and Human Services (HHS)
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Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD/NIH), (http://nichd.nih.gov)
Title: Limited Competition: Addressing Health Disparities in Maternal and Child Health through Community-Based Participatory Research (R03)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Request for Applications (RFA) Number: RFA-HD-09-010
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.
Catalog of Federal Domestic Assistance Number(s)
93.865
Key Dates
Release/Posted Date: July 24, 2009
September 28, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): New Date October 30, 2009 per NOT-HD-10-005; Original Date: September 28, 2009
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): New Date November 30, 2009 per NOT-HD-10-005; Original Date: October 28, 2009
AIDS Application Due Date(s): Not Applicable
Peer Review Date(s): February/March 2010
Council Review Date(s): May 2010
Earliest Anticipated Start Date(s): July 1,2010
Additional Information to Be Available Date (Activation Date): Not Applicable
Expiration Date: New Expiration Date December 1, 2009 per NOT-HD-10-005; Original Expiration Date: October 29, 2009
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria
Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency Contacts
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section VIII. Other Information - Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Purpose
The Eunice Kennedy Shriver National Institute of Child Health and Human Development, 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 initiative will encompass capacity building (i.e., data collection and management, recruitment and outreach, etc) as well as implementation of the developmental translational research projects designed in Phase I. Only one translational CBPR project will be supported per grant award.
Background
The Academic-Community Partnership Conference Series (U13) initiative was launched to assess the value of bringing communities and academic institutions together through meeting/workshops/symposia to conduct academic-community participatory health disparities reduction and elimination research within the community. Unprecedented advances in translating research findings into practice have been made; yet, such advances are not realized by all members of society according to age, race, ethnicity, and socioeconomic group. The Division of Special Populations seeks to narrow the gap in translational research, particularly within the NICHD health disparity areas of emphasis, through community partnered approaches. Such approaches provide opportunities to build closer collaborations between research and practice as well as generate better informed hypotheses, develop more efficacious and effective interventions and innovations and enhance the translation of research results into practice. The NICHD health disparity areas of emphasis include but are not limited to infant mortality; fibroid tumors; childhood, adolescent, and or adult obesity; literacy; and techniques for outreach and information dissemination.
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, 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). In contrast, two other Hispanic subpopulations (Cubans and Mexicans) and Asian Americans and Pacific Islanders have overall infant mortality rates that are lower than non-Hispanic whites (i.e., 4.6, 5.5, and 4.83 deaths/1000 live births respectively). Paradoxically, the gap in infant mortality, low birth weight and pre-term delivery increases for African Americans at the higher socioeconomic levels. And notably, recent immigrants seem to enjoy a reproductive advantage that erodes with acculturation and time in the United States. (Dominguez, TP, 2008Clinical Obstetrics and Gynecology, 51(2):360-370) Research is needed to identify and elucidate the factors that shape such risks in ethnic and racial minority populations. Research is also needed to identify and elucidate factors that mitigate such effects.
SIDS (Sudden Infant Death Syndrome)
The incidence of SIDS among American Indian and Alaska Native infants is 2.5 times higher than in non-Hispanic white infants. In 2004, the SIDS incidence for American Indians and Alaska Natives, non-Hispanic Blacks, non-Hispanic whites and Hispanic infants respectively was 124.0, 108.8, 50.5, and 25.6 deaths/100,000 population; and also in 2004, SIDS ranked as the third leading cause of death for African American infants under one year of age. The most important risk factors for SIDS include: maternal smoking during pregnancy; prone sleep position, which can cause the baby to breathe too much carbon dioxide and too little oxygen; and exposure to secondhand smoke. Other risk factors for SIDS include young maternal age, premature birth or low birth weight, bed sharing, soft sleep surfaces and loose bedding, and being male. Additional innovations and interventions are needed to further reduce the disparate incidence of SIDS among Native and African American populations.
Childhood, Adolescent, and/or Adult Obesity
Obesity is a rapidly growing public health problem worldwide, and consumption of energy-dense foods rich in fat and carbohydrate is considered an important contributing cause. The mechanisms underlying diet-induced obesity remain unclear; however, the rapidity with which overweight and obesity have become major health concerns suggests that the driving factors are behavioral and environmental as well as genetic. From an ecological perspective, health behavior is influenced by factors operating concurrently at different levels: (i) sociocultural factors (i.e., family structure, income and educational levels, ethnicity, gender); (ii) intra- and inter-personal factors (i.e., maternal psychological health and parenting quality); and (iii) environmental factors (i.e., proximal factors relating to energy intake and energy expenditure center-based child care, physical activity, time spent watching TV, and neighborhood safety). (O Brien, MO, etal. The ecology of childhood overweight: a 12-year longitudinal analysis, International Journal of Obesity (2007) 31: 1469-1478). Recent basic animal studies suggest that susceptibility to diet-induced obesity may also be related to the capacity to metabolize fatty acids. (Ji, H and Friedman, MI. Reduced hepatocyte fatty acid oxidation in outbred rats prescreened for susceptibility to diet-induced obesity, International Journal of Obesity (2008) 32:1331-1134). Research is needed to increase understanding as to why children from ethnic minority families, single-parent families, and families with low education levels are more heavily represented in the overweight groups. Research is also needed to increase understanding as to why socioeconomic status (SES) appears to have a protective effect in regard to adiposity in white children but not among African American children. (Lioret S, etal., Obesity, 4 September, 2008; Lioret S, European Journal of Clinical Nutrition, 21 November 2007). In addition, culturally sensitive interventions are needed to address mood disorders associated with overweight and obese children from ethnic minority families.
Fibroids
More than 80 percent of black women and about 70 percent of white women develop fibroids before they reach menopause; and, the incidences of new cases diagnosed annually for African American, Hispanic, white, and Asian women are 30.6, 11.0, 8.9, and 8.0 respectively. (National Uterine Fibroids Foundation) Fibroids also result in $2.1 billion dollars in direct costs annually, 80 percent of which is spent on inpatient hospital costs due to hysterectomy. Notably, Black women tend to have larger and more numerous fibroids; and fibroids tend to be more problematic in obese or overweight women. While estrogen and progesterone are promoters of fibroid growth, recent evidence suggests that vitamin D (or the absence thereof) might be involved in the pathology of fibroids Dark skinned individuals are often vitamin D deficient. The National Institute of Environmental Health Sciences is currently examining the impact of vitamin D and insulin-like growth factor-I on fibroid tumor development insulin-like growth factor-I is a protein that stimulates cell growth. Increased emphasis on preventing and/or reducing the incidence of fibroids, a condition that poses a serious reproductive threat for many women and which represents a disproportionate burden for African American women, enhances our ability to preserve the fertility and reproductive health of all women.
Literacy
Within the United States, literacy reflects an individual's ability to read, write, and speak in English, and to compute and solve problems at levels of proficiency necessary to function in the family, on the job, and in society. Accordingly, within the context of managing chronic health related conditions, individuals with low literacy skills are likely to possess a poor working knowledge of their disease or condition and its treatment. In fact, low literacy is a predictor of poor health outcomes in low-income urban populations even after other socio-demographic variables are considered. It has been documented in children that enhancement in literacy, coupled with enhancements in disease self-management skills, significantly improved self-efficacy which resulted in improved health-related outcomes. (Robinson, LD, etal. Journal of the National Medical Association, 100(8):892-896, 2008) Literacy therefore provides a particularly effective area in which to focus efforts on addressing and eliminating health disparities. Since literacy can potentially be improved across the lifespan and because literacy-related demands of the health care system can be directly targeted by both large-scale policy and individual action, this is an important avenue for addressing health disparities. (Sentell, TL, J. Gen Intern Med; 21:862-866, 2006).
Outreach and Information Dissemination
Unprecedented advances in translating research findings into practice have been seen; yet, such advances are not realized by all members of society according to age, race, ethnicity, and economic status. Two factors that may operate as barriers to translating new knowledge into practice are health literacy and culture. For the purpose of this FOA, culture is a shared way of life that includes knowledge, attitudes, beliefs, customs, and values of a group. Culture guides behaviors, enables 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. There is specific interest in the design and implementation of integrated community-centered strategies for addressing and eliminating health disparities that integrate cultural and health literacy considerations into information dissemination and the development of interventions. Examples of established models or tools that can be adapted to help to inform the development of community-centered outreach and information dissemination programs that address health disparities include but are not limited to: Meade’s Health Education Model for Cancer Education and Outreach (Cancer Control, 14(1):70-76, 2007); the PREDEDE-based outreach model used by Chandra L. Ford, etal. (AIDS Education and Prevention, 19(2):173-186, 2007); and the University of Kansas Community Toolbox (http://ctb.ku.edu/en/tablecontents/).
Pediatric and Maternal HIV/AIDS Prevention
Perinatal HIV transmission transmission from mother to child during pregnancy, labor and delivery, or breastfeeding is the most common route of HIV infection in children and is now the source of almost all AIDS cases in children in the United States. And of the perinatally infected children living with HIV/AIDS at the end of 2005, an estimated 66% were black and 20% were Hispanic/Latino. Moreover, of the women living with HIV/AIDS, 64, 19, and 15 percent respectively are Black, white, and Hispanic; and the rate of diagnosis for African American women (i.e., 50.2 per 100,000 cases) is four times the rate for Hispanic women (12.4/100,000 population) and approximately 25 times the rate for white women (2.0 per 100,000 cases). The main risk factor, which is also a barrier to the prevention of perinatal HIV transmission, is lack of awareness of HIV status among pregnant women. Because many women who are infected with HIV may not know they are infected, continued efforts are needed to ensure that all women know their HIV status as early as possible in pregnancy. In addition, reducing the prevalence of HIV infection in women through the use of innovative interventions that decrease susceptibility to infection would reduce maternal and pediatric HIV/AIDS rates even further.
Violence Prevention
The well-being of youth, especially in racial and ethnic minority communities, is threatened by increasing rates of unintentional and intentional injuries or violence. In 2004, more than 750,000 young people ages 10 to 24 were treated in emergency departments for injuries sustained due to violence; and during that same timeframe an estimated 30% of 6th to 10th graders in the United States were involved in bullying as a bully, a target of bullying, or both. In 2005, non-Hispanic black children had a reported maltreatment rate of 19.5 per 1,000 children, Pacific Islander children had a rate of 16.1 per 1,000 children, and American Indian and Alaskan Native children had a reported maltreatment rate of 16.5 per 1,000 children, compared with 10.8 per 1,000 non-Hispanic white children, 10.7 per 1,000 Hispanic children, and 2.5 per 1,000 Asian children. Risk factors for violence include individual factors (i.e., learning disabilities, involvement with drugs, poor behavioral control, etc.); family factors (i.e., child rearing attitudes, low parental involvement, parental alcohol and substance abuse, etc.); peer/school factors (gang involvement, social rejection, poor academic performance, lack of involvement in conventional activities, etc.) and community factors (i.e., socially disorganized neighborhoods, diminished economic opportunities, low levels of community participation, etc.). A particular area of need is identifying and understanding factors that protect against violence. Culturally sensitive interventions are also needed to address psychiatric symptoms that may develop in minority children who were exposed to family and community violence.
Definition of Health Disparities
For the purpose of this FOA health disparities is the differences in the incidence, prevalence, mortality, and burden of diseases and other adverse health conditions that exist among specific population groups in the United States. Health disparities research conducted under the Academic-Community Partnerships initiatives includes research-based innovations biomedical, biobehavioral, translational, policy related that will reduce excess mortality and morbidity among and within population groups defined by race/ethnicity and socio-economic status.
Scope
This FOA seeks to support translational research within a community-based participatory research context. Broadly defined, translational research seeks to ensure that new discoveries and best practices benefit the lives of people in all communities urban, suburban, and rural communities; racial and ethnically diverse communities; and poor, medium-income, and wealthy communities. The term translational research encompasses at least four distinct but related research processes. Phase 1 translational research (T1) seeks to move basic discoveries into candidate health applications (basic research to clinical trials) while Phase 2 research (T2) assesses the value of Phase 2 applications for health practice, leading to the development of evidence-based guidelines (clinical trials to academic health center practice). Phase 3 translational research (T3) attempts to move evidence-based guidelines into health practice, through delivery, dissemination, and diffusion research (community practice). Phase 4 translational research (T4) seeks to evaluate the real world health outcomes of T1 applications in practice (community). (Westfall, JM, etal., Practice-Based Research Blue Highways on the NIH Roadmap, JAMA, Vol 297, No.4, January 24/31/2 7, pp. 403-406.); Blumberg, DS, Translational Research for Community Partnerships, http://www.hsc.unt.edu/healthdisparities/documents/BlumenthalMay3008.pdf. The best new treatments will achieve little if: (i) the treatments never reach the patients for whom they were developed or (ii) if such treatments or interventions fail to take into consideration socio-cultural, literacy and economic factors that are relevant to the target community.
This FOA specifically seeks to support T3 and T4 translational research activities, planned and implemented within a CBPR context, within the six NICHD health disparity areas of emphasis. The goal is to employ CBPR as a collaborative approach that combines knowledge with action to increase to potential of achieving improvements in health outcomes. It is anticipated that research goals identified in Phase I of the Academic-Community Partnership would be implemented in Phase 2 competitive awards.
Research Objectives
The translational research objectives for the Academic-Community Partnership Phase II initiative include:
Partnership Objectives
The defining features of the CBPR process is that community members, persons affected by health disparity diseases/disorders/conditions, and other key stakeholders in the community’s health are given the opportunity to be full partners in each phase of the research from conception to communication and dissemination of results. Partners may also change over the life of the project, depending on their strengths and connections. One partner might be well suited for the recruitment of community participation in an intervention, another might be better suited to test an approach, and yet another partner might be better suited to take an intervention to scale. Importantly, partnerships can also help to create the tipping point that leads to widespread adoption of innovations and new ideas.
Academic institutions are encouraged to form as many partners as necessary to accomplish the goals of the proposed CBPR research. In addition, it is anticipated that the academic-community partnerships will be:
Academic-community partnership objectives also include, but are not limited to:
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information
1. Mechanism of Support
This FOA will use the NIH Small Research Project Grant (R03) award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide). It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, a U.S. organization submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) must use the PHS398 Modular Budget component.
2. Funds Available
NICHD intends to commit a total of $350,000 per year for a total of $700,000 over two years to support 3 to 4 awards. Depending on the nature and scope of the research proposed, applicants may request budgets for up to $75,000 in direct costs per year over a two-year project period. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.
Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The following organizations/institutions are eligible to apply:
Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the 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 this FOA, eligible applicants include previous awardees of the Academic-Community Partnership Series Conference awards (U13) under PAR-08-106 and RFA-HD-06-019. Should the PD/PI on the initial Academic-Community Partnership Series Conference award (U13) be unable to participate in this limited competition, an alternate PD/PI may be designated by the applicant institution, with the approval of the community partner(s) identified during the period of the U13 grant award.
More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
2. Cost Sharing or Matching
This program does not require cost sharing as defined in the current NIH Grants Policy Statement.
3. Other-Special Eligibility Criteria
You may submit an application if you and your institution meet two of the following criteria:
Number of Applications. Applicants may submit only one application in response to this solicitation.
Resubmissions. Resubmission applications are not permitted in response to this FOA.
Renewals. Renewal applications are not permitted in response to this FOA.
Section IV. Application and Submission Information
To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.
Several additional separate actions are required before an applicant can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:
Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget, as appropriate
(See Section IV.6., Special Instructions, regarding appropriate required budget component.)
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan [Section 14 of the Research Plan Component in the SF424 (R&R)], must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A. Submission, Review, and Anticipated Start Dates
Opening Date: September 28, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): September 28, 2009
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): October 28, 2009
AIDS Application Due Date(s): Not applicable
Peer Review Date(s): February/March 2010
Council Review Date(s): May 2010
Earliest Anticipated Start Date(s): July 1, 2010
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
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.
The letter of intent is to be sent by the date listed in Section IV.3.A.
The letter of intent should be sent to:
Regina Smith James, M.D.
Acting Director, Division of Special Populations
The Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 435-2692
Fax: (301) 480-0393
Email: rjames@mail.nih.gov
3.B. Submitting an Application Electronically to the NIH
To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C. Application Processing
Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.
Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and non-responsive applications will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commonshttps://commons.era.nih.gov/commons/. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
4. Intergovernmental Review
This initiative is not subject to intergovernmental review.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see the NIH Grants Policy Statement).
Allowable costs
Support should be targeted to both the academic and community settings. Examples of types of support allowable under this program include, but are not limited to:
6. Other Submission Requirements
Special Requirements for Academic-Community Partnerships
1. The applicant must include the following types of individuals in the senior/key person profile component of the grant application:
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.
2. In the Background and Significance section, include a description of the community or communities that will participate in the study. Be sure to use a set of tangible and explicit criteria that may include but are not limited to: demographic profile, geographical locality, documented health disparity condition(s)/disease(s), and other salient health disparity related data.
3. In the Research Design and Methods section, applicants must also include the following types of information:
4. Also include a copy of any consortium/contractual arrangements (i.e., Memorandum of Understanding (MOU)) at Item 15 of the PHS 398 Research Plan Component. The purpose of the MOU is to provide evidence of an effective community partnership (or partnerships) the objective of which is to collaborate on the design, implementation, and evaluation of an evidence-based intervention aimed at addressing a health disparity condition/disease within one of the NICHD health disparity areas of emphasis.
5. Surveys, questionnaires, and informed consent documents, etc. may be included in the Appendix of the PHS 398 Research Plan.
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.
Organizational DUNS
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
PHS398 Research Plan Component Sections
Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) Application Guide. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:
Appendix Materials
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not comply with the required page limitations may be delayed in the review process.
The following resource sharing policies do not apply to this FOA:
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NICHD and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
As part of the scientific peer review, all applications will:
Applications submitted in response to this FOA will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Overall Impact. 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 five core review criteria, and additional review criteria (as applicable for the project proposed).
Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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? Is (Are) the partner(s) well suited for participation in the CBPR project, particularly with regard to their expertise and agreed upon roles or to their status as a community institution?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, 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 any community members/representatives serving in leadership roles with regard to the proposed CBPR project? 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? Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in translational as well as health disparities research? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for translational research? Did the partnership challenge existing paradigms for community involvement in CBPR? Are there aspects of the partnership that can serve as a model for other CBPR projects?
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? Particularly with regard to this FOA: Is the proposed partnership adequate for the research? Is there evidence that the partnership will be effectively managed by the PI or project manager? Is the partnership strategy well planned and documented? Is there evidence that the partners from academia and the community can work together effectively, have an impact on achieving the research goals, and disseminate the developed intervention?
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?
Additional Review Criteria. As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, 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.
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.
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.
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.
Additional Review Considerations. As applicable for the project proposed, reviewers will address 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.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
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).
3. Anticipated Announcement and Award Dates
Not Applicable
Section VI. Award Administration Information
1. Award Notices
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 NIH eRA Commons.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.
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. See Section IV.5., Funding Restrictions.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.
3. Reporting
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 Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research (program), peer review, and financial or grants management issues:
1. Scientific/Research Contact(s):
Carl V. Hill, Ph.D., M.P.H.
Health Scientist Administrator
Division of Special Populations
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 435-2736
Fax: (301) 480-0393
Email: hillcv@mail.nih.gov
Jean L. Flagg-Newton, Ph.D.
Health Scientist Administrator
Division of Special Populations
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 435-2722
Fax: (301) 480-0393
Email: flaggnej@mail.nih.gov
2. Peer Review Contact(s):
Robert H. Stretch, Ph.D.
Director, Division of Scientific Review
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-1485
Fax: (301) 402-4101
Email: stretchr@mail.nih.gov
3. Financial/Grants Management Contact(s):
Bonnie Jackson
Grants Management Specialist
Grants Management Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A01B, MSC7510
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-5482
Fax: (301) 451-5510
Email: jacksobo@mail.nih.gov
Section VIII. Other Information
Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.
Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants ( NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.
Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.
Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.
Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.
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NIH Funding Opportunities and Notices
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