Department of Health
and Human Services (HHS)
and Human Services (HHS)
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
National Cancer Institute (NCI)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)
Office of Behavioral and Social Sciences Research (OBSSR)
R01 Research Project Grant
New
None
93.279, 93.399
The purpose of this funding opportunity announcement is to support (1) research to test the efficacy or effectiveness of interventions to prevent initiation and/or escalation of ENDS (electronic nicotine delivery system) use among adolescents; and(2 )research on the impact of tobacco control policies, including ENDS-specific policies, on adolescent ENDS use behavior. Of priority is research that is theoretically based and identifies specific risk and protective factors to target through prevention intervention, or research on policies that can impact adolescent ENDS use. Particularly, for prevention intervention research (e.g., school, community, and clinic-based), collaboration with stakeholders and likely program adopters is required to ensure feasibility for implementation, scalability, dissemination and sustainability. For this funding announcement, individuals as young as 12 and as old as 18 encompass the core target age range. Justification for the specific age or age range of the target population is required, including studies that propose targeting youth outside the core age range.
September 19, 2020
October 19, 2020
No late applications will be accepted for this Funding Opportunity Announcement.
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
March 2021
May 2021
July 2021
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from 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.
Purpose
The purpose of this funding opportunity announcement is to support (1) research to test the efficacy or effectiveness of interventions to prevent initiation and/or escalation of ENDS (electronic nicotine delivery system) use among adolescents; and (2) research on the impact of tobacco control policies, including ENDS-specific policies, on adolescent ENDS use behavior. Of priority is research that is theoretically based and identifies specific risk and protective factors to target through prevention intervention, or research on policies that can impact adolescent ENDS use. Particularly, for prevention intervention research (e.g., school, community, and clinic-based), collaboration with stakeholders and likely program adopters is required to ensure feasibility for implementation, scalability, dissemination and sustainability. For this funding announcement, individuals as young as 12 and as old as 18 encompass the core target age range. Justification for the specific age or age range of the target population is required, including studies that propose targeting youth outside the core age range.
Background
Electronic Nicotine Delivery Systems (ENDS) are battery operated devices that convert a liquid solution into an aerosol that is inhaled by the user. ENDS are a heterogeneous and evolving class of products with varying designs and characteristics; some are disposable, cartridge-based (e.g., pods), or have refillable tanks. Various terms are used to refer to ENDS products, including electronic cigarettes, pod-mods, vape pens, mods, and use of ENDS is often referred to as vaping. Typically, the ENDS liquid contains solvents (propylene glycol and vegetable glycerin), flavorings and nicotine. However, many products are open systems, with tanks (reservoirs for the liquid), that can be filled by the user with liquid, which may contain other substances such as tetrahydrocannabinol (THC), the primary psychoactive drug in marijuana. Despite minimum age of legal sale laws, adolescent e-cigarette use has risen dramatically since 2017. According to data from the National Youth Tobacco Survey (NYTS), from 2017 to 2018, past month (current) e-cigarette use among U.S. middle and high school students rose by 48% and 78% to 4.9% and 20.8%, respectively. There were further increases documented by the NYTS 2019 data, with 27.5% of high school students and 10% of middle school students reporting current use. This represents an estimated 5.3 million middle and high school students. Another nationally representative survey of U.S. 8th, 9th, and 10th graders, Monitoring the Future (MTF), found that between 2017 and 2019, the prevalence of 30 day use of e-cigarettes with nicotine more than doubled from 3.5 percent to 9 percent for 8th graders, from 8.2 percent to 20.2 percent for 10th graders, and from 11 percent to 25.4 percent for 12th graders. THC vaping increased between 2018 and 2019 by 1.3 percent, 5.6 percent and 6.5 percent for 8th, 10th, and 12th graders, respectively. In addition, the outbreak of e-cigarette or vaping product use associated lung injury (EVALI) that occurred in 2019 was predominantly linked to products containing THC and/or acquired through illicit and/or informal sources; 15% of the cases were in adolescents under 18.
There are many risks associated with ENDS use among adolescents. E-cigarette use is associated with increased risk for combustible cigarette use among adolescents. Nicotine can negatively affect adolescent brain development, increasing risk for nicotine addiction, attention and learning deficits and priming the brain for addiction to other substances. While research on risk and protective factors for ENDS use is still developing, potential targets for prevention intervention have been emerging from the literature. The 2016 Surgeon General’s Report on E-cigarettes among Youth and Young Adults found that the three main reasons for youth ENDS use were curiosity, appealing flavors and friends use. Similarly, results from the 2019 MTF survey of 12th graders reasons for vaping showed that common reasons included experimentation- to see what it’s like, taste, enjoyment with friends, and for relaxation or to relieve tension. Some ENDS devices have features that appeal to adolescents and can increase curiosity about the products, such as ease of concealment and use and availability of devices containing different flavorings, alone or in combination with nicotine. Also, several studies have found that adolescents may view ENDS as less harmful than combustible cigarettes or view them as an alternative to cigarettes. Adolescents who have used e-cigarettes have reported being curious about the devices, being influenced to use them by family members or peers, and being influenced by ENDS-related media, including social media. Some adolescents may be more susceptible to using e-cigarettes than others for example, adolescents with prior use of other substances have been found to be more likely to use e-cigarettes. In addition, adolescents who overestimate the use of ENDS products by peers, and lack skills to resist or refuse their use may be at increased risk of ENDS use.
The policy responses to risks associated with youth ENDS use have evolved over time. Since a warning label requirement for ENDS products went into effect on August 8, 2018, ENDS products containing nicotine have been required to be labeled with a warning stating that the product contains nicotine and that nicotine is an addictive chemical. Federally, since December 20, 2019, the legal age of sale for tobacco products, including ENDS, was raised to age 21 from age 18. The growing public health concerns related to vaping and youth exposure have led to changes in the availability of flavors through state and local legislation prohibiting the sale of certain flavored ENDS, as well as voluntary removals from the market of certain ENDS products by some companies. As of February 6, 2020, the FDA is prioritizing enforcement of premarket review requirements for certain flavored, cartridge-based ENDS products (except menthol and tobacco) and other ENDS products where adequate measures have not been taken to prevent access by minors, and ENDS products with marketing that is likely to promote use by minors.
Within this context of increasing rates of adolescents using ENDS containing nicotine and THC and the documented negative health effects, evidence-based approaches to prevent ENDS use among youth and research on the impact of tobacco control and ENDS-specific policies on youth ENDS use are needed.
Research Objectives
This FOA is clinical trial optional and seeks studies on:
1) the efficacy or effectiveness of prevention interventions that are theoretically and empirically supported and that target specific risk and protective factors at the individual, family, peer, community, or multiple levels; and/or
2) the impact of tobacco control and ENDS-specific policies on adolescent ENDS use.
Examples of responsive applications include studies of prevention interventions targeting individual, family and peer-networks; interventions to prevent ENDS use in medical and dental settings; approaches to counter social and media influences; research to inform best practices for prevention of ENDS use in education and youth-focused community-based settings; and the impact of policies restricting availability of and access to ENDS for adolescents on ENDS-use outcomes. Studies to adapt or optimize evidence-based substance use prevention approaches to prevent ENDS use are allowed but must be well justified. Applications should specify the ENDS use devices and/or tobacco control and ENDS-specific policies focused on in the research. In addition, prevention intervention studies must include collaborator or stakeholder representation from the system or setting (as co-investigator) that may, ultimately, adopt and implement the intervention. Also, intervention research studies are expected to include assessment of fidelity of implementation and should consider including, as relevant, research questions related to assessing intervention readiness or barriers and facilitators of intervention delivery within the setting/system, in order to enhance the relevance and scalability of the interventions.
Specific Areas of Research Interest for Participating ICs
The participating NIH ICs below identify priority research areas and examples of specific topics within the scope of their institute’s scientific mission and consistent with their interests toward prevention of adolescent ENDS use.
National Institute on Drug Abuse
The mission of the National Institute on Drug Abuse (NIDA) is to advance science on the causes and consequences of drug use and addiction and to apply that knowledge to improve individual and public health. For this announcement, NIDA seeks to support research on interventions to prevent initiation and escalation of ENDS use among adolescents, and research on the impact of tobacco control and ENDS-specific policies on adolescent ENDS use outcomes. Interventions to prevent use of ENDS containing nicotine, THC, flavorings or other substances, independently, or their co-use, are encouraged. Prevention interventions may target adolescent populations of varying levels of risk. For prevention intervention studies, collaborator/stakeholder representation on the research team (i.e., as co-investigator) is required to ensure feasibility for implementation, scalability, dissemination and sustainability.
Specific research topics of interest to NIDA include but are not limited to:
National Cancer Institute
The National Cancer Institute encourages the submission of applications to address current gaps in the evidence base regarding intervention research to prevent the initiation and escalation of youth ENDS use. NCI is particularly interested in studies that develop and test prevention interventions that address determinants of risk and protective factors for youth ENDS use (with or without other tobacco products) to prevent initiation and escalation of ENDS use among youth. Studies are also encouraged that investigate how to prevent concomitant ENDS and other tobacco product use (referred to as dual/poly tobacco use), especially escalation to use of other smoked tobacco products. Studies are also needed to understand whether social media may play a role in ENDS prevention and to understand and/or enhance the impact of policy approaches to address ENDS use among youth.
Specific research topics of interest to NCI include, but are not limited to:
Office of Disease Prevention (ODP)
The Office of Disease Prevention is interested in co-funding research that makes use of the strongest design, measurement, and analytic methods relevant to the overall objectives of this funding opportunity announcement. Applications must also be relevant to the objectives of at least one of the participating NIH Institutes and Centers (IC) listed above. ODP does not award grants. Please contact one of the IC program contacts listed for questions related to funding.
ODP is particularly interested in studies that will:
Special Considerations
Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community. Please see (http://www.drugabuse.gov/about-nida/advisory-boards-groups/national-advisory-council-drug-abuse-nacda/council-statements/points-to-consider-regarding-) for details.
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.drugabuse.gov/funding/clinical-research/nacda-guidelines-administration-drugs-to-human-subjects.
Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit: In order to encourage data integration and replication, the participating Institutes and Centers strongly encourage investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection and the Tobacco Regulatory Research Collection of the PhenX Toolkit (www.phenxtoolkit.org). Please see NOT-DA-12-008 (https://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html) and NOT-OD-17-034 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-034.html) for further details.
Methodological and Statistical Resources: Applicants are encouraged to employ the strongest prevention study designs and analytic methods. For guidance on state of the art study designs, methods and analytic techniques please visit these resources developed by NIH on Training in Prevention Methods Research, Resources for Researchers and GRTs.
Projects must include a timeline as part of the Research Strategy with distinct Milestones that briefly proposes operationally defined indicators of progress at critical junctures.
Applications that do not propose (1) research to test the efficacy or effectiveness of interventions to prevent initiation and/or escalation of ENDS use among adolescents; and/or (2) research on the impact of tobacco control and ENDS-specific policies on adolescent ENDS use outcomes will be considered nonresponsive and will not be reviewed. Applications that do not include a study timeline with milestones will be considerednon-responsive and will be withdrawn without review.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
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NIDA intends to commit $1,000,000 to fund 1-3 awards
NCI intends to commit$1,000,000 to fund 1-3 awards
The scope of the proposed project should determine the project period. The maximum project period is 5 years
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
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
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
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.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
Letter of Intent
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to: NIDALetterofIntent@mail.nih.gov.
Applicants are encouraged to send the letter of intent by email to the email address above but as an alternative the letter may also be sent to:
Office of Extramural Policy and Review
NATIONAL INSTITUTES OF HEALTH
NIDA/DER/OEPR
3WFN 9th floor MSC 6021
301 NORTH STONESTREET AVE
BETHESDA MD 20892
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy
Applications should clearly detail:
A description of the theoretical basis for the prevention intervention, and developmental appropriateness for the target population.
A description of the tobacco control and ENDS-specific policy/policies and a framework (or model) guiding the study of the impact on ENDS use outcomes.
A description of the specific gaps in the availability of interventions to prevent ENDS use among adolescents that the project will address.
A clear description of the risk population and justification for selection of the population for intervention or ENDS policy-focused research
Inclusion and collaboration with stakeholders and likely program adopters in the research process.
A clear description of the primary and secondary outcomes that will be evaluated and the proposed measures.
The study design for testing the prevention intervention or examining the impact of policies on ENDS-use outcomes.
Timeline and Milestones: A timeline must be included as part of the Research Strategy and should include a distinct final section, entitled Milestones , that briefly proposes operationally defined indicators of progress at critical junctures. The milestones should be tailored to the unique scope of the project and written concretely enough to evaluate exactly what will have been achieved during the project. Applications that lack timeline and/or milestones information will be considered non-responsive and will be withdrawn without review.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
When involving human subjects research, clinical research, and/or NIH-definedclinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date 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.
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.
Applications must be submitted electronically following the instructions described in the SF424 (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 How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
In addition, for applications involving clinical trials: A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Reviewers will provide an overall impact 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).
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? Is the prior research that serves as the key support for the proposed project rigorous? 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?
How well does the evidence presented support the need for research on the proposed prevention intervention strategy or ENDS-specific policies?
For research on policy, is the research design robust enough to provide convincing evidence of impact on behavior or behavior change processes?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Does the study team have the expertise for developing and testing the efficacy or effectiveness of prevention interventions targeting ENDS use among adolescents or studying the impact of ENDS-specific policies on behavior change? Does the team include expertise in prevention science or communications, and adolescent use of tobacco products? Are stakeholders and/or likely program adopter representation included as part of study team?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center.
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?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
Is empirical support for the identified risk and/or protective factors for ENDS use among the target population appropriately addressed?
Given the focus of the research, are the selection and measurement of the primary outcome(s) for ENDS use appropriate?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
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?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
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 score, but will not give separate scores for these items.
Timeline and Milestones: Are the milestones tailored to the unique scope of the project and written concretely enough to assess whether they can be achieved during the course of the project?
Study Timeline
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
For research that involves human subjects but does not involve one of thecategories 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 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. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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.
Not Applicable.
Not Applicable.
Not Applicable.
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 score.
Not Applicable.
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).
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) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIDA, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
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 submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by theappropriate national Advisory Council or Board. The following will be considered in making funding decisions:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety
Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
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.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Not Applicable
A final RPPR, 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 agreementsare 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.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings.Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threatensubmission by the due date, and post-submission issues)
Finding Help Online:http://grants.nih.gov/support/(preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email:GrantsInfo@nih.gov(preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support(Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email:support@grants.gov
Belinda E. Sims, PhD
National Institute on Drug Abuse(NIDA)
Telephone: 301-402-1533
Email: bsims@nida.nih.gov
Rachel Grana Mayne, PhD, MPH
National Cancer Institute (NCI)
Telephone: 240-276-5899
Email: Rachel.Mayne@nih.gov
Kay Wanke, PhD, MPH
Office of Disease Prevention (ODP)
Telephone: 301-451-1856
Email: Kay.Wanke@nih.gov
Elizabeth Ginexi, PhD
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-594-4574
Email: LGinexi@mail.nih.gov
Dharmendar Rathore, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-6965
Email: dharmendar.rathore@nih.gov
Garlin Hallas
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-4507
Email: garlin.hallas@nih.gov
Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@nci.nih.gov
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.
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 Part 75.
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