and Human Services (HHS)
EXPIRED
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/)
National Cancer Institute (NCI), (http://cancer.gov/)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD), (https://www.nidcd.nih.gov/)
Office of Behavioral and Social Science Research (OBSSR), (http://obssr.od.nih.gov/)
National Institute of Nursing Research (NINR), (http://ninr.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov/)
Office of Dietary Supplements (ODS), (http://dietary-supplements.info.nih.gov/)
Announcement Type
This is a reissue
of PAR-06-071, which was
previously released November 14, 2005.
Update: The following update relating to this announcement has been issued:
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-06-520
Catalog of Federal Domestic Assistance Number(s)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, 4/22/2009
NOTE: On time submission
requires that applications be successfully submitted to Grants.gov no later
than 5:00pm 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(s): 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
Table of Contents
Part
I Overview Information
Part
II Full Text of Announcement
Section
I. Funding Opportunity Description
1. Research Objectives
Section
II. Award Information
1. Mechanism of Support
2. Funds Available
Section
III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section
IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
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
Section
VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section
VII.Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section
VIII. Other Information - Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
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.
This FOA addresses priorities laid out in a number of reports including: The Road Ahead: A Report by the National Advisory Mental Health Council's Services Research and Clinical Epidemiology Workgroup (http://www.nimh.nih.gov/council/TheRoadAhead.pdf); Translating Behavioral Science into Action: A Report of the National Advisory Mental Health Council's Behavioral Science Workgroup (http://www.nimh.nih.gov/publicat/nimhtranslating.pdf); Designing for Dissemination Conference Summary Report (http://cancercontrol.cancer.gov/d4d/info.html#conferences); Diffusion and Dissemination of Evidence-based Cancer Control Interventions (http://www.ahcpr.gov/clinic/epcsums/canconsum.htm); National Institute on Drug Abuse Blue Ribbon Task Force Report on Services Research (http://www.drugabuse.gov/about/organization/nacda/HSRReport.pdf).
For additional resources on dissemination research please visit http://cancercontrol.cancer.gov/d4d.
For additional information on dissemination and implementation research in blood diseases, http://www.nhlbi.nih.gov/resources/docs/index.htm#blood, and for the reports on sickle cell disease, http://www.nhlbi.nih.gov/meetings/scdmtg/execsum.htm and http://www.nhlbi.nih.gov/meetings/workshops/conscd.htm, may be useful.
RESEARCH OBJECTIVES
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."
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 needs 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 FOA will identify other important research areas.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1.
Mechanism(s) of Support
This Funding Opportunity Announcement (FOA) will use the NIH Small Research
Grant (R03) 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.
All applications submitted in response to this FOA must use the modular budget
format. 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).
Competing renewal (formerly competing continuation ) applications will not be accepted for the R03 grant mechanism. Small grant support may not be used for thesis or dissertation research. Up to two resubmissions (formerly revisions/amendments") of a previously reviewed small grant application may be submitted. See NOT-OD-05-046, April 29, 2005.
For specific information
about the R03 programs, see: http://grants.nih.gov/grants/funding/r03.htm.
2. Funds Available
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
A project period of up to two years and a budget for direct costs of up to two $25,000 modules, or $50,000 per year, may be requested (i.e., a maximum of $100,000 over two years in four modules of $25,000 each). Commensurate Facilities and Administrative (F&A) costs are allowed.
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:
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.
2. Cost Sharing or Matching
This program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special
Eligibility Criteria
Applicants may submit more
than one application, provided each application is scientifically distinct.
Section IV. Application and Submission Information
To download an 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:
Grants.gov (http://www.grants.gov/GetStarted) and
PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
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]
2) Organizational/Institutional Registration in the eRA Commons
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]
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
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 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/APPLY will 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 R03 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:
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. Submission Dates and Times
See Section IV.3.A for details.
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
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although
a letter of intent is not required, is not binding, and does not enter into the
review of a subsequent application, the information that it contains allows IC
staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning of this
document.
The letter of intent should be sent to:
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.
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).
4.
Intergovernmental Review
This initiative
is not subject to intergovernmental
review.
5.
Funding Restrictions
All NIH awards are subject to
the terms and conditions, cost principles, and other considerations described
in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH
prior approval, incur obligations and expenditures to cover costs up to 90 days
before the beginning date of the initial budget period of a new or competing
renewal award if such costs: 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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
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 R03 applications:
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
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The NIH R03 small grant is a mechanism for supporting discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the Research Plan component is restricted to 10 pages, a small grant application will not have the same level of detail or extensive discussion found in an R01 application. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem, placing 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 from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.
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 priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
Significance: Does
this study address an important problem? If the aims of the application are
achieved, how will 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: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research. The priority score
should not be affected by the evaluation of the budget.
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.
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.
A formal notification in the form of a Notice
of Award (NoA) will be provided to the applicant organization. The NoA
signed by the grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the grantee business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Section IV.5.,
Funding Restrictions. .
2. Administrative and National
Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms
of award, see the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General and Part
II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions
for Specific Types of Grants, Grantees, and Activities.
3. Reporting
When multiple years are involved, awardees will be
required to submit the Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required in
the NIH
Grants Policy Statement.
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
One Center Drive, Room 256, MSC 0183
Bethesda, MD 20892-0183
Telephone: (301) 496-0979
Fax: (301) 402-1150
Email: [email protected]
Martha
L. Hare, Ph.D., R.N
Program Director
National Institute of Nursing Research
6701 Democracy Boulevard, Room 710, MSC 4870
Bethesda, MD 20892-4870
Bethesda, MD 20817 (for express/courier service)
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, MSC 9304
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
6701 Rockledge Drive, Room 3028A, MSC 7770
Bethesda, MD 20892
Bethesda, MD 20817 (for overnight mail)
Telephone: (301) 435-1712
FAX: (301) 480-1056
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
Telephone: (301) 443-6710
Fax: (301) 594-6847
Email: [email protected]
Christopher Myers
Grants Management Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400B
Bethesda, MD 20892
Telephone: (301) 435-0713
Fax: (301) 402-1758
Email: [email protected]
Brian
Albertini
Office of Grants and Contracts Management
National Institute of Nursing Research
6701 Democracy Boulevard, Room 710, MSC 4870
Bethesda, MD 20892-4870
Bethesda, MD 20817 (for express/courier service)
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
Telephone: (301) 594-4800
Fax: (301) 480-8303
Email: [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.
For more information about the Policy or the submission process please visit
the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).
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/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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