Department of Health and Human Services
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: Epidemiology Of Drug Abuse (R21)
This Funding Opportunity Announcement (FOA) is a reissue of PA-06-329.
Update: The following update relating to this announcement has been issued:
Announcement (PA) Number: PA-08-125
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)
Release/Posted Date: March 28, 2008
Opening Date: May 16, 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
AIDS Application Due Date(s): Optional. 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: May 8, 2011
Dates for E.O. 12372
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
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
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
1. Research Objectives
This Funding Opportunity Announcement (FOA) issued by the National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), supersedes PA-06-329 and is intended to stimulate innovative investigations, based on the R21 mechanism, that enhance our understanding of: (1) drug use patterns and trends within and across populations; (2) interplay of social interactions, social environment, structural context with individual behavioral characteristics and genetic vulnerability; (3) the phenotypic heterogeneity of drug abuse; (4) causal mechanisms leading to onset, maintenance, and remittance of drug abuse and HIV risk behaviors, as well as protective mechanisms that reduce these risk behaviors; (5) drug abuse over the life course, including developmental processes that influence drug use and HIV risk trajectories and behavioral, health, and social consequences of drug abuse and HIV; and (6) medical consequences of drugs of abuse and co-occurring viral and bacterial infections (e.g., HIV, HCV, TB, STIs and others). In addition, research is encouraged to develop methodologies to improve the accuracy, efficiency, scope, timeliness, and analytic yield of drug abuse epidemiologic data. Because of the breadth of epidemiology research, applications are anticipated to reflect diverse and multidisciplinary putative approaches and multiple levels of causation. To take advantage of the strength of specific research fields in an efficient manner, and to maximize the generalizability of findings, researchers are encouraged to develop and/or incorporate innovations in epidemiologic study design. Such designs may include nesting of biological and/or basic research, contextual analysis, and contemporary longitudinal analyses.
Drug abuse epidemiologic research focuses on understanding the nature, extent, consequences, and etiology of drug abuse across individuals, families, age groups, gender, communities, and population groups. Epidemiologic research plays a critical public health role by providing an estimate of the magnitude, impact, and risk of drug abuse and related problems on a population, and by laying the foundation for developing strategies to prevent drug abuse, plan and evaluate drug abuse services, and suggest new areas for basic, clinical, and treatment research.
The natural history of drug use, abuse, and addiction can be observed most validly in epidemiologic studies. The population-based approach provides specific advantages over research relying on samples of convenience, such as clinical samples, by reducing the potential for selection bias in observed associations while enhancing generalizability. There are, however, limitations to epidemiologic research. Large sample sizes can pose difficulties in terms of time and cost to obtain intensive and detailed measures, particularly over extended periods of time. The observational nature of epidemiologic drug abuse research can limit experimental control and manipulation of variables under study. However, underutilized applications in epidemiologic study design, such as nested case control studies, enable integration of focused intensive measurement in the context of epidemiologic research. It is possible to draw epidemiologically informative samples, based on specific characteristics, for recruitment into laboratory-based research. Although collaboration between laboratory-based and epidemiologic research is becoming more widespread in other areas of health research, it is less common in the field of drug abuse research. This FOA encourages innovative research that incorporates the strengths of epidemiologic and laboratory-based designs.
Recent advances in health science research have recognized behavioral, social, psychosocial, biological, and genetic factors across the spectrum of diseases, including drug abuse and addiction. For diseases with a substantial environmental component, however, these as individually or in combination, these factors are not sufficient to explain or predict disease patterns. In order to better understand the epidemiology of drug abuse and its consequences within and across populations, research is encouraged on the interactive influence of environmental, social and cultural factors, on the initiation and progression of drug use among population groups. Novel conceptualization and measurement of environmental, social, and cultural contexts within theoretically grounded research are important to the advancement of drug abuse research. Ultimately, the successful identification of specific genes and related biological/physiological systems and other etiologic processes of complex diseases like addiction depend on precise, quantitative measurements of personal environmental exposures to evaluate their impact on disease risk. Increased understanding of how genetic, biological, social, cultural and contextual phenomena interact to influence behavior will inform prevention and treatment for individuals at risk for drug abuse and addiction.
Research indicates that there are significant gender-specific differences in biological factors in drug abuse and related risk behaviors, antecedents and consequences of drug abuse, and responses to prevention and treatment. Investigators should, wherever possible, include adequate numbers of both male and female subjects in their studies in order to make meaningful gender comparisons. Researchers are also encouraged to design studies to explore gender differences in the nature and extent of drug-using behaviors, including sexual risk behavior associated with injecting and non-injecting drug abuse, in the pathways and determinants of initiation, progression and maintenance of drug abuse, and the behavioral and social consequences of drug abuse. For more information on research on this topic, see the Women, Gender Differences and Drug Abuse: http://www.nida.nih.gov/WHGD/whgdpa.html#focus; http://grants.nih.gov/grants/guide/pa-files/PAR-06-476.html. For additional information on these announcements, contact Cora Lee Wetherington, Ph.D. at Wetherington@nih.gov.
HIV/AIDS and drug abuse are frequently referred to as twin epidemics, and whenever possible, it is essential that epidemiologic studies address this interrelationship. Investigators are encouraged to incorporate appropriate measures and analyses of factors critical to understanding transmission risks for HIV/AIDS and other sexually transmitted diseases (STDs), Hepatitis (HCV and HCB), and Tuberculosis (TB), as well as related disparities across different population groups. The aim is to promote integrated approaches to understanding and addressing co-factors and interactions among individuals and their environments that contribute to the continuum of problems related to drug abuse, including HIV/AIDS. For more information on research on this topic, see http://hiv.drugabuse.gov ; http://www.drugabuse.gov/MeetSum/HIVworkshop.html; and www.nida.nih.gov/about/organization/arp/arp_pa&rfa.htm.
Research shows that minority groups, particularly Blacks and Hispanics, are in some instances less likely to use licit or illicit drugs, but that such groups tend to be over-represented among those who suffer from co-occurring and adverse health, behavioral, and social consequences related to drug use (e.g., HIV/AIDS, premature births, intentional and unintentional injuries, violence, crime, unemployment and school dropout). Epidemiologic research is clearly needed to inform prevention and intervention strategies aimed at reducing and eliminating drug-related health disparities, as well as services research on access, utilization, and retention of racial and ethnic minority populations in drug abuse treatment. This announcement therefore encourages research that focuses on identifying risk factors and consequences that are unique to or more prevalent in subpopulations in socioeconomically disadvantaged (i.e., low education level, poverty) and medically underserved rural and urban communities. For more on NIDAs interest in this topic, see http://www.drugabuse.gov/StrategicPlan/HealthStratPlan.html.
Advances in the field of drug abuse epidemiology will require innovations in statistical, epidemiologic, sociologic, and genetic epidemiologic designs to meet challenges in the rapidly evolving drug abuse field. As well, advancements in statistical and survey methods designed to improve epidemiologic research, as well as data sharing and opportunities for dissemination. These advancements include issues relating to diagnosis and classification, such as refining diagnostic instruments and nomenclature. This announcement encourages methodological innovations that address transitions in stages and trajectories of drug abuse, intergenerational transmission of drug abuse, and heterogeneous pathways to and consequences of drug abuse. Especially encouraged are approaches that facilitate: (a) nested case-control and case- cohort designs that efficiently combine the advantages of epidemiologic samples with more intensive laboratory-based and biological measures, (b) innovations in measurement such as real-time measures of drug abuse and associated risk factors through the use of handheld devices, and (c) secondary analyses of existing epidemiologic data sets that contain high-quality information about drug abuse.
A great pubic investment has been made in datasets that describe the risk factors, mediators, moderators, course and progression of drug abuse and associated disorders. While many important findings have emanated from these datasets, they remain rich sources of data which can be further mined to advance the field. Specifically, these datasets can be used for analyses to answer outstanding questions in the field, to re-examine the data deploying new approaches based on methodological and theoretical advances, and to undertake small projects that will help identify appropriate directions for larger scale studies. For instance, NIDA-funded genetic epidemiologic studies have generated a great deal of strong, developmentally informed data, much of which remains to be analyzed, using state-of-the-art approaches to existing data. Outstanding issues include the conditionality of drug use disorders on drug exposure and methods of combining data across studies to increase power. More work on nosology, causal modeling, quantitative approaches, co-morbidity, phenotying, gender and ethnic differences, and testing alternative models are merited. In addition, many advances have been made in conceptualizing how the environment interacts with individual factors over time to affect developmental outcomes. Taking advantage of these advances, researchers have the opportunity to re-explore datasets rich in environmental data to help pinpoint what features of the environment are critical for drug addiction outcomes and at what points in time relative to individual development.
For more information on research using secondary analyses, particularly research on psychopathology vulnerability for drug abuse, see PA-06-439, Risk Factors for Psychopathology Using Existing Data. For more information on research supporting development of measurement technologies, see the Exposure Biology Program of the NIH Genes, Environment and Health Initiative (GEI): http://www.gei.nih.gov/exposurebiology/index.asp.
Major Program Areas
The epidemiologic drug abuse research program is further organized into major program areas that are described below. It is important to note that the crosscutting issues of gender, HIV/AIDS, health disparities, and methodological innovations apply across all of these topics. Examples of the types of research topics include, but are not limited to, the following:
Emerging and current trends in drug abuse and drug-related disorders Research directed at examining drug abuse trends is particularly important in the contemporary context where a variety of new substances are available to increasingly diverse populations and in an expanding range of settings. Changing availability and changing social and cultural trends influence patterns of use. Research continues to reveal new drug use trends and issues warranting further exploration such as the high level of abuse of prescription drugs, patterns of use of drugs in combination, and the association between non-injection drug use and HIV-risk behaviors in some contexts. This program of research encourages: (a) studies that develop more effective and timely ways to identify the nature, extent, and changes of new trends at an early stage within local, national and international contexts, and to identify associated health, social and behavioral consequences; (b) theory-driven research models for understanding the diffusion of drug trends into new populations including the impact of cultural factors, social networks, drug distribution mechanisms and media; (c) exploratory descriptive hypothesis-generating ethnographic studies as well as analytic studies that examine factors impacting initiation, continuation, progression and cessation of use of novel drugs; (d) studies that examine the relation between the use of novel drugs and HIV-risk behaviors; (e) research into whether users of these new substances experience substance use disorders; (f) innovative studies to improve methods for characterizing drug use behaviors such as, for example, the use of different substances strategically in combination or in sequence within specified periods of time; and (g) studies on the impact of drug trends and patterns on drug-related mortality.
Social epidemiology of drug abuse and drug-related problems Drug abuse research has focused largely on individual risk factors, while the universe of determinants includes individual, familial, neighborhood, community, population-specific, and societal factors. There is urgent need to extend drug abuse research to incorporate the concept of interactivity (individual susceptibility interacting with social environment, genetic environment, neighborhood environment) and cumulative history (how these determinants differentially impose risk across time, generations, and the life course). This program specifically encourages: (a) studies that examine the interaction of individual and social environmental factors on drug use/abuse/dependence; (b) studies that consider both immediate and cumulative (life-course and trans- generational) effects of interactions among drug abusing behaviors, environments, and genes; (c) studies that draw upon current research on the effects of social environmental factors on health and disease in general; (d) research that identifies whether and how the environment as culture can be meaningfully disaggregated into measurable components and tested for effects on drug abuse; (e) studies that inform the debate on which aspects or dimensions of the social environment (e.g., society, social institution, small group, dyad, social networks) also should be included, when they should be included, and how they should be measured; (f) investigations of the collective impact of neighborhood factors such as residential stability/instability, collective efficacy, social cohesion or other aspects of locally shared environments on drug abuse among different groups; (g) studies of how social and cultural factors influence or predict drug use/abuse, drug use related risk behavior, and its consequences; and (h) studies that incorporate tools from geography and spatial epidemiology such as GIS and other geomapping techniques to understand the interaction of environmental context and drug use and abuse.
Genetic liability and phenotypic heterogeneity Numerous genetic epidemiologic studies confirm that drug abuse "runs" in families, and that such transmission is due in part to genetic factors. These findings have been tremendously important, and have set the stage for additional research to specify drug abuse phenotype(s) and gene-by-environment-by development interactions inherent to complex disorders such as drug abuse. Indeed, untangling the complicated pathways from genotypes to phenotypes is one of the biggest challenges in the drug abuse field. The objective of this program area is to further explicate the transmissibility of drug abuse phenotypes as well as individual differences, familial processes, and social/environmental factors that confer risk for or protect against the expression of genetic liability. This program area encourages research on the following topics: (a) the refinement of drug abuse phenotypes and nosology to inform prevention, services, and molecular genetic research; (b) identification of key individual and environmental characteristics that affect genetic vulnerability and/or the course of drug abuse, including psychopathological conditions; (c) the interplay among genetic, environmental, and developmental factors (heritability, interactions, and correlations) for identifying and fine-tuning preventive interventions with high-risk populations; (d) studies that inform the debate on the general liability versus specificity of genetic risk for drug abuse; (e) genetically- informative assessments that are nested within epidemiologic-based studies; (f) development of statistical and analytic approaches to model complex disorders and traits. Further details on the genetic epidemiology program can be found at http://grants.nih.gov/grants/guide/pa-files/PA-07-413.html, http://grants.nih.gov/grants/guide/pa-files/PA-07-415.html, and http://grants.nih.gov/grants/guide/pa-files/PA-07-414.html.
Drug abuse and psychopathology: vulnerability and comorbidity Cross-sectional and longitudinal studies of adolescents and adults in both clinical and general populations have found high rates of co-occurrence between drug abuse and psychiatric disorders, particularly the conduct/antisocial disorders and the mood disorders. Far fewer studies have examined the temporal order or causal relationships, including potentially common pathways, for specific psychiatric disorders and drug abuse. Thus, the nature of the association among drug use disorders and other psychiatric disorders remains unclear. Understanding the relations between precursor and comorbid psychiatric disorders and drug abuse is a key focus of this program and has important prevention and treatment implications. Specifically, this program of research encourages studies that focus on: (a) child psychiatric precursors to drug abuse, with a particular emphasis on attentional, externalizing, and internalizing disorders; (b) the impact of mental health and behavioral interventions on drug abuse risk; (c) moderating and mediating factors that can inform the association between psychiatric disorders and drug abuse; (e) temperament and personality, particularly behavioral disinhibition and impulsivity, as stand-alone etiologic or potential mediating factors; and (f) dynamic relations between the timing and course of psychiatric illness and the timing and course of drug abuse, including drug use initiation, maintenance, escalation, and remittance. Towards this end, research approaches of particular interest to this program include: epidemiologic (population-based) cross-sectional and longitudinal studies, genetic epidemiologic and other studies of familial risk, clinical prospective and clinical follow-up studies, innovative designs that characterize the interactions between individual psychiatric and genetic factors with the environment, nested studies, and secondary data analyses. For additional information related to psychopathology and vulnerability for drug abuse, see http://www.drugabuse.gov/Meetings/Childhood.
Human development in adolescence and adulthood This program focuses on three key adolescent developmental issues that have relevance for drug abuse: timing, transitions, and biologic maturation. The developmental stage when drugs are introduced has implications for drug abuse, as evidenced by recent research showing that initiation during early developmental periods is associated with greater subsequent use. Similarly, developmental transitions (e.g., pubertal, cognitive, social, and achievement related), and individual variation in the timing of these, are also likely to influence trajectories of use. Studies of particular interest under this program include, but are not limited to, those that assess: (a) how developmental timing and the timing of drug use act and interact to influence the course of drug using behavior and related outcomes; (b) the implications of emerging cognitive, emotional, and social capacities across developmental periods for drug abuse; (c) the impact of the adoption of stage-specific roles on drug abuse and the impact of drug abuse on the adoption of such roles; (d) the creation of new or implementation of existing methodologic approaches that adequately capture the developmental nature of individual change; (e) real-time assessment methodologies to capture the capricious and context-dependent nature of drug using behaviors over developmental periods; and (f) translational research including epidemiologic studies that incorporate lab-based findings on adolescent brain development, measures of shifts in emotional and cognitive processes, and assessments of biological changes associated with puberty.
Family processes and early risks for drug use This program focuses on family processes and the consequences of parental drug abuse as risk factors associated with youth drug abuse. Parent drug abuse may influence childrens development through direct and indirect pathways. Direct pathways include genetic transmission of vulnerability to substance use disorders and prenatal exposure to drugs. Parent substance abuse can also indirectly impact development through its effect on childrens environments. Longitudinal, prospective, and multidisciplinary studies are needed to investigate the independent and combined contributions of biologic/genetic, psychosocial, and contextual factors that influence both drug use and the development of children and adolescents. Youth populations at heightened risk for drug abuse (e.g., homeless youth, youth in foster care) are of particular interest. This program of research encourages studies that focus on family processes, parent drug abuse, and risk behaviors (e.g., aggression, self-regulation, coercive family interactions) as they relate to youth drug abuse, as well as to early developmental processes linked with later drug use. This program also encourages research focusing on other developmental outcomes as well as the processes by which these factors influence child development. Specifically, (a) independent and combined effects of family processes, parent drug abuse, exposure to family and/or community violence and/or child maltreatment; (b) effects of exposure to lifestyles associated with parent involvement in illicit drug activities and related activities; (c) effects of forced parent-child separations due to parental drug-related illness, death, or imprisonment; (d) post-traumatic stress disorder (PTSD) as a risk factor for youth drug use; (e) individual child characteristics, sociocultural risks, contextual risks, and/or family dynamics that influence the development of youth drug use and other developmental outcomes; and (f) family, peer, school, and community influences on drug use/abuse.
Social and behavioral consequences of street drugs This program focuses on the range of behavioral and social consequences arising from street-level drug abuse. Behavioral consequences include educational and occupational problems, crime and violence, and comorbid conditions (overdose, suicide, trauma, abuse, STDs/HIV, and cognitive impairment). Social consequences include drug trafficking and distribution, gang activities, family disruption, and neighborhood dysfunction. Little attention has been given to how abuse of particular drugs and combinations of drugs affects these consequences. Understanding retail street drug activity and consumption patterns are important to understanding drug distribution networks and drug price/purity and availability. Data are available on the frequency of drug use, but better estimates of drug price and purity, and a better understanding of the quantity of drug used are sorely needed. Specifically, the street-level drugs program encourages research on: (a) what, how much, and how often drugs are actually consumed by drug users; (b) which adulterants, diluents, and contaminants are present in retail drugs; (c) the patterns of use of different drugs, including teasing apart patterns of polydrug use; and patterns of injecting and non-injecting drug abuse, variations in those patterns, and correlated risk behaviors associated with the acquisition and transmission of HIV and other diseases; (d) economic analyses to understand issues such as price/purity, consumption, and cross-elasticities; (e) small-scale epidemiologic studies could characterize price, demand, and consequences at the level of a city or other small geographic area; and (f) ethnographic studies to describe price and availability effects on behavior of those who use, abuse, or are dependent to explore whether elasticity of demand varies with severity of drug use.
Drug markets and behavior economics Research increasingly points to the importance of studying drug abuse as the behavior of individuals in their environments. While the immediate (proximal) environments of drug abusers have received considerable research attention, the context of broader and more distal environmental influences have received less consideration. Principles of behavior derived from more macro-environmental disciplines, particularly economics, have great potential for expanding understanding of the full set of influences on drug abuse. It is important to examine the intersection of psychological, economic and environmental concepts and findings and their relevance to drug abuse etiology, continuation, relapse and hopefully, more effective preventive and treatment interventions. By applying the research and perspectives of behavioral economics, marketing research, drug availability market factors, the psychology of decision making and other related areas, important but understudied pieces of the drug abuse puzzle will be investigated. The following issues are of particular interest: (a) nested case control studies within larger epidemiologic studies that enable laboratory-based behavioral economic analysis of defined populations; (b) research on the influence of environmental factors on behavioral economic measures such as delayed discounting functions or impulsivity and risk taking; and (c) interactions among broad social forces (e.g., neighborhood quality and socioeconomic status), racial and ethnic health disparities, and drug abuse trajectories and consequences.
Health and medical consequences of drugs of abuse and co-occurring infections Research on the epidemiology and natural history of HIV/AIDS among drug using populations includes studies of changing social and behavioral patterns and trends in the epidemic of HIV/AIDS among drug users e.g., injection and non-injection drug users and their sexual partners and risk, peer, and social networks. As well, emphasis is place on understanding health outcomes and clinical manifestations of HIV disease and co-morbid conditions in drug using populations.
Topics of interest to the Epidemiology Research Branch include, but are not limited to, studies that characterize the risk factors and mechanisms of acquisition and transmission of HIV and co-infections; multidisciplinary research on the behavioral, cultural, social, and economic risk factors and HIV-related consequences of drug abuse; research that advances qualitative and quantitative methodologies in behavioral and social science investigations of drug abuse, HIV/AIDS, and other infectious diseases; studies of individual or environmental factors (including the neurobiological changes induced by acute or chronic drugs of abuse) that affect HIV acquisition/transmission, disease progression, or response to antiviral therapies; studies to identify and understand potential cofactors, mediators, and interactions of HIV and other diseases, their progression, and their outcomes in diverse groups (e.g., by HIV subtype, by socio-demographic factors) of active drug users; and studies of new and improved approaches to access and recruit hard-to-reach cohorts of active drug users to participate in biomedical and behavioral interventions to reduce drug use-related risk behaviors, disease transmission, and co-morbidity (e.g., sampling and survey methods, and strategies, including the use of the Internet, to link community-based outreach to drug users with referral and access programs for HIV counseling and testing services, diagnostic screening for other diseases, drug treatment, and medical care). For these types of studies, contact the Epidemiology Research Branch. For more on NIDAs interest in this area, see also http://www.nida.nih.gov/about/organization/arp/arp-pa&rfa.htm and http://grants1.nih.gov/grants/guide/pa-files/PA-07-307.html.
The Medical Consequences Branch in the Division of Pharmacotherapies and Medical Consequences of Drug Abuse encourages basic and clinical studies to better understand how HIV infection is established and maintained and the medical consequences of HIV/AIDS in drug abusers. This research includes studies of the role of drugs of abuse and related compounds (including adulterants and contaminants of drugs of abuse) or drug abuse treatment medications on the progression of HIV disease, antiretroviral-resistant HIV strains, AIDS-associated opportunistic infections, and drug-associated mental health disorders in drug users; of the medical/clinical consequences of drug use, HIV, and co-occurring infections, which ranges across physiological and biochemical systems, e.g., metabolic/nutritional factors, that might impact the pathogenesis of HIV/AIDS; physiological factors that affect resistance and susceptibility to infection, e.g., effects of drug abuse on mucosal barriers, drug-drug interactions; medical interventions for drug abuse, psychiatric illness, and HIV and associated clinical conditions; interactions between drugs of abuse and medications to treat drug abuse and pharmacotherapies for HIV/AIDS and comorbid conditions; and pharmacological, physiological, genetic, and clinical factors in the progression of infectious diseases in vulnerable and underserved minority populations of drug users. For these types of studies, please refer to http://www.nida.nih.gov/about/organization/DPMCDA/mcb/MCBHome.html.Also see http://www.nida.nih.gov/about/organization/arp/arp-pa&rfa.htm and http://grants1.nih.gov/grants/guide/pa-files/PA-07-307.html and contact Jag H. Khalsa, Ph.D., firstname.lastname@example.org.
The evolution and vitality of the biomedical sciences require a constant infusion of new ideas, techniques, and points of view. These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data. By using the R21 mechanism, the NIH seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance biomedical research.
The R21 mechanism is intended to encourage new exploratory and developmental research projects. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.
Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications. Projects of limited cost or scope that use widely accepted approaches and methods within well established fields are better suited for the R03 small grant mechanism. Information on the R03 program can be found at http://grants.nih.gov/grants/funding/r03.htm.
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.
VIII, Other Information - Required Federal Citations, for policies related
to this announcement.
Section II. Award Information
Mechanism of Support
This FOA will use the NIH Exploratory/Developmental Research Grant (R21) 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 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 3.4, Modular Budget Component, of the Application Guide).
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 Institutes and Centers (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications . The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project; direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.
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
This program does not require cost sharing as defined in the current NIH Grants Policy Statement.
3. Other-Special Eligibility Criteria
Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation) applications will not be accepted.
Applicants may submit a resubmission, but such application must include an Introduction addressing issues raised in the previous critique (Summary Statement).
Applicants may submit more than one application, provided each application is scientifically distinct.
download a SF424 (R&R) Application Package and SF424 (R&R) SBIR/STTR
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 SBC can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered.
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/PI 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 SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
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 301-435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
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/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 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:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Modular Budget
PHS398 Cover Page Supplement
PHS398 Modular Budget or Research & Related Budget, as appropriate (See Section IV.6., Special Instructions, regarding appropriate required budget component.)
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form
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.
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: May 16, 2008 (Earliest date an application may be submitted to Grants.gov)
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
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 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.
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.
This initiative is not subject to intergovernmental review.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement.
6. Other Submission Requirements
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Registration FAQs Important Tips -- Electronic Submission of Grant Applications.
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
While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, incorporating "Just-in-Time" information concepts, and with the following requirements for R21 applications:
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.
Foreign Applications (Non-domestic (non-U.S.) Entity)
Indicate how the proposed project has specific relevance to the mission and objectives of the IC and has the potential for significantly advancing the health sciences in the United States.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: Not Applicable
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where 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 (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)
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.
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.
Review and Selection Process
Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established Public Health Service (PHS) referral guidelines.
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 initial merit review, all applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications submitted in response to this FOA. 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 Strategy is limited to 6 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 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?
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 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).
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or impact/priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
After the peer review of the application is completed, the PD/PI will be able to access his/her Summary Statement (written critique) via the NIH eRA Commons.
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:
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.
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:
Marsha F. Lopez, Ph.D., M.H.S.
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse
6001 Executive Blvd.
Bethesda, MD 20892-9589
Telephone: (301) 443-6504
3. Financial or Grants
Grants Management Specialist
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard
Suite 270 MSC 8403
Bethesda MD 20892-8403
Telephone: (301) 443-6710
FAX: (301) 594-6847
Section VIII. Other Information
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.
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
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).
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
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
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
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
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 (). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.
Standards for Privacy of Individually Identifiable
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.
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 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 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/.
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