Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Funding Opportunity Title

Implications of New Digital Media Use for Underage Drinking, Drinking-Related Behaviors, and Prevention Research (R21)

Activity Code

R21 Exploratory/Developmental Research Grant Award

Announcement Type

New 

Related Notices

  • August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.

Funding Opportunity Announcement (FOA) Number

PA-13-263

Companion Funding Opportunity

PA-13-262, R01 Research Project Grant

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.273

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages R21 research grant applications from institutions/organizations that propose to investigate whether, and how, heavy involvement in new digital media usage, particularly social media and social networking sites, may influence adolescent alcohol use and drinking patterns, as well as drinking-related problems. This FOA also encourages applications proposing to explore the ways in which new digital media may be utilized as platforms for preventive interventions aimed at underage drinking and related problems. 

Key Dates
Posted Date

July 8, 2013

Open Date (Earliest Submission Date)

September 16, 2013

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

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.

AIDS Application Due Date(s)

Standard AIDS dates apply, by 5:00 PM local time of applicant organization.

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.

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date

Standard dates apply

Expiration Date

September 8, 2016  

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (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.


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Table of Contents

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

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Purpose

By using the R21 activity code, the NIAAA seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance biomedical research. Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications.

The use of new digital media—including, e.g., the Internet as well as the various forms of social media such as the status updating site Twitter, chat rooms, blogs, the video sharing site YouTube, the photo sharing site Flickr, instant messaging, and social networking sites (SNSs)—has increased dramatically among adolescents over the past decade, with virtually no end in sight. Ninety-three percent (93%) of U.S. teenagers ages 12-17 report that they go online—and  63% of teen internet users go online every day—to download movies, music, and software as well as for e-mail, shopping, job searching, banking, game playing, gambling, checking sports scores, etc. On SNSs, users can develop a personal profile that is linked with others’ profiles to form a personal online network. Social networking sites allow users to share ideas, activities, events, and interests within their individual networks. College students indicate that SNSs fulfill several needs, including socializing, entertainment, self-status seeking, information, and to stay in touch with family members and friends. Among the more popular SNSs are MySpace, LinkedIn, Friendster, and Facebook, the latter having more than 600 million active users as of January, 2011. A mid-2009 study found that 73% of online American teenagers reported using SNSs, a significant increase from the previous year.

This FOA is intended to stimulate two lines of research into adolescent alcohol activities. One focus is motivated by recent reports (see below) suggesting that alcohol use increasingly is mentioned and visually displayed on many adolescents’ SNS profiles. While it should be noted that most surveys that track youthful drinking patterns generally have not shown recent upturns in drinking frequency in this age group, the fact that these SNS profiles are created and displayed by peers who the adolescent perceives to be similar to him/herself raise concerns about whether, and how, such pervasive references may be influencing adolescent alcohol use. Moreover, as the enormously popular SNS among adolescents, Facebook, was virtually unknown—outside of a handful of elite East Coast colleges—less than a decade ago, any impact of Facebook participation on youthful drinking in the U.S. may only become apparent in the years ahead. Finally, as support for formal recognition of the concept of Internet addiction within the spectrum of addictive disorders lately has been advanced—and heavy SNS use might be regarded as a component of such behavior—it should be noted that several recent studies have reported an association between Internet addiction and problematic alcohol use in samples of Taiwanese high school and college students. In the U.S., as well, some recent research (Epstein, 2011) has reported an association between hours per week spent on the computer and adolescent drinking, with self-reported lifetime drinkers in this study using the computer for social networking more frequently than never drinkers. Insofar as consistent evidence has found that higher alcohol consumption in late adolescence often continues into adulthood and may be associated with alcohol-related problems, it appears prudent to remain vigilant as to the possible effects of SNS and social media usage for adolescent drinking patterns so that appropriate prevention steps may be considered.

Social media-based interventions research with adolescent populations comprises the other line of research that this FOA is intended to stimulate. Regardless of the roles of social media and SNSs as possible contributors to adolescent drinking and drinking-related problems, it should be clear that—as detailed below—they offer an exciting platform for preventive interventions aimed at underage drinking and related problems.

Research Focus

1. Understanding social media-related underage drinking, drinking-related norms and expectancies, and drinking-related problems

Possible avenues through which underage drinking patterns may be influenced by SNS and social media usage were explored at a NIAAA-sponsored workshop that convened in September, 2010. Some of these mechanisms are described below:

Expansion of adolescent social networks

SNSs enable adolescents to develop and maintain contact with more people in far-flung locations than would otherwise be possible. In a recent study of 92 U.S. undergraduates (Pempek et al., 2009), young women reported an average of 401 Facebook friends and young men reported an average of 269 friends, compared to an average of only 150 offline friends. Insofar as some evidence suggests that social network phenomena may influence alcohol consumption, it is possible that the creation of a means for such extended exposure to individuals (and their behaviors) who one may “know” only casually offline—if at all—may play a role in altering SNS users’ drinking initiations and trajectories. In this regard, it should be noted that Ridout et al (2011) recently reported, in a sample of 163 college students, greater alcohol consumption by respondents who reported more Facebook friends, while Egan and Moreno (2011) found that an increase in number of Facebook friends was significantly associated with an increase in displayed alcohol references.

Alcohol advertising and marketing on SNSs and social media

Substantial alcohol marketing can be found on social media sites where it can be easily accessed by adolescents. Many alcohol companies have their own channels on YouTube and/or a Twitter page, and some post photos on Flickr containing images of partying behavior. Several Facebook features—including Groups, Events, Applications, and Pages—also can play a role in the dissemination of alcohol-related images on this site. A Group can be created by any user and may be formed around virtually any topic, and Group membership is displayed on the users’ profile. Group pages contain a wall for members’ comments, videos or photos. Alcohol-related groups on Facebook (e.g., “I’m not an alcoholic, I just like to drink") are created by users who wish to display their liking for drinking-related activity or a particular brand of alcohol. Events allow users, as well as companies, to advertise the time, date and location of a particular event—e.g., concerts, sporting events, nightclubs, or keg parties—that often are sponsored by brewers or distillers, advertise alcohol use, and can include descriptions of excessive drinking behavior. Applications are designed to allow SNS users to engage in interactive behavior, such as game playing and quiz taking (e.g., “What sort of drunk are you?”, “What is your partying personality?”). Applications may advertise alcohol with specific brand names, photos, graphics, and links to brand websites. Facebook Pages represent a public personality, organization, brand or product. Users can become “fans” of Pages, and Pages may contain links to, for instance, the official website of a particular brand of alcohol, applications, photos of the product, a wall for comments extolling the virtues of the brand, and marketing messages from the company.

Clearly, SNSs offer an attractive venue for targeted marketing, including marketing of alcohol. Moreover, in the world of the Internet, there are a variety of ways in which showing one’s allegiance to a particular brand may become known to others in one’s social network. For instance, adolescents who indicate that they ‘like’ a YouTube copy of a TV commercial advertising a particular brand of alcohol can send it to their personal profile page, and friends who subsequently visit this individuals' page may view the video and, if they so choose, copy it to their own page, thereby extending the viral transmission of the ad. Through such viral sharing of alcohol advertisements, the young social media user essentially endorses the product to an audience comprising his/her friends. This relatively low-cost form of advertising relies upon consumers to pass on favorable or compelling marketing and brand-related messages to others via e-mails, text messaging, online forums, suggested links to websites, and word of mouth, in addition to SNSs.

In summary, the alcohol industry’s presence on online social media is pervasive. Insofar as substantial research indicates that adolescents’ exposure to alcohol marketing—as well as to alcohol cues in television advertising and music videos—are associated with increased likelihood of initiating alcohol use, research that addresses the question of whether adolescents’ exposure to alcohol advertising on the Internet is similarly influential is urgently needed.

Creation of greater awareness of, and opportunities for, drinking

Being logged on to a SNS—or to one of the new GPS location-based applications available on many cell phones—may make it easier for adolescents to find a drinking party, to engage in pre-party activity, and/or to party longer (e.g., by finding out where the next party is and/or who else may be out drinking/partying at that particular time). SNSs also may be used in creating and advertising drinking events.

Display of images and text depicting alcohol use

Adolescents’ exposure to alcohol references, including descriptions of alcohol use experiences and photographs that depict alcohol use, is the apparent consequence of SNS involvement that has drawn the most attention from health researchers. Thus, in a recent sample of college undergraduates, one-third reported having posted a picture depicting substance use on a SNS (Morgan et al., 2010), while a recent content analysis of 225 college males’ Facebook profiles (Egan and Moreno, 2011) found that alcohol references were present in 85% of the profiles, with an average of 8.5 alcohol references per profile and increasing with undergraduate year. While it may questioned whether adolescents view such online drinking images as depicting “real” behavior or merely as adolescent poses, recent studies generally have found that adolescents typically interpret such references as representing actual use and acknowledge their potential influence on peer behavior.

Creation of adolescent drinking identities

Fruitful research might explore whether, taken together, the aforementioned potential outgrowths of SNS involvement may be playing a significant role in creating what McCreanor et al. (2008) have called “intoxigenic” social identities, created through “…discursive social practices that engage with and utilize pro-intoxication talk to create and maintain expectations, norms and behaviors around alcohol consumption”. Indeed, some researchers have noted that, in the SNS environment, the portrayal of oneself as a drinker, especially as one able to consume significant amounts of alcohol, is considered by many young people to be a socially desirable component of one’s identity. Importantly, however, researchers recently have found that presentation of such an alcohol-related self-identity—as operationalized by, for instance, number of photographs in college students’ photo essays chosen to describe their typical everyday environments, lifestyle, life tasks, or self-defining inner values—

predicts alcohol use quantity and frequency as well as alcohol-related problem behaviors. Moreno et al (2012) found that undergraduate students at two US state universities who displayed references to intoxication or problem drinking on their Facebook profiles were more likely to meet clinical screening criteria for problem drinking—and more likely to report experience of an alcohol-related injury in the past year—than those students who did not display such references.

SNSs and adolescent drinking: consideration of mediators

Ideally, future research aimed at investigating whether—and the degree to which—SNS use may impact underage drinking patterns will also examine potential mediating and moderating mechanisms through which such impact occurs. Any list of potential mediators likely will include adolescent alcohol expectancies as well as salience of prevailing peer drinking norms. Friends’ use of alcohol and perceived peer norms have been found to be major predictors of drinking and alcohol consequences among adolescents and college students, as well as nonstudent emerging adults. Thus, frequent and/or continuous exposure to images of drinking behavior on SNSs might act to reinforce or clarify adolescents’ sense of prevailing drinking norms, and their perception of the kind of behavior that their peers approve of. Moreover, a selective sharing of information may occur, whereby information that seems inconsistent with what other people in the network seemingly want to hear is not shared.

Alcohol expectancies are beliefs regarding the positive or negative effects or consequences of alcohol use. As a potential shaper of alcohol expectancies, SNSs may be particularly powerful due to their regular presentation of a profusion of images and narratives depicting what are treated as relatively “normal” levels of alcohol use, all in a relatively public forum and often coupled with information about upcoming drinking opportunities. Perusal of any sample of fairly typical SNS posts suggests that underage drinking generally is not viewed as deviant behavior on such sites, that drinking on school nights is seemingly quite acceptable, and that getting “wasted” (including blackouts) is hardly a cause for concern—indeed, reconstructing with others the full range of “lost” events following a bout of binge drinking seems mostly regarded as a fun activity.

Moreover, insofar as the posted images on SNSs undoubtedly are selected ones, they are more likely to convey positive images of drinking, thus making it more likely that perusal of SNS images will increase positive alcohol expectancies rather than negative ones. SNS postings and images might especially influence the alcohol expectancies of younger adolescents who, for instance, may be able to view an older sibling’s drinking behaviors on his/her Facebook page.

Suggested research topics

The growth in popularity of SNSs and the pervasive display of alcohol-related images on the most popular SNSs suggests a need for research into a variety of topics related to the understanding and epidemiology of SNS-related underage drinking, drinking-related norms and expectancies, and drinking-related problems. The following list is only meant to be suggestive:

Is the display of underage alcohol use on SNSs increasing over time, and are SNS communications concerning alcohol use increasing as a proportion of total communications?

Net of other influences, is exposure to depictions of alcohol use on SNSs associated with earlier onset of drinking or to increased likelihood of involvement in alcohol misuse or binge drinking?

What are the relatively most important aspects of SNSs and social media use in influencing alcohol-related risk behavior, and what are the characteristics of SNS users who are most likely to be vulnerable to pro-drinking messages as conveyed by each of these features?

Do SNS postings increase offline communications about alcohol, and are these associated with increased intentions to drink?

Are those adolescents whose online “profile” displays many images of alcohol use at elevated risk of being labeled by other network members as a heavy drinker or to have a drinking problem, and does this encourage their further substance use?

How might SNS communication promote 21st birthday celebrations that involve drinking, Spring Break drinking behaviors, and pre-partying drinking behavior?

To what extent can Facebook and Twitter be used to provide valid and reliable estimates and surveillance of alcohol use and alcohol-related problems?

Regardless of the role of social media and SNSs as contributors to adolescent drinking and drinking-related problems, it should be clear that they offer an exciting platform for preventive interventions aimed at underage drinking and related problems. These are discussed next.

2. Social media and SNSs in the prevention of underage drinking and related problems

The Internet increasingly is perused for health communication and utilized in health prevention efforts, and this extends to alcohol-related health communication and intervention. An array of interactive, Web-based treatment programs for people with alcohol problems have been devised, and a number of commercially available Web-based alcohol education and intervention programs that utilize a mix of educational, skills-based, and motivational strategies are available. That being said, the mounting of health interventions on SNSs is relatively new research territory, although one that is developing rapidly. It is clear that SNSs possess a number of features that would appear to make them particularly attractive in the conduct of preventive intervention research with adolescents. Chief among these is the fact that many—maybe even most—adolescents seem to truly enjoy spending time in these utilities, thus presumably eliminating or minimizing the common vexing issue of intervention recruitment. Moreover, rather than requiring participants to travel to the intervention site, the new mobile technologies enable the investigator to bring the intervention to the participant wherever the latter happens to be in physical space.

Suggested research topics

In general, SNS-based preventive interventions might usefully build upon any of the various primary and secondary prevention approaches long utilized in offline settings, such as peer-led, family-based, and community-wide prevention strategies. For instance:

Subjects recruited on a SNS might be directed to a webinar, or network friends might be utilized in an interactive intervention

SNSs might play a role in parent support networks that address underage alcohol use

SNSs might play a role in enhancing community communication, strategizing, and activation aimed at reducing alcohol availability in the community

Local coalitions and health departments might use Twitter to promote health messages

Smart phone applications might provide prevention or treatment advice

SNSs might play a role in promoting alcohol screening among college students

This list, not meant to be exhaustive, suggests the potential of social media-based interventions for prevention efforts aimed at underage drinking and related problems.  

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Resubmission
Revision

The OER Glossary and the SF424 (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.

Award Budget

Direct costs may not exceed $200,000 in any year or $275,000 over the 2 year project period.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 2 years.  

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

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

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

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 and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.

Eligible Individuals (Program Director/Principal Investigator)

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.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility


Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


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.

2. Content and Form of Application Submission

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.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required 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.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

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.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Foreign Institutions

Foreign (non-U.S.) 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 applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

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.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable 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 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 Applying Electronically.

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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post-Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information


1. Criteria

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.

Overall Impact

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).

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.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Investigator(s)    

Are the PD(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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?   

Additional Review Criteria

As applicable for the project proposed, reviewers will 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.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

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.

Renewals

Not Applicable

Revisions

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 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) convened by the NIAAA, 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:

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 NIAAA National Advisory Council. 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/PI 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.

Section VI. Award Administration Information


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 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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) 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. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Robert C. Freeman, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-8820
Email: rfreeman@mail.nih.gov

Peer Review Contact(s)

Ranga Srinivas, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451 2067
Email: srinivar@mail.nih.gov 

Financial/Grants Management Contact(s)

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

Section VIII. Other Information

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.


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