This notice has expired. Check the NIH Guide for active opportunities and notices.
EXPIRED
Part I Overview Information
Department of Health and Human
Services
Participating Organizations National
Institutes of Health (NIH), (http://www.nih.gov/)
Components of Participating Organizations National Institute of Mental Health
(NIMH), (http://www.nimh.nih.gov/) Eunice Kennedy Shriver National Institute of Child Health and Human Development
(NICHD), (www.nichd.nih.gov/) National Institute of Nursing Research
(NINR), (http://www.ninr.nih.gov/)
Title:Dissemination, Implementation,
and Operational Research for HIV Prevention Interventions (R01)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
November 25, 2009 -
This FOA has been updated to reflect the new requirements from NIH’s Enhancing Peer Review Initiative. The new requirements are effective for submissions intended for due dates January 25, 2010 and beyond. If submitting an application intended for a due date of January 25, 2010 and beyond, follow the guidance below and be sure to use the Adobe-Forms-B version of the application forms and instructions. If applying for a due date before January 25, 2010, follow the guidance in the archived version of this FOA and be sure to use the Adobe-Forms-A version of the application forms and instructions.
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 weeks prior to the grant
submission date. See Section IV.
Program Announcement (PA) Number:
PA-08-166
Catalog
of Federal Domestic Assistance Number(s) 93.242,
93.865, 93.361
Purpose.This Funding Opportunity
Announcement (FOA) issued by the National Institute Mental Health (NIMH), the Eunice Kennedy Shriver National
Institute of Child Health and Human Development (NICHD), and the National
Institute of Nursing Research (NINR) invites research to enhance the
science of technology transfer, dissemination, implementation, and operational research for evidence-based HIV-prevention
interventions in the United States. Gaps in the scientific literature and research
opportunities have been identified in a collaborative process involving
NIH and the Centers for Disease Control and Prevention
(CDC) staff.
Mechanism of Support. This FOA will utilize the NIH
Research Project Grant (R01) award mechanism. Applications
addressing the scientific aims may also be submitted under the NIH Small
Research Grant (R03), the NIH Exploratory/Developmental Research Grant
(R21), and the NIMH Clinical Exploratory/Developmental Research Grant
(R34) award mechanisms, responding to FOAs PA-06-180, PA-06-181,
and PA-06-248,
respectively.
Funds Available and
Anticipated Number of Awards. Awards issued
under this FOA are contingent upon the
availability of funds and the submission of a sufficient number of
meritorious applications.
Budget and Project Period.The total project period for an
application submitted in response to this funding opportunity may not
exceed 5 years.Applicants for an R01 award are not limited in
dollars but need to reflect the actual needs of the proposed project.
Application Research Strategy Length: The R01 application Research Plan component
of the PHS398 (Item 3) may not exceed 12 pages, including tables,
graphs, figures, diagrams, and charts. http://grants.nih.gov/grants/funding/funding_program.htm.
Eligible Institutions/Organizations.Institutions/organizations
listed in Section III, 1.A. are
eligible to apply.
Eligible Project
Directors/Principal Investigators (PDs/PIs).Individuals with the
skills, knowledge, and resources necessary to carry out the proposed
research are invited to work with their institution/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.
Number of PDs/PIs. More than one PD/PI, or
multiple PDs/PIs, may be designated on the application.
Number of
Applications. Applicants may submit more than one application,
provided each application is scientifically distinct.
Resubmissions. Applicants may submit a
resubmission application, but such application must include an
Introduction addressing the previous peer review critique (Summary
Statement).
Renewals. Applicants may submit
a renewal application.
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
This Funding Opportunity Announcement
(FOA) issued by the National Institute Mental Health (NIMH), the Eunice Kennedy
Shriver National Institute of Child Health and Human Development, and the
National Institute of Nursing Research (NINR) invites research to enhance the
science of technology transfer, dissemination, implementation, and operational
research for evidence-based HIV-prevention interventions. Gaps in the
scientific literature and research opportunities have been identified in a
collaborative process involving NIH and the Centers for Disease Control and
Prevention (CDC) staff. Studies are particularly encouraged, but not required,
to capitalize on the intervention dissemination services, trainings, and
evaluation conducted by the CDC. Potential applicants are encouraged to contact
the NIMH program officer in advance of their submission because, when
appropriate to the research question of interest, the program officer will
liaise with CDC program staff to explore whether CDC-facilitated access to
organizational information, interventionist information, and/or access to
recipients of services can result in an application that optimally advances the
science.
Background
As one piece of the United States efforts to curb the HIV epidemic, efficacy trials to develop and test
behavioral and social interventions to reduce risk for HIV transmission have
been given high priority, and identified as an important component of the
Trans-NIH Strategic Plan for HIV-related Research. As a result, there are
numerous primary and secondary HIV prevention interventions available for
implementation by clinical and community agencies (for examples, see http://www.effectiveinterventions.org).
Efficacious intervention modalities include individual and group format, and
have been designed to be appropriate for many different subpopulations at risk for
HIV in the United States. One way that these interventions are being
distributed is through the CDC Disseminating Evidence Based Interventions
(DEBI) project.
However, there is consensus among the
relevant federal agencies, community service providers, the academic community,
and community members that the science-to-practice gap remains problematic.
Whether it is referred to as dissemination and implementation research,
operations research, systems science, or technology transfer, the collective understanding
of how to best ensure that these interventions are adopted and effectively
implemented remains underdeveloped. These research domains are also emphasized
as critical for the field, in the most recent Trans-NIH Strategic Plan for
HIV-related Research. Therefore, in this FOA, a wide range of theoretical,
methodological, and outcome studies are encouraged to assist the process of
dissemination and implementation of HIV prevention interventions. A
well-articulated and empirically based conceptual framework is essential in
applications solicited under this announcement.
Applicants may refer to a special
supplement of AIDS Education and Prevention (August 2006) focused on Moving
Science into Practice for HIV/STD Prevention, which outlines the CDCs national
system to diffuse evidence-based interventions and describes lessons learned
from the field in utilizing this system. The proposed work should build upon
the existing science and experiences with HIV prevention interventions, as well
as the dissemination science field for other disease areas, more broadly.
Applicants are highly encouraged to submit applications that both advance the
science and meet critical public health priorities to help curb the HIV
epidemic in the United States. Relevance of the proposed work to the HIV
epidemiology in the targeted locality will therefore build a more compelling
rationale for the project.
Applications studying the process for
both primary and secondary HIV prevention interventions are encouraged.
However, much of the published literature for dissemination research for HIV
prevention has used primary prevention interventions, so less is known about
what unique factors may be germane to the implementation of interventions
developed for use in community and clinical settings that serve HIV-positive
men, women, and families.
In this FOA, there are five categories of
projects where additional research activities could assist in the effective and
efficient implementation of HIV prevention interventions: Dissemination
strategies, adoption of interventions, implementation fidelity and adaptation,
intervention effectiveness, and sustainability of interventions. Three general
considerations should be noted. First, under each category below, the
appropriate outcome(s) may be assessed at the individual, provider, or
organizational level. Second, research opportunities listed under one category
may also be an appropriate investigation for the other categories. Third,
studies that intersect these categories may also be appropriate.
Research Scope
Dissemination Strategies
Development and testing of different
modes for transferring efficacious interventions into community and
clinic-based settings and developing the capacity of local providers to
effectively implement these interventions
Analysis of factors that influence
the transmission and reception of interventions into delivery settings,
ranging from psychological and socio-cultural factors affecting individual
practitioners, consumers, primary caregivers and other stakeholder groups
to investigations addressing large service delivery systems and local,
state and federal funding resources.
Examining the individual and
organizational needs with respect to the successful identification,
adoption, adaptation, and implementation of proven interventions.
Studies of the capacity of
alternative prevention delivery settings (primary care, correctional
settings, community health settings, churches, emergency departments) to
incorporate dissemination or implementation efforts within their
organizations.
Studies on how target audiences are defined, and how evidence is
packaged for specific target audiences. This could include, for example,
using the science of message framing to enhance uptake.
Studies testing the utility of alternative dissemination
strategies for service delivery systems targeting rural, minority, and/or
other underserved populations. Although tailoring risk-reduction
interventions has been an important part of the prevention research
agenda, studies are also needed to understand how best to tailor the
strategies for dissemination to these communities.
Adoption of Interventions
Studies that will investigate the
process of intervention selection and adoption by community based
providers. A variety of factors (e.g., intervention packaging, complexity,
modality, organizational mission, resources, and staffing) could influence
intervention adoption. For CDC-related end-users, the selection process
of interest may be among those interventions available from CDC training
courses. For other community-based providers and treatment settings, the
selection process may be broader and unique factors such as access and
resources may influence the selection and adoption process.
Regarding measurement issues, in
most prior evaluations of implementation, the primary outcome has been
whether an intervention is adopted and implemented by an organization.
Studies to investigate the incremental steps to this dichotomous outcome
(e.g., attitudes about the
dissemination strategy and intervention modality, use of this knowledge in
practice decision-making).
Understanding the organizational
changes required for an agency to adopt an evidence-based intervention
Understanding the roles of
individuals within organizations who manage the process of implementation
and overcoming barriers. Studies to examine whether a mentoring process
for these agents within organizations enhance adoption.
Organizations often gain knowledge
and expertise about intervention adoption and implementation through organizational
networks in communities. Studies of the systematic examination of this
process.
Studies
of systemic interventions to influence organizational structure, climate,
and culture, in order to promote organizational readiness and capacity for
intervention dissemination and adoption.
Implementation Fidelity and Adaptation
Development of methods to define and
evaluate core elements of interventions that are essential for
intervention efficacy
Studies to better the understanding
and measurement of fidelity to efficacious behavioral interventions.
Further, are there incremental steps to fidelity? Does fidelity influence
effectiveness?
It is not evident how much change an
intervention can tolerate before it no longer has the essential elements
of the originally tested version, or how much it can be tailored to suit
the local population. General understanding of the adaptation process at
all levels of the organization (provider/facilitator, organizationally,
socio-cultural adaptations).
Studies to examine how recruitment
and retention for intervention participants affect intervention
adaptation.
Effectiveness of Interventions
Understanding the contribution of
program components (core elements) to the intervention outcome variable
(effectiveness) so as to better guide agencies in directing effort and
resources to different aspects of intervention delivery.
Examining how changes in
organizational leadership, staff turnover, agency instability, and
organizational size affect implementation, effectiveness, and
sustainability of interventions.
Studies linking organizational
factors (e.g., staff retention and satisfaction) to individual outcomes
(e.g., service utilization, HIV testing uptake, reduced risk behavior)
using multi-level, multi-method approaches.
Studies of the organizational
factors that are related to the organizations capacity to conduct ongoing
outcomes assessment of the intervention, and adjust practice according to
these outcomes.
Client outcomes and reactions in
effectiveness evaluations of prevention interventions, including
qualitative, behavioral, and biological outcomes, where appropriate.
Examination of the effectiveness of
what community-based organizations are implementing, if not from among the
interventions disseminated in the CDCs DEBI program.
Sustainability of Interventions
Understanding the relationships
between agency capacity to implement and sustain an intervention and the
complexity of the behavioral intervention.
Services-related research questions
related to how financing of organizations (and reimbursement) affect
intervention adoption, effectiveness, and sustainability.
Studies designed to assess and/or
intervene upon the capacity of community-based organizations to document
intervention outcomes and conduct program evaluations for the purposes of
maintaining and enhancing ongoing intervention programs.
Cost-effectiveness of different
dissemination and intervention strategies.
For research applications that focus on
the dissemination and implementation of effective interventions not
specifically related to HIV Prevention, please refer to PAR-07-086, PAR-06-520,
and PAR-06-521,
Dissemination and Implementation Research in Health, or contact Dr. David
Chambers at dchamber@mail.nih.gov.
This Funding Opportunity Announcement (FOA) will use
the NIH 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 Institutes and
Centers (ICs) provide support for this program, awards pursuant to this funding
opportunity are contingent upon the availability of funds.
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:
Public/State
Controlled Institutions of Higher Education
Private
Institutions of Higher Education
Hispanic-serving Institutions
Historically Black Colleges
and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Nonprofits with 501(c)(3) IRS Status (Other than
Institutions of Higher Education)
Nonprofits without 501(c)(3)
IRS Status (Other than Institutions of Higher Education)
Small Businesses
For-Profit Organizations (Other than Small Businesses)
State
Governments
Indian/Native
American Tribal Governments (Federally Recognized)
Indian/Native
American Tribally Designated Organizations
CountyGovernments
City or
Township Governments
Special
District Governments
Independent
School Districts
Public
Housing Authorities/Indian Housing Authorities
U.S. Territory or Possession
Indian/Native American Tribal Governments (Other than Federally Recognized)
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, or multiple PDs/PIs, may be
designated on the application for projects that require a team science
approach that clearly does 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 athttp://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior
to the submission of the application (seehttp://era.nih.gov/ElectronicReceipt/preparing.htmfor instructions).
The decision of whether to apply for a single PD/PI or
multiple PD/PI grant is the responsibility of the investigators and applicant
organizations and should be determined by the scientific goals of the project.
Applications for multiple PD/PI grants will require additional information, as
outlined in the instructions below. When considering multiple
PDs/PIs, 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 PD/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 seehttp://grants.nih.gov/grants/multi_pi.
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 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, link to http://www.grants.gov/applicants/apply_for_grants.jsp and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
If
your organization does not have a Taxpayer Identification Number (TIN) or
Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN
is necessary for CCR registration.
The
CCR also validates the EIN against Internal Revenue Service records, a step
that will take an additional one to two business days.
Direct
questions regarding Grants.gov registration to: Grants.gov Customer
Support
Contact Center Phone: 800-518-4726
Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
Email support@grants.gov
Direct
questions regarding the Commons registration to:
eRA Commons Help Desk
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
Email commons@od.nih.gov
The individual(s) designated as
PDs/PIs on the application must be registered also in the NIH eRA Commons.In the case of multiple PDs/PIs, all PDs/PIs must be registered and be assigned
the PI role in the eRA Commons prior to the submission of the application.
Each PD/PI must hold a PD/PI
account in the Commons. Applicants should not share a Commons account for both
an Authorized Organization Representative/Signing Official (AOR/SO) role and a
PD/PI role; however, if they have both a PD/PI role and an Internet Assisted
Review (IAR) role, both roles should exist under one Commons account.
When multiple PDs/PIs are
proposed, all PDs/PIs at the applicant organization must be affiliated with
that organization.PDs/PIs located at another institution need not be
affiliated with the applicant organization, but must be affiliated with their
own organization to be able to access the Commons.
This registration/affiliation must
be done by the AOR/SO or his/her designee who is already registered in the Commons.
Both
the PD/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: GrantsInfo@nih.gov.
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. There are fields within the SF424 (R&R) application
components that, 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/APPLYincludes 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
Prepare detailed budgets for all
applications (that is, complete the Research & Related Budget
component of the SF424 (R&R) application forms not the PHS398
Modular Budget component)(see NOT-OD-06-096);
Not include
any charge-back of customs and import fees;
Comply with
the format specifications, which are based upon a standard U.S. paper size of 8.5 x 11 within each PDF;
If
appropriate, request funds for up to 8% Facilities and Administrative
(F&A) costs (excluding equipment) ( seeNOT-OD-01-028, March 29,
2001);
Comply with
Federal/NIH policies on human subjects, animals, and biohazards; and
Comply with Federal/NIH biosafety and biosecurity
regulations (see Section VI.2.,
Administrative and National Policy Requirements)
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 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 of the 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,
including communication plans, process for making decisions on scientific
direction, and procedures for resolving conflicts.The roles and
administrative, technical, and scientific responsibilities for the project or
program should be delineated for the PDs/PIs and other collaborators.
If
budget allocation is planned, the distribution of resources to specific
components of the project or the individual PDs/PIs should be delineated in the
Leadership Plan. In the event of an award, the requested allocations may be
reflected in a footnote on the Notice of Award.
Applications
Involving a Single Institution
When
all PDs/PIs are within a single institution, follow the instructions contained
in the SF424 (R&R) Application Guide.
Applications
Involving Multiple Institutions
When
multiple institutions are involved, one institution must be designated as the
prime institution and funding for the other institution(s) must be requested
via a subcontract to be administered by the prime institution. When submitting
a detailed budget, the prime institution should submit its budget using the
Research & Related Budget component.All other institutions should
have their individual budgets attached separately to the Research & Related
Subaward Budget Attachment(s) Form.See Section 4.8 of the SF424 (R&R)
Application Guide for further instruction regarding the use of the subaward
budget form.
When
submitting a modular budget, the prime institution completes the PHS398 Modular
Budget component only.Information concerning the consortium/subcontract
budget is provided in the budget justification. Separate budgets for each
consortium/subcontract grantee are note 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.
A letter of intent is not required for the funding
opportunity.
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 submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt
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.
If everything is acceptable, no
further action is necessary. The application will automatically move forward to
the Division of Receipt and Referral in the Center for Scientific Review for
processing after two weekdays, excluding Federal holidays.
Prior to the submission deadline,
the AOR/SO can Reject the assembled application and submit a
changed/corrected application within the two-day viewing window. This option should
be used if it is determined that some part of the application was lost or did
not transfer correctly during the submission process, the AOR/SO will have the
option to Reject the application and submit a Changed/Corrected application.
In these cases, please contact the eRA Help Desk to ensure that the issues are
addressed and corrected. Once rejected, applicants should follow the
instructions for correcting errors in Section 2.12, including the requirement
for cover letters on late applications. The Reject feature should also be
used if you determine that warnings are applicable to your application and need
to be addressed now. Remember, warnings do not stop further application
processing. If an application submission results in warnings (but no errors),
it will automatically move forward after two weekdays if no action is taken.
Some warnings may need to be addressed later in the process.
If the two-day window falls after
the submission deadline, the AOR/SO will have the option to Reject the application
if, due to an eRA Commons or Grants.gov system issue, the application does not
correctly reflect the submitted application package (e.g., some part of the
application was lost or didnt transfer correctly during the submission
process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the
system error, document the issue, and determine the best course of action. NIH
will not penalize the applicant for an eRA Commons or Grants.gov system issue.
If the AOR/SO chooses to Reject
the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted,
but it will be subject to the NIH late
policy guidelines and may not be accepted. The reason for this delay should
be explained in the cover letter attachment.
Both the AOR/SO and PD/PI
will receive e-mail notifications when the application is rejected or the
application automatically moves forward in the process after two days.
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 receives
the Grants.gov acknowledgments. The AOR 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.
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 (formerly competing continuation) award if such costs: are
necessary to conduct the project, and 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 the NIH Grants
Policy Statement.
6. Other Submission Requirements
PD/PI Credential (e.g., Agency
Login)
The NIH requires the PD/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:
Special 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 you are developing plans for the
study;
2) Obtain agreement from the IC staff that the IC will
accept your application for consideration for award; and,
3) Include the PHS398 Cover Letter component with the
application to identify the staff member and IC who agreed to accept assignment
of the application.
This
policy applies to all new applications, competing renewal (formerly competing
continuation) applications, resubmission (formerly revised/amended)
applications, and revision (formerly competing supplemental) applications.
See NOT-OD-02-004,
October 16, 2001.
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.
Indicate how the proposed project has specific relevance to
the mission and objectives of the IC and has the potential for significantly advancing
the health sciences in the United States.
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: Investigators seeking $500,000
or more in direct costs in any year 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 in which the development of model organisms is
anticipated are expectedto 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-designatedGWAS 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(NOT-OD-07-088) and http://grants.nih.gov/grants/gwas/.
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.
Applications that are complete will be evaluated for scientific and technical
merit by (an) appropriate scientific review group(s) in accordance with NIH
peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.
As part of the initial merit review, all applications
will:
Undergo a selection process in which only those
applications deemed to have the highest scientific merit, generally the
top half of applications under review, will be discussed and assigned an impact/priority score.
Receive a
written critique.
Receive a
second level of review by the appropriate national advisory council or
board.
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:
Scientific merit of the proposed project as determined
by peer review.
Availability of funds.
Relevance of program priorities.
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, weighting them 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 high 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
As applicable for the project
proposed, reviewers will consider the following additional items in the
determination of scientific and technical merit, but will not give separate
scores for these items.
Protections for Human Subjects. For
research that involves human subjects but does not involve one of the six
categories of research that are exempt under 45 CFR Part 46, the committee will
evaluate the justification for involvement of human subjects and the proposed
protections from research risk relating to their participation according to the
following five review criteria: 1) risk to subjects, 2) adequacy of protection
against risks, 3) potential benefits to the subjects and others, 4) importance
of the knowledge to be gained, and 5) data and safety monitoring for clinical
trials.
For research that involves human subjects and meets
the criteria for one or more of the six categories of research that are exempt
under 45 CFR Part 46, the committee will evaluate: 1) the justification for the
exemption, 2) human subjects involvement and characteristics, and 3) sources of
materials.
Inclusion of Women, Minorities, and Children.
When the proposed project involves clinical research, the committee will
evaluate the proposed plans for inclusion of minorities and members of both
genders, as well as the inclusion of children.
Vertebrate Animals. The committee
will evaluate the involvement of live vertebrate animals as part of the
scientific assessment according to the following five points: 1) proposed use of
the animals, and species, strains, ages, sex, and numbers to be used; 2)
justifications for the use of animals and for the appropriateness of the species
and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting
discomfort, distress, pain and injury to that which is unavoidable in the
conduct of scientifically sound research including the use of analgesic,
anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and
5) methods of euthanasia and reason for selection if not consistent with the
AVMA Guidelines on Euthanasia.
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.
Renewal Applications. When reviewing
a Renewal application (formerly called a competing continuation application),
the committee will consider the progress made in the last funding period.
Revision Applications. When
reviewing a Revision application (formerly called a competing supplement
application), the committee will consider the appropriateness of the proposed
expansion of the scope of the project. If the Revision application relates to a
specific line of investigation presented in the original application that was
not recommended for approval by the committee, then the committee will consider
whether the responses to comments from the previous scientific review group are
adequate and whether substantial changes are clearly evident.
Biohazards. Reviewers will assess
whether materials or procedures proposed are potentially hazardous to research
personnel and/or the environment, and if needed, determine whether adequate
protection is proposed.
Additional Review Considerations
As applicable for the
project proposed, reviewers will address each of the following items, but will
not give scores for these items and should not consider them in providing an
overall impact/priority score.
Budget and Period Support. Reviewers
will consider whether the budget and the requested period of support are fully
justified and reasonable in relation to the proposed research.
Select 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 (
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.
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
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, peer
review, and financial or grants management issues:
1. Scientific/Research Contact(s):
Christopher
Gordon, Ph.D.
Division of AIDS and Health
and Behavior Research National
Institute of Mental Health
6001 Executive Boulevard, Room 6212, MSC-9619
Bethesda, MD 20892-9619
Telephone: (301) 443-1613
FAX: (301) 443-9719
Email: cgordon1@mail.nih.gov
Susan
Newcomer, Ph.D.
Demographic and Behavioral Sciences Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B07G, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-6981
Email: newcomes@mail.nih.gov
Jeanette Hosseini, PhD
Program Director, Office of Extramural Activities
National Institute of Nursing Research, NIH
6701 Democracy Blvd., Suite 710
One Democracy Plaza
Bethesda, MD 20892-4870
Telephone: (301) 594-5972
Fax: 301-480-8260
Email: hosseinij@mail.nih.gov
2. Peer Review Contact(s):
Not Applicable
3. Financial/Grants Management
Contact(s):
Rita Sisco
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
FAX: (310) 443-6885
Email: siscor@mail.nih.gov
Kelli Oster
National Institute of Nursing Research
6701 Democracy Boulevard, Room 710, MSC 4870
Bethesda, MD 20892-4870
Telephone: (301) 594-2177
FAX: (301) 451-5651
Email: OsterK@mail.nih.gov
Cecilia E. Bruce
Grants Management Specialist
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17L, MSC 7510
Rockville, MD 20852-7510
Telephone: (301) 496-1304
FAX: (301) 480-4782
Email: brucec@mail.nih.gov
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 athttp://www.cfda.gov/ and is not
subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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/.
