and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating
Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Agency for Health Care Research Quality (AHRQ), (http://www.ahrq.gov)
Components of Participating Organizations
Eunice Kennedy Shriver National Institute of Child Health and Human Development
(NICHD), (http://www.nichd.nih.gov)
National
Institute of Nursing Research (NINR), (http://www.ninr.nih.gov/)
Agency for Health Care Research Quality (AHRQ), (http://www.ahrq.gov)
Title: Research on Emergency Medical
Services for Children (R01)
Announcement Type
This Funding
Opportunity Announcement replaces PA-07-269.
Update: The following update relating to this announcement has been issued:
Program
Announcement (PA) Number: PAR-08-261
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):
93.242, 93.361, 93.865, 93.226
Key Dates
Release/Posted Date:
September 8, 2008
Opening Date: December 15, 2008 (Earliest date an
application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): December 15, 2008, August 19, 2009, August 15, 2010
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): January 15, 2009, September 19, 2009,
September 15, 2010
AIDS Application
Due Date(s): Not applicable
Peer Review
Date(s): June/July 2009; February/March 2010; February/March 2011
Council Review
Date(s): October 2009, May 2010, May 2011
Earliest Anticipated Start Date(s): December 2009, July 2010, July 2011
Additional Information to Be Available
Date (Activation Date): Not Applicable
Expiration Date: September 16, 2010
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. Submission, 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 multi-agency program Funding Opportunity Announcement (FOA) is designed to improve the quality and quantity of research related to emergency medical services for children (EMSC), to be conducted in the United States in FY 2008 and beyond. Specifically, this FOA seeks to inform prospective applicants regarding grant opportunities available to conduct EMSC research under the sponsorship of a group of Federal agencies, and to broadly describe the areas where research is invited. Each sponsoring agency has further delineated specific issues/questions as illustrative of topics of research interest and will provide additional information to prospective applicants upon request.
Background
In 1993, the Institute of Medicine (IOM) published a study of EMSC that recommended a dramatic increase in research addressing various aspects of children's emergency care. Subsequently, the Maternal and Child Health Bureau of the Health Resources and Services Administration and the Agency for Healthcare Research and Quality (AHRQ) jointly issued an FOA and funded projects addressing this topic, as did the Centers for Disease Control and Prevention. As of fiscal year 2007, all states, the District of Columbia, and all Territories have received grant support to address issues related to the 1993 IOM study findings at some time since the EMSC Program was established by federal legislation in 1984. States used these funds to identify specific pediatric EMS needs and make changes to their regional EMS systems.
However, even with these successes, the extent of EMSC research continued does not adequately address the need. In 1997, a multi-disciplinary group representing several professional organizations met to prioritize the research needs in children's emergency services and again affirmed the need for a national commitment to research in this area. In 1998, the Ambulatory Pediatrics Association developed a set of recommendations designed to encourage EMSC research. The 1999 IOM report, Reducing the Burden of Injury (http://books.nap.edu/catalog/6321.html), recommends that additional funding for surveillance, research, and program evaluation in injury research for children and adults be supported by a variety of federal agencies. In 1999, an expert panel of EMSC researchers prioritized conditions for EMS outcomes. This publication reported relief of discomfort as the central outcome parameter EMS professionals identified as having the most potential impact in top quartile conditions. In 2001, a National EMS Research Agenda was published after being commissioned by the National Highway Traffic Safety Administration and the Maternal and Child Health Bureau. It detailed the need for a national investment in the EMS research infrastructure to help facilitate the accumulation of essential evidence of the effectiveness of EMS practice. It also called for funding to train new researchers and to support the development of effective pre-hospital treatments for the diseases that drive the design of the EMS system, including injury and sudden cardiac arrest.
In 2006, the IOM released the Future of Emergency Care, a series of reports that included Emergency Medical Services at the Crossroads, Hospital Based Emergency Care: At the Breaking Point, and Emergency Care for Children: Growing Pains. (http://www.iom.edu/CMS/3809/16107.aspx ) The reports comprehensively described the fragmented system of emergency care with emphasis in the pediatric report on the uneven nature of emergency care for children. Key recommendations include: (a) improve coordination of care, (b) regionalize specialty pediatric medical care, (c) increase accountability, (d) arm the emergency care workforce with pediatric knowledge and skills, (e) enhance patient safety advancements in technology and information systems, (f) improve emergency preparedness for children involved in disasters, and (g) build an evidence base for pediatric emergency care.
This FOA, therefore, responds to a need that has been clearly identified in the last decade. The sponsoring institutes/agencies are jointly issuing this FOA because EMSC involves many agencies in its consequences, prevention, management, treatment, and control. This document is intended to go beyond what any single organization would be likely to accomplish individually, since EMSC requires visibility and multi-disciplinary approaches to effectively address the complicated and interwoven nature of the issues. Significant differences between the health care needs of children and adults mean that the dramatic changes now affecting the organization, financing, and delivery of health services may have differing effects on children than on adults. Children are different from adults in their patterns of use of health services, in their distinctive developmental vulnerabilities and strengths, and in their dependence on others for access to care and financial resources. The same is true in children's emergency care. Research in emergency medical services for children is essential to validate the clinical merit of care that is given, to identify better kinds of care, to devise better ways to deliver that care, and to learn where best to direct prevention activities. The use, costs, quality, accessibility, delivery, organization, financing, and outcomes of physical and mental health care services must be evaluated to increase understanding of the structure, processes, and effects of health services for both individual children and populations of children.
Objectives
Overall, seven broad areas of research on emergency medical services for children have been identified by recent national meetings, conferences, reports and symposia: (1) building the evidence base for clinical aspects of emergencies and emergency care; (2) improving data collection and evaluation systems in EMSC; (3) patient outcomes and outcome measures in pediatric emergency care; (4) costs and cost-effectiveness; (5) system organization, configuration, and operation to provide optimal care; (6) effective approaches to education and training, including re-training and skill retention; and (7) assuring pediatric safety and quality in emergency care.
Priority EMSC-Related Program Areas by Agency
Each agency has priority areas of scientific investigation, with some illustrative lists represented below.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD; http://www.nichd.nih.gov), NIH
The NICHD conducts and supports laboratory, clinical, epidemiological, and translational research on a variety of topics to assure that every individual is born healthy, is born wanted, and has the opportunity to fulfill his or her potential for a healthy life unhampered by disease or disability. The NICHD has programs that deal with behavioral and developmental aspects of pediatric health promotion and disease prevention, child abuse and maltreatment, pharmaceuticals for children, pediatric critical care and rehabilitation, and traumatic brain injury that share interest in EMSC research.
Examples of topics of interest to the NICHD include, but are not limited to:
National Institute of Mental Health (NIMH; http://www.nimh.nih.gov), NIH
The NIMH has active grant programs in the areas of developmental psychopathology, traumatic stress, mental health services research, and prevention, and treatment of mental disorders in children and adolescents. With growing numbers of children and adolescents seeking mental health care in emergency service settings, epidemiological research characterizing the nature and scope of this phenomenon and tracking the psychological sequelae of patients seen in emergency service settings, is of great interest. Broadly, NIMH is interested in studies that examine the quality and appropriateness of services for children and adolescents with mental health problems who are seen for emergency medical care, as well as the impact of the delivery of emergency care on mental health sequelae for children. Studies focusing on the prevention of youth suicide, and research developing and testing novel interventions to treat suicidal children and adolescents in emergency service settings are of interest, as are studies developing interventions to effectively link at-risk children and adolescents to mental health services from emergency care settings. NIMH is also interested in studies of the mental health consequences of traumatic events and the development and testing of interventions to assist victims and survivors. Knowledge is sought regarding the spectrum of responses to trauma and the influence that different stressor parameters (e.g., setting, frequency, controllability, severity) may have for pathological sequelae, treatment alternatives, and preventive options. A major challenge to progress in developing and testing pharmacological and psychotherapy interventions to prevent post-traumatic sequelae is the current inability to predict which youth are at highest risk for serious adjustment concerns. Accordingly, studies to identify risk markers and/or to develop decision tools for guiding preventive interventions and clinical are of interest.
Examples of relevant research topics include, but are not limited to, studies that:
National Institute of Nursing Research (NINR; http://www.ninr.nih.gov/), NIH
The NINR has grant programs in areas that promote and improve the health of individuals, families, communities, and populations. NINR supports and conducts clinical and basic research and research training on health and illness across the lifespan. The research focus encompasses health promotion and disease prevention, quality of life, health disparities, and end-of-life. NINR seeks to extend science by integrating the biological and behavioral sciences, employing new technologies to research questions, improving research methods, and developing the scientists of the future. NINR accomplishes this through research on preventing, delaying the onset, and slowing the progression of disease and disability. This includes finding effective approaches to achieving and sustaining a healthy lifestyle, easing the symptoms of illness, improving quality of life for patients and caregivers, eliminating health disparities, and addressing issues at the end of life. Strategic plan priority areas include: (1) biotechnological methods for monitoring adherence; (2) new measurements to determine illness progression; (3) efficacy and cost-effectiveness interventions to address barriers to care; (4) gene-environment interactions that improve symptoms; and (5) clinical/translational research.
For this announcement NINRs interest is on ethnic and racial minority children and underserved populations of children such as: children from low literacy, rural and low-income populations, geographically isolated children, hearing and visually impaired children, and physically or mentally disabled children requiring emergency medical services. Specific targeted areas of research include biobehavioral studies that incorporate multiple factors that influence child health disparities such as biological (e.g., genetics, cellular, organ systems), lifestyle factors, environmental (physical and family environments), social (e.g., peer influences), economic, institutional, and cultural and family influences; studies that target the specific health promotion needs of children with a known illness and/or disability; and studies that test and evaluate the cost effectiveness of health promotion interventions conducted in nontraditional settings where emergency medical services are provided to children.
The following are potential areas of research related to this funding opportunity announcement that is of interest to NINR. These examples are not listed in any priority order and are not to be viewed as exhaustive or an exclusive listing of potential areas. Topics for research include the following:
Agency for Healthcare Research and Quality (AHRQ; http://www.ahrq.gov)
AHRQ seeks to support research to better understand and improve the outcomes of health care and, in particular, what works, for whom, when, and at what cost. In terms of pediatric emergencies, AHRQ interests include, but are not limited to, studies that:
For more detailed information on the Agency's priority interests for extramural grants for research, demonstration, and evaluation projects, applicants are strongly encouraged to consult the following program announcement: AHRQ Health Services Research (R01), PA-07-243, released on March 6, 2007 (http://grants.nih.gov/grants/guide/pa-files/PA-07-243.html). Applicants considering submitting an application for AHRQ primary funding consideration are strongly encouraged to contact the AHRQ program contact listed in this FOA prior to submitting an application. AHRQ encourages research applications that will use data from the Medical Expenditure Panel Survey (MEPS), the Healthcare Cost and Utilization Project (HCUP), and other AHRQ data as referenced in this announcement.
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 Research Project Grant (R01) 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) should use the PHS398 Modular Budget component.
U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component.
2.
Funds Available
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:
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. 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
Applicants may submit a resubmission application, but such application must include an Introduction addressing issues raised in the previous critique (Summary Statement).
Applicants may submit a renewal application.
Applicants may submit more than one application, provided that each application is scientifically distinct.
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 PD(s)/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
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: [email protected].
Telecommunications for the hearing impaired: TTY
301-451-5936.
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/PIs 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
Foreign
Organizations (Non-domestic [non-U.S.] Entities)
NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from Foreign organizations must:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States (U.S.) or that augment existing U.S. resources.
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 13 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, 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 3.4 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: December 15, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s):December 15, 2008, August 19, 2009, August 15, 2010
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): January 15, 2009, September 19, 2009, September 15, 2010
AIDS Application
Due Date(s): Not applicable
Peer Review
Date(s): June/July 2009; February/March 2010; February/March 2011
Council Review
Date(s): October 2009, May 2010, May 2011
Earliest Anticipated Start Date(s): December 2009, July 2010, July 2011
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
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:
Lynne Haverkos, MD, MPH
Center for
Research for Mothers and Children
Eunice
Kennedy Shriver National Institute of Child Health and Human Development
(NICHD)
National
Institutes of Health (NIH)
Building
6100, Room Number 4B05G
6100
Executive Boulevard
Bethesda, MD 20892-7510
Phone:
(301) 435-6881
Fax: (30)
480-0230
Email: [email protected]
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(ofthe 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 Center for
Scientific Review, NIH. Incomplete 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 their application status in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.
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 competing
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 competing 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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements and Information.
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
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:
Specific Instructions for Applications Requesting $500,000 (direct
costs) or More per Year
Applicants requesting
$500,000 or more in direct costs for any year (excluding consortium F&A
costs) must carry out the following steps:
1) Contact the IC program staff at least 6 weeks
before submitting the application, i.e., as plans are being developed for the
study;
2) Obtain agreement
from the IC staff that the IC will accept the application for consideration for
award; and,
3) Include a cover letter with the application that
identifies the staff member and IC who agreed to accept assignment of the
application.
This policy applies to all new, renewal, revision, or resubmission applications. See NOT-OD-02-004, October 16, 2001.
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. 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: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)
(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 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/.)
Foreign Applications (Non-domestic [non-U.S.] Entities)
Indicate how the proposed project has specific relevance to the mission and objectives of the NIH/IC and has the potential for significantly advancing the health sciences in the United States
Section V. Application Review Information
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review criteria described below will be considered in the review process.
2.
Review and Selection Process
Applications
submitted for this funding opportunity will be assigned on the basis of
established PHS referral guidelines to the ICs for funding consideration.
Applications that are complete will be evaluated for scientific and technical merit by an appropriate scientific review group convened by CSR 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 funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
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 impact/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.
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?
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?
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?
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?
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?
2.A.
Additional Review Criteria
In addition to
the above criteria, the following items will be considered in the determination
of scientific merit and the rating:
Resubmission Applications: When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
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: If materials or procedures are proposed that are potentially
hazardous to research personnel and/or the environment, determine if the
proposed protection is adequate.
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 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 Agents 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).
Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.
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 impact/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.
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):
Lynne
Haverkos, MD, MPH
Child Development and Behavior Branch
Center for Research for Mothers and Children
Eunice Kennedy Shriver National Institute of Child
Health and Human Development (NICHD)
National Institutes of Health (NIH)
6100
Executive Blvd., Room 4B05G, MSC 7510
Bethesda, MD
20892-7510
Rockville, MD 20852 (for express/courier
service; non-USPS service)
Phone: (301) 435-6881
Fax: (301) 480-0230
Email: [email protected]
Carol Nicholson, MS, MD
National Center for Medical Rehabilitation Research
Eunice
Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National
Institutes of Health (NIH)
6100
Executive Blvd., Room
2A03, MSC 7510
Bethesda, MD 20892-7510
Phone:
(301) 435-6843
Fax: (301)
402-0832
Email: [email protected]
Anne
Zajicek, MD, PharmD
Obstetric
and Pediatric Pharmacology Branch
Center for
Research for Mothers and Children
Eunice
Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National
Institutes of Health (NIH)
6100
Executive Blvd., Room
4A01, MSC 7510
Bethesda, MD 20892-7510
Phone:
(301) 435-6865
Fax: (301)
480-2897
Email: [email protected]
Amy B.
Goldstein, PhD
Chief,
Child and Adolescent Preventive Intervention Program
National
Institute of Mental Health (NIMH)
National
Institutes of Health (NIH)
6001
Executive Blvd., Room
7146, MSC 9631
Bethesda, MD 20892-9631
Phone:
(301) 496-7227
Fax
: (301) 443-4045
E-mail: [email protected]
Karen
Huss, PhD,
RN, APRN-BC, FAAN, FAAAAI
Program
Director, Cardiopulmonary & Critical Care Science
National
Institute of Nursing Research (NINR)
National
Institutes of Health (NIH)
6701
Democracy Blvd., Rm 710
One
Democracy Plaza
Bethesda, MD 20892-4870
Phone:
(301) 594-5970
Fax:(301)
451-5649
Email: [email protected]
Ryan Mutter, PhD
Center for Delivery, Organization, and Markets
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Phone: (301) 427-1415
Fax: (301) 427-1430
Email: [email protected]
2. Peer Review Contact(s):
Not applicable
3. Financial/Grants Management Contact(s):
Bryan Clark
Grants
Management Officer
Eunice Kennedy
Shriver National Institute of Child Health and Human Development (NICHD)
National
Institutes of Health (NIH)
6100 Executive
Boulevard, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for
express/courier service; non-USPS service)
Phone: (301)
435-6995
Fax: (301)
480-4783
Email: [email protected]
Joy R. Knipple
Grants Management Branch
National Institute of Mental Health (NIMH)
National Institutes of Health (NIH)
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-8811
Fax: (301) 443-6885
Email: [email protected]
Lawrence Haller
Grants
Management Specialist
Office
of Grants/Contract Management
National
Institute of Nursing Research (NINR)
National Institutes of Health (NIH)
6701
Democracy Blvd, Rm. 710
One
Democracy Plaza
Bethesda, MD 20892-4870 (courier use
20817)
Phone:(301)
402-1878
Fax:(301) 451-5652
Email: [email protected]
Kevin Hornbeak
Division of Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1704
Fax: (301) 427-1462
E-mail: [email protected]
Section VIII. Other Information
Required Federal Citations
Vertebrate Animals:
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 impact/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, Minorities, and Children:
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-09-116.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
Medicines 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/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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