortia; and
• Engagement of a diverse group of scientists in biomedical research which includes but is not limited to participation of individuals from underrepresented backgrounds (i.e. racial and ethnic minorities, persons with disabilities, or persons from disadvantaged backgrounds), women, early-stage and experienced investigators with a track record of funding, and investigators from various disciplines/departments and specialties.

The findings of this evaluation including information available from previous NIH evaluations of the RCMI program will determine whether the program is continued as configured, continued with modifications, or discontinued. Should the findings indicate that the program is no longer needed or is not effective in meeting the overall goals, NIMHD may also consider terminating the program.

NIMHD will conduct a Technical Assistance webinar for prospective applicants. Information about the webinar will be published in the NIH Guide to Grants and Contracts and posted on the NIMHD website at www.nimhd.nih.gov.

See Section VIII. Other Information for award authorities and regulations.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from 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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

To be eligible for this FOA, the applicant institution must be a domestic institution located in the United States and its territories which:

• Has received an average of less than $50 million per year of NIH support for the past three fiscal years;
• Awards doctorate degrees in the health professions or the sciences related to health; and
• Has a historical and current mission to educate students from any of the populations that have been identified as underrepresented in biomedical research as defined by the National Science Foundation (NSF), see http://www.nsf.gov/statistics/wmpd/) (i.e., African Americans or Blacks, Hispanic or Latino Americans, American Indians, Alaska Natives, Native Hawaiians, U.S. Pacific Islanders, and persons with disabilities) or has a documented track record of: (1) recruiting, training and/or educating, and graduating underrepresented students as defined by NSF (see above), which has resulted in increasing the institution's contribution to the national pool of graduates from underrepresented backgrounds who pursue biomedical research careers and, (2) for institutions that deliver health care services, provide clinical services to medically underserved communities.

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

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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 SF424 (R&R) Application Guide.

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

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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

The letter of intent should be sent to:

Thomas Vollberg, Sr., PhD
Telephone: 301-594-8770
Fax: 301-480-4049
Email: [email protected]

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	6 pages
Admin Core (use for Administrative Core)	12 pages
Research Infr Core (use for Research Infrastructure Core)	6 pages
Investig Dev Core (use for Investigator Development Core)	6 pages
Comm Engag Core (use for Community Engagement Core)	6 pages
Recruitment Core	6 pages
Research Project (s)	12 pages each

Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required
• Administrative Core: required
• Research Infrastructure Core: required; maximum of 1
• Investigator Development Core: required; maximum of 1
• Community Engagement Core: required; maximum of 1
• Recruitment Core: optional; maximum of 1
• Research Project(s); required; maximum of 3

When preparing your application in ASSIST, use Component Type Overall .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Other Attachments: The application must include a single attachment titled "Institutional Information" that provides a description and evidence of the institution's explicit accomplishments in the education of students from backgrounds nationally underrepresented in biomedical research and, if applicable, efforts to provide clinical services to underserved communities.

• For institutions whose historical mission explicitly states that it was founded to educate students from nationally underrepresented backgrounds in biomedical research (i.e., underrepresented racial and ethnic groups [African Americans, Hispanic Americans, American Indians or Alaska Natives, Native Hawaiians, U.S. Pacific Islanders, and individuals with disabilities] and/or students from financially disadvantaged backgrounds, as defined in NOT-OD-18-129, provide the institution's original mission statement and any other information that justified the institution's creation and describes its main functions and services provided.
• For institutions whose mission statement does not explicitly state that they were founded to educate any of the underrepresented groups mentioned above but have a demonstrable historical track record of recruiting, retaining, training, and graduating underrepresented students, the institution must provide information and current figures compared to baseline data from ten years ago that show how the institution's historical track record of training and graduating underrepresented students in biomedical and behavioral-related sciences has improved significantly and how much it has contributed to a substantial increase in the national pool of graduates from underrepresented backgrounds who have pursued or are pursuing biomedical research careers.
• For institutions that deliver health care services, provide information on clinical services to medically underserved communities.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component.

Specific Aims: Describe the specific aims for the Center and summarize how the proposed components and activities will: (1) enhance institutional research capacity to conduct world-class basic biomedical, behavioral, and/or clinical research; (2) enable all levels of investigators to become more successful in obtaining competitive extramural support, especially from NIH, particularly for research on diseases and conditions that disproportionately impact minority and health disparity populations; (3) foster environments conducive to career development and enhancement for post-doctoral fellows, junior faculty, and other early stage investigators; (4) enhance the tools for, conduct of, and dissemination of research generally and specifically for advancing minority health and preventing and eliminating health disparities; and (5) establish sustainable relationships with community-based organizations that will partner with the RCMI Institution.

Research Strategy: Each applicant must assess and plan a program to address its own research needs and vision. The applicant must describe and justify how existing and requested resources will be utilized and leveraged to implement the institutional plan to develop, expand, and maintain an environment and framework suitable for achieving the objectives of their center. Moreover, plans for enhancement of biomedical research capacity must be consistent with the long-range goals of the applicant institution.

The overall research strategy section must include a Program Overview that describes:

• The significance of the basic biomedical, behavioral, and/or clinical research efforts that are a part of its institutional priorities.
• An analysis of organizational, educational, and scientific strengths and weaknesses.
• How the proposed activities will address research infrastructure needs.
• Goals for the center during proposed project period.
• A summary of the key activities that will be conducted to achieve each of the proposed goals.
• Innovation of the proposed activities.
• Specific institutional commitments that will be made to support the Center goals.
• The area(s) addressed by the application as a whole (i.e., basic science, and/or behavioral research, and/or clinical research) and the rationale for seeking support for the area(s), and if multiple areas are proposed, provide rationale for the importance of the larger program to the overall goals.

For renewal applicants, provide a Progress Report on previous RCMI funding.

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

• Indicate the commitment of the institution to the center goals and how the center activities will be integral to the broad institutional vision for biomedical, behavioral, and/or clinical research.
• Specify any institutional support, for example financial support, dedicated space, salary support for professional or administrative staff, interface with other grants, centers, and initiatives, etc.
• Indicate the commitment of the institution to participate in the RCMI Research Coordinating Network, RRCN, formerly the RTRN, and other national consortia working towards developing, adopting and implementing best practices in basic biomedical, behavioral, and/or clinical research and training.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application, use Component Type Admin Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of 'Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The Administrative Core must be directed by the PD(s)/PI(s) of the Center.

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

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

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

Applicants must also provide proposed programmatic activities (e.g., seminars, workshops or other activities) to support career enhancement for all investigator levels, including but not limited to post-doctoral fellows, junior faculty, and other early stage investigators from a variety of disciplines, as appropriate. In addition, applicants must describe the academic qualifications, research experience, and productivity of mentors including those from other institutions. Applicants must provide evidence of how the proposed activities will be integrated across the institution.

A management plan describing the Center’s organizational and governance structure must be included. Plans to manage and, where necessary, reassign institutional resources among the schools and/or departments should be described.

The management plan should describe the composition and roles of any committees proposed to help manage the Center activities. Each Center must have an Advisory Committee (AC). Depending on the scope and complexity of the center, the AC may consist of up to ten members. AC should include representatives from the target communities, external scientific advisors, and institutional scientists not directly supported by the RCMI. Applicants must describe the type of expertise of the members that will be recruited for the AC, but not give specific names. Meetings should occur at least every six months. The AC should review structure and progress and offer recommendations to the PD/PI(s) on an annual basis.

Also, include an evaluation plan to monitor progress for the Center activities. The evaluation plan is intended to facilitate ongoing Center project management to ensure successful completion of the stated aims. Describe how the evaluation will be conducted, principal measures and metrics to be used to assess achievement of short- and long-term goals of each core and project, and potential sources of data. The plan should address administrative functioning (process) as well as scientific, infrastructure and community-related accomplishments (outcomes). Describe key milestones and expected outcomes for each area, as appropriate

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix:

Limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application, use Component Type Research Infr Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Research Infrastructure Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Infrastructure Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Infrastructure Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Other Attachment: The application must include, if applicable, a single attachment titled "Alterations and Renovations" that provides:

A description of the functional units, including the size (dimensions) and square footage of each component (room, alcove, cubicle) that will be directly affected by the renovation project. Engineering criteria applicable to each component unit (mechanical, electrical, and utilities) must be included such as the number of air changes per hour, electrical power, light levels, hot and cold water, and steam. Applicants must also list appropriate architectural criteria (such as width of corridors and doors, surface finishes). All fixed equipment items requested for the renovated area must be listed and justified. If renovations to animal facilities are proposed, the proposed renovations must be related to the projected animal population by species and include the lines of authority and responsibility for administering the institution's animal care and use program. The role and composition of the Institutional Animal Care and Use Committee (IACUC) and how compliance with relevant laws, policies, and guidelines are achieved must also be included.

The line drawings of the proposed renovation that are legible, with the scale clearly indicated and adequate to explain the project. The drawings must indicate size (dimensions), function, and net and gross square feet of space for each room. The total net and gross square feet of space to be renovated must also be given. The plan must indicate the location of the proposed renovation area in the building. Include the as-built drawings of the proposed renovation area and indicate any areas that will be demolished. Any changes or additions to existing mechanical and electrical systems must be clearly described in notes made directly on the plan or attached to the plan. Indicate the type(s) of new finishes to be applied to room surfaces. Applicants must relate the proposed renovations to the research projects that will use the facility and detailed cost estimates must be included. Provide vendor quotes when available.

Project /Performance Site Location(s) (Research Infrastructure Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Infrastructure Core)

ASSIST will default to Project Lead . If you would like to use a different category, then replace Project Lead below with a different Category (e.g., Core Lead).

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Research Infrastructure Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Minor alteration and renovation (A&R) to improve existing research/core laboratories or animal facilities are allowed. This FOA will provide up to $500,000 in direct costs for A&R in addition to the overall direct cost cap, only in year one of the award period, as a one-time cost expenditure for a center. Funds designated for A&R under this FOA cannot support construction, modernization, or major alterations and renovation of research facilities as defined in Section 10.1 of the NIH Grants Policy Statement. A&R costs will be approved only for facility improvements at the applicant organization. Proposed improvements at consortium sites are not allowed.

PHS 398 Research Plan (Research Infrastructure Core)

Specific Aims: Describe the specific aims for the Research Infrastructure Core.

Research Strategy: Describe how the resources and services to be provided by the Core, at the eligible institution, will enhance the tools for, the conduct, quality and productivity of, and the dissemination of research generally, and especially for research projects and pilots seeking to advance minority health and prevent and eliminate health disparities.

Describe the services that the Research Infrastructure Core will provide, as applicable:

• Resources and services that will be offered, with plans for their prioritization, availability, management and tracking. Plans to ensure inclusion of infrastructure applicable to various disciplines in the institution for the benefit of researchers and research projects across a broad range of health-related research areas.
• The user pool for the requested resource that includes a description of the research projects, collaborators and funding sources.
• Services for study design and analyses with methodological and statistical expertise to support research projects, pilot studies and other investigators.
• Bioinformatics support for analyses.
• Health informatics support for data resources such as electronic medical records, public use sources, clinical studies, or other sources of health data on minority and other disparity populations.
• Common laboratory techniques to be used across basic science projects that require specialized skills.
• Laboratory equipment that will be used by RCMI investigators and fellows with pilot grants.
• Advice that may include but is not limited to conflict of interest, federal codes requirements, privacy and safety of research participants, especially as pertaining to vulnerable populations.
• Integration of research ethics into core services.
• Assessment of function and effectiveness of services provided to assist investigators in their documentation requirements for institutional compliance or enforcement offices.
• Integration of resources with similar resources at the institution and any affiliates.
• Support provided for operations, administration and research activities.
• The process by which standards and other mechanisms will be developed and used to maximize interoperability between internal systems and systems in external organizations.
• Interactions with the RCMI Translational Research Network (RTRN) and other partners.
• Assessment of informatics performance with external partners- RTRN, Clinical and Translational Science Awards (CTSA), Institutional Development Award (IDeA) Program Infrastructure for Clinical and Translational Research, etc.
• Plans for cost recovery from funded investigators and/or specific institutional support for the core.
• Any minor alteration and renovation (A&R) to improve existing research/core laboratories or animal facilities.

For renewal applicants, it is important to state how the current requested research infrastructure support builds upon or is complementary to previous RCMI funding.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Research Infrastructure Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application, use Component Type Investig Dev Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Investigator Development Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Investigator Development Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Investigator Development Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Investigator Development Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Investigator Development Core)

ASSIST will default to Project Lead . If you would like to use a different category, then replace Project Lead below with a different Category (e.g., Core Lead).

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Investigator Development Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Applicants may request support for three to five pilot projects per year at a minimum direct costs of $30,000 to a maximum $50,000 per pilot project. Minimum total allocation to the Pilot Project Program should be $150,000 per year in direct costs, total maximum total allocation is $250,000 per year direct costs. (plus consortium F&A costs).

Funds should not be requested to cover the cost of fees or stipends. Compensation for services rendered is allowable.

PHS 398 Research Plan (Investigator Development Core)

Specific Aims: Describe the specific aims for the Investigator Development Core.

Research Strategy: The main goal of the Investigator Development Program is to support the development of post-doctoral fellows, junior faculty, and other early stage investigators in basic biomedical, behavioral, and/or clinical sciences. Eligible applicants should be at the senior post-doctoral or fellowship level or assistant professor. Applicant institutions should address their outreach and recruitment strategies to ensure that applicants from underrepresented backgrounds are in the pool of applicants. Recipients of pilot funds will be expected to receive ongoing advice from RCMI faculty, meet on a regular schedule, participate in seminars and conduct their research pilot project. These investigators will be expected to work on publications based on their pilot project as well as collaborate on other projects. The goal is to succeed as researchers and apply for external funding such as mentored K-award or equivalent and ultimately a R01 grant as appropriate to their career level.

Applicants should describe the plan to solicit and review proposals, prioritize the pilot projects for funding and to review their methodology and research performance. The description of the Investigator Development program should include the scope; eligibility requirements; the limit on the dollars available and the number of years of support per pilot project; the solicitation, submission, review, and selection criteria and process; governance, oversight and evaluation procedures; and assurances that all pilot projects supported from this grant will comply fully with all applicable Federal policies, rules, and guidelines for research involving human subjects and vertebrate animals.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Investigator Development Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application, use Component Type Comm Engag Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Community Engagement Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Community Engagement Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Community Engagement Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Community Engagement Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Community Engagement Core)

ASSIST will default to Project Lead . If you would like to use a different category, then replace Project Lead below with a different Category (e.g., Core Lead).

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Community Engagement Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Community Engagement Core)

Specific Aims: Describe the specific aims for the Community Engagement Core.

Research Strategy: Applicants must describe activities designed to establish long-term relationships with community-based organizations in order to address priority community health-related concerns and to promote participation in research and recruitment and retention of study participants.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Community Engagement Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application, use Component Type Recruitment Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Recruitment Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Recruitment Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Recruitment Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Recruitment Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Recruitment Core)

ASSIST will default to Project Lead . If you would like to use a different category, then replace Project Lead below with a different Category (e.g., Core Lead).

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Recruitment Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Recruitment Core)

Specific Aims: Describe the specific aims for the Recruitment Core.

Research Strategy: Applicants should describe plans in the research strategy for recruiting and hiring additional research personnel that may be required to accomplish the goals of the center. This may include hiring of senior or mid-career investigators who have independent research support and can mentor junior investigators. These new faculty members may receive support to establish their research laboratories, acquire specialized equipment, and support postdoctoral fellows and technical assistants. For the proposed new faculty members who are to be recruited, the application must contain detailed planning and recruiting activities to ensure that applicants from underrepresented backgrounds are in the pool of applicants and that the advertisement, recruitment, interview and selection processes are equitable and ethical. Applicants must include a proposed timetable specifying the expected hiring date for each new faculty and/or staff member.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Recruitment Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application, use Component Type Research Projects.

Within the limitations of the budget, one to three Research Projects may be proposed with a project period up to five years in duration. However, each year of the project period must include Research Project(s) that meet the required budget allocation.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Research Project)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Research Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Project)

ASSIST will default to Project Lead . If you would like to use a different category, then replace Project Lead below with a different Category (e.g., Core Lead).

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Research Project)

Budget forms appropriate for the specific component will be included in the application package.

The RCMI research projects should total 20-30% maximum direct costs per year (plus consortium F&A costs). Therefore, combined research project budgets are limited to $450,000 in direct costs per year (plus consortium F&A costs) for applications that encompass one research area, $675,000 for two areas, and $900,000 for all three areas.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Research Project)

Specific Aims: Describe the specific aims for the Research Project.

Research Strategy: Specify the objectives of the Research Project. Explain how the proposed project will serve to advance scientific knowledge. All projects in the categories of behavioral and clinical/health services need to address a research question and a scientific premise within minority health and/or health disparities. Basic science projects are not required to conduct research relevant to minority health or health disparities.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Research Project)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

All instructions in the SF424 (R&R) Application Guide must be followed.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

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 submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIMHD. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

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.

In addition, for applications involving clinical trials:

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center 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 Center 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 Center that by its nature is not innovative may be essential to advance a field.

Does the Center address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the Center 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?

To what extent are the proposed Center components and activities likely to enhance institutional research capacity for basic biomedical, behavioral and/or clinical research and to foster investigator development particularly for new and early career investigators? If proposed, are the behavioral or clinical/health services research projects likely to advance understanding of diseases that disproportionately impact minority and other health disparity populations?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? If Early Stage Investigators or those 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?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

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?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the Center involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

How well does the selection of projects support the overall goals? Is the rationale for selecting project(s) in basic science and/or behavioral research and/or clinical research appropriate to the overall goals? If multiple areas are proposed, how important is pursuit of a larger program to the overall goals? To what extent are the proposed Center components and activities likely to help all levels of investigators at the institution become more successful in obtaining competitive extramural research support? To what extent are the proposed Center components and activities likely to enhance and sustain productive collaborations and partnerships with community-based organizations?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable?

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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?

To what extent are the proposed Center components and activities likely to foster environments conducive to investigator development, particularly for new and early career investigators? To what extent do the institutional letters of support indicate that the applicant institution is fully committed to achieving the goals and objectives of the proposed center, and that the center will be integral to achieving the broad institutional vision for health sciences?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

As applicable for the Center 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.

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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 Guidelines for the Review of Human Subjects.

When the proposed Center involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

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.

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

Not Applicable

As applicable for the Center 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.

Not Applicable

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).

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) Genomic Data Sharing Plan .

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Cores 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.

Administrative Core

Are strategies to ensure effective management, coordination, support and supervision of the entire range of proposed activities well described and likely to succeed? Do the proposed approaches for coordinating and supervising activities monitor progress adequately and support the likelihood that each component's aims will be achieved within the project period?

Are the proposed programmatic activities appropriate for the support of career enhancement for post-doctoral level professionals and junior faculty from a variety of disciplines, as appropriate?

Are the Core Lead, collaborators, and other researchers well suited to the roles in the management and conduct of the Core's activities?

Is the organizational and governance structure adequately described and appropriate for supporting the stated aims? Does the management plan adequately describe the composition and roles of the Advisory Committee (AC) and any other committees proposed to help manage the proposed activities?

Does the applicant include an evaluation plan that incorporates appropriate performance targets, objectives, and outcomes? Is the proposed evaluation plan well-conceived and described in sufficient detail to judge its utility for ongoing project management?

Research Infrastructure Core

To what extent are the proposed plans for providing research resources and services (e.g., study design, biostatistics consultation, informatics support, regulatory knowledge and support, shared instrumentation, etc.) likely to enhance the quality and productivity of research projects and pilot projects supported by the Center?

Does the description of the potential user pool for various services and resources support the likelihood that the core will substantially enhance institutional capacity for conducting a broad range of health-related research projects and collaborations?

Are plans to ensure inclusion of infrastructure applicable to various disciplines in the institution for the benefit of researchers and research projects across a broad range of health-related research areas well thought out and feasible?

Are the proposed resources likely to complement and be integrated with other research resources at the institution and any affiliates?

Are the services for study design and analysis with methodological and statistical expertise adequate and appropriate to support the research projects, pilot studies and other investigators? How likely is the core to function in a synergistic way to maximize the quality and productivity of the research projects, pilot studies and other investigators?

Do the involved personnel have the appropriate background and training to provide the services and effectively operate this core?

Are there appropriate plans for assessment of function and effectiveness of the services provided by this core, including the effectiveness in assisting investigators with documentation requirements for institutional compliance or enforcement offices?

Are plans for core operations, management, prioritization and tracking of services adequately described and justified?

Are the proposed processes for developing standards and other mechanisms to maximize interoperability between internal systems and systems in external organizations well thought out and feasible, and likely to enhance collaborations with other research consortia and networks?

Are there adequate institutional plans and procedures to assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects?

Are there well-considered plans for sustaining research infrastructure through cost recovery and/or institutional support?

Investigator Development Core

To what extent are the proposed activities likely to support the development and enhance the competitiveness of diverse investigators in basic biomedical, behavioral and/or clinical sciences, particularly early-stage investigators?

Is the potential pool of prospective investigators an indicator for a strong pipeline of pilot projects in future years?

Is the proposed plan for soliciting and evaluating research proposals, prioritizing projects, and monitoring their performance well thought out and likely to enhance investigator development?

Do the proposed plans for governance, oversight and evaluation support the likelihood that all projects supported by the center will fully comply with applicable Federal policies, rules, and guidelines for research involving human subjects and vertebrate animals?

Community Engagement Core

To what extent are the proposed activities likely to enhance and sustain productive collaborations and partnerships with community-based organizations to foster community awareness of and participation in health-related research?

For applicants that proposed behavioral or clinical/health services research projects, how well-suited are the community-based organizations to promote participation of minority health and/or health disparities populations in research and to foster recruitment and retention of study participants?

Optional Core

If a Recruitment Core is proposed, are plans for recruiting and hiring additional research personnel adequately justified in terms of accomplishing the goals of the center? Are the proposed investigator development plans likely to enhance the competitiveness of junior faculty and promote their success as independent investigators? Are the plans supportive to the establishment of a recruited faculty’s research program at the RCMI institution? Are there appropriate timelines of the hiring of new faculty and/or staff members?

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).

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? Is there a strong scientific premise for the project? 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?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the Project Lead, collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

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?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable?

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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.

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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

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) Genomic Data Sharing Plan.

Authentication of Key Biological and/or Chemical Resources

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 NIMHD 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:

• 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 score.
• Will receive a written critique.

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications 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.
• Geographic distribution of awardees.

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

Awardee-selected projects that involve human subjects or live vertebrate animals require prior approval by NIH prior to initiation.

• The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH s Instructions for Preparing the Human Subjects Section of the Research Plan.
• The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.
• If live vertebrate animals are to be involved, follow NOT-MD-08-002 and NOT-OD-16-006.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 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 award recipients 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

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

• Coordinating project activities technically, scientifically and administratively at the recipient institution and coordinating project activities at other sites that may be supported by the award.
• Defining objectives and approaches; collecting and analyzing data; and publishing results, interpretations, and conclusions of studies conducted under the terms and conditions of the award.
• Ensuring that appropriate Institutional Review Board approvals and certifications for research involving human subjects for all participating sites, collaborators or partners are obtained.
• Selecting external members for and participating in the Advisory Committee.
• Organizing biannual meetings of the Advisory Committee.
• Consulting with NIMHD to ensure compliance with relevant grant policies and regulations.
• Participating in the Advisory Committee meetings and other PD/PI meetings convened by NIMHD.

Recipients 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 (see below) and Project Scientist(s) to the award. The Project Scientist(s) will have substantial scientific involvement during the conduct of this activity, through technical assistance, advice, and coordination. Project Scientists(s) will:

• Review and comment on critical stages in the program implementation;
• Assist in the interaction between the recipient and investigators at other institutions to promote collaborations;
• Assist in coordinating access to other resources available through statewide, regional, or national specialized cores or resources;
• 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.

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

• Assist with the NIMHD’s monitoring of compliance of award-supported activities;
• 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;
• Help 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 center activities prior to implementation to ensure consistency with the goals of this FOA;
• Link the approaches developed from the center to other NIMHD-supported activities to ensure that information is shared and utilized on the widest basis possible;
• Monitor institutional commitments and resources to help ensure that the center receives the maximum chance of stabilization and success;
• Assist with the NIMHD’s monitoring of financial oversight of the Program.

Areas of Joint Responsibility include:

• Establishing an Advisory Committee consisting of: 1) the PD(s)/PI(s); 2) up to six other members selected by the PD(s)/PI(s); 3) the NIMHD Program Official; and 4) the NIH Project Scientist(s). Each committee member will have one vote except for the NIH staff members, who will share one vote. The Advisory Committee will convene by telephone as needed and will meet in person at least once a year.
• Identifying and facilitating partnerships with other NIMHD award recipients in the respective regions with expertise and/or interest health disparities or other relevant resources and expertise that could be leveraged to facilitate achievement of the center goals and objectives.
• Organizing and participating in the Advisory Committee meetings at least biannually to discuss matters of mutual interest and promote information exchange across regions.

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 Advisory 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 award recipient. This special dispute resolution procedure does not alter the recipient'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 Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Derrick Tabor, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8950
Email: [email protected]

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

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

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 Part 75.