May 29, 2009 - See Notice NOT-OD-09-104Error Correction Window Extended for Electronic Submission of NIH Opportunities with Due Dates Between May 20 and May 29, 2009.
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:PAR-06-521
Catalog of Federal Domestic Assistance
Number(s) 93.242, 93.393, 93.361, 93.173, 93.279, 93.837,
93.273, 93.121
Key Dates Release/Posted Date: August 10, 2006
Opening Date: August 10, 2006 (Earliest date an application may be submitted
to Grants.gov)
Letters of Intent Receipt Date(s): 08/22/2006,
04/24/2007, 12/28/2007, 08/25/2008, 04/22/2009 NOTE: On time submission requires that applications be successfully submitted
to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). Application Submission/Receipt Date(s): 09/22/2006,
05/24/2007, 01/24/2008, 09/24/2008, 05/22/2009
AIDS Application Submission/Receipt Date(s): 01/02/2007,
09/01/2007, 05/01/2008, 01/02/2009, 09/01/2009
Peer Review Date(s): 02/2007, 10/2007, 06/2008, 02/2009,
10/2009
Council Review Date(s): 05/2007, 1/2008, 09/2008,
05/2009, 01/2010
Earliest Anticipated Start Date: 07/2007, 04/2008,
12/2008, 07/2009, 04/2010
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: September 2, 2009
Due Dates for E.O. 12372 Not Applicable
Additional Overview Content
Executive Summary
This Funding Opportunity Announcement (FOA) encourages
investigators to submit research grant applications that will identify,
develop, and refine effective and efficient methods, structures, and strategies
that test models to disseminate and implement research-tested health behavior
change interventions and evidence-based prevention, early detection, diagnostic,
treatment, and quality of life improvement services into public health and
clinical practice settings.
This FOA will use the NIH Exploratory/Developmental
Research Grant Award (R21) mechanism and runs in parallel with an FOA of
identical scientific scope (PAR-06-520)
that will utilize the small research project grant (R03) mechanism.
Budget and Project Period: The total project period for an application
submitted in response to this funding opportunity may not exceed two years.
Direct costs are limited to $275,000 over an R21 two-year period.
Eligible Organizations: For-profit organizations; non-profit organizations;
public or private institutions, such as universities, colleges, hospitals,
and laboratories; units of State and local governments; eligible agencies
of the Federal government; domestic or foreign institutions/organizations;
faith-based or community-based organizations; Indian/Native American Tribal
Government (Federally Recognized); Indian/Native American Tribal Government
(Other than Federally Recognized); and Indian/Native American Tribally Designated
Organization.
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 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.
Applicants may submit more than one application, provided each application
is scientifically distinct.
See Section
IV.1 for application materials. The SF424 (R&R) Application Guide
for this FOA is located at these Web sites:
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
Section V. Application Review
Information 1. Criteria 2. Review and Selection Process A. Additional Review Criteria B. Additional Review Considerations
C. Sharing Research Data D. Sharing Research Resources 3. Anticipated Announcement and Award Dates
Each year, billions of U.S. tax dollars are spent
on research and hundreds of billions are spent on service delivery programs.
However, relatively little is spent on, or known about, how best to ensure
that the lessons learned from research inform and improve the quality of health
and human services and the availability and utilization of evidence-based
approaches. The National Institutes of Health have recognized that closing
the gap between research discovery and program delivery is both a complex
challenge and an absolute necessity if we are to ensure that all populations
benefit from the Nation’s investments in new scientific discoveries.
The National Institute of Mental
Health (NIMH), the National Cancer Institute (NCI), the National Institute
on Drug Abuse (NIDA), the National Institute on Deafness and Other Communication
Disorders (NIDCD), the Office of Behavioral and Social Science Research (OBSSR),
the National Institute of Nursing Research (NINR), the National Institute
on Alcohol Abuse and Alcoholism (NIAAA), the National Institute of Dental
and Craniofacial Research (NIDCR), and the Office of Dietary Supplements (ODS)
invite grant applications for research that will identify, develop, and refine
effective and efficient methods, structures, and strategies that test
models to disseminate and implement research-tested health behavior change
interventions and evidence-based prevention, early detection, diagnostic,
treatment, and quality of life improvement services into public health
and clinical practice settings. The purpose of this dissemination and implementation
research program announcement (FOA) is to support innovative approaches to
identifying, understanding, and overcoming barriers to the adoption of evidence-based
interventions that previous efficacy or effectiveness research has shown to
be effective, but where adoption to date has been limited or significantly
delayed.
Most researchers who propose to
develop and test disease control interventions either explicitly or implicitly
intend to promote efficacious interventions to the broader population from
which the efficacy study sample was drawn or the public health or clinical
practice settings in which the intervention was originally tested. Thus, for
many years, health researchers may have assumed that an intervention deemed
efficacious within clinical or community-based trials would be easily transmitted
to the field; evidence suggests that this has not been the case. Moreover,
little is known about effective approaches to overcome barriers to adoption
of evidence-based interventions.
Recent literature has underscored
the importance of understanding the many factors that affect whether the public
health or clinical practice communities will use a given intervention.
Invited research on dissemination will address how information about health
promotion and care interventions is packaged, transmitted, and interpreted
among a variety of important stakeholder groups. Research on implementation
will address the level to which health interventions can fit within real-world
public health and clinical service systems.
The goals of this FOA are to encourage
trans-disciplinary teams of scientists and practice stakeholders to work together
to develop and/or test conceptual models of dissemination and implementation
that may be applicable across diverse practice settings, and design studies
that will accurately assess the outcomes of dissemination and implementation
efforts.
Dissemination and implementation
research intends to bridge the gap between public health, clinical research,
and everyday practice by building a knowledge base about how health information,
interventions, and new clinical practices are transmitted and translated for
public health and health care service use in specific settings. Unfortunately,
there continues to be great variation in how these terms are used. Dissemination
and implementation have both been used to represent the complete process of
bringing "evidence" into practice, originally defined as "diffusion."
While using the terms dissemination and implementation to cover such a wide
area can be very helpful in facilitating discussion, it does not allow for
the division of this very complex diffusion process into smaller, more easily
addressed research questions that can develop a robust knowledge base.
We are inviting applications that will begin to break down the complexity
of bridging research and practice.
For the purpose of this FOA, we
make a distinction between "dissemination" and "implementation."
Dissemination is the targeted
distribution of information and intervention materials to a specific public
health or clinical practice audience. The intent is to spread knowledge
and the associated evidence-based interventions.
Implementation is the use of
strategies to adopt and integrate evidence-based health interventions and
change practice patterns within specific settings.
This distinction needs to be made
because interventions developed in the context of efficacy and effectiveness
trials are rarely transferable without adaptations to specific settings.
Therefore, research is needed to examine the process of transferring interventions
into local settings, settings that may be similar to but also somewhat different
from the ones in which the intervention was developed and tested.
Dissemination Research
We are currently missing critical
information about how, when, by whom, and under what circumstances research
evidence spreads throughout the agencies, organizations, and front line workers
providing public health and clinical services. As a necessary prerequisite
for unpacking how information can lead to treatment or service changes, we
need to understand how and why information on mental health, drug abuse, and
other disease treatments may or may not reach many different stakeholders.
We need to understand what underlies the creation, transmission, and reception
of information on evidence-based psychopharmacological, behavioral, and psychosocial
interventions. Successful dissemination of health information (including
information about underutilized interventions) may occur quite differently
depending on whether the audience consists of consumers, caregivers, practitioners,
policymakers, employers, administrators, or other stakeholder groups.
Moving the field forward will require studies identifying mechanisms and approaches
to package and convey the evidence-based information necessary to improve
public health and clinical care services.
Implementation Research
Previous efforts in dissemination
research have often assumed that interventions can be transferred into any
service setting without modification and that a unidirectional flow of information
(e.g., publishing a guideline) is sufficient to achieve practice change.
"Success" of the transfer has been largely assessed based on structural
measures (such as counts of personnel or contacts) or patient outcome measures
that do not specifically assess how the intervention was implemented or whether
the implementation remained faithful to the original conceptualization and
intent of the intervention. We need the field to develop a knowledge
base about "how" interventions are transported to real-world practice
settings, which is likely to require more than the dissemination of information
about the interventions. This research announcement encourages theory-driven
studies to test conceptual frameworks around the implementation process that
move away from an exclusively "top-down" approach to a greater emphasis
on the resources of local care settings and the needs of multiple stakeholders.
Dissemination and Implementation
research need to involve both interdisciplinary cooperation and trans-disciplinary
collaboration, utilizing theories, empirical findings, and methods from a
variety of fields not traditionally associated with health research.
Relevant fields include: information science, clinical decision-making,
organizational and management theory, finance, individual and systems-level
behavioral change, public health, business administration, statistics, anthropology,
learning theory, and marketing. Meaningful research will include collaboration
with stakeholders from multiple public health and/or clinical practice settings
as well as consumers of services and their families/social networks.
Research Issues: Listed below
are examples of topics supported by this program announcement for dissemination
and implementation research. The list is illustrative, not exhaustive.
It is expected that investigators responding to this PAR will identify other
important research areas.
Analysis of factors influencing
the creation, packaging, transmission and reception of valid health research
knowledge, 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 funding
sources.
Experimental studies to test the effectiveness of
individual and systemic dissemination strategies, focusing on outcomes related
to the direct outcomes of the strategies (e.g., acquisition of new knowledge,
maintenance of knowledge, attitudes about the dissemination strategies, use
of knowledge in practice decision-making).
Studies of systemic interventions to impact organizational
structure, climate, culture, and processes to enable dissemination and implementation
of clinical information and effective clinical interventions.
Studies of efforts to implement prevention, early
detection, and diagnostic interventions, as well as treatments or clinical
procedures of demonstrated efficacy into existing care systems to measure
the extent to which such procedures are utilized, and adhered to, by providers
and consumers.
Studies of the capacity of specific care delivery
settings (primary care, schools, community health settings, etc.) to incorporate
dissemination or implementation efforts within current organizational forms.
Studies that focus on the development and testing
of theoretical models for dissemination and implementation processes.
Studies on the fidelity of implementation efforts,
including the identification of components of implementation that will enable
fidelity to be assessed meaningfully.
Development of outcome measures and suitable methodologies
for dissemination and implementation approaches that accurately assess the
success of an approach to move evidence into practice (i.e., not just clinical
outcomes).
Longitudinal and
follow-up studies on the factors that contribute to the sustainability of
research-based improvements in public health and clinical practice.
Studies testing the utility of alternative dissemination
strategies for service delivery systems targeting rural, minority, and/or
other underserved populations.
Studies on how target audiences
are defined, and how evidence is packaged for specific target audiences.
This FOA will use the NIH Exploratory/Developmental
Research Grant (R21) award mechanism. As an applicant, you will be solely
responsible for planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. It also uses
the modular budget formats (see the Modular Applications and Awards
section of the NIH
Grants Policy Statement. Specifically, if you are submitting an application
with direct costs in each year of $250,000 or less (excluding consortium Facilities
and Administrative [F&A] costs), use the PHS398 Modular Budget component
provided in the SF424 (R&R) Application Package and SF424 (R&R) Application
Guide (see specifically Section 5.4, Modular Budget Component,
of the Application Guide).
Exploratory/developmental grant support is for new projects
only; competing renewal (formerly competing continuation ) applications
will not be accepted. Up to two resubmissions (formerly revisions/amendments")
of a previously reviewed exploratory/developmental grant application may be
submitted. See NOT-OD-03-041,
May 7, 2003.
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 and the submission of a sufficient
number of meritorious applications.
The total project period for an application submitted
in response to this funding opportunity may not exceed 2 years. Although the
size of award may vary with the scope of research proposed, it is expected
that applications will stay within the budgetary guidelines for an exploratory/developmental
project; direct costs are limited to $275,000 over an R21 two-year period,
with no more than $200,000 in direct costs allowed in any single year. Applicants
may request direct costs in $25,000 modules, up to the total direct costs
limitation of $275,000 for the combined two-year award period. 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.
F&A costs requested by consortium
participants are not included in the direct cost limitation. See
NOT-OD-05-004,
November 2, 2004.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an) application(s) if your organization
has any of the following characteristics:
For-profit organizations
Non-profit organizations
Public or private institutions, such as universities,
colleges, hospitals, and laboratories
Units of State government
Units of local government
Eligible agencies of the Federal government
Foreign Institutions
Domestic Institutions
Faith-based or community-based organizations
Indian/Native American Tribal Government (Federally Recognized)
Indian/Native American Tribal Government (Other than Federally Recognized)
Indian/Native American Tribally Designated Organizations
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary
to carry out the proposed research as the Project Director/Principal Investigator
(PD/PI) is invited to work with his/her organization to develop an application
for support. Individuals from underrepresented racial and ethnic groups as
well as individuals with disabilities are always encouraged to apply for NIH
support.
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/Apply/ 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 [email protected]
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 [email protected]
The individual designated as the PD/PI on the application must also be registered
in the NIH eRA Commons. It is not necessary for PDs/PIs to register with Grants.gov.
The PD/PI must hold a PD/PI account in the Commons and must be affiliated
with the applicant organization. This account cannot have any other role attached
to it other than the PD/PI.
This registration/affiliation must be done by the Authorized Organization
Representative/Signing Official (AOR/SO) or their designee who is already
registered in the Commons.
Both the PD/PI 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 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 (MS
Word or PDF).
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/PI’s assigned eRA Commons User ID). Agency-specific instructions
for such fields are clearly identified in the Application Guide. For additional
information, see Frequently Asked Questions Application Guide,
Electronic Submission
of Grant Applications.
The SF424 (R&R) application is comprised of data arranged
in separate components. Some components are required, others are optional.
The forms package associated with this FOA in Grants.gov/APPLYwill include all applicable
components, required and optional. A completed application in response to
this FOA will include 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 Modular Budget PHS398 Cover Page Supplement PHS398 Research Plan PHS398 Checklist
Optional Components:
PHS398 Cover Letter File Research & Related Subaward Budget Attachment(s)
Form
Note: While both budget components
are included in the SF424 (R&R) forms package, the NIH R21 uses ONLY the
PHS398 Modular Budget. (Do not use the detailed Research & Related Budget.)
Foreign Organizations
Several special provisions apply to applications submitted
by foreign organizations:
Charge back of customs and import fees is not allowed.
Format: Every effort should be made to comply with the format specifications,
which are based upon a standard U.S. paper size of 8.5 x 11
within each PDF.
Funds for up to 8% administrative costs (excluding equipment) may be requested.
See NOT-OD-01-028,
March 29, 2001.
Organizations must comply with Federal/NIH policies on human subjects, animals,
and biohazards.
Organizations must 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.
3.A. Submission, Review, and
Anticipated Start Dates
Opening Date: August 10, 2006 (Earliest date an application may be submitted
to Grants.gov)
Letters of Intent Receipt Date(s): 08/22/2006, 04/24/2007, 12/28/2007, 08/25/2008, 04/22/2009 Application Submission/Receipt Date(s): 09/22/2006,
05/24/2007, 01/24/2008, 09/24/2008, 05/22/2009 AIDS Application Submission/Receipt Date(s): 01/02/2007,
09/01/2007, 05/01/2008, 01/02/2009, 09/01/2009 Peer Review Date(s): 02/2007, 10/2007, 06/2008,
02/2009, 10/2009 Council Review Date(s): 05/2007, 1/2008,
09/2008, 05/2009, 01/2010 Earliest Anticipated Start Date(s): 07/2007,
04/2008, 12/2008, 07/2009, 04/2010
Prospective applicants are asked
to submit a letter of intent that includes the following information:
Descriptive title of proposed research.
Name, address, and telephone number of the PD/PI.
Names of other key personnel.
Participating institutions.
Number and title of this funding opportunity.
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.
David Chambers, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7133, MSC 9631
Bethesda, MD 20892-9631
Telephone: (301) 443-3747
FAX: (301) 443-3747
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/Apply
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 business days
to view the application image.
If everything is acceptable, no further action is
necessary. The application will automatically move forward for processing
by the Division of Receipt and Referral, Center for Scientific Review, NIH,
after two business days.
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 the AOR/SO determines that warnings should be addressed. Reminder: warnings
do not stop further application processing. If an application submission results
in warnings (but no errors) it will automatically move forward after two business
days if no action is taken. Please remember that some warnings may not
be applicable or may need to be addressed after application submission.
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 didn t 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. Information related to the assignment
of an application to a Scientific Review Group is also 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. This does not preclude the submission of an application
already reviewed with substantial changes, but such application must include
an Introduction addressing the previous critique. Note such
an application is considered a "resubmission" for the SF424 (R&R).
All NIH awards are subject to the
terms and conditions, cost principles, and other considerations described
in the NIH Grants Policy
Statement.
Pre-Award Costs are allowable. A grantee may, at its
own risk and without NIH prior approval, incur obligations and expenditures
to cover costs up to 90 days before the beginning date of the initial budget
period of a new award if such costs: 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 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
The NIH requires the PD/PI 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.
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 Registration
FAQs Important Tips -- Electronic Submission
of Grant Applications.
Renewal (formerly competing continuation
or Type 2 ) applications are not permitted.
All application instructions outlined in the SF424
(R&R) Application Guide (MS
Word or PDF) are to be followed, with the following requirements
for R21 applications:
R21 applications will use the
modular budget format and "Just-in-Time" information concepts,
with direct costs requested in $25,000 modules, up to the total direct costs
limitation of $275,000 over an R21 two-year period. No more than $200,000
in direct costs will be allowed in any single year.
Items 2-5 of the Research Plan component of the
R21 application may not exceed 15 pages, including tables, graphs, figures,
diagrams, and charts.
Introduction (required for a resubmission application)
is limited to one page.
Preliminary data are not required but may be included
if available.
R21 Appendix materials should be limited, as is
consistent with the exploratory nature of the R21 mechanism. The following
materials may be included in the Appendix.
Up to five publications, manuscripts (accepted for publication),
abstracts, patents, or other printed materials directly relevant to this project.
Do not include manuscripts submitted for publication.
Publications in press: Include only a publication list
with a link to the publicly available on-line journal article or the NIH
PubMed Central (PMC) submission identification number. Do not include
the entire article.
Manuscripts accepted for publication but not yet published: The
entire article may be submitted electronically as a PDF attachment.
Manuscripts published but a publicly available online journal link
is not available: The entire article may be submitted electronically
as a PDF attachment.
Surveys, questionnaires, data collection instruments,
clinical protocols, and informed consent documents.
Graphic images of gels, micrographs, etc. provided
that the image (may be reduced in size) is also included within the 15-page
limit of Items 2-5 of the Research Plan component. No images may be
included in the Appendix that are not also represented within the Research
Plan.
Do not use the Appendix to circumvent the page limitations
of the Research Plan component. An application that does not observe these
limitations may be delayed in the review process.
Note: While each section of the
Research Plan component needs to be uploaded separately as a PDF attachment,
applicants are encouraged to construct the Research Plan component as a single
document, separating sections into distinct PDF attachments just before uploading
the files. This approach will enable applicants to better monitor formatting
requirements such as page limits. All attachments must be provided to NIH
in PDF format, filenames must be included with no spaces or special characters,
and a .pdf extension must be used.
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary,
depending on the data being collected and how the investigator is planning
to share the data. Applicants who are planning to share data may wish to describe
briefly the expected schedule for data sharing, the format of the final dataset,
the documentation to be provided, whether or not any analytic tools also will
be provided, whether or not a data-sharing agreement will be required and,
if so, a brief description of such an agreement (including the criteria for
deciding who can receive the data and whether or not any conditions will be
placed on their use), and the mode of data sharing (e.g., under their own
auspices by mailing a disk or posting data on their institutional or personal
website, through a data archive or enclave). Investigators choosing to share
under their own auspices may wish to enter into a data-sharing agreement.
References to data sharing may also be appropriate in other sections of the
application.
Sharing Research Resources
NIH policy requires that grant awardee recipients make
unique research resources readily available for research purposes to qualified
individuals within the scientific community after publication (NIH Grants
Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm
and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan
for sharing research resources addressing how unique research resources will
be shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any related data sharing plans
will be considered by Program staff of the funding organization when making
recommendations about funding applications. The effectiveness of the resource
sharing will be evaluated as part of the administrative review of each non-competing
Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3. Reporting.
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 to the ICs on the basis of established Public Health Service (PHS)
referral guidelines.
Appropriate scientific review groups convened in accordance with the standard
NIH peer review procedures (http://www.csr.nih.gov/refrev.htm)
will evaluate applications for scientific and technical merit.
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 a 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 NIH R21 exploratory/developmental grant is a mechanism
for supporting novel scientific ideas or new model systems, tools, or technologies
that have the potential to significantly advance our knowledge or the status
of health-related research. Because the Research Plan component is limited
to 15 pages, an exploratory/developmental grant application need not have
extensive background material or preliminary information as one might normally
expect in an R01 application. Accordingly, reviewers will focus their
evaluation on the conceptual framework, the level of innovation, and the potential
to significantly advance our knowledge or understanding. Reviewers will
place less emphasis on methodological details and certain indicators traditionally
used in evaluating the scientific merit of R01 applications, including supportive
preliminary data. Appropriate justification for the proposed work can be provided
through literature citations, data from other sources, or, when available,
from investigator-generated data. Preliminary data are not required
for R21 applications; however, they may be included if available.
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.
Significance: Does this study address
an important problem? If the aims of the application are achieved, how will
scientific knowledge, public health or clinical practice be advanced? What
will be the effect of these studies on the concepts, methods, technologies,
treatments, services, or preventative interventions that drive this field?
Do the intervention efficacy data justify dissemination and implementation?
If the aims of the proposed project are achieved, how will dissemination and
implementation knowledge be advanced? What will be the effect on the concepts
or methods that drive this field? Will the study have a clear positive
impact on public health, community, or clinical contexts? How broad a reach
(to the population that will benefit from the knowledge/intervention) will
be achieved by the dissemination and implementation of the intervention through
the knowledge/service delivery contexts selected?
Approach: Are the conceptual or clinical
framework, design, methods, and analyses adequately developed, well integrated,
well reasoned, and appropriate to the aims of the project? Does the applicant
acknowledge potential problem areas and consider alternative tactics?
Has the applicant made appropriate changes in the intervention design based
on the current state-of-the-art and or contextual factors relevant to dissemination
and/or implementation? (See Section I for links)
Does the applicant demonstrate an understanding of dissemination and implementation
research principles? Is the dissemination or implementation approach appropriate
to the problem and population? Are the procedures to assess the dissemination
or implementation program appropriate? Is the evaluation plan linked to the
dissemination or implementation plan and does the evaluation incorporate the
best available data to track dissemination or implementation process and impact?
How appropriate are the plans to sustain effective dissemination and implementation
approaches once the research-funding period has ended?
Innovation: Is the project original and
innovative? For example: Does the project challenge existing paradigms, public
health or clinical practice; address an innovative hypothesis or critical
barrier to progress in the field? Does the project develop or employ novel
concepts, approaches, methodologies, tools, or technologies for this area?
Does the proposed dissemination or implementation research contribute new
and innovative design approaches to the study of dissemination or implementation
process and/or outcomes?
Investigators: Are the investigators appropriately
trained and well suited to carry out this work? Is the work proposed appropriate
to the experience level of the principal investigator and other researchers?
Does the investigative team bring complementary and integrated expertise to
the project (if applicable)? Does the investigator team include specific dissemination
and implementation expertise? Relevant letters of support from key partner
dissemination and implementation organizations, which plan to adopt the intervention,
are expected.
Environment: Does the scientific environment
in which the work will be done contribute to the probability of success? Do
the proposed studies benefit from unique features of the scientific environment,
or subject populations, or employ useful collaborative arrangements? Is there
evidence of institutional support? Do the proposed approaches take advantage
of unique features of the intervention delivery environment or employ useful,
collaborative arrangements? Is there evidence of institutional support to
sustain dissemination or implementation interventions once the research funding
ends?
2.A. Additional Review Criteria:
In addition to the above criteria, the following items will continue to be
considered in the determination of scientific merit and the priority score:
Protection of Human Subjects from Research Risk:The
involvement of human subjects and protections from research risk relating
to their participation in the proposed research will be assessed. See item
6 of the Research Plan component of the SF424 (R&R).
Inclusion of Women, Minorities and Children in Research: The
adequacy of plans to include subjects from both genders, all racial and ethnic
groups (and subgroups), and children as appropriate for the scientific goals
of the research will be assessed. Plans for the recruitment and retention
of subjects will also be evaluated. See item 7 of the Research Plan component
of the SF424 (R&R).
Biohazards: If materials or procedures are proposed that
are potentially hazardous to research personnel and/or the environment, determine
if the proposed protection is adequate.
2.B. Additional Review Considerations
Budget and Period of Support: The reasonableness of the proposed budget
and the appropriateness of the requested period of support in relation to
the proposed research may be assessed by the reviewers. Is the number of person
months listed for the effort of the PD/PI appropriate for the work proposed?
Is each budget category realistic and justified in terms of the aims and methods?
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the data
sharing plan or the rationale for not sharing research data may be assessed
by the reviewers. However, reviewers will not factor the proposed data sharing
plan into the determination of scientific merit or the priority score. The
funding organization will be responsible for monitoring the data sharing policy.
http://grants.nih.gov/grants/policy/data_sharing.
2.D. Sharing Research Resources
NIH policy requires that grant awardee recipients make
unique research resources readily available for research purposes to qualified
individuals within the scientific community after publication (See the NIH
Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr
and http://www.ott.nih.gov/policy/rt_guide_final.html).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be responsible for the administrative review of the plan
for sharing research resources.
The adequacy of the resources sharing plan will be considered by Program staff
of the funding organization when making recommendations about funding applications.
Program staff may negotiate modifications of the data and resource sharing
plans with the awardee before recommending funding of an application. The
final version of the data and resource sharing plans negotiated by both will
become a condition of the award of the grant. The effectiveness of the resource
sharing will be evaluated as part of the administrative review of each non-competing
Grant Progress Report (PHS 2590). See Section VI.3.
Reporting.
Model Organism Sharing Plan: Reviewersare asked to assess
the sharing plan in an administrative note. The sharing plan itself should
be discussed after the application is scored. Whether a sharing plan is reasonable
can be determined by the reviewers on a case-by-case basis, taking into consideration
the organism, the timeline, the applicant's decision to distribute the resource
or deposit it in a repository, and other relevant considerations. For the
R21 mechanism, the presence or adequacy of a plan should not enter into the
scoring of the application.
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/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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
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 Also 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 Contacts:
David A. Chambers, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
Neuroscience Center, Room 7133 MSC-9631
Bethesda, MD 20892-9631
Telephone: (301) 443-3747
FAX: (301) 443-4045
Email: [email protected]
Chris Gordon, Ph.D.
Division of AIDS and Health and Behavior Research
National Institute of Mental Health
Neuroscience Center, Room 6199 MSC-9619
Bethesda, MD 20892-9619
Telephone: (301) 443-1613
FAX: (301) 443-9719
Email: [email protected]
Jon F. Kerner, Ph.D.
Division of Cancer Control & Population Sciences
National Cancer Institute
EPN 6144
6130 Executive Blvd.
Bethesda, MD 20892
Telephone: (301) 594-7294
FAX: (301) 443-4505
Email: [email protected]
Redonna K. Chandler, Ph.D.
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse
6001 Executive Blvd.
Room 5177, MSC 9589
Bethesda, MD 20892-9589
Rockville, MD 20852 (for express/courier service)
Phone: (301) 443-6504
Fax: (301) 443-6815
E-mail: [email protected]
Amy Donahue, Ph.D.
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400C-10
Bethesda, MD 20892
Telephone: (301) 402-3458
Fax: (301) 402-6251
Email: [email protected]
Susan D. Solomon, Ph.D.
Senior Advisor
Office of Behavioral and Social Sciences Research
National Institutes of Health, Office of the Director
Building One, Room 256
One Center Drive
Bethesda, MD 20892-0183
Telephone: (301) 496-0979
Fax: (301) 402-1150
E-mail: [email protected]
Martha L. Hare, Ph.D., R.N
Program Director
National Institute of Nursing Research
6701 Democracy Boulevard
One Democracy Plaza, Room 710
Bethesda, MD 20892-4870 Courier: 20817
Telephone: (301) 451-3874
Fax: (301) 480-8260
Email: [email protected]
Peter J. Delany, Ph.D.
Program Director for Health Services Research
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2039
Bethesda, MD 20892-9304
Telephone: (301) 443-0788
Fax: (301) 443-8774
Email: [email protected]
Ruth Nowjack-Raymer, MPH, PhD
Director, Health Disparities Research Program
Center for Clinical Research
National Institute of Dental and Craniofacial Research
Building 45, Room 4AS-43F
Bethesda, Maryland 20892-6401
Telephone: (301) 594-5394
FAX: (301) 480-8322
Email: [email protected]
Elizabeth A. Yetley, Ph.D.
Senior Nutrition Research Scientist
Office of Dietary Supplements
National Institutes of Health
6100 Executive Boulevard, Suite 3B01
Bethesda MD 20892-7517
Telephone: (301) 496-0217
Fax: (301) 480-1845
Email: [email protected]
2. Peer Review Contacts:
Steven H. Krosnick, M.D.
SRA, Health of the Population (HOP) Integrated Review Group
Center for Scientific Review (CSR), NIH
6701 Rockledge Drive, Room 3028A, MSC 7770
Bethesda, MD 20892 (20817 for overnight mail)
301-435-1712
301-480-1056 (fax)
Email: [email protected]
3. Financial or Grants Management
Contacts:
Joy R. Knipple
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6131 MSC 9605
Bethesda, MD 20892-9605
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-8811
FAX: (301) 443-6885
Email: [email protected]
Crystal Wolfrey
Division of Extramural Activities
National Cancer Institute
6120 Executive Boulevard, Room 243
Bethesda, MD, 20892
Telephone: (301) 496-8634
FAX: (301) 496-8601
Email: [email protected]
Gary Fleming, J.D., M.A.
Office of Planning and Resource Management
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131 MSC 9541
Bethesda, MD 20892-9541
Phone: 301-443-6710
Fax: 301-594-6847
E-mail: [email protected]
Christopher Myers
Grants Management Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400B
Bethesda, MD 20892
Phone: 301 435 0713
Fax: 301 402 1758
Email: [email protected]
Brian Albertini
Chief, Office of Grants and Contracts Management
National Institute of Nursing Research
6701 Democracy Blvd, Room 710
Bethesda, MD 20892-4870 (Courier use 20817)
Telephone: (301) 594-6869
Fax: (301) 402-4502
Email: [email protected]
Judy S. Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3021
Bethesda, MD 20892-9304
Telephone: (301) 443-4704
FAX: 301-443-3891
Email: [email protected]
Mary E. Daley
National Institute of Dental and Craniofacial Research
45 Center Dr MSC 6402
Bethesda, MD 20892-6402
Phone: 301-594-4800
Fax: 301-480-8303
E-mail: [email protected]
Section
VIII. Other Information
Required Federal Citations
Human Subjects Protection:
Federal regulations (45CFR46) 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 IRB rules, as well as local, State and
Federal laws and regulations, including the Privacy Rule. Reviewers will consider
the data sharing plan but will not factor the plan into the determination
of the scientific merit or the priority score.
Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised
to provide access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a project
that is supported in whole or in part with Federal funds and (2) cited publicly
and officially by a Federal agency in support of an action that has the force
and effect of law (i.e., a regulation) may be accessed through FOIA. It is
important for applicants to understand the basic scope of this amendment.
NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity
in a public archive, which can provide protections for the data and manage
the distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design and
include information about this in the budget justification section of the
application. In addition, applicants should think about how to structure informed
consent statements and other human subjects procedures given the potential
for wider use of data collected under this award.
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and
their sub-populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided indicating
that inclusion is inappropriate with respect to the health of the subjects
or the purpose of the research. This policy results from the NIH Revitalization
Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing
clinical research should read the "NIH Guidelines for Inclusion of Women
and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new
OMB standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; 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.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission
(NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole
or in part with direct costs from NIH. The author's final manuscript is defined
as the final version accepted for journal publication, and includes all modifications
from the publishing peer review process.
NIH is requesting that authors submit manuscripts resulting from 1) currently
funded NIH research projects or 2) previously supported NIH research projects
if they are accepted for publication on or after May 2, 2005. The NIH Public
Access Policy applies to all research grant and career development award mechanisms,
cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein
National Research Service Awards, as well as NIH intramural research studies.
The Policy applies to peer-reviewed, original research publications that have
been supported in whole or in part with direct costs from NIH, but it does
not apply to book chapters, editorials, reviews, or conference proceedings.
Publications resulting from non-NIH-supported research projects should not
be submitted.
Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) 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 DHHS 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) must be used for publicly
accessible on-line journal articles. Unless otherwise specified in this
solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution reviewers
that their anonymity may be compromised when they directly access an Internet
site.
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 PA 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 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 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 NIH Grants Policy Statement can be
found at http://grants.nih.gov/grants/policy/policy.htm.
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.
