and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Centers for Disease Control and Prevention (CDC),
(http://www.cdc.gov)
Components of Participating Organizations
National Institute of Environmental Health Sciences
(NIEHS/NIH), (http://www.niehs.nih.gov)
National Institute for Occupational Safety and Health
(NIOSH), (http://www.cdc.gov/niosh/)
Title: Research to Action: Assessing and Addressing Community Exposures to Environmental Contaminants (R21)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Request for Applications (RFA) Number: RFA-ES-09-001
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)
93.113
Key Dates
Release/Posted Date: December 23, 2008
Opening Date: March 1, 2009 (Earliest date an application may be submitted
to Grants.gov)
Letters of Intent Receipt Date(s): March
1, 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): April
1, 2009
Peer Review Date(s): June
2009
Council Review Date(s): August
2009
Earliest Anticipated Start Date(s): September 30, 2009
Additional Information To Be Available Date (Activation
Date): Not Applicable
Expiration Date: April
2, 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 and Information
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
This Funding Opportunity Announcement (FOA) is part of a new umbrella program supported by the National Institute of Environmental Health Sciences (NIEHS) referred to as Partnerships for Environmental Public Health (PEPH). The PEPH program will support a variety of research, outreach, and educational activities to prevent, reduce, or eliminate environmental/occupational exposures that may lead to adverse health outcomes in communities. This particular FOA, which is being announced in partnership with the National Instititute for Occupational Safety and Health (NIOSH), solicits research applications designed to bring together community members and environmental and occupational health researchers to investigate the potential health risks of environmental and occupational exposures that are of concern to the community. Data collection, translation of research into public health action, and project evaluation are all required. Data collected can include information on a community’s exposure to environmental/occupational agents (i.e., quantify exposure levels or determine exposure sources) or the prevalence of a disease known or strongly suspected to be associated with an environmental or occupational exposure, or the interplay between multiple exposures and social factors which impact the health of community members. Information collected will be translated into public health action using a variety of strategies; applicants must develop an education, outreach, prevention or intervention program(s) designed to improve community members , healthcare professionals or policymakers understanding of the problems and to promote actions that will prevent or reduce harmful environmental or occupational exposures and improve human health. Finally, applicants must implement an evaluation plan to assess project outputs and impacts relevant to the proposed project’s goals and objectives.
The meaningful involvement of communities in both data collection and translation are vital to the success of this initiative. Placing an emphasis on community involvement in environmental/occupational health research will ensure that:
All projects must include at least one research scientist in environmental or occupational health sciences in addition to at least one member of a community-based organization (CBO) that works directly and regularly with the affected community. The partnership between the research scientist and CBO should be equitable and draw upon the unique strengths that each brings to the partnership.
All applications must include the following information:
Responsibilities of the research partner may include, but are not limited to, helping identify the most appropriate research design and methodology, clarifying what information the proposed study can and cannot provide, summarizing the scientific literature on exposure-related health risks and interpreting study results in light of the current state of evidence. Responsibilities of the community partner include, but are not limited to, identifying the environmental/occupational health issue(s) of greatest importance, representing the community perspective when designing the study to ensure acceptability, and helping translate and communicate study findings to community members. All members of the partnership are responsible for ensuring research findings are translated appropriately into public health action and that project evaluation is implemented across the study period. Applications that do not include at least one research scientist in environmental health sciences or occupational health sciences and a member of a community-based organization (CBO) will be considered non-responsive. The inclusion of co-investigators with additional expertise, such as a health care professional from the participating community, behavioral or social scientist, is also encouraged if appropriate.
Research questions must be co-developed by scientists and community members and focused on environmental or occupational agents or an occupational or environmentally-linked disease(s) that have been identified by the community as potential public health issues. Because participation of the affected community is essential for both the identification of environmental/occupational health risks to be studied and development of research and translation plans, it is expected that means for incorporating equitable input from both scientists and community members throughout the entire research process should be established prior to submission of the application and explained within. In addition, the environmental/occupational agent(s) of interest should be current, emerging or re-emerging environmental exposures believed to be widespread (e.g., phthalates, bisphenol A, nanoparticles, alternative fuels) or an exposure that disproportionately affects the community at hand (e.g., pesticide exposure among immigrant workers, toxic exposures associated with a hazardous waste site).
All applications to this FOA must demonstrate the public health relevance of the environmental/occupational exposure of interest, its potential impact on the community at hand, and the innovative aspects of the proposal, particularly with regard to translation of the research into action. Applications from previous and current NIEHS/NIOSH grantees must also meet at least one of the following three criteria to be considered responsive to this announcement.
(1) New partnership either the research scientist or community group must be new to the collaborative team.
(2) New research question the application focuses on a new environmental health or occupational health research question and clearly supports why this new question is of greatest concern to the impacted community.
(3) New data collection methodology and public health action for an existing research question the application focuses on a new public health action and clearly demonstrates why new data collection on an existing research question is necessary to support the identified public health action.
Applications that do not meet the criteria outlined above (i.e., a new NIEHS-supported or NIOSH-supported partnership, new research question, or new data collection and public health action) will be considered non-responsive. Grantees are encouraged to contact the Program Staff as listed under WHERE TO SEND INQUIRIES for guidance on whether their research proposal would be considered a new, responsive collaboration prior to submission.
Current and previous NIEHS grantees that would like to apply for continued funding of an established project are encouraged to explore funding opportunities under the trans-NIH Community Participation in Research Program (http://grants.nih.gov/grants/guide/pa-files/PA-08-074.html) or contact Program Staff for additional guidance.
The NIEHS has a significant commitment to the support of programs designed to increase the number of underrepresented minority and female scientists participating in biomedical, environmental, and behavioral research. Therefore, applications from minority individuals and women are encouraged. Since the projects are situated in the community, well-established community- based or faith-based organizations are encouraged to consider their capacity to serve as the primary applicant organization or submit applications using a multiple principle-investigator (PI) model in which the research scientist and member of the CBO serve as co-PIs of the project. Due to the complex administrative, programmatic, and financial responsibilities associated with this role, such groups should contact Program Staff listed under WHERE TO SEND INQUIRIES for guidance. Special instructions for submitting a multiple PI application is provided in Section IV Part 2 of this FOA under Applications with Multiple PDs/PIs . Additional information is also available on the NIH Office of Extramural Research webpage (http://grants.nih.gov/grants/multi_pi/overview.htm#background.)
RESEARCH OBJECTIVES
Background
In Fall 2007, NIEHS began an initiative to reinvigorate support in environmental public health and create a new, unified program referred to as Partnerships for Environmental Public Health (PEPH). A Request for Information (RFI) was released in the October 2007 NIH Guide (http://www.niehs.nih.gov/funding/grants/announcements/peph/index.cfm), and a workshop was held in June 2008 inviting thought leaders from the fields of public health, environmental justice, community-based research, communication and advocacy to help develop the framework for the new program. As a result of these activities, the following program goals were established:
(1) Strategically coordinate and integrate the various new and existing initiatives that involve communities and scientists working together on contemporary issues in Environmental Public Health research
(2) Develop and evaluate strategies to communicate environmental public health messages to a diversity of audiences
(3) Create and provide materials to increase awareness and literacy about environmental health risks
(4) Evaluate program contributions to the advancement of environmental public health.
This FOA is the first funding announcement released under this new NIEHS program and focuses on the conduct and translation of research findings into environmental/occupational public health action.
For the PEPH Program, Environmental Public Health is defined as the science of conducting and translating research into action to address environmental and occupational exposures and health risks of concern to the public . Environmental public health includes both the generation and dissemination of science-based information about environmental risks and diseases to communities and other stakeholders. Under this program, the distinctive needs of individual communities are considered key for identifying environmental or occupational health problems and devising appropriate disease and exposure prevention tactics. By fostering partnerships between and among community residents/organizations and researchers in the research process, vital information about the linkages between exposures and disease can be used to promote health and reduce the risk of disease across the populations at highest risk.
Outstanding scientific research is the cornerstone of all NIEHS programs. NIEHS is engaged in a number of on-going extramural research initiatives that address important areas in environmental public health, including the Children’s Environmental Health Centers, Breast Cancer and Environment Research Centers, Superfund Basic Research Program, Superfund Worker Education and Training Program, and several trans-NIH programs in community based participatory research, health literacy and health disparities (http://www.niehs.nih.gov/research/supported/index.cfm). A hallmark of research activities under the PEPH program is that communities will be actively engaged in all stages of the research, starting with hypothesis development and continuing through the translation and dissemination of research findings to community members and other stakeholders in order to support public health action. In addition, research supported under the PEPH program will also focus on:
Emerging environmental and occupational exposures include a wide variety of natural and manmade agents that can enter the environment and cause known (or strongly suspected) human health effects; however, there are no currently published health standards or guidelines for these contaminants (e.g., phthalates, bisphenol A, nanoparticles/nanotechnology), or there is debate over whether current standards adequately protect human health (e.g., lead, complex mixtures of air pollutants). In addition, environmental or occupational exposure levels to these chemicals often are not routinely monitored. These environmental agents may be new synthetic materials, or existing agents for which exposure was not recognized until the recent development of new detection method. Agents may also have been present for some time but are now considered re-emerging because changes in the use, production or disposal of existing contaminants or proximity to contaminant sources have altered or created a new source of exposure in a population.
Environmental justice refers to the need to remedy the unequal burden of exposure and disease borne by socioeconomically disadvantaged persons. Geographic location and socioeconomic status play important roles in environmental exposure of these sub-populations. In addition, the lack of resources for early identification of the effects of toxic agents may lead to an increased disease burden among people who are economically least able to cope with it. Research to identify and characterize environmental or occupational exposures that disproportionately burden low income or minority communities can lead to public health action that will reduce the associated health disparities. Furthermore, active participation of community members in the identification of environmental health research questions and in the conduct and translation of research findings in itself can help community members better understand the associated health risks and empower them to make informed decisions.
For the purposes of this initiative, public health action includes campaigns, programs, interventions and policies intended to elicit a change in behavior or practice that will lead to the prevention of disease and disability and promote the health of a population. Public health action may be targeted at the individual, neighborhood, community or national level. Examples of environmental public health action include, but are not limited to, a campaign to change individuals behaviors that will lead to exposure reduction, a program to educate community health care providers about the health risks associated with a prevalent environmental exposure in their community, or a local, regional or national strategy to raise policy maker awareness of the link between environmental/occupational exposures and adverse health outcomes.
More specific guidelines on the scope of the research and public health action plans proposed under this FOA are described below under I. Research Component and II. Public Health Action Component , respectively. The scope of the third required component for this FOA, an evaluation plan to assess the project s outputs and impacts relevant to the proposed project’s goals and objectives, is described under III. Evaluation Component .
Objectives and Scope
The two main objectives of this announcement are to: 1) conduct research to collect information about exposure levels, sources of exposure, or potential health effects of environmental agents or occupational agents of significance to a community and 2) develop a strategy to translate and disseminate research findings to community members, public health professionals and/or policymakers to support an action that will ultimately promote the reduction of exposure or reduce the health impact from environmental/occupational stressors.
To meet these stated objectives, there are three components required for each application, each discussed further below. The three components must be included in applications submitted in response to this FOA. Applications lacking any one of the following components will be considered non-responsive.
I. Research Component
The objective of this component is to support research that will increase our knowledge of how environmental or occupational exposures and other factors impact health and disease in communities. This can include determining the prevalence of health outcomes of concern in populations and/or determining the environmental and biological levels and sources of exposures in community members using existing or new technology. Applications should propose research designed to collect information on environmental/occupational public health issues of concern to the community involved. A key requirement is that research findings must possess the potential to generate data for public health action. Data may be collected on environmental/occupational agents known or suspected to be associated with a disease that has a large public health burden, environmental/occupational exposures that disproportionately impact the community at hand, and/or emerging or re-emerging environmental and occupational agents with potential widespread exposure. Applications that consider interactions between the social and physical environment are encouraged; however, social environmental stressors must be considered within the context of one or more traditional environmental or occupational exposures (e.g., as a potential modifier of the health risk associated with exposure to an environmental chemical). The type of data collected will depend on the environmental public health action identified for the second component of the application. Applicants must explain why this information is vital to support the planned environmental public health action.
Specific examples of research topics that are of interest for this FOA include, but are not limited to:
The ultimate goal of this program is to improve health in a population and reduce the burden of disease. Participation of the affected community in identifying the most important research question to answer is essential.
II. Public Health Action Component
Applicants must develop strategies that translate the findings from the research component of the study to action and builds the capacity of all partners to be most effective. The strategy should be designed to help support or promote action that will result in the prevention or reduction of exposure among community members at the local, regional or national level, ultimately leading to improved health outcomes and quality of life. Furthermore, applicants must clearly explain how their proposed strategy will lead to action. Examples of possible public health action strategies include, but are not limited to:
Again, the ultimate goal of this program is to improve health in a population and reduce the burden of disease. Participation of the affected community in identifying the most effective educational or outreach strategy is essential.
III. Evaluation Component
A plan for evaluating the project's processes and outcomes must be included in the proposal. Evaluations should be designed to reflect program goals and objectives. The plan should address intended purpose, intended audience(s), duration and frequency of evaluation activities (scope), cost, participation (staff and partners), and the expected product. The scope of the evaluation should reflect the scope of the project. A conceptual framework, or logic model, that describes program goals and objectives in terms of inputs, activities, outputs and outcomes can be useful for developing evaluation measures. For additional information on logic models, see the Logic Model Development Guide by the W.K. Kellogg Foundation (2001) available through the W. K. Kellogg Foundation website (http://www.wkkf.org/Pubs/Tools/Evaluation/Pub3669.pdf).
Process evaluation examines the relationship between inputs, activities and outputs. Examples of potential measures for process evaluation may include:
Outcome evaluation examines the impact of the data, materials, methods, publications, etc produced by the program. Examples of potential measures for outcome evaluation may include:
Applicants are encouraged to involve social scientists in the development of these quantitative and qualitative tools to assess progress and programmatic achievements. Applications that do not contain an evaluation plan will be considered non-responsive and returned to the applicant without review.
The research component of the application should be completed in a timeframe that will allow research findings to be fully incorporated into the action planning and implementation. Evaluation can be implemented during any and all phases of the study. All of the above elements are essential to fulfill the research, action and evaluation aims of this FOA. Applicants lacking any of the above three components will be considered non-responsive.
It is important to note that award of a grant under this FOA does not imply a commitment to future funding of any extensions or new projects planned with the support of such a grant. Separate applications must be submitted for such programs, and such applications will be evaluated on the basis of their own merits.
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 Exploratory/Developmental
(R21) grant mechanism 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 budget format (see http://grants.nih.gov/grants/funding/modular/modular.htm). 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
The NIEHS intends to commit $2 million in FY2009 to fund
five to seven new grants in response to this FOA. The NIOSH intends to
commit $500,000 in FY2009 to fund one to two new grants in response to this
FOA. Although the financial plans of the NIEHS and NIOSH provide support
for this program, awards pursuant to this FOA are contingent upon the availability
of funds and the receipt of a sufficient number of meritorious applications.
The total project period for an application submitted in response to this funding opportunity may not exceed four years. Direct costs are limited to $225,000 per year. The R21 is not renewable.
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:
Foreign institutions 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.
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. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. 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
Application must have the following characteristics to be considered responsive:
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.
Note: If a PD/PI is also an NIH peer-reviewer the DUNS number obtained and used in the reviewer role may NOT be used and is not applicable to any Grant Application to the Federal Government. This DUNS number is different from the DUNS number used by the applicant organization. The individual DUNS number should be used only for the purposes of personal reimbursement.
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.
Note: Only the forms package
directly attached to a specific FOA can be used. You will not be able
to use any other SF424 (R&R) forms (e.g., sample forms, forms from
another FOA), although some of the "Attachment" files may be
useable for more than one FOA.
For further assistance, contact GrantsInfo -- Telephone
301-710-0267; Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY
301-451-5939.
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 (See Section IV.6., Special Instructions, regarding appropriate required budget component.)
Research & Related Subaward Budget Attachment(s) Form
Optional Components:
PHS398 Cover Letter File
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 (NoA).
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: March
1, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): March 1, 2009
Application Due Date(s): April
1, 2009
Peer Review Date(s): June
2009
Council Review Date(s): August
2009
Earliest Anticipated Start Date(s): September
30, 2009
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:
Sally E. Eckert-Tilotta, PhD
Scientific Review Branch
Division of Extramural
Research and Training
National Institute of Environmental Health
Sciences
Building 530, Room 3076
P.O. Box 12233, K3-03
111. T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-1446
Fax: (919) 316-4606
Email: eckertt1@niehs.nih.go
Please note that electronic submission via email is preferred.
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 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 or renewal 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 or renewal 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).
6. Other Submission Requirements and Information
Researcher-Community Partnership
All projects must include at least one research scientist in environmental health sciences or occupational health sciences and a member of a community-based organization (CBO) that works directly and regularly with the affected community to be considered responsive. The partnership between the research scientist and CBO should be equitable and draw upon the unique strengths that each brings to the partnership. To help evaluate the adequacy of the proposed researcher-community partnership, all applications must:
This information should be included in the Research Design and Methods section of the Research Plan and should not exceed three pages.
Responsibilities of the research partner should include, but are not limited to, helping identify the most appropriate research design and methodology, clarifying what information the proposed study can and cannot provide, summarizing the scientific literature on exposure-related health risks and interpreting study results in light of the current state of evidence. Responsibilities of the community partner should include, but are not limited to, identifying the environmental health or occupational health issue(s) of greatest importance, representing the community perspective when designing the study to ensure acceptability, and helping translate and communicate study findings to community members. All members of the partnership are responsible for ensuring research findings are translated appropriately into public health action and that project evaluation is implemented across the study period.
Applications should request funding for the time and effort of the community partners who are serving as co-investigators on the project. Applicants also are encouraged to create a community-based advisory board or steering committee to facilitate planning, education, outreach, dissemination, and evaluation efforts.
To encourage applicants to share information gained via these grants, a member of each type of required personnel on each project (a scientist and a member of the community-based organization) will be asked to attend an annual meeting in the Research Triangle Park, NC area. Applicants should include such travel in their budget requests.
Application characteristics
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts.
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.
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.
Resource Sharing Plan(s)
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).
(a) Data Sharing Plan: Not Applicable
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for 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. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)
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 the National Institute of Environmental Health Sciences
(NIEHS) and in accordance with NIH
peer review procedures (http://grants.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 NIH R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools, or technologies that have the potential to significantly advance our knowledge or the status of health-related research. Because the Research Plan is limited to 15 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. While preliminary data may be included in the R21 application, they are not required and applicants will not be rewarded for including preliminary data.
The goals of NIH supported research are to advance
our understanding of biological systems, to improve the control of disease,
and to enhance health. In their written critiques, reviewers will be asked
to comment on each of the following criteria in order to judge the likelihood
that the proposed research will have a substantial impact on the pursuit
of these goals. Each of these criteria will be addressed and considered
in assigning the overall score, and weighted as appropriate for each application.
Note that an application does not need to be strong in all categories
to be judged likely to have major scientific impact and thus deserve a
meritorious priority score. For example, an investigator may propose to
carry out important work that by its nature is not innovative but is essential
to move a field forward.
Significance: Does
this study address an important problem? If the aims of the application
are achieved, how will environmental public health be advanced?
What will be the effect of these studies on the concepts, methods, technologies,
treatments, services, or preventative interventions that drive this field? Does the applicant sufficiently demonstrate the public
health importance of the environmental/occupational health research question
under study, particularly with respect to the community partner? Is the proposed research plan likely to produce data
that will support the proposed public health action? Is the proposed public health action plan likely to lead to the prevention or
reduction of harmful environmental or occupational exposures and improve human health?
Approach: Are the conceptual framework, design, methods, and
analyses adequately developed, well integrated, well reasoned, and appropriate
to the research aims of the project? Does the applicant acknowledge potential
problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, is the leadership
approach, including the designated roles and responsibilities, governance,
and organizational structure, consistent with and justified by the aims
of the project and the expertise of each of the PDs/PIs? Are
the conceptual framework, design, and methods adequately developed, well
integrated, well reasoned, and appropriate for the proposed public health
action plan? Does the evaluation plan reflect the proposed projects goals
and objectives and utilize the most appropriate process and outcomes measures
to assess projects outputs and impacts?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field, or utilize an innovative method for research translation and dissemination? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field, or utilize an innovative method for research translation and dissemination?
Investigators: Are
the PD(s)/PI(s) and other key personnel appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the principal investigator and other researchers? Do(es) the PD(s)/PI(s)
and investigative team bring complementary and integrated expertise to the
project? Is there evidence of a partnership between the research scientist
and CBO member and is the partnership adequate to ensure success of the
proposed project?
Environment: Do(es) the scientific environment(s) in which the
work will be done contribute to the probability of success? Do the proposed
studies benefit from unique features of the scientific and community
based organization environments,
and the collaboration of these two groups? Is there evidence of institutional support? Do
the proposed studies benefit from unique features of the scientific and community
based organization environments,
and the collaboration of these two groups?
2.A. Additional Review Criteria
In addition to the above criteria, the following
items will continue to be considered in the determination of scientific
merit and the rating:
Protection of Human Subjects
from Research Risk: The involvement of human subjects and protections from research
risk relating to their participation in the proposed research will be
assessed. See the Human Subjects Sections
of the PHS398 Research Plan component of the SF424 (R&R).
Inclusion of Women, Minorities and Children in Research: The adequacy
of plans to include subjects from both genders, all racial and ethnic groups
(and subgroups), and children as appropriate for the scientific goals of
the research will be assessed. Plans for the recruitment and retention of
subjects will also be evaluated. See the Human Subjects Sections of the
PHS398 Research Plan component of the SF424 (R&R)
Care and Use of Vertebrate Animals in Research: If vertebrate animals
are to be used in the project, the adequacy of the plans for their care
and use will be assessed. See the Other Research Plan Sections of the
PHS398 Research Plan component of the SF424 (R&R).
Biohazards: If materials or procedures are proposed that are potentially
hazardous to research personnel and/or the environment, determine if the
proposed protection is adequate.
2.B. Additional Review Considerations
Budget and Period of Support: The
reasonableness of the proposed budget and the appropriateness of the requested
period of support in relation to the proposed research may be assessed by
the reviewers. The priority score should not be affected by the evaluation
of the budget.
2.C. Resource Sharing Plan(s)
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
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):
Caroline H. Dilworth, PhD
Susceptibility and Population Health Branch
Division of Extramural Research and Training
Nation Institute of Environmental Health Sciences
Building 530, Room 3069
P.O. Box 12233,
K3-12
111 T.W. Alexander
Drive
Research Triangle Park, NC 27709
Telephone: (919) 541 -7727
Fax: (919) 316-4606
Email: dilworthch@niehs.nih.gov
Bernadine Kuchinski, Ph.D.
Office of Extramural Programs
National Institute for Occupational Safety and Health
Center for Disease
Control &
Prevention
Robert A. Taft Laboratories
4676 Columbia Pkwy. MS-C-7
Cincinnati, OH 45226
Telephone: (513) 533-8511
Fax: (513) 533-8564
Email: BKuchinski@cdc.gov
2. Peer Review Contact(s):
Sally E. Eckert-Tilotta, PhD
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Building 530, Room 3076
P.O. Box 12233,
K3-03
111. T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-1446
Fax: (919) 316-4606
Email: eckertt1@niehs.nih.gov
3. Financial/Grants Management Contact(s):
Carolyn Mason
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health
Sciences
Building 530, Room 3060
P.O. Box 12233,
K3-11
111. T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-1373
Fax: (919) 541-2860
Email: mason6@niehs.nih.gov
Mary Pat Shanahan
Procurement and Grants
Office
Centers for Disease Control & Prevention
P.O. Box 18070
626 Cochrans Mill Road
Pittsburgh, PA 15236
Telephone: (412) 386-4453
Fax: (412) 386-6429
Email: mpu0@cdc.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. Applications that do not provide
this information will be returned without review.
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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