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 (R01)
Announcement
Type
This Funding Opportunity Announcement
(FOA) is a reissue of PA-07-110.
Update: The following update relating to this announcement has been issued:
Program
Announcement (PA) Number: PA-08-217
NOTICE: Applications submitted in response
to this Funding Opportunity Announcement (FOA) for Federal assistance must be
submitted electronically through Grants.gov (http://www.grants.gov)
using the SF424 Research and Related (R&R) forms and the SF424 (R&R)
Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4)weeks prior to the grant submission date. See Section IV.
Catalog of Federal
Domestic Assistance Number(s)
93.279
Key Dates
Release/Posted Date: July 25, 2008
Opening Date:September 5, 2008 (Earliest date an application may be submitted to
Grants.gov)
Letters of Intent Receipt
Date(s): Not
applicable.
NOTE: On-time submission requires that
applications be successfully submitted to Grants.gov no later than 5:00 p.m.
local time (of the applicant institution/organization). Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review
Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review
Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest
Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional
Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: September 8, 2011
Due Dates for E.O. 12372
Not Applicable
Additional
Overview Content
Executive Summary
Table of Contents
Part I Overview
Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria
Section IV. Application and Submission
Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and
Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application
Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission
Requirements and Information
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
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 Contacts
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1.
Research Objectives
The
purpose of 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. The programs focus involves studies
targeting the prevention of many substances (often collectively) including but
not limited to nicotine, inhalants, marijuana, cocaine/crack, methamphetamine,
club drugs, and prescription/over the counter drugs. 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. Programs of research are intended to provide pathways
toward the discovery of population-level approaches for the prevention of drug
abuse and dependence, drug-related problems (such as interpersonal violence,
criminal involvement, and productivity loss), and
drug related illness (such as comorbid drug and mental health problems or
comorbid infections including HIV, hepatitis B (HBV), and
hepatitis C (HCV)).
Significance
Significant progress has been made in understanding effective approaches to prevention of drug abuse over the past few decades, in part because of careful attention given to understanding basic, developmental processes involved in the transition to drug use, abuse and dependence. 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 and neighborhood) 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, interpersonal violence, mental health problems, HIV, other sexually transmitted infections, and reproductive health problems. 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 sensation-seeking, aggressive behavior, academic problems and failure, poor social skills, misperceptions of social norms, poor parent-child attachment, and inappropriate parental expectations and responses. Because theoretical grounding of prevention programs is an essential feature for their success, further progress in prevention research relies on a stronger understanding of successful theories and their application and potentially the development of new theoretical approaches or meta-theories.
Prevention context impacts upon the feasibility, acceptability, and effectiveness of prevention approaches. Successful programs have 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, children of parents in the criminal justice system, and youth in the child welfare system. 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 intervention intensity for individuals at greater risk or with greater problem severity.
To advance the field, novel interventions must build on basic science findings from diverse fields. Opportunities exist to expand upon our growing knowledge by incorporating neuroscience, genetics, and physiology to better understand prevention pathways in order to improve effect sizes for successful approaches, increase the breadth of our impact, develop personalized prevention approaches, and build efficiency into the processes of increasing protection or decreasing risk. Furthermore, because of recent advances in a number of disciplines, important opportunities exist to build upon findings from drug abuse etiology and epidemiology research and the fields of human development, criminology, psychology, sociology, anthropology, and communications. An interdisciplinary approach to prevention, with research teams comprised of scientists bringing complementary expertise and critical and innovative research paradigms, will strengthen prevention efforts. In addition, studies addressing the unique opportunities to examine the interaction between biological, interpersonal, intrapersonal, and environmental variables in the context of the design and implementation of prevention research, need to be developed and tested.
Three underdeveloped areas of drug abuse/drug-related HIV prevention research are 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 normative transitions during this life course stage, such as learning to drive, entering college or the first job, and courtship and marriage as well as non-normative life events such as 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., loss 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 as needed 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 core content or 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. Moreover, research to elucidate under what conditions adaptation is indicated would advance our capability to understand how to optimize prevention services.
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 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. Moreover, there is some evidence that integrating media or other high-tech intervention components into existing interventions may potentiate effectiveness. Technologies that are promising for their role in prevention research include hand held devices to collect moment to moment data and new HIV testing technologies, particularly those that identify early infection and allow for the estimation of incidence in cross sectional samples.
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. 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
NIDA recognizes the need to maximize the use of existing underutilized approaches and basic science findings for the development of innovative preventive interventions targeting the initiation and escalation of drug abuse and the prevention of drug-related HIV infection. The goal of basic prevention research is to identify and test new prevention paradigms informed by basic science. Basic science discoveries utilized in basic prevention research include findings from biological (e.g. neurobiology, pubertal maturation, or physical development), psychological (e.g. emotional, behavioral, cognitive, and developmental) and social (e.g. social learning, peer network, and communications) sciences that address individual and group vulnerabilities to drug use initiation and escalation from occasional use to abuse. Investigators efforts over the past two decades have focused on the translation of basic research to produce prevention programs with proven efficacy and effectiveness in addition to science-based prevention principles. However, much existing basic science on biological, neurobiological, psychological, and social processes and mechanisms has not been fully utilized for purposes of developing and testing innovative, potentially efficacious, drug abuse prevention interventions. Moreover, recent scientific advances have provided opportunities to integrate knowledge from diverse fields such as biochemistry, biology, biomedicine, computational science, computer science, economics, engineering, geography, genetics, informatics/information science, mathematics, neurobiology, neuroscience, and physiology.
One opportunity for basic prevention research is the translation of intervention findings into further basic science study. Because preventive intervention trials include at least one non-intervention control group, they have unique contributions to make in advancing our understanding of the mechanisms through which risk and protective factors operate, including how biological, psychological, social and environmental factors interact to influence risk or how such mechanisms operate within and across different phases of development. Ultimately, this research will have implications for the further development of new intervention paradigms or refinement/improvement of existing programs and strategies, as well as for the natural history of problem behaviors and the effect of intervention on those behaviors.
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. Researchers are encouraged to consider proposing basic research applications as stand-alone applications or revision (i.e., competing supplement) applications associated with a prevention research study in its early stages. Possible research foci include:
Studies that use findings on learning styles and cognitive strategies and neurocognitive 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).
Research to discern what theoretical approaches have the greatest promise for informing intervention strategies/modalities leading to durable behavior change.
Construction and decomposition studies that systematically examine the impact of program components, alone and together, to determine mechanisms of effectiveness.
Using basic science research and emerging technologies to explicate under-explored mechanisms of neurobiological risk and to facilitate understanding of the biological and neurobiological effects of social, emotional, and behavioral preventive interventions.
2. Prevention Intervention Research
Research on prevention intervention programs and strategies should focus on the manipulation of presumed causal, malleable factors derived from basic prevention and other studies on the origins, pathways and mechanism of vulnerability to drug abuse, addiction, and drug-related HIV. Even relatively modest prevention intervention research trials can address complex and varied questions on drug etiology, theory testing, mechanisms of intervention effects, process measures, fidelity measures, and implementation cost in addition to assessing short term and long term trial outcomes. Three types of prevention intervention research that will be discussed further here include efficacy, effectiveness, and systems research.
Efficacy trials are designed to establish the impact of the intervention approach on targeted outcomes under ideal implementation conditions. In preparation for efficacy research, pilot studies are typically conducted to gather evidence for feasibility and potential efficacy in advance of proposing a small efficacy trial. While mechanisms other than the R01 are often more appropriate for pilot studies and other developmental work, such as the testing of methods and materials and manualization of the intervention, in special cases the R01 mechanism may be appropriate for such work. Efficacy trials may be small scale trials or more moderate in size depending on the level of current evidence for the work and other considerations regarding the design of the trial. It is strongly recommended that efficacy trials submitted using the R01 mechanism include promising pilot findings.
Efficacy trials utilize small randomized controlled trials (RCTs) or, if well justified, other highly rigorous research designs. Quasi-experimental designs are discouraged, except in cases where the research question can not be tested using a more rigorous approach. It is essential to articulate a theoretical framework or basis for the intervention effects anticipated. The theoretical or empirical basis of the intervention defines the role of mediating factors, that is, how various programmatic components have been designed to alter these elements in order to impact upon measurable intervention 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. One important area of prevention services research is replication of efficacious interventions with other population groups and in alternate contexts in an effort to develop a clear understanding of those features that are essential to program integrity and those that can be adapted to meet the needs of specific groups and 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, financing and sustainability 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. For that reason researchers are encouraged to integrate prevention practitioners into the research process, from inception through to completion to ensure that successful interventions meet identified needs and to foster ownership and sustainability. Examples of topics requiring further research 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.
Developing and testing preventive interventions designed to strategically target understudied periods in the lifecourse, such as intervening in early childhood to alter precursors, intervening in late adolescence with youth who discontinue their education, or intervening in adulthood with individuals experiencing high stress, such as military personnel, or displaced, bereaved, or victimized persons.
Studies on the efficacy of drug abuse prevention programs 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.
Studies of the effects of environmental manipulations, such as school policies and local law enforcement strategies, or the built environment on drug use and drug-related activities such as gang involvement.
Developing and testing the efficacy of brief HIV and drug abuse prevention interventions for specific contexts such as primary care settings and college or workplace health programs.
Testing theoretically grounded interventions with demonstrated efficacy for preventing drug use for effects on sexual risk behaviors.
Effectiveness
Independent replication studies of efficacious drug abuse and drug-related HIV prevention programs in multiple sites to determine cross-site and cross-population generalizability.
Tests for the effectiveness of proven prevention interventions with individuals at-risk for drug abuse and comorbid HIV/AIDS, anti-social behavior, high-risk health behaviors, and/or psychiatric disorders.
Analyzing longitudinal data to determine the long-term effects of drug abuse prevention programs on diagnoses of abuse and or dependence, associated health risk behaviors such as unsafe sexual practices leading to HIV infection, and on ancillary benefits such as reduced criminal justice involvement and improved educational or vocational outcomes.
Adapting and assessing the effectiveness of proven drug abuse and HIV prevention strategies for use in contexts with the potential to maximize access to target populations, such as accessing parents through the workplace or racial/ethnic minority populations in places of worship.
Examination of program effectiveness in reducing HIV sexual and drug use risks, as well as risks for acquiring related infections (i.e., other sexually transmitted infections, viral hepatitis), where research takes into account emerging knowledge about HIV risks such as population-based biological vulnerability, and network patterns.
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.
Comparisons of effective HIV prevention programs across sites such as health clinics, primary care settings, school health programs, and faith-based programs to determine equivalence in effectiveness by setting, delivery characteristics and financial and human resources.
Studies of the initiation, development, and continuity of community coalitions to prevent drug abuse and their impact on selection and implementation of effective drug abuse prevention strategies.
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.
Determination of the cost and cost-effectiveness of brief drug abuse and HIV prevention programs that have been integrated into standard health, mental health and community settings.
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 and longitudinal nature of most prevention trial 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:
Development, testing, and application of complex statistical models to examine differential impacts of preventive interventions across individuals, across time, and across contexts.
Designs to improve causal inference from non-experimental and quasi-experimental research and natural prevention experiments.
Research to improve the analysis of longitudinal data -- in particular, the analysis of correlated data, the modeling of different sources of error, and techniques for dealing with missing data at various levels of aggregation that may occur in prevention trials.
Methodological research to improve the analysis of complex prevention trial data, including the statistical modeling of non-response and other survey errors.
Analytic methods that appropriately model social structures, social processes, and spatial relationships such as social networks, social influence, diffusion, and contextual effects within randomized prevention trial datasets.
Methods for the detection and analysis of non-linear or discontinuous changes in response to preventive interventions.
Special Considerations
HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse: In light of recent significant advances in rapid testing for HIV and in effective treatments for HIV, NIDA has revised its 2001 policy on HIV counseling and testing. NIDA-funded researchers are strongly encouraged to provide and/or refer research subjects to HIV risk reduction education and education about the benefits of HIV treatment, counseling and testing, referral to treatment, and other appropriate interventions to prevent acquisition and transmission of HIV. This policy applies to all NIDA funded research conducted domestically or internationally. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-07-013.html.
National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects: The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects. 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 Web site at http://www.nida.nih.gov/about/organization/nacda/CouncilStatement.html.
See Section
VIII, Other Information - Required Federal Citations, for policies related to
this announcement.
Section
II. Award Information
1. Mechanism of Support
This
FOA will use the R01 award mechanism. The Project Director/Principal
Investigator (PD/PI) will be solely responsible for planning, directing, and executing the
proposed project.
This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide). It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, a U.S. organization submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) should use the PHS398 Modular Budget component.
U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component.
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.
Facilities and Administrative
(F&A) costs requested by consortium participants are not included in the
direct cost limitation, see NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1.
Eligible Applicants
1.A. Eligible Institutions
The following
organizations/institutions are eligible to apply:
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model.Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically.Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
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 a resubmission application, but such application must include an Introduction addressing issues raised in the previous critique (Summary Statement).
Applicants may submit a renewal application.
Applicants may submit more than one application, provided that each application is scientifically distinct.
Section IV. Application and Submission Information
Registration:
Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. 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 with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered ?on-time? (see 3.C.1 for more information about on-time submission).
To
download a SF424 (R&R) Application Package and SF424 (R&R) Application
Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for
Grant Electronically button in this FOA or 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 NIH eRA Commons.
Several additional separate actions are required before an applicant can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
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.
Both the PD(s)/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants must
download the SF424 (R&R) application forms and the 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 for this FOA through Grants.gov/Apply.
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, 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/PIs assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in 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 or Research & Related Budget,
as appropriate (See Section IV.6., Special Instructions, regarding appropriate
required budget component.)
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
Foreign
Organizations (Non-domestic [non-U.S.] Entities)
NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from Foreign organizations must:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States (U.S.) or that augment existing U.S. resources.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in Item 13 of the SF424 (R&R) Cover component.All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI.Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission.The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component.Failure to include this data field will cause the application to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan, must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts.The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component.All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form.See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only.Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 3.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A. Submission, Review, and
Anticipated Start Dates
Opening Date:September 5, 2008 (Earliest
date an application may be submitted to Grants.gov) Letter of Intent Receipt Date(s): Not applicable.
Application Due Date(s): Standard dates apply, please
see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply,
please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review
Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review
Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest
Anticipated Start Date(s): Standard dates apply, please see http://grants1.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. Submitting an Application Electronically to the NIH
To submit an application in
response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp 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 due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s)
and time, the application may be delayed in the review process or not reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.
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. The submitting AOR/SO
receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons
acknowledgments. Information related to the assignment of an application to a
Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status 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. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.
4. Intergovernmental Review
This initiative is not
subject to intergovernmental
review.
5.
Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award
costs are allowable. A grantee may, at its own risk and without NIH prior
approval, incur obligations and expenditures to cover costs up to 90 days
before the beginning date of the initial budget period of a new or competing
renewal award if such costs: 1) are necessary to conduct the project, and 2) would
be allowable under the grant, if awarded, without NIH prior approval. If
specific expenditures would otherwise require prior approval, the grantee must
obtain NIH approval before incurring the cost. NIH prior approval is required
for any costs to be incurred more than 90 days before the beginning date of the
initial budget period of a new or competing renewal award.
The incurrence
of pre-award costs in anticipation of a competing or non-competing award
imposes no obligation on NIH either to make the award or to increase the amount
of the approved budget if an award is made for less than the amount anticipated
and is inadequate to cover the pre-award costs incurred. NIH expects the
grantee to be fully aware that pre-award costs result in borrowing against
future support and that such borrowing must not impair the grantee's ability to
accomplish the project objectives in the approved time frame or in any way
adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements and Information.
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD(s)/PI(s) 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.
Organizational DUNS
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 Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
PHS398 Research Plan Component Sections
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:
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 (excluding consortium F&A
costs) must carry out the following steps:
1) Contact the IC program staff at least 6 weeks
before submitting the application, i.e., as plans are being developed for the
study;
2) Obtain agreement
from the IC staff that the IC will accept the 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 new, renewal, revision, or resubmission applications. See NOT-OD-02-004, October 16, 2001.
Appendix Materials
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations. An application that does not comply with the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)
(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)
(b) Sharing Model Organisms: Regardless of the amount requested, all applications in which the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible (see Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.)
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (NOT-OD-07-088) and http://grants.nih.gov/grants/gwas/.
Foreign Applications (Non-domestic [non-U.S.] Entities)
Indicate how the proposed project has specific relevance to the mission and objectives of the NIH/IC and has the potential for significantly advancing the health sciences in the United States
Section V. Application Review Information
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications submitted for this funding opportunity will be assigned on the basis of established PHS referral guidelines to the ICs for funding consideration.
Applications that are complete will be evaluated for scientific and technical merit by (an) appropriate scientific review group(s) in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.
As part of the scientific peer 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 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, and weighted 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 meritorious impact/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.
Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).
Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance: Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s): Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation: Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
Environment: Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
2.A.
Additional Review Criteria
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.
Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
3. Anticipated Announcement and Award Dates
Not Applicable.
Section
VI. Award Administration Information
1.
Award Notices
After the peer review of the application
is completed, the PD/PI will be able to access his or her Summary Statement
(written critique) via the NIH eRA Commons.
If
the application is under consideration for funding, NIH will request
"just-in-time" information from the applicant. For details,
applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the grantee business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Section
IV.5., Funding Restrictions.
2. Administrative and National Policy Requirements
All NIH grant
and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General and Part
II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions
for Specific Types of Grants, Grantees, and Activities.
3.
Reporting
When multiple
years are involved, awardees will be required to submit the Non-Competing Continuation
Grant Progress Report (PHS 2590) annually and financial statements as
required in the NIH Grants
Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
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 (program), peer review, and financial or grants management issues:
1. Scientific/Research Contact(s):
Elizabeth
B. Robertson, Ph.D.
Chief
Prevention Research Branch
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5160
Bethesda, MD 20892-9589
Telephone: (301) 443-6504
FAX: (301) 443-2636
Email: [email protected]
2. Peer Review Contact(s):
Not applicable.
3. Financial/Grants Management Contact(s):
Maryellen Connell
Grants Management Branch
National Institute on Drug Abuse
6101 Executive Boulevard, Room 270
Bethesda, MD 20892-8403
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: [email protected]
Section VIII. Other Information
Vertebrate Animals:
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 (45 CFR 46) 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 institutional review board (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 impact/priority score.
Policy for Genome-Wide
Association Studies (GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/
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. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal 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.
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, Minorities, and Children:
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) application; 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-09-116.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.
NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators
funded by the NIH must submit or have submitted for them to the National Library of
Medicines PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version
of their final, peer-reviewed manuscripts upon acceptance for
publication, to be made publicly available no later than 12 months after the
official date of publication. The NIH Public Access Policy is available
at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.
Standards for Privacy of Individually Identifiable
Health Information:
The Department
of Health and Human Services (HHS) 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 HHS
Office for Civil Rights (OCR).
Decisions about
applicability and implementation of the Privacy Rule reside with the researcher
and his/her institution. The OCR website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs
in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding
must be self-contained within specified page limitations. For publications
listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed
Central (PMC) submission identification numbers must be used for publicly
accessible on-line journal articles.Publicly accessible on-line journal
articles or PMC articles/manuscripts accepted for publication that are directly
relevant to the project may be included only as URLs or PMC
submission identification numbers accompanying the full reference in either
the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH grant application.
A URL or PMC submission identification number citation may be repeated in each
of these sections as appropriate. There is no limit to the number of URLs or
PMC submission identification numbers that can be cited.
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 FOA 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.. 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 Part 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 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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