Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Funding Opportunity Title	Limited Competition: Addressing Health Disparities in Maternal and Child Health through Community-Based Participatory Research (R03)
Activity Code	R03 Small Grant Program
Announcement Type	Reissue of RFA-HD-09-010
Related Notices	December 12, 2014 - This PAR has been reissued as PAR-15-072. August 25, 2011 - See Notice NOT-HD-11-023. The purpose of this Notice is to clarify eligibility.
Funding Opportunity Announcement (FOA) Number	PAR-11-241
Companion FOA	None
Number of Applications	Only one application per institution is allowed, as defined in Section III.3. Additional Information on Eligibility. Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.865
FOA Purpose	The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), requests applications to implement developmental community-based participatory research (CBPR) projects planned and developed by recipients of the Phase I Academic-Community Partnerships Conference Series awards under PAR-08-106 and RFA-HD-06-019. This FOA provides support for community based participatory research (CBPR) projects that were identified and planned during the Phase I grant award. Only one CBPR project will be supported per grant award. The areas of emphasis include: infant mortality; sudden infant death syndrome; fibroid tumors; childhood, adolescent, and/or adult obesity; literacy; techniques for outreach and information dissemination; pediatric and maternal HIV/AIDS prevention; and violence prevention.

Posted Date	June 22, 2011
Open Date (Earliest Submission Date)	July 19, 2011
Letter of Intent Due Date	July 19, 2011, July 19, 2012, July 19, 2013
Application Due Date(s)	August 19, 2011, August 19, 2012, August 19, 2013 by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	October/November 2011, October/November 2012, October/November 2013
Advisory Council Review	January 2012, January 2013, January 2014
Earliest Start Date(s)	April 2012, April 2013, April 2014
Expiration Date	August 20, 2013
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), requests applications to support developmental community-based participatory research (CBPR) projects planned and developed by recipients of the Phase I Academic-Community Partnerships Conference Series awards under PAR-08-106 and RFA-HD-06-019. Only one CBPR project will be supported per grant award. The areas of emphasis include: infant mortality; sudden infant death syndrome; fibroid tumors; childhood, adolescent, and/or adult obesity; literacy; techniques for outreach and information dissemination; pediatric and maternal HIV/AIDS prevention; and violence prevention.

The purpose of the Phase II initiative Addressing Health Disparities in Maternal and Child Health through Community-Based Participatory Research is to use the Community-Based Research Project (CBPR) methodology to conduct small research projects that (i) address a community health concern, (ii) increase understanding of community related factors and/or cultural beliefs and practices that significantly impact health outcomes in one of the areas of emphasis, or (iii) focus on the development of innovative health messages with the objective of increasing health literacy in areas of concern.

The Academic-Community Partnership Conference Series (U13) initiative was implemented to facilitate the development of academic-community partnerships for the purpose of identifying community health concerns within the mission areas of NICHD and specifically within the Division of Special Populations (DSP) areas of emphasis. Unprecedented advances in translating research findings into practice have been made; however, such advances have not been realized by all members of society according to age, race, ethnicity, and socioeconomic group. Narrowing the gap in translational research within the NICHD health equity areas of emphasis is a DSP priority. Additionally, it is expected that community partnership approaches to research will provide opportunities to build close collaborations between academic researchers and medical practitioners, generate better informed hypotheses, develop more efficacious and effective interventions, and enhance the translation of research results into practice.

Through the Phase I and II academic-community partnerships awards, it is intended that key stakeholders, including persons affected by disparate health outcomes, will become full participants in translational research. The level of participation may include project conception, design, and implementation; analysis and interpretation of data; and the communication of research results.

Use of the CBPR methodology is a requirement of this FOA. Examples of the types of CBPR studies that will be supported within the DSP areas of emphasis include, but are not limited to the following:

• Pilot or feasibility studies
• Development of research methodology
• Formative research
• Developmental translational research
• Ethnographic studies

Additionally for planning purposes, keep in mind that the small research grant mechanism (R03) provides limited, short-term funding support.

Partnership Objectives

Academic institutions are encouraged to form as many partners as necessary to accomplish the goals of the proposed CBPR research. Additionally, it is expected that the academic-community partnerships will be:

• Synergistic and lead to mutual learning for both researchers and community providers;
• Productive in terms of implementing innovations and/or interventions that address health equity.

Academic-community partnership objectives also include, but are not limited to:

• Development of collaborative relationships between multi-disciplinary and inter-disciplinary researchers and the community;
• Community involvement in assessing the need for specific studies/interventions and in planning and conducting the research itself this is key to overcoming distrust of researchers and research institutions (i.e., Community Coalition Board, etc.);
• Active engagement of communities in the research process through academic institution-led partnerships with community representatives, local patient advocates, and organizations that have expertise in health equity research.
  • Community representatives (CRs) may include: community-based service organizations; community-based health care providers that have patients interested in working with researchers to develop, test, and deliver new interventions; relevant agencies within the community (i.e., health departments, housing authorities, etc.); and/or individuals or groups that reside in the geographical area of interest;
  • Patient advocates (PAs) may include: individuals living with relevant health equity conditions, caregivers or family members of individuals with health equity conditions who may or may not be affiliated with related advocacy organizations, etc.
• Clear and meaningful roles for community partners in the planned translational research. For example, ensure that:
  • CRs & PAs have well defined and adequately communicated roles, responsibilities, expectations and length of service;
  • CRs & PAs are sufficiently trained for the activities they will undertake and activities are clearly defined and adequately communicated;
  • Individual investigators are trained in regard to optimal ways to integrate CRs/PAs into research activities.
• Development of reliable mechanisms for community feedback (i.e., the Community Advisory Board, newsletters, etc.)
• Provision of culturally sensitive training for academic researchers as it relates to literacy, health literacy levels, and the culture of the community of interest.

Specific Areas of Research Interest

For illustrative purposes, important considerations and selected research objectives in each DSP area of emphasis are provided below.

Childhood, Adolescent, and/or Adult Obesity

Obesity is a rapidly growing public health problem worldwide, and the consumption of energy-dense foods that are rich in fats and carbohydrate and physical inactivity are considered important contributing causes. CBPR projects of interest include, but are not limited to, studies that:

• Increase understanding of community related factors cultural, geographic, socio-economic, the built environment that contribute to obesity;
• Better characterize underlying perceptions of food, eating, physical activity, and weight and their roles in communities;
• Design and evaluate innovative weight-loss and weight-control strategies geared to families, etc.

Sudden Infant Death Syndrome (SIDS)

Campaigns to promote the supine sleep position have reduced SIDS rates by approximately 50 percent; however, the incidence of SIDS among American Indian and Alaska Native (AI/AN) infants and Black infants remains high. There are also regional differences in SIDS rates. Current findings support the belief that SIDS is caused by the interaction of multiple factors a critical developmental period (first 12 months of life), an underlying intrinsic vulnerability, and exogenous stressors. Within the context of this FOA, research is needed to identify and better understand external stressors associated with SIDS. Progress in this area can lead to the development of innovations in preventive measures for further reducing the incidence of SIDS in AI/AN and Black/African American populations. CBPR projects of specific interest include, but are not limited to studies that:

• Elucidate or increase understanding of sleep arrangements and behaviors in bed-sharing families;
• Increase understanding of the potential stressors in the home environment, including air quality in high and low SIDS regions of the U.S.;
• Identify potential cultural or geographically related external stressors that may impact the incidence of SIDS;
• Identify innovations or develop innovative ways of increasing awareness about SIDS in socio-economically disadvantaged populations, etc.

Infant Mortality

One of the most troubling health differentials in maternal and child health has been the long-standing gap in infant mortality and the leading antecedents low birth weight and preterm delivery experienced by some racial and ethnic minority populations. After controlling for a variety of risk factors, African Americans, American Indians and Alaska Natives (AI/AN), and Puerto Ricans (an Hispanic subpopulation) experience the highest rates of infant mortality 13.6, 8.73 and 8.2 deaths/1000 live births respectively compared to non-Hispanic whites (5.7 deaths/1000 live births). From a prevention perspective, research is needed in areas that include but are not limited to:

• Developing effective strategies for increasing health literacy in regard to low birth weight and infant mortality, especially addressing the causes of low birth weight in racial and ethnic minority populations and current evidence-based interventions;
• Development of behavioral change communication strategies that deter pregnancy until after adolescence;
• Identification of cultural beliefs and practices that can be used in the design of interventions to prevent low birth weight births, etc.

Pediatric and Maternal HIV/AIDS Prevention

HIV/AIDS disproportionately affects certain populations such as African Americans and Hispanics/Latinos as well as certain regions of the United States. African Americans and Hispanics/Latinos represent approximately 12 percent and 13 percent of the U.S. population and account for nearly 50 percent and 17 percent respectively of new infections. The rate of new HIV infection for African American women is nearly 15 times as high as that of white women and nearly four times that of Hispanic women. Further, overall rates among black women (and men) have increased between 2005 and 2008. Diagnosis of HIV/AIDS among Asian/Pacific Islander women and among American Indian/Native Alaskan women are also increasing. Additionally, perinatal HIV transmission is of particular concern among population groups that are disproportionately affected by HIV/AIDS. For example, of the perinatally infected children living with HIV/AIDS at the end of 2005, an estimated 66% were black and 20% were Hispanic/Latino. The main risk is lack of awareness of HIV status among pregnant women. Additionally, racial and ethnic minority women are from very diverse groups and without attention to factors such as national origin and geographical distribution the prevention needs of highly affected groups may be masked. For illustrative purposes, CBPR projects of particular interest include, but are not limited to, those that develop strategies for:

• Encouraging women to learn their HIV status before pregnancy and/or as early as possible in pregnancy, identifying structural and motivational barriers that might make access to HIV prevention challenging, increasing access to HIV prevention preventions;
• Developing effective prevention interventions that decrease susceptibility to infection;
• Increasing behavior change rates in terms of efficacy, current HIV prevention interventions produce behavior change at rates of approximately 30 to 40 percent.

Outreach, Information Dissemination, Health Literacy

Health literacy and culture are among the potential barriers to translating new knowledge. For the purpose of this FOA, culture is defined as a shared way of life that encompasses knowledge, attitudes, beliefs, customs, and values of a group. Culture guides behaviors, enable groups to share an identity, and shapes worldview expectations and perceptions. Health literacy is the degree to which individuals have the capacity to acquire, process, and understand the basic health information and services needed to make appropriate health decisions. People make choices about their health every day. Functional health literacy the ability to read, understand, and act on health information has direct implications for overall health status. For example, in order to enhance and maintain health, individuals are expected to read nutrition labels and purchase healthy food, prepare a dish from a recipe, understand charts and graphs such as Body Mass Index, and/or plan an exercise routine. For many people, there is a mismatch between the demands of the activity and their skill level. Additionally for the purpose of this FOA, outreach is defined as the ability to reach large numbers of people, especially racial/ethnic minorities and the socio-economically disadvantaged, to encourage their participation in activities designed to educate and or to assist participants with health related issues and/or to encourage their engagement in a health related activity. Information dissemination is the one-way flow of health related information through the most accessible conduit, in the most appropriate style, and at the most appropriate comprehension level for the intended audience. CBPR projects of interest include, but are not limited to, studies that:

• Increase understanding of the types of content (or information) that should be made available to groups in order for them to be considered health literate;
• Develop effective ways of accommodating individuals with low literacy levels in managing chronic health conditions;
• Investigate best practices for promoting long-term retention of health related information among different cultural and socio-economic groups;
• Clarify the pathways between health literacy and health outcomes by developing and testing hypotheses related to the linkage between literacy skills and health, etc.
• Use formative research to clarify the best approaches for outreach and information dissemination. Formative research helps researchers to identify and understand the characteristics interests, behaviors and needs of target populations, including communication channels, that influence their decisions.

Violence Prevention

Youth violence disproportionately involves racial and ethnic minorities. For example, the annual incidence of self-reported fighting among high school students is 40% in African Americans, 36% in Latinos, and 30% in whites. Fighting-related injuries generate medical and societal costs through premature death and disability. Additionally, physical fighting is also an antecedent behavior and the occasional cause of adolescent homicides. Fighting rates appear to vary by race/ethnicity, and risk and protective factors for fighting, particularly relationships with schools and families, may also vary by race/ethnicity. From a health perspective, fighting is a health risk behavior that can be conceptualized by means of the social developmental model the model hypothesizes that youth behavior is learned from socializing agents through a process that begins in childhood and continues throughout adolescence. Socializing agents include families, schools, peers and communities. For illustrative purposes, CBPR research of interest includes, but is not limited to:

• Use of the social developmental model (or any other appropriate model) to guide research aimed at identifying risk and protective factors among a local racial/ethnic group(s) that may be associated with either increase levels of violence and/or that mitigates or decrease violence;
• Development of strategies, within the participating community context, for increasing school and/or family connectedness to youth;
• Development of community related strategies and/or the identification of factors that have the potential to buffer children from risks associated with poverty;
• Elucidation of the type of factors that impact parental affection and support.

Areas of emphasis, such as fibroids, that were not selected by current academic-community partnerships awardees as an area of interest are not addressed in this limited competition FOA.

Research Related Requirements

To the extent feasible, the proposed CBPR project should focus on the original DSP area of emphasis that was identified in the Phase I Academic-Community Partnership Conference Series application. A description of each area of emphasis is provided in the section entitled Specific Areas of Research Interest. If more than one area of emphasis was selected in the Phase I application, the CBPR project should focus on only one of the selected areas.

Recognizing the community s role as a partner in this initiative, it is conceivable that the academic/ community partner(s) may decide, during the execution of Phase I, to pursue an alternate research agenda that addresses a higher health related priority within the community. In such a case, the proposed CBPR project may reflect the revised research agenda but only if the area of emphasis is encompassed within the mission area of one of the NICHD divisions or centers. Additionally, the applicant must provide a justification, with supporting data, for the change in focus and demonstrate the availability of the appropriate expertise to carry out the proposed CBPR project. A listing of the NICHD divisions and centers and a description of their mission areas can be found at the link: http://www.nichd.nih.gov/about/org/.

Funding Instrument	Grant
Application Types Allowed	New Resubmission The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Award Budget	Budgets for direct costs of up to $75,000 per year and a project duration of up to two years may be requested for a maximum of $150,000 direct costs over a two-year project period.
Award Project Period	The total project period for an application submitted in response to this FOA may not exceed two years.

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
• Eligible Agencies of the Federal Government

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Foreign (non-U.S.) components of U.S. Organizations are not allowed.

For this FOA, eligible applicants are limited to previous awardees of the Academic-Community Partnership Series Conference awards (U13) under PAR-08-106 and RFA-HD-06-019.

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) 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 SF 424 (R&R) Application Guide.

Special Criteria for Limited Competition

For this FOA, any individual with the skills, knowledge, and necessary resources may submit an application if the following additional criteria are met:

• You are/were the PD/PI on the Academic-Community Partnership Conference Series grant previously awarded to your institution.
• In cases where the PD/PI on the Academic-Community Partnership Series Conference award (U13) is unable to participate in this limited competition, you are designated by your institution as the PD/PI in this limited competition FOA, with the approval of the community partner(s) from the Phase I Academic-Community Partnership Series initiative. The community partner(s) should provide a letter(s) of support for the newly designated PD/PI.

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

Only one application per institution is allowed.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

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

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

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

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Regina Smith James, M.D.
Director, Division of Special Populations (DSP)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 5E03, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier or non-USPS service)
Telephone: 301-435-2692
Fax: 301-480-0393
Email: [email protected]

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

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

Follow all instructions provided in the SF424 (R&R Application Guide with the following modifications:

Facilities & Other Resources

Describe the research environment, including the facilities, laboratories, core or multiple user research resources that will be used in the CBPR project.

Advisory Committee (Uploaded via the "Other Attachments" Section)

A plan must be provided for the Community Advisory Committee and any other committee or board (i.e., Steering Committee, Community Coalition Board, etc.) established. Applicants are encouraged to create a community-based advisory board, steering committee, or community coalition to facilitate planning, education, outreach, dissemination, and evaluation of efforts. The plan should include the following types of information:

• A succinct description of the qualifications for the membership
• Description of the function of the Committee and/or Board

The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Commons.

R&R Budget Component

Follow all instructions provided in the SF424 (R&R) Application Guide with the following modifications: This FOA will use the non-modular budget.

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

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide with the following modification:

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

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, with the following modifications:

• No publications or other printed material, with the exception of pre-printed questionnaires or surveys, may be included in the Appendix.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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.

Allowable costs

Support should be targeted to both the academic and community settings. Examples of the types of support allowable under this program include, but are not limited to:

• Database and information management, ongoing data management and related technical support;
• Training and support of research assistants from the community or the academic setting;
• Treatment protocol and instrument development, adaptation, and/or translation of instruments for equivalency of meaning;
• Methodological, statistical, or theoretical consultation;
• Costs related to participant engagement for recruitment and retention;
• Costs related to testing, dissemination, and implementation strategies.

Applications must be submitted electronically following the instructions described in the SF 424 (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.

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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 Central Contractor Registration (CCR). 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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Special Requirements for Academic-Community Partnerships

The applicant may include one or more of the following types of individuals in the senior/key personnel profile component of the grant application:

• A community representative. Illustrative examples of community representatives include, but are not limited to: a recognized leader that resides within the local community or an officer of a community-based organization;
• An individual with expertise in CBPR (i.e., an epidemiological or behavioral or social scientist, etc.);
• A representative from each established partnership;
• A representative from a community institution (i.e., a highly respected and valued organization or agency such as the health department, medical practice, etc.).

Senior/key personnel are defined as all individuals who contribute in a substantive, meaningful way to the scientific development or execution of the project, whether or not salaries are requested. Consultants should be included if they meet this definition.

Be sure to describe the role(s) of all senior/key personnel in the budget justification section whether support is requested or an "in kind" contribution.

The guidance below is supplementary to the instructions provided in the SF424 (R&R) Application Guide.

Item 2. Specific Aims

• Summarize current knowledge in the field, based on the review of the literature; delineate the scientific gap in the knowledge base or unmet need (within the context of the participating community); explain why the continued gap or need constitutes an important problem.
• Identify the long-term goal of the proposed research, the overall objective of the CBPR project, and the central hypothesis for the proposed research. The central hypothesis reflects your overall strategy for the research, and is intended to give focus to the proposed project.
• Your specific aims should be developed with the goal of testing the components of the central hypothesis. The most effective specific aims are conceptual rather than procedural, limited in scope, and collectively test all parts of the hypothesis.
• As appropriate, briefly summarize the innovative aspects of the proposed CBPR project. Additionally, conclude the specific aims section with a statement of expected outcomes in terms of the positive impact of the proposed CBPR project for the community and/or in advancing the field and mission of DSP/NICHD.

Item 3. Research Strategy

(a) Significance

For the purpose of this FOA, CBPR is a specific model of community-based research in which the researcher and individuals and/or entities in the Community create a partnership that identifies questions of mutual interest, conducts studies that reflect mutual input and derive outcomes that provide mutual benefit. Be sure to clearly define the targeted community. For example, the term community may be applied to either of the following:

• A defined geographic or political area such as a neighborhood, town or region;
• A population that possesses certain common characteristics such as its race, ethnicity, age or gender;
• An entity that functions in society (and outside of the researcher’s own institution) such as a business, civic organization, educational facility, religious group, or governmental agency.

Additionally, the community profile should include but not be limited to documented evidence of the health equity condition or disease that the partnering community would like to address as well as other critical information and analyses related to the identified problem. The applicant should discuss how the proposed CBPR project will improve scientific knowledge, technical capability, and/or address the identified health inequity through increased knowledge, behavior, and/or social change resulting from the community partnership. The proposal should also convey the perceived importance and relevance of the research questions to the community partners and thus the likelihood for increased buy-in and participation. Based on a review of the literature, the applicant should also describe the state of the relevant field and explain how the proposed CBPR project will expand it and fill an identified gap. Overall, the literature review should be highly selective and focused in three primary areas: (i) justifying the need for the research strategy proposed, (ii) providing additional details in regard to the methods selected; and/or (iii) documenting published studies that effectively serve as preliminary data in support of the research strategy selected.

Remember that no preliminary data are required for the R03 research support mechanism but may be included if available. In the former case, published studies in the literature may be used as a basis for the proposed approach.

(b) Innovation

In addition to the guidance provided in the PHS SF424 (R&R) Application Guide, be sure to discuss as applicable, any advantage the proposed methodology, instrumentation, or intervention has over existing methodologies, instrumentation, or interventions, etc. Additionally as applicable, be sure to:

• Describe how innovative ideas resulted from community participation in developing the research questions, methods, and/or intervention approaches;
• Discuss how community input generated innovative approaches to overcoming research challenges.
• Discuss how the proposed study takes advantage of unique features of the scientific, institutional, or community environment or employs useful collaborative arrangements.

(c) Approach

In addition to the guidance provided in the PHS SF424 (R&R) Application Guide, be sure to include in the Approach the conceptual framework, experimental design, methodology and analyses adequately developed and appropriate to the specific aims of the CBPR project. Be sure to address the following:

• The degree to which community input has enhanced the conceptualization, design, methods, and analyses;
• The extent to which the proposed study design is the best possible balance of scientific rigor, implementation constraints, and the most effective participation of community partners;
• Role(s) of Community and/or Community Partners -- Succinctly describe the role(s) for the community and/or community partner(s) in the proposed CBPR project. Additionally as applicable, describe any training plan that will enable community partners or academic staff to carry out their roles. While substantial community involvement is strongly encouraged, the absolute minimum community involvement includes: (i) community participation at the front end of the study to help identify the research questions of importance to the community; and (ii) community involvement at the back end to help to interpret and apply research findings for the purpose of ensuring their relevance to the community.
• Communication and Information Dissemination Plan -- Describe the methods and process for keeping the community informed as well as for disseminating research outcomes within the community.
• Evaluation Plan -- Describe plans for evaluating the impact of the community partnership(s) in regard to accomplishing the partnership goals. Applicants should identify the means of establishing effective input from a community on matters such as priority areas of health or plausible approaches and constraints in addressing health concerns. Input could be obtained directly from members of a community as well as from representatives of such groups as community and neighborhood associations, churches, public housing resident councils, community health centers, local public health service departments, independent living centers, schools, and minority educational institutions.
• Timetable -- Conclude the Approach section by providing a timetable for completing the proposed studies and describing future directions.

Item 14. Letters of Support

Institutional and community support

Provide any relevant letters of support as directed in the SF 424 (R&R) Application Guide. Remember to include a copy of any consortium/contractual arrangements (i.e., Memorandum of Understanding (MOU) or letter of agreement). The purpose of the MOU is to provide evidence of an effective community partnership (or partnerships). The MOU/letter of agreement should identify the role of each partner, describe the health concerns to be addressed, and identify the research objectives which may include, for example, the intent to collaborate on the design, implementation, and evaluation of an evidence-based intervention aimed at addressing a health equity condition/disease within one of the NICHD health equity areas of emphasis.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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

For this particular announcement, note the following:

The R03 small grant supports discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research project usually is limited, an R03 grant application may not contain extensive detail or discussion. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies. Within the context of this Limited Competition FOA, similar to the Academic Research Enhancement Award (AREA) Program, support is provided to faculty and students in academic components that have not been major recipients of NIH research grant funds and their community partners.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

What is the potential significance of the proposed study for addressing health inequities through increased knowledge and/or social change resulting from the community partnership? What are the perceived importance and relevance of the proposed study to community partners and thus the likelihood for increased buy-in in regard to the outcomes?

Investigator(s)

Are the PD/PIs, 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 community partners assured a place at the table, and if so how? What expertise and strengths will be contributed by community partners? Were plans made for capacity development within the community, particularly in regard to enabling community representatives to better participate in agreed upon roles on the CBPR team?

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?

To what extent does innovation result from community participation in developing the research questions, methods, and/or intervention approaches?

Approach

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

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

To what degree are community input and/or participation reflected in the proposed CBPR project? How well does the study design reflect a good balance of scientific rigor, implementation constraints, and an effective integration of community partners into the CBPR study? Does the community partnership enhance recruitment, retention, measurement design, data collection, and analysis/interpretation? How will the CBPR process facilitate dissemination and translation of the findings?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Does the proposed study take advantage of unique features of the scientific, institutional, or community environment or employ useful collaborative arrangements? Is there evidence of institutional and community support through letters and/or a MOU/letter of agreement? Does the PD/PI provide an effective framework for evaluating the partnership?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

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

Not Applicable.

Revisions

Not Applicable.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NICHD Division of Scientific Review , in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review), will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Child Health and Human Development Council (NACHHD).

The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/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 business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Regina James, M.D.
Division of Special Populations (DSP)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 5E03, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier or non-USPS service)
Telephone: 301.435.2692
Email: [email protected]

Sherry Dupere, Ph.D.
Director, Division of Scientific Review (DSR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier or non-USPS service)
Telephone: (301) 496-1485
Email: [email protected].

Bonnie Jackson
Grants Management Specialist
Grants Management Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, 8A01B, MSC7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier or non-USPS service)
Telephone: 301-496-5482
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 Parts 74 and 92.