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/)
Title: Drug Abuse Prevention Intervention Research (R21)
Announcement Type
This is a reissue of PA-05-118,
which was previously released on June 9, 2005, and now is divided into separate
Funding Opportunity Announcements (FOAs) for 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-06-317
Catalog of Federal Domestic
Assistance Number(s)
93.279
Key Dates
Release/Posted Date: April 5, 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://grants.nih.gov/grants/funding/submissionschedule.htm.
AIDS Application Submission/Receipt Date(s): Please see http://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review Date(s): Please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest Anticipated Start Date(s): See http://grants.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
The goals of this Funding Opportunity Announcement (FOA) are to encourage exploratory/developmental research projects of cognitive, behavioral, and social processes as they relate to: 1) the development of novel drug abuse prevention approaches; 2) the efficacy and effectiveness of newly developed and/or modified prevention programs; 3) the processes associated with the selection, adoption, adaptation, implementation, sustainability, and financing of empirically validated interventions; and 4) methodologies appropriate for studying complex aspects of prevention science.
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. 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
1. Research Objectives
Purpose
The purpose of this Funding Opportunity Announcement (FOA) issued by the National Institute on Drug Abuse's (NIDA) Prevention Research Branch (PRB) is to support a developmentally grounded program of research on the prevention of the initiation of drug use, progression to abuse and dependence, and transmission of drug-related HIV infection. This research involves the use of rigorous scientific methods to test theoretically derived hypotheses to advance our understanding of the science of prevention within diverse populations and settings. Studies that support this purpose include investigations of cognitive, behavioral, and social processes as they relate to 1) the development of novel prevention approaches, 2) the efficacy and effectiveness of newly developed and/or modified prevention programs, 3) the processes associated with the selection, adoption, adaptation, implementation, sustainability, and cost effectiveness of science-based interventions, and 4) methodologies appropriate for studying complex aspects of prevention science.
Background and Significance
Drug abuse and dependence are disorders that interfere with the normal, healthy functioning of persons across the lifespan, and are preventable causes of health problems, injuries, lost income and productivity, and family dysfunction. While the initiation of licit and illicit drug use, a necessary precursor to abuse and dependence, grows dramatically during the adolescent years, this behavior is preceded by proximal and distal biological, psychological, social, and environmental precursors originating as early as the prenatal period. Furthermore, the misuse and illicit use of drugs extends well beyond adolescence and, for some, begins in adulthood, even in late adulthood.
The life course developmental perspective suggests that individual and environmental factors interact to increase or reduce vulnerability to drug use, abuse and dependence. Vulnerability can occur at many points along the life course but peaks at critical life transitions. Thus, prevention researchers should recognize the significance of timing interventions to coincide with important biological transitions, such as puberty; normative transitions, such as moving from elementary to middle school; social transitions, such as dating; and traumatic transitions, such as the death of a parent. In addition, because vulnerability to drug abuse involves dynamic intrapersonal (e.g., temperament), interpersonal (e.g., family and peer interactions) and environmental (e.g., school environment) influences, prevention intervention research must target interactions between individuals and social systems across the life span. To address this complexity, intervention research needs to test strategies designed to alter specified modifiable mediators to determine which are most related to and effective in reducing drug use initiation and escalation, with what audiences, and under what conditions. Drug use, abuse, and dependence often co-occur with delinquency and criminal behavior, violence, mental health problems and HIV, therefore understanding the prevention of co-occurring problems and their contribution to elevated levels of risk is important to NIDA's mission.
Successful drug abuse and drug-related HIV prevention programs have utilized a number of theoretical perspectives for predicting differential drug use trajectories and elucidating developmentally grounded mediators, or risk and protective factors, amenable to change. Notable among these theories are Problem Behavior Theory, Social Cognitive Theory, and the Social Development Model. Resulting research has focused on prevention approaches involving positive modification of various precursors of substance use, such as aggressive behavior, academic problems and failure, poor social skills, misperceptions of social norms, poor parent-child attachment, and inappropriate parental expectations and responses. Successful programs have also intervened in multiple contexts, such as schools, health care settings, community service organizations, and workplaces. Drug abuse and related HIV prevention research is most successful when the intervention delivery contexts provide ready access to the target population. That is, the more central the delivery context is to the target audience's existing life routines, the more likely the intervention and associated research will be able to recruit and retain members of the target population.
Audiences or targets for prevention interventions are generally classified into one of three categories depending on level of risk: universal, selective, or indicated. Universal prevention interventions are targeted to the general public or to a whole population group, such as all children in a school. Selective prevention interventions are targeted to individuals or subgroups of the population with defined risk factors for the development of substance abuse, such as children of drug abusers. Indicated prevention interventions are targeted to individuals or subgroups that are identified as having non-clinical but detectable signs or symptoms foreshadowing drug abuse, dependence, and addiction. A Tiered approach to prevention interventions incorporates two or more of these levels of intervention with increasing sensitivity to individuals with greater problem severity.
To advance the field, novel interventions must build on basic science findings from diverse fields such as neuroscience, epidemiology, human development, psychology, sociology, anthropology, and communications. Many factors that may hold promise for informing the development and testing of prevention interventions have received little if any attention, for example, individual learning styles and cognitive processing, intergenerational family communication patterns, quality of family child peer interactions, neighborhood cohesiveness and legislation on drug abuse. Work with children who have shown early aggressive behavior is an example of how the identification and targeting of etiological processes may hold promise for prevention. Early aggressive behavior was linked to subsequent interpersonal and academic problems, social alienation, association with deviant peers and eventual substance abuse. Thus, effective prevention strategies were developed, such as helping children to identify their behaviors and practice self-control, good classroom management practices that reinforce pro-social behaviors, and parental involvement in positive child activities. These strategies have been shown to have long-term impact on drug use and antisocial behavior.
The study of interactions between domains of variables (e.g., biological and social) may be a promising route of inquiry as the science of prevention progresses because interactions between risk factors in multiple domains can result in elevation of risk or protection. For example, early pubertal maturation in girls places them at risk for drug abuse and precocious sexual activity because they are perceived and treated, by both adults and peers, as older than their years and they tend to become involved with older male partners and as a result increase their opportunities for drug exposure and risky sexual behaviors. However, parental awareness, involvement and monitoring can be protective factors for this subpopulation of girls. Research that considers the potential for such interactions in the prevention process will better define the complex relationships that necessarily pervade investigations on drug abuse prevention.
Among the many underdeveloped areas of drug abuse prevention research, three will be discussed briefly here: developmental transitions, differential effectiveness and fidelity of implementation, and emerging technologies. Characteristics and differences that contribute to drug abuse risk during late adolescence and emerging adulthood have not been well studied. This is a particularly important area of research because late adolescence is a significant transition point in human development, and the initiation of use of so-called hard drugs often takes place during this period. Other transitions during this life course stage, such as learning to drive, entering college or the first job, courtship and marriage, and victimization have not been seriously considered as targets for drug abuse prevention interventions. Moreover, no prevention interventions for later stages of adulthood have been developed despite the fact that individuals who have used licit, prescription and illicit drugs for long periods of time without developing dependency can move toward abuse and dependence as the result of biological (e.g., lower tolerance with aging), normative (e.g., retirement), social (e.g., making new friends in retirement) or traumatic (e.g., lose of a spouse) transitions. Thus, greater attention to a wide variety of transitions and the risk and protective factors related to them is needed for the development and testing of innovative interventions that target high-risk periods across the life course.
Some effective prevention interventions show differential effectiveness by gender, ethnicity, and other factors. Research is needed to understand underlying biological, psychological and social processes and mechanisms that account for these differences so that interventions can be adapted for specific sub-groups while maintaining the integrity of the intervention core components. The importance of fidelity of implementation is well established, yet there are situations where strict adherence is not possible. Developing a better understanding of what constitutes the effective ingredients of an intervention and how modification can be made while maintaining or boosting effect sizes may be a superior approach to developing a wholly new intervention.
Emerging technologies, such as the Internet and wireless communication, may have application to both intervention design and prevention methodology. While the full impact of such changes on prevention programming and research is unknown, possible new improvements to intervention processes and data collection methodology should be explored. Technology-assisted interventions have the potential to be both more personalized, through the use of individualized programs, and more confidential, as they involve less face-to-face contact than more traditional methods. In addition, integrating media or other high-tech intervention components into existing interventions may potentiate effectiveness. Technology based innovations in data collection, such as using hand held devices to collect moment to moment data are already in use, but other methodological innovations are likely.
Specific Areas of Research Interest
NIDA's drug abuse prevention research program is comprehensive in nature and fully reflects the prevention research mission, objectives, and study areas advanced by the Department of Health and Human Services and the National Institutes of Health (NIH). The following sections address drug abuse prevention research areas of specific interest to NIDA. Under each research section, examples of topics requiring further study are given. However, many areas for future research are not addressed, and investigators should not view the examples provided as limiting the areas of research of interest to NIDA.
1. Basic Prevention Research
A priority of NIDA is to stimulate the translation of emerging scientific discoveries to the design and testing of innovative prevention intervention approaches. Previous research from the basic biological (e.g., neurobiological), psychological (e.g., emotional, behavioral, cognitive, communication, and developmental) and social (e.g., social learning, peer network, and communications) sciences and drug abuse epidemiology and etiology and have elucidated individual and group vulnerabilities and pathways to drug use initiation and escalation. Based on these findings and their underlying theoretical frameworks, prevention research has produced programs with proven efficacy and effectiveness. However, much existing research on biological, psychological and social processes and mechanisms has not been fully utilized for the purposes of developing and testing novel drug abuse prevention interventions. Basic prevention research uses empirically- and theoretically-derived hypotheses regarding malleable biological, psychological and social mediators of behavior to develop and test new prevention paradigms. Attention to specific patterns of interactions between individual, developmental and environmental factors that influence vulnerability to drug abuse and associated problems and health risking behaviors can be important elements of this research. In addition, drug abuse prevention research findings have the potential to inform epidemiology, etiology and basic science hypotheses with implications for the further development of new intervention paradigms or refinement/improvement of existing programs and strategies. Most basic prevention science investigations are expected to be human laboratory studies or small-scale field randomized controlled trial (RCT) studies of well-defined hypotheses derived from prior research. Possible exploratory/developmental research foci include:
Studies that use findings on learning styles and cognitive strategies and functioning to improve or develop targeted prevention strategies.
Examination of interaction between emotional and cognitive responses to prevention messages to construct messages more likely to elicit appropriate responses (e.g., triggering refusal behaviors when confronted with potential drug use situations).
Qualitative studies of ethnic or culturally defined sub-groups with low incidence and prevalence of substance abuse to determine what naturally occurring protective factors are operating for the purpose of testing those factors for possible inclusion in prevention interventions.
Examination of influences on program effectiveness when emerging knowledge about sub-population specific biological vulnerability to HIV, HCV, and other STDs is integrated into existing drug abuse prevention programs.
Construction and decomposition studies that systematically examine the impact of program components, alone and together, to determine mechanisms of effectiveness.
2. Prevention Intervention Research
Research on prevention intervention programs and strategies should focus on the manipulation of presumed causal factors derived from basic prevention and other studies on the origins, pathways and mechanism of vulnerability to drug abuse and addiction. Prevention intervention research includes efficacy, effectiveness, and systems research. Efficacy trials are generally the first step in testing innovative prevention strategies and interventions and utilize small RCTs. The theoretical or empirical basis of the intervention defines the role of modifiable mediating variables, how various programmatic components have been designed to address those elements and the hypothesized outcomes. An important aspect of efficacy studies is determining the relevance and acceptability of the program for translation to real world settings.
Effectiveness trials replicate efficacious strategies and interventions in less controlled real-world settings with larger more diverse samples, and generally employ a RCT or equivalent research design (such as, multiple baseline, cross over, etc.). In addition to determining effectiveness, these studies usually incorporate prevention services research questions related to factors such as participant recruitment and retention, dosage, cost, fidelity of implementation, and implementer training (for further discussion see below). That is, they examine issues that affect the transportability of programs to real world settings, facilitators and barriers to implementation, and generalizability to diverse populations and geographic settings.
Systems research takes prevention programs or strategies with demonstrated efficacy and effectiveness to scale. Systems trials are implemented through existing (e.g., schools, primary care settings, workplaces) or newly created delivery systems with large samples. Random assignment to intervention and control conditions remains the ideal study design. A major emphasis of systems trials is identifying and understanding how factors that affect the sustainability of programming operate. Thus, addressing prevention services research questions is a core goal of this type of study. All three intervention study types, efficacy, effectiveness, and systems, generally incorporate a longitudinal design to allow for the examination of the role of moderators, mediators and a variety of proximal and distal outcomes over time.
An important emphasis of NIDA's prevention research program is on prevention services research questions. Prevention services research involves identifying and determining how features internal and external to interventions contribute to efficacy and effectiveness. Examples of internal features are: content, implementation strategies, fidelity, dosage, delivery setting and implementer training. Examples of external features are: exposure to other programs, media, enforcement of regulations and laws related to substance use and community norms around substance abuse. A clear understanding these features is essential to adapting programs to meet the needs of specific groups and, when appropriate, to generalizing strategies to other settings. Prior research suggests that features such as program duration, reinforcement of prevention messages over time, consistency of messages across settings, use of developmentally appropriate content and materials, use of interactive teaching techniques, use of intermittent reinforcement, client-facilitator fit, grouping of clients, and interactions between these features need further investigation to improve the quality of programming and increase the potential for translation into real-world settings. Questions around these and other features that concentrate on the availability, organization, management and financing of prevention interventions fall into the broad category of prevention services research. Prevention services research is integral to intervention research and forms the link between research and practice. Examples of topics appropriate for exploratory/developmental research projects include:
Efficacy
Developing and testing strategies to strengthen existing group and environmental anti-drug norms and characteristics that have been show to be protective against drug abuse and addiction.
Studies on the efficacy of drug abuse prevention program and strategies that are untested but widely used such as: case management, mentoring, job training, and challenge activities.
Testing the efficacy of drug use and/or HIV/STI screening tests for their potential effects in reducing or preventing drug abuse and dependence and/or HIV/STI infection.
Developing and testing the efficacy of brief HIV and drug abuse prevention interventions for specific contexts such as primary care settings and college/workplace health programs.
Effectiveness
Analyzing longitudinal data to determine the long-term and potential cross-over effects of drug abuse prevention programs on associated health problem behaviors such as unsafe sexual practices leading to HIV infection.
Adapting and assessing the effectiveness of proven drug abuse prevention strategies for use in contexts with the potential to maximize access to hard to reach populations, such as accessing parents through the workplace or racial/ethnic minority populations in places of worship.
Systems
Examining how differences in school environments, including drug abuse rules, influence mediators of drug abuse--such as attitudes, norms and intentions --and eventually substance abuse behaviors with particular attention to the pattern and duration of the environmental change processes.
Determining the extent to which research-based strategies for training high-risk parents -- such as those who abuse drugs and those for which abusive child-rearing practices have been documented -- are available through existing service delivery systems.
3. Methodological Research
Methodological research is needed in the field of drug abuse prevention on promising data collection, data management, analysis, and reporting techniques. Special attention should be given to: the hierarchical nature of most prevention data; the adaptation of measures for intervention cohorts over the course of time and development; the measurement and analysis of complex theoretical process models including moderating and mediating variables; the problems of missing data and attrition when following intervention and control subjects over time; and the development of statistical strategies that can assist in identifying the most salient features of interventions. NIDA supports the adaptation and assessment of proven scientific procedures from other disciplines to determine their applicability to drug abuse prevention research. Specific areas of research include:
The development of more powerful designs for detecting differences in program effectiveness by attributes such as subgroup membership, content delivered, content exposure, and so forth.
The development and assessment of physiological and biochemical measures that may elucidate cognitive and affective factors associated with individual responsiveness to particular prevention interventions.
The development and trial use of real-time data collection strategies or other methods to strengthen, validate, or corroborate self-reported behaviors.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism(s) of Support
This funding opportunity will use the NIH Exploratory/Developmental 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. For example, the applicant may request $100,000 in the first year and $175,000 in the second year. The request should be tailored to the needs of the project, 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 as the Project Director/Principal Investigator (PD/PI) 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://grants.nih.gov/grants/funding/submissionschedule.htm.
AIDS Application Submission/Receipt Date(s): Please see http://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review Date(s): Please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest Anticipated Start Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
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
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.
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 scientific health 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.
When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:
1. Scientific/Research Contacts:
Elizabeth B. Robertson, Ph.D.
Chief
Prevention Research Branch
Division of Epidemiology, Services
and Prevention Research
National Institute on Drug
Abuse/NIH/DHHS
6001 Executive Boulevard, Room 5160
Bethesda, MD 20892-9589
Telephone: (301) 443-6504
FAX: (301) 480-2542
Email: [email protected]
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 20892-8403
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Human Subjects Protection:
Federal regulations (45CFR46) require
that applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is
required for all types of clinical trials, including physiologic toxicity and
dose-finding studies (Phase I); efficacy studies (Phase II); efficacy,
effectiveness and comparative trials (Phase III). Monitoring should be
commensurate with risk. The establishment of data and safety monitoring boards
(DSMBs) is required for multi-site clinical trials involving interventions that
entail potential risks to the participants (NIH Policy for Data and Safety
Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH
application seeking $500,000 or more in direct costs in any single year are
expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of scientific merit or the priority score.
Access to Research Data through the
Freedom of Information Act:
The Office of Management and Budget
(OMB) Circular A-110 has been revised to provide access to research data
through the Freedom of Information Act (FOIA) under some circumstances. Data
that are (1) first produced in a project that is supported in whole or in part
with Federal funds and (2) cited publicly and officially by a Federal agency in
support of an action that has the force and effect of law (i.e., a regulation)
may be accessed through FOIA. It is important for applicants to understand the
basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Inclusion of Women And Minorities in
Clinical Research:
It is the policy of the NIH that
women and members of minority groups and their sub-populations must be included
in all NIH-supported clinical research projects unless a clear and compelling
justification is provided indicating that inclusion is inappropriate with
respect to the health of the subjects or the purpose of the research. This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43). All investigators proposing clinical research should read the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the 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.
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 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:
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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