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 on Drug Abuse (NIDA), (http://www.nida.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov)
Title: Health Services Research on the Prevention and Treatment of Drug and Alcohol Abuse (R21)
Announcement Type
This is a reissue of PA-05-139,
which was previously released July 14, 2005, and is now divided into separate
Funding Opportunity Announcements (FOAs) for the R21, R03, and R01 grant mechanisms.
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this 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.
Two steps are required for on time submission:
1) The application must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the submission/receipt date (see Key Dates below).
2) Applicants must complete a verification step in the eRA Commons within two business days of notification from NIH. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the Commons.
Program Announcement (PA) Number:
PA-06-307
Catalog of Federal Domestic Assistance Number(s)
93.279, 93.273
Key Dates
Release/Posted Date: March 31, 2006
Opening Date: May 2, 2006 (Earliest date an application may be submitted
to Grants.gov
Letters of Intent Receipt Date(s): Not Applicable
Application Submission/Receipt
Date(s): Standard dates apply, please
see http://grants1.nih.gov/grants/funding/submissionschedule.htm.
AIDS Application Submission/Receipt Date(s):
Please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s):
Please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review Date(s): Please
see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest Anticipated Start Date(s): See http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Additional Information To Be Available Date (URL Activation
Date): Not Applicable
Expiration Date: September 2, 2008 (now September 8, 2008 per NOT-OD-07-093)
Due Dates for E.O. 12372
Not Applicable.
Additional Overview Content
Executive Summary
This Funding Opportunity Announcement (FOA) solicits health services research
on the prevention and treatment of drug and alcohol abuse. Proposed research
might emphasize any of the following subjects: (1) Factors that affect the
delivery of drug and alcohol abuse intervention and related services, such
as social factors, personal behaviors and attributes, financing, organization,
management, and health technologies; (2) Dimensions of drug and alcohol abuse
intervention and related services, such as accessibility, utilization, quality,
effectiveness, and costs; (3) Processes of blending science-based practices
into community-based provision of drug and alcohol abuse prevention services;
and (4) Research tools to facilitate higher quality health services research
on drug and alcohol abuse.
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. Sending an Application 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
Purpose
The goals of the health services research programs at both the National Institute on Drug Abuse (NIDA) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA) are to answer questions central to the delivery of prevention and treatment services for all substances of abuse: What works? Under what circumstances? For which conditions? and, At what cost? These questions may be studied from multiple perspectives, including those of the individual drug user or drinker; the individual's family, friends, and employer; the treatment provider and the provider's organization; of other organizations affected by problems of drug and alcohol abuse (e.g., criminal justice, social service, public health); and of purchasers of drug and alcohol abuse prevention and treatment services.
In past decades, health services research sought to improve health outcomes by improving overall care and individual components of care. More recently, researchers have begun to focus on understanding outcomes in the context of a system of care that interacts over time with those who have drug and/or alcohol problems, and that also interacts with other health and social systems in ways that affect the long-term health of individuals with, or at risk for developing, drug and/or alcohol use disorders. An important aspect of both NIDA's and NIAAA's health services research programs is to improve the transfer and adoption of science-based prevention and treatment practices into healthcare and social service settings. A cross-disciplinary research approach may be required to understand how social factors, personal behaviors and attributes, financing systems, organizational structures and processes, management practices, and health technologies affect the accessibility, utilization, quality, effectiveness, and cost of drug and/or alcohol abuse prevention and treatment, particularly when the disorder is a chronic or persistent condition.
Research Objectives
NIDA and NIAAA seek to stimulate research that will improve the accessibility, utilization, quality, effectiveness, and costs of prevention and treatment of drug use disorders and/or alcohol-related problems, and ultimately to reduce the consequences of drug and/or alcohol use and co-occurring medical, psychiatric, and behavioral problems. Equally important is production of new knowledge to help blend evidence-based drug and/or alcohol abuse prevention and treatment strategies into community practice (also known as Type II translational or implementation research). To that end, this PA encourages investigators to design research that will advance the delivery of drug and/or alcohol abuse care so that science-based prevention and treatment services are adopted in diverse settings, effectively implemented by a range of providers, and produce sustainable effects at reasonable cost for all those who need intervention. NIDA and NIAAA also encourage investigators to develop new study designs, measurement instruments, and data analytic methods that will facilitate a new generation of health services research.
Investigators should use the most rigorous research designs and data analytic procedures possible, given the purposes of their research. Proposed research should be hypothesis driven and theory-based. In designing research, investigators, should be fully aware of the complex social and psychological processes that lead to drug or alcohol use initiation, progression, and escalation to abuse. Investigators should also be aware of other important service delivery considerations, including developmental appropriateness for clients of different ages; gender sensitivity; cultural relevance; health disparities; co-occurring mental, social, and medical conditions; and links between drug and/or alcohol abuse and sexually transmitted and other infectious diseases. NIDA and NIAAA are especially interested in health services research that builds on the investments of other entities that address drug abuse, including but not limited to NIDA's Clinical Trials Network (CTN), NIDA's Criminal Justice Drug Abuse Treatment Studies (CJ-DATS), the Substance Abuse and Mental Health Services Administration (SAMHSA), state agencies, and private foundations. NIDA and NIAAA also welcome research proposals to conduct analysis or meta-analysis of existing data sets, or of diverse data sets that can be integrated to generate new knowledge. NIDA and NIAAA encourage timely reporting of findings, facilitation of practitioner access to and use of findings, and braiding of research questions with the information needs of service providers through collaborative partnerships.
Background
A report issued by the Blue Ribbon Task Force on Health Services Research at NIDA describes the current state of health services research at NIDA and offers recommendations for boosting the relevance and use of drug abuse research in practice and policy (See full report at http://www.drugabuse.gov/about/organization/nacda/HSRReport.pdf). The Task Force prefaced their recommendations with acknowledgement of several unique policy, financing, and service delivery aspects of the drug abuse field that influence the nature of intervention services and the adoption (or not) of science-based interventions in real-world settings. Among these unique aspects are the following:
The Task Force noted that safe and efficacious interventions are available to help prevent and reduce drug use and related criminal activity, interpersonal problems, and other risky behaviors, and also to help improve school, social, and job functioning. Yet, few communities provide sufficient intervention services to meet local needs, and improvements in prevention and treatment services in non-research settings have been limited. Moreover, investigator-initiated research rarely has examined or refined interventions that are widely practiced and relevant to clinicians.
To address these gaps, research is needed to examine the healthcare services, service delivery systems, technology transfer processes, and policies that affect provision of effective substance abuse prevention and treatment in real world settings (e.g., community clinics, primary care clinics, hospitals, prisons, schools, social service agencies, faith-based organizations). Findings from such research should have practical implications for the range of individuals and groups affected by or at risk for substance use problems, including individuals and their families, clinicians, healthcare administrators, policymakers, purchasers, and insurers.
Research Areas of Interest
Appropriate and fundable research under this PA falls into the following four related and overlapping areas:
Examples given below further clarify these four areas. These examples are illustrative, not exhaustive, and topics not mentioned should not be considered excluded under this PA.
Factors that Influence Service Delivery
Social Factors and Personal Behaviors and Attributes. Research on the personal and social factors that can affect accessibility, utilization, quality, effectiveness, and costs of drug and/or alcohol abuse prevention and treatment services largely is concerned with underserved populations. These populations are defined by many dimensions, including age; gender; sexual orientation; race/ethnicity; socioeconomic status; geographic location of residence; presence of co-occurring medical, psychiatric, or behavioral conditions; and participation in criminal activity; among others. Prevention and treatment services may need to be tailored for specific populations in order to address their unique needs, but little is known about how to assess client needs and target services based on these various factors. NIDA and NIAAA are especially interested in research on health disparities associated with these and other factors, including studies of service distribution and the concept of health equity. Areas of research interest include the following:
Financing. Research on financing drug and/or alcohol abuse prevention and treatment examines health insurance and/or payment mechanisms, alternative delivery systems and managed care, alternative payment systems, public and private financing systems, and the design of insurance. For those interested in doing finance studies, a separate funding opportunity is available at PA-05-111, Economics of Prevention and Treatment Services for Drug and Alcohol Abuse, released May 18, 2005.
Organization. Organizational research is concerned with examining structural (e.g., size, shape, charter, staffing) and environmental (e.g., climate, culture) factors that can affect service efficiency and effectiveness. NIDA and NIAAA are particularly interested in organizational change processes associated with improvements in therapeutic and business practices. On a micro level, research is needed to improve the environment in which care is delivered, from the perspective of both client and provider. On a macro level, research is needed on how provider organizations structure and coordinate prevention and treatment services, and on how they interact with other health, psychiatric, and social service delivery agencies to meet the needs of at-risk or substance using populations. Given the chronic relapsing nature of drug and alcohol dependence for many individuals, organizational research should incorporate such issues as continuity of care, availability and quality of services, service utilization patterns, and their relationship to overall health outcomes. Areas of research interest include the following:
Management. Management research is concerned with improving the effectiveness and efficiency of work practices, including practices related to delivering therapeutic services (e.g., medications, individual/group counseling) and to conducting the day-to-day business operations that sustain services (e.g., client screening; case management; quality control; staff recruitment, training, supervision, and retention). The synergy between business and therapeutic practices has received little attention in health services research on drug and/or alcohol abuse prevention and treatment. Areas of research interest include the following:
Health Technologies. Research on health technologies involves studies to understand how the introduction and implementation of new business and intervention technologies affect accessibility, utilization, quality, effectiveness, and costs of drug and/or alcohol abuse prevention and treatment services in all community care settings. For example, new health technologies may have direct and indirect effects on client identification and diagnosis, service delivery, data collection, information sharing, and management of substance abuse and related medical conditions (e.g. brain imaging, saliva testing for HIV, web-based service delivery, multi-agency management information systems). Areas of research interest include the following:
Dimensions of Drug and Alcohol Abuse Prevention and Treatment Services
Accessibility and Utilization. Research on the accessibility and utilization of prevention and treatment services deals with demand and availability of services and the factors that facilitate or hinder service access and use. A focus on health disparities is warranted because of the difficulty special populations often have in accessing and using drug abuse prevention or treatment services. Areas of research interest include the following:
Quality. Research on the quality of drug and alcohol abuse prevention and treatment services is concerned with optimizing the content, intensity, pace, modality, and timing of prevention and treatment interventions in order to maximize effectiveness. Once these optimal characteristics are identified and defined, standards of care and performance indicators can be established to guide providers in delivering high-quality services, help users select high-quality services, and assist funders and policymakers in monitoring service quality. Areas of research interest include the following:
Effectiveness. New research on the effectiveness of drug and/or alcohol abuse prevention and treatment services should extend beyond the question of whether services and service systems work in real-world settings to uncover how and why they work, for which individuals, under what circumstances, and at what cost? Areas of research interest include the following:
Costs. Economic research informs decisions related to the allocation of resources and the improvement of service efficiency and equity. Studies are sought on the economics of drug and/or alcohol abuse services for prevention and treatment, especially for research on alternative payment systems, public and private financing systems, and the design of insurance. For those interested in doing cost studies, a separate FOA is available at PA-05-111, Economics of Prevention and Treatment Services for Drug and Alcohol Abuse, released May 18, 2005. Investigators of cost evaluations may wish to develop their own studies or collaborate with other studies that are either ongoing or in the planning stage.
Blending Research and Practice
Research to translate evidence-based drug and/or alcohol abuse treatment interventions into community practice and to prompt wider use of new prevention strategies focuses on knowledge transfer, organizational change, and innovative financing strategies. NIDA and NIAAA view this type of translational science as a complex multidirectional blending process that involves the interaction of multiple individual- and systems-level factors. The process often involves providers recognizing a problem; finding information about science-based innovations that may address the problem; searching for a solution by assessing available innovations, often in comparison with usual practice; adopting an innovation that appears promising for some clients; and then implementing, reconsidering, adapting, and, sustaining use of the innovation over time. This view, although complex, acknowledges the multidirectional and iterative nature of innovation and practice improvement.
State, county, and municipal Alcohol and Drug Abuse Agencies have a unique and powerful role in bridging the gap between science and services. As administrators of publicly supported substance abuse service delivery, public health agencies are well positioned to bring synergy, coherence, accountability, and long-term success to practice improvement in drug and/or alcohol abuse prevention and treatment services. Because they set policy and allocate service resources, public health agencies can influence the nature and pace of innovation adoption. NIDA and NIAAA encourage these agencies to conduct the research they need to develop, implement, and sustain statewide adoption of meritorious science-based policies and therapeutic and business practices. Moreover, NIDA and NIAAA encourage research grant applicants to incorporate in their projects SAMHSA-supported activities designed to foster adoption of science-based practices, including State Incentive Grants (SIGs), and other service infrastructure development and block grants.
Areas of research interest include the following:
Research Methods and Instruments
Research on methods and instruments involves the development, refinement, and validation of new tools for examining how social factors, financing systems, organizational structures and processes, management practices, health technologies, and personal beliefs and behaviors affect the demand for and delivery of drug and/or alcohol abuse healthcare and related services specifically the accessibility and utilization, quality, effectiveness, and costs of healthcare and related services for the prevention and treatment of drug and/or alcohol abuse and the medical consequences of such abuse. Areas of research interest include the following:
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism of Support
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 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 NIH Institutes and Centers
(ICs) 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.
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 Program Announcement funding opportunity.
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 is invited to work with his/her
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.
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
Registration and Instructions for Submission via Grants.gov
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:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the 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
2) Organizational/Institutional Registration in the eRA Commons
3) ) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
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 Tips and Tools for Navigating Electronic Submission on the front page of 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 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget
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:
Proposed research should provide
a unique research opportunity not available in the United States.
3. Submission Dates and Times
See Section IV.3.A for
details.
3.A. Submission, Review, and
Anticipated Start Dates
Opening Date: May 2, 2006 (Earliest date an application may be submitted
to Grants.gov
Letters of Intent Receipt Date(s): Not Applicable
Application Submission/Receipt
Date(s): Standard dates apply, please
see http://grants1.nih.gov/grants/funding/submissionschedule.htm.
AIDS Application Submission/Receipt Date(s):
Please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s):
Please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review Date(s): Please
see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest Anticipated Start Date(s): See http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
3.A.1. Letter of Intent
A letter of intent is not required for this funding opportunity.
3.B. Sending an Application 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.
Upon receipt, applications will be transferred from Grants.gov
to the NIH Electronic Research Administration process for validation. Both
the PD/PI and the Signing Official for the organization must verify the submission
via Commons within two (2) business
days of notification of the NIH validation.
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 that 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.
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 Tips and Tools for Navigating Electronic Submission on
the front page of 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 are to be followed, with the following requirements for R21 applications:
Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan 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
Not Applicable.
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_2003/NIHGPS_Part7.htm#_Toc54600131).
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.
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). See Section VI.3.,
Reporting.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review
process.
2. Review and Selection Process
Applications submitted for this funding opportunity will be assigned to
the ICs on the basis of established 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:
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 R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools, or technologies that have the potential to significantly advance our knowledge or the status of health-related research. Because the Research Plan is limited to 15 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. 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.
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 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?
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?
Innovation: Is the project original and innovative? For example: Does the
project challenge existing paradigms or clinical practice; address an innovative
hypothesis or critical barrier to progress in the field? Does the project
develop or employ novel concepts, approaches, methodologies, tools, or technologies
for this area?
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 PD/PI and other researchers? Does the investigative team bring
complementary and integrated expertise to the project (if applicable)?
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?
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).
Care and Use of Vertebrate Animals in Research: If
vertebrate animals are to be used in the project, the five items described
under item 11 of the Research Plan component of the SF424 (R&R) will be
assessed.
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 percent effort
listed for 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
Not Applicable.
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_2003/NIHGPS_Part7.htm#_Toc54600131).
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 or her Summary Statement (written critique)
via the NIH eRA Commons.
If the application is under consideration
for funding, NIH will request "just-in-time" information from the
applicant. For details, applicants may refer to the NIH Grants
Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart
A: General.
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via
email notification from the awarding component to the grantee business official.
Selection of an application for award is not an authorization
to begin performance. Any costs incurred before receipt of the NoA are at
the recipient's risk. These costs may be reimbursed only to the extent considered
allowable pre-award costs. See Section IV.5., Funding
Restrictions.
2. Administrative and National
Policy Requirements
All NIH grant and cooperative agreement awards include
the NIH Grants Policy Statement as part of the NoA.
For these terms of award, see the NIH Grants
Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart
A: General and Part II:
Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions
for Specific Types of Grants, Grantees, and Activities
3. Reporting
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.
Section VII. Agency Contacts
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:
Direct inquiries regarding programmatic issues about drug abuse treatment
services to:
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]
Direct inquiries regarding programmatic issues about drug abuse prevention services to:
Elizabeth Robertson, Ph.D.
Chief, Prevention Research Branch
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5154, MSC 9589
Bethesda, MD 20892-9589
Telephone: (301) 443-1514
Fax: (301) 480-2542
E-mail: [email protected]
Direct inquiries regarding programmatic issues about alcohol-related services to:
Peter J. Delany, DSW
Division of Treatment & Recovery Research
National Institute on Alcohol Abuse & Alcoholism
National Institutes of Health
5635 Fishers Lane, Room 2039, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-0788
Fax: (301) 443-8774
E-mail: [email protected]
2. Financial or Grants Management
Contacts:
Gary Fleming, J.D.
Chief, Grants Management Branch/OPRM
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Room 270
Bethesda, MD 20892-8403
Telephone: (301) 443-6710
Fax: (301) 594-6849
Email: [email protected]
Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-4704
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use
of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal regulations (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 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.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model organisms
for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors
to elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement
http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the application/proposal
a description of a specific plan for sharing and distributing unique model
organism research resources generated using NIH funding or state why such
sharing is restricted or not possible. This will permit other researchers
to benefit from the resources developed with public funding. The inclusion
of a model organism sharing plan is not subject to a cost threshold in any
year and is expected to be included in all applications where the development
of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members
of minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators
proposing clinical research should read the "NIH Guidelines for Inclusion
of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new
OMB standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R); and updated roles and responsibilities
of NIH staff and the extramural community. The policy continues to require
for all NIH-defined Phase III clinical trials that: a) all applications or
proposals and/or protocols must provide a description of plans to conduct
analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic
groups, including subgroups if applicable; and b) investigators must report
annual accrual and progress in conducting analyses, as appropriate, by sex/gender
and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical
Research:
The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all clinical research, conducted
or supported by the NIH, unless there are scientific and ethical reasons not
to include them.
All investigators proposing research involving human
subjects should read the "NIH Policy and Guidelines" on the inclusion
of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject
Participants:
NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key personnel.
The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs
can be found at http://stemcells.nih.gov/index.asp
and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)to
be used in the proposed research. Applications that do not provide this information
will be returned without review.
NIH Public Access Policy:
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.
HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse : Researchers funded by NIDA who are conducting research in community outreach settings, clinical, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing service for persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.
National Advisory Council on Drug Abuse Recommended
Guidelines for the Administration of Drugs to Human Subjects : The National
Advisory Council on Drug Abuse recognizes the importance of research involving
the administration of drugs to human subjects and has developed guidelines
relevant to such research. Potential applicants are encouraged to obtain and
review these recommendations of Council before submitting an application that
will administer compounds to human subjects. The guidelines are available
on NIDA's Home Page at http://www.nida.nih.gov
under the Funding, or may be obtained by calling (301) 443-2755.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must
be self-contained within specified page limitations. Unless otherwise specified
in an NIH solicitation, Internet addresses (URLs) should not be used to provide
information necessary to 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
|
| ||||||
|
|
|
Department of Health and Human Services (HHS) |
|
|||
|
NIH... Turning Discovery Into Health® |
||||||