Required Application Instructions

It is critical that applicants follow the 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 goal of the NIMHD Community-Based Participatory Research (CBPR) Program is to promote and support collaborative interventions that involve all relevant partners in the translational research process planning, implementing, evaluating and disseminating community level interventions aimed at improving health and addressing health disparities. In the health disparities framework, this includes partnership approaches that focus on changing the determinants of health or the community conditions and environments, in which their members are born, mature, play, study, work and age. The research approach may begin with a needs assessment to identify a health-related issue for action, or a community-led proposal on an identified need or issue of importance to the community. The participatory research process is such that community members, persons affected or impacted, public health and policy professionals, and other key stakeholders in the community s health have the opportunity to be full participants in each phase of the research (from conception-design-conduct-analysis-interpretation-conclusions-communication of results). CBPR benefits are numerous and include the creation of bridges between the community, scientists and policy professionals to facilitate the bidirectional transfer of knowledge and skills, improved community research literacy and creation of appropriate and effective interventions.

This FOA invites applications for intervention studies using CBPR principles and methods. For the purpose of this FOA, community refers to a population that may be defined by geography, race, ethnicity, culture, gender, illness or other health condition, or to groups that have a common health-related interest or cause. Communities must include significant representation of one or more NIH-designated US health disparity populations, which include Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations and rural populations.

In 2012, NIMHD issued RFA-MD-12-006 to invite applications for a three-year planning grant. The first year of the planning grant was devoted to partnership development, community needs assessment, identifying the disease/condition for intervention research, and planning the intervention methodology with substantial input from the community. During the second and third years, a pilot health intervention study was conducted with community participation. This FOA is open to current NIMHD CBPR planning grantees and their community coalitions, and other applicants poised to implement and evaluate promising broad scale interventions using CBPR methods. The intervention study must take place in the United States or US Territories or Possessions.

Dramatic advances in the past decade have resulted in escalating growth in knowledge of the complexity of the interactive factors influencing health across the life course. There is extensive research evidence that still shows poorer health outcomes for socially disadvantaged populations, including low-income and racial and ethnic groups. As such, identifying effective interventions to address these health disparities is important. Despite recommendation for tailored and multilevel interventions, many community health promotion and disease prevention programs fail for various reasons that include the lack of a participatory approach or cultural sensitivity.

The rationale for this program is two-fold: (1) To address the need for improved transdisciplinary and intervention research methods and approaches addressing health disparities; and (2) To strengthen the science of community engagement in addressing health disparities in socially disadvantaged population groups. Effective research intervention science approaches require a comprehensive framework for planning, developing conceptual models, identifying theory-based or evidence-based measures and implementing strategies for change. It also requires an iterative participatory process in all phases of the intervention. There is a relative paucity of effective intervention research methods and participatory approaches addressing population health and disparities. Given current understanding of the determinants of health, (e.g. social, environmental and behavioral) and the biological mechanisms that these determinants operate to influence health status, an elaborate intervention research framework and phased structure are being sought to accomplish the goals of this CBPR Intervention Phase program.

The following describes elements of the research plan approaches required to achieve the following Specific Research Objectives:

1) Establishment of the health issue, disease or condition or related problem as a need in the community and amenable to the study intervention. The intervention design should include consideration of community preferences, and draw on community strengths, knowledge, resources and capacities. A consideration of the economic costs and benefits to the community is also of importance.

2) Development of an intervention research framework informed by a conceptual or theory-based model of health and synthesis of the evidence supporting the framework. The framework ensures that supporting conceptual and theory-based models guide the intervention in these areas: (a) documentation of the potential cause or etiology for the poor health status or outcomes; (b) identification of biological, behavioral, social and environmental determinants related to the target problem for action, where relevant; and (c) selection of the important and actionable health determinants and community attributes to inform the research design and methodology.

3) Design of an intervention mapping tool, i.e. a phased intervention structure that charts the stages of the intervention (from conception-evidence synthesis to the project design, conduct, analysis, interpretation, conclusions, and communication of results). The phased intervention map should be informed by the intervention research framework and enable the community and research team to build iteratively on findings from each stage and guide subsequent stages of the research. A participatory approach allows for an iterative process and flexibility throughout the implementation process. Preliminary studies demonstrating initial feasibility, acceptability, and efficacy of the intervention in the target community are required to include in the structure. Projects are expected to utilize rigorous research methods to determine intervention impact, including but not limited to randomized designs and quasi-experimental designs using appropriate comparison communities or populations, where relevant.

4) Establishment of a community coalition and Community Advisory Board that includes community members, researchers and other stakeholders with relevant expertise to inform the intervention process.

5) While intervention targets may include outcomes for health knowledge change in addition to health behaviors and environmental change, projects that use health knowledge as the sole outcome will be considered non-responsive to this FOA.

Projects are required to involve at least one community-based organization, either as the applicant organization or a partner organization. The individual or representative of the community organization will be named as key personnel in the Notice of Grant award. Projects that involve American Indian Tribal Governments instead of or in addition to community-based organizations are also acceptable. Additional collaborations with other types of partners, including but not limited to academic organizations, healthcare providers, school districts, and Federal or local government agencies, are strongly encouraged.

For the purposes of this FOA, interventions include health promotion programs, policies, services or resource provision that have the potential to impact a population group by changing the underlying conditions of increased risk or vulnerability. Examples of interventions include the implementation of organizational policies to support wellness and workplace safety, school-based policies to encourage physical activity, implementation of prevention programs, and environmental change approaches that address health disparities. It involves the use of current scientific data to inform interventions that may operate within or outside the health sector, but have the potential to impact health at the population level. Appropriate research intervention topics include, but are not limited to the following:

• Interventions to promote healthy lifestyle behaviors (e.g., physical activity, healthy diets) to prevent or reduce overweight/obesity and obesity-related complications (e.g., cardiovascular diseases, diabetes)
• Interventions that address adversity and chronic stress
• Interventions focusing on the prevention or cessation of tobacco use and substance abuse
• Interventions that promote healthy sexual behaviors that prevent or reduce the transmission of HIV/AIDS and other sexually-transmitted infections
• Interventions preventing or reducing intentional (e.g., suicide) or unintentional injuries and violence
• Interventions to promote preventive behaviors (e.g., vaccinations, health screenings) that lead to the early detection or prevention of diseases/conditions such as colon cancer, prostate cancer, cervical cancer, influenza and other vaccine-preventable diseases.

Areas of specific research interest include but are not limited to:

• Multi-level interventions that include a combination of individual, group (such as peers, family members, etc.), and/or community-level intervention components.
• Interventions that include health information technology applications (e.g. behavior monitoring tools, decision aids, health information portals, etc.) and/or social media elements.
• Interventions that draw upon existing community strengths and resilience.

Standardization and Coordination of the CBPR Program. Although the studies supported by this program will not use a common study protocol, whenever possible, investigators will be encouraged to collaborate on the coordination of standardized reporting, community formative assessment measures, evaluation plans, and the development and use of standardized protocols for similar intervention studies.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are 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 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).

Institutions of Higher Education and research organizations are required to partner with at least one community-based organization (or American Indian Tribal Government). Community-based organizations/ American Indian Tribal Governments are not required to partner with higher education institutions or research organizations.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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:

Maryline Laude-Sharp, PhD
Telephone: 301-451-9536
Fax: 301-480-4049
Email: [email protected]

All page limitations 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 an application to this FOA.

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

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

Projects are required to involve at least one community-based organization, either as the applicant organization or a partner organization. However, projects that involve American Indian Tribal Governments instead of or in addition to community-based organizations are also acceptable.

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

All instructions in the SF424 (R&R) Application Guide must be followed, with the following exception:

Applications in which the PD/PI is not from a community-based organization, must include at least one person from the partnering community-based organization as key personnel with a minimum of 3 calendar months or equivalent effort for academic calendars or other appointments (compensated or contributed).

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

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

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

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

Research Strategy: Define the target community or communities using a set of tangible and explicit criteria. The criteria can include a common geography, interest, identity, characteristic, or condition. Specify the representation of US health disparity populations within the target community or communities.

Identify partner organizations and describe their roles and contributions on the project. Identify the role of the Community Advisory Board on the project and the types of experience, expertise, or knowledge that will characterize board members (do not identify board members by name in the application). For effective translation, community stakeholders identified for the project should include individuals or organizations critical to the intervention process. This includes especially those who are likely to be able to use the knowledge generated through the research to make informed decisions about policies, programs and/or practices, and whose level of engagement in the research process as a knowledge consumer or provider may vary in intensity and complexity depending on the information needs.

Describe the intervention research framework with conceptual and/or theory-based model and specify how the intervention will reduce or eliminate health disparities. Applications should describe how community involvement or stakeholder input shaped the proposed intervention approach and study methodology, and how they will be involved in the implementation and testing of the intervention, data analysis and interpretation, and dissemination of findings, as appropriate. Address how pilot data support the feasibility, acceptability, and potential effectiveness of the intervention. Describe the study design and how intervention impact will be evaluated, including the impact on health disparities.

Describe a plan for community sustainability and how findings from the project will be disseminated to the community at large (not just community partners) as appropriate and consistent with achieving the goals of this program. Describe the potential generalizability of project findings to other populations, health conditions, locations, or settings.

Develop an evaluation plan and a program logic model that describes performance objectives and outcomes (process and impact). Intervention targets may include outcomes for health knowledge change in addition to health behaviors and environmental change.

Letters of Support: Provide letters of support from all proposed partner organizations indicating willingness to participate in the project. If the applicant organization is not a community-based organization, at least one letter of support from a partnering community-based organization indicating willingness to participate must be included.

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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. 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.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). 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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

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.

Important reminders:

All PD(s)/PI(s) 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. See Section III of this FOA for information on registration requirements.

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. 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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

To be considered complete, compliant, and responsive, applications must include the following:

• Identification of a target community that includes significant representation from one or more US health disparity populations (Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and Other Pacific Islanders, socioeconomically disadvantaged populations and rural populations).
• Involvement of at least one community-based organization/American Indian Tribal Government, either as the applicant or partnering organization. In the latter case, a letter of support from the organization clearly indicating willingness to participate in the project must be provided.
• Development of an intervention framework and intervention mapping including evidence that proposed intervention was developed with community input and pilot tested with the target community.
• An evaluation plan with a logic model that incorporates appropriate performance targets, objectives and intervention outcomes (process and impact.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact 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.

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is an appropriate intervention framework with conceptual and/or theory-based model provided that specifies how the intervention will reduce or eliminate health disparities? Is sufficient evidence provided in the intervention mapping to indicate that the project demonstrates convincing preliminary evidence of feasibility, acceptability, and effectiveness in the target community or communities?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Are the roles of partner organizations clearly described and justified? Is the role of Community Advisory Board clearly defined, as well as the types of experience, expertise, or knowledge that will characterize board members?

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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Does the project include a rigorous study design to determine intervention effectiveness that is responsive to community context and preferences? Are appropriate methods used to determine the impact of the intervention on health disparities? Are appropriate outcome measures of health behaviors and/or health status used? Is an appropriate plan to disseminate project findings to the community at large (rather than just community partners)? Are strategies outlined for involving community stakeholders in the implementation and testing of the intervention, data analysis and interpretation, and dissemination of findings? Is the potential generalizability of project findings to other populations, health conditions, locations, or settings described?

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?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Does the application indicate broad community support for the project as indicated by collaborations and letters of support from community-based organizations and other community stakeholders?

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.

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 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.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Not Applicable

Not Applicable

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.

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 Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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.

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.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

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

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

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

• Coordinating project activities technically, scientifically and administratively at the awarded institution and coordinating project activities at other sites that are to 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 project Steering Committee.
• Organizing an annual face-to-face meeting of the project Steering Committee.
• Submitting interim progress reports, when requested, to the NIMHD Program Official including as a minimum, summary data on protocol performance.
• Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

The NIH Project Scientists(s) will:

• Serve as the contact point for all facets of the scientific interaction with the awardee. As required for the coordination of activities and to expedite progress, NIMHD may designate additional NIH staff to provide advice to the awardee on specific scientific and/or analytic issues.
• Review and comment on critical stages in the program implementation.
• Convene meetings/workshops to address emerging areas of high priority.
• Facilitate communication between U01 awardees to share project information as appropriate.
• Participate in the project Steering Committee meetings as a voting member.
• The NIMHD Project Scientist or designee may be co-authors on study publications. In general, to warrant co-authorship, NIH staff must have contributed to the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; (c) participation in analysis and interpretation of study results and (d) preparation and authorship of pertinent manuscripts.

The NIMHD Program Official will:

• Interact with the Program Director(s)/Principal investigator(s) on a regular basis to monitor study progress. Monitoring may include: regular communications with the Program Director/Principal Investigator and staff, periodic site visits, observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters; as well as attendance at Steering Committee and related meetings.
• Enforce general statutory, regulatory or administrative assistance policy requirements;
• Make recommendations for continued funding based on: a) overall study progress, including sufficient participant and/or data accrual; and b) cooperation in carrying out the research (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements).
• Additionally, the Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• Establishing and participating in a Steering Committee consisting of: 1) the PD(s)/PI(s) (who will serve as Chair(s)); 2) the Chair of the Community Advisory Board, 3) two external members selected by the PD(s)/PI(s), at least one of whom is a representative from a community based organization not involved in the project, and 3) the NIMHD Project Scientist. Each member will have one vote. The Steering Committee will meet in person at least once a year and will convene by telephone or in-person as needed. The Steering Committee has primary responsibility to oversee research activities, establish priorities, review progress, and monitor participant accrual. Major scientific decisions regarding adjustments to the study protocol will be determined by the Steering Committee. The Steering Committee will document progress in written reports to the NIMHD Program Official, and will provide periodic supplementary reports upon request.

Dispute Resolution:

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

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Irene Dankwa-Mullan, MD, MPH
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-402-1366
Email: [email protected]

Maryline Laude-Sharp, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-451-9536
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.