Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Drug Abuse (NIDA)

Funding Opportunity Title

Using Social Media to Understand and Address Substance Use and Addiction (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • January 15, 2014 - See Notice NOT-CA-14-024. Notice of Clarification on Programmatic Priorities.

Funding Opportunity Announcement (FOA) Number

RFA-CA-14-008

Companion Funding Opportunity

RFA-CA-14-009, R21 Exploratory/Developmental Grant

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.399,  93.273, 93.279

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) is part of a trans-NIH initiative known as Collaborative Research on Addiction (CRAN).  The goal of this FOA is to inspire and support research projects investigating the role of social media in risk behaviors associated with the use and abuse of alcohol, tobacco, and other drugs (hereafter referred to as "ATOD") and projects using social media to ameliorate such behaviors. Each research project proposed in response to this FOA must be focused on one of the two distinct areas:  1) observational research using social media interactions as surveillance tools to aid in the understanding of the epidemiology, risk factors, attitudes, and behaviors associated with ATOD use and addiction, or 2) intervention research measuring the reach, engagement, and behavioral and health impact of social media-based interventions for the screening, prevention, and treatment, of ATOD use and addiction.  Original research preliminary data are not required but all projects are expected to be supported by a strong rationale that is based on integrating to the extent possible the available relevant information from various sources.

Key Dates
Posted Date

January 3, 2014

Open Date (Earliest Submission Date)

February 25, 2014

Letter of Intent Due Date(s)

February 25, 2014

Application Due Date(s)

March 25, 2014, 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)

Not Applicable

Scientific Merit Review

June-July 2014

Advisory Council Review

August 2014

Earliest Start Date

September 2014

Expiration Date

March 26, 2014

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.

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

This Funding Opportunity Announcement (FOA) is part of a trans-NIH initiative Collaborative Research on Addiction at NIH (CRAN, http://addictionresearch.nih.gov/).  The goal of this FOA is to inspire and support short-term (up to three years) research projects investigating the role of social media in risk behaviors associated with the use and abuse of alcohol, tobacco, and other drugs (hereafter referred to as "ATOD") and projects using social media to ameliorate such behaviors. Each research project proposed in response to this FOA must be focused on one of the two distinct areas:  1) observational research using social media interactions as surveillance tools to aid in the understanding of the epidemiology, risk factors, attitudes, and behaviors associated with ATOD use and addiction, or 2) intervention research measuring the reach, engagement, and behavioral and health impact of social media-based interventions for the screening, prevention, and treatment, of ATOD use and addiction. 

Background

CRAN Initiative. Addiction-related research has traditionally been supported separately by the National Institute on Drug Abuse (NIDA), National Institute on Alcohol Abuse and Alcoholism (NIAAA), and, in specific areas, by National Cancer Institute (NCI). In 2012, the CRAN initiative was conceived as a trans-NIH partnership involving NIDA, NIAAA, and NCI to facilitate a functional integration of support for the research related to substance use, abuse, and addiction.  The main goal for CRAN is to create strong collaborative framework that enables NIDA, NIAAA, and NCI to pool resources and expertise in order to create synergies in addiction science, address new research opportunities, and meet public health needs.  CRAN currently supports FOAs that promote collaborative research on crosscutting topics relevant to ATOD use.

Growth of social media.  Social influences play a key role in shaping health behaviors.  With the recent surge of social media, online user-generated content and social networking sites (such as Facebook, Instagram, and Twitter) are becoming an integral part of the communication landscape.  Consequently, social media are increasingly affecting people’s everyday behaviors, including their attitudes to issues relevant to health.  It is estimated that approximately 85% of US adults have online access.  Of those, approximately 72-80% regularly access social media/social networking sites. Importantly, the usage of social media is not limited to any particular ethnic or racial strata. For example, recent studies indicate that Hispanics and African Americans are engaging with social media at equal or greater rates than non-Hispanic White Americans. Social media engagement entails increased peer-to-peer interactions, and these interactions include health topics.  Moreover, evidence-based communications from health professional sources overlap on spontaneous social media communications on health issues and the distinction between these two types of the communications may be blurred.  In order to inform current health communication practice, it is important to understand health-related social media interactions and their role in shaping attitudes and behaviors about health.   

Despite the proliferation of commercially available technologies and tools to analyze social media interactions, public health research and practice have yet to take advantage of the emerging changes in communication media.  Various technologies and tools to analyze social media interactions have proliferated and are commercially available. In this context, behavioral scientists have the unprecedented opportunity to observe and systemically analyze the interactions occurring in social media in studies that may contribute to the goal of improving public health.

Social networking sites and social media interactions present an important data source for understanding health behaviors and attitudes.  However, current scientific evidence for social media’s utility in health promotion is limited and inconclusive. In addition, analyzing large volumes of unstructured content generated by large number of social media users (whose characteristics may not be known) may be challenging using conventional approaches of communication research and population studies.

Social media interactions may affect ATOD use in positive or negative ways.  Specifically, social media interactions may promote health by enhancing motivation for behavior change, increasing accountability, and facilitating peer support and/or information exchange for positive health behaviors (e.g., smoking cessation, alcohol abstention, or disclosure of personal struggles with drug addiction).  On the other hand, there is also a potential for social media to have adverse health effects, such as the spread of inaccurate health information through networks and the emergence of online communities with norms supportive of high-risk ATOD use.

Despite the associated challenges, research on social media may fill important gaps in current paradigms for ATOD prevention and treatment.  Specifically, traditional assessment of ATOD use is often limited by reliance on participant's recall of behavior. User-generated social media interactions may offer realistic insights into substance use patterns, intentions, consequences, situational factors, and triggering social contexts. Social media also have the potential to improve prevention and treatment approaches to ATOD use and abuse through technology-mediated solutions to the problems of reach, fidelity, and effectiveness. Traditional substance use and addiction treatment approaches are limited by various barriers, such as the need to cope with social stigma, treatment cost, time constraints, and/or lack of physical access to treatment venues. Many of these barriers may be overcome by Web-based interventions that would take advantage of social networks, mobile technology, and peer-to-peer communications. 

Research Objectives

Each research project proposed in response to this FOA must address a scientific opportunity that aligns with either Research Area 1 or Research Area 2 outlined below.

Research Area 1. Observational research exploring the nature and extent of social media interactions that may inform understanding of the epidemiology, risk factors, attitudes, and behaviors associated with ATOD use, abuse, and addiction. Examples of potential research topics include, but are not limited to, projects that are designed to:

Research Area 2. Interventions that take advantage of social media to prevent, control, and treat ATOD use and abuse.  Key outcomes to be systematically measured include, but are not limited to, message exposure, program reach and engagement, behaviors and health outcomes. Examples of research topics include, but are not limited to projects that are designed to:

A Focus on Advancing Methodology

Exploring the potential of social media for ATOD research will require new methods of analysis that would allow for processing and meaningful interpretation of large volumes of unstructured data arising from evolving systems.  Methods with a potential to generate insights relevant to the fields of cancer control, addiction and alcohol abuse may already exists for other uses but may not be immediately applicable. Therefore, emphasis on method development (and/or adaptation) is essential for the goals of this FOA.  

In addition to addressing a relevant scientific area, all projects proposed in response to this FOA need to focus also on advancing research methodologies suitable for the specific context of the project proposed.

Examples of methodological aspects that are deemed particularly relevant include (but are not limited to):

A Need for Multidisciplinary Efforts

Given the methodological challenges of research on social media, multidisciplinary efforts will be essential for projects proposed in response to this FOA. For example, research projects focused on ATOD and social media may be advanced by taking advantage of knowledge and analytic tools from fields such as information technology, systems science, engineering, economics, computational linguistics, and social marketing. Therefore, applicants are strongly encouraged and expected to build a team that would include representatives of disciplines that are usually considered to be outside of health sciences.

Emphasis on Polysubstance Use or Abuse

For both scientific areas, projects may be focused on single substance or polysubstance use or abuse. The latter, however, are particularly strongly encouraged and may receive programmatic priority.

Notes on Responsiveness

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

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIDA, NIAAA, and NCI jointly commit $3.5 million in FY 2014 to fund 6-7 awards.

Award Budget

Application budgets need to reflect the actual needs of the proposed project but are generally expected to range from $250,000 to $400,000 in direct costs per year. Budget requests exceeding $400,000 in direct costs per year are not allowed.

Award Project Period

The proposed project period must not exceed three 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

Foreign Institutions

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.

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.

Instructions for Application Submission

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.

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.

In addition, PD(s)/PI(s) and/or designated senior investigator(s) will be required to attend the CRAN grantee meeting to be held on the NIH campus in FY 2015. Applicants must budget appropriate travel funds (up to two representatives per award).

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:

Specific Aims: Indicate whether the project addresses Research Area 1 or 2 (as defined in Section I of this FOA). Outline the hypothesis or central problem to be tested and specific aims to accomplish. One of these Specific Aims needs to address the required research on innovative methodologies. The expected overall impact of the project should also be succinctly summarized in this section.

Research Strategy: This section must contain (within the standard page limits) the following elements.

Background and Significance

Outline the context of the proposed projects and indicate how it will advance the chosen area of research compared to the current state of the field. Applicants are strongly encouraged to propose projects focused on polysubstance use or abuse. Consistent with the overall goals of the CRAN initiative, such projects may receive programmatic priority over projects focused on single substance.

Rationale and/or Preliminary Data

Original research preliminary data are not required but are allowed and may be included here. However, all projects are expected to be supported by a strong rationale that is based on integrating to the extent possible the available relevant information from various sources.

Multidisciplinary Strategy

Outline the main, strategic capabilities of the multidisciplinary team and how these capabilities will benefit (or, perhaps, even make possible) the proposed project, including its methodological approach and the overall research goals in the context of ATOD and social media. For this aspect, applicants are strongly encouraged to establish collaborations with representatives from disciplines outside of health research, who may already have relevant technologies, expertise and/or analytic tool. Describe clearly how these technologies or tools will be adopted to health research and specific needs of the proposed project in context of ATOD and social media.

Approach

Address how the main hypothesis (or central issue) will be tested, provide benchmarks for accomplishing the stated goals and Specific Aims, outline how the results will be integrated and interpreted. In addition, indicate potential pitfalls and alternative strategies.

Sufficient emphasis should be given to ensuring a flexible research design that would allow investigators to address new emerging opportunities reflecting changes in the field, rapidly evolving social media technologies, changing styles and patterns of social media usage and user interactions, etc.

Some of the specific aspects to address include:

a) For Area 1 Projects: Development and/or adoption of systematic approaches to mining and analyzing social media interactions.

b) For Area 2 Projects: Development or adoption of validated and common measures and matrices for social media-based interventions and ways to evaluate the impact of such interventions on behaviors and outcomes.

c) For Area 1 and 2 Projects: Creation of a collaborative framework between behavioral/population sciences and disciplines traditionally outside of the health sciences (e.g. computer science, engineering, linguistics, economics, marketing).

Confidentiality and Ethical Expectations

The social media data to be mined and analyzed will contain various types of personally identifiable (directly or indirectly) health-related and/or substance use/abuse information. All applicants must address the strategies to protect the individual privacy of such information and privacy of the persons participating in social media interactions being analyzed.

All applicants must strictly adhere to human subject protection rules and regulations of the Office for Human Research Protections (OHRP) at the US Department of Health and Human Services.  This includes, when appropriate, IRB approval for subject recruitment, informed consent, and measures taken for privacy and confidentiality protection (including guarding against possibility of subject re-identification), data storage, and data sharing.

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. 

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 and responsiveness by NCI, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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.

The emphasis of this FOA is on the unique research opportunities offered by social media in the context of ATOD. Even though some of these opportunities can be explored using established research methods and analytic tools, innovative approaches are essential to take a full advantage. Therefore, the methodological research (such as development and/or adaptation of new data mining and/or analytic tools) is required and needs to be assessed as inseparable part of the entire ATOD-social media research project.

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?

In addition, specific to this FOA: How strong is the expertise of the PD(s)/PI(s) and other investigators in new methodologies suitable to studying social media interactions data? Is the composition and expertise of the multi-disciplinary team well fitted for maximizing the benefits of the project proposed?

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?

In addition, specific to this FOA:  How innovative is the proposed developmental research in terms of creative use or adaptation for research of various tools and approaches originally developed for other uses?    

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 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 children, justified in terms of the scientific goals and research strategy proposed?

In addition, specific to this FOA:    

For Area 1 Projects: How sufficient for the proposed project are the development and/or adoption of systematic approaches to mining and analyzing social media interactions?

For Area 2 Projects: Are the plans for development and/or adoption of validated common measures and matrices for social media-based interventions appropriate and well thought out? Will the approaches proposed result in realistic assessment of the impact of such interventions on behaviors and outcomes?

For both Area 1 and 2 Projects: How strong will be the proposed collaborative framework? Are the multidisciplinary strategies based on contributions from all the relevant fields?

Confidentiality and Ethical Expectations (For both Area 1 and 2 Projects): Are the plans proposed sufficient in terms of ethical expectations for massive mining, processing, and analyzing data from social media interactions? For example, how strong and efficient will be the protection of the confidentiality of mined and analyzed data and the protection of other aspects of privacy of the persons participating in social media interactions being analyzed?

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?

In addition, specific to this FOA:    Is the overall environment of the proposed project sufficiently conductive to multidisciplinary interactions?  

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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

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 children 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.

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

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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

Not Applicable

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 National Cancer Institute, 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:

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/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 CenterTelephone: 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)

For inquiries related to tobacco and cancer, please contact:

Wen-ying Sylvia Chou, PhD, MPH
National Cancer Institute (NCI)
Telephone: 240-276-6954
Email: chouws@mail.nih.gov

For inquiries related to drug use and addiction, please contact:

Bethany Deeds, PhD
National Institute of Drug Abuse (NIDA)
Telephone: 301-402-1935
Email: deedsb@nida.nih.gov

For applications related to alcohol use and addiction, please contact:

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

Peer Review Contact(s)

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: ncirefof@dea.nci.nih.gov

Financial/Grants Management Contact(s)

Jacquelyn Boudjeda
National Cancer Institute (NCI)
Telephone: 240-276-6312
Email: Boudjedaj@mail.nih.gov

Deborah Wertz
National Institute on Drug Abuse (NIDA)
Telephone: 301-649-1715
Email: dwertz@nida.nih.gov

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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices



NIH Office of Extramural Research Logo
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®



Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.