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
Announcement Type
This is a reissuance of PA-01-097, which was previously released May 21, 2001 and of PA-01-142, which was previously released September 27, 2001.
Update: The following update relating to this announcement has been issued:
Program Announcement (PA) Number: PA-05-139
Catalog of Federal Domestic Assistance Number(s)
93.279, 93.273
Key Dates
Release Date: July 14, 2005
Letters of Intent Receipt Date(s): Not applicable
Application Submission Dates(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
AIDS Application Receipt Dates(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS for guidance on dates.
Peer Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for guidance on dates.
Council Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for guidance on dates.
Earliest Anticipated Start Date: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for guidance on dates.
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date for R03 and R21 Non-AIDS Applications: March 2, 2006
Expiration Date for R03 and R21 AIDS and AIDS-Related Applications: May 2, 2006
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
Part II. Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) 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. Address to 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
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 Announcement1. Research Objectives
Purpose
This program announcement replaces in their entireties PA-01-097, Drug Abuse Health Services Research, and PA-01-142, Health Services Research on Alcohol-Related Problems.
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:
Drug abuse prevention and treatment services often are delivered outside healthcare settings by personnel with a wide range of backgrounds.
Many individuals who receive drug abuse treatment do not seek it voluntarily, but are pressured into it by family, friends, or the legal system.
Drug abuse treatment typically includes a combination of therapies and educational and social services, but only rarely medications.
Many prevention and treatment interventions are delivered as part of full-scale programs or curricula rather than as stand-alone treatments.
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:
Factors that affect the delivery of drug and/or alcohol abuse prevention, treatment, and related services: social factors, personal behaviors and attributes, financing, organization, management; and health technologies;
Dimensions of drug and/or alcohol abuse prevention, treatment, and related services: accessibility, utilization, quality, effectiveness, and costs;
Processes of (a) blending evidence-based drug and/or alcohol abuse prevention and treatment practices into community-based care, and conversely, (b) translating the questions of concern to practitioners into rigorous research; and
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:
How gender and race/ethnicity influence service needs and access to drug and/or alcohol abuse prevention and treatment services
How discrimination affects individuals' help-seeking behaviors and their attainment of optimal outcomes; how stigma hinders people from seeking care or how stigma is related to the gap between need and service availability and to the public's reluctance to pay for prevention or treatment services
How socioeconomic status of an individual, family, or neighborhood influences demand for and accessibility, quality, and costs of drug and/or alcohol abuse prevention or treatment services
Special needs of individuals with co-occurring medical (e.g., HIV/AIDS, HCV), psychiatric (e.g., depression, anxiety, ADHD), or behavioral conditions
Role of an individual's expectations, perceptions, and satisfaction in maximizing entry into care and minimizing early withdrawal (including, for example, individuals transitioning back into the community after incarceration)
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 program announcement is available at PA-05-111: Economics of Prevention and Treatment Services for Drug and Alcohol Abuse.
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:
Organizational models that optimize service appeal, availability, access, utilization, quality, and intervention outcomes, both for general prevention and treatment populations and for specific treatment subgroups, including models for integrating or linking drug and/or alcohol treatment with psychiatric and medical care
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:
Effects of various management models on organizational capacity to use resources and adapt to changes in programs, systems, or environments
Effectiveness and cost-effectiveness of human resources management practices for service delivery personnel, such as selection methods, staff credentialing, training, continuing education, supervision, and incentives
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:
Application of web-based and other technologies to facilitate use of evidence-based innovations in everyday prevention and treatment practice
Tools and techniques for introducing and sustaining more efficient business practices such as quality management/monitoring, empowered work teams, formalized goal setting, improved customer relations, linkages with other service providers, and new fiscal and resource management techniques
Developmentally appropriate technologies to provide prevention booster interventions to reinforce skills, knowledge, and behaviors developed during the original intervention
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:
Nature and extent of demand for prevention and treatment or unmet treatment need
Effects of public and institutional policies on service accessibility, duration, and quality; strategies for improving treatment entry, re-entry, engagement, retention in treatment; and satisfaction with treatment
Strategies for overcoming individual, program-level, and community barriers to care
Service delivery models explaining which interventions are available in different communities, who is using them, why they are selected, and how communities gain access to those interventions
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:
Adaptive service delivery strategies including clinical decision-making that capture how providers determine and adjust the level and modality of prevention and treatment services over time to address clients' changing needs
Performance measures (e.g., those developed by the Washington Circle Group) and standards of care to improve assessment of client needs, treatment progress, and outcomes
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:
Strategies to improve prevention and treatment adherence, retention, completion, and outcomes in usual care settings
How elements of prevention act alone or in combination to retard transition to drug and/or alcohol use and abuse
Effectiveness of commonly used interventions and practices, particularly those that are the mainstay of standard treatment
Optimal role of faith-based services, recovery-oriented social networks, self-help, nontraditional interventions, and other practices used by culturally indigenous groups in extending the benefits of intervention services
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 program announcement is available at PA-05-111: Economics of Prevention and Treatment Services for Drug and Alcohol Abuse. 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:
Factors affecting diffusion of innovation; models for rapid induction of proven innovations into existing therapeutic and business practices
Alternative models for systematic organizational change or learning, organizational decisionmaking, technology transfer, knowledge dissemination, and innovative financing
Staffing and staff recruitment, training, and supervision needs of organizations involved in continuous quality improvement
Decisionmaking processes to approve new treatment services, approaches, or interventions for reimbursement by payers; impact of managed care on adoption of research-based treatment interventions
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:
Study designs that yield stronger levels of inference regarding causality or mediation in quasi- and non-experimental designs as well as randomized clinical trials
Instruments and methods to assess community prevention needs, quantify severity of community drug and/or alcohol problems, and assess subgroup receptivity to prevention messages
Measurement of organizational factors and relationships between organizational entities such as treatment agencies and other health, social services, and criminal justice system agencies
Development, improvement, implementation, or testing of methods or instruments to better assess and characterize typical everyday practice
Quality-of-care indicators at the individual and organizational levels of analysis (e.g., performance indicators developed by the Washington Circle Group)
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information1. Mechanism(s) of Support
This funding opportunity will use the National Institutes of Health (NIH) research project (R01), small grant (R03), and exploratory/developmental (R21) award mechanisms. The total project years for an application submitted in response to this PA may not exceed five years for the R01, two years for the R03, and two years for the R21.
Information on the Small Grant (R03) is available at: http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html Information on the Exploratory/Developmental Grant (R21) is available at: http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html.As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.
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.
Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
Section III. Eligibility Information1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an) application(s) if your organization has any of the following characteristics:
For applications directed to NIDA only, Center grant (P30 and P50) award mechanisms can also be used. T he total project years for the P30 or P50 may not exceed five years.
Foreign Institutions are only eligible for the RO1, RO3 and R21 mechanisms.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.
2. Cost Sharing or Matching
Cost sharing is not required.
The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.
3. Other-Special Eligibility Criteria
Not applicable
1. Address to Request Application Information
The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. 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
Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.
The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.
Foreign Organizations
Several special provisions apply to applications submitted by foreign organizations:
Proposed research should provide a unique research opportunity not available in the U.S.
3. Submission Dates and Times
See Section IV.3.A for details.
3.A. Submission, Review and Anticipated Start Dates
Application Submission Dates(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
AIDS Application Receipt Dates(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS for guidance on dates.
Peer Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for guidance on dates.
Council Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for guidance on dates.
Earliest Anticipated Start Date: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for guidance on dates.
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
3.B. Sending an Application to the NIH
Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
3.C. Application Processing
Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.
Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.
Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.
4. Intergovernmental Review
This initiative is not subject to intergovernmental review.
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 continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation 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
Specific Instructions for Modular Grant applications.
Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.
Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.
Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:
1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;
2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,
3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
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.
All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.
The reasonableness of the data sharing plan or the rationale for not sharing research data will 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.
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 Information1. 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:
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? WHERE APPLICABLE: Does the proposal include a viable plan for integrating the results of this research into community practice? First, can the practices used in the study be replicated by a broad variety of community service provider organizations? Second, will community providers be able to access training and other resources necessary for adoption, implementation, and sustained use? Third, will implementation costs be estimated in sufficient detail to enable public health officials and others who finance health services to budget and plan for adoption of the new practices ?
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 principal investigator 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 the Research Plan, Section E on Human Subjects in the PHS Form 398).
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 the Research Plan, Section E on Human Subjects in the PHS Form 398).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions 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: 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 will 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 presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy. Program staff will be responsible for the administrative review of the plan for sharing research data.
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
1. Award Notices
After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.
Section VII. Agency ContactsWe 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:
Harold I. Perl, Ph.D.
Division of Treatment and Recovery Research
National Institute on Alcohol Abuse and Alcoholism/NIH/DHHS
5635 Fishers Lane, Room 2039, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-0788
Fax: (301) 443-8774
E-mail: hperl @mail.nih.gov
2. Peer Review Contacts:
Not applicable
3. 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
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: [email protected]
Judy Fox
Chief, Grants Management Branch
Chief Grants Management Officer
National Institute on Alcohol Abuse and Alcoholism/NIH?DHHS
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-4704
FAX: (301) 443-3891
Email: [email protected]
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 the scientific merit or the priority score.
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 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.
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.
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.
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
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