National Institutes of Health (NIH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Funding Opportunity Title
Screening and Brief Alcohol Interventions in Underage and Young Adult Populations (R21)
R21 Exploratory/Developmental Research Grant Award
Reissue of PA-07-407
Funding Opportunity Announcement (FOA) Number
Catalog of Federal Domestic Assistance (CFDA) Number(s)
The objective of this Funding Opportunity Announcement (FOA) is to encourage research on screening and brief interventions to prevent and/or reduce alcohol use and alcohol-related harms.
November 18, 2011
Open Date (Earliest Submission Date)
January 16, 2012
Letter of Intent Due Date
Application Due Date(s)
Standard dates apply, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)
Scientific Merit Review
Standard dates apply
Advisory Council Review
Standard dates apply
Earliest Start Date(s)
Standard dates apply
January 8, 2015
Due Dates for E.O. 12372
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The purpose of this Funding Opportunity Announcement (FOA) issued by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH), is to encourage research grant applications on screening and brief interventions to prevent and/or reduce alcohol use and its adverse consequences.
This FOA is designed to stimulate a developmentally grounded program of research on screening and brief interventions to prevent and/or reduce underage drinking and hazardous young adult drinking. Research objectives of this FOA include, but are not limited to: (1) testing strategies to improve screening methods for youth with or at high risk for alcohol-related problems; (2) testing the efficacy and effectiveness of novel or modified evidence-based brief prevention interventions to: (a) prevent or delay the initiation of alcohol use, or (b) decrease the risk for the development of alcohol use disorders (AUDs) and associated problems among youth; (3) examining individual, peer, familial, community, cultural, or other contextual factors (e.g., health care settings) that affect the adoption, implementation, and outcomes of empirically validated screening measures or brief interventions. Studies of racially and ethnically diverse populations in various social and cultural settings are encouraged. Investigations must be especially sensitive to unique human subject issues when conducting research in minors.
National surveys show that alcohol consumption is highly prevalent among youth under age 21 and young adults, with 71% reporting use by the end of high school (MTF, 2010). Underage drinking accounts for 16% of alcohol sales and $62 billion in medical, social, and lost quality of life. Among individuals ages 12 and older, 51.9% report being current drinkers (NSDUH, 2009) and 24% report binge drinking (NSDUH, 2009; YRBSS, 2009). The Monitoring the Future (2009) survey of college and young adult alcohol use found that 37% of this population reported high rates of heavy (binge) drinking. The typical age range for first development of alcohol dependence is 18 to 24. Early onset of alcohol use and greater levels of binge drinking during adolescence correlate strongly with the development of alcohol dependence later in life. Compared to those who delay the onset of use until age 21 or later, those who report beginning to drink at age 15 or younger are 4 times as likely to also describe drinking that is consistent with a diagnosis of alcohol dependence at some point in their lives.
Drinking trajectories among youth vary and have been shown to be characterized by amount and frequency of use, escalation patterns, and age of drinking onset. Individual variables (e.g., age, race/ethnicity, puberty and neurobiological maturation, individual, gender, temperament, poor self-regulation, delinquency, intellectual abilities, negative affect, psychiatric comorbidity, self-esteem, expectancies), familial factors (e.g., family history, genetic risk, parental monitoring, permissive attitudes), and environmental factors (e.g., poverty, college/non-college, peer use, social support, treatment for alcohol/drug problems) have all been implicated in the variability in drinking patterns among underage drinkers and young adult drinkers. According to national surveys (e.g., NESARC), gender disparities in drinking patterns tend to emerge in older adolescence when males exhibit greater frequency and quantity of alcohol consumption, although the gender gap for alcohol consumption patterns is narrowing. In addition, some minorities begin drinking at a later age and levels of consumption vary by gender as well as by specific minority group. For example, although rates of alcohol use, binge drinking, and AUDs have been shown to be greater among some American Indian or Alaska Native adolescents, other American Indian groups are more likely to abstain. Relative to the general population, lower levels of use are reported among African Americans during youth, but higher percentages of heavy and problematic use are reported in adulthood, particularly among males.
The period of adolescence through young adulthood is a heterogeneous period of vulnerability during which developmental transitions may differentially affect individuals. While underage drinking is associated with substantial morbidity and mortality, age-related risk/protective factors and differential consequences throughout pre-, middle, and late adolescence as well as young adulthood have not been fully explored. Underage drinking is multiply-determined and more research is needed to increase understanding of the interplay of adolescent development, alcohol use, and prevention of hazardous use and AUDs. A developmental approach to screening and prevention interventions may: (1) optimally identify those with greater vulnerability and critical periods of risk, (2) be more efficacious in minimizing risk and altering drinking trajectories (i.e., delaying and/or preventing the initiation and/or escalation of alcohol use, minimizing the risk for AUDs, promoting long-term positive health outcomes) thereby reducing morbidity and mortality among youth, and (3) assist in disentangling needs for universal versus targeted approaches to screening and brief interventions dependent on population and contextual features.
National and professional regulatory bodies (e.g., Surgeon General’s Call to Action to Prevent and Reduce Underage Drinking, Substance Abuse and Mental Health Services Administration, American College of Surgeons Committee on Trauma, American Academy of Pediatrics, National Quality Forum) have recommended screening and brief interventions in medical, educational, and criminal justice settings to identify individuals at risk and reduce alcohol-related harms. While the U.S. Preventive Services Task Force (2004) recommended screening and behavioral counseling interventions to reduce alcohol misuse by adults (in primary care settings), the evidence pro or con for screening and providing brief interventions for adolescents in primary care was determined to be inconclusive for efficacy and effectiveness. Underage drinking is a significant public health problem that is associated with costs to individuals and society, including intentional/unintentional injuries (e.g., motor vehicle crashes, suicide), violent crime, sexual assault, risky sexual behavior, physical health effects (e.g., possible adverse effects on the developing brain, alcohol poisoning), educational underachievement, occupational and social consequences (e.g., deviant peer network), licit and illicit drug use, and mental health problems. Early recognition and identification of alcohol misuse among youth has potential to reduce alcohol-related harm. A primary objective of screening is to identify individuals at risk for alcohol-related problems but measurement methods must show sensitivity, specificity, and have positive predictive value. Adolescents do not show the same chronic effects of alcohol use (e.g., liver damage, cirrhosis) as older adults do and less is known regarding their alcohol tolerance and sensitivity. Thus, screening measures may need to consider a wider range of health behaviors and adverse effects of alcohol exposure. Routine screening in a wide variety of settings may be useful in identifying those at risk for AUDs and provide an earlier entrée into developmentally appropriate and targeted interventions to reduce underage drinking and development of AUDs. In addition, there is a need for research that explores whether screening at an early age produces long term benefits throughout the life course; for example, lower alcohol consumption levels, reduced risk for AUDs, better overall health outcomes, etc.
Efforts to measure alcohol use among youth have included an examination of consumption levels (e.g., age of onset and prevalence of current or lifetime use; severity of use or hazardous use; concomitant substance use), consequences of use (e.g., physical, social, psychological effects), and diagnosis of alcohol abuse/dependence. Several measures have been empirically-developed or applied to adolescents and young adult populations in order to screen for hazardous use and/or alcohol-related problems; these include but are not limited to the Adolescent Alcohol Involvement Scale (Mayer & Filstead, 1979), Alcohol Use Disorders Identification Test (AUDIT; Babor et al., 1992), CAGE (Ewing, 1984), CRAFFT (Knight et al., 1999), Customary Drinking and Drug Use Record (CDDR; Brown et al., 1998), Drug Use Screening Inventory (DUSI; Tarter, 1990), A-Obsessive Compulsive Drinking Scale (A-OCDS; Deas et al., 2002), Personal Experience Screening Questionnaire (PESQ; Winters, 1992), Problem Oriented Screening Instrument for Teenagers (POSIT; Rahdert, 1991), RAFFT (Bastiaens et al., 2000), Rutgers Alcohol Problem Index (White & Labouvie, 1989), Substance Abuse Subtle Screening Inventory-Adolescent (SASSI-A; Miller, 1990; Miller & Lazowski, 2001), TWEAK (Russell, 1994), and Youth Diagnostic Screening Test (Alibrandi, 1978). In addition, the NIAAA developed a professional tool, Helping Patients Who Drink Too Much: A Clinician's Guide (http://www.niaaa.nih.gov/Publications/EducationTrainingMaterials/Pages/guide.aspx) to assist primary care and mental health clinicians in identifying individuals, including adolescents, with or at risk for alcohol-related problems. However, not all of these measures are sensitive in detecting alcohol misuse and related problems in adolescents, some may require modifications of thresholds for detection of use vs. diagnosis of problem drinking, and may not lend themselves to examination of longitudinal transitions in patterns of alcohol use. Others may not be transportable to all settings (e.g., schools, primary care, juvenile detention centers) or populations (e.g., ethnic minorities) and do not fully consider personality or temperamental traits that may pose a risk for the development of alcohol involvement. Some studies, but not all, show that the onset of alcohol use occurs during pre-adolescence with as many as 10% of youth beginning to drink as early as ages 9 to 10. More research is needed that evaluates screening and assessment measures that are developmentally appropriate, practical, and psychometrically valid as well as tailored to high risk and specific subpopulations (e.g., early adolescence, gender, race/ethnicity, rural/urban, adolescents with psychiatric comorbidity) and settings (e.g., schools, primary care, pediatric clinics, emergency/trauma settings, mental health settings, work-place, juvenile courts, traffic courts). Studies of barriers to screening (e.g., insurance and reimbursement issues, parental involvement, health care provider attitudes, lack of provider time and training, disincentives to reporting alcohol related injuries, large scale implementation problems, setting implementation processes, cultural bias, validation of self-report, other ethical issues) and evaluations of implementation processes that promote positive outcomes are needed. It is essential to establish psychometrically sound brief screening measures with high sensitivity and specificity to detect underage risky drinking that are effective across a variety of settings.
Examples of research that are encouraged by this FOA are given below, and are not meant to be exclusive:
Studies that evaluate novel or modified developmentally-matched, empirically-derived, screening instruments designed to measure initiation of alcohol use, hazardous use, and the transition to AUDs. More research is needed on: 1) the development of well-validated practical, efficient and cost-effective screening tools; 2) the feasibility of implementation of screening and setting-specific needs/barriers; and 3) developmentally-matched screening instruments that characterize drinking patterns and trajectories among youth that can be used to evaluate prevention intervention outcomes or spontaneous recovery.
Studies that examine alcohol screening test characteristics (e.g., single vs. multiple-item or multiple-problem instruments) and sensitivity to detect cases as these relate to developmental age, gender, drinking patterns and alcohol-related problems, diagnostic need(s), other risk behaviors, target populations, and setting variability. Greater understanding is sought about the effects of screening modality and intensity (e.g., interview, computerized, multi-stage), setting, and person variables that determine optimal screening tools for specific needs/sites.
Studies that examine the linkage of alcohol screening with other medical or health care services. More research is needed to evaluate how screening can be effectively implemented in medical services where youth are likely to seek access to care (e.g., primary care, pediatrician offices, college health clinics, emergency rooms, mental health clinics) and how implementation is affected by organizational, individual, and external (e.g., cultural, policy changes) factors.
Studies that examine alcohol screening in subpopulations. More research is needed to evaluate optimal screening methods and settings to target subpopulations among youth (e.g., females, pregnant women, ethnic minorities, individuals with psychiatric comorbidity, individuals with other drug-use comorbidity, individuals in criminal justice settings, individuals with gay/lesbian/bisexual orientation, individuals with positive family history of alcohol/other drug abuse or dependence), barriers to screening, and programmatic features designed to reduce such impediments.
Studies that examine the roles of youth social networks, schools, the workplace, community organizations (e.g., faith-based organizations), and technological aids in screening and dissemination of personalized or social norm feedback on the risks and consequences of hazardous alcohol use.
Studies that examine the utility of screening for single versus multiple licit/illicit drug use, other problem behaviors, or parental drinking patterns/attitudes in identifying target populations for prevention interventions.
Studies that examine multiple assessment modalities to improve the validity of self-report of alcohol consumption (e.g., ecological momentary assessment, interactive voice response, etc.).
Studies that assess whether adolescents and young adults are willing to participate in screening programs and/or that seek to increase participation.
Studies that examine the cost-effectiveness/cost-benefits of screening to provide earlier identification of underage drinking and youth at risk for AUDs and alcohol-related consequences.
Individuals who develop AUDs at younger ages are less likely to seek alcohol-related treatment and are more likely to experience chronic-relapsing alcohol disorders. Among adolescents approximately 10% receive treatment; for college students, less than 5% of those with AUDs have sought treatment. Earlier screening strategies and assessment of hazardous drinking can be used to delay the onset and escalation of AUDs, identify risk for AUDs, and classify individuals into developmentally-oriented or high risk typologies, thereby improving referral to appropriate interventions to reduce drinking and prevent AUDs.
Brief interventions have been implemented in a variety of settings to reduce alcohol-related harm in youth; for example, emergency rooms, primary care, school-based settings, and mass media. However, there are inconsistent findings regarding their effectiveness across settings and some locations (e.g., workplace, military settings) have not been fully explored. Work has been associated with hazardous alcohol consumption and other risky behaviors among youth, even when controlling for sociodemographic variables. Work settings offer an underutilized community-level arena where prevention interventions may be offered. In addition, research on brief interventions in military populations (personnel and family) is needed.
Recent reviews indicate that brief interventions can be effective in reducing alcohol use and alcohol-related consequences among adolescents and young adults. However, no single brief intervention has been reported to be effective across a wide range of populations and settings, and there is no consensus about best practices for adolescent/young adult interventions. Variable metrics used to determine effectiveness and breadth of applicability (at the individual and/or setting levels) can affect estimates of population impact of the intervention (Koepsell et al., 2011). Additionally, even when interventions have been subjected to efficacy and effectiveness trials, the transfer of evidence-based brief interventions into standard practice is often delayed. Brief intervention studies to date have suffered from limited outcome measurement, defined target population and measurement inconsistencies, lack of standardization of the intervention (including poor fidelity), variability in intensity and intervention goals, discordant outcomes, modest effect sizes and minimal risk reductions, poor implementation, and failure to fully examine implementation processes. Multidimensional developmental models need to inform the design and implementation of prevention interventions in light of the heterogeneity of adolescent populations and multiple risk pathways that influence the development and resolution of AUDs. Therefore, more research is needed to: (1) test the efficacy and effectiveness of theoretically-based, empirically-derived, and developmentally appropriate brief interventions, (2) test effective evidence-based interventions that target specific subpopulations and settings, (3) distinguish core vs. adaptable components of effective brief interventions, and (4) examine moderators and mediators of the differential effectiveness of these brief interventions. Greater understanding is required about the effects of the intervention modality (e.g., brief vs. enhanced, narrow vs. multiple risk-behavior focus, marketing strategy, parental/familial, in person vs. web/computerized, individual vs. group-based, provider vs. peer-led, etc.) and intervention enhancements (e.g., booster sessions, technological aids) on successful outcomes. Examination of critical variables that contribute to more widespread adoption and better translation of effective interventions into routine care are necessary.
Examples of research that are encouraged by this FOA are given below, and are not meant to be exclusive:
Studies that develop and test innovative brief interventions, adapt existing brief interventions with demonstrated efficacy for use in a variety of settings (e.g., schools, health care, juvenile justice, military), or examine novel approaches to the implementation of brief interventions in order to reduce risk for the development of AUDs. Work that examines organizational (including setting-specific), individual, provider, and intervention-related barriers to implementation is essential.
Studies that develop and test the efficacy of brief interventions and study whether these effects are maintained longitudinally. For example, are developmentally-targeted booster sessions needed to facilitate the maintenance of long term effects? What is the impact on longer-term morbidity and mortality?
Studies that evaluate the active ingredients of brief intervention effects.
Studies that determine population characteristics of responders/non-responders to brief interventions (e.g., drinking pattern and history, AUDs, family history, genetic predisposition, gender, race/ethnicity, other drug and/or mental health comorbidity, etc.).
Studies that examine the effects of the modality of the prevention intervention (e.g., brief vs. enhanced, single vs. multi-component, narrow vs. multiple risk-behavior focus, marketing strategy, parental/familial, in person vs. web/computerized, individual vs. group-based, provider vs. peer-led, etc.) on successful outcomes.
Studies that examine the reasons for response/non-response to brief interventions (e.g., neurocognitive processes, parental involvement, peer networks, etc.).
Studies that evaluate the role of associated problem behaviors (e.g., psychiatric comorbidity, other drug use, violence, driving under the influence, risky sex) on the effectiveness of brief interventions.
Studies that examine process variables that contribute to differential outcomes of particular brief interventions (e.g., content exposure, target populations, contextual factors, parental involvement).
Studies that assess the efficacy of stepped, adaptive care, on continuing care (boosters) approaches for individuals that fail to respond to an initial brief intervention.
Studies that examine longitudinal data to determine the long-term and potential cross-over effects of brief alcohol use prevention interventions on other associated high risk behaviors (e.g., risky sexual behavior, driving after drinking, violence, STD/HIV risk).
Studies that examine the integration of brief interventions in routine health care and other public or private institutional settings (e.g., primary care, mental health, emergency/trauma, and gynecologic/obstetric care). What are the barriers to successful integration or implementation of prevention interventions? What technological innovations, managerial practices, or other strategies facilitate the implementation or adoption of prevention interventions?
Studies that examine the cost-effectiveness/cost-benefits of alternative approaches to providing brief interventions to reduce alcohol consumption, risk for AUDs, and alcohol-related consequences.
Studies that seek to identify and reduce barriers (e.g., organizational, provider) to conducting screening and brief intervention for alcohol problems (e.g., lack of training, time constraints, reimbursement issues, lack of referral services, etc.).
Implementation studies that examine the translation of evidence-based brief interventions into standard practice (e.g., college health clinics, pediatric settings); studies that examine implementation processes and contextual factors that hinder or facilitate adoption, sustainability, and the effect of these on effectiveness outcomes.
Application Types Allowed
The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards
The number of awards is contingent upon NIH appropriations, 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.
1. Eligible Applicants
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.
Eligible Individuals (Program Director(s)/Principal Investigator(s))
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) 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.
2. Cost Sharing
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
1. Requesting an Application Package
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.
Required and Optional Components
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
PHS 398 Research Plan Component
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Resource Sharing Plan
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies; GWAS) as provided in the SF424 (R&R) Application Guide.
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide,
Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
3. Submission Dates and Times
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
4. Intergovernmental Review (E.O. 12372)
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
6. Other Submission Requirements and Information
Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. 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.
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 review criteria and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the review criteria below in the determination of scientific 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.
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?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, 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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
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?
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?
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 evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, 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.
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. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
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. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
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.
For Resubmissions, 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.
For Revisions, 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.
Additional Review Considerations
As applicable for the project proposed, reviewers will consider 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.
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.
Select Agent 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).
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; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
2. Review and Selection Process
Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
3. Anticipated Announcement and Award Dates
After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
1. Award Notices
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
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. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
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 the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Application Submission Contacts
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
eRA Commons Help Desk(Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Mariela C. Shirley, Ph.D.
Peer Review Contact(s)
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Financial/Grants Management Contact(s)
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Authority and Regulations
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.